Consumer medicine information

Menveo

Meningococcal oligosaccharide conjugate A, C, Y and W-135 vaccine

BRAND INFORMATION

Brand name

Menveo

Active ingredient

Meningococcal oligosaccharide conjugate A, C, Y and W-135 vaccine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Menveo.

What is in this leaflet

This leaflet answers some common questions about MENVEO.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up-to-date information on the medicine.

Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you or your child having MENVEO against the benefits they expect it will have for you.

If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist.

Keep this leaflet. You may need to read it again.

What MENVEO is used for

MENVEO is a vaccine used for active immunisation of children (from 2 months of age), adolescents and adults to prevent invasive disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y. The use of this vaccine should be in accordance with the official recommendations.

Meningitis is an infection of the spinal fluid and the tissues that surround the brain. Of the microbes that cause meningitis, one of the most severe is Neisseria meningitidis (meningococcus). Meningococcal meningitis is an infectious disease that is spread from person to person. It is a very serious disease that is sometimes fatal, and may cause permanent physical and neurological damage among survivors.

Please note that MENVEO can only protect you/ your child from meningitis caused by four groups of Neisseria meningitidis (A, C, W-135 and Y).

It will not protect you/ your child from Meningitis caused by other groups of Neisseria meningitidis, or meningitis caused by different kinds of microbes.

How it works

MENVEO works by causing your body to produce its own protection (or antibodies), against meningococcal bacteria. Your body usually takes a couple of weeks after vaccination to develop protection against Neisseria meningitidis.

If a vaccinated person comes into contact with Neisseria meningitidis, the body is usually able to destroy it. However, as with all vaccines, 100% protection cannot be guaranteed.

As with all vaccines, occasionally, individuals may react unfavourably to the vaccine.

The chance of a severe reaction from MENVEO is very small, but the risks from not being vaccinated against meningococcal disease may be very serious.

MENVEO should not be given to a person who has:

  • Ever had an allergic reaction to MENVEO or any of the ingredients listed at the end of this leaflet.
  • Ever had an allergic reaction to diphtheria toxoid (a substance used in a number of other vaccines)
  • A very high fever.
    In this case vaccination with MENVEO may have to be delayed. Please discuss this with your doctor.
  • Ever had an allergic reaction or became unwell after receiving any other meningococcal vaccine.
  • A severe infection with a high temperature.
    A minor infection such as a cold should not be a problem, but talk to your doctor, nurse or pharmacist about this before being vaccinated.

In addition, MENVEO should not be administered if:

  • the expiry date printed on the pack has passed
  • the packaging is torn or shows signs of tampering.

If you are not sure whether you or your child should have MENVEO talk to your doctor, nurse or pharmacist.

This medicine should be administered only to the person for whom it was prescribed.

Before You Receive MENVEO:

Tell your doctor or pharmacist if you have/your child has allergies to:

  • any other medicines
  • latex

Tell your doctor if you have/your child has had any of the following reactions after other vaccinations:

  • life-threatening allergic reaction
  • difficulty breathing
  • swelling of the throat
  • fits (convulsions), including fits associated with fever
  • high fevers
  • severe reactions at the injection site.

Tell your doctor if you have/your child has an infection or high temperature. Your doctor may decide to delay vaccination until the illness has passed. A mild illness, such as a cold, is not usually a reason to delay vaccination.

Fainting, feeling faint or other stress-related reactions can occur as a response to any needle injection.

Tell your doctor or nurse if you have experienced this kind of reaction previously.

Tell your doctor if you or your child have or have had any medical conditions especially the following:

  • an immune deficiency condition
  • allergies or allergic reaction
  • a low blood platelet count

Tell your doctor if you are pregnant or intend to become pregnant soon. Your doctor will discuss the possible risks and benefits of receiving MENVEO vaccine during pregnancy.

Tell your doctor if you are breastfeeding. Your doctor will discuss the possible risks and benefits of receiving MENVEO vaccine during breastfeeding.

Tell your doctor if you receive treatment that blocks the part of the immune system known as complement activation, such as eculizumab. Even if you have been vaccinated with MENVEO you remain at increased risk of disease caused by the Neisseria meningitidis groups A, C, W-135 and Y bacteria.

Important information about some of the ingredients of MENVEO:

Tell your doctor or pharmacist if you /your child) are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Having other vaccines

Tell your doctor if you/your child have had any vaccines recently. MENVEO may be given at the same time as other vaccinations.

Other injected vaccines must be given into a different arm or leg (children 2-23 months) from the site of the MENVEO injection. These include:

  • Tetanus, Reduced Diphtheria and Acellular Pertussis Vaccine,
  • Human Papillomavirus Vaccine

Your doctor or pharmacist may have more information on medicines and vaccines that require special precautions or should be avoided during vaccination with MENVEO.

How MENVEO is given

MENVEO is given as an injection, usually into your/your child’s upper arm muscle or for children under 2 years of age into the thigh muscle.

MENVEO should not be injected directly into a blood vessel.

MENVEO is for single use in one patient only.

If you have any concerns about how this vaccine is to be given, talk to your doctor, nurse or pharmacist.

How much is given

The dose is 0.5 mL given by injection.

You should keep a record of you/your child's vaccinations

Side effects

Tell your doctor or pharmacist as soon as possible if you or your child do not feel well after having MENVEO.

After being vaccinated with MENVEO, your doctor or pharmacist may ask you/your child to remain for observation for a few minutes.

MENVEO may have unwanted side effects in a few people. All medicines, including vaccines, can have side effects. Sometimes they are serious. However, most of the time, they are not.

The most common side effects include the following:

  • redness, firmness, and/or pain at the injection site
  • fever, chills, malaise
  • rash
  • headaches
  • muscle ache, joint ache
  • nausea

These side effects are usually mild, self limited, and do not require any specific treatments. Other side effects that have been reported during marketed use include:

  • impaired hearing, ear pain, spinning sensation
  • injection site itching, inflammation, swelling, including extensive swelling of the injected limb, tiredness
  • enlarged lymph nodes near injection site
  • allergic reactions, severe allergic reaction that may include swelling of the lips, mouth, throat (which may cause difficulty in swallowing), difficulty breathing with wheezing or coughing, rash and swelling of the hands, feet and ankles, loss of consciousness, very low blood pressure.
  • fall, head injury
  • increased liver enzymes on blood test results, body temperature increased
  • bone pain
  • dizziness, balance disorder, faint, seizure, facial nerve paralysis, upper eyelid fall
  • sore throat
  • raised bumps of fluid on the skin

As with all vaccines given by injection there is a very small risk of serious allergic reaction.

If someone who has just been vaccinated appears to be having a severe allergic reaction to the vaccine, medical help should be obtained immediately. These include difficulty breathing or hives.

Other side effects not listed above may occur in some patients.

Tell your doctor or pharmacist if you notice anything that is making you or your child feel unwell.

Some of the side effects may temporarily affect your ability to drive or use machinery.

Ask your doctor or pharmacist to answer any questions you may have.

Storing MENVEO

  • Keep MENVEO in the original pack until it is time for it to be given.
  • Keep it in the refrigerator, between 2°C and 8°C.
  • Do not freeze MENVEO.
  • Following reconstitution, to reduce microbiological hazard the product should be used as soon as practicable after reconstitution. If storage is necessary, hold at 2-8°C for not more than 24 hours.
  • Do not use MENVEO after the expiry date which is stated on the carton.

The vials left over after administration of MENVEO must be disposed of as medical waste.

Product description

What it looks like

MENVEO is a powder with liquid for reconstitution.

Each dose of MENVEO is supplied as a:

  • Vial containing the MenA lyophilised conjugate component as a white to off-white powder
  • Vial containing the MenCWY liquid conjugate component as a clear solution

The contents of the two components (MenA vial and MenCWY vial) are to be mixed prior to vaccination.

The other ingredients in the vial of MenA lyophilised conjugate component are: potassium dihydrogen phosphate and sucrose.

The other ingredients in the vial of MenCWY liquid conjugate component are: sodium chloride, sodium phosphate - monobasic monohydrate; dibasic sodium phosphate dihydrate and water for injections

The MENVEO vial/vial presentation is supplied either as a single dose pack (2 vials) or 5 doses multi-pack (10 vials).

Not all pack sizes may be marketed.

MENVEO does not contain lactose, gluten, thiomersal (organic mercurials), tartrazine or any other azo dyes.

Sponsor (license holder):

GlaxoSmithKline Australia Pty Ltd
Level 4,
436 Johnston Street,
Abbotsford, Victoria, 3067

AUST R 192696 - (vial / vial pack)

Date of preparation:
14 January 2020

Trademarks are owned by or licensed to the GSK group of companies.

© 2019 GSK group of companies or its licensor.

Version: 6.0

Published by MIMS May 2020

BRAND INFORMATION

Brand name

Menveo

Active ingredient

Meningococcal oligosaccharide conjugate A, C, Y and W-135 vaccine

Schedule

S4

 

1 Name of Medicine

Meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccine.

2 Qualitative and Quantitative Composition

Menveo powder and solution for solution for injection (2 vials).

Menveo consists of one vial containing the lyophilised Meningococcal group A (MenA) conjugate component plus excipients, and one vial containing the liquid Meningococcal groups C, W-135 and Y (MenCWY) conjugate component plus excipients. The reconstituted sterile liquid vaccine is administered by intramuscular injection and contains meningococcal serogroup A, C, W-135 and Y oligosaccharides conjugated individually to Corynebacterium diphtheriae CRM197 protein. The polysaccharides are produced from fermentation and purification of Neisseria meningitidis (serogroups A, C, W-135 or Y). MenA, MenW-135 and MenY polysaccharides are purified by several extraction and precipitation steps. MenC polysaccharide is purified by a combination of chromatography and precipitation steps.

Menveo solution for injection (1 vial).

Menveo consists of one vial containing Meningococcal Groups A, C, W-135 and Y (MenACWY) Conjugate Component plus excipients. The sterile liquid vaccine is administered by intramuscular injection and contains meningococcal serogroup A, C, W-135 and Y oligosaccharides conjugated individually to Corynebacterium diphtheriae CRM197 protein. The polysaccharides are produced from fermentation and purification of Neisseria meningitidis (serogroups A, C, W-135 or Y). MenA, MenW-135 and MenY polysaccharides are purified by several extraction and precipitation steps. MenC polysaccharide is purified by a combination of chromatography and precipitation steps.

All presentations.

The protein carrier (CRM197) is produced by bacterial fermentation and is purified by a series of chromatography and ultrafiltration steps.
The oligosaccharides are prepared by hydrolysis, sizing, activation and conjugation. Each oligosaccharide is covalently linked to the CRM197. The resulting glycoconjugates are purified to yield the four drug substances, which compose the final vaccine. No preservative or adjuvant is added during manufacturing. The vaccine contains no thiomersal.

List of excipients with known effect.

For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Menveo powder and solution for solution for injection (2 vials).

Menveo is presented as meningococcal group A (MenA) lyophilised conjugate component and a meningococcal group C, W-135 and Y (MenCWY) liquid conjugate component.
The MenA conjugated component is a white to off-white powder for injection and MenCWY conjugated component is a colourless clear solution for injection.

Menveo solution for injection (1 vial).

Menveo solution for injection is a meningococcal group A, C, W-135 and Y (MenACWY) conjugated vaccine presented as a colourless clear solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Menveo powder and solution for solution for injection (2 vials).

Menveo is indicated for active immunisation of infants and children (from 2 months of age), adolescents and adults to prevent invasive disease caused by Neisseria meningitidis serogroups A, C, W135 and Y. The use of this vaccine should be in accordance with official recommendations.

Menveo solution for injection (1 vial).

Menveo is indicated for active immunisation of children (from 2 years of age), adolescents and adults to prevent invasive disease caused by Neisseria meningitidis serogroups A, C, W135 and Y. The use of this vaccine should be in accordance with official recommendations.

4.2 Dose and Method of Administration

Menveo powder and solution for solution for injection (2 vials).

See Table 1.

Menveo solution for injection (1 vial).

1 single dose.
These dosing recommendations should be reviewed in conjunction with the Australian Immunisation Handbook. Menveo may be given as a booster dose in subjects who have previously received primary vaccination with Menveo, other conjugated meningococcal vaccine or meningococcal unconjugated polysaccharide vaccine. The need for and timing of a booster dose in subjects previously vaccinated with Menveo is based on national recommendations. Refer to the Australian Immunisation Handbook for further guidance.

Preparation for administration for Menveo powder and solution for solution for injection (2 vials).

Menveo must be prepared for administration by reconstituting the lyophilised MenA conjugate component with the liquid MenCWY conjugate component.
Using a syringe and suitable needle (21 G, 1 ½ inch length or 21G, 40 mm length) withdraw the entire contents of the vial of solution and inject into the vial of powder to reconstitute the MenA conjugate component.
Invert and shake the vial vigorously and then withdraw 0.5 mL of reconstituted product. Please note that it is normal for a small amount of liquid to remain in the vial following withdrawal of the dose. Prior to injection, change the needle with one suitable for the administration. Ensure that no air bubbles are present in the syringe before injecting the vaccine.
Following reconstitution, the vaccine is a clear, colourless solution, free from visible foreign particles. In the event of any foreign particulate matter and/or variation of physical aspect being observed, discard the vaccine.

Method of administration.

Menveo powder and solution for solution for injection (2 vials) should be administered as a single 0.5 mL intramuscular injection, preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle (upper arm) in children, adolescents and adults.
Menveo solution for injection (1 vial) should be administered as a single 0.5 mL intramuscular injection, preferably into the deltoid muscle (upper arm) in children, adolescents and adults. Using a syringe and a suitable needle, withdraw 0.5 mL of the vaccine. Prior to injection, change the needle for one suitable for administration. Ensure that no air bubbles are present in the syringe before injecting the vaccine.
Do not administer Menveo intravenously, subcutaneously or intradermally.
The vaccine should be visually inspected before administration.
The vaccine is a clear, colourless solution, free from visible foreign particles. In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine.
Prior to injection, change the needle for one suitable for administration.
Separate injection sites must be used if more than one vaccine is being administered at the same time.
Menveo must not be mixed with other vaccines in the same vial.
Menveo is for single use in one patient only. Discard any residue.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients of the vaccine (see Section 6.1 List of Excipients), including diphtheria toxoid (CRM197).
Known hypersensitivity to other diphtheria-containing vaccines.
Acute febrile illness of any cause.
A life-threatening reaction after previous administration of a vaccine containing similar components is a contraindication to vaccine administration.

4.4 Special Warnings and Precautions for Use

Menveo has not been evaluated in persons with thrombocytopenia or bleeding disorders. Because of the risk of hematoma, Menveo should not be administered to persons with any bleeding disorder, such as haemophilia or thrombocytopenia, or to persons receiving anticoagulant therapy, unless the potential benefit outweighs the risk of administration. When intramuscular vaccine is indicated for a patient with a bleeding disorder or a person receiving anticoagulant therapy, the vaccine should be administered intramuscularly if, in the opinion of a physician familiar with the patient's bleeding risk, the vaccine can be administered with reasonable safety by this route. If the patient receives anti-haemophilia or similar therapy, intramuscular vaccinations can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or finer) should be used for the vaccination and firm pressure applied to the site, without rubbing, for 2 minutes or more. The patient or family should be instructed concerning the risk of hematoma from the injection.
Appropriate precautions should be taken before administration of Menveo to minimise the risk of adverse reactions. These precautions include reviewing the subject's immunisation and medical history for the presence of any contraindications to immunisation, such as possible hypersensitivity to Menveo or similar vaccines (including diphtheria-containing vaccines) and evaluating the patient's current health status.
As with all injectable vaccines, as a precautionary measure, adrenaline injection (1:1000), other appropriate agents and equipment, and appropriate medical treatment and supervision must always be immediately available in case of a rare anaphylactic event or serious allergic reactions following administration of the vaccine.
As with other vaccines, vaccination with Menveo should be postponed in individuals suffering from an acute severe febrile illness (see Section 4.3 Contraindications). The presence of a minor infection is not contraindicated.
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see Section 4.8 Adverse Effects (Undesirable Effects)). It is important that procedures are in place to avoid injury from fainting.
As for all vaccines, the date of vaccine administration, the lot number and the manufacturer of the vaccine administered should be recorded in the patient's immunisation record.
Do not administer the vaccine intravascularly, subcutaneously or intradermally.
Care should be taken to avoid injecting Menveo vaccine subcutaneously, since clinical studies have not been conducted to establish the vaccine's safety and immunogenicity when administered subcutaneously.
A separate sterile syringe and needle should be used for each patient to prevent transmission of blood-borne infectious agents from person to person. Needles should not be recapped and should be disposed of according to guidelines for management of biohazardous waste.
The four dose schedule should be considered for infants travelling internationally to areas where serogroup A is endemic, see Section 5.1 Pharmacodynamic Properties.
Menveo is not indicated to prevent invasive meningococcal disease caused by serogroup B or other serogroups of N. meningitidis not present in the vaccine, nor to prevent infections caused by other microorganisms.
Menveo is not indicated for treatment of meningococcal disease.
There are no data on the applicability of the vaccine for post-exposure prophylaxis.
As with any vaccine, a protective immune response may not be elicited in all vaccinees (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
In immunocompromised individuals, vaccination may not result in an appropriate protective antibody response. Menveo has not been evaluated in the immunocompromised, including individuals with HIV infection, complement deficiencies and individuals with functional or anatomical asplenia may not mount an immune response to meningococcal group A, C, W-135 and Y conjugate vaccines.
A possible association between Guillain-Barré Syndrome (GBS) and receipt of the US and Canadian licensed quadrivalent diphtheria toxoid conjugate A, C, W-135 and Y vaccine (Menactra, Sanofi Pasteur) was reported in 2005. At present, it is unclear if this represents a true or a fortuitous association. The US Centres for Disease Control and Prevention (CDC) conducted an analysis of the 17 cases of GBS occurring among Menactra recipients and concluded that the relative risk for GBS post-Menactra, relative to the background risk in the general population, was 1.78 (95% CI 1.02-2.85). Since the background rate of GBS is very low (0.1/100,000 person months) and the disease is generally self-limited with a low case fatality rate in this population, this equates to an extremely small burden of attributable disease impact. In subsequent analysis, when factoring in the prevention of meningococcal disease, and thus the overall risk/benefit balance, the CDC concluded that vaccination was clearly beneficial, with vaccination saving 2400 Quality Adjusted Life Years (QALYs) due to prevention of meningococcal disease, at a cost of 5 QALYs due to vaccine induced GBS (Cho, 2010). On this basis, vaccination was judged to be the preferred strategy and for this reason, the recommendation for routine use of Menactra in adolescents continues. The decision to administer Menveo to subjects with a known history of Guillain-Barré Syndrome should take into account the potential benefits and risks.
Individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) remain at increased risk of invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y even following vaccination with Menveo.

Use in the elderly.

Limited data are available.

Paediatric use.

Menveo powder and solution for solution for injection (2 vials).

Safety and immunogenicity of Menveo in children under 2 months of age have not been established.

Menveo solution for injection (1 vial).

Safety and immunogenicity of Menveo in children under 2 years of age have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Menveo must not be mixed with other vaccines in the same syringe or vial. Concomitant vaccines should always be administered at separate and preferably contralateral sites.
If a vaccine recipient is undergoing immunosuppressant treatment, the immunological response may be diminished.

Children from 2 to 23 months of age.

Menveo powder and solution for solution for injection (2 vials) can be given concomitantly with any of the following monovalent or combination vaccines: diphtheria, acellular pertussis, tetanus, Haemophilus influenzae type b (Hib), inactivated polio, hepatitis B (HBV), inactivated hepatitis A, 7-valent and 13-valent pneumococcal conjugate vaccine (PCV7 and PCV13), pentavalent rotavirus, and measles, mumps, rubella and varicella (MMRV), and meningococcal group B vaccine. No increase in the reactogenicity or change in the safety profile of the routine vaccines was observed in clinical trials.
No immune interference was observed for the concomitantly administered vaccines with exception of pneumococcal vaccine serotype 6B and 19A in one study, and against pneumococcal vaccine serotype 19A in another study, both post-dose 3. No immune interference was observed post-dose 4 for any pneumococcal vaccine serotypes.

Children from 2 to 10 years of age.

The safety and immunogenicity of other childhood vaccines when administered concomitantly with Menveo have not been evaluated.

Adolescents from 11 to 18 years of age.

Menveo can be given concomitantly with any of the following monovalent or combination vaccines: tetanus, reduced diphtheria and acellular pertussis vaccine (dTpa) and human papillomavirus quadrivalent (Types 6, 11, 16 and 18) recombinant vaccine (HPV). There was no evidence of increased reactogenicity, change in safety profile, or impact on the antibody response of the vaccines following co-administration in clinical trials.
The sequential administration of Menveo one month after dTpa resulted in lower immune response for serogroup W-135 as measured by subjects with sero response. The clinical relevance of this observation is however unknown.

Adults.

Menveo can be given concomitantly with any of the following monovalent or combination vaccines: hepatitis A and B, yellow fever, typhoid fever (V1 polysaccharide), Japanese encephalitis and rabies. No change in the safety profile of the vaccines was observed when co-administered with Menveo in clinical trials and no clinically relevant interference was shown in the antibody response to the vaccines.
Concomitant administration of Menveo and other vaccines than those listed above has not been studied. If Menveo is given at the same time as another injectable vaccine, the vaccine should always be administered at a different injection site.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There were no effects on mating performance or fertility of female rabbits receiving the clinical dose of Menveo three times pre-mating and twice during gestation. Each dose was approximately 15-fold higher than the human dose on body weight basis. Impairment of male fertility in rabbits was not evaluated.
(Category B1)
Insufficient clinical data on exposed pregnancies are available.
No information is available on administration of Menveo to pregnant women. Menveo vaccine should be given to pregnant women following assessment of the risk and benefit.
In a study in rabbits immunised with Menveo three times prior to mating, and on gestation days 7 and 20, there were no treatment-related effects on pregnancy, foetuses, or kits. Antibodies to the vaccine were detected in vaccine-treated dams, foetuses, and kits.
 It is not known whether Menveo is secreted in human milk. However, as with other polysaccharide vaccines, it is unlikely that secreted antibodies in milk would be harmful when ingested by a breastfed infant. Menveo should only be administered to women who are breastfeeding when needed and the possible advantages outweigh the possible risks.
Menveo administration to maternal animals prior to mating and during gestation had no effects on development of offspring, assessed to lactation day 29. The vaccine was immunogenic in maternal animals and antibodies were detected in the offspring, but antibodies levels in milk were not determined.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed. Dizziness has been very rarely reported following vaccination. This may temporarily affect the ability to drive or use machines.

4.8 Adverse Effects (Undesirable Effects)

The safety profile presented below is based on data from clinical trials conducted with Menveo powder and solution for solution for injection (2 vials) formulation.

Children 2 to 23 months of age.

Four dose infant series.

The safety of Menveo with 4-dose schedule was evaluated in three randomised, controlled multicentre clinical studies in which 8735 infants 2 months of age at enrolment received Menveo concomitantly with routine paediatric vaccines (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). A total of 2864 infants received the routine paediatric vaccines alone.
The reported frequencies of solicited local and systemic adverse reactions in the largest multinational Menveo safety study are presented in Table 2.

Three dose infant series.

The safety of Menveo was assessed in 476 infants who completed a 3-dose infant series, including 297 who received doses at 2, 6 and 12 months and 179 who received doses are 2, 4 and 12 months of age.
The reported frequencies of solicited local and systemic adverse reactions in study V59_36 for the 3-dose and 4-dose infant series were comparable.

Two dose primary series.

The safety of Menveo with 2-dose schedule was assessed in 1985 children immunised between 6 and 23 months of age, in three randomised studies that addressed the safety of Menveo administered concomitantly with routine paediatric vaccines.
In two studies, the safety of one dose of Menveo when given concomitantly with routine paediatric vaccines in the second year of life was evaluated in 345 subjects.
Most of the common adverse reactions occurred within the first several days after vaccination and few were severe.
Table 3 lists the solicited adverse reactions following Menveo administered alone at 7-9 months and concomitantly with MMRV at 12 months in a randomised, controlled, multicentre study conducted in the U.S (V59P21). The rates of solicited adverse reactions reported were comparable between the concomitantly administered group (Menveo with MMRV) and the group which received MMRV alone, or Menveo alone. The frequency and severity of solicited local and systemic reactions occurring within 7 days following vaccination at 12 months of age, are shown in Table 3.

Serious adverse events.

Serious adverse events in subjects receiving a four-dose series of Menveo at 2, 4, 6 and 12-16 months were evaluated in three randomised multicentre clinical studies. In the two controlled studies, the proportions of infants randomised to receive the four-dose Menveo series concomitantly with routine vaccinations and infants who received routine vaccinations alone that reported serious adverse events during different study periods were, respectively: a) 2.7% and 2.2%, during the infant series; b) 2.5% and 2.5%, between the infant series and the fourth dose; c) 0.3% and 0.3%, in the one month following the fourth dose; and d) 1.6% and 2.2%, during the 6 months follow up period after the last dose. In the third study, which was controlled up to the fourth dose, the proportions of infants randomised to dosing regimens that included receiving four doses of Menveo concomitantly with routine vaccinations at 2, 4, 6, and 12-16 months and infants who received routine vaccinations alone that reported serious adverse events during different study periods were, respectively: a) 3.5% and 3.6%, during the infant series; and b) 2.8% and 3.3%, between the infant series and the 12-16 dose; and c) 0.5% and 0.7%, in the one month following the fourth dose. In the same study, 1.9% of infants randomised to receive the four-dose Menveo series concomitantly with routine vaccinations reported serious adverse events during the 6 month follow up period after the fourth dose. The most common serious adverse events reported in these three studies were wheezing, pneumonia, gastroenteritis and convulsions, and most occurred at highest frequency after the infant series.
In a study of children aged 7-23 months randomised to receive the two-dose Menveo series concomitantly with MMRV at 12 months of age, the rates of serious adverse events during the study, including the 6-month follow-up period after the last dose, were 3.6% and 3.8%, for the Menveo with MMRV and Menveo-only groups, respectively. Infants receiving MMRV alone, who had a shorter period of study participation as they were enrolled at 12 months of age, had a lower rate of serious adverse events (1.5%). Among 1597 study subjects, included in the safety population, the most commonly reported serious adverse events in all study arms combined were dehydration (0.4%) and gastroenteritis (0.3%).
Across the submitted studies of individuals 2 through 23 months of age, within 28 days of vaccination, two deaths were reported in the Menveo treatment groups (one case of sudden death and one case of sepsis), while no deaths were reported in the control group. None of the deaths was assessed as related to vaccination.
Among subjects with symptom onset within 42 days of vaccination (days 12, 25, 29), 3/12049 [0.02%, 95% CI: (0.01%, 0.07%)] Menveo recipients and 0/2877 [0%, 95% CI: (0%, 0.13%)] control recipients were diagnosed with Kawasaki Disease. One case of acute disseminated encephalomyelitis with symptom onset 29 days post-dose 4 was observed in a participant given Menveo co-administered with routine US childhood vaccines at 12 months of age (including MMR and varicella vaccines).

Children 2 to 10 years of age.

The characterisation of the safety profile of Menveo in children 2 to 10 years of age is based on data from 4 clinical trials in which 3181 subjects received Menveo. Table 4 shows the solicited reactions from the pivotal study comparing Menveo to Menactra (V59P20) in children 2 to 10 years of age.

Serious adverse events.

The information regarding serious adverse events in subjects aged 2 to 10 years was derived from 3 randomised, controlled clinical trials, in which subjects received Menveo, Menomune or Menactra. A fourth supportive trial provided serious adverse event information for subjects after one or two doses of Menveo. Safety follow-up ranged from 6 to 12 months and included 2883 subjects administered Menveo.
Serious adverse events reported during the safety follow-up periods occurred in 21/2883 (0.7%) of Menveo subjects, in 7/1255 (0.6%) of Menactra subjects, and 2/861 (0.2%) of Menomune subjects. In the subjects receiving either one or two doses of Menveo, there were 6 subjects with pneumonia, 3 subjects with appendicitis, and 2 subjects with dehydration; all other events were reported for only one subject. Among 1255 subjects receiving a single dose of Menactra and the 861 subjects receiving Menomune, there were no events reported by more than one subject.
The serious adverse events occurring within the first 30 days of vaccination were as follows: Menveo (6/2883 [0.2%]) - appendicitis, pneumonia, staphylococcal infection, dehydration, febrile convulsion, and tonic convulsion; Menactra (1/1255 [0.1%]) - inguinal hernia; Menomune (2/861 [0.2%]) - abdominal pain, lobar pneumonia. In an additional 4th supportive study, 298 subjects received one or two doses of Menveo and 22 (7%) had serious adverse events over a 13-month follow-up period including 13 subjects with varicella and 2 subjects with laryngitis. All other events were reported to occur in one subject. During the 30 days post vaccination in this study, one limb injury and one case of varicella were reported.

Adolescents and adults from 11 to 65 years of age.

The safety of Menveo was evaluated in 5 randomised controlled clinical trials including 6724 participants (from 11 years of age through adulthood) who received Menveo and 1966 who received a comparator vaccine (either Menomune or Menactra). Demographic characteristics of subjects who received Menveo were similar to those who received the comparator vaccine.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Frequencies are defined as follows: Very common: (≥ 1/10); Common: (≥ 1/100 to < 1/10); Uncommon: (≥ 1/1,000 to < 1/100); Rare: (≥ 1/10,000 to < 1/1,000); Very rare: (< 1/10,000); Not known: (cannot be estimated from the available data).

Infections and infestations.

Uncommon: nasopharyngitis.

Nervous system disorders.

Very common: headache. Uncommon: dizziness.

Gastrointestinal disorders.

Very common: nausea.

Skin and subcutaneous tissue disorders.

Common: rash.

Musculoskeletal and connective tissue disorders.

Very common: myalgia. Common: arthralgia.

General disorders and administration site conditions.

Very common: injection site pain, injection site erythema (≤ 50 mm), injection site induration (≤ 50 mm), malaise.
Common: injection site erythema (> 50 mm), injection site induration (> 50 mm), fever ≥ 38°C, chills.
Uncommon: injection site pruritus.

Solution for injection formulation (1 vial).

In a pooled analysis of two clinical trials, 1,337 subjects aged 10 to 44 years received a single dose of the solution for injection formulation. These data show that the clinical tolerability and safety profile of the solution for injection formulation is comparable to the powder and solution for injection formulation.

Post-marketing observational safety study.

In a post-marketing observational safety study conducted in a United States health maintenance organization, data from electronic health records of 48899 persons 11 through 21 years of age were used to evaluate pre-specified events of interest following vaccination with Menveo. Using a self-controlled case series method, Bell's palsy showed a statistically significant increased risk in the period 1 to 84 days post-vaccination compared to the control period, with an overall adjusted relative incidence of 2.9 (95% CI: 1.1-7.5). Among the 8 reported cases of Bell's palsy, 6 cases occurred in persons who received Menveo concomitantly with one or more of the following vaccines: dTpa, HPV, and Influenza vaccine. All reported Bell's palsy cases resolved.

Adverse reactions from post-marketing spontaneous reports.

Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure.

Blood and lymphatic system disorders.

Local lymphadenopathy.

Immune system disorders.

Hypersensitivity including anaphylaxis.

Nervous system disorders.

Dizziness, syncope, tonic convulsion, febrile convulsion, headache, facial paresis, balance disorder.

Eye disorders.

Eyelid ptosis.

Ear and labyrinth disorders.

Hearing impaired, ear pain, vertigo, vestibular disorder.

Respiratory, thoracic and mediastinal disorders.

Oropharyngeal pain.

Skin and subcutaneous tissue disorders.

Bullous conditions.

Musculoskeletal and connective tissue disorders.

Arthralgia, bone pain.

General disorders and administration site conditions.

Injection site pruritus, pain, erythema, inflammation and swelling, including extensive swelling of the injected limb, fatigue, malaise, pyrexia.

Investigations.

Alanine aminotransferase increased, body temperature increased.

Injury, poisoning and procedural complications.

Fall, head injury.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at https://www.tga.gov.au/reporting-problems.

4.9 Overdose

Insufficient data are available.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Meningococcal vaccines, ATC doe: JO7AH08.

Mechanism of action.

Meningococcal disease is caused by a Gram-negative diplococcus, Neisseria meningitidis. N. meningitidis causes life-threatening disease worldwide. Based on antigenic variations in capsular polysaccharide structure, 13 serogroups of N. meningitidis have been identified.
Globally, 5 serogroups, A, B, C, W-135 and Y, cause almost all invasive meningococcal infections. Invasive infection by N. meningitidis most often manifests as bacteraemia and/or meningitis and can also more rarely present as arthritis, myocarditis, pericarditis, endophthalmitis, pneumonia or infection at other anatomic sites.
Early clinical manifestations of meningococcal disease are often nonspecific and may initially be difficult to distinguish from less serious illnesses. Symptoms may include headache, stiff neck, fever, chills, malaise and prostration. Disease can progress rapidly, with most cases seeking medical attention within 24 hours of symptom onset. About 10% of cases die, even with appropriate antimicrobial and supportive treatment; with meningococcal septicaemia up to 40% of cases die (Rosenstein, 1999). Permanent sequelae, including scarring, limb or digit loss, neurologic dysfunction, and/or hearing loss occur in 11-19% of survivors (Erickson, 1998).
Asymptomatic colonisation of the upper respiratory tract by encapsulated N. meningitidis is common. Transmission is thought to occur by droplet transmission of respiratory tract secretions. Only a small percentage of colonised individuals develop disease.
The incidence of meningococcal disease is highest in children less than 5 years old, with infants under 12 months old at the greatest risk. Another incidence peak occurs in adolescents.
Bactericidal anti-capsular antibodies protect against invasive meningococcal disease. Vaccination with Menveo leads to the production of bactericidal antibodies directed against the capsular polysaccharides of serogroups A, C, W-135 and Y. The original correlate of protection against meningococcal disease was a bactericidal activity (using human serum as the complement source (hSBA)) of ≥ 1:4 (Goldschneider, J. Exp Med, 1969); an hSBA ≥ 1:8 is a more conservative correlate of protection.

Clinical trials.

Immunogenicity of the powder and solution for solution for injection (2 vials) formulation. The immunogenicity of Menveo was evaluated in randomised, multicentre, active controlled clinical trials that enrolled persons from 2 months through 65 years of age.
The primary serologic endpoint for many of the clinical trials was subject serological response. This was defined as a post vaccination titre of ≥ 1:8 for subjects who were seronegative at baseline, or a fourfold rise for subjects who were seropositive at baseline. Other endpoints included the proportion of subjects who had post vaccination titres of ≥ 1:8 or ≥ 1:4 and geometric mean titres (GMTs).
Correlate of protection due to the infrequency of clinical disease, the efficacy of Menveo is inferred from the results of a functional assay. The primary measure of immune response and protection was induction of serogroup-specific anti-capsular antibodies with bactericidal activity. Serum bactericidal activity (SBA) was measured using human serum as the source of exogenous complement (hSBA). The hSBA was the original correlate of protection against meningococcal disease (Goldschneider I., et al, 1969 a, b).

Immune responses following a 4-dose infant series (2 months through 16 months of age).

The pre-specified endpoint for immunogenicity of Menveo in infants receiving a 4-dose series at 2, 4, 6 and 12 months of age was the proportion of subjects achieving an hSBA ≥ 1:8, with the lower limit of the 2-sided 95% Confidence Intervals (CI) for the point estimate being ≥ 80% of vaccinees for serogroup A, and ≥ 85% of vaccinees for serogroups C, W-135 and Y one month following the final dose. Sera were obtained at 2 months (prior to the first infant dose), at 7 months (1 month after the infant series), 12 months (prior to the older infant dose), and 13 months of age (1 month after the final dose) which allowed evaluation of the immunogenicity of the infant series as well as of the complete series.
The immunogenicity of Menveo in infants was assessed in two pivotal randomised, controlled, multicentre studies of infants, who received a 4-dose series at 2, 4, 6 and 12 months of age and subjects who received a 4-dose series at 2, 4, 6, and 16 months of age. The pre-defined criteria for immunogenicity were met for all four serogroups A, C, W-135 and Y at one month following completion of a 4-dose series at 2, 4, 6 and 12 - 16 months (Table 5).

Immune responses following a 3-dose infant series (2 months through 12 months of age).

In study V59_36, children 2 months of age at enrolment were administered either 4 doses at 2, 4, 6 and 12 months of age or 3 doses at 2, 4 and 12 months of age. By one month after the second vaccination (5 months of age), substantial increases in immune responses were seen for all 4 serogroups. The 3-dose series was shown to be noninferior to the 4-dose series for serogroups C, W-135 and Y at 1 month after the 12 month vaccination. The hSBA GMTs at 13 months were also similar between the 3-dose and 4-dose groups for serogroups C, W-135 and Y (Table 6). Although immune responses to serogroup A were not included in the non-inferiority assessment, a relevant proportion of participants (88%) achieved seroprotective (hSBA titre ≥ 1:8) titre one month following the 3-dose primary schedule. Long term antibody persistence was not measured in this study (see Table 7).
In study V59P14, children 2 months of age at enrolment were administered either 3 doses at 2, 6 and 12 months of age or 4 doses at 2, 4, 6 and 18 months of age, and were assessed for immune response at 7 months of age. Among 284 infants who received doses at 2 and 6 months, 74%, 94%, 99%, 97% had hSBA ≥ 1:8 against serogroups A, C, W-135 and Y, respectively, compared to 89%, 97%, 98%, and 98% of 277 infants who received doses at 2, 4, and 6 months. Pre-specified non-inferiority criteria were met for serogroups C, W-135, and Y.

Immune responses following a 2-dose series in children 7 months through 23 months of age.

In study V59P21, the immunogenicity of Menveo was assessed in children, who did not receive the 4-dose series but instead received a 2 dose series. Among the per protocol population of 386 subjects, after Menveo administered at 7-9 and at 12 months, the proportions of subjects with hSBA ≥ 1:8 for serogroups A, C, W-135, and Y were respectively: 88% (84-91), 100% (98-100), 98% (96-100), 96% (93-99) (Table 8).
A 2-dose series was also examined in a study of Latin American children, who received Menveo at 12 and 16 months of age. Among the per protocol population of 106 subjects, the proportions of subjects with hSBA ≥ 1:8 for serogroups A, C, W-135 and Y were 97% (92-99), 100% (96-100), 100% (96-100), and 100% (96-100), respectively.

Immunogenicity in children (2-10 years of age).

In the pivotal study V59P20 immunogenicity of Menveo was compared to Menactra (Sanofi Pasteur); 1170 children were vaccinated with Menveo and 1161 received the comparator vaccine in the per protocol populations.
In the pivotal, randomised, observer-blind study V59P20, in which participants were stratified by age (2 through 5 years and 6 through 10 years), the immunogenicity of a single dose of Menveo one-month post vaccination was compared with the single dose of Menactra. In both age groups, non-inferiority of Menveo to Menactra for the proportion of subjects with a seroresponse and percentage of subjects with hSBA ≥ 1:8 was demonstrated for serogroups C, W-135 and Y, but not for serogroup A. For both age groups (2-5 years and 6-10 years of age), the immune response as measured by hSBA GMTs was non-inferior for all serogroups (Table 9). In addition, the percentage of subjects with a seroresponse, percentage of subjects with hSBA ≥ 1:8, and GMT levels were statistically higher among Menveo recipients for serogroups W-135 and Y. GMT levels were also statistically higher among Menveo recipients for serogroup C.
In the same study, a separate group of children, 2 through 5 years of age (N=297) in the per protocol population were immunised with two doses of Menveo, two months apart. The observed seroresponse rates (with 95% CI) at 1 month after the second dose were: 91% (87-94), 98% (95-99), 89% (85-92), and 95% (91-97) for serogroups A, C, W-135 and Y, respectively. The proportion of subjects with hSBA ≥ 1:8 (95% CI) were 91% (88-94), 99% (97-100), 99% (98-100), and 98% (95-99) for serogroups A, C, W-135 and Y, respectively. The hSBA GMTs (95% CI) for this group were 64 (51-81), 144 (118-177), 132 (111-157), and 102 (82-126) for serogroups A, C, W-135 and Y, respectively.

Persistence of immune response and booster response in children (2-10 years of age).

Persistence of immune response 1 year after primary vaccination with Menveo was evaluated in study V59P8. At 1-year post vaccination, Menveo continued to be statistically higher than Menomune for serogroups A, W-135 and Y, as measured by percentage of subjects with hSBA ≥ 1:8 and GMTs. Menveo was non-inferior on these endpoints for serogroup C (Table 10).
Antibody persistence at 5 years after primary vaccination was assessed in the extension study V59P20E1. There was substantial antibody persistence observed against serogroups C, W and Y, with the percentages of subjects with hSBA ≥ 1:8 being 32% and 56% against serogroup C in subjects 2-5 and 6-10 years of age, respectively, 74% and 80% against serogroup W, and 48% and 53% against serogroup Y. GMTs were respectively 6.5 and 12 for serogroup C, 19 and 26 for serogroup W, and 8.13 and 10 for serogroup Y. For serogroup A, 14% and 22% of subjects 2-5 and 6-10 years of age, respectively, had hSBA ≥ 1:8 (GMTs 2.95 and 3.73). Levels for all serogroups were higher than those seen in meningococcal vaccine-naïve children of similar ages. The children also received a booster dose of Menveo, 5 years after a single dose primary vaccination. All subjects in both age groups had hSBA ≥ 1:8 across serogroups, with antibody titres several fold higher than seen after the primary vaccination (Table 11).

Demonstration of immunologic non-inferiority to Menactra (Sanofi Pasteur) among subjects aged 11-55 years.

Immunogenicity was evaluated in a Phase 3, randomised, multicentre, active controlled clinical trial V59P13 that enrolled adolescents (11-18 years of age) and adults (19-55 years of age). Participants received either a dose of Menveo (N = 2649) or Menactra (N = 875). Sera were obtained both before vaccination and 28 days after vaccination. Demographic characteristics between Menveo and Menactra vaccine groups were comparable within each age group.

Immunogenicity in adolescents.

In the 11 to 18 year old population of the pivotal study, V59P13, noninferiority of Menveo to Menactra was demonstrated for all four serogroups using the primary endpoint (hSBA seroresponse) and two secondary endpoints, percentage of all subjects with 1-month post-vaccination hSBA ≥ 1:8, and geometric mean titre (GMT). Furthermore, hSBA GMTs for all four serogroups were statistically superior in the Menveo group, as compared to the Menactra group. The percentages of subjects with hSBA seroresponse and with hSBA ≥ 1:8 were statistically superior for serogroups A, W, and Y in the Menveo group, as compared to the Menactra group (Table 12). The clinical relevance of higher immune responses is uncertain.
In the non-inferiority study, V59P6, immunogenicity was assessed among adolescents aged 11-17 years who had been randomised to receive either Menveo or Menomune (Sanofi Pasteur Ltd), a quadrivalent meningococcal polysaccharide vaccine. Responses to Menveo were shown to be non-inferior to those to Menomune for all four serogroups (A, C, W and Y) based on seroresponse, proportions achieving hSBA titres ≥ 1:8, and GMTs. At one-year post vaccination, the percentage of Menveo recipients with hSBA ≥ 1:8 remained significantly higher compared with Menomune recipients for serogroups C, W and Y, and similar between the two study groups for serogroup A (Table 13).

Immunogenicity in adults.

In the 19 to 55 year-old population of the pivotal study, V59P13, noninferiority of responses to Menveo to those to Menactra was demonstrated for all four serogroups using all three endpoints (seroresponse [primary endpoint], hSBA ≥ 1:8, and hSBA GMTs). Furthermore, both hSBA GMTs and the percentage of subjects with hSBA seroresponse were statistically superior for serogroups C, W, and Y in the Menveo group, as compared to the Menactra group. The percentage of subjects with hSBA ≥ 1:8 was statistically superior for serogroups C and Y in the Menveo group, as compared to the Menactra group (Table 14). The clinical relevance of higher immune responses is uncertain.
Immunogenicity of the solution for injection (1 vial) formulation. Table 15 presents the immunogenicity of solution for injection formulation, as evaluated in a phase 2b observer-blind, randomised, multicentre, controlled clinical trial in subjects aged 10 to 40 years that assessed the non-inferiority for MenA of the solution for injection formulation (for the product aged 24 and 30 months) to the powder and solution for solution for injection formulation.
Non-inferiority of solution for injection formulation to powder and solution for solution for injection formulation was demonstrated for MenA as per the 2 co-primary study endpoints (between groups ratio of GMTs at 1-month post vaccination).

5.2 Pharmacokinetic Properties

Evaluation of pharmacokinetic properties is not required for vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

Genotoxicity studies have not been performed with Menveo.

Carcinogenicity.

Carcinogenesis and mutagenesis studies have not been performed with Menveo.

6 Pharmaceutical Particulars

6.1 List of Excipients

Menveo powder and solution for solution for injection (2 vials).

Vial containing MenA lyophilised conjugate component.

Sucrose, potassium dihydrogen phosphate.

Vial containing MenCWY liquid conjugate component.

Monobasic sodium phosphate monohydrate, dibasic sodium phosphate dihydrate, sodium chloride, water for injections.

Menveo solution for injection (1 vial).

Dibasic sodium phosphate dihydrate, monobasic sodium phosphate monohydrate, sodium chloride, water for injections.

6.2 Incompatibilities

The medicinal product must not be admixed with other medicinal products (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Menveo powder and solution for solution for injection (2 vials).

Store between 2°C and 8°C away from a freezer compartment. Do not freeze. Product that has been frozen should not be used. Keep the MenA (vial) and MenCWY vial components in the outer carton in order to protect from light. Do not use after the expiry date.
Following reconstitution, to reduce microbiological hazard the product should be used as soon as practicable after reconstitution. If storage is necessary, hold at 2-8°C for not more than 24 hours. The two components of the product may have different expiry dates. The outer carton bears the earlier of the two dates and the product should be used before this date. The carton and all of its contents must be discarded on reaching this outer carton expiry date.

Menveo solution for injection (1 vial).

Store between 2° and 8°C away from a freezer compartment. Do not freeze. Product that has been frozen should not be used. Keep in the outer carton in order to protect from light. Do not use after the expiry date.

6.5 Nature and Contents of Container

One dose (0.5 mL of the vaccine) contains (see Table 16).

Menveo powder and solution for solution for injection (2 vials).

Menveo is presented in a Type I glass vial containing the MenA lyophilised conjugate component with a butyl rubber stopper.
The MenCWY liquid conjugate component is presented in a Type I glass vial. The vial has a butyl rubber stopper.
The vial/vial presentation is presented in single-dose (2 vials) and 5-doses (10 vials) multi-packs.

Menveo solution for injection (1 vial).

Menveo is presented in a Type I glass vial with a butyl rubber stopper.
Menveo is available in single dose packs which contain 1 vial of solution or pack sizes of 10 doses which have 10 vials of solution.
Not all presentations and pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

N/A.

CAS number.

N/A.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes