Consumer medicine information

Menitorix

Haemophilus B conjugate vaccine; Neisseria meningitidis vaccine

BRAND INFORMATION

Brand name

Menitorix

Active ingredient

Haemophilus B conjugate vaccine; Neisseria meningitidis vaccine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Menitorix.

What is in this leaflet?

Please read this leaflet carefully before you use MENITORIX.

This leaflet answers some common questions about MENITORIX. It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the expected benefits of your child having MENITORIX against the possible risks.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What is MENITORIX used for?

MENITORIX is a vaccine that can be given to children to prevent illness caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis group C (MenC) bacteria. The vaccine works by causing the body to produce its own protection (antibodies) against these bacteria. The vaccine cannot cause these serious diseases.

  • Haemophilus influenzae type b (Hib): Hib bacteria most often cause meningitis (inflammation of the coverings of the brain and spinal cord). Even after recovery from Hib meningitis there can be problems from the illness such as mental retardation, spastic paralysis, deafness or epilepsy. Hib infection can also cause severe swelling of the throat that can cause severe breathing problems (suffocation). Less commonly, the bacteria can infect other parts of the body, such as the lungs and the bones and joints.
  • Neisseria meningitidis group C (MenC): Like Hib bacteria, MenC bacteria most often cause meningitis. They may also cause severe blood infections and infect the heart, throat and other organs. Death from MenC infections may be very rapid.

As with all vaccines, MENITORIX may not protect all people who are vaccinated.

Also, MENITORIX does not protect against meningitis caused by other bacteria or viruses, including other types and groups of Haemophilus or Neisseria bacteria.

Before your child receives MENITORIX

MENITORIX should not be given if your child:

  • has had any allergic reaction to MENITORIX, to any Hib, MenC or tetanus vaccine, or any ingredient in this vaccine. The active substances and other ingredients in MENITORIX are listed at the end of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.

Before your child is vaccinated, make sure your doctor knows if any of the following apply to your child:

  • has a severe infection with a high temperature. In these cases, the vaccination will be postponed until recovery. A minor infection such as a cold should not be a problem, but talk to your doctor first.
  • has a bleeding problem or bruises easily
  • is taking medicines or having any treatment which may affect the immune system. Also, if your child has HIV infection or any other illness that can reduce his or her immunity to infections. Your child can still be given MENITORIX if your doctor or nurse advises it but your child may not develop as good immunity as other children
  • receives treatment that blocks the part of the immune system known as complement activation, such as eculizumab. Even if your child has been vaccinated with MENITORIX your child remains at increased risk of disease caused by the Neisseria meningitidis serogroup C bacteria.
  • has breathing difficulties, please contact your doctor. This may be more common in the first three days following vaccination if your child is born prematurely (before or at 28 weeks of pregnancy).

Fainting can occur following, or even before, any needle injection, therefore please tell the doctor or nurse if your child fainted with a previous injection.

Using other medicines or vaccines Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.

MENITORIX may be given at the same time your child receives other normally recommended vaccinations, such as diphtheria (D), tetanus (T), pertussis (whooping cough) (Pa), inactivated polio (IPV), hepatitis B (HBV), combined measles-mumps-rubella (MMR) and pneumococcal vaccines.

MENITORIX must not be used if:

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

Tell your doctor if your child is:

  • taking any other medicines, including medicines you buy without a prescription.

How MENITORIX is given

If your child has received three doses of a Haemophilus influenzae type b vaccine during the first year of life, he/she may receive a dose of MENITORIX in the second year of life.

In order to get the most benefit from the vaccine, make sure your child finishes the complete vaccination course as recommended by your doctor.

MENITORIX is given as an injection into the muscle.

If a dose is missed

If your child misses a scheduled dose, talk to your doctor and arrange another visit.

It is important that you follow the instructions of your doctor or nurse regarding return visits. If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.

What are the side effects?

Like all medicines, MENITORIX can cause side effects, although not everybody gets them.

Tell your doctor or nurse as soon as possible if your child does not feel well during or after having had a dose of MENITORIX.

Side effects found to occur with MENITORIX include:

Very common (these may occur with more than 1 in 10 doses of the vaccine):

  • Pain, redness or swelling at the site of the injection
  • Fever (more than or equal to 38°C)
  • Drowsiness
  • Loss of appetite
  • Irritability

Common (these may occur with up to 1 in 10 doses of the vaccine):

  • Injection site reaction, such as a hard lump

Uncommon (these may occur with up to 1 in 100 doses of the vaccine):

  • Crying
  • Diarrhoea
  • Vomiting
  • Skin allergies
  • Generally feeling unwell
  • High fever (more than 39.5°C)
  • Rash

Rare (these may occur with up to 1 in 1,000 doses of the vaccine):

  • Abdominal pain
  • Sleeplessness
  • Fatigue

Very rare (these may occur with up to 1 in 10,000 doses of vaccine)

Contact your doctor immediately or take your child to the casualty department of your nearest hospital if any of the following happens:

  • Convulsions (fits) caused by a fever.
  • Sudden life-threatening allergic reaction. Symptoms include sudden signs of allergy such as:
    - rash, itching or hives on the skin,
    - swelling of the face, lips, tongue or other parts of the body,
    - shortness of breath, wheezing or trouble breathing.

This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.

Tell your doctor or pharmacist if you notice any side effects which are not mentioned here.

Do not be alarmed by this list of possible side-effects. Your child may not experience any of them.

How do I store MENITORIX?

MENITORIX is usually stored at the doctor’s clinic or surgery, or at the pharmacy. But if you need to store MENITORIX always:

  • Keep MENITORIX in a refrigerator stored between +2°C and +8°C. DO NOT FREEZE. Do not store it in the bathroom, or leave it in the car. Avoid exposing the vaccine to sunlight.
  • Keep the vaccine out of reach and sight of children.
  • Keep MENITORIX in the original pack in order to protect from light.

Ask your pharmacist what to do with any left over MENITORIX that has expired or has not been used.

Product description

What MENITORIX looks like

MENITORIX is supplied as a white powder of Hib-MenC vaccine in a glass vial, together with half a millilitre (0.5 ml) of clear colourless sodium chloride solvent in a pre-filled syringe for a 1 dose vaccine. The powder is dissolved in the solvent provided, just before injection.

MENITORIX is available in packs of 1 or 10 with 2 separate needles or without needles.

Ingredients

MENITORIX contains agents that stimulate an immune response to Haemophilus influenzae type b and Neisseria meningitidis serogroup C bacteria.

MENITORIX also contains trometamol, sucrose.

The diluent contains the excipients sodium chloride and water for injections.

Sponsor

MENITORIX is supplied in Australia by:

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

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

This leaflet was prepared on: 30 October 2018.

The information provided applies only to: MENITORIX.

MENITORIX: AUST R 160539

Trade marks are owned by or licensed to the GSK group of companies

©2018 GSK group of companies or its licensor

Version 4.0

Published by MIMS July 2019

BRAND INFORMATION

Brand name

Menitorix

Active ingredient

Haemophilus B conjugate vaccine; Neisseria meningitidis vaccine

Schedule

S4

 

1 Name of Medicine

Haemophilus influenzae type b polyribose ribitol phosphate and serogroup C meningococcal polysaccharide conjugate vaccine (Hib-MenC).

6.7 Physicochemical Properties

Not applicable for vaccines.

2 Qualitative and Quantitative Composition

After reconstitution, one dose (0.5 mL) contains:
Haemophilus influenzae type b polyribose ribitol phosphate 5 microgram conjugated to tetanus toxoid as carrier protein 12.5 microgram.
Meningococcal polysaccharide group C 5 microgram conjugated to tetanus toxoid as carrier protein 5 microgram.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder and diluent for solution for injection.
White powder in a glass vial, together with clear colourless diluent in a pre-filled syringe for a 1 dose vaccine.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Menitorix confers immunisation against Haemophilus influenzae type b and Neisseria meningitidis serogroup C. Conjugation of polysaccharide antigens with carrier protein is thought to result in T cell dependant activation of polysaccharide specific B lymphocytes leading to B cell antibody response and induction of immunological memory.

Clinical trials.

Menitorix has been studied in clinical trials in children between the ages of 6 weeks to 2 years in both primary and booster vaccination, administered concomitantly with other routine childhood vaccines. These included Infanrix Penta (DTPa-HBV-IPV) or Infanrix IPV (DTPa-IPV) in the primary vaccination studies. In booster studies, depending on study and group, Menitorix was administered alone, or with Infanrix Penta or a DTPa containing vaccine or with Priorix (MMR vaccine). In addition, pneumococcal conjugate vaccines (10 valent Synflorix and 7 valent) were coadministered.
The trials demonstrated noninferiority of the immune responses elicited by Menitorix compared to the responses elicited by commercially available, comparator vaccines; Infanrix Hexa (DTPa-HBV-IPV/Hib), DTPa-IPV-Hib and Hiberix (Hib) for investigation of the Hib response; and for investigation of the MenC response a MenC vaccine conjugated with Corynebacterium diphtheriae (CRM).
Immunogenicity against Haemophilus influenzae type b was evaluated by measuring antipolyribosylribitol phosphate antibodies (anti-PRP) with an enzyme linked immunosorbent assay (ELISA). Immunogenicity against Neisseria meningitidis serogroup C was measured by a serum bactericidal activity assay using rabbit complement (rSBA-MenC).
The correlates indicative of protection in the Menitorix development program were an anti-PRP antibody concentration of 0.15 microgram/mL and a rSBA-MenC antibody titre of 1:8, which are very widely accepted.
Study Hib-MenC-TT-016 was a pivotal clinical trial conducted in Australia and according to the National Immunisation Program, to evaluate the use of Menitorix as a single dose in children primed in infancy with a Hib vaccine but not with a MenC vaccine.

Primary vaccination course.

The antibody responses after completion of a 3 dose primary vaccination course of Menitorix at one month after the second and third doses were as follows (see Table 1).

Antibody persistence prebooster.

Antibody persistence after a 3 dose primary vaccination course up to preboosting time point has been demonstrated for Menitorix in five clinical trials with subjects aged 11-18 months and primed with Menitorix in infancy at 2-3-4 or 2-4-6 months of age. Following completion of the 3 dose primary series with Menitorix, 97.0% of the subjects (847/873) had anti-PRP titres ≥ 0.15 microgram/mL and 84.9% of the subjects had rSBA-MenC* titres ≥ 1:8 (595/701).
* Testing performed at GSK laboratories.

Booster vaccination.

In six clinical trials booster vaccination was given at age 12 to 15 months. The antibody responses one month after administration of a booster dose of Menitorix were as follows (see Table 2).

Immunogenicity of a single dose in MenC unprimed toddlers.

A study was carried out in Australia in toddlers primed in infancy with a Hib conjugate vaccine but not with a Men C conjugate vaccine. These participants had received Hib vaccine either as 2 doses of a Hib-outer membrane protein [Hib-OMP] containing vaccine or as 3 doses of Hib-TT (as part of a combination vaccine with diphtheria, tetanus, acellular pertussis). This study investigated the noninferiority of one dose of Menitorix compared with coadministration of Hib-TT and MenC-CRM vaccines. Both groups also received measles-mumps-rubella vaccine, Priorix.
The data in Table 3 demonstrate noninferiority of Menitorix to the comparator (Hib+MenC) based on the prespecified noninferiority in terms of percentages of subjects with rSBA-MenC titres ≥ 1:8 and percentages of subjects with anti-PRP antibody concentrations ≥ 0.15 microgram/mL.
The antibody responses after the administration of a single dose of Menitorix in toddlers primed in infancy with a Hib conjugate vaccine but not with a meningococcal C conjugate vaccine was evaluated at months 1, 12, 48 and 60 after the vaccination with Menitorix (see Table 4).

Long-term persistence.

Long-term antibody persistence was evaluated in subjects primed and boosted with Menitorix.
A study was conducted in subject primed at 2-3-4 months of age with either Menitorix coadministered with Infanrix-IPV or with MenC-CRM vaccine coadministered with DTPa-HBV-IPV vaccine. These subjects received a booster dose of Menitorix coadministered with Priorix at 12-15 months of age. Twelve months after booster vaccination, all subjects (N = 261) had anti-PRP antibody concentrations ≥ 0.15 microgram/mL, while 89.0% (178/200) of the subjects primed with Menitorix and 69.5% (41/59) of the subjects primed with a MenC-CRM vaccine had anti-SBA-MenC titres ≥ 8.
In another study 100% of the subjects (n = 52) primed with Menitorix and Infanrix Penta and boosted with Menitorix at respectively 2-4-6 and 13-14 months of age had anti-PRP concentrations of ≥ 0.15 microgram/mL eighteen months after the administration of the Menitorix booster dose. At that time, 86.5% (45/52) of the subjects had anti-SBA-MenC titres ≥ 1:8.
Estimates of vaccine effectiveness from the UK's routine immunisation programme (using various quantities of three meningococcal serogroup C conjugate vaccines other than Menitorix) covering the period from introduction at the end of 1999 to March 2004 have demonstrated the need for a booster dose after completion of the primary series (three doses administered at 2, 3 and 4 months). Within one year of completion of the primary series, vaccine effectiveness in the infant cohort was estimated at 93% (95% confidence intervals 67-99%). However, more than one year after completion of the primary series, there was clear evidence of waning protection.
Up to 2007, the overall estimates of effectiveness in age cohorts from 1-18 years that received a single dose of meningococcal group C conjugate vaccine during the initial catch-up vaccination programme in the UK fall between 83 and 100%.
Study Hib-MenC-TT-035 evaluated the long-term antibody persistence in children up to 6 years of age who previously received a full vaccination course (primary and booster vaccination) with Menitorix or MenC conjugate vaccines (MenC-CRM197 or MenC-TT) coadministered with DTPa containing and pneumococcal conjugate vaccines (10 valent or 7 valent). The percentage of subjects with rSBA-MenC* titres ≥ 1:8 at 6 years of age was at least 25.4% in the children that received Menitorix, 24.2% in the children that received MenC-CRM197 and 40.1% in the children that received MenC-TT as a booster in the second year of life. The percentage of subjects with anti-PRP concentrations ≥ 0.15 microgram/mL at 6 years of age was 100% in children vaccinated with Menitorix.
* Testing performed at Public Health England (PHE) in the United Kingdom.

5.2 Pharmacokinetic Properties

Not applicable for vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

Menitorix has not been evaluated for genotoxicity.

Carcinogenicity.

The carcinogenic potential of Menitorix has not been established.

4 Clinical Particulars

4.1 Therapeutic Indications

Menitorix is indicated for the prevention of invasive diseases caused by Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroup C (MenC).

4.3 Contraindications

Hypersensitivity to the active substances, including tetanus toxoid, or to any of the excipients.
Hypersensitivity reaction after previous administration of Menitorix.

4.4 Special Warnings and Precautions for Use

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
As with other vaccines, the administration of Menitorix should be postponed in subjects suffering from acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Menitorix will only confer protection against Haemophilus influenzae type b and Neisseria meningitidis serogroup C.
As for any vaccine, Menitorix may not completely protect against the infections it is intended to prevent in every vaccinated individual.
Immunisation with this vaccine does not substitute for routine tetanus immunisation.
No data are available on the use of Menitorix in immunodeficient subjects. In individuals with impaired immune responsiveness (whether due to the use of immunosuppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes) a protective immune response to Hib and MenC conjugate vaccines may not be obtained. Individuals with complement deficiencies and individuals with functional or anatomical asplenia may mount an immune response to Hib and MenC conjugate vaccines; however the degree of protection that would be afforded is unknown.
Individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) remain at increased risk of invasive disease caused by Neisseria meningitidis serogroup C even following vaccination with Menitorix.
There are no data available on the use of Menitorix in infants who were born before 36 weeks gestation. Therefore the degree of protection that would be afforded is unknown.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Although symptoms of meningism such as neck pain/ stiffness or photophobia have been reported following administration of other MenC conjugate vaccines, there is no evidence that MenC conjugate vaccines cause meningitis. Clinical alertness to the possibility of coincidental meningitis should be maintained.
Since the Hib capsular polysaccharide antigen is excreted in the urine a false positive urine test for Hib infection can be observed within 1-2 weeks following vaccination. Other tests should be performed in order to confirm Hib infection during this period.
Menitorix should under no circumstances be administered intravascularly or intradermally.
The vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder. No data are available on subcutaneous administration of Menitorix, therefore the possibility of any toxicity or reduced efficacy that might occur with this route of administration is unknown.
The need for booster doses in subjects primed with a single dose of MenC conjugate (i.e. aged 12 months or more when first immunised) has not been established.
The duration of protection in a vaccinated individual against Meningococcal serogroup C disease is unknown. However a decline over time has been observed in the percentages of individuals with at least 1:8 rSBA-MenC titres (see Section 5.1 Pharmacodynamic Properties, Clinical trials).

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Menitorix must not be mixed with any other vaccine in the same syringe.
Separate injection sites should be used if more than one vaccine is being administered.
Menitorix can be given concomitantly with any of the following monovalent or combination vaccines: Diphtheria (D) - Tetanus (T) - acellular Pertussis (aP) - hepatitis B vaccine (HBV) - inactivated polio vaccines (IPV), Measles-Mumps-Rubella (MMR) vaccines and pneumococcal conjugate vaccines. Clinical studies demonstrated that the immune responses and the safety profiles of the coadministered vaccines were unaffected.
Care should be taken to ensure that Menitorix is not administered concurrently with another vaccine containing either Haemophilus influenzae b or meningococcal C vaccine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no data on the potential of Menitorix to impair fertility.
The safety of Menitorix vaccination in pregnancy has not been assessed as the vaccine is not intended for adult use.
 The effect of Menitorix in lactation has not been assessed as the vaccine is not intended for adult use.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial data.

In clinical studies, Menitorix was administered as a 3 or 2 dose primary series in infants (N = 2,452) or as a booster (N = 2,190) dose in the second year of life. Coadministered vaccines in studies in infants included, a DTPa-HBV-IPV vaccine or a DTPa-IPV vaccine or a DTPa-HBV-IPV vaccine and pneumococcal conjugate vaccine (10 valent, Synflorix or 7 valent). When Menitorix was administered as a booster dose, a DTPa-HBV-IPV vaccine or a MMR vaccine or a DTPa containing vaccine and pneumococcal conjugate vaccine (10 valent, Synflorix or 7 valent) was coadministered in some studies.
In another clinical study, Menitorix was also administered as a single dose to more than 300 toddlers (between 12 and 24 months of age) who had been primed in infancy with Hib but not with MenC conjugates. A dose of MMR vaccine was administered concomitantly.
Adverse reactions occurring during these studies were mostly reported within 48 hours following vaccination. The majority of these reactions were of mild to moderate severity and resolved during the follow-up period. There was no evidence that the reactions other than injection site reactions were related to Menitorix rather than the concomitant vaccine.
Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency as follows.
Frequencies per dose are defined as follows. Very common: ≥ 10%. Common: ≥ 1% and < 10%. Uncommon: ≥ 0.1% and < 1%. Rare: ≥ 0.01% and < 0.1%. Very rare: < 0.01%.

Psychiatric disorders.

Very common: irritability. Uncommon: crying. Rare: insomnia.

Nervous system disorders.

Very common: drowsiness.

Gastrointestinal disorders.

Very common: loss of appetite. Uncommon: diarrhoea, vomiting. Rare: abdominal pain.

Skin and subcutaneous tissue disorders.

Uncommon: dermatitis atopic, rash.

General disorders and administration site conditions.

Very common: injection site reactions (pain, redness and swelling), fever (rectal ≥ 38°C). Common: injection site reactions (including induration and nodule). Uncommon: fever (rectal > 39.5°C). Rare: malaise.

Postmarketing data.

Blood and lymphatic system disorders.

Lymphadenopathy.

Nervous system disorders.

Febrile seizures, hypotonia, headache, dizziness.

Respiratory, thoracic and mediastinal disorders.

Apnoea in very premature infants (≤ 28 weeks of gestation).

Immune system disorders.

Allergic reactions (including urticaria and anaphylactoid reactions).

Other possible side effects.

The following have not been reported in association with administration of Menitorix but have occurred very rarely during routine use of licensed meningococcal group C conjugate vaccines.
Severe skin reactions, collapse or shock-like state (hypotonic-hyporesponsiveness episode), faints, seizures in patients with pre-existing seizure disorders, hypoaesthesia, paraesthesia, relapse of nephrotic syndrome, arthralgia, petechiae and/or purpura.

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 www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

There are no data on immunogenicity, safety and reactogenicity of Menitorix administered to preterm infants born before 36 weeks gestation, nor in children beyond the second year of life.
Menitorix is for intramuscular injection only, preferably in the anterolateral thigh region. In children 12 to 24 months of age, the vaccine may be administered in the deltoid region (see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). Menitorix should not under any circumstances be administered intravascularly or intradermally.

Primary vaccination in infants from 6 weeks up to 12 months of age.

Three doses, each of 0.5 mL, should be given with an interval of at least 1 month between doses.

Booster vaccination of children primed in infancy with Hib and MenC conjugate vaccines.

A single (0.5 mL) dose of Menitorix may be used to boost immunity to Hib and MenC in children who have previously completed a primary immunisation series with Menitorix or with other Hib or MenC conjugate vaccines. The timing of the booster dose of Menitorix should be in accordance with available official recommendations and would usually be given from the age of 12 months onwards and at least 6 months after the last priming dose. The need for booster doses in subjects primed with a single dose of MenC conjugate (i.e. aged 12 months or more when first immunised) has not been established.

Vaccination of children primed in infancy with Hib but not with MenC conjugate vaccines.

A single (0.5 mL) dose of Menitorix may be used to elicit immunity against MenC and to boost immunity to Hib. The timing of the dose should be in accordance with available official recommendations and should usually be from the age of 12 months onwards and before the age of 2 years.
Further guidance regarding the use of vaccines can be found in the Australian Immunisation Handbook (see Section 5.1 Pharmacodynamic Properties, Clinical trials for schedules evaluated in clinical trials).

Directions for reconstitution.

Menitorix must be reconstituted by adding the entire contents of the prefilled syringe of diluent to the vial containing the powder.
To attach the needle to the syringe, see Figure 1. However, the syringe provided with Menitorix might be slightly different than the syringe described in Figure 1.
1. Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise.
2. To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock (see Figure 1).
3. Remove the needle protector, which on occasion can be a little stiff.
Add the diluent to the powder. After the addition of the diluent to the powder, the mixture should be well shaken until the powder is completely dissolved in the diluent.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine.
A new needle should be used to administer the vaccine.
Inject the entire contents of the vial.
After reconstitution, the vaccine should be administered promptly or kept in the refrigerator (2°C-8°C). If it is not used within 24 hours, it should be discarded.
Menitorix is for single use in a single patient only. Any unused product or waste material should be disposed of in accordance with local requirements.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

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

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Powder for reconstitution.

Trometamol, sucrose.

Diluent.

0.9% sodium chloride in water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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

Store at 2°C - 8°C (in a refrigerator). Do not freeze.
To reduce microbiological hazard, use as soon as practicable after reconstitution. If storage is necessary, hold at 2°C - 8°C for not more than 24 hours.
Store in the original packaging in order to protect from light.

6.5 Nature and Contents of Container

Powder in a vial (type I glass) with a stopper (butyl rubber), 0.5 mL of diluent in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) with or without separate needles in the following pack sizes:
Pack size of 1 vial of powder plus 1 pre-filled syringe of diluent with or without separate needles.
Pack size of 10 vials of powder plus 10 pre-filled syringes of diluent with or without separate needles.
Not all pack sizes may be distributed in Australia.

6.6 Special Precautions for Disposal

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

Summary Table of Changes