Consumer medicine information

Priorix

Measles vaccine, live; Mumps vaccine, live; Rubella vaccine, live

BRAND INFORMATION

Brand name

Priorix Powder for injection

Active ingredient

Measles vaccine, live; Mumps vaccine, live; Rubella vaccine, live

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Priorix.

WHAT IS IN THIS LEAFLET

This leaflet answers some of the common questions about PRIORIX vaccine. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of you or your child having PRIORIX against the expected benefits.

If you have any concerns about PRIORIX talk to your doctor, nurse or pharmacist.

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

WHAT PRIORIX IS USED FOR

PRIORIX is a vaccine used to prevent three diseases, measles, mumps and rubella (German measles). The vaccine is sometimes called MMR vaccine.

Measles, mumps and rubella are all infectious diseases caused by viruses. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

Measles

Measles is a highly infectious viral illness. Measles is spread by small droplets from the nose, throat or mouth of an infected person (often before it is obvious they have measles). Measles often begins with a fever, runny nose, hacking cough and conjunctivitis (eye inflammation). The rash appears 3-5 days after the onset of symptoms and spreads rapidly all over the body. Measles is often a severe disease complicated by ear infection and pneumonia (lung infection). Encephalitis (swelling of the brain) can also occur and can sometimes result in permanent brain damage or death.

Unimmunised children in the following groups are at particular risk from severe measles infection:

  • children with chronic conditions such as cystic fibrosis, congenital heart or kidney disease, failure to thrive, Down's Syndrome
  • children from the age of 1 year upwards in child care centres, family day care and playgroups
  • children living in institutions
  • Aboriginal and Torres Strait Islander children.

Mumps

Mumps is an infectious viral disease spread by infected droplets of saliva. Symptoms often begin with chilly sensations, headache, loss of appetite, general unwellness and fever. The salivary glands on one or both sides of the face can then become very painful and swollen. Complications include meningoencephalitis (swelling around the brain) and in older patients the disease may involve other organs e.g. testes in males.

Rubella (German measles)

Rubella is generally a mild infectious viral illness spread by airborne droplets. It can cause mild fever, general unwellness, swollen glands and mild red rash. It often goes unnoticed in adolescents and adults. However rubella can cause miscarriage, stillbirth or birth defects in infants born to mothers infected with rubella during the early months of pregnancy.

Vaccination is the best way to protect against these severe diseases. The vaccine will not protect against diseases caused by other types of viruses or organisms.

BEFORE RECEIVING PRIORIX

DO NOT HAVE PRIORIX IF:

  • you have/your child has had an allergic reaction to PRIORIX or any ingredient contained in this vaccine. The ingredients are listed at the end of this leaflet. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.
  • you have/your child has ever had a severe allergic reaction to eggs or anything that contained eggs. Signs of an allergic reaction are listed above.
  • if you have/your child has had PRIORIX or another MMR vaccine before and became unwell, tell your doctor or nurse before the next dose is given.
  • you have/your child has a severe infection with a high temperature. A minor infection such as a cold should not be a problem, but talk to your doctor or nurse about this before being vaccinated.
  • you are or think you may be pregnant or if you intend to become pregnant within one month. Your doctor will discuss with you the risks of receiving PRIORIX during pregnancy.
  • you have/your child has lowered immunity. This can occur in persons:
    - with inherited (or family history of) immune deficiency conditions
    - with abnormal blood conditions or blood protein (immunoglobulin) disorders
    - with cancer
    - receiving or who have received certain drugs (i.e. cyclosporin, corticosteroids, and cancer medicines)
    - receiving or who have received radiation therapy

PRIORIX may generally be given to people with Human Immunodeficiency Virus (HIV) infection.

If needed, you can talk to your doctor about use of PRIORIX in HIV-positive people.

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

If you are not sure whether PRIORIX should be given, talk to your doctor or nurse. Do not give this vaccine to anyone else; your doctor has prescribed it specifically for you/or your child.

BEFORE HAVING PRIORIX TELL YOUR DOCTOR IF

  • you have any medical problems such as:
    - tuberculosis (TB) - PRIORIX may affect the tuberculin skin test. Tuberculin testing may be done before or at the same time that PRIORIX is given.
    - a history or family history of convulsions (fits or seizures)
    - a history or family history of allergic diseases
    - a skin allergy to neomycin
    - a bleeding disorder. Sometimes PRIORIX may need to be given differently in people with bleeding problems.
    - a weakened immune system. You/your child should be closely monitored as the response to the vaccine may not be sufficient to ensure protection against the illness.
  • you have/your child has allergies to any other medicines or substances, such as dyes, foods or preservatives.
  • you are breast feeding. Your doctor will discuss the risks and benefits of vaccination.
  • you have received another vaccine within the last month.
  • you have/your child has received a blood or plasma transfusion, or been given gamma globulin or other immunoglobulin within the last 3 months. PRIORIX may be less effective if given within 3 months of these products. Your doctor will decide when to give the vaccine.
  • you are/your child is taking any prescription or OTC (over-the-counter) medicines. Some vaccines may be affected by other vaccines or medicines. Your doctor, nurse or pharmacist will be able to tell you what to do if PRIORIX is to be given with another vaccine or medicine.
  • you have/ your child has had a side effect after vaccination against measles, mumps or rubella that involved easy bruising or bleeding for longer than usual.

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

HOW PRIORIX IS GIVEN

The doctor or nurse will give PRIORIX as an injection.

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

HOW MUCH IS GIVEN

PRIORIX is generally given as a single 0.5 mL dose. The same dose is used for children and adults.

HOW IT IS GIVEN

The vaccine comes as a powder which is mixed with sterile water before use. PRIORIX is injected under the skin (subcutaneously) or into muscle. PRIORIX is generally injected into the upper leg muscle in infants under 12 months of age. In children over 12 months of age and older children and adults the injection may be given in the upper arm muscle.

PRIORIX should never be given into a vein.

WHEN IT WILL BE GIVEN

The first dose of PRIORIX is generally given to children at 12 months of age. A second dose is then administered to children at 4-6 years of age; preferably before commencement at school.

IF A DOSE IS MISSED

If your child misses a scheduled dose, talk to your doctor or nurse and arrange another visit as soon as possible.

AFTER RECEIVING PRIORIX

THINGS YOU MUST NOT DO:

  • do not become pregnant for one month after receiving PRIORIX vaccination. Talk to your doctor as soon as possible, if you do become pregnant within this time.

THINGS YOU MUST DO:

Tell your doctor you/your child has received PRIORIX if:

  • you/they are to have a tuberculin skin test for tuberculosis within 4-6 weeks after vaccination. The results of the test may be affected by the vaccine.
  • you/they are to have another vaccine within 1 month after vaccination.
  • you/they are to have a blood or plasma transfusion, or be given gamma globulin or other immunoglobulin within 2 weeks after vaccination.

THINGS TO BE CAREFUL OF:

Be careful driving or operating machinery until you know how PRIORIX affects you. PRIORIX should not normally interfere with your ability to drive a car or operate machinery. But in some people vaccination can cause dizziness or lightheadedness. Make sure you know how you react to PRIORIX before you drive a car or operate machinery, or do anything that could be dangerous if you are dizzy or lightheaded.

It is advised to remain in the clinic for about 15 minutes after receiving the injection. There is a risk of allergic reactions. These may be local or widespread rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness. These reactions will usually occur before leaving the doctor’s surgery. If these symptoms occur, you should contact a doctor immediately.

SIDE EFFECTS

Tell your doctor, nurse or pharmacist as soon as possible if you (or your child) have troublesome symptoms after having had a dose of PRIORIX.

PRIORIX helps protect most people from measles, mumps and rubella infection, but it may have unwanted side effects in a few people. All medicines and vaccines can have side effects. Sometimes they are serious; most of the time they are not. Some side effects may need medical treatment. The chance of your child having a serious side effect is very much less than the chance of you or your child having a permanent injury from the natural infections.

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

Most unwanted effects with PRIORIX are mild. These effects, as with other vaccines, generally occur around the injection site.

Side effects that occurred during clinical trials with PRIORIX were as follows:

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

  • pain and redness at the injection site
  • fever greater than or equal to 38°C (rectal)

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

  • swelling at the injection site
  • fever greater than 39.5°C (rectal)
  • rash (spots and/or blisters)
  • upper respiratory tract infection
  • infection of the middle ear
  • viral infection
  • nervousness
  • bronchitis
  • cough
  • runny nose
  • diarrhoea
  • vomiting
  • headache
  • sore throat and discomfort when swallowing

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

  • allergic reactions
  • tiredness (fatigue)
  • swelling of the mouth and throat
  • toothache
  • loss of appetite
  • nausea
  • abnormal crying
  • not being able to sleep (insomnia)
  • discharge with itching of the eyes and crusty eyelids (conjunctivitis)
  • swollen glands in the cheek
  • swollen glands in the neck, armpit or groin
  • itchiness
  • cold sores, shingles
  • feeling generally unwell, dizziness, tiredness
  • harsh breathing sounds
  • pneumonia
  • nose bleeds
  • stomach pain or discomfort
  • dizziness

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

  • seizures with fever

After commercialisation, the following additional side effects have been rarely reported in people vaccinated with PRIORIX:

  • mumps like symptoms (including transient, painful swelling of the testicles and swollen glands in the neck)
  • temporary lumpy rash that may affect the skin, mouth and other parts of the body
  • bleeding or bruising more easily than normal which may be associated with skin rashes/peeling or fever
  • joint and muscle pains
  • infection around the brain or spinal cord (meningitis)
  • infection or inflammation of the nervous system resulting in temporary loss of control of bodily movements, walking or sensation changes

Other side effects not listed above, can also occur during or soon after a dose of PRIORIX.

Check with your doctor or nurse if you or your child has any other effects.

Do not be alarmed by this list of possible side effects. You or your child may not experience any of them.

STORAGE

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

  • Keep PRIORIX in the refrigerator stored between 2°C and 8°C. DO NOT STORE PRIORIX IN THE FREEZER. Do not store it in the bathroom, near the sink, or leave it in the car on hot days. Avoid exposing the vaccine to sunlight.
  • Keep the vaccine out of the reach of children.
  • Keep PRIORIX in the original pack until it is time for it to be given.

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

PRODUCT DESCRIPTION

WHAT IT LOOKS LIKE

PRIORIX comes as a whitish to slightly pink powder in a glass vial. This is mixed (reconstituted) with water diluent supplied in a prefilled syringe. The reconstituted vaccine may vary in colour from clear peach to fuchsia pink.

The vaccine should be injected as soon as possible after reconstitution, and no later than 8 hours after reconstitution.

INGREDIENTS

The active ingredients of PRIORIX are live weakened measles, mumps and rubella viruses in a dry powder. Each 0.5 mL dose contains not less than:

  • 103.0 CCID50 (cell culture infectious dose 50%) of the Schwarz measles
  • 103.7 CCID50 of the RIT 4385 mumps, and
  • 103.0 CCID50 of the Wistar RA 27/3 rubella virus strains.

The inactive ingredients in the vaccine are: lactose monohydrate, amino acids, sorbitol and mannitol. Neomycin sulphate is present as a residual from the manufacturing process. The vaccine is mixed with sterile Water for Injection before use.

The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

FURTHER INFORMATION

PRIORIX is only available if prescribed by a doctor.

PRIORIX comes as single or 10 dose packs containing a whitish to slightly pink powder in a glass vial and the diluent in a prefilled syringe (AUST R 97842).

MANUFACTURER

GlaxoSmithKline Biologicals s.a.
Rue de l'Institut 89,
1330 Rixensart, Belgium.

DISTRIBUTED IN AUSTRALIA BY

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

Date of Preparation:

18 July 2017

Version 6.0

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

©2017 GSK group of companies or its licensor.

BRAND INFORMATION

Brand name

Priorix Powder for injection

Active ingredient

Measles vaccine, live; Mumps vaccine, live; Rubella vaccine, live

Schedule

S4

 

1 Name of Medicine

Measles virus, mumps virus and rubella virus vaccine.

6.7 Physicochemical Properties

Not relevant to vaccines.

2 Qualitative and Quantitative Composition

Priorix is a live virus vaccine for immunisation against measles, mumps and rubella.
Priorix is a sterile lyophilised mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Each virus strain is separately obtained by propagation in either chick embryo tissue cultures (mumps and measles) or MRC5 human diploid cells (rubella).
Each 0.5 mL dose of the reconstituted vaccine contains not less than 103.0 CCID50 (cell culture infectious dose 50%) of the Schwarz measles, not less than 103.7 CCID50 of the RIT 4385 mumps and not less than 103.0 CCID50 of the Wistar RA 27/3 rubella virus strains. The three virus strains are mixed prior to lyophilisation.
The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.
Priorix meets the World Health Organisation requirements for manufacture of biological substances and for measles, mumps and rubella vaccines and combined vaccines (live).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder and diluent for solution for injection.
Priorix is presented as a whitish to slightly pink powder. The sterile water diluent is clear and colourless. The reconstituted vaccine may vary in colour from clear peach to fuchsia pink, without deterioration of the vaccine potency.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Priorix induces antibodies against all vaccine components.

Clinical trials.

Seroconversion has been shown to equate with protection against each of the measles, mumps and rubella viruses.

Primary immunisation.

In clinical studies, Priorix has been demonstrated to be highly immunogenic.
In previously seronegative vaccinees, antibodies were detected in 98.0%, 96.1% and 99.3% of subjects against measles, mumps and rubella respectively.
In a pooled analysis of comparative studies of over 1400 children, antibodies against measles, mumps and rubella were detected in 98.7%, 95.5% and 99.5% of previously seronegative subjects (n = 1094) who received Priorix. Antibodies against measles, mumps and rubella were detected in 96.9%, 96.9% and 99.5% of subjects (n = 388) respectively, who had received a commercially available combined MMR vaccine.
Similar seroconversion rates were seen in subjects who received Priorix by the intramuscular route.
Seroconversion rates in a limited number of subjects (n = 60) aged 9-11 months were also measured. 100% of these subjects developed antibodies against mumps and rubella. 96.6% of the subjects developed anti-measles antibodies.
Antibody levels of participants in the pooled studies have been monitored for up to 12 months following vaccination. All subjects remained seropositive for anti-measles and anti-rubella antibodies. Anti-mumps antibodies were detected in 88.4% of subjects. A similar result was observed with a commercially available MMR vaccine.
In a more recent study comparing the current formulation of Priorix (albumin-free) with the previous formulation containing albumin, antibodies against measles, mumps and rubella were detected in 98.4, 94.8 and 100% of previously seronegative subjects (n = 191) who received the current formulation. Antibodies against measles, mumps and rubella were detected in 99.5, 94.7 and 100% of subjects (n = 190) respectively, who had received the formulation used in the earlier studies containing albumin. There were no significant differences in immunogenicity between the current formulation of Priorix (albumin-free) and the formulation containing albumin used in the earlier studies.

Booster immunisation.

A booster dose of Priorix was administered to children aged 4-6 years or 11-12 years, who had been primed with a different MMR vaccine. All subjects aged 4-6 years who were seronegative at the time of booster, subsequently seroconverted. In subjects aged 11-12 years who were seronegative at the time of booster, seroconversion rates of 85.7%, 93.5% and 100% were observed for measles, mumps and rubella respectively.

5.2 Pharmacokinetic Properties

Not relevant to vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Priorix is indicated for active immunisation against measles, mumps and rubella from 12 months of age.

4.3 Contraindications

Priorix is contraindicated in pregnant women. If vaccination of postpubertal women occurs, pregnancy should be avoided for one month (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).
Priorix should not be administered to children and adults with known hypersensitivity to any components of the vaccine (for egg allergy, see Section 4.4 Special Warnings and Precautions for Use). Vaccination is contraindicated in children and adults who are allergic to neomycin, although a history of contact dermatitis to neomycin is not a contraindication.
Priorix is contraindicated in children and adults having shown signs of hypersensitivity after previous administration of measles, mumps and/or rubella vaccines.
As with other vaccines, the administration of Priorix should be postponed in children and adults suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication.
Priorix is contraindicated in patients with severe humoral or cellular (primary or acquired) immunodeficiency e.g. symptomatic HIV infection (see Section 4.4 Special Warnings and Precautions for Use), those receiving high dose steroids (further guidance is found in the Australian Immunisation Handbook).

4.4 Special Warnings and Precautions for Use

Priorix must not be administered intravascularly.
As with all injectable vaccines, appropriate medical treatment (i.e. adrenaline) and supervision should always be readily available in case of anaphylactic reactions following the administration of the vaccine.
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.
Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine as they can inactivate the attenuated viruses in the vaccine.
Infants below 12 months of age may not respond sufficiently to the measles component of the vaccine due to the possible persistence of maternal measles antibodies. This should not preclude the use of the vaccine in younger infants (< 12 months) as vaccination may be indicated in certain situation such as high risk areas (see Section 4.1 Therapeutic Indications). In these circumstances revaccination at or after 12 months should be considered.
Limited protection against measles may be obtained by vaccination up to 72 hours after exposure to natural measles. If the vaccination status of the child is in doubt, the vaccine should be given as there are no ill effects of vaccinating individuals who are already immune. The antibody response to the rubella and mumps components is too slow for effective post-exposure prophylaxis.
Transmission of measles and mumps virus from vaccinees to susceptible contacts has never been documented. Pharyngeal excretion of the rubella virus is known to occur about 7 to 28 days after vaccination with peak excretion around the 11th day. However there is no evidence of transmission of this excreted virus to susceptible contacts.
Priorix should be given with caution to persons with a history or family history of allergic disease or those with a history or family history of convulsions.
The measles and mumps components of the vaccine are produced in chick embryo cell culture and may therefore contain traces of egg protein. Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension or shock) subsequent to egg ingestion should not be vaccinated with Priorix.
It appears that persons are not at increased risk if they have egg allergies that are not anaphylactic or anaphylactoid in nature. Such persons may be vaccinated in the usual manner. There is no evidence to indicate that persons with allergies to chickens or feathers are at increased risk of reaction to the vaccine.
As for any vaccine, immunisation with measles, mumps, rubella vaccine may not result in seroconversion in 100% of susceptible persons given the vaccine.
Cases of worsening thrombocytopenia and recurrence of thrombocytopenia in children and adults who suffered thrombocytopenia after the first dose have been reported following vaccination with live measles, mumps and rubella vaccines. In such cases, the risk benefit of immunising with Priorix should be carefully evaluated.
There is limited data on the use of Priorix in immunocompromised patients, therefore vaccination should be considered with caution and only when, in the opinion of the physician, the benefits outweigh the risks (e.g. asymptomatic HIV subjects) further guidance is found in the Australian Immunisation Handbook.
Immunocompromised patients who have no contraindication for this vaccination (see Section 4.3 Contraindications) may not respond as well as immunocompetent children and adults, therefore some of these patients may acquire measles, mumps or rubella despite appropriate vaccine administration. Immunocompromised patients should be monitored carefully for signs of measles, mumps and rubella.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.4 Special Warnings and Precautions for Use.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Clinical studies have demonstrated that Priorix can be given simultaneously with any of the following monovalent or combination vaccines: hexavalent vaccine (DTPa-HBV-IPV/Hib), diphtheria-tetanus-acellular pertussis vaccine (DTPa), reduced antigen diphtheria-tetanus-acellular pertussis vaccine (dTpa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hepatitis A vaccine (HAV), meningococcal serogroup B vaccine (MenB), meningococcal serogroup C conjugate vaccine (MenC), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (MenACWY), varicella vaccine and pneumococcal conjugate vaccine (PCV).
In addition, it is generally accepted that combined measles, mumps and rubella vaccines may be given at the same time as oral polio vaccine (OPV) or the combined diphtheria-tetanus and whole cell pertussis vaccines (DTPw).
If Priorix is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
If Priorix cannot be given at the same time as another live attenuated vaccine, an interval of at least 1 month should be left between the two vaccinations.
If tuberculin (Mantoux) testing is needed, it should be carried out before, or simultaneously with measles, mumps and rubella vaccination. It has been reported that live measles (and possibly mumps) vaccine may cause a temporary depression of tuberculin skin sensitivity which could last 4 to 6 weeks. Tuberculin testing is therefore unreliable (false negative) for 4 to 6 weeks after administration of measles, mumps, rubella vaccine.
In children and adults who have received human gammaglobulins or blood transfusions, vaccination should be delayed for at least 3 months because of the possibility of vaccine failure due to passively acquired measles, mumps and rubella antibodies.
Priorix should not be mixed with other vaccines in the same syringe.
Priorix can be used as a booster dose in children and adults who have previously been vaccinated with Priorix or another measles, mumps and rubella combined vaccine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Pregnant women must not be vaccinated with Priorix.
However, foetal damage has not been documented when measles, mumps or rubella vaccines have been given to pregnant women.
Even if a theoretical risk cannot be excluded, no cases of congenital rubella syndrome have been reported in more than 3500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated with rubella containing vaccines. Therefore, inadvertent vaccination of unknowingly pregnant women with measles, mumps and rubella containing vaccines should not be a reason for termination of pregnancy.
Women of child bearing age should be tested for rubella antibodies prior to pregnancy. All seronegative women, provided they are not pregnant, should be offered rubella vaccine. Pregnancy should be avoided for one month after vaccination. Women who intend to become pregnant should be advised to delay pregnancy.
There is little human data regarding use in breastfeeding women. Persons can be vaccinated where the benefit outweighs the risk.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial experience.

Primary immunisation.

A total of approximately 12,000 subjects were administered Priorix in clinical trials. During controlled clinical studies, the signs and symptoms were actively monitored during a 42 day follow-up. The vaccinees were also requested to report any other clinical events which manifested during the study period. Table 1 lists the pooled incidence of solicited symptoms from 9 comparative studies for children vaccinated with Priorix according to protocol. (The results for the comparator vaccine are based on 8 studies, n = 1074).

Other events.

The safety profile presented below is based on a total of approximately 12,000 subjects administered Priorix in clinical trials. Causality has not been established. The incidence of adverse reactions described below were similar to the comparator MMR vaccine.
The events are listed within body systems and categorised by frequency according to the following definitions. Very common: ≥ 10%; common: ≥ 1% and < 10%; uncommon: ≥ 0.1% and < 1%; rare: ≥ 0.01% and < 0.1%; very rare: < 0.01%.

Body as a whole.

Very common: redness at the injection site, fever ≥ 38°C (rectal) or ≥ 37.5°C (axillary/ oral). Common: pain and swelling at the injection site, fever > 39.5°C (rectal) or > 39°C (axillary/ oral), viral infection. Uncommon: injury, infection, allergy, abnormal crying, fatigue, infection bacterial, infection fungal.

Skin and appendages.

Common: rash. Uncommon: dermatitis, eczema, pruritus, herpes simplex, herpes zoster.

Respiratory.

Common: pharyngitis, bronchitis, coughing, respiratory disorder, other upper respiratory tract infection, rhinitis. Uncommon: pneumonia, laryngitis, stridor.

Gastrointestinal.

Common: diarrhoea. Uncommon: anorexia, gastrointestinal disorder, parotid gland enlargement, toothache, vomiting, enteritis, gastroenteritis, stomatitis, stomatitis aphthous.

Central nervous system.

Common: nervousness. Uncommon: insomnia. Rare: febrile convulsions.

Special senses.

Common: otitis media. Uncommon: conjunctivitis.

Haematologic/ lymphatic.

Uncommon: anaemia, lymphadenopathy.
Five adverse events experienced by three subjects were considered by the investigators to be serious and related or possibly related. These events were: granulocytopenia, fever, exanthema, vomiting and epididymitis.

Booster immunisation.

In a study examining booster doses of Priorix administered to children aged 4-6 years, the following solicited symptoms in Table 2 were reported.
In a study examining booster doses of Priorix administered to children aged 11-12 years of age, the following solicited symptoms in Table 3 were reported.

Other events.

All unsolicited events reported in this booster study, are listed below. The events are listed within body systems and categorised by frequency according to the following definitions. Very common: ≥ 10%; common: ≥ 1% and < 10%; uncommon: ≥ 0.1% and < 1%; rare: ≥ 0.01% and < 0.1%; very rare: < 0.01%. Causality has not been established.

Booster in 4-6 year old children.

Body as a whole.

Very common: pain and redness at the injection site, fever ≥ 38°C (rectal) or ≥ 37.5°C (axillary/ oral). Common: swelling at the injection site, fever > 39.5°C (rectal) or > 39°C (axillary/ oral), allergy.

Respiratory.

Common: bronchitis, coughing, pharyngitis, rhinitis. Uncommon: asthma, epistaxis, sinusitis.

Gastrointestinal.

Common: diarrhoea, vomiting. Uncommon: colitis, gastroenteritis, parotid gland enlargement.

Central nervous system.

Common: headache. Uncommon: dysphonia.

Skin and appendages disorder.

Common: rash, eczema. Uncommon: dermatitis, urticaria.

Vision disorders.

Uncommon: conjunctivitis.

Resistance mechanism disorders.

Common: upper respiratory tract infection, otitis media, herpes zoster (varicella). Uncommon: herpes simplex, infection viral.

Booster in 11-12 year old children.

Body as a whole.

Uncommon: viral infection, lymphadenopathy.

Respiratory.

Common: upper respiratory tract infection, rhinitis, pharyngitis, asthma. Uncommon: coughing, epistaxis.

Gastrointestinal.

Uncommon: abdominal pain, gastroenteritis, diarrhoea.

Central nervous system.

Common: headache. Uncommon: dizziness.

Skin and appendages disorder.

Uncommon: pruritus, skin exfoliation, nail disorder, injection site reaction, urticaria.

Post-marketing data.

During post-marketing surveillance, the following reactions have been reported additionally in temporal association with Priorix vaccination.

Infections and infestations.

Rare: meningitis, measles-like syndrome, mumps-like syndrome (including orchitis, epididymitis and parotitis).

Blood and lymphatic system disorders.

Rare: thrombocytopenia, thrombocytopenic purpura.

Immune system disorders.

Rare: anaphylactic reactions.

Nervous system disorders.

Rare: encephalitis, cerebellitis, cerebellitis-like symptoms (including transient gait disturbance and transient ataxia), Guillain-Barre syndrome, transverse myelitis, peripheral neuritis.

Vascular disorders.

Rare: vasculitis (including Henoch-Schonlein purpura and Kawasaki syndrome).

Skin and subcutaneous tissue disorders.

Rare: erythema multiforme.

Musculoskeletal and connective tissue disorders.

Rare: arthralgia, arthritis.
As in natural rubella infection, myalgia may occur 2 to 4 weeks after administration of live rubella vaccines.
Accidental intravascular administration may give rise to severe reactions or even shock. Immediate measures depend on the severity of the reaction. (See Section 4.4 Special Warnings and Precautions for Use).

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

All parenteral drug and vaccine products should be inspected visually for any particulate matter and/or variation of physical aspects prior to reconstitution or administration. In the event of either being observed, do not use the vaccine.

Dosage (dose and interval).

A reconstituted dose of 0.5 mL is recommended for children and adults.

Children.

Two doses are usually given. The first dose is usually given at 12 months of age, followed by a booster dose at 4 - 6 years of age (see Section 4.1 Therapeutic Indications).

Adults.

A single dose may be given to adults who do not have immunity.

Method of administration.

Priorix is administered by subcutaneous or intramuscular injection, in the deltoid region or in the anterolateral area of the thigh. The vaccine should never be administered intravascularly.
The vaccine should be administered subcutaneously in subjects with bleeding disorders (e.g. thrombocytopenia or any coagulation disorder).
Further guidance regarding the use of vaccines is found in the Australian Immunisation Handbook.

Reconstitution.

Instructions for reconstitution of the vaccine with diluent presented in ampoules.

Priorix must be reconstituted by adding the entire contents of the supplied ampoule of diluent to the vial containing the powder. The mixture should be well shaken until the powder is completely dissolved in the diluent.
After reconstitution, the vaccine should be used promptly.
Withdraw the entire contents of the vial. Inject the entire contents of the syringe, using a new needle for administration.

Instructions for reconstitution of the vaccine with the diluent presented in pre-filled syringe.

Priorix must be reconstituted by adding the entire contents of the pre-filled syringe of diluent to the vial containing the powder.
To attach a needle to the syringe, carefully read the instructions given with Figure 1. However, the syringe provided with Priorix might be slightly different than the syringe illustrated.
Always hold the syringe by the barrel, not by the syringe plunger or the Luer Lock Adaptor (LLA), and maintain the needle in the axis of the syringe (as illustrated in Figure 1). Failure to do this may cause the LLA to become distorted and leak.
During assembly of the syringe, if the LLA comes off, a new vaccine dose (new syringe and vial) should be used.
1. Unscrew the syringe cap by twisting it anticlockwise (as illustrated in Figure 1).
2. Attach a needle to the syringe by gently connecting the needle hub into the LLA and rotate a quarter turn clockwise until you feel it lock (as illustrated in Figure 1).
3. Remove the needle protector, which may be stiff.
4. Add the diluent to the powder. The mixture should be well shaken until the powder is completely dissolved in the diluent.
After reconstitution, the vaccine should be used promptly.
5. Withdraw the entire contents of the vial.
6. A new needle should be used to administer the vaccine. Unscrew the needle from the syringe and attach an injection needle by repeating step 2 above.
Inject the entire contents of the syringe.
The vaccine should be injected as soon as possible after reconstitution. The reconstituted vaccine can be stored between 2 and 8°C, for up to 8 hrs before use.
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

Cases of overdose (up to 2 times the recommended dose) have been reported during post-marketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.
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

The lyophilised vaccine contains lactose monohydrate, amino acids and sorbitol and mannitol as stabilisers. Neomycin sulphate is present as a residual from the manufacturing process.

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

The vaccine should be stored between 2°C and 8°C in a refrigerator.

6.5 Nature and Contents of Container

The powder is presented in a glass vial. The diluent is presented in a glass prefilled syringe or ampoule.
Priorix is available in pack sizes of 1 or 10.
The vials and prefilled syringes are made of neutral glass type I, which conforms to European Pharmacopoeia Requirements.
Not all pack sizes and container types 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