Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about M-M-R II. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed the risks of you being given M-M-R II against the benefits they expect it will have for you.

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

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

What M-M-R II is used for

M-M-R II is a vaccine used to help protect people from getting measles, mumps and rubella (German measles). It can be given to people 12 months of age and older.

Protection against these infections is important as they can cause serious problems in some people.

Measles is a serious disease that causes a high fever (temperature), runny nose, cough, conjunctivitis and a rash. It usually lasts for about 1 to 2 weeks. It is very easily passed from one person to another in the tiny droplets of moisture which are expelled during coughing or sneezing. One out of every 10 children who catch measles will also have an ear infection or pneumonia. On rare occasions, measles can also cause an infection of the brain that could lead to seizures, hearing loss, mental retardation, and even death. Babies and adults who catch measles are often much sicker for a longer time or are more likely to die than school children and teenagers who catch measles.

Mumps causes fever, headache, and swollen, painful glands under the jaw (salivary glands) and usually lasts several days. It is easily passed from one person to another by the tiny droplets of moisture expelled during coughing or sneezing. Mumps can sometimes be a very serious disease, causing a mild inflammation of the coverings of the brain and spinal cord (meningitis) in about one person in every 10 who catch it. About one out of every 4 teenage or adult males with mumps will have a painful swelling of the testicles for several days. This does not usually affect their ability to father children, but can cause sterility in rare cases. Teenagers and adults, especially males, who catch mumps are often much sicker and more likely to suffer longer than children do.

Rubella is usually a mild disease that causes a mild fever, swollen glands in the neck, pain and swelling in the joints, and a rash that lasts for 2 or 3 days. Rubella is very dangerous if a pregnant woman catches it. Pregnant women who catch rubella can have babies who are stillborn, or have heart disease, blindness, deafness, or problems with learning. Rubella is also spread to others in the tiny droplets of moisture expelled during coughing or sneezing.

M-M-R II contains weakened strains of living measles, mumps and rubella viruses. These strains of live viruses cause either mild or no symptoms of infection. When injected the vaccine causes the body to produce its own protection by making disease-fighting substances (antibodies) against these infections. If a vaccinated child comes into contact with measles, mumps or rubella virus, the body is usually ready, and produces antibodies to destroy the virus. However, as with all vaccines, 100% protection against measles, mumps and rubella cannot be guaranteed. Also it may take up to 4-6 weeks for maximum protection to develop, so occasionally infections may occur during this time.

The chance of a severe reaction from M-M-R II is very small, but the risks from not being vaccinated are very serious.

Before you are given M-M-R II

When you or your child must not be given it

Do not have the vaccine if you have an allergy to M-M-R II or any of the ingredients listed at the end of this leaflet, including gelatin.

Do not have M-M-R II if you have a serious allergy to:

• the antibiotic neomycin
• eggs - this is because the strains of measles and mumps viruses used to make M-M-R II are grown in eggs.

Symptoms of a serious allergic reaction include swelling of the face, lips, tongue, throat, difficulty in breathing, or hives.

Do not have M-M-R II if:

• you have an infection with fever (high temperature)
• you have active untreated tuberculosis (TB)
• you are taking medicines which decrease the body's immune defence system (eg, corticosteroids, cyclosporin, cancer medicines).
  This does not include taking corticosteroids (eg, cortisone, prednisone) as replacement therapy for Addison's disease.
• you have diseases which decrease the body's immune defence system, such as cancers of the blood cells (eg, leukaemia, lymphoma) and AIDS

Do not have M-M-R II if you are pregnant. Also, do not become pregnant for 1 month after being given the vaccine.

Do not have M-M-R II if the expiry date on the pack has passed. If the vaccine is used after the expiry date has passed, it may not work.

If you are not sure whether you or your child should have M-M-R II, talk to your doctor.

Before you or your child are given it

Tell your doctor if:

1. you have the following medical conditions or a family history of them:

• febrile convulsions (fits or seizures due to a high temperature)
• brain damage
• epilepsy
• low blood platelet count
• HIV

2. you have recently had a blood transfusion or been given immune serum globulins

Your doctor may need to delay giving the vaccine for 3 months.

3. you are breast feeding

Your doctor will discuss the possible risks and benefits of you being given M-M-R II while breast-feeding.

4. you have allergies to any other medicines or vaccines, or any other substances, such as foods, preservatives or dyes.
5. you have a blood clotting disorder or bleed or bruise more easily. In this case your doctor will give you the vaccine under the skin (subcutaneously).

If you have not told your doctor about any of the above, tell them before you or your child are given M-M-R II.

Taking other medicines

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

M-M-R II may not work as well as it should if you or your child are taking medicines that decrease the immune system, such as corticosteroids (eg. prednisone) or cyclosporin.

Your doctor will advise you if you are taking any of these or other medicines that decrease the immune system. Your doctor will decide whether or not to give the vaccine.

M-M-R II should be given one month before or after administration of other vaccines. However, other schedules have been used. Your doctor will decide the vaccination schedule.

How M-M-R II is given

How much is given

The dose for children, teenagers and adults is 0.5 mL.

How it is given

M-M-R II is usually injected just under the skin or into the muscle (subcutaneously or intramuscularly) of the upper arm or in the area of the outer thigh by a doctor or trained nurse.

If your child has a blood-clotting disorder or bleeds or bruises more easily, the vaccine should be given under the skin because bleeding may occur following administration into the muscle.

The vaccine should not be injected directly into blood vessels (intravascularly).

Vaccination schedule

M-M-R II is usually given once to people 12 months of age or older. If the vaccine is given to children younger than 12 months old, a second injection should be given on or after 15 months of age.

Keep a record of your child's vaccinations and update this after each injection.

Keep your child's follow-up appointment with your doctor or clinic. It is important for your child to have the follow-up dose of M-M-R II, if indicated, at the appropriate time to make sure the vaccine has the best chance of providing protection against measles, mumps and rubella.

If you miss a dose

If you miss a scheduled dose, talk to your doctor and arrange another visit as soon as possible.

Side Effects

Tell your doctor or pharmacist as soon as possible if you or your child does not feel well during or after having had an injection of M-M-R II.

M-M-R II helps protect most people from measles, mumps and rubella, 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. You may need medical treatment if you get some of the side effects.

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

Tell your doctor if you or your child have any of the following and they are troublesome or ongoing:

• mild burning and/or stinging at the injection site
• local reaction around the injection site such as soreness, redness, swelling, or a hard lump
• fever, feeling unwell, sore throat, cough, runny or blocked nose
• dizziness, headache
• feeling sick (nausea), vomiting, diarrhoea
• unsteadiness when walking
• irritability
• limited rash
• swelling of the glands in the neck
• swelling of the salivary glands (in front of the ear and/or under the back of the jaw)
• unusual bleeding or bruising under the skin, and swelling of the testicles
• swelling of the epididymis, a part of the male reproductive system
• itchiness of the skin
• Transient joint pain and/or swelling have occurred more frequently in adult females; sometimes these symptoms may be chronic

These are the more common side effects of M-M-R II. For the most part these have been mild. They usually improve or disappear within a few days.

Tell your doctor immediately if you notice any of the following:

• rash all over the body
• aches or pains in joints, arthritis
• bruising or purple spots on the skin
• swelling of the lungs causing coughing, difficulty breathing and wheezing with or without fever, chills, shortness of breath, cough, phlegm and occasionally blood

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor immediately or go to accident and emergency at your nearest hospital if you or your child get any of the following:

• a seizure or convulsion, which may or may not be accompanied by a very high fever
• headache and fever, progressing to hallucinations, confusion, stiff neck and sensitivity to light
• pain, numbness, or tingling of the hands, arms, legs or feet
• fainting
• severe blisters with bleeding in the lips, eyes, mouth, nose or genitals

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

Other side effects may also occur rarely and some of these may be serious. These include allergic reactions, seizures, and inflammation of the nervous system (brain and/or spinal cord).

Allergic Reaction:

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

Tell your doctor immediately or go to accident and emergency if you notice any of the following:

• wheezing or shortness of breath
• swelling of the face, lips, mouth, throat or neck which may cause difficulty in swallowing or breathing
• swelling of the hands, feet, or ankles
• pinkish, itchy swellings on the skin, also called hives or nettlerash
• skin rash, itchiness

If you have these, you may have had a serious allergic reaction to M-M-R II. You may need urgent medical attention or hospitalisation. Most of these side effects occur within 15-30 minutes of vaccination, before you or your child leave the doctor's surgery or clinic.

Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.

Tell your doctor promptly about any of these or any other unusual symptoms. If the condition persists or worsens, seek medical attention.

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

Storage

M-M-R II is usually stored in the doctor's surgery or clinic, or at the pharmacy. However if you need to store M-M-R II:

• Keep it where children cannot reach it.
• Keep it in the refrigerator at a temperature between 2°C and 8°C, but not in the door compartment. Do not freeze it.
• Protect the injection from light by keeping it in the original pack until it is time for it to be given.

Product description

What it looks like

M-M-R II comes as light-yellow powder in glass vials. It is reconstituted with a special diluent to make a solution suitable for injection.

Ingredients

The active ingredients of M-M-R II are weakened strains of measles, mumps and rubella (German measles) viruses.

Inactive ingredients:

• neomycin
• sorbitol
• hydrolysed porcine gelatin
• dibasic sodium phosphate
• sucrose
• monobasic sodium phosphate
• dibasic potassium phosphate
• monobasic potassium phosphate
• phenolsulfonphthalein
• sodium bicarbonate
• monosodium glutamate monohydrate

This product may also contain residual recombinant human albumin, foetal bovine serum and other buffer and media ingredients.

The product contains no preservative.

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.

Supplier

M-M-R II is supplied in Australia by:

Seqirus (Australia) Pty Ltd
63 Poplar Road
PARKVILLE VIC 3052

This leaflet was prepared in
December 2020.

Australian Register Numbers:

AUST R 118449

AUST R 118451

AUST R 201877

(S-WPPI-V205C-I-022020)

Published by MIMS October 2023

Notes

Sponsored by Merck Sharp & Dohme (Australia) Pty Ltd

1 Name of Medicine

Measles, mumps and rubella virus vaccine live.

2 Qualitative and Quantitative Composition

M-M-R II is a sterile lyophilised preparation containing a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell cultures; the Jeryl Lynn (B level) strain of mumps virus propagated in chick embryo cell cultures; and the Wistar RA 27/3 strain of live attenuated rubella virus propagated in human diploid cell (WI-38) culture. The three viruses are mixed before being lyophilised.
The reconstituted vaccine is for subcutaneous (SC) or intramuscular (IM) administration. When reconstituted as directed, the dose for injection is 0.5 mL and contains not less than the equivalent of 1000 TCID₅₀ (50% tissue culture infectious doses) of measles virus; 12,500 TCID₅₀ of mumps virus; and 1000 TCID₅₀ of rubella virus.
Powder for injection.
Before reconstitution, the lyophilised vaccine is a light yellow crystalline powder. M-M-R II, when reconstituted, is clear yellow.
Excipients with known effect: The vaccine contains 14.5 mg of sorbitol.
For the full list of excipients, see Section 6.1 List of Excipients.
This product may also contain residual recombinant human albumin, foetal bovine serum and other buffer and media ingredients.
The product contains no preservative.
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.

3 Pharmaceutical Form

See Section 2 Qualitative and Quantitative Composition.

4 Clinical Particulars

4.1 Therapeutic Indications

M-M-R II is indicated for simultaneous immunisation against measles, mumps and rubella.
Refer to the NHMRC Australian Immunisation Handbook (AIH) for vaccination recommendations and schedule.
There is some evidence to suggest that infants immunised against measles at less than 12 months of age, or who are born to mothers who had wild type measles and who are vaccinated at less than one year of age may not develop sustained antibody levels when later revaccinated. The advantage of early protection must be weighed against the chance for failure to respond adequately on reimmunisation.
Infants who are less than 12 months of age may fail to respond to one or more components of the vaccine due to presence in the circulation of residual antibodies of maternal origin, the younger the infant, the lower the likelihood of seroconversion. In geographically isolated or other relatively inaccessible populations for whom immunisation programmes are logistically difficult, and in population groups in which wild type measles infections may occur in a significant proportion of infants before 15 months of age, it may be desirable to give the vaccine to infants at an earlier age. Infants vaccinated under these conditions at less than 12 months of age should be revaccinated after reaching 12 to 15 months of age.
Previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella vaccine to reduce the risk of exposure of the pregnant woman.

Nonpregnant adolescent and adult females.

Postpartum women.

Revaccination.

4.2 Dose and Method of Administration

For subcutaneous or intramuscular administration. Do not inject intravascularly.
The preferred injection sites are the anterolateral area of the thigh in younger children and the deltoid area in older children, adolescents, and adults.
The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.
Refer to the Australian NHMRC Immunisation Handbook for vaccination recommendations and schedule. This handbook is available online at http://www.immunise.health.gov.au.
Do not give immune globulin (IG) concurrently with M-M-R II. (See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.)
The dosage of vaccine is the same for all persons. Inject the total volume of the single dose vial (about 0.5 mL) subcutaneously, preferably into the outer aspect of the upper arm.

Caution.

Single dose vial.

4.3 Contraindications

Hypersensitivity to any component of the vaccine, including gelatin.
Do not give M-M-R II to pregnant females; the possible effects of the vaccine on foetal development are unknown at this time. If vaccination of postpubertal females is undertaken for protection against rubella, pregnancy should be avoided for one month following vaccination. (See Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy.)
Anaphylactic or anaphylactoid reaction to neomycin (each dose of reconstituted vaccine contains approximately 25 microgram of neomycin). A history of contact dermatitis to neomycin is not a contraindication; however, the possibility of a flare-up of skin lesions should be borne in mind.
History of anaphylactic or anaphylactoid reaction to eggs (see Section 4.4 Special Warnings and Precautions for Use, Hypersensitivity to eggs).
Any febrile respiratory illness or other active febrile infection.
Active untreated tuberculosis.
Patients receiving immunosuppressive therapy. This contraindication does not apply to patients who are receiving corticosteroids as replacement therapy, e.g. for Addison's disease.
Individuals with blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
Primary and acquired immunodeficiency states, including patients who are immunosuppressed in association with AIDS or other clinical manifestations of infection with human immunodeficiency viruses; cellular immune deficiencies; and hypogammaglobulinaemic and dysgammaglobulinaemic states.
Measles inclusion body encephalitis (MIBE), pneumonitis and death as a direct consequence of disseminated measles vaccine virus infection have been reported in severely immunocompromised individuals inadvertently vaccinated with measles containing vaccine.
Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.

4.4 Special Warnings and Precautions for Use

Adequate treatment provisions including adrenaline (epinephrine), should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.
Patients should be observed for a sufficient period (at least 20 minutes) for the occurrence of early onset reactions seen with measles vaccine (see Section 4.8 Adverse Effects (Undesirable Effects)).
Due caution should be employed in administration of M-M-R II to persons with individual or family histories of convulsions, cerebral injury or any other condition in which stress due to fever should be avoided. The physician should be alert to the temperature elevation which may occur following vaccination (see Section 4.8 Adverse Effects (Undesirable Effects)).
Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of human immune serum globulin.
Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7-28 days after vaccination. There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals. Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk. However, transmission of the rubella vaccine virus to infants via breast milk has been documented (see Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation).
There are no reports of transmission of live attenuated measles or mumps viruses from vaccinees to susceptible contacts.
It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or at least 4 to 6 weeks after M-M-R II.
As for any vaccine, vaccination with M-M-R II may not result in seroconversion in 100% of susceptible persons given the vaccine.

Hypersensitivity to eggs.

Thrombocytopenia and coagulation disorders.

Use in the elderly.

Paediatric use.

Other.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Administration of immune globulins concurrently with M-M-R II may interfere with the expected immune response. Vaccination should be deferred for 3 months or longer following administration of immune globulin (human) and blood or plasma transfusions.

Use with other vaccines.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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.

4.8 Adverse Effects (Undesirable Effects)

The adverse reactions associated with the use of M-M-R II are those which have been reported following administration of the combination vaccines.

Common.

Occasional.

Body as a whole.

Skin.

Rare.

Body as a whole.

Cardiovascular.

Digestive.

Haematologic/lymphatic.

Hypersensitivity.

Musculoskeletal.

Nervous/psychiatric.

Respiratory system.

Skin.

Special senses.

Urogenital.

Other.

Children who received M-M-R II intramuscularly.

Arthralgia and/or arthritis.

Subacute sclerosing panencephalitis (SSPE).

Aseptic meningitis.

Encephalitis/encephalopathy.

Panniculitis.

Reporting suspected adverse effects.

4.9 Overdose

Overdose has been reported rarely and was not associated with any serious adverse events.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sorbitol, monobasic sodium phosphate, dibasic potassium phosphate, dibasic sodium phosphate, monobasic potassium phosphate, hydrolysed porcine gelatin, phenolsulfonphthalein, sodium bicarbonate, sucrose, neomycin, monosodium glutamate monohydrate.

6.2 Incompatibilities

Not applicable. Please see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for further information.

6.3 Shelf Life

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

6.4 Special Precautions for Storage

Before reconstitution, store the vial of lyophilised vaccine at 2-8°C or colder. The diluent may be stored in the refrigerator with the lyophilised vaccine or separately at room temperature. Do not freeze the diluent.
To reduce microbiological hazard, it is recommended the vaccine be used as soon as possible after reconstitution. If storage of reconstituted vaccine is necessary, store in a dark place at 2°C-8°C and discard if not used within 8 hours.
The vaccine must be maintained at a temperature of 2-8°C during shipment, to ensure that there is no loss of potency. Freezing during shipment will not affect potency of the vaccine.
Protect the vaccine from light at all times, since such exposure may inactivate the viruses.

6.5 Nature and Contents of Container

M-M-R II is supplied as:
(1) a combination pack of a single-dose vial of lyophilised vaccine and a diluent-containing syringe.
(2) a box of ten combination packs of single-dose vials of lyophilised vaccine with diluent-containing syringes.
(3) a single-dose vial of lyophilised vaccine and a vial of diluent.
(4) a box of five combination packs of single-dose vials of lyophilized vaccine with diluent-containing vials.
(5) a box of ten combination packs of single-dose vials of lyophilised vaccine with diluent-containing vials.
(6) a single-dose vial of lyophilised vaccine, with diluent supplied separately.
(7) a box of ten single-dose vial of lyophilized vaccine, with diluent supplied separately.
Combination pack containing lyophilised vaccine and diluent together should be stored at 2-8°C.
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.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine S4.

Summary Table of Changes