M-M-R II powder for injection vial with diluent pre-filled syringe, single dose

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Rubella virus, Quantity: 1000 TCID50; Measles virus, Quantity: 1000 TCID50; Mumps virus, Quantity: 12500 TCID50

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Measles virus,Mumps virus,Rubella virus

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: hydrolysed gelatin; sorbitol; neomycin; phenolsulfonphthalein; monobasic potassium phosphate; sodium bicarbonate; monosodium glutamate monohydrate; dibasic potassium phosphate; sucrose; monobasic sodium phosphate; dibasic sodium phosphate; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; water for injections; ascorbic acid; polysorbate 80; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; histidine hydrochloride; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; Biotin; ergocalciferol; menadione; nicotinic acid; aminobenzoic acid; pyridoxal hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium

Administration route:

Subcutaneous

Units in package:

10 vials of powder and 10 syringes of diluent, 1 vial of powder and 1 syringe of diluent

Prescription type:

(S4) Prescription Only Medicine

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.,Non-Pregnant Adolescent and Adult Females: Immunisation of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (See 4.4 Special Warnings and Precautions for Use and 4.6 Fertility, Pregnancy and Lactation). Vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the foetus and consequent congenital rubella injury. Congenital malformations do occur in up to seven percent of all live births, and their chance appearance after vaccination should be borne in mind.,Women of childbearing age should be advised not to become pregnant for one month after vaccination against rubella (which is included in M-M-R II) and should be informed of the reasons for this precaution (See 4.6 Fertility, Pregnancy and Lactation, Use in Pregnancy).,The Australian Immunisation Handbook recommends that effort should be made to identify and immunise non-pregnant seronegative women of child-bearing age.,Women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. However, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing. Please refer to AIH for recommendations for further information regarding serological testing for immunity to rubella.,Postpubertal females should be informed of the frequent occurrence of generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination against rubella (see 4.8 Adverse Effects (Undesirable Effects)).,Post-Partum Women It has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period using an appropriate rubella-containing vaccine. (See 4.6 Fertility, Pregnancy and Lactation, Use in Lactation).,Revaccination Children vaccinated when younger than 12 months of age should be revaccinated at 12 to 15 months of age. Persons who were vaccinated originally when 12 months of age or older should be revaccinated with a MMR-containing vaccine, as per the recommended vaccination schedule. Revaccination is intended to seroconvert those who did not respond to the first dose. However, data on long term persistence of antibodies are limited and continued surveillance will be required to allow firm recommendations to be made on revaccination. However, persons should be revaccinated if there is evidence to suggest that initial immunisation was ineffective.

Product summary:

Visual Identification: Lyophilised powder; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-12-12

Patient Information leaflet

M-M-R
® II
_Measles, Mumps and Rubella Virus Vaccine Live_
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 mum

Summary of Product characteristics

S-IPC-V205C-022020
1
AUSTRALIAN PRODUCT INFORMATION
M-M-R
® II (MEASLES, MUMPS AND RUBELLA VIRUS VACCINE LIVE)
1
NAME OF THE MEDICINE
Measles, Mumps and Rubella Virus Vaccine Live
2
QUALITATIVE AND QUANTITATIVE COMPOSITION AND
3
PHARMACEUTICAL FORM
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 TCID
50
(50% tissue culture infectious doses) of Measles Virus; 12,500
TCID
50
of Mumps Virus; and 1000 TCID
50
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.
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.
S-IPC-V205C-022020
2
There is some evidence to suggest that inf