Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
Rubella virus, Quantity: 1000 TCID50; Mumps virus, Quantity: 12500 TCID50; Measles virus, Quantity: 1000 TCID50
Merck Sharp & Dohme (Australia) Pty Ltd
Measles virus,Mumps virus,Rubella virus
Injection, powder for
Excipient Ingredients: monobasic potassium phosphate; hydrolysed gelatin; monosodium glutamate monohydrate; monobasic sodium phosphate; sodium bicarbonate; neomycin; phenolsulfonphthalein; dibasic potassium phosphate; sorbitol; sucrose; dibasic sodium phosphate; glucose monohydrate; ascorbic acid; polysorbate 80; sodium chloride; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; 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; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; Biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium; dibasic sodium phosphate dihydrate; sodium pyruvate; cystine; tyrosine; arginine; histidine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; water for injections
Subcutaneous
1 vial + 1 diluent vial, 5 vials + 5 diluent vials
(S4) Prescription Only Medicine
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. M-M-R II is indicated for simultaneous immunisation against measles, mump and rubella. The Australian NH&MRC Immunisation Handbook recommendations for MMR vaccination are as follows. MMR vaccine is recommended for all children at 12 months of age and again at 4 years of age unless there is a genuine contraindication. In populations with a high incidence of early measles, vaccination at 9 months of age is recommended. Because of the risk to Aboriginal children, the Northern Territory health authority has adopted a practice of administering the first dose of MMR vaccine to Aboriginal children at the age of 9 months. This conforms with WHO recommendations for such populations. The second dose should be given at 12-15 months of age (See paragraph Infants who are less than a 15 months for explanation). 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 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. HIV positive individuals may be given measles, mumps, rubella combined vaccines in the absence of other contraindications
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
Licence status A
2006-02-14
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 Lesen Sie das vollständige Dokument
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 Lesen Sie das vollständige Dokument