Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - mumps virus, quantity: 12500 tcid50; measles virus, quantity: 1000 tcid50; rubella virus, quantity: 1000 tcid50 - injection, powder for - excipient ingredients: gelatin; neomycin; sorbitol; sucrose; dibasic potassium phosphate; monobasic potassium phosphate; phenolsulfonphthalein; dibasic sodium phosphate; monosodium glutamate monohydrate; sodium bicarbonate; monobasic sodium phosphate; albumin; bovine serum albumin; 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 - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - rubella virus, quantity: 1000 tcid50; mumps virus, quantity: 12500 tcid50; measles virus, quantity: 1000 tcid50 - 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 - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - measles virus - enders edmonston strain mumps virus - jerylynn strain rubella virus - wistar ra27/3 strain - 0.5ml millilitre

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - measles vaccine 1000 tcid50 (edmonston b strain (3 log per dose)); mumps virus, jeryl-lynn strain 19952 tcid50 (b level (4.3 log per dose)); rubella virus, wistar ra27/3 strain 1000 tcid50 ((3 log per dose) ); varicella vaccine 9772 pfu (oka/merck strain (3.99 log per dose));   - injection with diluent - 0.5 ml - active: measles vaccine 1000 tcid50 (edmonston b strain (3 log per dose)) mumps virus, jeryl-lynn strain 19952 tcid50 (b level (4.3 log per dose)) rubella virus, wistar ra27/3 strain 1000 tcid50 ((3 log per dose) ) varicella vaccine 9772 pfu (oka/merck strain (3.99 log per dose))   excipient: dibasic potassium phosphate dibasic sodium phosphate gelatin minimum essential medium eagle medium 199 monosodium glutamate phenolsulfonphthalein potassium chloride sodium bicarbonate sodium chloride sorbitol sucrose urea water for injection - proquad is indicated for vaccination against measles, mumps, rubella, and varicella in individuals 12 months through 12 years of age.

Canada - English - Health Canada

merck canada inc - measles virus vaccine live attenuated; mumps virus vaccine live attenuated (jeryl lynn strain); rubella virus vaccine live attenuated (wistar ra27/3 strain) - powder for solution - 1000unit; 5000unit; 1000unit - measles virus vaccine live attenuated 1000unit; mumps virus vaccine live attenuated (jeryl lynn strain) 5000unit; rubella virus vaccine live attenuated (wistar ra27/3 strain) 1000unit - vaccines

United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - measles virus strain enders' attenuated edmonston live antigen (unii: mfz8i7277d) (measles virus strain enders' attenuated edmonston live antigen - unii:mfz8i7277d), mumps virus strain b level jeryl lynn live antigen (unii: 47qb6mx9ku) (mumps virus strain b level jeryl lynn live antigen - unii:47qb6mx9ku), rubella virus strain wistar ra 27/3 live antigen (unii: 52202h034z) (rubella virus strain wistar ra 27/3 live antigen - unii:52202h034z), varicella-zoster virus strain oka/merck live antigen (unii: gpv - measles virus strain enders' attenuated edmonston live antigen 1000 [tcid_50] in 0.5 ml - proquad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age. do not administer proquad to individuals with a history of hypersensitivity to any component of the vaccine (including gelatin) {1} or to a previous dose of m-m-r ii (measles, mumps, rubella, live), proquad or varivax (varicella virus vaccine live) vaccine, or any other measles, mumps, and rubella or varicella-containing vaccine. do not administer proquad to individuals with a history of anaphylaxis to neomycin [see description (11)] . do not administer proquad vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. measles inclusion body encephalitis {2} (mibe), pneumonitis {3} and death as a direct consequence of disseminated measles vaccine virus infection have been reported in immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. in this population, disseminated mump

United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - measles virus strain enders' attenuated edmonston live antigen (unii: mfz8i7277d) (measles virus strain enders' attenuated edmonston live antigen - unii:mfz8i7277d), mumps virus strain b level jeryl lynn live antigen (unii: 47qb6mx9ku) (mumps virus strain b level jeryl lynn live antigen - unii:47qb6mx9ku), rubella virus strain wistar ra 27/3 live antigen (unii: 52202h034z) (rubella virus strain wistar ra 27/3 live antigen - unii:52202h034z) - measles virus strain enders' attenuated edmonston live antigen 1000 [tcid_50] in 0.5 ml - m-m-r ii is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older. do not administer m-m-r ii vaccine to individuals with a history of hypersensitivity to any component of the vaccine (including gelatin) {3} or who have experienced a hypersensitivity reaction following administration of a previous dose of m-m-r ii vaccine or any other measles, mumps and rubella-containing vaccine. do not administer m-m-r ii vaccine to individuals with a history of anaphylaxis to neomycin [see description (11)]. do not administer m-m-r ii vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. measles inclusion body encephalitis {4} (mibe), pneumonitis {5} and death as a direct consequence of disseminated measles vaccine virus infection have been reported in immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. in this population, disseminated mumps and rubella vaccin

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - rubella virus live attenuated; mumps virus live attenuated; measles virus live attenuated - powder and solvent for suspension for injection

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sharp & dohme (malaysia) sdn bhd - live attenuated measles virus; live attenuated rubella virus; live attenuated mumps virus; live attenuated varicella oka strain virus -

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - measles virus (more attenuated ender's strain) (live); mumps virus (jeryl lynn strain) (live); rubella virus (wistar ra 27/3 strain) (live) - injection, powder, for solution - min 1000 ccid50/0.5 ml - measles virus (more attenuated ender's strain) (live) min 1000 ccid50/0.5 ml; mumps virus (jeryl lynn strain) (live) min 12500 ccid50/0.5ml; rubella virus (wistar ra 27/3 strain) (live) min 1000 ccid50/0.5 ml