Malasja - Ingliż - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

averroes pharmaceuticals sdn. bhd. - bovine lipids extract surfactant -

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

intervet ireland limited - bovine respiratory syncytial virus inactivated, parainfluenza-3 virus strain sf4 inactivated, pasteurella haemolytica serotype a1 antigen - suspension for injection - unknown - inactivated bovine parainfluenza virus vaccine + inactivated bovine respiratory syncytial virus va - bovine - immunological - inactivated vaccine

Stati Uniti - Ingliż - NLM (National Library of Medicine)

merck sharp & dohme llc - human rotavirus a type g1p7(5) strain wi79 live antigen (unii: 25vc15141q) (human rotavirus a type g1p7(5) strain wi79 live antigen - unii:25vc15141q), human rotavirus a type g2p7(5) strain sc2 live antigen (unii: ju499is53h) (human rotavirus a type g2p7(5) strain sc2 live antigen - unii:ju499is53h), human rotavirus a type g3p7(5) strain wi78 live antigen (unii: 236ygp181o) (human rotavirus a type g3p7(5) strain wi78 live antigen - unii:236ygp181o), human rotavirus a type g4p7(5) strain brb live antigen - human rotavirus a type g1p7(5) strain wi79 live antigen 2200000 [iu] in 2 ml - rotateq® is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types g1, g2, g3, g4, and g9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. the first dose of rotateq should be administered between 6 and 12 weeks of age [see dosage and administration (2)] . a demonstrated history of hypersensitivity to any component of the vaccine. infants who develop symptoms suggestive of hypersensitivity after receiving a dose of rotateq should not receive further doses of rotateq. infants with severe combined immunodeficiency disease (scid) should not receive rotateq. post-marketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered rotateq and later identified as having scid [see adverse reactions (6.2)] . infants with a history of intussusception should not receive rotateq. rotateq is not approved for individuals 32 weeks of age and older. no human or

Awstralja - Ingliż - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - live fowl adenovirus - misc. vaccines or anti sera - live fowl adenovirus vaccine-viral active 0.0 ml - immunotherapy - poultry chicks - up to 28 days old | chicks of vaccinated hens - homologous types of fowl adenovirus infe | inclusion body hepatitus

Awstralja - Ingliż - APVMA (Australian Pesticides and Veterinary Medicines Authority)

virbac (australia) pty ltd - feline calicivirus - live; live feline herpes virus; feline panleucopenia virus - live - parenteral liquid/solution/suspension - feline calicivirus - live vaccine-viral active 12589.254 tci50/vi; live feline herpes virus vaccine-viral active 100000.0 tci50/vi; feline panleucopenia virus - live vaccine-viral active 1000.0 tci50/vi - immunotherapy - cat | cat - queen | cat - tom | kitten - feline calicivirus | feline enteritis | feline leukaemia virus | feline rhinotracheitis | calicivirus (feline) | disease caused by | enteritis (feline) | fcv | feline herpesvirus type 1 | feline infectious enteritis | feline panleucopenia (fp) | fhv-1 | fvr | herpesvirus 1 (feline) | herpesvirus type 1 (feline) | panleucopenia (feline) | rhinotracheitis (feline)

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

intervet ireland limited - bovine rotavirus, bovine coronavirus inactivated, e.coli k99 antigen - emulsion for injection - unknown - inactivated bovine rotavirus vaccine + inactivated bovine coronavirus vaccine + inactivated escheri - bovine - immunological - inactivated vaccine

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

forte healthcare ltd - bovine rotavirus strain tm-91 (inactivated), bovine coronavirus strain c-197 (inactivated), escherichia coli adhesion f5 (k99) (inactivated) - emulsion for injection - unknown - inactivated bovine rotavirus vaccine + inactivated bovine coronavirus vaccine + inactivated escheri - bovine - immunological - inactivated vaccine

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

forte healthcare ltd - bovine coronavirus strain c-197 (inactivated); bovine rotavirus strain tm-91, serotype g6p1 (inactivated). ; escherichia coli strain ec/17, (inactivated) expressing f5(k99) adhesin - emulsion for injection - . - bovine rotavirus + bovine coronavirus + escherichia - cattle - immunological - inactivated vaccine

Awstralja - Ingliż - 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.

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - insulin protamine zinc bovine - suspension for injection - 100unit/1ml