الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

zoetis belgium sa. - canine parainfluenza type 2 virus, strain cpiv-2 bio 15 (live attenuated), leptospira interrogans serogroup australis serovar bratislava, strain mslb 1088, l. interrogans serogroup icterohaemorrhagiae serovar icterohaemorrhagiae, strain mslb 1089, l. interrogans serogroup canicola serovar canicola, strain mslb 1090 and l. kirschneri serogroup grippotyphosa serovar grippotyphosa, strain mslb 1091 (all inactivated) - immunologicals for canidae, live viral and inactivated bacterial vaccines - dogs - active immunisation of dogs from six weeks of age. - to prevent clinical signs and reduce viral excretion caused by canine parainfluenza virus, - to prevent clinical signs, infection and urinary excretion caused by leptospira serovars bratislava, canicola, grippotyphosa and icterohaemorrhagiae. onset of immunity: immunity has been demonstrated from 3 weeks after completion of the primary course for cpiv and from 4 weeks after completion of the primary course for leptospira components. duration of immunity: at least one year following the primary vaccination course for all components of versican plus pi/l4.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

medimmune, llc - influenza a virus a/norway/31694/2022 (h1n1) live (attenuated) antigen (unii: fv9fgc9yzw) (influenza a virus a/norway/31694/2022 (h1n1) live (attenuated) antigen - unii:fv9fgc9yzw), influenza a virus a/norway/16606/2021 (h3n2) live (attenuated) antigen (unii: l7z42hp5rz) (influenza a virus a/norway/16606/2021 (h3n2) live (attenuated) antigen - unii:l7z42hp5rz), influenza b virus b/austria/1359417/2021 live (attenuated) antigen (unii: jv6nd6vmy5) (influenza b virus b/austria/1359417/2021 live (attenuated) - influenza a virus a/slovenia/2903/2015 (h1n1) live (attenuated) antigen 10000000 [ffu] in 0.2 ml - flumist®  quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine [see description (11)] . flumist quadrivalent is approved for use in persons 2 through 49 years of age. do not administer flumist quadrivalent to persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see description (11)] including egg protein, or after a previous dose of any influenza vaccine. do not administer flumist quadrivalent to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy because of the association of reye’s syndrome with aspirin and wild-type influenza infection [see drug interactions (7.1)] . risk summary flumist quadrivalent is not absorbed systemically following intranasal administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations disease-ass

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

novartis vaccines and diagnostics ltd - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) (unii: k9p8pva2ug) (influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) - unii:k9p8pva2ug) - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - influenza a (h1n1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza disease caused by pandemic (h1n1) 2009 virus. influenza a (h1n1) 2009 monovalent vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of influenza a (h1n1) 2009 monovalent vaccine, or who has had a life-threatening reaction to previous influenza vaccinations [see description (11)]. novartis’ influenza a (h1n1) 2009 monovalent vaccine and seasonal trivalent influenza virus vaccine (fluvirin) are manufactured by the same process. available information for fluvirin is provided in this section. pregnancy category c: animal reproduction studies have not been conducted with influenza a (h1n1) 2009 monovalent vaccine or fluvirin. it is also not known whether influenza a (h1n1) 2009 monovalent vaccine or fluvirin can cause fetal harm when administered to

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

sanofi pasteur inc. - influenza a virus a/california/7/2009(h1n1)-like antigen (formaldehyde inactivated) (unii: 5i5hvc73i8) (influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (formaldehyde inactivated) - unii:euj84un96z) - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (formaldehyde inactivated) 15 ug in 0.5 ml - influenza a (h1n1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (h1n1) 2009 virus. do not administer influenza a (h1n1) 2009 monovalent vaccine to anyone with a known severe hypersensitivity to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine. [see warnings and precautions (5) and description (11) ] sanofi pasteur's influenza a (h1n1) 2009 monovalent vaccine and seasonal trivalent influenza virus vaccine (fluzone vaccine) are manufactured by the same process. available information for fluzone vaccine is provided in this section. pregnancy category c: animal reproduction studies have not been conducted with influenza a (h1n1) 2009 monovalent vaccine or fluzone vaccine. it is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction

أيرلندا - الإنجليزية - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - measles virus - schwarz strain live attenuated; mumps vaccine rit 4385 live attenuated; rubella virus (ra 27/3 strain) - powder and solvent for solution for injection in pre-filled syringe - 0 percent - measles vaccines; measles, combinations with mumps and rubella, live attenuated

ماليزيا - الإنجليزية - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sm pharmaceuticals sdn. bhd. - caesalpinia sappan; live attenuated measles virus -

مالطا - الإنجليزية - Malta Medicines Authority

nm pharma limited 3/4, cantrija complex triq it-targa, il-maghtab naxxar nxr 6613 , malta - powder and solvent for solution for injection - measles virus - schwarz strain 50 % mumps virus jeryl lynn (level b) strain (live, attenuated) 50 % rubella virus - wistar ra27/3 strain 50 % - vaccines

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - live attenuated human rotavirus 1e+006 ccid50 ((rix 4414 strain)) - oral suspension - 1e+006 ccid50 - active: live attenuated human rotavirus 1e+006 ccid50 ((rix 4414 strain)) excipient: di-sodium adipate dulbecco's modified eagle medium sucrose water for injection - rotarix is indicated for the prevention of rotavirus gastroenteritis

إسرائيل - الإنجليزية - Ministry of Health

glaxo smith kline (israel) ltd - live attenuated measles virus; live attenuated mumps virus; live attenuated rubella virus; live attenuated varicella virus - powder and solvent for solution for injection - live attenuated measles virus 10^ 3.0 ccid50; live attenuated mumps virus 10^ 4.4 ccid50; live attenuated rubella virus 10^ 3.0 ccid50; live attenuated varicella virus 10^ 3.3 pfu - measles, combinations with mumps, rubella and varicella, live attenuated - measles, combinations with mumps, rubella and varicella, live attenuated - priorix-tetra is indicated for active immunisation against measles, mumps, rubella and varicella in children from the age of 12 months up and including 12 years of age.

إسرائيل - الإنجليزية - Ministry of Health

glaxo smith kline (israel) ltd - live attenuated human rotavirus rix4414 strain - suspension - live attenuated human rotavirus rix4414 strain - rota virus, live attenuated - rota virus, live attenuated - rotarix is indicated for the active immunization of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection. in clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of types g1p[8], g2p[4], g3p[8], g4p[8] and g9p[8]. the use of rotarix should be based on official recommendations.