Sibnayal Europäische Union - Dänisch - EMA (European Medicines Agency)

sibnayal

advicenne s.a. - potassium citrate monohydrated, potassium hydrogen carbonate - acidosis, renal tubular - mineral supplements - sibnayal is indicated for the treatment of distal renal tubular acidosis (drta) in adults, adolescents and children aged one year and older.

Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) Europäische Union - Dänisch - EMA (European Medicines Agency)

adjupanrix (previously pandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals)

glaxosmithkline biologicals s.a. - splittet influenzavirus, inaktiveret, indeholdende antigen: a / vietnam / 1194/2004 (h5n1) som brugt belastning (nibrg-14) - influenza, human; immunization; disease outbreaks - vacciner - prophylax af influenza i en officielt erklæret pandemisk situation. pandemic influenza vaccine bør anvendes i overensstemmelse med officielle retningslinjer.

Eravac Europäische Union - Dänisch - EMA (European Medicines Agency)

eravac

laboratorios hipra, s.a. - inactivated rabbit haemorrhagic disease type 2 virus (rhdv2), strainv-1037 - inaktiverede viral vacciner - kaniner - til aktiv immunisering af kaniner fra en alder af 30 dage til at reducere dødeligheden forårsaget af rabbit haemorrhagic disease type 2-virus (rhdv2).

Suvaxyn Circo+MH RTU Europäische Union - Dänisch - EMA (European Medicines Agency)

suvaxyn circo+mh rtu

zoetis belgium sa - inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 orf2 protein, inactivated mycoplasma hyopneumoniae, strain p-5722-3 - inaktiveret virus og bakterier inaktiverede vacciner - svin - til aktiv immunisering af svin fra 3 ugers alderen mod porcine circovirus type 2 (pcv2) for at reducere viral belastning i blod og lymfoide væv og fækalt afgivelse forårsaget af infektion med pcv2. til aktiv immunisering af svin over 3 uger mod mycoplasma hyopneumoniae for at reducere lungelæsioner forårsaget af infektion med m. hyopneumoniae.

Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals Europäische Union - Dänisch - EMA (European Medicines Agency)

prepandemic influenza vaccine (h5n1) (split virion, inactivated, adjuvanted) glaxosmithkline biologicals

glaxosmithkline biologicals s.a. - splittet influenzavirus, inaktiveret, indeholdende antigen: a / vietnam / 1194/2004 (h5n1) som brugt belastning (nibrg-14) - influenza, human; immunization; disease outbreaks - vacciner - aktiv immunisering mod h5n1-subtype af influenza a-virus. denne angivelse er baseret på immunogenicitet data fra raske forsøgspersoner i alderen fra 18 år og op efter administration af to doser vaccine, der er fremstillet af en/vietnam/1194/2004 nibrg-14 (h5n1) (se afsnit 5. prepandemic influenza vaccine (h5n1) (split virion, inaktiveret, adjuvanted) glaxosmithkline biologicals 3. 75 µg bør anvendes i overensstemmelse med officielle retningslinjer.

Mhyosphere PCV ID Europäische Union - Dänisch - EMA (European Medicines Agency)

mhyosphere pcv id

laboratorios hipra, s.a. - mycoplasma hyopneumoniae, strain 7304 (nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - svin - for the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by mycoplasma hyopneumoniae. also, to reduce the incidence of these lesions (as observed in field studies). to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by porcine circovirus type 2 (pcv2). efficacy against pcv2 genotypes a, b and d has been demonstrated in field studies. to reduce culling rate and the loss of daily weight gain caused by mycoplasma hyopneumoniae and/or pcv2 related diseases (as observed at 6 months of age in field studies). mycoplasma hyopneumoniae: onset of immunity: 3 weeks after vaccinationduration of immunity: 23 weeks after vaccinationporcine circovirus type 2:onset of immunity: 2 weeks after vaccinationduration of immunity: 22 weeks after vaccinationin addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of pcv2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

Enteroporc Coli Europäische Union - Dänisch - EMA (European Medicines Agency)

enteroporc coli

ceva santé animale - inactivated fimbrial adhesins of escherichia coli f4ab, inactivated fimbrial adhesins of escherichia coli f4ac, inactivated fimbrial adhesins of escherichia coli f5, inactivated fimbrial adhesins of escherichia coli f6 - immunologiske stoffer til suidae - svin - for the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce clinical signs (severe diarrhoea) and mortality caused by escherichia coli strains expressing the fimbrial adhesins f4ab, f4ac, f5 and f6.

Zulvac BTV Europäische Union - Dänisch - EMA (European Medicines Agency)

zulvac btv

zoetis belgium sa - en af de følgende inaktiveret bluetongue virus-stammer:inaktiverede bluetongue virus, serotype 1, stamme btv-1/alg2006/01 e1inactivated bluetongue virus, serotype 8, stamme btv-8/bel2006/02inactivated bluetongue virus, serotype 4, stamme spa-1/2004 - immunologicals, immunologicals for bovidae, inaktiveret, viral vacciner, bluetongue virus, fÅr - sheep; cattle - aktiv immunisering af får fra 6 ugers alderen, til forebyggelse af viraemia forårsaget af bluetongue virus, serotyper 1 og 8, og til reduktion af viraemia forårsaget af bluetongue virus, serotype 4 og aktiv immunisering af kvæg fra 12 ugers alderen, til forebyggelse af viraemia forårsaget af bluetongue virus, serotyper 1 og 8.

Cevenfacta Europäische Union - Dänisch - EMA (European Medicines Agency)

cevenfacta

laboratoire francais du fractionnement et des biotechnologies - eptacog beta (activated) - hemophilia a; hemophilia b - antihemorrhagics - cevenfacta is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:in patients with congenital haemophilia with high-responding inhibitors to coagulation factors viii or ix (i. ≥5 bethesda units (bu)); in patients with congenital haemophilia with low titre inhibitors (bu.