FrancophonIA/ELRC3.0 huggingface dataset:
English: Milbemycin oxime distributes into tissues with a volume of distribution of 2.7 ± 0.4 l/kg and 2.6 ± 0.6 l/kg for the A3 and A4 forms, respectively.
Danish: Milbemycinoxim fordeles til væv med et fordelingsvolumen på hhv. 2,7 ± 0,4 l/kg og 2,6 ± 0,6 l/kg for A3 og A4 formerne.
English: Macrogol 15 hydroxystearate Glycerol (E422) Triglycerides, medium-chain Citric acid monohydrate (E330) Butylhydroxytoluene (E321)
Danish: Triglycerider, middelkædelængde Citronsyre monohydrat (E330) Butylhydroxytoluen (E321)
English: Afoxolaner: Afoxolaner is an insecticide and acaricide of the isoxazoline family.
Danish: Afoxolaner: Afoxolaner er et insekticid og acaricid hørende til isoxazolinfamilien.
English: Fleas and ticks need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of vector-borne diseases cannot be excluded.
Danish: Lopper og flåter skal starte indtag af føde på værtsdyret for at blive eksponeret for afoxolaner; derfor kan risikoen for overførsel af vektorbårne lidelser ikke udelukkes.
English: After treatment of the nematode infestations, further flea and tick treatment should be continued with a monovalent product.
Danish: Efter behandling af infestationen med nematoder bør yderligere loppe- og flåtbehandling fortsættes med et middel som kun virker mod lopper og flåter.
English: Soy protein fines Beef braised flavouring Povidone (E1201) Macrogol 400
Danish: Povidon (E1201) Macrogol 400
English: Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks.
Danish: Behandling af loppeinfestation (Ctenocephalides felis og C.canis) hos hund i 5 uger.
English: Treatment of flea and tick infestations and gastrointestinal nematodes:
Danish: Behandling af loppe- og flåtinfestationer samt gastrointestinale nematoder:
English: Ancylostoma ceylanicum is reported as being endemic only in South-East Asia, China, India, Japan, some Pacific islands, Australia, the Arab Peninsula, South Africa and South America.
Danish: Det er kun rapporterer, at Ancylostoma ceylanicum er udbredt i Sydøstasien, Kina, Indien, Japan, visse stillehavsøer, Australien, Den Arabiske Halvø, Sydafrika samt Sydamerika.
English: Fleas and ticks need to start feeding on the host to become exposed to the substance afoxolaner; therefore the risk of the transmission of diseases by fleas and ticks cannot be excluded.
Danish: Lopper og flåter skal begynde at suge blod fra værtsdyret for at blive udsat for stoffet afoxolaner; derfor kan risikoen for overførsel af sygdomme fra lopper og flåter ikke udelukkes.
English: NEXGARD SPECTRA can be used as part of the seasonal treatment of fleas and ticks (replacing a product authorised for the treatment of fleas/ticks only) in dogs with diagnosed concurrent gastrointestinal worm infestations.
Danish: NEXGARD SPECTRA kan anvendes som del af den sæsonmæssige behandling mod lopper og flåter (og derved erstatte behandling med et middel som kun virker mod lopper og flåter) til hunde, som er diagnosticeret med samtidig infestation med gastrointestinale nematoder.
English: In endemic areas, monthly administration of the product will reduce the level of infection with immature adults (L5) and adults of Angiostrongylus vasorum in the heart and lungs.
Danish: I endemiske områder vil månedlig behandling med produktet reducere infektionsniveauet af umodne voksne (L5) og voksne stadier af Angiostrongylus vasorum i hjerte og lunger.
English: Therefore, the use of this product should be adapted to each individual case based on local information relating to disease status, including current susceptibility of the target parasites to the active substances in this product, in order to limit the possibility of a future selection for resistance.
Danish: Derfor bør anvendelsen af dette præparat baseres på en individuel vurdering af hvert enkelt tilfælde samt på lokale informationer om målarternes aktuelle følsomhed for at begrænse sandsynligheden for fremtidig resistensudvikling.
English: Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs.
Danish: Behandling af loppeangreb (Ctenocephalides felis og C.canis) hos hund.
English: EU/2/14/177/007 - 38 mg/ 8 mg, 1 chewable tablet EU/2/14/177/008 - 38 mg/ 8 mg, 3 chewable tablets EU/2/14/177/009 - 38 mg/ 8 mg, 6 chewable tablets EU/2/14/177/018 - 38 mg/ 8 mg, 15 chewable tablets EU/2/14/177/010 - 75 mg/ 15 mg, 1 chewable tablet EU/2/14/177/011 - 75 mg/ 15 mg, 3 chewable tablets EU/2/14/177/012 - 75 mg/ 15 mg, 6 chewable tablets EU/2/14/177/019 - 75 mg/ 15 mg, 15 chewable tablets EU/2/14/177/013 -150 mg/ 30 mg, 1 chewable tablet EU/2/14/177/014 -150 mg/ 30 mg, 3 chewable tablets EU/2/14/177/015 -150 mg/ 30 mg, 6 chewable tablets EU/2/14/177/020 -150 mg/ 30 mg, 15 chewable tablets
Danish: EU/2/14/177/007 - 38 mg/ 8 mg, 1 tyggetablet EU/2/14/177/008 - 38 mg/ 8 mg, 3 tyggetabletter EU/2/14/177/009 - 38 mg/ 8 mg, 6 tyggetabletter EU/2/14/177/018 - 38 mg/ 8 mg, 15 tyggetabletter EU/2/14/177/010 - 75 mg/ 15 mg, 1 tyggetablet EU/2/14/177/011 - 75 mg/ 15 mg, 3 tyggetabletter EU/2/14/177/012 - 75 mg/ 15 mg, 6 tyggetabletter EU/2/14/177/019 - 75 mg/ 15 mg, 15 tyggetabletter EU/2/14/177/013 -150 mg/ 30 mg, 1 tyggetablet EU/2/14/177/014 -150 mg/ 30 mg, 3 tyggetabletter EU/2/14/177/015 -150 mg/ 30 mg, 6 tyggetabletter EU/2/14/177/020 - 150 mg/ 30 mg, 15 tyggetabletter
English: In heartworm endemic areas, dogs should be tested for existing heartworm infestation prior to administration of NEXGARD SPECTRA.
Danish: Hunde, som lever i områder med endemisk hjerteorm, bør testes for eksisterende infestation med hjerteorm før administration af NEXGARD SPECTRA.
English: Dogs 2-3.5 kg Dogs >3.5-7.5 kg Dogs >7.5-15 kg Dogs >15-30 kg Dogs >30-60 kg
Danish: Hund 2-3,5 kg Hund >3,5-7,5 kg Hund >7,5-15 kg Hund >15-30 kg Hund >30-60 kg
English: EU/2/14/177/001 - 9 mg/ 2 mg, 1 chewable tablet EU/2/14/177/002 - 9 mg/ 2 mg, 3 chewable tablets EU/2/14/177/003 - 9 mg/ 2 mg, 6 chewable tablets EU/2/14/177/016 - 9 mg/ 2 mg, 15 chewable tablets EU/2/14/177/004 - 19 mg/ 4 mg, 1 chewable tablet EU/2/14/177/005 - 19 mg/ 4 mg, 3 chewable tablets EU/2/14/177/006 - 19 mg/ 4 mg, 6 chewable tablets EU/2/14/177/017 - 19 mg/ 4 mg, 15 chewable tablets
Danish: EU/2/14/177/001 - 9 mg/ 2 mg, 1 tyggetablet EU/2/14/177/002 - 9 mg/ 2 mg, 3 tyggetabletter EU/2/14/177/003 - 9 mg/ 2 mg, 6 tyggetabletter EU/2/14/177/016 - 9 mg/ 2 mg, 15 tyggetabletter EU/2/14/177/004 - 19 mg/ 4 mg, 1 tyggetablet EU/2/14/177/005 - 19 mg/ 4 mg, 3 tyggetabletter EU/2/14/177/006 - 19 mg/ 4 mg, 6 tyggetabletter EU/2/14/177/017 - 19 mg/ 4 mg, 15 tyggetabletter
English: Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs for 4 weeks.
Danish: Behandling af flåtinfestation (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) hos hund i 4 uger.
English: Mottled red to reddish brown, circular shaped (tablets for dogs 2-3.5 kg) or rectangular shaped (tablets for dogs >3.5-7.5 kg, tablets for dogs >7.5-15 kg, tablets for dogs >15-30 kg and tablets for dogs >30-60 kg).
Danish: Marmoreret rød til rødbrun, rund (tablet til hund 2-3,5 kg) eller rektangulær (tablet til hund >3,5-7,5 kg, tablet til hund >7,5-15 kg, tablet til hund >15-30 kg og tablet til hund >30-60 kg).
English: - Keep tablets in the blister packs until required, and keep the blisters in the outer carton.
Danish: Tabletterne skal forblive i blisteret og opbevares i den ydre karton, indtil de skal bruges.
English: Erythema and neurological signs (convulsions, ataxia and muscle tremors) have been reported very rarely.
Danish: Der er i meget sjældne tilfælde rapporteret om rødmen og neurologiske symptomer (kramper, ataksi og muskelrysten).
English: Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs.
Danish: Behandling af flåtangreb (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) hos hund.
English: A single treatment is effective for gastrointestinal worms.
Danish: En enkelt behandling er effektiv mod orm i mave-tarmkanalen.
English: It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum, and Haemaphysalis longicornis.
Danish: Det virker over for voksne lopper samt over for flere flåtarter såsom Rhipicephalus sanguineus, Dermacentor reticulatus og D. variabilis, Ixodes ricinus og I. scapularis, Amblyomma americanum, og Haemaphysalis longicornis.
English: Milbemycin oxime acts by disrupting the glutamate neuro-transmission in invertebrates.
Danish: Milbemycinoxim virker ved at afbryde glutamatneurotransmissionen hos hvirvelløse dyr.
English: For each strength, the chewable tablets are available in the following pack sizes: Carton with 1 thermoformed blister containing 1, 3 or 6 chewable tablets or 15 thermoformed blisters containing 1 chewable tablet.
Danish: Æske med 1 termoformet blister som indeholder 1, 3 eller 6 tyggetabletter eller 15 termoformede blistre med 1 tyggetablet.
English: Prevention of heartworm disease:
Danish: Forebyggelse af tropisk hjerteorm:
English: Laboratory studies in rats and rabbits have not produced any evidence of birth defects, or any adverse effect on the reproductive capacity in males and females.
Danish: Laboratorieundersøgelser af rotter og kaniner har ikke afsløret fosterskadende virkninger eller bivirkninger på avlsevnen hos hanner og hunner.
English: Monthly administration of the product prevents establishment of infection with adult Thelazia callipaeda eyeworm.
Danish: Månedlig behandling med produktet forebygger etablering af infektion med voksne stadier af øjenormen Thelazia callipaeda.
English: In regions where heartworm disease is present, dogs should be tested for existing heartworm infestation prior to administration of NEXGARD SPECTRA.
Danish: Hunde, som lever i områder, hvor der findes hjerteorm, bør testes for eksisterende smitte med hjerteorm, før NEXGARD SPECTRA gives.
English: It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus, Ixodes hexagonus and I. scapularis, Amblyomma americanum and Haemaphysalis longicornis.
Danish: Det virker over for voksne lopper såvel som adskillige flåtarter såsom Rhipicephalus sanguineus, Dermacentor reticulatus og D.variabilis, Ixodes ricinus, Ixodes hexagonus og I.scapularis, Amblyomma americanum, og Haemaphysalis longicornis.
English: Heartworm disease prevention is critical.
Danish: Det er af afgørende betydning at kunne forebygge smitte med hjerteorm.
English: Prevention of angiostrongylosis (by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum) with monthly administration.
Danish: Forebyggelse af kronisk infektion med fransk hjerteorm (angiostrongylose) (ved reduktion af umodne voksne (L5) og voksne stadier af Angiostrongylus vasorum) med månedlig behandling.
English: For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease (Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum), thelaziosis (adult Thelazia callipaeda) and/or treatment of gastrointestinal nematode infestations is indicated.
Danish: Behandling af loppe- og flåtinfestation hos hund hvor samtidig forebyggelse af tropisk hjerteorm (Dirofilaria immitis larver), angiostrongylose (reduktion af umodne voksne (L5) og voksne stadier af Angiostrongylus vasorum), øjenorm (voksne stadier af Thelazia callipaeda) og/eller behandling af infestationer med gastrointestinale nematoder er indiceret.
English: Prevention of thelaziosis:
Danish: Forebyggelse af øjenorm:
English: Prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection) with monthly administration.
Danish: Forebyggelse af etablering af øjenorm (infektion med voksne stadier af Thelazia callipaeda øjenorm) med månedlig behandling.
English: Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense and Ancylostoma ceylanicum) and whipworm (Trichuris vulpis).
Danish: Behandling af infestationer med følgende voksne gastrointestinale nematoder: spolorm (Toxocara canis og Toxascaris leonina), hageorm (Ancylostoma caninum, Ancylostoma braziliense og Ancylostoma ceylanicum) samt piskeorm (Trichuris vulpis).
English: Prevention of angiostrongylosis:
Danish: Forebyggelse af kronisk infektion med fransk hjerteorm (angiostrongylose):
English: Milbemycin oxime is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and heartworm (Dirofilaria immitis larvae).
Danish: Milbemycinoxim virker mod adskillige gastrointestinale orm (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), voksne og umodne voksne stadier (L5) af fransk hjerteorm (Angiostrongylus vasorum) samt tropisk hjerteorm (Dirofilaria immitis larver).
English: It is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and larvae of the heartworm Dirofilaria immitis.
Danish: Det virker mod adskillige orm i mave-tarmkanalen ( Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), voksne og umodne voksne stadier (L5) af fransk hjerteorm Angiostrongylus vasorum samt larver af tropisk hjerteorm Dirofilaria immitis.
English: For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease (Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum), thelaziosis (adult Thelazia callipaeda) and/or treatment of gastrointestinal worm infestations is indicated.
Danish: Behandling af loppe- og flåtangreb hos hund, hvor der samtidig er grundlag for forebyggelse af tropisk hjerteorm (Dirofilaria immitis larver), angiostrongylose (reduktion af umodne voksne (L5) og voksne stadier af Angiostrongylus vasorum), øjenorm (voksne stadier af Thelazia callipaeda) og/eller behandling af orm i mave-tarmkanalen.
English: Number and strength of tablet to be administered
Danish: Tyggetablet, styrke og antal
English: Treatment of flea and tick infestations and gastrointestinal worms:
Danish: Behandling af loppe- og flåtangreb samt orm i mave-tarmkanalen:
English: NEXGARD SPECTRA 19 mg/ 4 mg
Danish: SPECTRA 19 mg/4 mg
English: Prevention of heartworm disease (Dirofilaria immitis larvae) with monthly administration.
Danish: Behandling af skab (forårsaget af Sarcoptes scabiei var. canis) Forebyggelse af tropisk hjerteorm (Dirofilaria immitis larver) med månedlig behandling.
English: Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
Danish: Behandling af infektion med Demodex canis (”hårsækmider”) Behandling af skab (forårsaget af Sarcoptes scabiei var. canis) Forebyggelse af tropisk hjerteorm (Dirofilaria immitis larver) med månedlig behandling.
English: NEXGARD SPECTRA 9 mg/ 2 mg dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg dogs >7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg dogs >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg dogs >30-60 kg afoxolaner / milbemycin oxime Tablets
Danish: NEXGARD SPECTRA 9 mg/2 mg hund 2-3,5 kg NEXGARD SPECTRA 19 mg/4 mg hund >3,5-7,5 kg NEXGARD SPECTRA 38 mg/8 mg hund >7,5-15 kg NEXGARD SPECTRA 75 mg/15 mg hund >15-30 kg NEXGARD SPECTRA 150 mg/30 mg hund >30-60 kg afoxolaner./milbemycin.oxim.
English: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg Afoxolaner, milbemycin oxime
Danish: NEXGARD SPECTRA 9 mg/ 2 mg tyggetabletter til hund 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tyggetabletter til hund >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tyggetabletter til hund >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tyggetabletter til hund >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tyggetabletter til hund >30-60 kg Afoxolaner, milbemycinoxim
English: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg
Danish: NEXGARD SPECTRA 9 mg/ 2 mg tyggetabletter til hund 2-3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tyggetabletter til hund >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tyggetabletter til hund >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg tyggetabletter til hund >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg tyggetabletter til hund >30-60 kg
English: PACKAGE LEAFLET: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg
Danish: INDLÆGSSEDDEL NEXGARD SPECTRA 9 mg/2 mg tyggetabletter til hund 2-3,5 kg NEXGARD SPECTRA 19 mg/4 mg tyggetabletter til hund >3,5-7,5 kg NEXGARD SPECTRA 38 mg/8 mg tyggetabletter til hund >7,5-15 kg NEXGARD SPECTRA 75 mg/15 mg tyggetabletter til hund >15-30 kg NEXGARD SPECTRA 150 mg/30 mg tyggetabletter til hund >30-60 kg
English: United Kingdom GENERICS (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, UK
Danish: Storbritannien GENERICS (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, UK
English: CENTRAFARM SERVICES B.V.; Nieuwe Donk 9; 4879 AC ETTENLEUR/NL, Netherlands
Danish: ; Nieuwe Donk 9; 4879 AC ETTENLEUR/NL, Netherlands
English: Powder for Injection
Danish: Pulver til injektionsvæske, opløsning
English: MEDA PHARMA B.V. Krijgsman 20, 1186 DM AMSTELVEEN/NL, Netherlands
Danish: Krijgsman 20, 1186 DM AMSTELVEEN/NL, Netherlands
English: Dihydroergocryptine containing medicinal products with Marketing Authorisation in the European Union
Danish: Lægemidler indeholdende dihydroergocryptin med markedsføringstilladelse i EU
English: Novartis Farma S.P.A. Largo Umberto Boccioni 1 21040 Origgio Varese, Italy
Danish: Largo Umberto Boccioni 1 21040 Origgio Varese, Italy
English: Bromocriptine containing medicinal products with Marketing Authorisation in the European Union
Danish: Lægemidler indeholdende bromocriptin med markedsføringstilladelse i EU
English: Meda Pharma S.A. - N.V. Chaussee de la Hulpe 166 - B-1170 Brussels
Danish: Chaussee de la Hulpe 166 - B-1170 Brussels
English: Intramuscular Use
Danish: Intramuskulær anvendelse
English: Czech Republic MEDA PHARMA s.r.o., Záhřebská, 577, 120 00, Praha 2, Czech Republic
Danish: MEDA PHARMA s.r.o., Záhřebská, 577, 120 00, Praha 2, Czech Republic
English: Film-coated Tablet
Danish: Filmovertrukket tablet
English: Lisuride containing medicinal products with Marketing Authorisation in the European Union
Danish: Lægemidler indeholdende lisurid med markedsføringstilladelse i EU
English: 0,3 mg/1 m Solution for Injection Intravenous use
Danish: 0,3 mg/1 m Injektionsvæske, opløsning
English: Oral Drops
Danish: Orale dråber
English: Prolonged-Release Capsule, hard
Danish: Depotkapsel, hård
English: MEDA PHARMA GmbH & Co. KG, Benzstr.
Danish: MEDA PHARMA GmbH & Co.
English: <Content (concentration)>
Danish: Indhold (koncentration)
English: 3 pre-filled syringes + 3 needles
Danish: 3 fyldte injektionssprøjter + 3 kanyler
English: MA (EU) number (Invented) name Strength Pharmaceutical form
Danish: MF (EU)nummer
English: European Medicines Agency Veterinary Medicines
Danish: Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: Locatim is an oral solution produced from colostrum which is given to calves in the first 12 hours of life.
Danish: Oral opløsning Nyfødte kalve under 12 timer gamle
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Danish: EU/2/99/011/001 Locatim >2.8log10 /ml Bovin, koncentreret valle
English: Page 2/2
Danish: 60 ml
English: Information on the prescription status of this product may be found on the label/outer package.
Danish: Indgivelsesvej Emballage Indhold Pakningsstørrelse
English: Locatim is presented in a 60 ml glass bottle.
Danish: Type III glasflaske
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) LOCATIM EPAR summary for the public
Danish: EU-nummer Særnavn Styrke
English: The withdrawal period is zero days.
Danish: Tilbageholdelsestid
English: These adverse effects are listed below.
Danish: Disse bivirkninger angives nedenfor.
English: - If you have further questions, please ask your doctor or your pharmacist.
Danish: - Hvis De har yderligere spørgsmål, bedes De kontakte Deres læge eller apotek.
English: There are no data with regard to overdose.
Danish: Der er ingen data tilgængelige med hensyn til overdosering.
English: The vaccine may not prevent
Danish: Vaccinen giver muligvis ikke
English: Read all of this leaflet carefully before your child is vaccinated.
Danish: Læs hele denne indlægsseddel omhyggeligt inden dit barn bliver vaccineret.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/05/1999
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første makedsføringstilladelse: 07/05/1999
English: - This vaccine has been prescribed for your child and you should not pass it on to others.
Danish: - Denne vaccine er ordineret til dit barn og må ikke overdrages til andre.
English: Of these, 1,110 were monitored for both serious and non-serious adverse experiences.
Danish: Af disse blev 1110 monitoreret med henblik på både alvorlige og ikke-alvorlige bivirkninger.
English: Official batch release: in accordance with Article 114 Directive 2001/83/EEC, the official batch release will be undertaken by a state laboratory or a laboratory disignated for that purpose.
Danish: Officiel batchfrigivelse: i overensstemmelse med artikel 114 i Rådets direktiv 2001/83/EØF vil den officielle batchfrigivelse blive foretaget af et statsligt laboratorium eller et laboratorium beregnet
English: No serious vaccine-related side effects were reported.
Danish: Ingen alvorlige vaccinerelaterede bivirkninger blev rapporteret.
English: Thorough agitation is necessary to achieve suspension of the vaccine.
Danish: Omhyggelig omrystning er påkrævet for at opnå suspensionen af vaccinen.
English: Date of latest renewal: 02/08/2004
Danish: Dato for seneste fornyelse af markedsføringstilladelsen: 02/08/2004
English: Post marketing Experience
Danish: Erfaringer efter markedsføring
English: After thorough agitation, PROCOMVAX is a slightly opaque, white suspension.
Danish: Efter omhyggelig omrystning er PROCOMVAX en svagt uigennemsigtig, hvid suspension.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator Do not freeze
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab
English: - in infants born to HBsAg positive mothers.
Danish: - Hos spædbørn født af HBsAg-positive mødre.
English: All three doses must be administered to complete the vaccination regimen.
Danish: Alle 3 doser skal administreres for at fuldføre vaccinations
English: Tell your doctor promptly about these or any other unusual symptoms.
Danish: De bedes straks meddele lægen om enhver bivirkning eller andre usædvanlige symptomer.