FrancophonIA/ELRC3.0 huggingface dataset:
English: Difloxacin hydrochloride can be bactericidal in activity and acts primarily through inhibition of bacterial DNA gyrase.
Icelandic: Dífloxacín hýdróklóríð getur haft bakteríudrepandi áhrif og verkar aðallega með því að hamla DNA gýrasa í bakteríum.
English: Cattle: Meat and offal: 46 days
Icelandic: : Kjöt og innmatur 46 dagar.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Geymið ekki við hærra hitastig en 25C.
English: The volume administered per injection site in dogs should not exceed 5 ml.
Icelandic: Hámarksrúmmál sem gefa má á hverjum stungustað hjá hundum er 5 ml.
English: For complicated respiratory disease the dose can be doubled to 5 mg/kg bodyweight / day.
Icelandic: Þegar um er að ræða öndunarfærasjúkdóm með fylgikvillum má tvöfalda skammtinn í 5 mg/kg líkamsþunga/dag.
English: 7 OJ No. L 143 of 27.06.95
Icelandic: EB L 143, 27.06.95
English: A fraction of difloxacin is eliminated by the urine.
Icelandic: Örlítill hluti af dífloxacíni skilst út í þvagi.
English: The majority of difloxacin is excreted via the faeces.
Icelandic: Meginhluti dífloxacíns skilst út í saur.
English: A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Icelandic: FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
Icelandic: B. SKILYRÐI EÐA TAKMARKANIR Á MARKAÐSLEYFI SEM VARÐA AFGREIÐSLU
English: PACKAGE SIZE 10 tablets 20 tablets 100 tablets
Icelandic: PAKKNINGASTÆRÐ 10 töflum20 töflum
English: The screw cap on the 1 litre bottle can be used as measuring device.
Icelandic: Nota má skrúflokið á 1 lítra flöskunni sem mælibúnað.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Icelandic: OG SKILYRÐI EÐA TAKMARKANIR VARÐANDI AFGREIÐSLU OG NOTKUN
English: Muscle Fat Liver Kidney
Icelandic: Vöðvar Fita Lifur Nýru
English: Micronised brewer's yeast
Icelandic: Örkorna bruggger
English: In cattle: Dicural 50 mg/ml solution for injection is indicated for the treatment of bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp.
Icelandic: Dicural 50 mg/ml stungulyf er ætlað til meðferðar öndunarfærasjúkdóma í nautgripum [flutningssótt (shipping fever), kálfalungnabólga] sem rekja má til sýkinga af völdum einnar eða fleiri eftirtalinna bakteríutegunda:
English: Difloxacin concentrations equal to or greater than the MICs for the relevant pathogens are achieved in all relevant tissues and maintained for as long as medication is continued.
Icelandic: Jafnmikil eða meiri þéttni dífloxacíns en lágmarkshömlunarþéttni (MIC) sem þarf fyrir viðkomandi sýkla næst í öllum vefjum sem máli skipta og helst þann tíma sem lyfjagjöf varir.
English: DOSAGE FOR EACH SPECIES, METHOD AND ROUTE OF ADMINISTRATION Dicural oral solution must be administrated daily via the drinking water in such a concentration that the dose is 10 mg/kg bodyweight.
Icelandic: OG AÐFERÐ VIÐ LYFJAGJÖF Gefa skal Dicural mixtúru daglega í drykkjarvatni í þeim styrk að skammturinn nemi 10 mg/kg líkamsþunga.
English: Dicural Coated Tablets should only be used based on susceptibility testing.
Icelandic: Dicural töflum skal ávallt byggja á næmisprófun.
English: At very high doses adverse effects on the nervous system (ataxia, unsteadiness, twitching, tremors, convulsions, etc.) may occur in cattle.
Icelandic: Þegar notaðir eru mjög stórir skammtar geta komið fram aukaverkanir á taugakerfið hjá nautgripum (slingur, óstöðugleiki, vöðvakippir, skjálfti, krampar, o.s.frv.).
English: WITHDRAWAL PERIOD Cattle: Meat and offal: 46 days
Icelandic: Nautgripir: Kjöt og innmatur 46 dagar.
English: In target animal safety studies, subcutaneous administration was generally well tolerated.
Icelandic: Í rannsóknum á öryggi við meðhöndlun þeirra dýrategunda sem lyfið er ætlað reyndust dýrin yfirleitt þola vel gjöf undir húð.
English: Meat and offal (chicken and turkeys): 24 hours.
Icelandic: Kjöt og innmatur (kjúklinga og kalkúna):
English: Cattle: Cardboard box with one glass vial of 50ml, 100ml or 250 ml with a rubber stopper and aluminium cap.
Icelandic: Pappaaskja með einu 50 ml, 100 ml eða 250 ml hettuglasi.
English: Difloxacin is an aryl-fluoroquinolone with a broad spectrum of antimicrobial activity.
Icelandic: Dífloxacín er arýl-flúórókínólón sem er breiðvirkt gegn örverum.
English: 8 OJ No. L 143 of 26.06.95
Icelandic: EB L 143, 26.06.95
English: Difloxacin hydrochloride is bactericidal in activity and acts by inhibition of bacterial DNA gyrase.
Icelandic: Dífloxacín hýdróklóríð hefur bakteríudrepandi áhrif og verkar með því að hamla DNA gýrasa í bakteríum.
English: Ramsgate Road
Icelandic: Pfizer Limited Ramsgate Road Sandwich
English: Dogs: Not applicable
Icelandic: Hundar: Á ekki við.
English: • Superficial pyoderma caused by Staphylococcus intermedius.
Icelandic: Graftarkvilla í yfirborði húðar (superficial pyoderma) af völdum Staphylococcus intermedius.
English: METHOD AND ROUTE OF ADMINISTRATION
Icelandic: VIRK INNIHALDSEFNI OG STYRKLEIKAR
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance
Icelandic: VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI Virkt innihaldsefni
English: A new injection site should be used each day.
Icelandic: Nota ber nýjan stungustað daglega.
English: As for other quinolones, due to possible adverse effects on the articular cartilage of weight bearing joints difloxacin should not be used during the rapid growth phase.
Icelandic: Eins og á við um aðra kínólóna skal ekki nota dífloxacín á hröðu vaxtarskeiði vegna hugsanlegra aukaverkana á liðbrjósk burðarliða.
English: Pfizer
Icelandic: Pfizer Italia
English: In another study dogs treated orally with difloxacin at 10 times the recommended dose for 10 days showed occasionally mild adverse reactions such as orange/yellowing discoloration of the faeces, emesis and hypersalivation.
Icelandic: 10 sinnum ráðlögðum skammti í 10 daga sýndu stundum vægar aukaverkanir, og má þar nefna appelsínugular/gular hægðir, uppköst og of mikla munnvatnsmyndun.
English: MARKETING AUTHORISATION NUMBERS EU/2/97/003/016-018
Icelandic: MARKAÐSLEYFISNÚMER EU/2/97/003/015-018
English: Benzyl alcohol
Icelandic: Kalíumhýdroxíð
English: People with known hypersensitivity to quinolones should avoid any contact with the product.
Icelandic: Þeir sem hafa ofnæmi fyrir kínólónum skulu forðast snertingu við dýralyfið.
English: Difloxacin acts primarily through inhibition of bacterial DNA gyrase.
Icelandic: Dífloxacín verkar aðallega með því að hamla DNA gýrasa í bakteríum.
English: In dogs the oral administration of difloxacin at up to 5 times the recommended dose rate for 30 days did not result in any adverse reactions.
Icelandic: Hjá hundum hlutust ekki aukaverkanir af inntöku dífloxacíns í skömmtum sem námu allt að 5 sinnum ráðlögðum skammti í 30 daga.
English: Therefore, do not use in small and medium-sized breeds of dogs up to and including 8 months of age, in large breeds up to 1year of age and in giant breeds up to 18 months of age.
Icelandic: Því skal ekki nota lyfið til meðhöndlunar smávaxinna til meðalstórra hundategunda upp í og að meðtöldum 8 mánaða aldri, stórvaxinna tegunda upp að eins árs aldri og risavaxinna tegunda upp að 18 mánaða aldri.
English: The clearance of difloxacin after subcutaneous administration to cattle is 229 ml/h/kg.
Icelandic: Blóðhreinsun dífloxacíns eftir gjöf undir húð hjá nautgripum er 229 ml/klst./kg; helmingunartími hefur reynst vera 7,7 klst.
English: WITHDRAWAL PERIOD Withdrawal periods - Meat and offal (chickens and turkeys): 24 hours.
Icelandic: BIÐTÍMI FYRIR AFURÐANÝTINGU Kjöt og innmatur (kjúklinga og kalkúna):
English: • Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp
Icelandic: Bráðra þvagrásarsýkinga, án fylgikvilla, af völdum Escherichia coli or Staphylococcus spp
English: In chickens and turkeys: Dicural oral solution is indicated for treatment of chronic respiratory infections caused by sensitive strains of Escherichia coli and Mycoplasma gallisepticum.
Icelandic: Dicural mixtúra er ætluð til meðferðar á langvinnum öndunarfærasýkingum af völdum næmra stofna af Escherichia coli og Mycoplasma gallisepticum.
English: Tél.
Icelandic: Pfizer Tél:
English: [Not required on the immediate label] Dispose of waste material in accordance with local requirements.
Icelandic: [Not required on the immediate label]
English: Following continuous oral dosing of Dicural oral solution at 10 mg/kg/day for five consecutive days the mean difloxacin steady state plasma concentrations are approximately 60 ng/ml.
Icelandic: Dicural mixtúru í skammtinum 10 mg/kg/dag í fimm daga í röð er meðalþéttni dífloxacíns í stöðugu ástandi í plasma u.þ.b.
English: Do not store above 25 C.
Icelandic: Geymið ekki við hærra hitastig en 25C.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains:
Icelandic: VIRK(T) INNIHALDSEFNI Hver tafla inniheldur:
English: Pfizer Luxembourg SARL Tel: + 359 2 970 41 71
Icelandic: Pfizer Romania SRL Tel: + 0040 21 207 28 93
English: Pharmacotherapeutic group: general anti-infectives for systemic use; antibacterials for systemic use, quinolone antibacterials.
Icelandic: Flokkun eftir verkun: almenn sýkingalyf til almennrar verkunar; sýklalyf til almennrar verkunar, kínólónar
English: In the absence of incompatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Icelandic: Ekki má blanda þessu dýralyfi saman við önnur lyf, þar sem rannsóknir á samrýmanleika hafa ekki verið gerðar.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Icelandic: Sérstakar varúðarreglur fyrir þann sem gefur dýrinu dýralyfið
English: For animal treatment only - to be supplied only on veterinary prescription..
Icelandic: Einungis ætlað dýrum - aðeins afgreitt gegn lyfseðli dýralæknis.
English: • Acute uncomplicated urinary tract infections caused by Escherichia coli or Staphylococcus spp.
Icelandic: Bráðra þvagrásarsýkinga, án fylgikvilla, af völdum Escherichia coli or Staphylococcus spp.
English: As for other quinolones, due to possible adverse effects on the articular cartilage of weight bearing joints, difloxacin should not be used during the rapid growth phase, that is, do not use in small-and medium breed dogs up to and including 8 months of age, in large breeds up to 1 year of age and in giant breeds up to 18 months of age.
Icelandic: Eins og á við um aðra kínólóna skal ekki nota dífloxacín á hröðu vaxtarskeiði vegna hugsanlegra aukaverkana á liðbrjósk burðarliða, þ.e. ekki skal nota lyfið til meðhöndlunar smávaxinna til meðalstórra hundategunda upp í og að meðtöldum 8 mánaða aldri, stórvaxinna tegunda upp að 1 árs aldri og risavaxinna tegunda upp að 18 mánaða aldri.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 50 mg/ml, solution for injection for cattle and dogs CARTON for 50 ml vial
Icelandic: YTRI UMBÚÐUM Dicural 50 mg/ml stungulyf, lausn, fyrir nautgripi og hunda 50 ml pappaaskja
English: DATE OF RENEWAL OF THE AUTHORISATION
Icelandic: 14. DAGSETNING SÍÐUSTU SAMÞYKKTAR FYLGISEÐILSINS
English: The volume administered per injection site in cattle should not exceed 7 ml.
Icelandic: Hámarksrúmmál sem gefa má á hverjum stungustað hjá nautgripum er 7 ml.
English: PHARMACEUTICAL PARTICULARS
Icelandic: LYFJAFRÆÐILEGIR EIGINLEIKAR
English: ADVICE ON CORRECT ADMINISTRATION In cattle, the volume administered per injection site should not exceed 7 ml.
Icelandic: LYFJAGJÖF Hámarksrúmmál sem gefa má á hverjum stungustað hjá nautgripum er 7 ml.
English: PHARMACEUTICAL FORM Solution for injection.
Icelandic: OG AÐFERÐ VIÐ LYFJAGJÖF
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 150 mg Coated tablets
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM Dicural 150 mg húðaðar töflur
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/016
Icelandic: 16. MARKAÐSLEYFISNÚMER EU/2/97/003/016
English: Treatment of Bovine respiratory disease (shipping fever, calf pneumonia) caused by single or mixed infections with Pasteurella haemolytica, Pasteurella multocida, and/or Mycoplasma spp.
Icelandic: Pasteurella haemolytica, Pasteurella multocida, og/eða Mycoplasma spp.
English: Sodium starch glycollate Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide Sodium lauryl sulphate
Icelandic: Örkristalla sellúlósi Magnesíum stearat Silíkondíoxíð sem myndar sviflausn Natríum laurýl súlfat
English: Active substance:
Icelandic: ATCvet flokkur:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
Icelandic: VIRK INNIHALDSEFNI OG STYRKLEIKAR Innihaldsefni í hverjum ml:
English: Excipients Benzyl alcohol
Icelandic: Benzýl alkóhól
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 150 mg coated tablets
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM Dicural 150 mg húðaðar töflur
English: PACKAGE SIZE 1 x 250 ml 1 x 1000 ml 6 x 1000 ml
Icelandic: 6 x 1000 ml
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) Each ml contains:
Icelandic: INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI Innihaldsefni í hverjum ml:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/013 - 10 tablets EU/2/97/003/014 - 20 tablets EU/2/97/003/015 - 100 tablets
Icelandic: 16. MARKAÐSLEYFISNÚMER EU/2/97/003/013 - 10 töflum EU/2/97/003/014 - 20 töflum EU/2/97/003/015 - 100 töflum
English: 10 OJ No L 143 of 26.06.95 11 OJ No. L 240 of 10.09.99
Icelandic: EB L 143, 26.06.95 11 Stjtíð.
English: Dicural 100 mg difloxacin (as hydrochloride)
Icelandic: Dicural 100 mg dífloxacín (sem hýdróklóríð)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/004 - 10 tablets EU/2/97/003/005 - 20 tablets EU/2/97/003/006 - 100 tablets
Icelandic: 16. MARKAÐSLEYFISNÚMER EU/2/97/003/004 - 10 töflum EU/2/97/003/005 - 20 töflum EU/2/97/003/006 - 100 töflum
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 150 mg coated tablets for dogs Difloxacin
Icelandic: HEITI DÝRALYFS Dicural 150 mg húðaðar töflur fyrir hunda Dífloxacín
English: Antagonism may be observed with nitrofurantoin.
Icelandic: Andvirkni getur komið fram við nítrófúrantóín.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/010 - 10 tablets EU/2/97/003/011 - 20 tablets EU/2/97/003/012 - 100 tablets
Icelandic: 16. MARKAÐSLEYFISNÚMER EU/2/97/003/010 - 10 töflum EU/2/97/003/011 - 20 töflum EU/2/97/003/012 - 100 töflum
English: If filled to the brim the measuring device provides 50ml.
Icelandic: Barmafyllt inniheldur það 50 ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 100 mg Coated tablets
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM Dicural 100 mg húðaðar töflur
English: Dicural 150 mg difloxacin (as hydrochloride)
Icelandic: Dicural 150 mg dífloxacín (sem hýdróklóríð)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/97/003/007 - 10 tablets EU/2/97/003/008 - 20 tablets EU/2/97/003/009 - 100 tablets
Icelandic: 16. MARKAÐSLEYFISNÚMER EU/2/97/003/007 - 10 töflum EU/2/97/003/008 - 20 töflum EU/2/97/003/009 - 100 töflum
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg coated tablets for dogs Difloxacin
Icelandic: HEITI DÝRALYFS Dicural 100 mg húðaðar töflur fyrir hunda Dífloxacín
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 150 mg coated tablets for dogs
Icelandic: HEITI DÝRALYFS Dicural 150 mg húðaðar töflur fyrir hunda
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 15 mg Coated tablets
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM Dicural 15 mg húðaðar töflur
English: Animal Species
Icelandic: Dýra-tegundir
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 100 mg coated tablets for dogs
Icelandic: HEITI DÝRALYFS Dicural 100 mg húðaðar töflur fyrir hunda
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 100 mg
Icelandic: VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI Dífloxacín (sem hýdróklóríð) 100 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 100 mg coated tablets
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM Dicural 100 mg húðaðar töflur
English: Edetic acid Potassium hydroxide Propylene glycol Benzyl alcohol Purified water
Icelandic: Etýlendíamíntetraedikssýra Kalíumhýdroxíð Própýlen glýkól Benzýlalkóhól Hreinsað vatn (aqua)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 15 mg coated tablets for dogs Difloxacin
Icelandic: HEITI DÝRALYFS Dicural 15 mg húðaðar töflur fyrir hunda Dífloxacín
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg coated tablets for dogs
Icelandic: HEITI DÝRALYFS Dicural 50 mg húðaðar töflur fyrir hunda
English: Dicural 15 mg difloxacin (as hydrochloride)
Icelandic: Dicural 15 mg dífloxacín (sem hýdróklóríð)
English: Dicural 50 mg/ml, solution for injection for cattle and dogs is available in the following presentations: Dogs: 50 ml vial.
Icelandic: Dicural 50 mg/ml stungulyf, lausn fyrir nautgripi og hunda er fáanlegt sem:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Dicural 50 mg Coated tablets
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM Dicural 50 mg húðaðar töflur
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 50 mg coated tablets
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM Dicural 50 mg húðaðar töflur
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg coated tablets for dogs Difloxacin
Icelandic: HEITI DÝRALYFS Dicural 50 mg húðaðar töflur fyrir hunda Dífloxacín
English: The oral administration of difloxacin at up to 5 times the recommended dose rate for 30 days did not result in any adverse reactions.
Icelandic: Ekki hlutust aukaverkanir af inntöku dífloxacíns í skömmtum sem námu allt að 5 sinnum ráðlögðum skammti í 30 daga.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 15 mg coated tablets for dogs
Icelandic: HEITI DÝRALYFS Dicural 15 mg húðaðar töflur fyrir hunda
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg/ml solution for injection for cattle and dogs.
Icelandic: HEITI DÝRALYFS Dicural 50 mg/ml stungulyf, lausn, fyrir nautgripi og hunda.
English: Target tissues
Icelandic: HEITI DÝRALYFS
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Dicural 15 mg coated tablets
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM Dicural 15 mg húðaðar töflur
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dicural 50 mg/ml solution for injection for cattle
Icelandic: HEITI DÝRALYFS Dicural 50 mg/ml stungulyf, lausn, fyrir nautgripi .
English: B. PACKAGE LEAFLET
Icelandic: D. STAÐHÆFING UM HÁMÁRK
English: Store in a dry place.
Icelandic: Geymið hettuglas í ytri umbúðum.
English: Dicural 50 mg difloxacin (as hydrochloride)
Icelandic: Dicural 50 mg dífloxacín (sem hýdróklóríð)
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 50 mg
Icelandic: VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI Dífloxacín (sem hýdróklóríð) 50 mg
English: Ethanol
Icelandic: Etýlendíamíntetraedikssýra
English: The observed reactions were inappetence, emesis, diarrhoea, and anal irritation.
Icelandic: Þær verkanir sem fram komu voru minnkaðar eðlishneigðir, uppköst, niðurgangur og erting í endaþarmsopi.
English: Medium Large
Icelandic: Meðalstór
English: PHARMACEUTICAL FORM Solution for injection
Icelandic: LYFJAFORM Stungulyf, lausn
English: The fluoroquinolones exert their antibacterial effect against both replicating and non-replicating micro-organisms.
Icelandic: Flúórókínólónar verka sem sýklalyf bæði gegn örverum sem eru og eru ekki að fjölga sér.
English: TARGET SPECIES Cattle (calves and young cattle)
Icelandic: Nautgripir (kálfar og kvígur).
English: The recommended dose is 5.0 mg difloxacin/kg body weight in a single injection Treatment should be continued with Dicural coated tablets (read the package leaflet of this product)
Icelandic: Ráðlagur skammtur er 5,0 mg dífloxacín/kg líkamsþunga með einni inndælingu.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride) 15 mg
Icelandic: VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI Dífloxacín (sem hýdróklóríð) 15 mg
English: The fluoroquinolones exert their antibacterial effects against both replicating and dormant microorganisms.
Icelandic: Flúórókínólónar verka sem sýklalyf bæði gegn örverum sem eru að fjölga sér og þeim sem eru í dvala.
English: PHARMACEUTICAL FORM Coated tablets
Icelandic: LYFJAFORM Húðuð tafla.
English: Coated tablets
Icelandic: Natríumsterkju glýkólat
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Icelandic: SKILYRÐI EÐA TAKMARKANIR Á MARKAÐSLEYFI SEM VARÐA AFGREIÐSLU OG NOTKUN
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Icelandic: Geymsluþol dýralyfsins í söluumbúðum:
English: Sandwich
Icelandic: Saltsýra
English: WITHDRAWAL PERIODS
Icelandic: BIÐTÍMI VEGNA AFURÐANÝTINGAR
English: Benzyl alcohol6
Icelandic: B. FYLGISEÐILL
English: PHARMACEUTICAL FORM
Icelandic: LYFJAFRÆÐILEGR UPPLÝSINGAR
English: Teva Sweden AB Järnvägsgatan 11 Box 1070
Icelandic: Teva Svíþjóð AB Järnvägsgatan 11 Box 1070
English: Veluwezoom 22 1327 AH Almere The Netherlands
Icelandic: Veluwezoom 22 1327 AH Almere Holland
English: Mylan S.A.S 117 Allée des Parcs FR-69800 Saint Priest France
Icelandic: Mylan S.A.S 117 Allée des Parcs FR-69800 Saint Priest Frakkland
English: 42110 Ólvega (Soria) Spain
Icelandic: 42110 Ólvega (Soria) Spánn
English: Tietokuja 4
Icelandic: Oy Tietokuja 4
English: Bayer Hungaria ltd Alkotás street 50.
Icelandic: Ungverjaland Bayer Hungaria ltd Alkotás street 50.
English: Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland
Icelandic: Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Írland
English: MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung Lindenplatz 1
Icelandic: Þýskaland MSD Sharp & Dohme Gesellschaft mit beschränkter Haftung Lindenplatz 1
English: Teva Pharmaceuticals Bulgaria EOOD Gogol 15
Icelandic: Teva Pharmaceuticals Búlgaría EOOD Gogol 15
English: Organon (Ireland) Ltd, PO Box 2857, Drynam Road, Swords,
Icelandic: Organon (Írland) Ltd, PO Box 2857, Drynam Road, Swords,
English: 64295 Darmstadt Germany
Icelandic: 64295 Darmstadt Þýskaland
English: 08184 Palau-Solitá i Plegamans Barcelona
Icelandic: 08184 Palau-Solitá i Plegamans
English: Rivium Westlaan 142 2909 LD Capelle a/d IJssel
Icelandic: Rivium Westlaan 142 2909 LD Capelle a/d IJssel Holland
English: Str. Domniţa Ruxandra nr. 12, parter, Sector
Icelandic: Str. Domniţa Ruxandra nr. 12, parter, Sector 2 Bucureşti
English: Empreendimento Lagoas Park, Edifício 7 - 3º Piso - Porto Salvo
Icelandic: Empreendimento Lagoas Park, Edifício 7 - 3º PisoPorto Salvo
English: Belgium SANDOZ N.V. Telecom Gardens Medialaan 40
Icelandic: SANDOZ N.V. Telecom Gardens Medialaan 40
English: 02130 Espoo Finland
Icelandic: 02130 Espoo Finnland
English: Poligono Industrial Navatejera,
Icelandic: Industrial Navatejera,
English: Surrey RH2 9RJ United Kingdom
Icelandic: Surrey RH2 9RJ Bretland
English: 4879 AC Etten-Leur The Netherlands
Icelandic: 4879 AC Etten-Leur Holland
English: 95100 Catania Italy
Icelandic: 95100 Catania Ítalía
English: 05-825 Grodzisk Mazowiecki Poland
Icelandic: 05-825 Grodzisk Mazowiecki
English: Farmaceutiche Via Alcide De Gasperi, 165 B
Icelandic: Industrie Chimico Farmaceutiche Via Alcide De Gasperi, 165 B
English: Pfizer Italia S.r.l., via Isonzo, 71 04100 Latina Italy
Icelandic: Pfizer Italia S.r.l., via Isonzo, 71 04100 Latina Ítalía
English: Postbox 23033, Ynglingagatan 14, SE-10435 Stockholm, Sweden
Icelandic: Postbox 23033, Ynglingagatan 14, SE-10435 Stockholm, Svíþjóð
English: C/Roa de la Vega 15 1-24008 Leon Spain
Icelandic: C/Roa de la Vega 15 1-24008 Leon Spánn
English: Bayer d.o.o., Bravničarjeva 13, Ljubljana, Slovenia
Icelandic: Bayer d.o.o., Bravničarjeva 13, Ljubljana, Slóvenía
English: MSD France 34 avenue Léonard de Vinci
Icelandic: MSD Frakkland 34 avenue Léonard de Vinci
English: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom
Icelandic: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, Bretland