FrancophonIA/ELRC3.0 huggingface dataset:
English: FLUENZ demonstrated 64.4% (1.4, 88.8) fewer cases than injectable influenza vaccine in 476 infants and toddlers 6-23 months of age and 48.2% (12.7, 70.0) fewer cases in 1,579 children 24-71 months of age.
Danish: FLUENZ havde 64,4 % (1,4; 88,8) færre tilfælde end injicerbar influenzavaccine hos 476 spædbørn og små børn i alderen 6-23 måneder og 48,2 % (12,7; 70,0) færre tilfælde hos 1.579 børn i alderen 24-71 måneder.
English: NAME OF THE MEDICINAL PRODUCT FLUENZ nasal spray suspension Influenza vaccine (live attenuated, nasal) 2013/2014 season
Danish: LÆGEMIDLETS NAVN FLUENZ næsespray, suspension Influenzavaccine (levende svækket, nasal) Sæson 2013/2014
English: The suspension is a colourless to pale yellow liquid that is clear to slightly cloudy.
Danish: Suspensionen er en farveløs til let gullig væske, som er klar til let uigennemsigtig.
English: D153-P501 Asia/Oceania 12 to 35 M 2,764
Danish: D153-P501 Asien/ Oceanien 12 til 35 M 2.764
English: FLUENZ demonstrated 55.7% (39.9, 67.6) fewer cases than injectable influenza vaccine in 3,659 infants and toddlers 6-23 months of age and 54.4% (41.8, 64.5) fewer cases in 4,166 children 24-59 months of age.
Danish: FLUENZ havde 55,7 % (39,9; 67,6) færre tilfælde end injicerbar influenzavaccine hos 3.659 spædbørn og små børn i alderen 6-23 måneder og 54,4 % (41,8; 64,5) færre tilfælde hos 4.166 børn i alderen 24-59 måneder.
English: FLUENZ should not be used in infants and toddlers below 24 months of age because of safety concerns (see section 4.4).
Danish: FLUENZ bør ikke anvendes til spædbørn og små børn i alderen under 24 måneder på grund af problemstillinger vedrørende sikkerhed (se pkt.
English: In study participants who received 2 doses in year 1 and placebo in year 2, efficacy in year 2 was 56.2% (95% CI: 30.5, 72.7) and 44.8% (95% CI: 18.2, 62.9), respectively, in D153-P501, thus supporting the need for second-season revaccination.
Danish: Hos deltagere i studiet, som fik 2 doser i år 1 og placebo i år 2, var virkningen i år 2 hhv. 56,2 % (95 % CI: 30,5; 72,7) og 44,8 % (95 % CI: 18,2; 62,9) i D153-P501, hvilket støtter behovet for en gentagen vaccination i 2. sæson.
English: Marketing Authorisation Holder: MedImmune, LLC, Lagelandseweg 78, 6545 CG Nijmegen, Netherlands, (Tel) +31 24 371 7310
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen: MedImmune, LLC, Lagelandseweg 78, 6545 CG Nijmegen, Holland, (Tlf.) +31 24 371 7310
English: Do not administer FLUENZ to infants and toddlers younger than 12 months.
Danish: FLUENZ må ikke administreres til spædbørn og små børn under 12 måneder.
English: Respiratory, thoracic, and mediastinal disorders Very common: Nasal congestion/rhinorrhoea Uncommon: Epistaxis
Danish: Luftveje, thorax og mediastinum Meget almindelig: Tilstoppet næse/rhinorré Ikke almindelig: Epistakse
English: Fluenz must not be injected.
Danish: FLUENZ MÅ IKKE INJICERES.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/661/002
Danish: EU/1/10/661/002
English: Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in clinical studies.
Danish: I kliniske studier forekom den højeste udskillelse af vaccine-virus 2-3 dage efter vaccinationen.
English: Dibasic potassium phosphate Monobasic potassium phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections
Danish: Dibasisk kaliumphosphat Monobasisk kaliumphosphat Gelatine (svin, Type A) Argininhydrochlorid Mononatriumglutamatmonohydrat Vand til injektionsvæsker
English: The rate of hospitalisations was not increased in FLUENZ recipients 12 months and older.
Danish: Hyppigheden af indlæggelser var ikke forøget hos modtagere af FLUENZ i alderen 12 måneder og derover.
English: In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus.
Danish: skal den potentielle risiko for transmission af virus fra influenzavaccinen vægtes i forhold til risikoen for at få og transmittere vildtype-influenzavirus.
English: Efficacy (95% CI)b Matched strains
Danish: Forbedring i beskyttelsesgrad (95 % CI)b Matchede stammer
English: Prophylaxis of influenza in individuals 24 months to less than 18 years of age.
Danish: 4.1 Terapeutiske indikationer Influenzaprofylakse hos personer i alderen 24 måneder op til 18 år.
English: FLUENZ is not indicated for use in infants and toddlers younger than 24 months (see section 4.4).
Danish: FLUENZ er ikke indiceret til brug hos spædbørn og små børn under 24 måneder (se pkt.
English: Very rare (may affect up to 1 in 1,000,000 people):
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 1.000.000):
English: Do not administer FLUENZ to children and adolescents younger than 18 years of age receiving salicylate therapy (see section 4.3).
Danish: FLUENZ må ikke administreres til børn og unge under 18 år, som er i behandling med salicylater (se pkt.
English: The active substances are:
Danish: Fluenz indeholder:
English: • Do not give acetylsalicylic acid to children aged less than 18 years for 4 weeks after vaccination with Fluenz unless your doctor, nurse or pharmacist tells you otherwise.
Danish: • Giv ikke acetylsalicylsyre til børn i alderen under 18 år i 4 uger efter vaccination med
English: In a clinical study, an increase in hospitalisations was observed in infants and toddlers younger than 12 months after vaccination (see section 4.8).
Danish: I et klinisk studie blev der observeret et forøget antal indlæggelser af spædbørn og småbørn under 12 måneder efter vaccination (se pkt.
English: Latin America
Danish: Afrika, Latinamerika
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029)
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Reassortant influenzavirus* (levende svækket) fra følgende stammer**: A/California/7/2009 (H1N1)pdm09-lignende stamme (A/California/7/2009, MEDI 228029)
English: This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2013/2014 season.
Danish: Denne vaccine følger WHO's (World Health Organisation) anbefalinger (nordlige halvkugle) og EU's beslutning for sæson 2013/2014.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 (e.g. gelatin), or to gentamicin (a possible trace residue), eggs or egg proteins (e.g. ovalbumin).
Danish: 6 (f.eks. gelatine), eller over for gentamicin (et muligt reststof), over for æg eller æggeproteiner (f.eks. ovalbumin).
English: Depress the plunger With a single motion, depress plunger as rapidly as possible until the dose-divider clip prevents you from going further.
Danish: Stemplet trykkes ned Stemplet trykkes ned så hurtigt som muligt med en enkelt bevægelse, indtil klipsen til
English: Fluenz nasal spray suspension Influenza vaccine (live attenuated, nasal)
Danish: Fluenz næsespray, suspension Influenzavaccine (levende svækket, nasal)
English: Contains also: sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections.
Danish: Indeholder også: sakkarose, dibasisk kaliumphosphat, monobasisk kaliumphosphat, gelatine (svin, type A), argininhydrochlorid, mononatriumglutamatmonohydrat, vand til injektionsvæsker.
English: Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029)
Danish: Reassortant influenzavirus* (levende svækket) fra følgende stammer**: A/California/7/2009 (H1N1)pdm09-lignende stamme (A/California/7/2009, MEDI 228029)
English: This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2013/2014 season.
Danish: Denne vaccine følger WHO's anbefalinger (nordlige halvkugle) og EU's beslutning for sæson 2013/2014.
English: The other ingredients are sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for injections.
Danish: Øvrige indholdsstoffer: Sakkarose, dibasisk kaliumphosphat, monobasisk kaliumphosphat, gelatine (svin, type A), argininhydrochlorid, mononatriumglutamatmonohydrat og vand til injektionsvæsker.
English: *** fluorescent focus units.
Danish: Dette produkt indeholder genetisk *** fluorescent focus units (FFU)
English: In a clinical study, an increased rate of wheezing was observed in infants and toddlers 12-23 months of age after vaccination (see section 4.8).
Danish: I et klinisk studie blev der efter vaccination observeret en forøget hyppighed af hvæsen hos spædbørn og småbørn i alderen 12-23 måneder (se pkt.
English: NAME OF THE MEDICINAL PRODUCT FLUENZ nasal spray suspension Influenza vaccine (live attenuated, nasal)
Danish: FLUENZ næsespray, suspension Influenzavaccine (levende svækket, nasal)
English: remove the dose-divider clip from plunger.
Danish: Fjern klipsen til dosisfordeling Klem klipsen til dosisfordeling sammen og fjern den fra stemplet,
English: FLUENZ has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
Danish: I 3 kontrollerede studier med aktiv injicerbar influenzavaccine som kontrol var profylakse med FLUENZ forbundet med statistisk forbedret beskyttelse mod influenza.
English: 10 single-use nasal applicators (0.2 ml each)
Danish: Næsespray, suspension 10 nasale applikatorer til engangsbrug (0,2 ml)
English: MedImmune, LLC Lagelandseweg 78
Danish: MedImmune, LLC
English: Tell your doctor, nurse or pharmacist if the person being vaccinated is taking, has recently taken or might take any other medicines.
Danish: Brug af anden medicin og andre vacciner sammen med Fluenz Fortæl altid lægen, sundhedspersonalet eller på apoteket, hvis du eller dit barn bruger anden medicin eller har gjort det for nylig.
English: Breastfeeding
Danish: Stempelstang
English: What Fluenz looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: USA
Danish: Amerikas Forenede Stater (USA)
English: Summary of adverse reactions
Danish: Resume af bivirkninger
English: 6 to 35 M 2,107
Danish: 11 til 24 M 1.150
English: 6545 CG Nijmegen Netherlands (Tel) +31 24 371 7310
Danish: MedImmune, LLC Lagelandseweg 78 6545 CG Nijmegen Holland (Tlf.) +31 24 371 7310
English: This is because of the risk of Reye's syndrome, a very rare but serious disease that can affect the brain and liver.
Danish: Reyes syndrom er en meget sjælden, men alvorlig
English: Do not pass it on to others.
Danish: Lad derfor være med at
English: How to store Fluenz
Danish: Du vil ikke få Fluenz
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING
English: D153-P513 Asia/ Oceania
Danish: D153-P513 Asien/ Oceanien 6 til 35 M 2.107
English: Posology
Danish: • udslæt
English: D153-P515 Europe fewer cases than injectable fewer cases than injectable a
Danish: færre tilfælde end for injicerbar færre tilfælde end for injicerbar a
English: Follow your doctor, nurse or pharmacist's instructions about when your child should return for the second dose.
Danish: Følg vejledningen fra lægen, sundhedspersonalet eller apoteket om,
English: Marketing Authorisation Holder and Manufacturer
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE
English: Packaging Content Package size Withdrawal period
Danish: Indgivelsesvej Emballage Indhold Pakningsstørrelse
English: EU number Invented name
Danish: EU-nummer
English: Strength
Danish: Tilbageholdelsestid
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER OG RESTRIKTIONER I FORBINDELSE MED EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES AF MEDLEMSLANDET
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BILAG BETINGELSER OG RESTRIKTIONER I FORBINDELSE MED EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES AF MEDLEMSLANDET
English: Overdose studies were not conducted in animals over 14 months of age.
Danish: Overdoseringsstudier blev ikke udført på dyr, der var over 14 måneder gamle.
English: Date of first authorisation: 13/09/2004 Date of last renewal: 29/05/2009
Danish: Dato for første markedsføringstilladelse: 13.09.2004 Dato for seneste fornyelse af markedsføringstilladelse: 29.05.2009
English: These reactions are generally of a transitory nature and are reversible when the treatment is stopped.
Danish: Disse reaktioner er sædvanligvis af forbigående karakter og reversible, når behandlingen ophører.
English: Following multiple oral administrations, the steady state is reached by the third daily dose.
Danish: Efter flere orale administrationer opnås ”steady state” ved den tredje daglige dosis.
English: As with other NSAIDs, serious adverse effects can occur and, in very rare cases, may be fatal.
Danish: Som for alle andre NSAID-præparater kan alvorlige bivirkninger forekomme, og disse kan i meget sjældne tilfælde være fatale.
English: The elimination half-life (t½) is 7.59 (± 1.53) hours.
Danish: Eliminerings-halveringstiden (t½) er 7,59 (± 1,53) timer.
English: *The frequency of possible adverse effects is defined using the following convention: Rare (affects 1 to 10 animals in 10,000)
Danish: *Hyppigheden af mulige bivirkninger er defineret ved hjælp af følgende konvention: Sjældne (sker hos mellem 1 og 10 ud af 10.000 dyr) Meget sjældne (sker hos færre end 1 ud af 10.000 dyr)
English: Do not use in animals less than 10 weeks of age or less than 3 kg body weight.
Danish: Må ikke anvendes til dyr under 10 uger gamle eller under 3 kg legemsvægt.
English: Do not use after the expiry date stated on the label.
Danish: Bør ikke anvendes efter udløbsdatoen angivet på pakningen.
English: If such use cannot be avoided, those dogs require careful veterinary monitoring.
Danish: Såfremt en sådan anvendelse ikke kan undgås, bør hundene være under nøje overvågning af en dyrlæge.
English: 4 Chemin de Calquet 31000 Toulouse France
Danish: 4 chemin du Calquet 31000 Toulouse Frankrig
English: Firocoxib is approximately 96 % bound to plasma proteins.
Danish: Ca. 96 % firocoxib bindes til plasmaproteiner.
English: Special precautions for use in animals The recommended dose, as indicated in the dosing table, should not be exceeded.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Den anbefalede dosis, som angivet i doseringstabellen, bør ikke overskrides.
English: Concurrent use of other active substances that have a high degree of protein binding may compete with firocoxib for binding and thus lead to toxic effects.
Danish: Samtidig brug af andre aktive stoffer, der har en høj proteinbinding, kan konkurrere med firocoxibs binding og således føre til toksiske virkninger.
English: Tablets can be administered with or without food.
Danish: Tabletterne kan anvendes samtidig med eller uafhængig af fodring.
English: Duration of treatment will be dependent on the response observed.
Danish: Varighed af behandlingen vil afhænge af den iagttagne virkning.
English: 10 tablets 30 tablets 60 tablets 180 tablets
Danish: 10 tabletter 30 tabletter 60 tabletter 180 tabletter
English: If clinical signs of overdosing are observed, discontinue treatment.
Danish: Hvis der iagttages kliniske symptomer på overdosering, bør behandlingen ophøre.
English: Relief of post-operative pain:
Danish: Lindring af postoperativ smerte:
English: Firocoxib is metabolised predominantly by dealkylation and glucuronidation in the liver.
Danish: Firocoxib metaboliseres primært ved dealkylering og glucoronisering i leveren.
English: Following oral administration in dogs at the recommended dose of 5 mg per kg of bodyweight, firocoxib is rapidly absorbed and the time to maximal concentration (Tmax) is 1.25 (± 0.85) hours.
Danish: Efter oral administration til hund i den anbefalede dosis på 5 mg pr. kg. legemsvægt, absorberes firocoxib hurtigt, og tiden til maksimal koncentration (Tmax) er 1,25 (± 0,85) timer.
English: Coxibs therefore display analgesic, anti-inflammatory and antipyretic properties.
Danish: Coxib har således analgetiske, anti-inflammatoriske og anti-pyretiske egenskaber.
English: The concentration of firocoxib required to inhibit 50 % of the COX-2 enzyme (i.e., the IC50) is 0.16 (± 0.05) µM, whereas the IC50 for COX-1 is 56 (± 7) µM.
Danish: Den koncentration af firocoxib, der kræves for at hæmme 50 % af COX-2 enzymet (i.e. IC50) er 0,16 (± 0,05) μM, hvorimod IC50 for COX-1 er 56 (± 7) μM.
English: Previcox tablets are supplied in blisters (transparent PVC /aluminium foil) or in 30 ml or 100 ml high density polyethylene bottles (with polypropylene closure).
Danish: Previcox tabletter opbevares i æsker med blistre (transparent PVC /aluminium folie eller i 30 ml eller 100 ml polyethylen beholder med polypropylen lukke).
English: Manufacturer for the batch release: MERIAL, 4 Chemin du Calquet, 31000 Toulouse, France
Danish: Fremstiller af batchfrigivelse: Merial, 4 Chemin du Calquet , 31000 Toulouse; Frankrig
English: The chewable tablets (57 mg or 227 mg) are available in the following pack sizes:
Danish: Tyggetabletterne (57 mg eller 227 mg) fås i følgende pakningsstørrelser:
English: Use in very young animals, or animals with suspected or confirmed impairment of renal, cardiac or hepatic function may involve additional risk.
Danish: Anvendelse til meget unge dyr eller dyr med mistanke om eller kendt nedsat nyre-, hjerte- eller leverfunktion kan medføre øget risiko.
English: Iron oxides (E172) Caramel (E150d)
Danish: Jernoxider (E172) Karamel (E150d)
English: For the reduction of post-operative pain and inflammation, the animals can be dosed starting approximately 2 hours before surgery for up to 3 consecutive days as needed.
Danish: For at nedsætte smerte og betændelse efter operation kan behandling af dyrene påbegyndes ca. 2 timer før operation i op til 3 dage efter behov.
English: Peri-operative pain management.
Danish: Perioperativ smertebehandling.
English: 5 mg/kg once daily.
Danish: 5 mg pr. kg én gang dagligt.
English: As field studies were limited to 90 days, longer-term treatment should be considered carefully and regular monitoring undertaken by the veterinarian.
Danish: Da kliniske undersøgelser var begrænset til 90 dage, bør længere varende behandling overvejes nøje og være under regelmæssig overvågning af en dyrlæge.
English: As anaesthetic drugs may affect renal perfusion, the use of parenteral fluids during surgery should be considered to decrease potential renal complications when using NSAIDs peri-operatively.
Danish: Da anæstetika kan påvirke den renale perfusion, bør anvendelse af parenteral væsketerapi under kirurgi overvejes for at reducere potentielle nyrekomplikationer ved brug af NSAID perioperativt.
English: Half tablets should be returned to the original market container and may be stored for up to 7 days.
Danish: Halverede tabletter skal lægges tilbage i originalpakningen og kan opbevares i 7 dage.
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE D. STATEMENT OF THE MRLs
Danish: BILAG II A. INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG C. FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG D. ANGIVELSE AF MRL-VÆRDIER
English: Appropriate laboratory testing is recommended prior to treatment in order to detect subclinical (asymptomatic) renal or hepatic disorders that may predispose to adverse effects.
Danish: Det anbefales at udføre relevante laboratorieundersøgelser forud for behandling for at afdække subklinisk (asymptomatisk) nyre- eller leverlidelse som kan disponere for bivirkninger.
English: Rarely, nervous system disorders have been reported in treated dogs.
Danish: I sjældne tilfælde er der rapporteret sygdomme i nervesystemet hos behandlede hunde.
English: EXP {month/year} Half tablets should be returned to the original market container and may be stored for up to 7 days.
Danish: EXP. {måneder/år} Halverede tabletter skal lægges tilbage i originalpakningen og kan opbevares i 7 dage.
English: Tan-brown, round, convex, engraved scored tablets.
Danish: Tyggetabletter Gyldenbrune, runde, konvekse, prægede tabletter med delekærv.
English: Emesis and diarrhoea have occasionally been reported.
Danish: Opkastning og diarre er af og til iagttaget.
English: - 1 cardboard box containing 10 tablets in one blister - 1 cardboard box containing 30 tablets in three blisters - 1 cardboard box containing 180 tablets in eighteen blisters - 1 cardboard box containing 60 tablets in one bottle
Danish: - 1 æske med et blister, indeholdende 10 tabletter - 1 æske indeholdende 30 tabletter, fordelt på tre blistre, - 1 æske indeholdende 180 tabletter fordelt på med atten blistre - 1 æske indeholdende en beholder med 60 tabletter
English: Lactose Monohydrate Microcrystalline Cellulose Chartor Hickory Smoke Flavour Hydroxypropyl Cellulose Croscarmellose Sodium Magnesium Stearate Caramel (E150d) Silica, colloidal anhydrous Iron Oxides (E172)
Danish: Laktosemonohydrat Mikrokrystallinsk cellulose Røget smag af Chartor valnød Hydroxypropylcellulose Croscarmellosenatrium Magnesiumstearat Karamel (E150d)
English: Previcox Chewable tablets are scored to facilitate accurate dosing and contain caramel and smoke flavours to facilitate administration to dogs.
Danish: Previcox tyggetabletter har delekærv for at gøre nøjagtig dosering mulig og indeholder karamel og smagsstoffer for at lette administration til hund.
English: COX-2 is also thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central nervous system functions (fever induction, pain perception and cognitive function).
Danish: COX-2 menes også at være involveret i ovulation, implantation og lukningen af ductus arteriosus samt centralnervøse funktioner (induktion af feber, smerteopfattelse og kognitiv funktion).
English: In those target animal safety studies, clinical signs of toxicity were reversible in some dogs following cessation of therapy.
Danish: I sikkerhedsundersøgelser for måldyret var kliniske symptomer på toksicitet reversible hos nogle hunde efter ophør af behandling.
English: 4.6 Adverse reactions (frequency and seriousness)*
Danish: 4.6 Bivirkninger (forekomst og sværhedsgrad)*
English: Do not use in animals suffering from gastrointestinal bleeding, blood dyscrasia or haemorrhagic disorders.
Danish: Må ikke anvendes til dyr, der lider af gastrointestinale blødninger, bloddyskrasi eller blødningsforstyrrelser.
English: Pain and inflammation associated with osteoarthritis.
Danish: Smerte og betændelse i forbindelse med osteoarthritis.
English: At dose rates equal or greater to 15 mg/kg/day (3 times the recommended dose) for six months, similar clinical signs were observed, albeit that the severity and frequency were less and duodenal ulcers were absent.
Danish: Ved doser svarende til eller større end 15 mg/kg/dag (3 gange den anbefalede dosis) i 6 måneder blev lignende kliniske symptomer observeret, skønt graden og hyppigheden var mindre og duodenale sår ikke forekom.
English: Therefore, appropriate laboratory testing to establish baseline renal or hepatic biochemistry parameters is recommended prior to and periodically during administration.
Danish: Det anbefales derfor at udføre relevante laboratorieundersøgelser for at fastsætte de basale renale eller hepatiske biokemiske værdier før behandlingens start og løbende under behandlingen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton Box labelling
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske