FrancophonIA/ELRC3.0 huggingface dataset:
English: The bactericidal action of orbifloxacin results from interference with the enzymes DNA topoisomerase II (DNA-gyrase) and DNA topoisomerase IV which are needed for the synthesis and maintenance of bacterial DNA.
Danish: Orbifloxacins baktericide virkning skyldes hæmning af enzymerne DNA- topoisomerase II (DNA-gyrase) og DNA- topoisomerase IV, som er nødvendige for dannelsen og vedligeholdelsen af bakterielt DNA.
English: Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: Decrease of the bacterial wall permeability, expression of efflux pump, or mutation of enzymes responsible for the molecule's binding site.
Danish: Resistens mod fluorokinoloner sker ved kromosomal mutation via tre mekanismer: Mindsket permeabilitet i bakteriernes cellevæg, aktivering af effluxpumpe eller mutation af enzymer, der er ansvarlige for molekylets receptorbinding.
English: 17.5 mL and 35.1 mL: 28 days
Danish: 17,5 ml eller 35,1 ml: 28 dage
English: PACKAGE SIZE 17.5 mL
Danish: PAKNINGSSTØRRELSE 17,5 ml
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/081/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/08/081/001
English: Quinolone class veterinary medicinal products have been associated with cartilage erosions in weightbearing joints and other forms of arthropathy in immature animals of various species.
Danish: Kinoloner, klassificeret som veterinærlægemiddel, har været associeret med bruskerosioner i vægtbærende led og andre former for arthropatier hos ikke udvoksede dyr af forskellige arter.
English: Prolonged and intensive use of topical corticosteroids preparation is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed healing.
Danish: Langvarig og intensiv brug af topikale kortikosteroider er kendt for at udløse lokale og systemiske effekter, inklusive nedsat binyrefunktion, atrofi af epidermis og forlænget helingstid.
English: Excess hair around the treatment area should be cut.
Danish: Kraftig hårvækst fjernes fra området, der skal behandles.
English: Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular Malassezia pachydermatis.
Danish: Til behandling af akut otitis externa og akut forværring af recidiverende otitis externa, der er forårsaget af bakterier, der er følsomme over for orbifloxacin, og svampe, der er følsomme over for posaconazol, specielt Malassezia pachydermatis.
English: The use of the veterinary medicinal product is not recommended during lactation.
Danish: Brugen af dette veterinærlægemiddel kan ikke anbefales under diegivning.
English: Special precautions for use in animals:
Danish: Særlige forholdsregler vedrørende brug hos dyr:
English: Lauric acid
Danish: Laurinsyre
English: Do not use in case of hypersensitivity to any of the ingredients of the veterinary medicinal product, to corticosteroids, to other azole antifungal agents or to other fluoroquinolones.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for nogen af stofferne i lægemidlet, kortikosteroider, andre azol-svampemidler eller andre fluorokinoloner.
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION Auricular use.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle 8.8 mL
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Flaske label 8,8 ml
English: After application, the base of the ear may be massaged briefly and gently to allow the veterinary medicinal product to penetrate the lower part of the ear canal.
Danish: Efter applicering kan ørets basis masseres kortvarigt og forsigtigt for at fremme fordelingen af veterinærlægemidlet til den indre del af øregangen.
English: QUANTITY OF THE ACTIVE SUBSTANCES Orbifloxacin
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Orbifloxacin
English: STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS Orbifloxacin
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Orbifloxacin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box 8.8 mL
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton på 8,8 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle 17.5 mL and 35.1 mL
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Flaske label 17,5 ml eller 35,1 ml
English: Manufacturer for the batch release:
Danish: Fremstiller ansvarlig for batchfrigivelse:
English: Do not use in case of hypersensitivity to the active substances, to any of the ingredients, to corticosteroids, to other azole antifungal agents or to other fluoroquinolones.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne, kortikosteroider, andre azol-antimykotika eller andre fluorokinoloner.
English: Do not use if the eardrum is perforated.
Danish: Må ikke anvendes, hvis trommehinden er perforeret.
English: The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Danish: Lægemidlets sikkerhed under drægtighed og laktation er ikke fastlagt.
English: PHARMACEUTICAL FORM Ear drops suspension
Danish: LÆGEMIDDELFORM Øredråber, suspension
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 17.5 mL
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Store in the original bottle and carton.
Danish: Opbevar flasken i den ydre karton.
English: After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate the lower part of the ear canal.
Danish: Efter applikation kan øret masseres kortvarigt og forsigtigt for at fremme fordelingen af præparatet til den indre del af øregangen.
English: Shelf-life after first opening the bottle:
Danish: Opbevaringstid efter første åbning af den indre emballage:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box 17.5 mL and 35.1 mL
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton: 17,5 ml eller 35,1 ml.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Posatex ear drops for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Posatex øredråber til hunde
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after first opening the immediate packaging: 8.8 mL: 7 days
Danish: Opbevaringstid efter første åbning af den indre emballage: 8,8 ml: 7 dage
English: PACKAGE SIZE 8.8 mL
Danish: 8,8 ml
English: Dogs weighing 15 kg or more, apply 8 drops to the ear once a day.
Danish: Applicér 2 dråber i øret en gang dagligt på hunde med en kropsvægt på mindre end 2 kg. Applicér 4 dråber i øret en gang dagligt på hunde med en kropsvægt på mellem 2-15 kg. Applicér 8 dråber i øret en gang dagligt på hunde med en kropsvægt på 15 kg eller mere.
English: METHOD AND ROUTE OF ADMINISTRATION For auricular use only.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til anvendelse i øret.
English: Studies with a range of proprietary ear cleaners have shown no chemical incompatibilities.
Danish: Der er ikke fundet kemiske uforligeligheder ved undersøgelse af en række af de ørerensemidler, der er i handelen.
English: Lactation: The use of the veterinary medicinal product is not recommended during lactation.
Danish: Laktation: Anvendelse frarådes under laktation.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Posatex ear drops suspension for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Posatex øredråber, suspension til hunde.
English: Paraffin liquid
Danish: Paraffinolie
English: PACKAGE LEAFLET FOR: Posatex ear drops suspension dogs
Danish: INDLÆGSSEDDEL TIL Posatex øredråber, suspension til hunde
English: EXPIRY DATE EXP {2 month/year} Once opened use within 28 days.
Danish: Opbevaringstid efter første åbning af den indre emballage: 28 dage
English: EXPIRY DATE EXP {2 digits /year} Once opened use within 7 days.
Danish: Opbevaringstid efter første åbning af den indre emballage: 7 dage
English: AUTHORISATION
Danish: TILBAGEHOLDELSESTID
English: SPECIAL WARNINGS
Danish: 4.4 Særlige advarsler
English: Quinolone class drugs have been associated with cartilage erosions in weight-bearing joints and other forms of arthropathy in immature animals of various species.
Danish: Bruskforandringer i vægtbærende led og andre former for ledsygdomme hos ikke udvoksede dyr af forskellige arter kan være forbundet med brugen af kinoloner, og må derfor ikke anvendes til dyr under 4 måneder.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, and marketing authorisation holders in the Member States
Danish: Liste med navne, lægemiddelformer, styrker, administrationsveje, indehavere af markedsføringstilladelsen i medlemslandene
English: Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA ul.
Danish: ChemicznoFarmaceutyczna Spółdzielnia Pracy ESPEFA ul.
English: 1304 Nicosia Cyprus
Danish: 1304 Nicosia
English: Arrow Generiques 26 Avenue Tony Garnier 69007 Lyon
Danish: Frankrig Arrow Generiques 26 Avenue Tony Garnier 69007 Lyon
English: Actavis EAD 29 Atanas Dukov Str. Sofia 1407
Danish: Bulgarien Actavis EAD 29 Atanas Dukov Str. Sofia 1407
English: 4822 NK BREDA The Netherlands
Danish: 4822 NK BREDA
English: UCB Pharma Ireland Ltd United Drug House Magna Drive, Magna Business Park Citywest Road
Danish: UCB Pharma Ireland Ltd United Drug House Magna Drive, Magna Business Park Citywest Road Dublin 24
English: Olvos Science AE Eleftherias 4
Danish: Grækenland Olvos Science AE Eleftherias 4
English: 180 00 Praha 8
Danish: 180 00 Praha 8 Czech Republic
English: Slovak Republic UCB s.r.o Thámova 13
Danish: UCB s.r.o Thámova 13
English: United Kingdom UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE
Danish: UCB Pharma Limited 208 Bath Road, Slough Berkshire SL1 3WE United Kingdom
English: Alliance Pharmaceuticals Limited Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB United Kingdom
Danish: Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB United Kingdom
English: Uni-Pharma Kleon Tsetis Farmakeftika Ergastria ABEE 14 Km.
Danish: Grækenland Uni-Pharma Kleon Tsetis Farmakeftika Ergastria ABEE
English: Inopharm limited 7 Florinis Street Greg Tower, 6th Floor PO Box 24854
Danish: Greg Tower, 6th Floor PO Box 24854
English: Ag. Dimitriou 63 17456, Alimos, Athens Greece
Danish: 17456, Alimos, Athens Greece
English: 420 Avenue Estienne d'Orves Défense Ouest
Danish: Frankrig UCB Pharma S.A. 420 Avenue Estienne d'Orves
English: Rua Victor Câmara, Edifício Q 60, D. Maria I, Piso 1 Fracção D, Quinta da Fonte 2770-229 Paço de Arcos Porgutal
Danish: Rua Victor Câmara, Edifício Q 60, D. Maria I, Piso 1
English: UCB Magyarország Kft. Árpád fejedelem útja 26-28 1023 Budapest Hungary
Danish: UCB Magyarország Kft. Árpád fejedelem útja 26
English: United Kingdom Alliance Pharmaceuticals Limited Avonbridge House
Danish: Alliance Pharmaceuticals Limited
English: HYDROXYZINE RENAUDIN 100 mg /2 ml, solution injectable
Danish: Hydroxyzindihydrochlorid HYDROXYZINE RENAUDIN 100 mg /2 ml, solution injectable
English: Nat. Road Athens-Lamia 14564, K. Kifisia Greece
Danish: 14564, K. Kifisia
English: 100 mg Coated tablet
Danish: 100 mg Overtrukket tablet
English: Hydroxyzine dihydrochloride Propyphenazone Codeine phosphate
Danish: Hydroxyzindihydrochlorid Propyphenazon Kodein fosfat
English: Partyzancka 133/151
Danish: Partyzancka 133/151 95-200 Pabianice Poland
English: Hydroxyzinum Aflofarm
Danish: Hydroxyzindihydrochlorid Hydroxyzinum Aflofarm
English: Atarax 10mg tablets
Danish: 10 mg Tablet
English: Belgium UCB Pharma S.A. Allée de la Recherche, 60 1070 Bruxelles
Danish: Belgien UCB Pharma S.A. Allée de la Recherche, 60 1070 Bruxelles
English: ATARAX 2mg/ml JARABE
Danish: Hydroxyzindihydrochlorid ATARAX 2mg/ml JARABE
English: ATARAX 25 mg COMPRIMIDOS
Danish: 25 mg Tablet
English: Syrup
Danish: ATARAX
English: Ucerax 10mg/5ml Syrup
Danish: Hydroxyzindihydrochlorid Ucerax 10mg/5ml Syrup
English: Hydroxyzine-2 HCl 25
Danish: Hydroxyzindihydrochlorid Hydroxyzine-2 HCl 25
English: Hydroxyzine-2 HCl 10
Danish: Hydroxyzindihydrochlorid Hydroxyzine-2 HCl 10
English: ATARAX 100 mg/2 ml, solution injectable
Danish: Hydroxyzindihydrochlorid ATARAX 100 mg/2 ml, solution injectable
English: Hydroxyzinum Biogened
Danish: Hydroxyzindihydrochlorid Hydroxyzinum Biogened
English: ATARAX sirop 2 mg/ml
Danish: Hydroxyzindihydrochlorid ATARAX sirop 2 mg/ml
English: Hydroxyzinum Teva
Danish: Hydroxyzin
English: DERMOGEN PHARMA, S.A. Aragoneses, 15
Danish: Spanien UCB Pharma, S.A. Paseo de la Castellana planta 15
English: Czech Republic UCB Pharma S.A. Allée de la Recherche, 60 1070 Bruxelles
Danish: Bulgarien UCB Pharma S.A. Allée de la Recherche, 60 1070 Bruxelles
English: Atarax 10mg film-coated tablets
Danish: Hydroxyzindihydrochlorid Atarax 10mg film-coated tablets
English: Hydroxyzinum Espefa
Danish: Hydroxyzindihydrochlorid Hydroxyzinum Espefa
English: Hydroxyzine dihydrochloride
Danish: Hydroxyzindihydrochlorid Neurolax
English: HYDROXYZINE INOPHARM 25 mg, comprimé pelliculé sécable
Danish: Hydroxyzindihydrochlorid HYDROXYZINE INOPHARM 25 mg, comprimé pelliculé sécable
English: UCB Pharma B.V. Lage Mosten 33
Danish: Lage Mosten 33
English: HYDROXYZINE ARROW 25 mg, comprimé pelliculé sécable
Danish: Hydroxyzindihydrochlorid HYDROXYZINE ARROW 25 mg, comprimé pelliculé sécable
English: EFIDAC
Danish: Athens-Lamia
English: Ucerax 25 mg film-coated tablets
Danish: Hydroxyzindihydrochlorid Ucerax 25 mg film-coated tablets
English: Atarax 25mg film-coated tablets
Danish: Hydroxyzindihydrochlorid Atarax 25mg film-coated tablets
English: Atarax 25mg tablets
Danish: Hydroxyzindihydrochlorid Atarax 25mg tablets
English: HYDROLAX 25 mg, comprimé pelliculé sécable
Danish: Hydroxyzindihydrochlorid TADRO 25 mg, comprimé pelliculé sécable
English: Hydroxyzinum VP 25 mg
Danish: Hydroxyzindihydrochlorid ATARAX 25 mg COMPRIMIDOS
English: ATARAX 100 mg, comprimé pelliculé sécable
Danish: Hydroxyzindihydrochlorid ATARAX 100 mg, comprimé pelliculé sécable
English: Hydroxyzinum VP 10 mg
Danish: Hydroxyzindihydrochlorid Atarax 10mg tablets
English: 84 (3 x 28 capsules) (multipack)
Danish: 84 (3 x 28 kapsler) (multipakning)
English: Therefore, appropriate clinical monitoring is advisable.
Danish: Hensigtsmæssig klinisk monitorering er derfor tilrådelig.
English: Children under 12 years.
Danish: Børn under 12 år:
English: Alcoholism, drug addiction.
Danish: Alkoholisme, narkotiamisbrug.
English: Simultaneous use of different NSAIDs is not recommended.
Danish: Samtidig anvendelse af forskellige NSAID-midler anbefales ikke.
English: Treatment should be discontinued if no benefit is seen.
Danish: Behandlingen skal afbrydes, hvis der ikke ses nogen bedring.
English: Do not give TRADEMARK to a child aged less than 12.
Danish: TRADEMARK må ikke gives til børn under 12 år.
English: The usual dose is 1 <unit> of 100 mg twice a day after a meal.
Danish: Den sædvanlige dosis er 1 <enhed> a 100 mg to gange dagligt efter et måltid.
English: Liver damage, in most cases reversible, has been reported following short exposure to the drug.
Danish: Leverskade, i de fleste tilfælde reversibel, er indberettet efter kort eksponering for lægemidlet.
English: Concomitant exposure to other potentially hepatotoxic substances.
Danish: Samtidig eksponering for andre potentielt levertoksiske stoffer.
English: NSAIDs may mask the fever related to an underlying bacterial infection.
Danish: NSAID-midler kan skjule den feber, der relaterer til en underliggende bakterieinfektion..
English: Primary dysmenorrhoea.
Danish: Primær dysmenoré.
English: Always take TRADEMARK exactly as your doctor has instructed you.
Danish: Tag altid TRADEMARK nøjagtigt efter lægens anvisning.
English: Before prescribing TRADEMARK your doctor will assess the benefits this medicine may give you against your risks of developing side effects.
Danish: Før du får ordineret TRADEMARK, vil lægen vurdere, hvilke fordele denne medicin kan give dig i forhold til risikoen for bivirkninger.
English: Nimesulide should only be prescribed as second line treatment.
Danish: Nimesulide skal kun ordineres som andenlinjebehandling.
English: - If you are elderly, your doctor may want to see you at intervals to make sure that TRADEMARK is not causing stomach, kidney, heart or liver problems.
Danish: - Hvis du er ældre, vil din læge måske se dig regelmæssigt for at sikre sig, at TRADEMARK ikke giver problemer med mave, nyrer, hjerte eller lever.
English: HOW TO TAKE TRADEMARK
Danish: SÅDAN SKAL DU TAGE TRADEMARK
English: The minimum effective dose should be used for the shortest duration to reduce the undesirable effects.
Danish: Den mindste virkningsfulde dosis skal anvendes i kortest mulig tid for at mindske bivirkninger.
English: Patients with fever and/or flu-like symptoms.
Danish: Patienter med feber og/eller influenzalignende symptomer.
English: Gastrointestinal bleeding or ulceration / perforation can occur at any time during treatment with or without warning symptoms or a previous history of gastrointestinal events.
Danish: Gastrointestinal blødning eller sårdannelse/perforation kan opstå når som helst i løbet af behandlingen med eller uden advarselssymptomer eller tidligere tilfælde af gastrointestinale hændelser.
English: WHAT TRADEMARK IS AND WHAT IT IS USED FOR
Danish: TRADEMARKS VIRKNING, OG HVAD DU SKAL BRUGE DET TIL
English: In the event of deterioration, the treatment should be discontinued (see also section 4.5).
Danish: I tilfælde af svækkelse skal behandlingen afbrydes (se også pkt.
English: These patients should not be rechallenged with nimesulide.
Danish: Disse patienter må ikke genbelastes med nimesulide.
English: Adolescents (from 12 to 18 years): on the basis of the kinetic profile in adults and on the pharmacodynamic characteristics of nimesulide, no dosage adjustment in these patients is necessary.
Danish: Unge (fra 12 til 18 år): På grundlag af den kinetiske profil hos voksne og de farmakodynamiske egenskaber for nimesulide er dosisjustering ikke nødvendig hos disse patienter.
English: Elderly: In elderly patients there is no need to reduce the daily dosage (see section 5.2).
Danish: Ældre: Der er ikke behov for at reducere den daglige dosis hos ældre patienter (se pkt.
English: BEFORE YOU TAKE TRADEMARK Do not use TRADEMARK if you:
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE TRADEMARK Tag ikke TRADEMARK:
English: It is used for treatment of acute pain, for the treatment of symptoms of painful osteoarthritis, and for the treatment of period pains.
Danish: Det bruges til behandling af akutte smerter, til behandling af symptomer på smertefuld osteoarthritis og til behandling af menstruationssmerter.
English: TRADEMARK is a non-steroidal anti-inflammatory drug (“NSAID”), with pain-killing and feverlowering properties.
Danish: TRADEMARK er et non-steroidt antiinflammatorisk lægemiddel ("NSAID"), der virker smertestillende og febernedsættende.
English: - If you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
Danish: - Hvis du ikke kan tåle visse former for sukker, skal du kontakte læge, før du tager denne medicin.
English: 100mg bid after meal.
Danish: 100 mg 2 gange dagligt efter måltid.
English: If gastrointestinal bleeding or ulceration occurs, nimesulide should be discontinued.
Danish: Hvis der indtræder gastrointestinal blødning eller sårdannelse, skal nimesulide afbrydes.
English: Take special care with TRADEMARK
Danish: Vær ekstra forsigtig med at tage TRADEMARK
English: The decision to prescribe nimesulide should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4).
Danish: Beslutning om at ordinere nimesulide skal baseres på en vurdering af den enkelte patients samlede risiko (se pkt.
English: - If you are planning a pregnancy, you should inform your doctor since TRADEMARK may decrease fertility.
Danish: - Hvis du har planer om at blive gravid, skal du informere din læge om det, da TRADEMARK kan mindske muligheden for at blive gravid.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET OF NIMESULIDE CONTAINING MEDICINAL PRODUCTS (SYSTEMIC FORMULATIONS)
Danish: ÆNDRINGER, SOM SKAL INDFØRES I DE RELEVANTE AFSNIT AF INDLÆGSSEDLEN FOR LÆGEMIDLER MED NIMESULIDE (SYSTEMISKE FORMULERINGER)
English: As nimesulide can interfere with platelet function, it should be used with caution in patients with bleeding diathesis (see also section 4.3).
Danish: Da nimesulide kan påvirke blodpladernes funktion, skal det anvendes med forsigtighed hos patienter med blødningsdiatese (se også pkt.
English: History of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
Danish: Tilfælde med overfølsomhedsreaktioner (f.eks. bronkospasme, rhinitis, urticaria) som reaktion på acetylsalicylsyre eller andre non-steroide antiinflammatoriske midler.
English: Nimesulide 100mg Tablets/granules should be used for the shortest possible duration, as required by the clinical situation.
Danish: Nimesulide 100 mg tabletter/granulat bør anvendes i den kortest mulige tid, som den kliniske situation kræver.
English: However, Nimesulide 100mg Tablets/granules is not a substitute for acetylsalicylic acid for cardiovascular prophylaxis.
Danish: Nimesulide 100 mg tabletter/granulat er imidlertid ikke en erstatning for acetylsalicylsyre til kardiovaskulær profylakse.
English: The maximum duration of a treatment course with nimesulide is 15 days.
Danish: Behandling med nimesulide må maksimalt ske i 15 dage.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS OF NIMESULIDE CONTAINING MEDICINAL PRODUCTS (SYSTEMIC FORMULATIONS)
Danish: ÆNDRINGER, SOM SKAL INDFØRES I DE RELEVANTE AFSNIT AF PRODUKTRESUMEET FOR LÆGEMIDLER MED NIMESULIDE (SYSTEMISKE FORMULERINGER)
English: Active gastric or duodenal ulcer, a history of recurrent ulceration or gastrointestinal bleeding, cerebrovascular bleeding or other active bleeding or bleeding disorders.
Danish: Aktivt mavesår eller duodenalsår, tilfælde med tilbagevendende ulceration eller gastrointestinal blødning, cerebrovaskulær blødning eller anden aktiv blødning eller blødningssygdomme.
English: Known hypersensitivity to nimesulide or to any of the excipients of the products.
Danish: Kendt overfølsomhed over for nimesulide eller over for et eller flere af produkternes hjælpestoffer.
English: If you have ever suffered from peptic ulcers, bleeding from the stomach or bowel, ulcerative colitis or Crohn's disease, you should tell your doctor before taking TRADEMARK.
Danish: Hvis du har lidt af mavesår, blødninger fra mave eller tarm, colitis ulcerosa eller Crohns sygdom, skal du fortælle din læge det, før du tager TRADEMARK.
English: The third trimester of pregnancy and breastfeeding (see sections 4.6 and 5.3).
Danish: Tredje trimester af graviditet og amning (se pkt.
English: Patients who experience symptoms compatible with hepatic injury during treatment with Nimesulide 100mg Tablets/granules (e.g. anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine) or patients who develop abnormal liver function tests should have treatment discontinued.
Danish: Patienter, som oplever symptomer, som er forligelige med leverskade under behandling med Nimesulide 100 mg tabletter/granulat (f.eks. anoreksi, kvalme, opkastning, mavesmerter, træthed, mørk urin), eller patienter, som udvikler abnorme leverfunktionstester, skal afbryde behandlingen.
English: Nimesulide should be used with caution in patients with gastrointestinal disorders, including history of peptic ulceration, history of gastrointestinal haemorrhage, ulcerative colitis or Crohn's disease.
Danish: Nimesulide bør anvendes med forsigtighed hos patienter med gastrointestinale sygdomme, herunder tilfælde af peptisk ulceration, tilfælde af gastrointestinal blødning, colitis ulcerosa eller Crohns sygdom.
English: Patients receiving nimesulide who develop fever and/or flu-like symptoms should discontinue treatment
Danish: Patienter, som får nimesulide, og som udvikler feber og/eller influenzalignende symptomer, skal ophøre med behandlingen.