FrancophonIA/ELRC3.0 huggingface dataset:
English: Exjade 90 mg granules in sachet deferasirox
Danish: Exjade 90 mg granulat i brev deferasirox
English: Exjade 90 mg granules deferasirox
Danish: Exjade 90 mg granulat deferasirox Oral anvendelse
English: • If you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes,
Danish: • Hvis du oplever en kombination af nogle af følgende symptomer: udslæt, rød hud, blistre på læberne, øjne eller i munden, hudafskalninger, høj feber, influenzalignende symptomer,
English: - if you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes
Danish: - hvis du oplever en kombination af nogle af følgende symptomer: udslæt, rød hud, blistre på læberne, øjne eller mund, hudafskaldninger, høj feber, influenzalignende symptomer,
English: Possible side effects
Danish: ”Bivirkninger”).
English: 3.5 - 7 mg/kg/day Up to 28 mg/kg/day
Danish: 3,5 - 7 mg/kg/dag Op til
English: If you take more EXJADE than you should
Danish: Hvis du har taget for meget EXJADE
English: • If you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes,
Danish: • Hvis du oplever en kombination af nogle af følgende symptomer: udslæt, rød hud, blistre på læberne, øjne eller i munden, hudafskalninger, høj feber, influenzalignende symptomer, forstørrede lymfekirtler (tegn på alvorlige hudreaktioner)
English: Each sachet contains 90 mg of deferasirox.
Danish: Hvert brev indeholder 90 mg deferasirox.
English: Dose adjustment
Danish: Øget dosis
English: EU/1/06/356/010 294 (3 packs of 98) dispersible tablets
Danish: 294 (3 pakninger med 98) dispergible tabletter
English: preferably at the same time each day (see sections 4.5 and 5.2).
Danish: 4.5 og 5.2).
English: The CHMP opinion will now be sent to the European Commission for a legally binding decision applicable in all EU Member States.
Danish: CHMP's udtalelse vil nu blive fremsendt til Europa-Kommissionen med henblik på en retligt bindende afgørelse, der er gyldig i alle EU's medlemsstater.
English: Healthcare professionals will also receive a letter in the coming weeks reminding them of the problem.
Danish: Sundhedspersoner vil i de kommende uger modtage et brev, der henleder opmærksomheden på problemet.
English: More information about Noxafil can be found on the Agency's website: ema.europa.eu/Find_medicine.
Danish: Yderligere oplysninger om Noxafil findes på agenturets websted: ema.europa.eu/Find_medicine.
English: This review was conducted by EMA's Committee for Medicinal Products for Human Use (CHMP) in the context of a procedure known as a ‘type II variation'.
Danish: Denne gennemgang blev foretaget af EMA's Udvalg for Lægemidler til Mennesker (CHMP) i forbindelse med en "type II-ændring".
English: It contains the active substance posaconazole.
Danish: Det indeholder det aktive stof posaconazol.
English: Prescriptions should indicate which dose form is intended
Danish: Ordinationerne bør indeholde en angivelse af, hvilken dosisform, der skal anvendes
English: • Noxafil is a medicine used to treat serious infections caused by fungi, when other medicines cannot be used or are not effective.
Danish: • Noxafil er et lægemiddel, der anvendes til behandling af alvorlige svampeinfektioner, når andre lægemidler ikke kan anvendes eller ikke virker.
English: Noxafil, a medicine for serious fungal infections, is available by mouth as tablets (100 mg) and oral suspension (40 mg/ml), but the recommended doses for the two forms are different.
Danish: Noxafil, der er et lægemiddel mod alvorlige svampeinfektioner, fås til indtagelse gennem munden som tabletter (100 mg) og oral suspension (40 mg/l), men den anbefalede dosis er forskellig for de to lægemiddelformer.
English: • Patients should not switch between taking Noxafil tablets and Noxafil oral suspension without talking to their doctor or pharmacist first as it may result in a decreased effectiveness or an increased risk of side effects.
Danish: • Patienterne bør ikke skifte mellem Noxafil tabletter og Noxafil oral suspension uden først at have talt med lægen eller apotekspersonalet, da det kan medføre nedsat virkning eller øget risiko for bivirkninger.
English: It is also used in patients with weakened immune systems (such as transplant patients) to treat thrush (fungal infection of the throat or mouth due to Candida) or prevent invasive fungal infections.
Danish: Det anvendes desuden hos patienter med svækket immunsystem (såsom transplantationspatienter) til behandling af trøske (infektion i halsen eller munden forårsaget af svampen Candida) eller forebyggelse af invasive svampeinfektioner.
English: • The usual dose of tablets is three tablets (300 mg) twice a day on the first day, then 300 mg once a day.
Danish: • Den sædvanlige dosis af tabletterne er tre tabletter (300 mg) to gange dagligt den første dag, derefter 300 mg én gang dagligt.
English: • When the medicine is given by mouth, it can be given either as tablets or a liquid, but the dose needed when using the tablets (how much and how often) is different from the one needed when using the liquid.
Danish: • Når lægemidlet indgives gennem munden, kan det enten gives som tabletter eller i væskeform, men den nødvendige dosis (hvor meget og hvor ofte) af tabletterne er ikke den samme som af væsken.
English: • Patients who have any concerns about their medicine should speak to their pharmacist or the prescriber.
Danish: • Patienter, der har spørgsmål til deres behandling, bedes kontakte apotekspersonalet eller lægen.
English: Doses of the liquid (200 mg, one 5-ml spoonful) are taken three or four times a day.
Danish: Doserne af væsken (200 mg, én 5 ml-skefuld), tages tre eller fire gange dagligt.
English: • It is important that the dosage form as well as the relevant dose be specified on the prescription, and that pharmacists ensure the correct oral dosage form is dispensed.
Danish: • Det er vigtigt, at både lægemiddelformen og den relevante dosis angives i recepten, og at apotekspersonalet sørger for at udlevere den korrekte orale lægemiddelform.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 June 2016 EMA/425762/2016
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Noxafil is an antifungal medicine containing the active substance posaconazole, a member of the group of triazole antifungals.
Danish: Noxafil er et svampemiddel med det aktive stof posaconazol, der hører til triazol-svampemidlerne.
English: Some patients have mistakenly received oral solution instead of tablets, leading to underdosing and to a potential lack of effect.
Danish: Nogle patienter har fejlagtigt fået oral opløsning i stedet for tabletter, hvilket har medført underdosering og muligvis manglende virkning.
English: Similarly, there are reports of patients given tablets instead of oral solution, leading to overdosage and side effects.
Danish: Tilsvarende er der indberettet om patienter, som har fået tabletter i stedet for oral opløsning, hvilket har medført overdosering og bivirkninger.
English: • Noxafil tablets and oral suspension are not interchangeable due to the differences between these two formulations in the frequency of dosing, administration with food and plasma drug concentration achieved.
Danish: • Noxafil tabletter og oral suspension kan ikke erstatte hinanden på grund af forskelle mellem de to formuleringer i doseringshyppighed, administration sammen med et måltid og den opnåede plasmakoncentration af lægemidlet.
English: • Medication errors have been reported following erroneous switching, resulting in over- or underdosage and consequent dose-related toxicity or lack of efficacy.
Danish: • Der er beskrevet medicineringsfejl efter fejlagtigt skift mellem formerne, hvilket har resulteret i over- eller underdosering og dermed dosisafhængig toksisk virkning eller manglede virkning.
English: Product information for Noxafil (posaconazole) is to be updated to strengthen warnings that the two dose forms given by mouth cannot be simply interchanged at the same dose.
Danish: Produktinformationen for Noxafil (posaconazol) vil blive ajourført med skærpede advarsler om, at de to dosisformer til indgivelse gennem munden ikke uden videre kan erstatte hinanden ved samme dosis.
English: The recommended oral dosage is 300 mg once a day with the tablets (after a loading dose of 300 mg twice daily on day 1) and 200 mg three to four times a day (600 to 800 mg daily) with the oral suspension.
Danish: Den anbefalede orale dosis for tabletterne er 300 mg én gang dagligt (efter en støddosis på 300 mg to gange dagligt på dag 1) og for den orale suspension 200 mg tre-fire gange dagligt (600-800 mg dagligt).
English: It is available as a solution for infusion (drip) into a vein, but also as tablets and oral suspension for use by mouth.
Danish: Det fås infusionsvæske, opløsning, til indgivelse i en vene (drop), men desuden som tabletter og oral suspension til indgivelse gennem munden.
English: It is used when other medicines do not work or cannot be given, to treat adults with the serious fungal infections invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, or coccidioidomycosis.
Danish: Det anvendes til behandling af voksne med alvorlige svampeinfektioner såsom invasiv aspergillose, fusariose, chromoblastomykose, mycetom eller coccidioidomykose, når andre lægemidler er utilstrækkelige eller ikke kan anvendes.
English: Prescribers are advised to make clear which form is intended when they write a prescription, and pharmacists should ensure that the correct form is dispensed.
Danish: Læger rådes til i deres ordination klart at angive den lægemiddelform, der skal anvendes; apotekerne bør være påpasselige med at udlevere den korrekte lægemiddelform.
English: • There have been cases where patients were provided with the wrong form of the medicine, and so took the wrong dose, resulting either in side effects or in the medicine not being effective.
Danish: • I nogle tilfælde har patienterne fået den forkerte lægemiddelform og dermed en forkert dosis, hvilket enten har medført bivirkninger eller manglende virkning af lægemidlet.
English: The product information is therefore to be updated to strengthen existing warnings that the two forms cannot be simply interchanged, and the packaging will also be changed to distinguish the two forms more clearly and to carry a warning statement that they should not be substituted for one another without adjusting the dose.
Danish: Pakningen vil desuden blive ændret, så forskellen mellem de to lægemiddelformer er tydeligere, og med påføring af en advarsel om, at de ikke må anvendes som erstatning for hinanden uden tilpasning af dosis.
English: • The SmPC and patient information leaflet for Noxafil are being updated to strengthen warnings about the differences between the two formulations, and the outer cartons will be revised to further differentiate the two and to include a warning statement that they cannot be simply substituted without adjusting the dose.
Danish: • Produktresuméet og patientbrochuren for Noxafil er under ajourføring med henblik på at skærpe advarslerne om forskellene mellem de to formuleringer.
English: Avoid contact with skin or eyes.
Danish: Undgå kontakt med hud eller øjne.
English: Allergic reactions to these substances may occasionally be serious.
Danish: Allergiske reaktioner over for disse stoffer kan lejlighedsvis være alvorlige.
English: These reactions will resolve within a maximum of 23 days.
Danish: Disse reaktioner vil forsvinde inden for maksimalt 23 dage.
English: ATCvet code: QJ01DD90.
Danish: ATCvet-kode: QJ01DD90.
English: In the event of contact, wash with clean water.
Danish: I tilfælde af kontakt vask med rent vand.
English: The active substance in Naxcel is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Den aktive substans i Naxcel er godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010:
English: Milk: zero days.
Danish: Mælk: 0 dage.
English: Antiinfectious agents / Antibiotics
Danish: Antimikrobielle lægemidler / antibiotika
English: Take appropriate precautions to avoid intra-arterial or intravenous injection.
Danish: Tag passende forholdsregler for at undgå intraarteriel eller intravenøs injektion.
English: BATCH NUMBER Lot {number}
Danish: BATCH NUMMER Lot {nummer}
English: If clinical signs have not improved 48 hours after treatment, the diagnosis and treatment of the condition should be re-evaluated.
Danish: Hvis kliniske symptomer ikke er aftaget 48 timer efter behandlingen, skal diagnosen og behandling af tilstanden revurderes.
English: Lactation: This veterinary medicinal product can be used during lactation.
Danish: Laktation: Dette veterinærlægemiddel kan anvendes under laktation.
English: Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Danish: Anvendelse af lægemidlet bør baseres på følsomhedstest og tage hensyn til officiel og lokal antibiotikapolitik.
English: Opaque white to light brown suspension.
Danish: Uigennemsigtig hvid til lysebrun suspension.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Danish: Brug ikke dette vetrinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP.
English: Approximately 60% and 15% of the dose are excreted in the urine and faeces, respectively, within 10 days after administration.
Danish: Omkring 60% og 15% af dosis udskilles i henholdsvis urin og fæces inden for 10 dage efter administrationen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én ml indeholder:
English: Pregnancy and fertility:
Danish: Drægtighed og fertilitet:
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: 6.1 i produktresuméet, er enten tilladte stoffer, hvor tabel 1 i bilaget til Forordning (EU) nr. 37/2010 tilkendegiver, at ingen MRL-værdier er påkrævet eller betragtes som værende ikke omfattet af Forordning (EC) nr. 470/2009, når de anvendes i dette veterinære lægemiddel.
English: Meat and offal: 9 days.
Danish: Kød og indvolde: 9 dage.
English: Occasionally, transient local swelling may occur following intramuscular injection.
Danish: Lejlighedsvis kan lokal forbigående hævelse forekomme efter intramuskulær injektion.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/05/2005.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Første tilladelse: 19/05/2005.
English: Whenever possible, cephalosporins should only be used based on susceptibility testing.
Danish: Cephalosporiner bør, når det er muligt, kun anvendes på grundlag af følsomhedstest.
English: Date of last renewal: 26/05/2010.
Danish: Fornyelse: 26/05/2010.
English: In cattle, although Naxcel has not been specifically tested for overdoses, no signs of systemic toxicity related to ceftiofur have been observed following 55 mg/kg parenteral daily overdoses of ceftiofur sodium for five days.
Danish: Selvom Naxcel ikke er testet specifikt for overdosering, er der hos kvæg ikke set tegn på systemisk toksicitet, der er relateret til ceftiofur efter daglige parenterale overdoser af 55 mg/kg ceftiofurnatrium i 5 dage.
English: 2,000 µg/kg Fat 2,000 µg/kg Liver 6,000 µg/kg Kidney 100 µg/kg Milk
Danish: 1000 µg/kg 2000 µg/kg 2000 µg/kg 6000 µg/kg 100 µg/kg
English: No effects on the reproductive performance were observed in both species.
Danish: Hos begge arter blev der ikke observeret påvirkning af reproduktionen.
English: When considering the treatment strategy, it is appropriate to consider improvement of the herd management practice and use supporting treatment with suitable local products (e.g. disinfectants).
Danish: Når behandlingsstrategien overvejes, er det hensigtsmæssigt at overveje forbedring af management i besætningen og anvende understøttende behandling med egnede produkter til lokal anvendelse (f.eks. desinfektionsmidler).
English: Resolution has been observed at 56 days post-injection.
Danish: Forandringerne er konstateret forsvundet 56 dage efter injektionen.
English: In very rare cases, sudden death has been reported following administration of the product.
Danish: I meget sjældne tilfælde er der rapporteret om pludselig død efter administration af lægemidlet.
English: Bordetella bronchiseptica is inherently insensitive to ceftiofur in vitro.
Danish: Bordetella bronchiseptica er fra naturens side ikke følsom overfor ceftiofur in vitro.
English: Base of the ear administration:
Danish: Administration ved basis af øret:
English: Pharmacotherapeutic group: Antibacterials for systemic use, third-generation cephalosporins.
Danish: Farmakoterapeutisk gruppe: Antibakterica til systemisk brug, tredje generations cephalosporiner.
English: Mild tissue reactions at the injection site, such as small areas (less than 6 cm²) of discolouration and small cysts have been observed for up to 42 days after injection.
Danish: Mild reaktion på injektionsstedet som små områder (mindre end 6 cm²) med misfarvning og småcyster er observeret i op til 42 dage efter injektionen.
English: Diagram of the head showing the direction for the base of the ear injections administered toward the animal's opposite eye.
Danish: Diagram af hovedet, der viser retningen for administration af injektionen fra basis af øret mod dyrets modsatte øje.
English: Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur
Danish: Summen af alle restkoncentr ationer med betalactamst ruktur udtrykt som desfuroylcef tiofur
English: Maximum concentrations in plasma (about 5 µg/ml) occurred from 12 hours following administration.
Danish: Maksimale plasmakoncentrationer (cirka 5 µg/ml) forekom 12 timer efter administrationen.
English: • Administer in the posterior part of the ear base (see Figure 1).
Danish: • Injicér i den bageste del af ørets basis (se figur 1).
English: People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this veterinary medicinal product.
Danish: Personer med kendt overfølsomhed over for penicilliner og cephalosporiner bør undgå kontakt med disse veterinærlægemidler.
English: Visible swellings have been noted at the injection site in about two thirds of treated animals, two days after injection in field conditions.
Danish: Synlige hævelser er set ved injektionsstedet hos ca. to tredjedele af de behandlede dyr to dage efter injektion til kvæg i kliniske felt-studier.
English: Protein binding of ceftiofur and its major metabolite is high, approximately 70% - 90%.
Danish: Proteinbinding af ceftiofur og dets hovedmetabolit er høj, cirka 70% - 90%.
English: In very rare cases anaphylactic type reactions may occur following administration of the product.
Danish: I meget sjældne tilfælde kan anafylaktiske reaktioner forekomme efter administration af lægemidlet.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Owing to the low toxicity of ceftiofur in pigs overdoses do not typically lead to any clinical signs, other than transient local swellings as described in section 4.6 (Adverse reactions).
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt På grund af den lave toksicitet af ceftiofur i svin fører overdosering typisk ikke til nogen symptomer, andre end forbigående lokal hævelse, som beskrevet i afsnit 4.6 (Bivirkninger).
English: One hour after a single administration, plasma concentrations are above 1 µg/ml.
Danish: En time efter en enkelt administration er plasmakoncentrationen over 1 µg/ml.
English: Marker residue Animal species
Danish: Restmarkør Dyreart
English: Desfuroylceftiofur is the principal active metabolite.
Danish: Desfuroylceftiofur er den vigtigste aktive metabolit.
English: Plasma concentrations above 0.2 µg/ml of ceftiofur and its metabolite are maintained for an appropriate period of time.
Danish: Plasmakoncentrationer over 0,2 µg/ml af ceftiofur og dets metabolitter opretholdes i en passende lang periode.
English: In cattle, ceftiofur is active against the following micro-organisms which are involved in acute postpartum (puerperal) metritis: Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum; and interdigital necrobacillosis: Bacteroides spp., Fusobacterium necrophorum, Porphyromonas spp.
Danish: Hos kvæg er ceftiofur aktivt over for følgende mikroorganismer, som er involveret i akut post-partum (puerperal) metritis: Escherichia coli, Arcanobacterium pyogenes og Fusobacterium necrophorum, og interdigital necrobacillose: Bacteroides spp., Fusobacterium necrophorum, Porphyromonas spp.
English: To ensure a correct dosage, bodyweight should be accurately determined to avoid under-dosing.
Danish: For at sikre en korrekt dosis, skal legemsvægten bestemmes nøjagtigt for at undgå underdosering.
English: Injection site swellings may result in mild to moderate pain in some animals in the initial days following injection.
Danish: Hos nogle dyr kan hævelserne ved injektionsstedet medføre let til moderat smerte i de første dage efter injektionen.
English: Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa.
Danish: Overfølsomhed over for penicilliner kan medføre krydsreaktion over for cephalosporiner og omvendt.
English: Total plasma concentrations above 0.2µg/ml and 1µg/ml of ceftiofur and its active metabolites are maintained for at least 7 and 4 days, respectively.
Danish: Totale plasmakoncentrationer over 0,2 µg/ml og 1 µg/ml af ceftiofur og dets aktive metabolitter opretholdes i mindst henholdsvis 7 og 4 dage.
English: Ceftiofur is well absorbed in cattle following base of the ear injection.
Danish: Ceftiofur er velabsorberet hos kvæg efter injektion ved basis af øret.
English: Maximum concentrations in plasma (4.2±0.9 µg/ml) are reached at approximately 22 hours after administration.
Danish: De maksimale plasmaværdier (4,2+0,9 µg/ml) nås omkring 22 timer efter administrationen.
English: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Danish: Når lægemidlet anvendes, bør der tages højde for officielle, nationale og lokale retningslinier for anvendelse af antibiotika.
English: Ceftiofur is a third generation cephalosporin antibiotic, which is active against many Gram-positive and Gram-negative pathogens.
Danish: Ceftiofur er et tredjegenerations cephalosporin-antibiotikum, som er aktivt mod mange grampositive og gramnegative patogener.
English: Treatment of acute post-partum (puerperal) metritis in cases where treatment with another antimicrobial has failed.
Danish: Behandling af akut post-partum (puerperal) metritis i de tilfælde, hvor behandling med et andet antibiotikum er mislykket.
English: Treatment of acute interdigital necrobacillosis in cattle also known as Panaritium or foot rot.
Danish: Behandling af akut interdigital necrobacillose hos kvæg, også kendt som Panaritium eller klovspalteforrådnelse.
English: Protein binding of ceftiofur and its major metabolite is approximately 70%.
Danish: Proteinbindingen af ceftiofur og dets hovedmetabolit er omkring 70%.
English: Owing to the low toxicity of ceftiofur in pigs overdoses do not typically lead to any clinical signs, other than transient local swellings as described in section 6 (Adverse reactions).
Danish: På grund af den lave toksicitet af ceftiofur i svin fører overdosering typisk ikke til nogen symptomer, andre end forbigående lokal hævelse, som beskrevet i afsnit 6 (Bivirkninger).