natgillin/translations-raw huggingface dataset:
En startdosis på 30 mg/kg kan tages i betragtning for patienter, der har brug for reduktion af forhøjede jern-niveauer, og som også modtager mere end 14 ml/kg/måned pakkede røde blodceller (omkring > 4 enheder/måned for en voksen). 
An initial daily dose of 30 mg/kg may be considered for patients who require reduction of elevated body iron levels and who are also receiving more than 14 ml/kg/month of packed red blood cells (approximately >4 units/month for an adult).
Eksempelvis kan en patient, der modtager 40 mg/kg/dag af deferoxamin fem dage om ugen (eller tilsvarende), overføres til en daglig startdosis på 14 mg/kg/dag af EXJADE granulat. 
For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE granules that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 14 mg/kg/day of EXJADE granules).
30 mg/kg/dag 
30 mg/kg/day
En startdosis på 10 mg/kg kan tages i betragtning for patienter, der ikke har brug for reduktion af jernniveauer i kroppen, og som også modtager mindre end 7 mg/kg/måned pakkede røde blodceller (omkring < 2 enheder/måned for en voksen). 
An initial daily dose of 10 mg/kg may be considered for patients who do not require reduction of body iron levels and who are also receiving less than 7 ml/kg/month of packed red blood cells (approximately <2 units/month for an adult).
10 mg/kg/dag 
10 mg/kg/day
Pancytopeni1, trombocytopeni1, forværret anæmi1, neutropeni1 
Stevens-Johnson syndrome1, hypersensitivity vasculitis1, urticaria1, erythema multiforme
Eksempelvis kan en patient, der modtager 40 mg/kg/dag af deferoxamin fem dage om ugen (eller tilsvarende), overføres til en daglig startdosis på 14 mg/kg/dag af EXJADE filmovertrukne tabletter. 
For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE film-coated tablets that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 14 mg/kg/day of EXJADE film-coated tablets).
Hver EXJADE dispergibel tablet 125 mg indeholder 125 mg deferasirox. 
• Each dispersible tablet of EXJADE 125 mg contains 125 mg deferasirox.
Hver dispergibel tablet indeholder 500 mg deferasirox. 
Each dispersible tablet contains 500 mg of deferasirox.
Hver dispergibel tablet indeholder 250 mg deferasirox. 
Each dispersible tablet contains 250 mg of deferasirox.
Hver tablet indeholder 180 mg of deferasirox. 
Each tablet contains 180 mg of deferasirox.
Hver tablet indeholder 90 mg deferasirox. 
Each tablet contains 90 mg of deferasirox.
EXJADE er yderligere indiceret til behandling af kronisk jernophobning, forårsaget af blodtransfusioner, i de tilfælde hvor deferoxamin-behandling er kontraindiceret eller utilstrækkelig. 
EXJADE is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.
• Den sædvanlige daglige dosis af EXJADE granulat ved start af behandlingen for patienter, der ikke får regelmæssige blodtransfusioner, er 7 mg pr. kg kropsvægt. 
• The usual daily dose for EXJADE granules at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
Hver tablet indeholder 360 mg of deferasirox. 
Each tablet contains 360 mg of deferasirox.
Hver EXJADE dispergibel tablet 250 mg indeholder 250 mg deferasirox. 
• Each dispersible tablet of EXJADE 250 mg contains 250 mg deferasirox.
EU/1/06/356/022 30 breve 
EU/1/06/356/022 30 sachets
• Den sædvanlige daglige dosis af EXJADE filmovertrukne tabletter ved start af behandlingen for patienter, der ikke får regelmæssige blodtransfusioner, er 7 mg pr. kg kropsvægt. 
• The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
• Den sædvanlige dosis af EXJADE granulat ved start af behandling for patienter, der får regelmæssige blodtransfusioner er 14 mg pr. kg kropsvægt. 
• The usual daily dose for EXJADE granules at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
• Den sædvanlige dosis af EXJADE dispergible tabletter ved start af behandlingen for patienter, der får regelmæssige blodtransfusioner, er 20 mg pr. kg kropsvægt. 
• The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients receiving regular blood transfusions is 20 mg per kilogram body weight.
• Den sædvanlige daglige dosis af EXJADE dispergible tabletter ved start af behandlingen for patienter, der ikke får regelmæssige blodtransfusioner, er 10 mg pr. kg kropsvægt. 
• The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients not receiving regular blood transfusions is 10 mg per kilogram body weight.
Målinterval 
Target range
Hver EXJADE dispergibel tablet 500 mg indeholder 500 mg deferasirox. 
• Each dispersible tablet of EXJADE 500 mg contains 500 mg deferasirox.
EU/1/06/356/020 30 breve 
EU/1/06/356/020 30 sachets
• Den sædvanlige dosis af EXJADE filmovertrukne tabletter ved start af behandling for patienter, der får regelmæssige blodtransfusioner er 14 mg pr. kg kropsvægt. 
• The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
EU/1/06/356/021 30 breve 
EU/1/06/356/021 30 sachets
Exjade 360 mg granulat i brev deferasirox 
Exjade 360 mg granules in sachet deferasirox
Exjade 180 mg granulat i brev deferasirox 
Exjade 180 mg granules in sachet deferasirox
Inden behandling. 
Prior to therapy.
Dosis må ikke overstige 10 mg/kg hos patienter, hvor LIC ikke blev bestemt, og serumferritin er ≤ 2000 µg/l. 
In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 10 mg/kg.
1, nefrolitiasis 
1, hypersensitivity vasculitis
EXJADE udleveres som filmovertrukne tabletter. 
What EXJADE looks like and contents of the pack EXJADE is supplied as film-coated tablets.
Det skal du vide, før du begynder at tage EXJADE Sådan skal du tage EXJADE Bivirkninger 
What EXJADE is and what it is used for What you need to know before you take EXJADE How to take EXJADE
Exjade 90 mg granulat i brev deferasirox 
Exjade 90 mg granules in sachet deferasirox
Exjade 90 mg granulat deferasirox Oral anvendelse 
Exjade 90 mg granules deferasirox
• 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, 
• 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,
- hvis du oplever en kombination af nogle af følgende symptomer: udslæt, rød hud, blistre på læberne, øjne eller mund, hudafskaldninger, høj feber, influenzalignende symptomer, 
- 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
”Bivirkninger”). 
Possible side effects
3,5 - 7 mg/kg/dag Op til 
3.5 - 7 mg/kg/day Up to 28 mg/kg/day
Hvis du har taget for meget EXJADE 
If you take more EXJADE than you should
• 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) 
• 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,
Hvert brev indeholder 90 mg deferasirox. 
Each sachet contains 90 mg of deferasirox.
Øget dosis 
Dose adjustment
294 (3 pakninger med 98) dispergible tabletter 
EU/1/06/356/010 294 (3 packs of 98) dispersible tablets
4.5 og 5.2). 
preferably at the same time each day (see sections 4.5 and 5.2).
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. 
The CHMP opinion will now be sent to the European Commission for a legally binding decision applicable in all EU Member States.
Sundhedspersoner vil i de kommende uger modtage et brev, der henleder opmærksomheden på problemet. 
Healthcare professionals will also receive a letter in the coming weeks reminding them of the problem.
Yderligere oplysninger om Noxafil findes på agenturets websted: ema.europa.eu/Find_medicine. 
More information about Noxafil can be found on the Agency's website: ema.europa.eu/Find_medicine.
Denne gennemgang blev foretaget af EMA's Udvalg for Lægemidler til Mennesker (CHMP) i forbindelse med en "type II-ændring". 
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'.
Det indeholder det aktive stof posaconazol. 
It contains the active substance posaconazole.
Ordinationerne bør indeholde en angivelse af, hvilken dosisform, der skal anvendes 
Prescriptions should indicate which dose form is intended
• Noxafil er et lægemiddel, der anvendes til behandling af alvorlige svampeinfektioner, når andre lægemidler ikke kan anvendes eller ikke virker. 
• Noxafil is a medicine used to treat serious infections caused by fungi, when other medicines cannot be used or are not effective.
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. 
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.
• 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. 
• 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.
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. 
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.
• Den sædvanlige dosis af tabletterne er tre tabletter (300 mg) to gange dagligt den første dag, derefter 300 mg én gang dagligt. 
• The usual dose of tablets is three tablets (300 mg) twice a day on the first day, then 300 mg once a day.
• 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. 
• 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.
• Patienter, der har spørgsmål til deres behandling, bedes kontakte apotekspersonalet eller lægen. 
• Patients who have any concerns about their medicine should speak to their pharmacist or the prescriber.
Doserne af væsken (200 mg, én 5 ml-skefuld), tages tre eller fire gange dagligt. 
Doses of the liquid (200 mg, one 5-ml spoonful) are taken three or four times a day.
• Det er vigtigt, at både lægemiddelformen og den relevante dosis angives i recepten, og at apotekspersonalet sørger for at udlevere den korrekte orale lægemiddelform. 
• 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.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom 
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 June 2016 EMA/425762/2016
Noxafil er et svampemiddel med det aktive stof posaconazol, der hører til triazol-svampemidlerne. 
Noxafil is an antifungal medicine containing the active substance posaconazole, a member of the group of triazole antifungals.
Nogle patienter har fejlagtigt fået oral opløsning i stedet for tabletter, hvilket har medført underdosering og muligvis manglende virkning. 
Some patients have mistakenly received oral solution instead of tablets, leading to underdosing and to a potential lack of effect.
Tilsvarende er der indberettet om patienter, som har fået tabletter i stedet for oral opløsning, hvilket har medført overdosering og bivirkninger. 
Similarly, there are reports of patients given tablets instead of oral solution, leading to overdosage and side effects.
• 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. 
• 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.
• Der er beskrevet medicineringsfejl efter fejlagtigt skift mellem formerne, hvilket har resulteret i over- eller underdosering og dermed dosisafhængig toksisk virkning eller manglede virkning. 
• Medication errors have been reported following erroneous switching, resulting in over- or underdosage and consequent dose-related toxicity or lack of efficacy.
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. 
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.
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). 
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.
Det fås infusionsvæske, opløsning, til indgivelse i en vene (drop), men desuden som tabletter og oral suspension til indgivelse gennem munden. 
It is available as a solution for infusion (drip) into a vein, but also as tablets and oral suspension for use by mouth.
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. 
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.
Læger rådes til i deres ordination klart at angive den lægemiddelform, der skal anvendes; apotekerne bør være påpasselige med at udlevere den korrekte lægemiddelform. 
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.
• I nogle tilfælde har patienterne fået den forkerte lægemiddelform og dermed en forkert dosis, hvilket enten har medført bivirkninger eller manglende virkning af lægemidlet. 
• 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.
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. 
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.
• Produktresuméet og patientbrochuren for Noxafil er under ajourføring med henblik på at skærpe advarslerne om forskellene mellem de to formuleringer. 
• 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.
Undgå kontakt med hud eller øjne. 
Avoid contact with skin or eyes.
Allergiske reaktioner over for disse stoffer kan lejlighedsvis være alvorlige. 
Allergic reactions to these substances may occasionally be serious.
Disse reaktioner vil forsvinde inden for maksimalt 23 dage. 
These reactions will resolve within a maximum of 23 days.
ATCvet-kode: QJ01DD90. 
ATCvet code: QJ01DD90.
I tilfælde af kontakt vask med rent vand. 
In the event of contact, wash with clean water.
Den aktive substans i Naxcel er godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) Nr. 37/2010: 
The active substance in Naxcel is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Mælk: 0 dage. 
Milk: zero days.
Antimikrobielle lægemidler / antibiotika 
Antiinfectious agents / Antibiotics
Tag passende forholdsregler for at undgå intraarteriel eller intravenøs injektion. 
Take appropriate precautions to avoid intra-arterial or intravenous injection.
BATCH NUMMER Lot {nummer} 
BATCH NUMBER Lot {number}
Hvis kliniske symptomer ikke er aftaget 48 timer efter behandlingen, skal diagnosen og behandling af tilstanden revurderes. 
If clinical signs have not improved 48 hours after treatment, the diagnosis and treatment of the condition should be re-evaluated.
Laktation: Dette veterinærlægemiddel kan anvendes under laktation. 
Lactation: This veterinary medicinal product can be used during lactation.
Anvendelse af lægemidlet bør baseres på følsomhedstest og tage hensyn til officiel og lokal antibiotikapolitik. 
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Uigennemsigtig hvid til lysebrun suspension. 
Opaque white to light brown suspension.
Brug ikke dette vetrinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP. 
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Omkring 60% og 15% af dosis udskilles i henholdsvis urin og fæces inden for 10 dage efter administrationen. 
Approximately 60% and 15% of the dose are excreted in the urine and faeces, respectively, within 10 days after administration.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Én ml indeholder: 
QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
Drægtighed og fertilitet: 
Pregnancy and fertility:
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. 
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.
Kød og indvolde: 9 dage. 
Meat and offal: 9 days.
Lejlighedsvis kan lokal forbigående hævelse forekomme efter intramuskulær injektion. 
Occasionally, transient local swelling may occur following intramuscular injection.
DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Første tilladelse: 19/05/2005. 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/05/2005.
Cephalosporiner bør, når det er muligt, kun anvendes på grundlag af følsomhedstest. 
Whenever possible, cephalosporins should only be used based on susceptibility testing.
Fornyelse: 26/05/2010. 
Date of last renewal: 26/05/2010.
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. 
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.
1000 µg/kg 2000 µg/kg 2000 µg/kg 6000 µg/kg 100 µg/kg 
2,000 µg/kg Fat 2,000 µg/kg Liver 6,000 µg/kg Kidney 100 µg/kg Milk
Hos begge arter blev der ikke observeret påvirkning af reproduktionen. 
No effects on the reproductive performance were observed in both species.
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). 
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).
Forandringerne er konstateret forsvundet 56 dage efter injektionen. 
Resolution has been observed at 56 days post-injection.
I meget sjældne tilfælde er der rapporteret om pludselig død efter administration af lægemidlet. 
In very rare cases, sudden death has been reported following administration of the product.
Bordetella bronchiseptica er fra naturens side ikke følsom overfor ceftiofur in vitro. 
Bordetella bronchiseptica is inherently insensitive to ceftiofur in vitro.
Administration ved basis af øret: 
Base of the ear administration:
Farmakoterapeutisk gruppe: Antibakterica til systemisk brug, tredje generations cephalosporiner. 
Pharmacotherapeutic group: Antibacterials for systemic use, third-generation cephalosporins.
Mild reaktion på injektionsstedet som små områder (mindre end 6 cm²) med misfarvning og småcyster er observeret i op til 42 dage efter injektionen. 
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.
Diagram af hovedet, der viser retningen for administration af injektionen fra basis af øret mod dyrets modsatte øje. 
Diagram of the head showing the direction for the base of the ear injections administered toward the animal's opposite eye.
Summen af alle restkoncentr ationer med betalactamst ruktur udtrykt som desfuroylcef tiofur 
Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur
Maksimale plasmakoncentrationer (cirka 5 µg/ml) forekom 12 timer efter administrationen. 
Maximum concentrations in plasma (about 5 µg/ml) occurred from 12 hours following administration.
• Injicér i den bageste del af ørets basis (se figur 1). 
• Administer in the posterior part of the ear base (see Figure 1).
Personer med kendt overfølsomhed over for penicilliner og cephalosporiner bør undgå kontakt med disse veterinærlægemidler. 
People with known hypersensitivity to penicillins and cephalosporins should avoid contact with this veterinary medicinal product.