FrancophonIA/ELRC3.0 huggingface dataset:
English: Each coated tablet contains 2 mg sirolimus.
Danish: Hver overtrukken tablet indeholder 2 mg sirolimus.
English: Protein in the urine, occasionally severe and associated with side effects, such as swelling Scarring in the kidney that may reduce kidney function Too much fluid collecting in the tissues due to irregular lymph function Low blood platelets, with or without rash (thrombocytopaenic purpura) Serious allergic reactions that can cause peeling of the skin Tuberculosis
Danish: - kræft i lymfevæv (lymfom/lymfoproliferativ sygdom efter transplantation), en kombination af faldende antal røde og hvide blodlegemer og blodplader - blødning fra lungen - protein i urinen, lejlighedsvis alvorligt og forbundet med bivirkninger som f.eks. oppustning - ardannelse i nyren, hvilket kan forringe nyrefunktionen - ophobning af lymfevæske på grund af nedsat lymfedrænage - lavt antal blodplader, med eller uden udslæt (trombocytopenisk purpura) - alvorlige allergiske reaktioner, som kan få huden til at skalle af - tuberkulose - Epstein-Barr virusinfektion - diarré på grund af infektion med Clostridium difficile - alvorlig leverskade.
English: INFORMATION IN BRAILLE Rapamune 2 mg
Danish: Rapamune 2 mg
English: Blood creatinine increased *See section below.
Danish: * Se afsnit nedenfor.
English: Sirolimus has been administered concurrently with the following agents in clinical studies: tacrolimus, ciclosporin, azathioprine, mycophenolate mofetil, corticosteroids and cytotoxic antibodies.
Danish: Immunsuppressiva (kun nyretransplanterede patienter) Sirolimus har i kliniske forsøg været givet sammen med følgende stoffer: tacrolimus, ciclosporin, azathioprin, mycophenolatmofetil, kortikosteroider og cytotoksiske antistoffer.
English: Each mL of Rapamune contains 1 mg sirolimus.
Danish: Hver ml Rapamune indeholder 1 mg sirolimus.
English: Each Rapamune 2 mg coated tablet contains 2 mg of sirolimus.
Danish: Hver Rapamune 2 mg overtrukken tablet indeholder 2 mg sirolimus.
English: Controlled clinical studies with posology comparable to that currently indicated for the use of Rapamune in adults have not been conducted in children or adolescents below 18 years of age.
Danish: Der er ikke udført kontrollerede kliniske forsøg med børn og unge (under 18 år) med en dosering, der svarer til den, der på nuværende tidspunkt er godkendt for Rapamune til brug hos voksne.
English: How to take Rapamune
Danish: Sådan skal De tage Rapamune
English: The incidence of biopsy confirmed acute rejection was higher (p=0.020*) for patients in the sirolimus group (11, 8.4%) compared to the tacrolimus group (2, 1.6%) through 2 years; most rejections were mild in severity (8 of 9 [89%] T-cell BCAR, 2 of 4 [50%] antibody mediated BCAR) in the sirolimus group.
Danish: De fleste afstødninger var af mild grad (8 af 9 [89 %] T-celle BCAR, 2 af 4 [50 %] antistofmedieret BCAR) i sirolimus-gruppen.
English: No dose adjustment is required (see section 5.2).
Danish: Nedsat nyrefunktion Dosisjustering er ikke nødvendig (se pkt.
English: EXP Date opened
Danish: Dato for åbning
English: Rifampicin (CYP3A4 inducer)
Danish: Rifampicin (CYP3A-induktor)
English: Sirolimus Cmax, tmax, and AUC were increased 1.4-fold, 1.3-fold, and 1.6-fold, respectively.
Danish: Sirolimus Cmax, tmax og AUC steg henholdsvis 1,4 gange, 1,3 gange og 1,6 gange.
English: INFORMATION IN BRAILLE Rapamune 0.5 mg
Danish: Rapamune 0,5 mg
English: Rapamune 0.5 mg is supplied to you as tan-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 0.5 mg” on one side.
Danish: Rapamune 0,5 mg leveres som beige, trekantede, overtrukne tabletter mærket ”RAPAMUNE 0.5 mg” på den ene side.
English: Thrombocytopaenia; Anaemia;
Danish: Trombocytopeni, anæmi, leukopeni
English: Whole blood sirolimus Cmax, tmax, and AUC were increased 4.4-fold, 1.4-fold, and 4.2-fold, respectively.
Danish: Sirolimus-Cmax, -tmax og -AUC i fuldblod øges henholdsvis 4,4 gange, 1,4 gange og 4,2 gange.
English: Whole blood trough sirolimus concentrations, as measured by LC/MS/MS, were significantly correlated (r2=0.85) with AUC,ss.
Danish: Dalkoncentrationer af sirolimus i fuldblod målt ved LC-MS/MS er signifikant korreleret (r
English: Verapamil (CYP3A4 inhibitor)
Danish: Verapamil (CYP3A4-hæmmer)
English: In the stratum with baseline calculated GFR above 40 mL/min, the mean and median urinary protein to creatinine ratios were significantly higher in the Rapamune conversion group as compared to those of the calcineurin inhibitors continuation group at 24 months (see section 4.4).
Danish: er forholdet mellem gennemsnitlig og median urinprotein og kreatinin efter 24 måneder signifikant højere i den gruppe, der var skiftet til Rapamune, end i den gruppe, hvor behandlingen med calcineurinhæmmere fortsatte (se pkt.
English: Erythromycin (CYP3A4 inhibitor)
Danish: Erythromycin (CYP3A4-hæmmer)
English: Each Rapamune 1 mg coated tablet contains 1 mg of sirolimus.
Danish: Hver Rapamune 1 mg overtrukken tablet indeholder 1 mg sirolimus.
English: Hypersensitivity vasculitis
Danish: Overfølsomhedsvaskulitis
English: INFORMATION IN BRAILLE Rapamune 1 mg
Danish: Rapamune 1 mg
English: Rapamune 0.5 mg coated tablets Rapamune 1 mg coated tablets Rapamune 2 mg coated tablets sirolimus
Danish: Rapamune 0,5 mg overtrukne tabletter Rapamune 1 mg overtrukne tabletter Rapamune 2 mg overtrukne tabletter sirolimus
English: Rapamune 2 mg coated tablets
Danish: Rapamune 2 mg overtrukne tabletter
English: INTERMEDIATE CARTON: 60 mL BOTTLE
Danish: INDRE EMBALLAGE, 60 ml FLASKE
English: If necessary, you may store the bottle at room temperature up to 25C for a short period of time, but no longer than 24 hours.
Danish: Hvis nødvendigt kan De opbevare flasken ved stuetemperatur op til 25
English: Rapamune 1 mg coated tablets
Danish: Rapamune 1 mg overtrukne tabletter
English: An updated RMP should be submitted: • At the request of the European Medicines Agency;
Danish: Der skal fremsendes en opdateret RMP
English: Rapamune 0.5 mg coated tablets sirolimus
Danish: Rapamune 0,5 mg overtrukne tabletter sirolimus
English: Each mL of Rapamune oral solution contains 1 mg of sirolimus.
Danish: Hver ml Rapamune oral opløsning indeholder 1 mg sirolimus.
English: Cases of BK virus-associated nephropathy, as well as cases of JC virus-associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Rapamune.
Danish: BK-virusassocieret nephropati og JC-virusassocieret progressiv multifokal leukoencefalopati (PML) er blandt disse infektioner hos nyretransplanterede patienter.
English: Effective contraception must be used during Rapamune therapy and for 12 weeks after Rapamune has been stopped (see section 4.5).
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med Rapamune og i 12 uger efter afslutning af behandlingen med Rapamune (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) Rapamune 0.5 mg coated tablets EU/1/01/171/013-14
Danish: Rapamune 0,5 mg overtrukne tabletter EU/1/01/171/013-14
English: Diltiazem (CYP3A4 inhibitor)
Danish: Diltiazem (CYP3A4-hæmmer)
English: Each coated tablet contains 1 mg sirolimus.
Danish: Hver overtrukken tablet indeholder 1 mg sirolimus
English: Rapamune 0.5 mg coated tablets
Danish: Rapamune 0,5 mg overtrukne tabletter
English: Voriconazole (CYP3A4 inhibitor)
Danish: Voriconazol (CYP3A4-hæmmer)
English: Rapamune 1 mg is supplied to you as white-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 1 mg” on one side.
Danish: Rapamune 1 mg leveres som hvide, trekantede, overtrukne tabletter mærket ”RAPAMUNE 1 mg” på den ene side.
English: Whole blood sirolimus Cmax, tmax, and AUC were increased 2.3-fold, 1.1-fold, and 2.2-fold, respectively.
Danish: Sirolimus-Cmax, -tmax og -AUC i fuldblod øges henholdsvis 2,3 gange, 1,1 gang og 2,2 gange.
English: Based on monitoring in all patients during the period of concomitant therapy with ciclosporin, mean (10th, 90th percentiles) troughs (expressed as chromatographic assay values) and daily doses were 8.6 
Danish: Baseret på monitorering af alle patienter, i perioden med samtidig behandling med ciclosporin, er gennemsnit af dalkoncentrationer (10., 90. percentil) (udtrykt ved kromatografiske testværdier) og daglige doser henholdsvis 8,6  3,0 ng/ml (5,0-13 ng/ml) og 2,1  0,70 mg (1,5-2,7 mg) (se pkt.
English: Uncommon: may affect up to 1 in 100 people
Danish: Almindelige (forekommer hos mellem 1 og 10 ud af 100 patienter):
English: Based upon the analysis of data from 36 months and beyond, which showed a growing difference in graft survival and renal function, as well as significantly lower blood pressure in the ciclosporin elimination group, it was decided to discontinue subjects from the Rapamune with ciclosporin group.
Danish: Det blev besluttet at seponere behandlingen med Rapamune hos forsøgspersonerne i den gruppe, som også fik ciclosporin, på baggrund af analysen af data fra måned 36 og frem, som viste en større og større forskel mellem transplantatoverlevelse og nyrefunktion samt et signifikant lavere blodtryk hos gruppen med ciclosporin-elimination.
English: Rapamune 2 mg is supplied to you as yellow to beige-coloured, triangular-shaped, coated tablets marked “RAPAMUNE 2 mg” on one side.
Danish: Rapamune 2 mg leveres som gul-beige, trekantede, overtrukne tabletter mærket ”RAPAMUNE 2 mg” på den ene side.
English: Rare: may affect up to 1 in 1,000 people
Danish: Sjældne (forekommer hos mellem 1 og 10 ud af 10.000 patienter):
English: Maintenance therapy: From month 3 to month 12, following discontinuation of ciclosporin, mean (10th, 90th percentiles) troughs (expressed as chromatographic assay values) and daily doses were 19 
Danish: Vedligeholdelsesbehandling: Fra måned 3 til måned 12, efter seponering af ciclosporin, er gennemsnit af dalkoncentrationer (10., 90. percentil) (udtrykt ved kromatografiske testværdier) og daglige doser henholdsvis 19  4,1 ng/ml (14-24 ng/ml) og 8,2  4,2 mg (3,6-13,6 mg) (se pkt.
English: Hepatic failure*
Danish: Leversvigt*
English: Therapeutic monitoring of the medicinal product and dose adjustment
Danish: ETIKETTERING OG INDLÆGSSEDDEL
English: Kidney damage with low blood platelets and low red blood cell counts, with or without rash (haemolytic uraemic syndrome)
Danish: - væskeansamling i maven - nyreskade med lavt antal blodplader og lavt antal røde blodlegemer, med eller uden udslæt
English: Before vaccinations, please inform your doctor or pharmacist that you are receiving Rapamune.
Danish: Fortæl Deres læge, at De får Rapamune, før De bliver vaccineret.
English: GENERAL CLASSIFICATION FOR SUPPLY INSTRUCTIONS ON USE INFORMATION IN BRAILLE
Danish: INFORMATION I BRAILLE-SKRIFT
English: Do not take a double dose to make up for a forgotten dose, and always take Rapamune and ciclosporin approximately 4 hours apart.
Danish: Tag altid Rapamune og ciclosporin med ca. 4 timers mellemrum.
English: NAME OF THE MEDICINAL PRODUCT Rapamune 0.5 mg coated tablets Rapamune 1 mg coated tablets Rapamune 2 mg coated tablets
Danish: Rapamune 0,5 mg overtrukne tabletter Rapamune 1 mg overtrukne tabletter Rapamune 2 mg overtrukne tabletter
English: Leucopenia
Danish: Lymfødem
English: Each tablet contains 86.4 mg of lactose monohydrate and 214.4 mg of sucrose.
Danish: Rapamune 2 mg overtrukne tabletter Hver tablet indeholder 86,4 mg lactosemonohydrat og 214,4 mg saccharose.
English: If you take more Rapamune than you should
Danish: Hvis De har taget for meget Rapamune
English: Each tablet contains 86.4 mg of lactose monohydrate and 215.7 mg of sucrose.
Danish: Rapamune 0,5 mg overtrukne tabletter Hver tablet indeholder 86,4 mg lactosemonohydrat og 215,7 mg saccharose.
English: Tan-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 0.5 mg” on one side.
Danish: Rapamune 0,5 mg overtrukne tabletter Beige, trekantede overtrukne tabletter mærket “RAPAMUNE 0.5 mg” på den ene side.
English: NAME OF THE MEDICINAL PRODUCT Rapamune 0.5 mg tablets sirolimus
Danish: Rapamune 0,5 mg tabletter sirolimus
English: White-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 1 mg” on one side.
Danish: Rapamune 1 mg overtrukne tabletter Hvide, trekantede overtrukne tabletter mærket “RAPAMUNE 1 mg” på den ene side.
English: Each tablet contains 86.4 mg of lactose monohydrate and 215.8 mg of sucrose.
Danish: Rapamune 1 mg overtrukne tabletter Hver tablet indeholder 86,4 mg lactosemonohydrat og 215,8 mg saccharose.
English: Yellow to beige-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 2 mg” on one side.
Danish: Rapamune 2 mg overtrukne tabletter Gule til beige, trekantede overtrukne tabletter mærket “RAPAMUNE 2 mg” på den ene side.
English: Neutropaenia
Danish: Lungeblødning
English: NAME OF THE MEDICINAL PRODUCT Rapamune 1 mg tablets sirolimus
Danish: Rapamune 1 mg tabletter sirolimus
English: Fever
Danish: BLISTER
English: NAME OF THE MEDICINAL PRODUCT Rapamune 1 mg/mL oral solution
Danish: Rapamune 1 mg/ml, oral opløsning
English: Protein build-up in the air sacs of the lungs that may interfere with breathing Serious allergic reactions that can affect blood vessels (see above paragraph on allergic reactions) Not known: frequency cannot be estimated from the available data Posterior reversible encephalopathy syndrome (PRES), a serious nervous system syndrome that has the following symptoms: headache, nausea, vomiting, confusion, seizures, and visual loss.
Danish: - ardannelse i nyren, hvilket kan forringe nyrefunktionen - ophobning af lymfevæske på grund af nedsat lymfedrænage - lavt antal blodplader, med eller uden udslæt (trombocytopenisk purpura) - alvorlige allergiske reaktioner, som kan få huden til at skalle af - tuberkulose - Epstein-Barr virusinfektion - diarré på grund af infektion med Clostridium difficile - alvorlig leverskade.
English: NAME OF THE MEDICINAL PRODUCT Rapamune 2 mg tablets sirolimus
Danish: Rapamune 2 mg tabletter sirolimus
English: See section 4
Danish: BILAG III
English: Shingles
Danish: Shellac
English: Maintenance therapy
Danish: Vedligeholdelsesbehandling
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: FREMSTILLERENS BATCHNUMMER, DONATION OG PRODUKTKODER
English: Undesirable effects observed with prophylaxis of organ rejection in renal transplantation The most commonly reported adverse reactions (occurring in 10% of patients) are thrombocytopaenia, anaemia, pyrexia, hypertension, hypokalaemia, hypophosphataemia, urinary tract infection, hypercholesterolaemia, hyperglycaemia, hypertriglyceridaemia, abdominal pain, lymphocoele, peripheral oedema, arthralgia, acne, diarrhoea, pain, constipation, nausea, headache, increased blood creatinine, and increased blood lactate dehydrogenase (LDH).
Danish: - væskeansamling omkring nyren - hævelser i kroppen, herunder hævede hænder og fødder - smerte - feber - hovedpine - forhøjet blodtryk - mavesmerter, diarré, forstoppelse, kvalme - lavt antal røde blodlegemer, lavt antal blodplader - øget fedt i blodet (kolesterol og/eller triglycerid), forhøjet blodsukker, lavt kaliumindhold i blodet, lavt fosforindhold i blodet, forhøjet laktatdehydrogenase i blodet, forhøjet kreatinin i blodet - ledsmerte - akne - urinvejsinfektion - lungebetændelse og andre bakterie-, virus- og svampeinfektioner - nedsat antal hvide blodlegemer (bekæmper infektion) - sukkersyge - unormale analyser for leverfunktionen, forhøjede ASAT- og/eller ALAT-leverenzymer - udslæt - forhøjet protein i urinen - menstruationsforstyrrelser (herunder udebleven, sjælden eller voldsom menstruation) - langsom heling (dette kan omfatte løsning af lagene i operationssåret eller stinglinjen) - hurtig puls (hjerterytme) - en generel tendens til væskeansamlinger i forskellige væv.
English: anti-epileptic medicines including carbamazepine, phenobarbital, phenytoin.
Danish: Tabletkernen: lactosemonohydrat, macrogol, magnesiumstearat, talcum.
English: Icepharma hf Tel: +354 540 8000
Danish: Tel: +354 540 8000
English: (glass) in prefilled pen
Danish: (glas) i fyldt pen
English: 100 iu/ml Suspension for
Danish: 100 ie/ml Injektionsvæske,
English: Cartridge injection
Danish: Subkutan anvendelse Cylinderampul suspension
English: The final opinion was converted into a Decision by the European Commission on 5 August 2011.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 5. august
English: The mutual recognition procedure (UK/V/0355/001/MR) started on 26 November 2009.
Danish: Den gensidige anerkendelsesprocedure (UK/V/0355/001/MR) indledtes den 26. November 2009.
English: Oral explanations were given on 12 January 2011.
Danish: Der blev afgivet mundtlige redegørelser den 12. januar 2010.
English: On 2 July 2010, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by the Concerned Member State, the Netherlands, that the safety and efficacy of the product had not been sufficiently demonstrated.
Danish: Den 2. juli 2010 indbragte Det Forenede Kongerige som referencemedlemsstat sagen for Det Europæiske Lægemiddelagentur i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF, eftersom den berørte medlemsstat, Nederlandene, havde udtrykt bekymring for, at der ikke var fremlagt tilstrækkelig dokumentation for produktets sikkerhed og virkning.
English: The referral procedure started on 14 July 2010.
Danish: Indbringelsesproceduren påbegyndtes den 14. juli 2010.
English: The Committee appointed Mr Johan Schefferlie as rapporteur and Mrs Ruth Kearsley as co-rapporteur.
Danish: Udvalget udpegede Johan Schefferlie som rapportør og Ruth Kearsley som medrapportør.
English: Nine CVMP members expressed divergent positions, which are appended to the opinion.
Danish: Ni medlemmer af CVMP afgav afvigende udtalelser, der er vedlagt som bilag til udtalelsen.
English: There was disagreement between the Reference Member State and Concerned Member State on the demonstration of bioequivalence and the adequacy of the proposed withdrawal period.
Danish: Der var uenighed blandt referencemedlemsstaten og den berørte medlemsstat om påvisningen af bioækvivalens og hensigtsmæssigheden af den foreslåede tilbageholdelsestid.
English: The grounds for the lifting of the suspension of the marketing authorisation are provided in Annex III.
Danish: Begrundelserne for ophævelse af suspenderingen af markedsføringstilladelsen gives i bilag III.
English: Written explanations were provided by the marketing authorisation holder on 13 September 2011 and 10 March 2011.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 13. september 2011 og den 10. marts 2011.
English: The marketing authorisation holder, Norbrook Laboratories Ltd, submitted an application for Nisamox via a mutual recognition procedure in the Netherlands on the basis of the marketing authorisation granted by the United Kingdom.
Danish: Indehaveren af markedsføringstilladelsen, Norbrook Laboratories Ltd, indgav en ansøgning vedrørende Nisamox via en gensidig anerkendelsesprocedure i Nederlandene på grundlag af den markedsføringstilladelse, der er udstedt af Det Forenede Kongerige.
English: International non-proprietary name (inn): amoxicillin, clavulanic acid and prednisolone
Danish: Internationalt fællesnavn (INN): amoxicillin, clavulansyre og prednisolon
English: Further to the resignation of Mrs Ruth Kearsley as CVMP member, Ms Helen Jukes was appointed to replace her and took over the co-rapporteurship.
Danish: Som følge af at Ruth Kearsley trak sig som medlem af CVMP, blev Helen Jukes udpeget til at afløse hende og overtog medrapportørfunktionen.
English: The list of product names concerned is given in Annex I. The scientific conclusions and the grounds for refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisation are provided in Annex II.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De videnskabelige konklusioner og begrundelserne for afslaget på markedsføringstilladelsen og suspenderingen af den eksisterende markedsføringstilladelse findes i bilag II.
English: Nisamox Lactating Cow Intramammary Suspension (Nisamox) is an intramammary suspension containing amoxicillin, clavulanic acid and prednisolone.
Danish: Nisamox Lactating Cow Intramammary Suspension (Nisamox) er en intramammær suspension, der indeholder amoxicillin, clavulansyre og prednisolon.
English: Nisamox is intended for the treatment of mastitis in lactating cows.
Danish: Nisamox er beregnet til behandling af mastitis hos diegivende kvæg.
English: The application was submitted as a generic of the reference product, Synulox Lactating Cow Intramammary Suspension marketed by Pfizer Ltd.
Danish: Ansøgningen blev indgivet som en generisk form af referencelægemidlet, Synulox Lactating Cow Intramammary Suspension, som markedsføres af Pfizer Ltd.
English: Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Nisamox Lactating Cow Intramammary Suspension is
Danish: På grundlag af evalueringen af rapportørens vurdering af de aktuelt foreliggende data var CVMP af den opfattelse, at risk/benefit-forholdet for Nisamox Lactating Cow Intramammary Suspension er negativ, og vedtog derfor den 6. april 2011 en udtalelse, der anbefaler afslag på ansøgningen om markedsføringstilladelse og suspendering af den eksisterende markedsføringstilladelse.
English: After the Commission Decision the Member State Competent Authorities will update the product information as required.
Danish: Efter Kommissionens beslutning vil myndighederne i de enkelte medlemslande opdaterer produktinformationen efter behov.
English: The extent of interactions in the paediatric population is not known.
Danish: Omfanget af interaktioner i den pædiatriske population er ikke kendt.
English: Titration should be conducted according to the individual response and tolerability in paediatric patients.
Danish: Titrering skal foretages i overensstemmelse med individuel respons og tolerabilitet hos den pædiatriske patient.
English: This medicinal product is authorised in the Member States of the EEA under the following names: {To be completed nationally}.
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: [Udfyldes nationalt]
English: Drug-drug interaction studies have only been performed in adults.
Danish: Interaktionsundersøgelser er kun udført hos voksne.
English: Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Danish: Atorvastatin er ikke indiceret til behandling af børn under 10 år.
English: They are marked with 5 on one side and Pfizer on the other side.
Danish: De er præget med ”5” på den ene side og ”Pfizer” på den anden side.
English: BATCH NUMBER Batch:
Danish: BATCHNUMMER Batch
English: The National Health Authorities shall ensure the following conditions are fulfilled by the Marketing Authorisation Holder:
Danish: De nationale myndigheder skal sørge for, at indehaveren af markedsføringstilladelsen opfylder følgende betingelser:
English: These amendments to the SPC, labelling and package leaflet are valid at the time of the Commission Decision.
Danish: Disse ændringer til produktresumé, mærkning og indlægsseddel er gældende fra Kommissionens beslutning.
English: A total of 39 children and adolescents, 6 to 17 years of age, were enrolled.
Danish: Der deltog i alt 39 børn og unge i alderen 6-17 år.
English: Common: Abdominal pain
Danish: Almindelig: Abdominalsmerter
English: United Kingdom Pfizer Ireland Pharmaceuticals,
Danish: Storbritannien Pfizer Ireland Pharmaceuticals,
English: Safety information for paediatric patients treated with doses above 20 mg, corresponding to about 0.5 mg/kg, is limited.
Danish: Sikkerhedsinformation for børn og unge behandlet med doser over 20 mg, svarende til ca. 0,5 mg/kg, er begrænset.
English: For subjects whose dose was doubled, additional decreases were observed as early as 2 weeks, at the first assessment, after dose escalation.
Danish: Hos de patienter, hvor dosis blev fordoblet, sås yderligere fald så tidligt som ved første evaluering 2 uger efter dosisøgning.