FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 100 mg hard capsules Imatinib Teva B.V. 400 mg hard capsules
Danish: 100 mg hårde kapsler Imatinib Teva B.V.
English: Imatinib Teva B.V. 400 mg hard capsules are non-transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
Danish: 400 mg hårde kapsler er uigennemsigtige orange kapsler, præget med 7630 med sort trykfarve på kapslens underdel og præget med TEVA på kapslens overdel.
English: The recommended dose of Imatinib Teva B.V. is 400 mg/day for adult patients with unresectable and/or
Danish: er 400 mg/dag til voksne patienter med inoperable
English: If your daily dose is 800 mg (2 capsules), you should take one capsule in the morning and a
Danish: Hvis din daglige dosis er 800 mg (2 kapsler), skal du tage 1 kapsel om morgenen og 1 kapsel om aftenen.
English: Non transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
Danish: Ikke-transparent orange kapsel præget i sort blæk med 7630 på kapselbunden og præget i sort blæk med TEVA på kapselhætten.
English: If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 400 mg. 3.
Danish: Hvis cytopeni ikke er leukæmirelateret, reducer imatinib-dosis til 400 mg. 3.
English: Imatinib Teva B.V. 400 mg film-coated tablets Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Danish: 400 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 400 mg imatinib (som mesilat).
English: 2-3 (total of 8 courses)
Danish: (2 timer, q 12 timer), dag 23 (total af 8 omgange)
English: Imatinib Teva B.V. 100 mg hard capsules are non-transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
Danish: 100 mg hårde kapsler er uigennemsigtige orange kapsler, præget med 7629 med sort trykfarve på kapslens underdel og præget med TEVA på kapslens overdel.
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis,
Danish: Stomatitis, mundulcera, gastrointestinalblødning7, sure opstød, melæna, betændelse i spiserøret, ascites, mavesår, hæmatemese, cheilitis, dysfagi,
English: Imatinib Teva B.V. 100 mg film-coated tablets Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Danish: 100 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 100 mg imatinib (som mesilat).
English: Teva Italia S.r.l.
Danish: TEVA PHARMA, S.L.U.
English: Your doctor may decide to increase the dose to 400 mg, to be taken as one capsule of 400 mg once a day, depending on how you respond to treatment.
Danish: Din læge kan beslutte at øge dosis til 400 mg, som skal tages som 1 kapsel a 400 mg én gang daglig afhængig af, hvordan du responderer på behandlingen.
English: Imatinib Teva B.V. 100 mg hard capsules are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Danish: 100 mg hårde kapsler fås i perforerede enkeltdosisblisterpakninger med 20x1, 60x1, 120x1 eller 180x1 hårde kapsler.
English: Consolidation therapy I, III, V MTX 500 mg/m i.v.
Danish: Konsoliderende behandling II, IV Ara-C 75 mg/m i.v.
English: Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Periorbital oedema, dermatitis/eczema/rash Pruritus, face oedema, dry skin, erythema, alopecia, night sweats,
Danish: Periorbitalt ødem, dermatitis/eksem/udslæt Pruritus, ansigtsødem, tør hud, erythem, alopeci, natlig svedtendens,
English: a occurring at least after 1 month of treatment
Danish: ANC = fuldstændigt antal neutrofilocytter a opstået efter mindst 1 måneds behandling
English: MTX 15 mg intrathecal, day 1; Methylprednisolone 40 mg intrathecal, day 1
Danish: Methylprednisolon 40 mg intrathecal, dag 1
English: Imatinib Teva B.V. 100 mg film-coated tablets are dark yellow to brownish orange round film-coated tablets with a score line on one side.
Danish: 100 mg filmovertrukne tabletter er mørkegule til brunlig-orange runde filmovertrukne tabletter med delekærv på den ene side.
English: Your doctor may decide to increase the dose to 400 mg, to be taken as one tablet of 400 mg once a day, depending on how you respond to treatment.
Danish: Din læge kan beslutte at øge dosis til 400 mg, som skal tages som 1 tablet a 400 mg én gang daglig afhængig af, hvordan du responderer på behandlingen.
English: The starting dose is 400 mg, to be taken as one capsule once a day.
Danish: Startdosis er 400 mg, som skal tages som 1 kapsel én gang daglig.
English: Each hard capsule contains 100 mg of imatinib (as mesilate).
Danish: hård kapsel indeholder 100 mg imatinib (som mesilat).
English: Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as
Danish: I tilfælde af svær neutropeni og trombocytopeni anbefales dosisreduktion eller seponering af behandlingen, som angivet i nedenstående tabel:
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: Imatinib Teva B.V. inhibits the growth of these cells in a certain subtype of these diseases.
Danish: hæmmer væksten af disse celler i en vis undergruppe af disse sygdomme.
English: Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5% of newly diagnosed CML patients taking imatinib.
Danish: Hos ca. 2,5% af nyligt diagnosticerede CML-patienter i behandling med imatinib er der rapporteret tilfælde af svær væskeretention (pleuraeksudat, ødem, pulmonalt ødem, ascites, perifert ødem).
English: Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Danish: filovertrukken tablet indeholder 100 mg imatinib (som mesilat).
English: 2/day, PO): days 1-7 and 15-21
Danish: 2/dag, p.o.): dag 1-56
English: Each hard capsule contains 400 mg of imatinib (as mesilate).
Danish: hård kapsel indeholder 400 mg imatinib (som mesilat).
English: i.v., days 1, 8;
Danish: ): dag 1, 8, og 15
English: The Kaplan-Meier estimate for survival after 36-month follow-up is 68%.
Danish: Kaplan-Meier estimatet for overlevelse efter 36
English: RFS
Danish: Hrvatska
English: • Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
Danish: - Kvalme, åndenød, uregelmæssig hjerterytme (puls), uklar urin, træthed og/eller ubehag forbundet med abnorme resultater af laboratorieprøver (f.eks. højt indhold af kalium, urinsyre og calcium i blodet og lavt indhold af fosfor i blodet).
English: Headache2
Danish: Delvist
English: The starting dose is 400 mg, to be taken as one tablet once a day.
Danish: Startdosis er 400 mg, som skal tages som 1 tablet én gang daglig.
English: Imatinib Teva B.V. 400 mg film-coated tablets
Danish: 400 mg filmovertrukne tabletter imatinib
English: Imatinib Teva B.V. 100 mg film-coated tablets
Danish: 100 mg filmovertrukne tabletter
English: Czech Republic
Danish: United Kingdom
English: Haematological experts in the management of this disease should supervise the therapy throughout all phases
Danish: Gennem alle faser af omsorgen bør behandlingen overvåges af hæmatologiske eksperter, som er
English: Muscular weakness, arthritis, rhabdomyolysis/myopathy Avascular necrosis/hip necrosis*, growth retardation in children* Renal pain, haematuria, renal failure acute, urinary frequency increased Reproductive system and breast disorders Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal Haemorrhagic corpus luteum/haemorrhagic ovarian cyst General disorders and administration site conditions Weakness, pyrexia, anasarca, chills, rigors
Danish: Gynækomasti, erektil dysfunktion, menoragi, uregelmæssig menstruation, seksuel dysfunktion, smerter i brystvorterne, brystforstørrelse, skrotalt Hæmoragisk corpus luteum/hæmoragisk ovariecyste Almene symptomer og reaktioner på administrationsstedet Svaghed, pyreksi, anasarka, kuldegysninger og kulderystelser
English: In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive
Danish: I dyremodeller, hvor der anvendes Bcr-Abl-positive tumorceller, har stoffet som enkeltstof in vivo
English: If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 400 mg.
Danish: Hvis cytopeni ikke er leukæmirelateret, reducer imatinib-dosis til 400 mg. 7.
English: Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Danish: Leucovorin (75 mg/m2 i time 36, i.v.
English: • Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet derived growth factor receptor (PDGFR) gene re-arrangements.
Danish: som er forbundet med platelet-derived growth factor receptor-omlejring (PDGFR-omlejring).
English: 18 Gy in 10 fractions for patients that are CNS3 at diagnosis
Danish: 18 Gy i 10 fraktioner for patienter, som er CNS3 ved diagnosticering VCR (1,5 mg/m2/dag, i.v.
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 100 mg film-coated tablets Imatinib Teva B.V. 400 mg film-coated tablets
Danish: 100 mg filmovertrukne tabletter Imatinib Teva B.V.
English: Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Very common:
Danish: Hud og subkutane væv Meget almindelig:
English: Caution should be taken when administering imatinib with inhibitors of the CYP3A4
Danish: Forsigtighed bør udvises, når imatinib administreres sammen
English: Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Danish: filmovertrukkentablet indeholder 400 mg imatinib (som mesilat).
English: CML (CML-AP and CML-BC) than in patients with chronic CML.
Danish: 5 Pleural effusion blev observeret oftere hos patienter med GIST og hos patienter med transformeret CML (CML-AP og CML-BC) end hos patienter med kronisk CML.
English: Imatinib Teva B.V. 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
Danish: 100 mg hårde kapsler Hver hård kapsel indeholder 100 mg imatinib (som mesilat).
English: Daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
Danish: oral, dag 1-5; i.v., dag 6-7, 13-14 i.v.
English: The recommended dose of Imatinib Teva B.V. is 800 mg/day for adult patients with DFSP.
Danish: er 800 mg/dag til voksne patienter med DSFP.
English: Imatinib Teva B.V. 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate).
Danish: 400 mg hårde kapsler Hver hård kapsel indeholder 400 mg imatinib (som mesilat).
English: Ara-C 75 mg/m2 i.v.
Danish: ; 15 mg/m2 i.v.
English: imatinib teva b.v. 400 mg hard capsules
Danish: 400 mg hårde kapsler
English: Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets once a day, depending on how you respond to treatment.
Danish: Din læge kan beslutte at øge dosis til 400 mg, som skal tages som 4 tabletter én gang daglig afhængig af, hvordan du
English: Imatinib Teva B.V. 400 mg hard capsules are available in pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Danish: 400 mg hårde kapsler fås i perforerede enkeltdosisblisterpakninger med 30x1 eller
English: Your doctor may decide to increase the dose to 400 mg, to be taken as 4 capsules once a day, depending on how you respond to treatment.
Danish: Din læge kan beslutte at øge dosis til 400 mg, som skal tages som 4 kapsler én gang daglig afhængig af, hvordan du
English: • Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
Danish: - Flåd fra øjet med kløe, rødme og hævelse (betændelse af øjets bindehinde), øget tåreflåd eller
English: These measures will help protect the environment.
Danish: kan hjælpe dig med at bekæmpe denne tilstand.
English: In the event of recurrence of ANC < 1.0 x 109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.
Danish: I tilfælde af recidiverende ANC < 1.0 x 109/l og/eller trombocytter < 50 x 109/l, gentag trin 1 og genoptag behandling med imatinib i en reduceret dosis på 260 mg/m2.
English: - Do not breast-feed during the treatment with Imatinib Teva B.V. - Patients who are concerned about their fertility while taking Imatinib Teva B.V. are advised to consult
Danish: - Hvis du er bekymret for din frugtbarhed, mens du tager Imatinib Teva B.V., skal du kontakte
English: Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, Colitis, ileus, inflammatory bowel disease Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
Danish: Colitis, ileus, inflammatorisk tarmsygdom Ileus/intestinal obstruktion*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
English: Imatinib Teva is also a treatment for adults and children for: - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Danish: - Philadelphia-kromosom-positiv akut lymfoblastær leukæmi (Ph-positiv ALL).
English: Italia
Danish: Spanien
English: 12 months 24 months
Danish: ): dag 22-26
English: ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l,
Danish: NEL: Samme kriterier som for CHR, men ANC ≥1 x 109/l og trombocytter ≥20 x 109/l.
English: 5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed
Danish: 1 Pneumoni blev oftest observeret hos patienter med transformeret CML og hos patienter med GIST.
English: What Imatinib Teva B.V. looks like and contents of the pack Imatinib Teva B.V. 400 mg film-coated tablets are dark yellow to brownish orange oblong film-coated tablets with a score line on one side.
Danish: 400 mg filmovertrukne tabletter er mørkegule til brunlig-orange aflange filmovertrukne tabletter med delekærv på den ene side.
English: VCR (1.5 mg/m2/day, IV): days 1, 8 and 15
Danish: VCR (1,5 mg/m2/dag, i.v.
English: 31.6%, respectively).
Danish: 5.1 og 5.2).
English: Posology for DFSP The recommended dose of Imatinib Teva B.V. is 800 mg/day for adult patients with DFSP.
Danish: Dosering ved DFSP Den anbefalede dosis af Imatinib Teva B.V.
English: (3 h), days 1-4; Mitoxantrone 10 mg/m2 i.v.
Danish: (3 timer), dag 1; Daunorubicin 60 mg/m2 i.v.
English: Methotrexate (5 g/m over 24 hours, IV): days 1 and 15 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Danish: ): dag 1 og 15 Leucovorin (75 mg/m2 i time 36, i.v.
English: (1 h) days 4-5; Ara-C 2x 2 g/m2 i.v.
Danish: (1 time), dag 26, 46; Ara-C 75 mg/m2 i.v.
English: imatinib teva b.v. 100 mg hard capsules
Danish: 100 mg hårde kapsler
English: Dark yellow to brownish orange round film-coated tablets with a score line on one side.
Danish: 100 mg filmovertrukne tabletter Mørkegule til brunlig-orange runde filmovertrukne tabletter med delekærv på den ene side.
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 400 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Imatinib Teva B.V.
English: In the event of recurrence of ANC < 1.0 x 109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Danish: I tilfælde af tilbagevenden af ANC < 1,0 x 109/l og/eller trombocytter < 50 x 109/l, gentages trin 1 og imatinib reintroduceres med nedsat dosering på 400 mg.
English: Prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28;
Danish: DEX 10 mg/m2 oral, dag 6-7, 13-16; VCR 1 mg i.v., dag 7, 14; i.v.
English: Confusional state Nervous system disorders Very common:
Danish: Blod og lymfesystem Meget almindelig:
English: Hypertension, haematoma, subdural haematoma, peripheral coldness,
Danish: Hypertension, hæmatom, subduralt hæmatom, kuldefornemmelser i ekstremiteter, hypotension, Raynaud's syndrom
English: Name and address of the manufacturers responsible for batch release Teva Czech Industries s.r.o.
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse
English: 6.6 Special precautions for disposal
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING
English: Teva Norway AS
Danish: Teva Sweden AB
English: In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
Danish: I tilfælde af recidiverende ANC < 1,0 x 109/l og/eller trombocytter < 50 x 109/l, gentag trin 1 og genoptag behandling med imatinib i en reduceret dosis på 300 mg. 1.
English: The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.
Danish: Dosis er 800 mg pr. dag (8 tabletter).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/983/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/983/001
English: You will take Exviera for either 12 or 24 weeks.
Danish: Du skal tage Exviera i enten 12 eller 24 uger.
English: Main demographics in TURQUOISE-III
Danish: Vigtigste demografiske karakteristika i TURQUOISE-III
English: There are very limited data from the use of Exviera in pregnant women.
Danish: Der er meget begrænsede data fra anvendelse af Exviera til gravide kvinder.
English: • If you have severe liver problems other than hepatitis C.
Danish: • hvis du har andre alvorlige leverproblemer end hepatitis C
English: 60%) of drug related radioactivity in plasma.
Danish: (ca. 60 %) i den lægemiddelrelaterede radioaktivitet i plasma.
English: Effect of baseline HCV substitutions/polymorphisms on treatment response
Danish: Virkning af baseline-HCV-substitutioner/polymorfismer på behandlingsrespons
English: Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AX16 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug; direkte virkende antivirale midler; ATC-kode: J05AX16
English: • If you are allergic to dasabuvir or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for dasabuvir eller et af de øvrige indholdsstoffer i Exviera (angivet i punkt 6)
English: • Discontinue treatment in patients who develop evidence of hepatic decompensation.
Danish: • Behandlingen afbrydes hos patienter, som udvikler tegn på dekompenseret leversygdom.
English: NS5A M28T M28V
Danish: NS5A M28T M28Ve
English: Hepatitis B Virus Reactivation)
Danish: Reaktivering af hepatitis B-virus
English: The recommended dose of dasabuvir is 250 mg (one tablet) twice daily (morning and evening).
Danish: Den anbefalede dosis dasabuvir er 250 mg (én tablet) to gange dagligt (morgen og aften).
English: If an HIV protease inhibitor is added (atazanavir, darunavir), rilpivirine exposure may increase even further and is therefore not recommended.
Danish: Hvis en HIV-proteasehæmmer tilføjes (atazanavir, darunavir), kan rilpivirin-eksponeringen øges endnu mere; derfor anbefales dette ikke.
English: Co-administration of Exviera with other antivirals has not been studied and, therefore, cannot be recommended.
Danish: Samtidig administration af Exviera og andre antivirale midler er ikke undersøgt og anbefales derfor ikke.
English: b. Other includes early drug discontinuation not due to virologic failure and missing HCV RNA values in the SVR12 window.
Danish: b. 'Andet' omfatter tidlig stop i behandlingen som ikke skyldes virologisk svigt og manglende HCV-rna-værdier i SVR12-vinduet.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Exviera, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Danish: For at vurdere recidiv af hepatocellulært karcinom associeret med Exviera skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne fra et prospektivt sikkerhedsstudie baseret på en vedtagen protokol med brug af data fra en kohorte af en veldefineret gruppe patienter.
English: Treatment with Exviera should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Danish: Behandling med Exviera skal påbegyndes og overvåges af en læge med erfaring i behandling af kronisk hepatitis C.
English: Q30R
Danish: Q30Re
English: • Monitor for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage).
Danish: • Overvåg for kliniske tegn og symptomer på dekompenseret leversygdom (såsom ascites, hepatisk encefalopati og varice-blødning).
English: Do not take Exviera:
Danish: Tag ikke Exviera:
English: Talk to your doctor or pharmacist before taking Exviera if you: -have liver disease other than hepatitis C; -have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Exviera, hvis du: - har en anden leversygdom end hepatitis C; - har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere.
English: Rilpivirine should be used cautiously, in the setting of repeated ECG monitoring.
Danish: Rilpivirin skal anvendes med forsigtighed og under løbende EKG-monitorering.
English: Contraceptive medicines that contains ethinylestradiol cannot be used in combination with Exviera.
Danish: Prævention, der indeholder ethinylestradiol, kan ikke anvendes i kombination med Exviera.
English: If more than 6 hours have passed since Exviera is usually taken, the missed dose should NOT be taken and the patient should take the next dose per the usual dosing schedule.
Danish: Hvis der er gået mere end 6 timer siden det tidspunkt, hvor patienten normalt tager sin dosis Exviera, må den manglende dosis IKKE tages, idet patienten skal vente til den efterfølgende dosis i henhold til doseringsplanen.
English: Because of the potential for adverse reactions from the medicinal product in breastfed infants, a decision must be made whether to discontinue breastfeeding or discontinue treatment with Exviera, taking into account the importance of the therapy to the mother.
Danish: På grund af de potentielle bivirkninger for det diende barn skal det besluttes, om amning eller behandling med Exviera skal ophøre, idet der skal tages højde for behandlingens betydning for moderen.
English: Exviera film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blister packs.
Danish: Exviera filmovertrukne tabletter fås i blisterpakninger fremstillet af PVC/PE/PCTFE-aluminiumsfolie.
English: It contains the active substance dasabuvir.
Danish: Exviera indeholder det aktive stof dasabuvir.
English: Age, median (range) years Male gender, n (%) IL28B Non-CC genotype, n (%) Prior HCV Treatment:
Danish: Alder, median (interval) år Mænd, køn, n (%) IL28B Non-C/C genotype, n (%) Tidligere HCV-behandling:
English: The dose of ribavirin was individualized at the discretion of the investigator, with most patients receiving 600 to 800 mg as a starting dose, and most patients also receiving 600 to 800 mg per day at the end of treatment.
Danish: Ribavirin-dosen blev fastsat individuelt efter investigators skøn; de fleste patienter fik 600800 mg som startdosis, og de fleste patienter fik også 600-800 mg pr. dag ved slutningen af behandlingen.
English: The recommended dose is one tablet, twice a day.
Danish: Så meget skal du tage Den anbefalede dosis er 1 tablet 2 gange dagligt.
English: No increase in incidence of ALT elevations was observed with other types of systemic estrogens commonly used for hormone replacement therapy (e.g., estradiol and conjugated estrogens).
Danish: Der sås ingen stigning i incidensen af ALAT-forhøjelser med andre typer af systemisk østrogen, som normalt bruges i hormonbehandling (f.eks. estradiol og konjugerede østrogener).
English: R155K D168A D168V
Danish: I132Vc R155K D168A D168V
English: Potential for Exviera to affect the pharmacokinetics of other medicinal products
Danish: Exvieras potentielle indvirkning på andre lægemidlers farmakokinetik