natgillin/translations-raw huggingface dataset:
100 mg hårde kapsler fås i perforerede enkeltdosisblisterpakninger med 20x1, 60x1, 120x1 eller 180x1 hårde kapsler.
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.
Konsoliderende behandling II, IV Ara-C 75 mg/m i.v.
Consolidation therapy I, III, V MTX 500 mg/m i.v.
Periorbitalt ødem, dermatitis/eksem/udslæt Pruritus, ansigtsødem, tør hud, erythem, alopeci, natlig svedtendens,
Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Periorbital oedema, dermatitis/eczema/rash Pruritus, face oedema, dry skin, erythema, alopecia, night sweats,
ANC = fuldstændigt antal neutrofilocytter a opstået efter mindst 1 måneds behandling
a occurring at least after 1 month of treatment
Methylprednisolon 40 mg intrathecal, dag 1
MTX 15 mg intrathecal, day 1; Methylprednisolone 40 mg intrathecal, day 1
100 mg filmovertrukne tabletter er mørkegule til brunlig-orange runde filmovertrukne tabletter med delekærv på den ene side.
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.
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.
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.
Startdosis er 400 mg, som skal tages som 1 kapsel én gang daglig.
The starting dose is 400 mg, to be taken as one capsule once a day.
hård kapsel indeholder 100 mg imatinib (som mesilat).
Each hard capsule contains 100 mg of imatinib (as mesilate).
I tilfælde af svær neutropeni og trombocytopeni anbefales dosisreduktion eller seponering af behandlingen, som angivet i nedenstående tabel:
Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as
B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND
hæmmer væksten af disse celler i en vis undergruppe af disse sygdomme.
Imatinib Teva B.V. inhibits the growth of these cells in a certain subtype of these diseases.
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).
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.
filovertrukken tablet indeholder 100 mg imatinib (som mesilat).
Each film-coated tablet contains 100 mg of imatinib (as mesilate).
2/dag, p.o.): dag 1-56
2/day, PO): days 1-7 and 15-21
hård kapsel indeholder 400 mg imatinib (som mesilat).
Each hard capsule contains 400 mg of imatinib (as mesilate).
): dag 1, 8, og 15
i.v., days 1, 8;
Kaplan-Meier estimatet for overlevelse efter 36
The Kaplan-Meier estimate for survival after 36-month follow-up is 68%.
Hrvatska
RFS
- 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).
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
Delvist
Headache2
Startdosis er 400 mg, som skal tages som 1 tablet én gang daglig.
The starting dose is 400 mg, to be taken as one tablet once a day.
400 mg filmovertrukne tabletter imatinib
Imatinib Teva B.V. 400 mg film-coated tablets
100 mg filmovertrukne tabletter
Imatinib Teva B.V. 100 mg film-coated tablets
United Kingdom
Czech Republic
Gennem alle faser af omsorgen bør behandlingen overvåges af hæmatologiske eksperter, som er
Haematological experts in the management of this disease should supervise the therapy throughout all phases
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
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
I dyremodeller, hvor der anvendes Bcr-Abl-positive tumorceller, har stoffet som enkeltstof in vivo
In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive
Hvis cytopeni ikke er leukæmirelateret, reducer imatinib-dosis til 400 mg. 7.
If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 400 mg.
Leucovorin (75 mg/m2 i time 36, i.v.
Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
som er forbundet med platelet-derived growth factor receptor-omlejring (PDGFR-omlejring).
• Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet derived growth factor receptor (PDGFR) gene re-arrangements.
18 Gy i 10 fraktioner for patienter, som er CNS3 ved diagnosticering VCR (1,5 mg/m2/dag, i.v.
18 Gy in 10 fractions for patients that are CNS3 at diagnosis
100 mg filmovertrukne tabletter Imatinib Teva B.V.
NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 100 mg film-coated tablets Imatinib Teva B.V. 400 mg film-coated tablets
Hud og subkutane væv Meget almindelig:
Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Very common:
Forsigtighed bør udvises, når imatinib administreres sammen
Caution should be taken when administering imatinib with inhibitors of the CYP3A4
filmovertrukkentablet indeholder 400 mg imatinib (som mesilat).
Each film-coated tablet contains 400 mg of imatinib (as mesilate).
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.
CML (CML-AP and CML-BC) than in patients with chronic CML.
100 mg hårde kapsler Hver hård kapsel indeholder 100 mg imatinib (som mesilat).
Imatinib Teva B.V. 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
oral, dag 1-5; i.v., dag 6-7, 13-14 i.v.
Daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
er 800 mg/dag til voksne patienter med DSFP.
The recommended dose of Imatinib Teva B.V. is 800 mg/day for adult patients with DFSP.
400 mg hårde kapsler Hver hård kapsel indeholder 400 mg imatinib (som mesilat).
Imatinib Teva B.V. 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate).
; 15 mg/m2 i.v.
Ara-C 75 mg/m2 i.v.
400 mg hårde kapsler
imatinib teva b.v. 400 mg hard capsules
Din læge kan beslutte at øge dosis til 400 mg, som skal tages som 4 tabletter én gang daglig afhængig af, hvordan du
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.
400 mg hårde kapsler fås i perforerede enkeltdosisblisterpakninger med 30x1 eller
Imatinib Teva B.V. 400 mg hard capsules are available in pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Din læge kan beslutte at øge dosis til 400 mg, som skal tages som 4 kapsler én gang daglig afhængig af, hvordan du
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.
- Flåd fra øjet med kløe, rødme og hævelse (betændelse af øjets bindehinde), øget tåreflåd eller
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
kan hjælpe dig med at bekæmpe denne tilstand.
These measures will help protect the environment.
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.
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.
- Hvis du er bekymret for din frugtbarhed, mens du tager Imatinib Teva B.V., skal du kontakte
- 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
Colitis, ileus, inflammatorisk tarmsygdom Ileus/intestinal obstruktion*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
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)*
- Philadelphia-kromosom-positiv akut lymfoblastær leukæmi (Ph-positiv ALL).
Imatinib Teva is also a treatment for adults and children for: - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Spanien
Italia
): dag 22-26
12 months 24 months
NEL: Samme kriterier som for CHR, men ANC ≥1 x 109/l og trombocytter ≥20 x 109/l.
ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l,
1 Pneumoni blev oftest observeret hos patienter med transformeret CML og hos patienter med GIST.
5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed
400 mg filmovertrukne tabletter er mørkegule til brunlig-orange aflange filmovertrukne tabletter med delekærv på den ene side.
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.
VCR (1,5 mg/m2/dag, i.v.
VCR (1.5 mg/m2/day, IV): days 1, 8 and 15
5.1 og 5.2).
31.6%, respectively).
Dosering ved DFSP Den anbefalede dosis af Imatinib Teva B.V.
Posology for DFSP The recommended dose of Imatinib Teva B.V. is 800 mg/day for adult patients with DFSP.
(3 timer), dag 1; Daunorubicin 60 mg/m2 i.v.
(3 h), days 1-4; Mitoxantrone 10 mg/m2 i.v.
): dag 1 og 15 Leucovorin (75 mg/m2 i time 36, i.v.
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
(1 time), dag 26, 46; Ara-C 75 mg/m2 i.v.
(1 h) days 4-5; Ara-C 2x 2 g/m2 i.v.
100 mg hårde kapsler
imatinib teva b.v. 100 mg hard capsules
100 mg filmovertrukne tabletter Mørkegule til brunlig-orange runde filmovertrukne tabletter med delekærv på den ene side.
Dark yellow to brownish orange round film-coated tablets with a score line on one side.
LÆGEMIDLETS NAVN Imatinib Teva B.V.
NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 400 mg film-coated tablets
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.
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.
DEX 10 mg/m2 oral, dag 6-7, 13-16; VCR 1 mg i.v., dag 7, 14; i.v.
Prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28;
Blod og lymfesystem Meget almindelig:
Confusional state Nervous system disorders Very common:
Hypertension, hæmatom, subduralt hæmatom, kuldefornemmelser i ekstremiteter, hypotension, Raynaud's syndrom
Hypertension, haematoma, subdural haematoma, peripheral coldness,
Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse
Name and address of the manufacturers responsible for batch release Teva Czech Industries s.r.o.
GENEREL KLASSIFIKATION FOR UDLEVERING
6.6 Special precautions for disposal
Teva Sweden AB
Teva Norway AS
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.
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.
Dosis er 800 mg pr. dag (8 tabletter).
The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/983/001
MARKETING AUTHORISATION NUMBER(S) EU/1/14/983/001
Du skal tage Exviera i enten 12 eller 24 uger.
You will take Exviera for either 12 or 24 weeks.
Vigtigste demografiske karakteristika i TURQUOISE-III
Main demographics in TURQUOISE-III
Der er meget begrænsede data fra anvendelse af Exviera til gravide kvinder.
There are very limited data from the use of Exviera in pregnant women.
• hvis du har andre alvorlige leverproblemer end hepatitis C
• If you have severe liver problems other than hepatitis C.
(ca. 60 %) i den lægemiddelrelaterede radioaktivitet i plasma.
60%) of drug related radioactivity in plasma.
Virkning af baseline-HCV-substitutioner/polymorfismer på behandlingsrespons
Effect of baseline HCV substitutions/polymorphisms on treatment response
Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug; direkte virkende antivirale midler; ATC-kode: J05AX16
Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AX16 Mechanism of action
• hvis du er allergisk over for dasabuvir eller et af de øvrige indholdsstoffer i Exviera (angivet i punkt 6)
• If you are allergic to dasabuvir or any of the other ingredients of this medicine (listed in section 6).
• Behandlingen afbrydes hos patienter, som udvikler tegn på dekompenseret leversygdom.
• Discontinue treatment in patients who develop evidence of hepatic decompensation.
NS5A M28T M28Ve
NS5A M28T M28V
Reaktivering af hepatitis B-virus
Hepatitis B Virus Reactivation)
Den anbefalede dosis dasabuvir er 250 mg (én tablet) to gange dagligt (morgen og aften).
The recommended dose of dasabuvir is 250 mg (one tablet) twice daily (morning and evening).
Hvis en HIV-proteasehæmmer tilføjes (atazanavir, darunavir), kan rilpivirin-eksponeringen øges endnu mere; derfor anbefales dette ikke.
If an HIV protease inhibitor is added (atazanavir, darunavir), rilpivirine exposure may increase even further and is therefore not recommended.
Samtidig administration af Exviera og andre antivirale midler er ikke undersøgt og anbefales derfor ikke.
Co-administration of Exviera with other antivirals has not been studied and, therefore, cannot be recommended.
b. 'Andet' omfatter tidlig stop i behandlingen som ikke skyldes virologisk svigt og manglende HCV-rna-værdier i SVR12-vinduet.
b. Other includes early drug discontinuation not due to virologic failure and missing HCV RNA values in the SVR12 window.
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.
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.
Behandling med Exviera skal påbegyndes og overvåges af en læge med erfaring i behandling af kronisk hepatitis C.
Treatment with Exviera should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
• Overvåg for kliniske tegn og symptomer på dekompenseret leversygdom (såsom ascites, hepatisk encefalopati og varice-blødning).
• Monitor for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage).
Tag ikke Exviera:
Do not take Exviera:
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.
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.
Rilpivirin skal anvendes med forsigtighed og under løbende EKG-monitorering.
Rilpivirine should be used cautiously, in the setting of repeated ECG monitoring.
Prævention, der indeholder ethinylestradiol, kan ikke anvendes i kombination med Exviera.
Contraceptive medicines that contains ethinylestradiol cannot be used in combination with Exviera.
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.
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.
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.
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.
Exviera filmovertrukne tabletter fås i blisterpakninger fremstillet af PVC/PE/PCTFE-aluminiumsfolie.
Exviera film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blister packs.
Exviera indeholder det aktive stof dasabuvir.
It contains the active substance dasabuvir.
Alder, median (interval) år Mænd, køn, n (%) IL28B Non-C/C genotype, n (%) Tidligere HCV-behandling:
Age, median (range) years Male gender, n (%) IL28B Non-CC genotype, n (%) Prior HCV Treatment:
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.
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.
Så meget skal du tage Den anbefalede dosis er 1 tablet 2 gange dagligt.
The recommended dose is one tablet, twice a day.
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).
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).
Exvieras potentielle indvirkning på andre lægemidlers farmakokinetik
Potential for Exviera to affect the pharmacokinetics of other medicinal products
Efter en dosis på 400 mg 14C-dasabuvir hos mennesker var uomdannet dasabuvir den væsentligste komponent
Following a 400 mg 14C-dasabuvir dose in humans, unchanged dasabuvir was the major component (approximately
Der skal træffes skærpede forholdsregler for at undgå graviditet hos kvindelige patienter og hos mandlige patienters kvindelige partnere, når Exviera administreres i kombination med ribavirin.
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Exviera is used with ribavirin.
Til gengæld var forekomsten af forhøjet ALAT hos de forsøgspersoner, som anvendte andre typer østrogener, herunder dem, der typisk anvendes i hormonerstatningsbehandling (dvs. estradiol til oral og topikal anvendelse samt konjugerede østrogener), den samme som hos de forsøgspersoner, der ikke brugte østrogenholdige lægemidler (ca. 1 % i hver gruppe).
In contrast, the rate of ALT elevations in subjects using other types of estrogens as typically used in hormonal replacement therapy (i.e., oral and topical estradiol and conjugated estrogens) was similar to the rate observed in subjects who were not using estrogen-containing products (approximately 1% in each group).
Hvis en patient glemmer at tage en dosis Exviera, kan den ordinerede dosis tages op til 6 timer senere.
In case a dose of Exviera is missed, the prescribed dose can be taken within 6 hours.
Se produktresuméerne for de lægemidler, der anvendes i kombination med Exviera.
Refer to the Summary of Product Characteristics of the medicinal products that are used in combination with Exviera.
Effekt af justering af ribavirin-dosis på sandsynligheden for SVR
Impact of ribavirin dose adjustment on probability of SVR
LISTE OVER HJÆLPESTOFFER Indeholder også laktose.
LIST OF EXCIPIENTS Also contains lactose.
Selvom der ikke forventes ændringer af warfarins farmakokinetik, anbefales tæt monitorering af INR
While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Interaktioner mellem Exviera med ombitasvir/paritaprevir/ritonavir og andre lægemidler
Interactions between Exviera with ombitasvir/paritaprevir/ritonavir and other medicinal products
Pilens retning angiver ændringen i eksponering (Cmax og AUC) for paritaprevir, ombitasvir, dasabuvir og det samtidigt administrerede lægemiddel (↑= stigning på over 20 %, ↓ = fald på over 20 %, ↔ =
The direction of the arrow indicates the direction of the change in exposures (Cmax, and AUC) in the paritaprevir, ombitasvir, dasabuvir and the co-administered medicinal product (↑= increase more than 20%, ↓ = decrease more than 20%, ↔ = no change or change less than 20%).
Forsøgspersonerne var på en stabil HIV-1-antiretroviral behandling (antiretroviral therapy (ART)), der omfattede ritonavirboostet atazanavir eller raltegravir, der blev administreret samtidig med en baggrundsbehandling bestående af tenofovir + emtricitabin eller lamivudin.
Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or raltegravir, co-administered with a backbone of tenofovir plus emtricitabine or lamivudine.
Mikrokrystallinsk cellulose (E460(i)) Laktosemonohydrat Copovidon
Microcrystalline cellulose (E460(i)) Lactose monohydrate Copovidone
Dasabuvirs virkning hos patienter med andre HCV-genotyper end genotype 1 er ikke klarlagt, og Exviera må derfor ikke bruges til behandling af patienter med andre genotyper end genotype 1.
The efficacy of dasabuvir has not been established in patients with HCV genotypes other than genotype 1; Exviera should not be used for the treatment of patients infected with other genotypes than
For at maksimere absorptionen skal Exviera tages sammen med mad; fedt- og kalorieindholdet er ligegyldigt.
To maximise absorption, Exviera should be taken with food without regard to fat or calorie content.
INFORMATION I BRAILLESKRIFT exviera
INFORMATION IN BRAILLE exviera
Exviera må ikke gives som enkeltstofbehandling.
Exviera must not be administered as monotherapy.
TURQUOISE II: Recidivrate ud fra laboratorieværdier ved baseline efter 12 og 24 ugers behandling hos patienter med genotype 1a-infektion og kompenseret cirrose
TURQUOISE-II: relapse rates by baseline laboratory values after 12 and 24 weeks of treatment in subjects with genotype 1a infection and compensated cirrhosis
ANTIDEPRESSIVA Escitalopram 10 mg enkeltdosis
ANTIDEPRESSANTS Escitalopram 10 mg single dose
Lægemidler, der er stærke CYP2C8-hæmmere, kan øge plasmakoncentrationen af dasabuvir og må ikke administreres samtidig med Exviera (se pkt.
Medicinal products that are strong CYP2C8 inhibitors may increase dasabuvir plasma concentrations and must not be co-administered with Exviera (see section 4.5).