natgillin/translations-raw huggingface dataset:
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. 
100 mg trde kapsule je pakirano v škatli po 20x1, 60x1, 120x1 ali 180x1 trdih kapsul v perforiranem pretisnem omotu za posamezne odmerke.
Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 
metotreksat (20 mg/m2/teden, peroralno): 8., 15., 22., 29., 36., 43. in 50. dan VCR (1,5 mg/m2/dan, i.v.
The recommended dose of Imatinib Teva B.V. is 100 mg/day for adult patients with HES/CEL. 
pri odraslih bolnikih s HES/CEL je 100 mg/dan.
Table 6 Summary of Z9001 trial RFS analyses by NIH and AFIP risk classifications 
Preglednica 6 Povzetek študije Z9001: analiza preživetja brez ponovitve bolezni po tveganj kov skupno razmerje tveganj (95 % IZ)*
Imatinib Teva B.V. 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate). 
100 mg trde kapsule Ena kapsula vsebuje 100 mg imatiniba (v obliki mesilata).
Therefore, caution should be recommended when driving a car 
Zato je treba bolnikom, ki vozijo avto ali uporabljajo
In a planned subgroup analysis by mutation type, the HR for RFS for 36 months of treatment for patients with mutations of exon 11 was 0.35 [95% CI: 0.22, 0.56]. 
razmerje tveganj za preživetje brez ponovitve bolezni 0,35 [95-odstotni IZ: 0,22, 0,56].
The recommended dose of Imatinib Teva B.V. is 600 mg/day for adult patients in blast crisis. 
za odrasle bolnike v blastni krizi je 600 mg/dan.
The recommended dose of Imatinib Teva B.V. is 400 mg/day for the adjuvant treatment of adult patients following resection of GIST. 
Za adjuvantno zdravljenje odraslih bolnikov po resekciji GIST je priporočeni odmerek zdravila Imatinib Teva B.V.
The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m2 daily. 
Ti bolniki so bili stari od starosti novorojenčka do 14 let, imatinib pa so prejemali v odmerku 50 mg na dan oziroma v na dan.
The recommended dose of Imatinib Teva B.V. is 800 mg/day for adult patients with DFSP. 
pri odraslih bolnikih z DFSP je 800 mg/dan.
If any of these apply to you, tell your doctor before taking Imatinib Teva B.V. 
Če kaj od zgoraj navedenega velja za vas, se še pred jemanjem zdravila Imatinib Teva B.V.
The increase in mean AUC with increasing dose was linear and dose proportional in the range of 25-1,000 mg imatinib after oral administration. 
Po peroralnem dajanju zdravim prostovoljcem je bil t1/2 približno 18 ur, kar kaže na ustreznost enega odmerka na dan. Zvečevanje povprečne AUC z večanjem odmerka je bilo po peroralnem dajanju linearno in sorazmerno odmerku v območju 25-1000 mg imatiniba.
Imatinib Teva B.V. 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate). 
400 mg trde kapsule Ena kapsula vsebuje 400 mg imatiniba (v obliki mesilata).
CPM (250 mg/m2/dose q12h x 4 doses, IV): days 3 and 4 
): 1. in 2. dan CPM (250 mg/m2/odmerek vsakih 12 ur x 4 odmerki, i.v.
Increased hepatic enzymes 
hemolitična anemija
Clinical studies in chronic myeloid leukaemia 
Preglednica 2 Odziv pri odraslih bolnikih s KML v kliničnih študijah
Prephase 
Študija ADE10 Predhodna faza
Imatinib Teva B.V. 400 mg hard capsules 
400 mg trde kapsule imatinib
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. 
400 mg filmsko obložene tablete so temno rumene do rjavkastooranžne, podolgovate filmsko obložene tablete, z zarezo na eni strani ter z oznako “IT” na eni strani zareze in “4” na drugi strani zareze.
Posology for CML in children 
Za otroke s kronično fazo KML
These include some types of cancer. 
lahko enako vpliva na nekatera druga zdravila.
Posology for DFSP The recommended dose of Imatinib Teva B.V. is 800 mg/day for adult patients with DFSP. 
Odmerjanje pri DFSP Priporočeni odmerek zdravila Imatinib Teva B.V.
Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP) Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and 
lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, izpuščaj zaradi zdravila z eozinofilijo in sistemskimi simptomi (DRESSdrug rash with eosinophilia and systemic symptoms)*
4.4 Special warnings and precautions for use 
OZNAČEVANJE IN NAVODILO ZA UPORABO
100 vs. 98.1 100 vs. 93.0 
v pr. z 98,1
Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, 
ginekomastija, erektilna disfunkcija, menoragija,
Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Periorbital oedema, dermatitis/eczema/rash Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, 
Bolezni jeter, žolčnika in žolčevodov zvišani jetrni encimi hiperbilirubinemija, hepatitis, ikterus odpoved jeter8, nekroza jeter periorbitalni edemi, dermatitis/ekcem/izpuščaj pruritus, edem obraza, suha koža, eritem,
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15 
): 1. in 29. dan DEX (6 mg/m2/dan, peroralno): 1.-5. dan in 29.-33. dan 6-MP (75 mg/m2/dan, peroralno: 8.-28. dan metotreksat (20 mg/m2/teden, peroralno): 8., 15. in 22. dan
imatinib teva b.v. 100 mg hard capsules 
100 mg trde kapsule imatinib
1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, 
Odmerki od 1200 mg do 1600 mg (trajanje zdravljenja od 1 do 10 dni): navzea, bruhanje, driska,
Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction 
alopecija, nočno potenje, fotosenzitivna reakcija gnojen izpuščaj, kontuzije, povečano potenje,
100 vs. 100 97.8 vs. 100 
v pr. z 98,7
Bilirubin 
Blister
G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir VCR (1.5 mg/m2/day, IV): days 1, 8, and 15 
G-CSF (5 μg/kg, s.c.): 6.-15. dan oziroma do ANC > 1500 po doseženem i.t.
Hyperkalaemia, hypomagnesaemia 
hipokaliemija, povečan apetit, hipofosfatemija,
imatinib teva b.v. 400 mg hard capsules 
400 mg trde kapsule
- 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 
Med zdravljenjem z zdravilom Imatinib Teva B.V ne dojite.
They are usually 
Navadno so blagi do zmerni.
AUC (7.4%) compared to fasting conditions. 
11 %, tmax pa se je podaljšal za 1,5 ure), AUC pa se je v primerjavi z razmerami na tešče malo zmanjšala (7,4 %).
12 months 24 months 
zmerno 24,6
VCR (1.5 mg/m2/day, IV): days 1, 8 and 15 
VCR (1,5 mg/m2/dan, i.v.
Imatinib Teva B.V. is indicated for 
Imatinib Teva B.V.
• Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Teva B.V. or after you have stopped taking Imatinib Teva B.V. 
• mišični krči ali bolečine v sklepih, mišicah ali kosteh v obdobju, ko se zdravite z zdravilom
Study AIT07 was a multicentre, open-label, randomised, phase II/III study that included 128 patients (1 to < 18 years) treated with imatinib in combination with chemotherapy. 
128 bolnikov (starih od 1 do manj kot 18 let) in jih zdravili z imatinibom v kombinaciji s kemoterapijo.
Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as 
Pri hudi nevtropeniji in trombocitopeniji je priporočljivo zmanjšanje odmerka ali prekinitev zdravljenja, kot kaže spodnja preglednica.
Hyperbilirubinaemia, hepatitis, jaundice 
želodčna razjeda, hematemeza, vnetje ustnice,
18 Gy in 10 fractions for patients that are CNS3 at diagnosis 
18 Gy v 10 frakcijah za bolnike, ki imajo ob postavitvi diagnoze CNS3 VCR (1,5 mg/m2/dan, i.v.
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. 
109/l in/ali koncentracija trombocitov < 50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 400 mg.
Main demographics in TURQUOISE-III 
Glavne demografske značilnosti v TURQUOISE-III
MARKETING AUTHORISATION NUMBER(S) EU/1/14/983/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/983/001
You will take Exviera for either 12 or 24 weeks. 
Zdravilo Exviera boste jemali bodisi 12 ali 24 tednov.
Component of a multipack, can't be sold separately. 
Komponente večkratnega pakiranja se ne sme izdati posebej.
Changes in selected laboratory parameters are described in Table 4. 
Spremembe izbranih laboratorijskih vrednosti so opisane v preglednici 4.
Limited data in patients with end-stage renal disease indicate no clinically significant changes in exposure also in this patient group. 
Omejeni podatki pri bolnikih z ledvično odpovedjo ne kažejo nobenih klinično pomembnih sprememb pri izpostavitvi tudi pri tej skupini bolnikov.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015 
Datum prve odobritve: 15.01.2015
25 mg once daily administered in the morning, with food 
25 mg enkrat na dan zjutraj, s hrano
The recommended dose of dasabuvir is 250 mg (one tablet) twice daily (morning and evening). 
Priporočeni peroralni odmerek dasabuvirja je 250 mg (ena tableta) dvakrat na dan (zjutraj in zvečer).
Co-administration of Exviera with other antivirals has not been studied and, therefore, cannot be recommended. 
Exviera z drugimi protivirusnimi zdravili ni bila raziskana in je zato ni mogoče priporočati.
Drug interaction studies have only been performed in adults. 
Pediatrična populacija Študije medsebojnega delovanja so bile izvedene le pri odraslih.
In case a dose of Exviera is missed, the prescribed dose can be taken within 6 hours. 
Če bolnik izpusti odmerek zdravila Exviera, lahko predpisani odmerek vzame v 6 urah.
No (for any parameter listed above) *AFP= serum alpha fetoprotein 
Da (za vse tri zgoraj naštete parametre) Ne (za kateri koli zgoraj našteti parameter) *AFP = alfa-fetoprotein v serumu
Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AX16 Mechanism of action 
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, zdravila z direktnim delovanjem na viruse, oznaka ATC: J05AX16
Peg-IFN + RBV, n (%) Baseline albumin, median g/L 
Peg-IFN + RBV, n (%) Izhodiščni albumin, median g/L
Expected: ↓ esomeprazole, lansoprazole 
Pričakovano: ↓ esomeprazol, lansoprazol
AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment 
AFP* < 20 ng/ml, trombociti ≥ 90 x 109/l IN albumin ≥ 35 g/l pred zdravljenjem
The increase in exposure was similar regardless of meal type (e.g., high-fat versus moderate-fat) or calorie content (approximately 600 kcal versus approximately 1000 kcal). 
Zvečanje izpostavljenosti je bilo podobno ne glede na vrsto obroka (npr. zelo masten obrok v primerjavi z zmerno mastnim) ali kalorično vrednost (približno 600 kcal v primerjavi s približno 1000 kcal).
Age, median (range) years Male gender, n (%) IL28B Non-CC genotype, n (%) Prior HCV Treatment: 
Starost, mediana leta (razpon) Moški spol, n (%) IL28B ne-CC genotip, n (%) Predhodno zdravljenje za HCV:
Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System. 
Koncentracijo HCV RNA v plazmi so v kliničnih preskušanjih merili s testom COBAS TaqMan HCV test (verzija 2.0), ki je namenjen za uporabo s sistemom High Pure System.
Contraceptive medicines that contains ethinylestradiol cannot be used in combination with Exviera. 
Zdravila za kontracepcijo, ki vsebujejo etinilestradiol, se ne smejo uporabljati v kombinaciji z zdravilom Exviera.
The assay had a lower limit of quantification (LLOQ) of 25 IU per mL. 
Preizkus je imel spodnjo mejo kvantifikacije (LLOQ) 25 i.e./ml.
If an HIV protease inhibitor is added (atazanavir, darunavir), rilpivirine exposure may increase even further and is therefore not recommended. 
Če je dodan zaviralec proteaze HIV (atazanavir, darunavir), se lahko izpostavljenost rilpivirinu še dodatno zveča, zato takšna uporaba ni priporočljiva.
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. 
Da bi lahko ugotovili ponovitev hepatocelularnega karcinoma, povezanega z zdravilom Exviera, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate prospektivne študije varnosti s podatki, ugotovljenimi v kohortah natančno določenih skupin bolnikov, dogovorjenih v protokolu.
Mechanism: possible enzyme induction by efavirenz. 
Mehanizem: Možna indukcija encimov z efavirenzom.
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. 
Ker ima zdravilo lahko neželene učinke na dojene otroke, se je treba odločiti, ali naj ženska prekine dojenje ali zdravljenje z zdravilom Exviera, pri čemer je treba upoštevati pomen zdravljenja za mater.
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. 
Odmerek ribavirina je bil prilagojen individualno po raziskovalčevi presoji; večina bolnikov je kot začetni odmerek prejemala od 600 do 800 mg in večina bolnikov je tudi na koncu zdravljenja prejemala od 600 do 800 mg na dan.
Treatment with Exviera should be initiated and monitored by a physician experienced in the management of chronic hepatitis C. 
Zdravljenje z zdravilom Exviera mora uvesti in nadzirati zdravnik, ki ima izkušnje z vodenjem kroničnega hepatitisa C.
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. 
Pred začetkom jemanja zdravila Exviera se posvetujte z zdravnikom ali farmacevtom, če: - imate tudi bolezen jeter, ki ni hepatitis C; - imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno spremljal.
INFORMATION IN BRAILLE exviera 
PODATKI V BRAILLOVI PISAVI exviera
The interactions with pitavastatin and fluvastatin have not been investigated. 
Pitavastatin in fluvastatin Medsebojnega delovanja s pitavastatinom in fluvastatinom niso raziskana.
Medicinal Product/ Possible Mechanism of Interaction 
Zdravilo/možn i mehanizem medsebojnega delovanja
The highest documented single dose of dasabuvir administered to healthy volunteers was 2 g. No study drug-related adverse reactions or clinically significant laboratory abnormalities were observed. 
Največji dokumentirani enkratni odmerek dasabuvirja, uporabljen pri zdravih prostovoljcih, je bil 2 g. Opazili niso nobenih neželenih učinkov, povezanih z raziskovanim zdravilom, ali klinično pomembnih laboratorijskih nepravilnosti.
Concerning genotype-specific virological and clinical activity, see section 5.1. 
Za virološko in klinično aktivnost, specifično za genotip, glejte poglavje 5.1.
ANTIBIOTICS (SYSTEMIC ADMINISTRATION) Sulfamethoxazole, trimethoprim 
ANTIBIOTIKI (SISTEMSKA UPORABA) sulfametoksazol , trimetoprim
Excipient with known effect: each film-coated tablet contains 44.94 mg lactose (as monohydrate). 
Pomožna snov z znanim učinkom: ena filmsko obložena tableta vsebuje 44,94 mg laktoze (kot monohidrat).
OATP/BCRP /P-gp inhibition by ciclosporin. 
OATP/BCRP/P -gp s ciklosporinom.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
4.3 Kontraindikacije Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Exviera film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blister packs. 
Tablete Exviera so na voljo v pretisnih omotih iz PVC/PE/PCTFE aluminijaste folije.
Purpose of the medicine alprazolam, diazepam for anxiety, panic attacks and trouble sleeping ciclosporin, tacrolimus to suppress the immune system cyclobenzaprine, carisoprodol for muscle spasms dabigatran to thin the blood deferasirox to help reduce iron levels in the blood digoxin, amlodipine for heart problems or high blood pressure furosemide for the build-up of too much fluid in the body hydrocodone for pain imatinib for the treatment of some cancers of the blood levothyroxine for thyroid problems darunavir/ritonavir, atazanavir/ritonavir, rilpivirine for HIV infection omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems rosuvastatin, pravastatin, fluvastatin, pitavastatin to lower blood cholesterol s-mephenytoin for epilepsy teriflunomide for multiple sclerosis sulfasalazine to treat and manage inflammatory bowel disease or to treat rheumatoid arthritis warfarin and other similar medicines called vitamin K antagonists* 
Alprazolam, diazepam pri tesnobi, napadih panike in težavah s spanjem ciklosporin, takrolimus za zaviranje imunskega sistema ciklobenzaprin, karisoprodol pri mišičnih krčih dabigatran za redčenje krvi deferasiroks pomaga pri zmanjševanju ravni železa v krvi digoksin, amlodipin pri težavah s srcem in visokem krvnem tlaku furosemid pri prekomernem kopičenju tekočine v telesu hidrokodon proti bolečini imatinib za zdravljenje nekaterih krvnih rakov levotiroksin pri težavah s ščitnico darunavir/ritonavir, atazanavir/ritonavir, rilpivirin pri okužbah z virusom HIV omeprazol, lansoprazol, esomeprazol pri želodčnih razjedah in drugih težavah z želodcem rosuvastatin, pravastatin, fluvastatin, pitavastatin za zniževanje holesterola v krvi s-mefenitoin pri epilepsiji teriflunomid pri multipli sklerozi sulfasalazin za zdravljenje in nadziranje vnetne črevesne bolezni ali za zdravljenje revmatoidnega artritisa varfarin in druga podobna zdravila imenovana antagonisti vitamina K*
ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4) Haemoglobin <100-80 g/L (grade 2) <80-65 g/L (grade 3) <65 g/L (Grade 4) Total bilirubin >3-10 × ULN (grade 3) >10 × ULN (grade 4) *ULN: Upper Limit of Normal 
ALT > 5-20 × ZNM* (3. stopnja) > 20 × ZMN (4. stopnja) Hemoglobin < 100-80 g/l (2. stopnja) < 80-65 g/l (3. stopnja) < 65 g/l (4. stopnja) Celokupni bilirubin > 3-10 × ZNM (3. stopnja) > 10 × ZNM (4. stopnja) *ZNM: zgornja normalna meja
These ALT elevations were significantly more frequent in the subgroup of subjects who were using ethinylestradiol -containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (6 of 25 subjects); (see section 4.3). 
Ta zvišanja ALT so bila bistveno pogostejša v podskupini preiskovank, ki so uporabljale zdravila z etinilestradiolom, na primer kombinirane peroralne kontraceptive ali kontracepcijske vaginalne obročke (6 od 25 oseb); (glejte poglavje 4.3).
5 mg single dose and other vitamin K antagonists 
Posamezen odmerek 5 mg in drugi antagonisti vitamina K
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. 
Če je od časa, ko po navadi vzame zdravilo Exviera, minilo že več kot 6 ur, NE SME vzeti izpuščenega odmerka, temveč mora vzeti naslednji odmerek po običajnem urniku jemanja.
Refer to the Summary of Product Characteristics of the medicinal products that are used in combination with Exviera. 
Glejte tudi povzetke glavnih značilnosti zdravil, uporabljenih v kombinaciji z zdravilom Exviera.
Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description 
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe: Opis
Coadministration with ethinylestradiol may lead to increased risk of ALT elevations (see sections 4.3 and 4.4). 
Sočasna uporaba z etinilestradiolom lahko zveča tveganje za zvišanje ALT (glejte poglavji 4.3 in 4.4).
Skin and subcutaneous tissue disorders Very common 
Bolezni kože in podkožja Zelo pogosti pruritus
To maximise absorption, Exviera should be taken with food without regard to fat or calorie content. 
Da bi bila absorpcija čim večja, je treba zdravilo Exviera vzeti s hrano, ne glede na vsebnost maščob in kalorij.
Tell your doctor or pharmacist if you notice any of the following side effects: 
Obvestite zdravnika ali farmacevta, če opazite kateri koli neželeni učinek naveden v nadaljevanju:
There are very limited data from the use of Exviera in pregnant women. 
Podatki o uporabi zdravila Exviera pri nosečnicah so zelo omejeni.
OATP1B1 inhibition by gemfibrozil. 
OATP1B1 z gemfibrozilom.
It contains the active substance dasabuvir. 
Vsebuje zdravilno učinkovino dasabuvir.
Characteristics 
Značilnosti
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Exviera is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information. 
Da bi se izognili nosečnosti pri bolnicah in partnericah bolnikov, kadar se zdravilo Exviera jemlje v kombinaciji z ribavirinom, je potrebna skrajna previdnost, glejte poglavje 4.6 in za dodatne informacije povzetek glavnih značilnosti zdravila za ribavirin.
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. 
Preiskovanci so prejemali stabilno shemo antiretrovirusne terapije (ART) za HIV1, ki je vključevala z ritonavirjem okrepljeni atazanavir ali raltegravir, uporabljen z osnovno shemo tenofovirja ter emtricitabina ali lamivudina.
Exviera must not be administered as monotherapy. 
Zdravilo Exviera se ne sme uporabljati kot monoterapija.
It is not known whether the active substance in Exviera (dasabuvir), passes into breast milk. 
Ni znano ali zdravilna učinkovina v zdravilu Exviera (dasabuvir) prehaja v materino mleko.
TURQUOISE-II: relapse rates by baseline laboratory values after 12 and 24 weeks of treatment in subjects with genotype 1a infection and compensated cirrhosis 
TURQUOISE-II: Deleži recidivov glede na izhodiščne laboratorijske vrednosti po 12 in 24 tednih zdravljenja pri preiskovancih s kompenzirano cirozo, okuženih z genotipom 1a
The safety and efficacy of dasabuvir in children below 18 years have not been established. 
Varnost in učinkovitost dasabuvirja pri otrocih, mlajših od 18 let, nista bili ugotovljeni.
Not Studied. 
Ni raziskan.
Recommended co-administered medicinal product(s) and treatment duration for Exviera by patient population 
Priporočena sočasna zdravila in trajanje zdravljenja z zdravilom Exviera po populacijah bolnikov Populacija bolnikov
Ethinylestradiol is contraindicated in combination with Exviera (see section 4.3). 
Etinilestradiol je kontraindiciran v kombinaciji z zdravilom Exviera (glejte poglavje 4.3).
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). 
V nasprotju s tem so bila zvišanja ALT pri tistih, ki so uporabljale druge vrste estrogenov, kakršne so tipično sestavine hormonskega nadomestnega zdravljenja (tj. peroralni in lokalni estradiol in konjugirani estrogeni), opažena v podobnem deležu kot med neuporabnicami zdravil z estrogenom (približno 1 % v vsaki skupini).
PHARMACEUTICAL FORM AND CONTENTS Multipack: 56 (4 packs of 14) film-coated tablets 
FARMACEVTSKA OBLIKA IN VSEBINA Večkratno pakiranje: 56 (4 škatle po 14) filmsko obloženih tablet