FrancophonIA/ELRC3.0 huggingface dataset:
English: - Depending upon the results of these tests, your doctor may change/adjust the number of capsules you or the child you are caring for take, prescribe a different pack size of this medicine, and/or change the length of time to take this treatment.
Slovenian: - Glede na izvide teh preiskav bo zdravnik lahko spremenil/prilagodil število trdih kapsul, ki jih vi ali otrok, za katerega skrbite, jemljete, in vam predpisal drugo velikost pakiranja tega zdravila in/ali spremenil dolžino zdravljenja.
English: Ninety four of 107 children enrolled in the 5 year long-term follow up trial.
Slovenian: Štiriindevetdeset od 107 otrok je bilo vključenih v 5-letno dolgoročno spremljevalno preskušanje.
English: Date of first authorisation: 31 March 2009 Date of latest renewal: 16 January 2014
Slovenian: Datum podaljšanja dovoljenja za promet: 16. januar 2014
English: This should be discussed with your doctor (see “Do not take Ribavirin Teva”).
Slovenian: O tem se pogovorite s svojim zdravnikom (glejte poglavje “Ne jemljite zdravila Ribavirin Teva”).
English: ≥ 2 g/dL decrease in haemoglobin during any 4 week period during treatment (permanent dose reduction)
Slovenian:  2 g/dl znižanje hemoglobina v katerem koli 4-tedenskem obdobju med zdravljenjem (stalno zmanjšanje odmerka)
English: The use of Ribavirin Teva is contraindicated during pregnancy.
Slovenian: Uporaba zdravila Ribavirin Teva je kontraindicirana med nosečnostjo.
English: EU/1/09/509/001 - 84 capsules EU/1/09/509/002 - 112 capsules EU/1/09/509/003 - 140 capsules EU/1/09/509/004 - 168 capsules
Slovenian: EU/1/09/509/001 - 84 kapsul EU/1/09/509/002 - 112 kapsul EU/1/09/509/003 - 140 kapsul EU/1/09/509/004 - 168 kapsul
English: Ribavirin Teva capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Slovenian: Kapsule Ribavirin Teva naj bolnik jemlje peroralno vsak dan v dveh deljenih odmerkih (zjutraj in zvečer) s hrano.
English: Talk to your doctor if you or your child you are caring for
Slovenian: Zdravniku povejte, če ste vi ali otrok za katerega skrbite:
English: Elderly (≥ 65 years of age)
Slovenian: Starejši (stari  65 let)
English: Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax= 1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively).
Slovenian: Ribavirin se hitro absorbira po zaužitju enkratnega odmerka (srednji Tmax = 1,5 ure), čemur sledita hitra faza porazdelitve in faza podaljšanega izločanja (razpolovna doba absorpcije, porazdelitve in izločanja po enkratnem odmerku je 0,05; 3,73 in 79 ur).
English: Ribavirin Teva is available in different pack sizes containing 84, 112, 140 or 168 capsules to be swallowed.
Slovenian: Zdravilo Ribavirin Teva je na voljo v različnih velikostih pakiranj, ki vsebujejo 84, 112, 140 ali 168 kapsul, ki jih je potrebno pogoltniti.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of Ribavirin therapy:
Slovenian: Sprejemljive začetne vrednosti, ki lahko služijo kot smernice pred uvedbo zdravljenja z zdravilom Ribavirin Teva:
English: If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for 7 months after treatment has stopped.
Slovenian: Če vaša partnerka sicer trenutno ni noseča, a je v rodni dobi, mora opraviti test nosečnosti vsak mesec med vašim zdravljenjem in še 7 mesecev po koncu zdravljenja.
English: EU/1/09/509/001 (84 capsules) EU/1/09/509/002 (112 capsules) EU/1/09/509/003 (140 capsules) EU/1/09/509/004 (168 capsules)
Slovenian: EU/1/09/509/001 (84 kapsul) EU/1/09/509/002 (112 kapsul) EU/1/09/509/003 (140 kapsul) EU/1/09/509/004 (168 kapsul)
English: Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, either male patients or their female partners of childbearing age must be advised to use an effective contraceptive during treatment with ribavirin and for seven months after treatment.
Slovenian: Četudi podatki o približno 300 prospektivno spremljanih nosečnostih z izpostavljenostjo očeta ribavirinu niso pokazali ne povečanega tveganja za pojav malformacij v primerjavi s splošno populacijo ne specifičnega vzorca malformacij, morate moškim bolnikom ali njihovim partnerkam v rodni dobi svetovati, naj uporabljajo učinkovito kontracepcijo med zdravljenjem z zdravilom Ribavirin Teva in še sedem mesecev po koncu zdravljenja.
English: − change in colour of the tongue.
Slovenian: (srčno zaklopko) in srcem, - sprememba barve jezika.
English: What Ribavirin Teva is and what it is used for
Slovenian: Kaj je zdravilo Ribavirin Teva in za kaj ga uporabljamo
English: Although ribavirin has no direct cardiovascular effects, anaemia associated with ribavirin may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease, or both.
Slovenian: Čeprav ribavirin nima neposrednih srčnožilnih učinkov, lahko anemija povezana z ribavirinom povzroči poslabšanje delovanja srca, poslabšanje simptomov koronarne bolezni ali oboje.
English: You or your female partner must use an effective contraceptive during the time you are taking this medicine and for 7
Slovenian: Vi ali vaša partnerka morate uporabljati učinkovito kontracepcijo v času jemanja tega zdravila in še 7 mesecev po zaključku zdravljenja.
English: Ribavirin has no or negligible influence on the ability to drive and use machines; however, other medicinal products used in combination may have an effect.
Slovenian: Zdravilo Ribavirin Teva nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji, druga zdravila, uporabljena pri kombiniranem zdravljenju pa imajo lahko tovrsten učinek.
English: 3 capsulesa
Slovenian: 3 kapsulea
English: What you need to know before you use Ribavirin Teva Do not take Ribavirin Teva
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ribavirin Teva Ne jemljite zdravila Ribavirin Teva
English: Ribavirin capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC)-aluminium blister packs
Slovenian: Kapsule zdravila Ribavirin Teva so pakirane v pretisne omote iz polivinilklorida (PVC)/polietilena (PE)/polivinilidenklorida (PVdC) - pakiranja v aluminijasti pretisni omot.
English: Ribavirin Teva is a white, opaque, hard capsule imprinted with blue ink.
Slovenian: Zdravilo Ribavirin Teva je bela, neprozorna trda kapsula, z natisnjenim napisom z modrim črnilom.
English: Patients whose dose of Ribavirin Teva is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Slovenian: Bolniki, katerih odmerek ribavirina je zmanjšan na 600 mg na dan, naj prejmejo po eno 200 mg kapsulo zjutraj in dve 200 mg kapsuli zvečer.
English: If the child is weighing less than 47 kg or unable to swallow capsules an oral solution of ribavirin should be used.
Slovenian: Če otrok tehta manj kot 47 kg ali ne more požirati kapsul, je treba uporabiti peroralno raztopino ribavirina.
English: 4 capsulesb Refer to adult dose recommendation a: 1 morning, 2 evening b: 2 morning, 2 evening
Slovenian: 4 kapsuleb Glejte priporočila za odmerjanje pri odraslih bolnikih a 1 zjutraj, 2 zvečer b 2 zjutraj, 2 zvečer
English: Ribavirin Teva must be used in combination therapy as described in section 4.1.
Slovenian: Zdravilo Ribavirin Teva je treba uporabljati v kombinaciji z drugimi zdravili, kot je opisano v poglavju 4.1.
English: For children or adolescents who cannot swallow a hard capsule, an oral solution of ribavirin is available.
Slovenian: Za otroke in mladostnike, ki ne morejo pogoltniti trde kapsule, je na voljo peroralna raztopina zdravila z ribavirinom.
English: Do not take a double dose to make up for a forgotten dose
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Paediatric population: No data are available in children below 3 years of age.
Slovenian: Podatkov pri otrocih, mlajših od 3 let, ni na voljo.
English: Preclinical data: - Fertility: In animal studies, ribavirin produced reversible effects on spermatogenesis (see section 5.3).
Slovenian: - Plodnost: V študijah na živalih je ribavirin povzročil reverzibilne učinke na spermatogenezo (glejte poglavje 5.3).
English: As in adult patients, children and adolescents also experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence) (see section 4.4).
Slovenian: Kot odrasli bolniki so imeli tudi otroci in mladostniki še druge psihiatrične neželene učinke (npr. depresijo, čustveno labilnost in zaspanost) (glejte poglavje
English: If you take more Ribavirin Teva than you should
Slovenian: Če ste vzeli večji odmerek zdravila Ribavirin Teva, kot bi smeli
English: Genotype 2/3/4 (n=26)
Slovenian: Genotip 1 (n=92) Genotip 2/3/4 (n=26)
English: Other medicines and Ribavirin Teva
Slovenian: Druga zdravila in zdravilo Ribavirin Teva
English: If you forget to take Ribavirin Teva
Slovenian: Če ste pozabili vzeti zdravilo Ribavirin Teva
English: This medicine does not effect your ability to drive or use machines; however, other medicines used in combination with Ribavirin Teva may cause sleepiness, tiredness or confusion.
Slovenian: To zdravilo ne vpliva na vašo sposobnost za vožnjo ali upravljanje s stroji, medtem ko druga zdravila, uporabljena v kombinaciji z zdravilom Ribavirin Teva, lahko vplivajo na vašo sposobnost za vožnjo ali upravljanje s stroji.
English: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Ribavirin Teva must be discontinued immediately and appropriate medical therapy instituted.
Slovenian: Če se razvije akutna preobčutljivostna reakcija (npr. urtikarija, angioedem, bronhokonstrikcija, anafilaksa), morate jemanje zdravila Ribavirin Teva takoj prekiniti in uvesti ustrezno zdravljenje.
English: Ribavirin therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Slovenian: Zdravljenja z zdravilom Ribavirin Teva ne smete uvesti, dokler ne dobite negativnega izvida testa nosečnosti tik pred začetkom zdravljenja.
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis
Slovenian: pljučnica, askarioza, enterobiaza, herpes zoster, celulitis
English: Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excl. reverse transcriptase inhibitors, ATC code: J05AB04.
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, nukleozidi in nukleotidi (razen zaviralcev reverzne transkriptaze), oznaka ATC: J05AB04
English: Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARVtreatment reassessed.
Slovenian: Če bolezen napreduje do jetrne dekompenzacije, je treba pri teh bolnikih nemudoma ukiniti zdravljenje hepatitisa in ponovno oceniti učinkovitost antiretrovirusnega zdravljenja.
English: White, opaque and imprinted with blue ink.
Slovenian: trda kapsula bele, neprozorne in z natisnjenim napisom z modrim črnilom.
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Slovenian: Brampton Road, Hampden Park, Eastbourne East Sussex, BN22 9AG Velika Britanija
English: This decline was significant among responders (0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among nonresponders.
Slovenian: Ta upad je bil statistično značilen pri bolnikih, ki so se odzvali na zdravljenje (-0,3 pri oceni po Metavirju in -1,2 pri oceni po Ishaku) in stabilen (-0,1 pri oceni po Metavirju in -0,2 pri oceni po Ishaku) pri tistih, ki se niso odzvali na zdravljenje.
English: In this trial, the combination of ribavirin and peginterferon alfa-2b (1.5 micrograms/kg/week) was significantly more effective than the combination of ribavirin and interferon alfa-2b, particularly in patients infected with Genotype 1.
Slovenian: V tem preskušanju je bila kombinacija ribavirina in peginterferona alfa-2b (1,5 mikrograma/kg/ teden) bistveno bolj učinkovita od kombinacije ribavirina in interferona alfa-2b, še posebej pri bolnikih, okuženih z genotipom 1.
English: Extreme care must be taken to avoid pregnancy in partners of male patients taking ribavirin (see sections 4.3, 4.4 and 5.3).
Slovenian: Izjemno skrbno moramo paziti, da preprečimo zanositev pri partnerkah moških bolnikov, ki jemljejo zdravilo Ribavirin Teva (glejte poglavja 4.3, 4.4 in 5.3).
English: In clinical trials of 118 children and adolescents 3 to 16 years of age treated with combination therapy of interferon alfa-2b and ribavirin, 6 % discontinued therapy due to adverse events.
Slovenian: V kliničnih preskušanjih pri 118 otrocih in mladostnikih, starih od 3 do 16 let, zdravljenih s kombinacijo interferona alfa-2b in ribavirina, so pri 6 % ukinili terapijo zaradi neželenih učinkov.
English: Two large long-term follow-up studies enrolled 1,071 patients and 567 patients after treatment in prior studies with nonpegylated interferon alfa-2b (with or without ribavirin) and pegylated interferon alfa-2b (with or without ribavirin), respectively.
Slovenian: V dve veliki, dolgoročni študiji spremljanja bolnikov po zdravljenju v prejšnjih študijah so vključili skupaj 1.071 bolnikov po končanem zdravljenju z nepegiliranim interferonom alfa-2b (z ali brez ribavirina) ter 567 bolnikov po končanem zdravljenju s pegiliranim interferonom alfa-2b (z ali brez ribavirina).
English: d: Ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Slovenian: d: odmerek ribavirina je znašal 800 mg za bolnike s telesno maso < 60 kg, 1000 mg za bolnike s telesno maso od 60 do 75 kg in 1200 mg za tiste s telesno maso > 75 kg.
English: For patients receiving a 800 mg (< 65 kg) - 1,000 mg (65-80 kg) - 1,200 mg (81-105 kg) or 1,400 mg (> 105 kg) dose, 1st dose reduction of Ribavirin Teva is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day).
Slovenian: Pri bolnikih, ki prejemajo odmerek 800 mg (< 65 kg) - 1.000 mg (65-80 kg) - 1.200 mg (81-105 kg) ali 1.400 mg (> 105 kg), naj bo prvo zmanjšanje odmerka ribavirina za 200 mg/dan (razen pri bolnikih, ki prejemajo 1.400 mg - pri njih odmerek zmanjšajte za 400 mg/dan).
English: Multiple-dose pharmacokinetic properties for ribavirin capsules and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 10.
Slovenian: Farmakokinetične lastnosti pri večkratnem odmerjanju kapsul ribavirina in interferona alfa-2b pri otrocih in mladostnikih s kroničnim hepatitisom C v starosti od 5 do 16 let so povzete v preglednici 10.
English: Anaemia (haemoglobin < 9.4 g/dL) was reported in 12 % (23/194) of patients treated with ribavirin in combination with peginterferon alfa-2b.
Slovenian: O anemiji (hemoglobin < 9,4 g/dl) so poročali pri 12 % (23/194) bolnikov, zdravljenih z ribavirinom v kombinaciji s peginterferonom alfa-2b.
English: Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCV-RNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received ribavirin 15 mg/kg per day plus interferon alfa-2b 3 MIU/m times a week for 1 year followed by 6 months follow-up after treatment.
Slovenian: Otroci in mladostniki, stari od 3 do 16 let in s kompenziranim kroničnim hepatitisom C in merljivimi količinami serumske RNA-HCV (kar je ocenil osrednji laboratorij z uporabo raziskovalnega testa RTPCR), so bili vključeni v dve multicentrični preskušanji in so ribavirin prejemali v odmerku 15 mg/kg na dan skupaj z interferonom alfa-2b v odmerku 3 mio i.e./m2 trikrat na teden v času enega leta, čemur je sledilo 6-mesečno spremljanje po zdravljenju.
English: For children and adolescents weighing less than 47 kg a solution formulation is available.
Slovenian: Za pediatrične bolnike (otroke in mladostnike), ki tehtajo manj kot 47 kg je na voljo peroralna raztopina.
English: What Ribavirin Teva is and what it is used for What you need to know before you use Ribavirin Teva How to use Ribavirin Teva
Slovenian: Kaj je zdravilo Ribavirin Teva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ribavirin Teva Kako jemati zdravilo Ribavirin Teva Možni neželeni učinki
English: - have any blood disorder, such as anaemia (low blood count), thalassemia or sickle-cell anaemia
Slovenian: - če imate katero od krvnih bolezni, kot,so anemija (premajhno število krvnih celic), talasemija ali anemija srpastih celic,
English: How to store Ribavirin Teva Contents of the pack and other information
Slovenian: Shranjevanje zdravila Ribavirin Teva Vsebina pakiranja in dodatne informacije
English: The other ingredients are calcium hydrogen phosphate, croscarmellose sodium, povidone, magnesium stearate.
Slovenian: Druge sestavine so kalcijev hidrogenfosfat, premreženi natrijev karmelozat, povidon, magnezijev stearat.
English: Contents of the pack and other information What Ribavirin Teva contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ribavirin Teva
English: Note: For patients who weigh < 47 kg, or are unable to swallow capsules, ribavirin oral solution is available and should be used if appropriate.
Slovenian: Opomba: Za bolnike, ki tehtajo < 47 kg ali ne morejo pogoltniti kapsule, je na voljo peroralna raztopina ribavirina.
English: Dosing of ribavirin for children and adolescent patients is determined by the patient body weight.
Slovenian: Odmerek ribavirina za otroke in mladostnike se za zdravilo Ribavirin Teva določi na podlagi bolnikove telesne mase.
English: Daily ribavirin dose
Slovenian: Dnevni odmerek ribavirina
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10), and uncommon (≥ 1/1,000 to
Slovenian: Neželeni učinki so navedeni po organskih sistemih, z naslednjimi kategorijami pogostnosti: zelo pogosti (≥ 1/10), pogosti (od ≥ 1/100 do < 1/10) in občasni (od ≥ 1/1.000 do < 1/100).
English: Method of administration Ribavirin capsules should be administered orally with food.
Slovenian: Način uporabe Zdravilo Ribavirin Teva je treba uporabljati peroralno s hrano.
English: Cardiac murmur * Since ribavirin has always been prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using ribavirin in combination with interferon alfa-2b (pegylated or nonpegylated).
Slovenian: * Ker je bil ribavirin vedno predpisan skupaj z zdravili, ki vsebujejo interferon alfa, in ker našteti neželeni učinki temeljijo na izkušnjah v obdobju trženja in ne omogočajo natančne opredelitve pogostnosti, so zgoraj navedene pogostnosti vzete iz kliničnih preskušanj z uporabo ribavirina v kombinaciji z interferonom alfa-2b (pegiliranim ali nepegiliranim).
English: > 4 mg/dL (adults) * For patients receiving a 1,000 mg (< 75 kg) or 1,200 mg (> 75 kg) dose, ribavirin dose should be reduced to 600 mg/day (administered as one 200 mg capsule in the morning and two 200 mg capsules in the evening).
Slovenian: *Pri bolnikih, ki prejemajo odmerek 1.000 mg (< 75 kg) ali 1.200 mg (> 75 mg), je treba odmerek ribavirina zmanjšati na 600 mg/dan (uporabljen kot ena 200-mg kapsula zjutraj in dve 200 mg kapsuli zvečer).
English: There were some cases of more severe neutropenia in patients treated with ribavirin in combination with peginterferon alfa-2b (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]); WHO grade 3 leukopenia was also reported in 7 % of this treatment group.
Slovenian: Bilo je tudi nekaj primerov hujše nevtropenije (3. stopnje po WHO: 39 od 186 [21 %] in 4. stopnje po WHO: 13 od 186 [7 %]) med bolniki, zdravljenimi z ribavirinom v kombinaciji s peginterferonom alfa-2b; pri 7 % bolnikov iz te terapevtske skupine so poročali tudi o levkopeniji 3. stopnje po WHO.
English: Ribavirin Teva is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b.
Slovenian: Zdravilo Ribavirin Teva je indicirano za zdravljenje kroničnega hepatitisa C (HCV) pri odraslih, otrocih starejših od 3 let in mladostnikih in ga morate uporabljati izključno v kombinaciji z interferonom alfa-2b.
English: Please refer to the corresponding SmPC of medicinal products used in combination with ribavirin as some combination regimens do not adhere to the ribavirin dosing guidance provided in Table 1.
Slovenian: Prosimo, glejte ustrezne povzetke glavnih značilnosti zdravil, uporabljenih v kombinaciji z ribavirinom, ker za nekatere kombinirane sheme ne veljajo smernice za odmerjanje ribavirina, navedene v preglednici 1
English: There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e. not alfa-2b).
Slovenian: Ni podatkov o varnosti ali učinkovitosti uporabe zdravila Ribavirin Teva skupaj z drugimi oblikami interferona (to je ne alfa-2b).
English: Upon multiple dosing, ribavirin accumulates extensively in plasma with a six-fold ratio of multipledose to single-dose AUC12hr.
Slovenian: Po večkratnem odmerjanju se ribavirin obsežno kopiči v plazmi, s šestkratnim razmerjem med vrednostima AUC12 ur za večkratno in za enkratno odmerjanje.
English: Do not store above 30oC
Slovenian: Shranjujte pri temperaturi do 30 oC.
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm was observed in 4 % (8/194) of patients and decrease in platelets below 50,000/mm was observed in
Slovenian: V študiji 1 (glejte poglavje 5.1) so opazili zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/mm3 pri 4 % (8/194) bolnikov in zmanjšanje števila trombocitov pod 50.000/mm3 pri 4 % (8/194) bolnikov, ki so prejemali ribavirin v kombinaciji s peginterferonom alfa-2b.
English: Ribavirin must not be used by females who are pregnant (see sections 4.3, 4.4 and 5.3).
Slovenian: Nosečnice ne smejo uporabljati zdravila Ribavirin Teva (glejte poglavja 4.3, 4.4 in 5.3).
English: 1,200 mg/day) d + peginterferon alfa-2b (100 or 150c µg/week)
Slovenian: 1.200 mg/dan) d + peginterferon alfa-2b (100 or 150c µg/teden)
English: Teva Denmark A.S. Tlf: +45 44 98 55 11
Slovenian: Tlf: +45 44 98 55 11
English: Adult patients: Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA (see section 4.4).
Slovenian: Odrasli bolniki: Zdravilo Ribavirin Teva je indicirano v kombinaciji s interferonom alfa-2b za zdravljenje odraslih bolnikov z vsemi tipi kroničnega hepatitisa C, razen genotipa 1, ki predhodno še niso bili zdravljeni, nimajo jetrne dekompenzacije, imajo zvišano vrednost alanin-aminotransferaze (ALT) in so pozitivni na ribonukleinsko kislino virusa hepatitisa C RNA-HCV (glejte poglavje 4.4).
English: Ribavirin monotherapy must not be used.
Slovenian: Zdravila Ribavirin Teva ne smete uporabljati v monoterapiji.
English: Dose modification for adults
Slovenian: Glejte odmerek za odrasle
English: Do not use this medicine after the expiry date which is stated on the outer packaging.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini, poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.