FrancophonIA/ELRC3.0 huggingface dataset:
English: Response week 12 was defined as undetectable HCVRNA after 12 weeks of treatment.
Slovenian: Odziv v 12. tednu so opredelili kot nezaznavno količino HCV-RNA po 12. tednih zdravljenja.
English: Adult: ≥ 12g/dL (females); ≥ 13g/dL (males) Children and adolescents: ≥ 11g/dL (females); ≥ 12g/dL (males)
Slovenian: • hemoglobin odrasli  12 g/dl (ženske);  13 g/dl (moški) otroci in mladostniki  11 g/dl (ženske);  12 g/dl (moški
English: Reduce only interferon alfa-2b dose (see note 2) if:
Slovenian: alfa-2b (glejte opombo 2), če:
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Slovenian: pljučnica, askarioza, enterobioza, herpes zoster, celulitis Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Pogosti:
English: Case by case benefit/risk assessment in children: The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials (see sections 4.8 and 5.1).
Slovenian: Pričakovano korist zdravljenja je treba skrbno pretehtati glede na znane izsledke kliničnih preskušanj o varnosti zdravila pri otrocih in mladostnikih (glejte poglavji 4.8 in 5.1).
English: 56x1 hard capsules 84x1 hard capsules 112x1 hard capsules 140x1 hard capsules 168x1 hard capsules56 hard capsules 84 hard capsules
Slovenian: 56 x 1 trda kapsula 84 x 1 trda kapsula 112 x 1 trda kapsula 140 x 1 trda kapsula 168 x 1 trda kapsula 56 trdih kapsul 84 trdih kapsul 112 trdih kapsul 140 trdih kapsul 168 trdih kapsul
English: Each Ribavirin Mylan hard capsule contains a small amount of lactose.
Slovenian: Vsaka kapsula zdravila Ribavirin Mylan vsebuje majhno količino laktoze.
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 reactions.
Slovenian: V kliničnih preskušanjih pri 118 otrocih in mladostnikih starih od 3 do 16 let zdravljenih s kombinacijo interferona alfa-2b in ribavirina, je bilo pri 6 % zdravljenje ukinjeno zaradi neželenih učinkov.
English: Ribavirin Mylan must be used in combination therapy as described in section 4.1.
Slovenian: Zdravilo Ribavirin Mylan je treba uporabljati v kombiniranem zdravljenju, kot je navedeno v poglavju
English: HCV 2 ≤ 600,000 IU/ml > 600,000 IU/mL 100% (22/22) HCV 3 ≤ 600,000 IU/ml > 600,000 IU/ml
Slovenian: Vsi preiskovanci HCV 2  600.000 i.e./ml > 600.000 i.e./ml HCV 3  600.000 i.e./ml > 600.000 i.e./ml
English: BGP Products SRLTel: +40 372 579 000
Slovenian: BGP Products SRL Tel: +40 372 579 000
English: Thirty two percent (30/94) of subjects demonstrated > 15 percentile decrease in height-for-age percentile 5 years after completion of therapy (see sections 4.8 and 5.1).
Slovenian: Pri dvaintridesetih odstotkih (30/94) preiskovancev je bilo 5 let po koncu zdravljenja zmanjšanje percentila telesne višine za starost > 15 percentilov (glejte poglavji 4.8 in 5.1).
English: The Ribavirin Mylan hard capsule is available in different pack sizes:
Slovenian: Trde kapsule zdravila Ribavirin Mylan so na voljo v različnih velikostih pakiranj:
English: Genotype 1/4 59.7 (129/216)
Slovenian: Genotip 1/4 59,7 (129/216) 51,2 (66/129)
English: Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see section 4.4).
Slovenian: Objavljena so bila poročila o primerih toksičnosti za mitohondrije, še posebej v obliki laktacidoze in pankreatitisa, in nekateri od njih so vodili do bolnikove smrti (glejte poglavje 4.4).
English: Based on published data, single-dose ribavirin pharmacokinetics was altered (increased AUCtf and Cmax) in patients with renal dysfunction compared with control subjects (creatinine clearance >90 ml/minute).
Slovenian: Glede na objavljene podatke je bila farmakokinetika ribavirina po enkratnem odmerku pri bolnikih z motnjami delovanja ledvic spremenjena (povečanje AUCtf in Cmax) glede na kontrolno skupino (očistek kreatinina >90 ml/minuto).
English: As in adult patients, children and adolescents experienced other psychiatric adverse reactions (e.g., depression, emotional lability, and somnolence).
Slovenian: Tako kot pri odraslih bolnikih so tudi pri otrocih in mladostnikih opazili druge psihiatrične neželene učinke (npr. depresijo, čustveno labilnost in zaspanost).
English: What you need to know before you take Ribavirin Mylan
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Ribavirin Mylan
English: In general, the adverse reaction profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric-specific concern regarding growth inhibition, as decrease in height percentile (mean percentile decrease of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment Within the 5 years follow-up post-treatment period, the children had a mean height of 44
Slovenian: Na splošno je bil profil neželenih učinkov v omejeni proučevani populaciji otrok in mladostnikov podoben kot pri odraslih, čeprav obstaja pri pediatričnih bolnikih še posebna skrb glede zastoja rasti, saj so med zdravljenjem opazili zmanjšanje percentila višine (srednje percentilno zmanjšanje za 9 percentilov) in percentila telesne mase (srednje percentilno zmanjšanje za 13 percentilov).
English: The combination of Ribavirin Mylan and other medicines is used to treat adult patients who have chronic hepatitis C (HCV).
Slovenian: Kombinacija zdravila Ribavirin Mylan in drugih zdravil se uporablja za zdravljenje odraslih bolnikov s kronično okužbo z virusom hepatitisa C (HCV)
English: Previously treatment failure patients
Slovenian: Predhodno neuspešno zdravljeni bolniki
English: There does not appear to be a significant age-related effect on the pharmacokinetics of ribavirin.
Slovenian: Kat kaže starost nima bistvenega vpliva na farmakokinetiko ribavirina.
English: However, absolute bioavailability is approximately 45%-65%, which appears to be due to first pass metabolism.
Slovenian: Približno 10 % radioaktivno označenega odmerka se izloči z blatom, vendar je absolutna biološka uporabnost zdravila približno 45 % do 65 %, verjetno zaradi presnove pri prvem prehodu skozi jetra.
English: Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Slovenian: sindrom Vogt-Koyanagi-Harada, sistemski lupus eritematozus, vaskulitis, akutne preobčutljivostne reakcije vključno z urtikarijo, angioedem, bronhokonstrikcija, anafilaksija
English: Ribavirin Mylan must be used in combination with interferon alfa-2b (3 million international units [MIU] three times a week).
Slovenian: Zdravilo Ribavirin Mylan je treba uporabljati v kombinaciji z interferonom alfa-2b (trikrat na teden 3 milijone mednarodnih enot [MIU]).
English: Do not use this medicine after the expiry date which is stated on the bottle or blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki ali pretisnem omotu poleg oznake ''Uporabno do:''/''EXP:''.
English: Not Known:
Slovenian: Neznana:
English: p Value a
Slovenian: Vredn ost p a
English: By Week 12 (n=215) HCV-RNA negative or ≥ 2 log decrease in viral load
Slovenian: Do 12. tedna (n= 215) Negativen izvid testa na HCV-RNA ali zmanjšanje virusnega bremena za ≥ 2 log
English: 36 months
Slovenian: 24 tednov
English: The haemolytic anaemia associated with ribavirin therapy may result in deterioration of cardiac function and/or worsening of pre-existing cardiac disease.
Slovenian: Hemolitična anemija, povezana z uporabo ribavirina, lahko poslabša delovanje srca in/ali že obstoječo srčno bolezen.
English: Any potential for interactions may persist for up to two months (five half-lives for ribavirin) after cessation of Ribavirin Mylan therapy due to the long half-life (see section 5.2).
Slovenian: Zaradi dolge razpolovne dobe lahko do medsebojnega delovanja pride še do dva meseca (5 razpolovnih dob ribavirina) po koncu terapije z zdravilom Ribavirin Mylan (glejte poglavje 5.2).
English: † These criteria were used in the protocol: If week 12 HCV-RNA is positive and < 2 log10 decrease from baseline, patients to stop therapy.
Slovenian: † V protokolu so bili uporabljeni naslednji kriteriji: Če je izvid določanja HCV-RNA v 12. tednu pozitiven in se je virusno breme zmanjšalo za < 2 log10 glede na začetne vrednosti, naj bolnik preneha z zdravljenjem.
English: Table 13 Sustained virological response rates (na,b (%)) in previously untreated children and adolescents by genotype and treatment duration - All subjects n = 107 24 weeks
Slovenian: (%)) pri predhodno nezdravljenih otrocih in mladostnikih po genotipu in dolžini zdravljenja - vsi preizkušanci n = 107
English: The use of ribavirin in combination with peginterferon alfa-2b had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Slovenian: Uporaba ribavirina v kombinaciji s peginterferonom alfa-2b ni imela opaznega negativnega vpliva na nadzor viremije HIV med samim zdravljenjem ali pozneje, med spremljanjem bolnikov.
English: peginterferon alfa-2b (1.5 µg /kg/ week)
Slovenian: peginterferon alfa-2b (1,5 µg/kg/ teden)
English: Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Slovenian: Dodatek terapije z alfa interferoni, samimi ali v kombinaciji z ribavirinom, lahko poveča tveganje pri tej podskupini bolnikov.
English: At the peginterferon alfa-2b 1.5 µg/kg plus ribavirin dose, sustained virologic response rates were lower in patients with cirrhosis, in patients with normal ALT levels, in patients with a baseline viral load > 600,000 IU/ml and in patients > 40 years old.
Slovenian: Pri odmerku peginterferona alfa-2b 1,5 µg/kg z odmerkom ribavirina pa so bile pogostnosti trajnega virološkega odziva nižje pri bolnikih s cirozo, pri tistih z normalnimi vrednostmi ALT, pri tistih z začetnim virusnim bremenom > 600.000 i.e./ml in pri tistih, ki so bili starejši od 40 let.
English: Thus, Ribavirin Mylan must be administered with caution to patients with pre-existing cardiac disease (see section 4.3).
Slovenian: Zato morate zdravilo Ribavirin Mylan pri bolnikih z obstoječo boleznijo srca uporabljati previdno (glejte poglavje 4.3).
English: Alternating doses, 200 mg and 400 mg every other day Less than 30 mL/min 200 mg daily
Slovenian: 30 do 50 ml/min izmenična odmerka 200 mg in 400 mg vsak drugi dan manj kot 30 ml/min
English: Each Ribavirin Mylan hard capsule contains 15 mg of lactose monohydrate.
Slovenian: Vsaka kapsula zdravila Ribavirin Mylan vsebuje 15 mg laktoze monohidrata.
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: The capsule shell contains gelatine and titanium dioxide (E171).
Slovenian: Ovoj kapsule vsebine želatino in titanov dioksid (E171).
English: If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Ribavirin and peginterferon alfa-2b or interferon alfa-2b be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Slovenian: Če psihiatrični simptomi ne prenehajo ali se celo poslabšajo, ali če ugotovite, da ima bolnik samomorilne misli, je priporočljivo, da prekinete zdravljenje z ribavirinom in peginterferonom alfa-2b ali interferonom alfa-2b in bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
English: * Any subject with an undetectable HCV-RNA level at the follow-up week 12 visit and missing data at the follow-up week 24 visit was considered a sustained responder.
Slovenian: *Vsakega preiskovanca z nemerljivo koncentracijo HCV-RNA ob obisku v 12. tednu spremljanja bolnikov ali z manjkajočimi podatki ob obisku v 24. tednu spremljanja bolnikov so šteli med bolnike s stalnim virološkim odzivom.
English: % (number) of patients peginterferon alfa-2b 1.5 µg/kg + Ribavirin peginterferon alfa-2b 1 µg/kg + Ribavirin peginterferon alfa-2a 180 µg + Ribavirin
Slovenian: % (število) bolnikov peginterferon alfa-2b 1,5 µg/kg + ribavirin peginterferon alfa-2b 1 µg/kg + ribavirin peginterferon alfa-2a 180 µg + ribavirin
English: Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorder, mania, confusion and alterations of mental status have been observed with alpha interferons.
Slovenian: Opažali so tudi druge učinke interferonov alfa na CŽS, vključno z agresivnostjo (ki je včasih usmerjena proti drugim, kot je ideja o umoru), bipolarna motnja, mania, zmedenostjo in spremembami duševnega statusa.
English: - Genotoxicity: ribavirin induces genotoxicity (see section 5.3).
Slovenian: - Genotoksičnost: ribavirin povzroča genotoksične učinke (glejte poglavje 5.3).
English: The selection of formulation is based on individual characteristics of the patient (see section 4.1).
Slovenian: Farmacevtsko obliko izberemo glede na specifične lastnosti posameznega bolnika (glejte poglavje 4.1).
English: Combination therapy with ribavirin and interferon alfa-2b resulted in a sustained virological response that was ten-fold higher than that with interferon alfa-2b alone (49% vs 5 %, p < 0.0001).
Slovenian: Pri kombinirani terapiji z ribavirinom in interferonom alfa-2b je bil trajen virološki odziv kar desetkrat večji kot pri monoterapiji z interferonom alfa-2b (49 % proti 5 %, p < 0,0001).
English: Following oral dosing with 600 mg BID, steady-state was reached by approximately four weeks, with mean steady state plasma concentrations approximately 2,200 ng/ml.
Slovenian: Po peroralnem odmerjanju ribavirina 600 mg dvakrat na dan je bilo stanje dinamičnega ravnovesja doseženo v približno štirih tednih; srednja plazemska koncentracija v stanju dinamičnega ravnovesja je bila približno 2200 ng/ml.
English: For HCV/HIV co-infected patients receiving ribavirin in combination with peginterferon alfa-2b, other adverse reactions (that were not reported in mono-infected patients) which have been reported in the studies with a frequency > 5% were: oral candidiasis (14%), lipodystrophy acquired (13%), CD4 lymphocytes decreased (8%), appetite decreased (8%), gamma-glutamyltransferase increased (9%), back pain (5%), blood amylase increased (6%), blood lactic acid increased (5%), cytolytic hepatitis (6%), lipase increased (6%) and pain in limb (6%).
Slovenian: Bolniki, ki so bili sočasno okuženi s HCV in HIV in so prejemali ribavirin v kombinaciji s peginterferonom alfa-2b, so imeli naslednje dodatne neželene učinke, ki jih niso opažali pri bolnikih s samo eno okužbo, v študijah pa so jih prijavljali s pogostnostjo > 5 %: peroralna kandidiaza (14 %), pridobljena lipodistrofija (13 %), zmanjšano število limfocitov CD4 (8 %), zmanjšan tek (8 %), zvišana vrednost gama glutamiltransferaze (9 %), bolečine v hrbtu (5 %), zvišana vrednost amilaze v krvi (6 %), zvišana koncentracija mlečne kisline v krvi (5 %), citolitični hepatitis (6 %), zvišana vrednost lipaze (6 %) in bolečine v udih (6 %).
English: P 1.5/R P 0.5/R
Slovenian: P 0,5/R
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with peginterferon alfa-2b (1.5 µg/kg)/ ribavirin combination therapy resulted in a higher sustained virologic response rate compared to peginterferon alfa-2b 1 µg/kg dose.
Slovenian: Pri Američanih črne rase (kar je znan neugoden prognostični dejavnik za izkoreninjenje HCV) je zdravljenje s kombinirano terapijo z peginterferonom alfa-2b (1,5 µg/kg) in ribavirinom vodilo do večje pogostnosti trajnega virološkega odziva kot pri odmerku peginterferona alfa-2b 1 µg/kg.
English: a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week peginterferon alfa-2b and subjects ≥ 75 kg received 150 µg/week peginterferon alfa-2b .
Slovenian: Mio i.e. = milijonov mednarodnih enot a: vrednost p pri Cochran-Mantel Haenszelovem testu hi-kvadrat b: vrednost p pri testu hi-kvadrat c: preiskovanci s telesno maso < 75 kg so prejemali 100 µg peginterferona alfa-2b na teden, preiskovanci s telesno maso ≥ 75 kg pa so prejemali 150 µg peginterferona alfa-2b na teden.
English: Blisters: Cardboard box containing 56 or 168 hard capsules in PVC/Aclar - Aluminium foil blisters
Slovenian: Pretisni omoti: Kartonska škatla s po 56 ali 168 trdimi kapsulami v PVC/Aclar - aluminijevih pretisnih omotih.
English: Extreme care must be taken to avoid pregnancy in partners of male patients taking Ribavirin Mylan (see sections 4.3, 4.4 and 5.3).
Slovenian: Preprečitvi zanositve pri partnerkah moških bolnikov, ki jemljejo zdravilo Ribavirin Mylan, je treba posvetiti posebno pozornost (glejte poglavja 4.3, 4.4 in 5.3).
English: The purpose of the study was to annually evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes for patients who were sustained responders 24 weeks post-treatment with 24 or 48 weeks of peginterferon alfa-2b and ribavirin treatment.
Slovenian: Namen študije je bilo letno ocenjevanje trajanja trajnega virološkega odziva (SVRsustained virologic response) in ugotavljanje vpliva nadaljnje virološke negativnosti na klinične izide pri bolnikih, ki so imeli trajen odziv 24 tednov po 24- ali 48-tedenskem zdravljenju s peginterferonom alfa2b in ribavirinom.
English: This medicine can be very damaging to your unborn baby (embryo).
Slovenian: Če ste noseči ne smete jemati tega zdravila, saj lahko resno škoduje vašemu nerojenemu otroku (plodu).
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and pegylated interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Slovenian: Skupina bolnikov, vključenih v preskušanje, je bila sestavljena predvsem iz otrok z blagim do zmernim hepatitisom C. Zaradi pomanjkanja podatkov pri otrocih z močno napredovalo boleznijo in zaradi nevarnosti za pojav neželenih učinkov je treba pri tej skupini bolnikov skrbno pretehtati razmerje med tveganji in koristmi zdravljenja s kombinacijo ribavirina in pegiliranega interferona alfa-2b (glejte poglavja 4.1, 4.4 in 4.8).
English: How to store Ribavirin Mylan Contents of the pack and other information
Slovenian: Shranjevanje zdravila Ribavirin Mylan Vsebina pakiranja in dodatne informacije
English: In the HIV-positive population receiving an NRTI regimen, physicians should carefully monitor markers of mitochondrial toxicity and lactic acidosis when ribavirin is administered.
Slovenian: Pri bolnikih, pozitivnih na HIV, ki se zdravijo po shemi NRTI, mora zdravnik skrbno spremljati pokazatelje mitohondrijske toksičnosti in laktacidoze pri sočasnem zdravljenju z ribavirinom.
English: Seek medical help immediately if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while taking this treatment.
Slovenian: Če se med zdravljenjem pojavijo simptomi hude alergijske reakcije, nemudoma poiščite zdravniško pomoč (npr. težave z dihanjem, piskanje v pljučih ali koprivnica).
English: Prior to initiation of interferon alfa-2b therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Slovenian: Pred uvedbo zdravljenja z interferonom alfa-2b je treba oceniti vrednosti TSH, morebitne motnje delovanja žleze ščitnice, ki jih pri tem ugotovite, pa je treba zdraviti z običajno terapijo.
English: In clinical trials with ribavirin used in combination with peginterferon alfa-2b or interferon alfa-2b, the maximum overdose reported was a total dose of 10 g of ribavirin (50 x 200 mg capsules) and 39 MIU of interferon alfa-2b (13 subcutaneous injections of 3 MIU each) taken in one day by a patient in an attempt at suicide.
Slovenian: V kliničnih preskušanjih ribavirina v kombinaciji s peginterferonom alfa-2b ali interferonom alfa-2b je bilo največje preveliko odmerjanje skupni odmerek 10 g ribavirina (50 x 200 mg kapsul) in 39 mio i.e. interferona alfa-2b (13 subkutanih injekcij po 3 mio i.e. vsaka), ki ga je v enem dnevu vzel bolnik v poskusu samomora.
English: Periodontal disorder, dental disorder, tongue pigmentation
Slovenian: parodontalne bolezni, zobne bolezni, pigmentacija jezika
English: For use in patients with decompensated cirrhosis, see the corresponding SmPC of the medicinal products used in combination with Ribavirin Mylan.
Slovenian: Za uporabo pri bolnikih z dekompenzirano cirozo jeter glejte ustrezne povzetke glavnih značilnosti zdravil, uporabljenih v kombinaciji z zdravilom Ribavirin Mylan
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 30 IU/ml), a liver biopsy consistent with a histological diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Slovenian: V te klinične raziskave so vključili bolnike s kroničnim hepatitisom C, potrjenim s pozitivnim izvidom testa polimerazne verižne reakcije (PCR) na HCV-RNK (> 30 i.e./ml), izvid jetrne biopsije pa je bil v skladu s histološko diagnozo kroničnega hepatitisa brez drugih vzrokov za kronični hepatitis, poleg tega pa so imeli bolniki tudi nenormalne serumske vrednosti ALT.
English: Ribavirin Mylan must not be used by females who are pregnant (see sections 4.3 and 5.3).
Slovenian: Nosečnice ne smejo uporabljati zdravila Ribavirin Mylan (glejte poglavji 4.3 in 5.3).
English: Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite
Slovenian: hiperglikemija, hiperurikemija, hipokalcemija, dehidracija, povečan tek
English: Failure to prior therapy was defined as relapse or non-response (HCV-RNA positive at the end of a minimum of 12 weeks of treatment).
Slovenian: Neuspešnost prejšnjega zdravljenja so opredelili kot ponovitev bolezni (relaps) ali odsotnost odziva na zdravljenje (bolniki so imeli pozitiven izvid na HCV-RNA ob koncu najmanj 12-tedenskega zdravljenja).
English: Hepatic decompensation in HCV/HIV co-infected patients with advanced cirrhosis Co-infected patients with advanced cirrhosis receiving combined anti-retroviral therapy (cART) may be at increased risk of hepatic decompensation and death.
Slovenian: Jetrna dekompenzacija pri bolnikih, ki so sočasno okuženi s HCV/HIV in imajo napredovalo cirozo jeter Sočasno okuženi bolniki z napredovalo cirozo, ki prejemajo kombinirano protivirusno terapijo (cART), imajo lahko povečano tveganje za nastanek jetrne dekompenzacije in smrt.
English: Anorexia, increased appetite, decreased appetite
Slovenian: anoreksija, povečan tek, zmanjšan tek
English: During the course of interferon (standard and pegylated)/ribavirin therapy lasting up to 48 weeks in patients ages 3 through 17 years, weight loss and growth inhibition were common.
Slovenian: Med kombinirano terapijo z interferonom (standardnim in pegiliranim) ribavirinom, ki traja do 48 tednov, sta bila pri bolnikih, starih od 3 do 17 let, hujšanje in zastoj rasti pogosta .
English: The safety and efficacy of this combination have been established only using ribavirin capsules together with peginterferon alfa-2b or interferon alfa-2b solution for injection.
Slovenian: Varnost in učinkovitost te kombinacije je bila ugotovljena le pri uporabi zdravila Ribavirin Mylan trde kapsule skupaj s peginterferonom alfa-2b ali interferonom alfa-2b raztopina za injiciranje.
English: Initiation of peginterferon alfa-2b is contraindicated in HCV/HIV patients with cirrhosis and a ChildPugh score ≥ 6.
Slovenian: Začetek zdravljenja s pegiliranim interefonom alfa-2b je kontraindiciran pri HCV/HIV bolnikih s cirozo in z oceno po Child-Pughu > 6.