FrancophonIA/ELRC3.0 huggingface dataset:
English: Ribavirin is embryotoxic or teratogenic, or both, at doses well below the recommended human dose in all animal species in which studies have been conducted.
Slovenian: Ribavirin je bil pri vseh živalskih vrstah, pri katerih so bile opravljene študije, embriotoksičen, teratogen ali oboje v odmerkih, precej manjših od priporočenega odmerka za človeka.
English: Ribavirin has been shown to produce high inter and intra subject pharmacokinetic variability following single oral doses (intrasubject variability of approximately 30 % for both AUC and Cmax), which may be due to extensive first pass metabolism and transfer within and beyond the blood compartment.
Slovenian: Pokazalo se je, da ima ribavirin veliko inter- in intra-individualno variabilnost farmakokinetičnih parametrov po enkratnem peroralnem odmerku (variabilnost pri posamezniku je bila približno 30 % tako za AUC kot za Cmax).
English: All Genotype
Slovenian: Vsi Genotip
English: The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14 %.
Slovenian: Biološka uporabnost ribavirina v odmerku 600 mg se je zmanjšala pri sočasni uporabi antacida z magnezijem, aluminijem in simetikonom.
English: When deciding not to defer combination treatment with peginterferon alfa-2b or interferon alfa-2b until adulthood, it is important to consider that this combination therapy induced a growth inhibition that may be irreversible in some patients.
Slovenian: Pri odločitvi, da se kombiniranega zdravljenja s peginterferonom alfa-2b ali interferonom alfa-2b ne odloži do odrasle dobe, je pomembno upoštevati, da je to kombinirano zdravljenje povzročilo zastoj rasti, ki je pri nekaterih bolnikih lahko ireverzibilen.
English: Haemolitic anaemia, leukopenia, thrombocytopenia, lymphadenopathy, lymphopenia
Slovenian: hemolitična anemija, levkopenija, trombocitopenija, limfadenopatija, limfopenija
English: Diabetes mellitus, hypertriglyceridemia*
Slovenian: sladkorna bolezen, hipertrigliceridemija*
English: Blood thyroid stimulating hormone increased, thyroglobulin increased
Slovenian: zvečana količina ščitnico stimulirajočega hormona v krvi, zvečana količina tiroglobulina
English: The decline of height, weight and BMI Z scores observed during the treatment phase in comparison to a normative population did not fully recover at the end of long-term follow-up period for children treated with 48 weeks of therapy (see section 4.4).
Slovenian: Pri otrocih, zdravljenih 48 tednov, se zmanjšanje Z vrednosti telesne višine, telesne mase in ITM, ki so ga opazili v času zdravljenja, v primerjavi z normativno populacijo na koncu dolgoročnega spremljanja ni povsem popravilo (glejte poglavje 4.4).
English: Most of the changes in laboratory values in the ribavirin/peginterferon alfa-2b clinical trial were mild or moderate.
Slovenian: V kliničnem preskušanju z ribavirinom in peginterferonom alfa-2b so bile spremembe v laboratorijskih vrednostih večinoma blage ali zmerne.
English: Single-dose pharmacokinetics of ribavirin in patients with mild, moderate or severe hepatic dysfunction (Child-Pugh Classification A, B or C) is similar to those of normal controls.
Slovenian: Pri bolnikih z blagimi, zmernimi ali hudimi motnjami delovanja jeter (A, B ali C po Child-Pughu) je farmakokinetika enkratnih odmerkov ribavirina podobna kot pri normalnih preiskovancih iz kontrolne skupine.
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCVRNA 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 ta klinična preskušanja so vključili bolnike s kroničnim hepatitisom C, potrjenim s pozitivnim izvidom testa polimerazne verižne reakcije (PCR) na HCV-RNA (> 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: 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 Pharma B.V. 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 zdravila Ribavirin Teva Pharma B.V.
English: Standard haematologic tests, blood chemistries (complete blood count [CBC] and differential, platelet count, electrolytes, serum creatinine, liver function tests, uric acid) and pregnancy tests must be conducted in all patients prior to initiating therapy.
Slovenian: Laboratorijske preiskave Pred pričetkom zdravljenja morate pri vseh bolnikih opraviti standardne hematološke, biokemične preiskave krvi (celotno krvno sliko in diferencialno krvno sliko, število trombocitov, določanje vrednosti elektrolitov in serumskega kreatinina, teste delovanja jeter, določanje vrednosti sečne kisline) in test nosečnosti.
English: • Men
Slovenian: • Moški:
English: Two trials have been conducted in patients co-infected with HIV and HCV.
Slovenian: Pri bolnikih, sočasno okuženih z virusoma HIV in HCV, sta bili opravljeni dve preskušanji.
English: There were some cases of more severe neutropenia in patients treated with Ribavirin Teva Pharma B.V. 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: For example, the body weight dosing used in conjunction with interferon alfa-2b is shown in Table 1.
Slovenian: Kot primer je odmerjanje glede na telesno maso med souporabo z interferonom alfa-2b prikazano v preglednici 1.
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/m2 3
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: During combination therapy for up to 48 weeks with pegylated interferon alfa-2b and ribavirin, growth inhibition was observed that resulted in reduced height in some patients (see section 4.4).
Slovenian: V času kombinirane terapije s pegiliranim interferonom alfa-2b in ribavirinom, ki je trajala do 48 tednov, so opazili zastoj rasti, ki je pri nekaterih bolnikih povzročil manjšo telesno višino (glejte poglavje 4.4).
English: Anaemia, neutropenia
Slovenian: anemija, nevtropenija
English: Limited safety data (N = 25) are available in co-infected patients with CD4+ cell counts < 200/µL (see section 4.4).
Slovenian: Za sočasno okužene bolnike s številom celic CD4+ < 200/µl je na voljo malo podatkov o varnosti zdravila (N = 25) (glejte poglavje 4.4).
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 ozanke EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: If an entire day has gone by, check with your doctor.
Slovenian: Če je minil že ves dan, se posvetujte s svojim zdravnikom ali farmacevtom.
English: There is no safety or efficacy information on the use of ribavirin with pegylated or other forms of interferon (i.e., not alfa-2b).
Slovenian: Ni podatkov o varnosti in učinkovitosti uporabe ribavirina s peginterferonom ali z ostalimi oblikami interferonov (t.j., ne alfa-2b).
English: Hypothyroidism
Slovenian: hipotiroidizem
English: HCV/HIV Co-infection
Slovenian: Sočasna okužba s HCV/HIV
English: Neuralgia, lethargy, psychomotor hyperactivity
Slovenian: nevralgija, letargija, psihomotorična hiperaktivnost
English: Hypertriglyceridemia, hyperuricemia
Slovenian: hipertrigliceridemija, hiperurikemija
English: Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder, Male: testicular pain
Slovenian: Pogosti ženske: amenoreja, menoragija, menstrualne motnje, bolezni nožnice; moški: bolečine v testisih
English: Tablet core; Calcium hydrogen phosphate anhydrous, croscarmellose sodium, povidone, magnesium stearate.
Slovenian: Jedro tablete: brezvodni kalcijev hidrogenfosfat, premreženi natrijev karmelozat, povidon, magnezijev stearat.
English: Discontinue breastfeeding before starting to take this medicine.
Slovenian: Pred začetkom jemanja tega zdravila morate prenehati z dojenjem.
English: However, response rates in this trial were shown to be dependent also on the dose of ribavirin administered in combination with peginterferon alfa-2b or interferon alfa-2b.
Slovenian: Vendar pa je bil odziv v tem preskušanju odvisen tudi od odmerka ribavirina, ki so ga dajali v kombinaciji s peginterferonom alfa-2b ali interferonom alfa-2b.
English: Periodontal disorder, dental disorder, tongue pigmentation
Slovenian: parodontalna bolezen, zobna bolezen, pigmentacija jezika
English: In individual cases where the benefit of administering ribavirin concomitantly with azathioprine warrants the potential risk, it is recommended that close hematologic monitoring be done during concomitant azathioprine use to identify signs of myelotoxicity, at which time treatment with these medicines should be stopped (see section 4.4).
Slovenian: V posameznih primerih, kjer je korist sočasnega zdravljenja z ribavirinom in azatioprinom večja kot možno tveganje, je med sočasnim zdravljenjem z azatioprinom priporočljivo skrbno spremljanje hematoloških parametrov, da se lahko ugotovijo znaki mielotoksičnosti.
English: thoughts about threatening the life of others, mania (excessive or unreasonable enthusiasm), pericarditis (inflammation of the lining of the heart), pericardial effusion [a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself], change in colour of the tongue.
Slovenian: - misli kako ogroziti življenja drugih, - manija (pretirano in nerazumno navdušenje), - perikarditis (vnetje srčne zaklopke), perikardno iztekanje tekočina se nabira med perikardom
English: When used in combination with peginterferon alfa-2b or interferon alfa-2b, ribavirin did not cause any effects not previously seen with either active substance alone.
Slovenian: Ribavirin v kombinaciji s peginterferonom alfa-2b ali interferonom alfa-2b ni povzročil nobenih učinkov, ki ne bi že bili opisani v zvezi s samostojno uporabo obeh učinkovin.
English: A reduction in haemoglobin concentrations by > 4 g/dL was observed in 30 % of patients treated with ribavirin and peginterferon alfa-2b and 37 % of patients treated with ribavirin and interferon alfa-2b.
Slovenian: Znižanje koncentracije hemoglobina za > 4 g/dl so opazili pri 30 % bolnikov, ki so prejemali ribavirin in peginterferon alfa-2b, ter pri 37 % bolnikov, ki so prejemali ribavirin in interferon alfa-2b.
English: Hypothyroidism, hyperthyroidism
Slovenian: hipotiroidizem, hipertiroidizem
English: Reminder: This medicine is only to be used in combination with other medicines for hepatitis C virus infection.
Slovenian: Opozorilo: To zdravilo se lahko uporablja samo v kombinaciji z drugimi zdravili za zdravljenje virusne okužbe s hepatitisom C. Za popolnejše informacije morate prebrati tudi poglavje
English: However, ribavirin systemic exposure of a female partner after sexual intercourse with a treated patient has been estimated and remains extremely limited compared to therapeutic plasma concentration of ribavirin.
Slovenian: Koncentracija ribavirina v semenski tekočini je približno dvakrat večja kot v serumu, vendar ko so ocenili sistemsko izpostavljenost ribavirinu pri partnerki po spolnem odnosu z zdravljenim bolnikom, je bila ta še vedno zelo majhna v primerjavi s terapevtskimi plazemskimi koncentracijami ribavirina.
English: Light pink to pink, (debossed with “93” on one side and “7232” on the other).
Slovenian: filmsko obložena tableta Svetlo rožnate do rožnate tablete (z vtisnjenim »93« na eni strani in »7232« na drugi strani).
English: Palpitation, tachycardia
Slovenian: palpitacije, tahikardija
English: Ribavirin concentrations are essentially unchanged by haemodialysis.
Slovenian: Hemodializa praktično ne spremeni koncentracije ribavirina.
English: If you take more Ribavirin Teva Pharma B.V. than you should
Slovenian: Če ste vzeli večji odmerek zdravila Ribavirin Teva Pharma B.V., kot bi smeli
English: The exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Slovenian: Kadar je bil zidovudin vključen v shemo zdravljenja okužbe s HIV, so poročali o poslabšanju anemije zaradi uporabe ribavirina, čeprav natančen mehanizem tega pojava ni znan.
English: Reminder: Please read the “Other medicines” section of the Package Leaflet for the other medicines used in combination with Ribavirin Teva Pharma B.V. before you begin combination treatment with this medicine.
Slovenian: Opozorilo: Prosimo, preberite tudi poglavje “Druga zdravila” v navodilih za druga zdravila, uporabljena v kombinaciji z zdravilom Ribavirin Teva Pharma B.V., preden začnete s kombiniranim zdravljenjem s tem zdravilom.
English: During combination therapy for up to 48 weeks with interferon alfa2b and ribavirin, growth inhibition was observed that resulted in reduced final adult height in some patients.
Slovenian: V času kombinirane terapije z interferonom alfa-2b in ribavirinom, ki je trajala do 48 tednov, so opazili zastoj rasti, ki je pri nekaterih bolnikih povzročil manjšo končno telesno višino v odrasli dobi.
English: Note: For patients who weigh < 47 kg, or are unable to swallow tablets, ribavirin oral solution is available and should be used if appropriate.
Slovenian: Opomba: Za bolnike, ki tehtajo < 47 kg ali ne morejo pogoltniti tablete, je na voljo peroralna raztopina ribavirina.
English: In addition, injection site disorders, pyrexia, anorexia, vomiting, and emotional lability occurred more frequently in children and adolescents compared to adult patients.
Slovenian: Poleg tega so se pri otrocih in mladostnikih pogosteje kot pri odraslih bolnikih pojavile težave na mestu injiciranja, pireksija, anoreksija, bruhanje in čustvena labilnost.
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 pri sočasnem zdravljenju z ribavirinom skrbno spremljati pokazatelje mitohondrijske toksičnosti in laktacidoze.
English: Table 5 Adverse reactions reported during clinical trials or following the marketing use of ribavirin with pegylated interferon alfa-2b or interferon alfa-2b
Slovenian: Preglednica 5 Neželeni učinki, o katerih so poročali med kliničnimi preskušanji ali v obdobju trženja z uporabo ribavirina skupaj s pegiliranim interferonom alfa-2b ali interferonom alfa-2b
English: Tabulated list of adverse reactions in paediatric population Reported adverse reactions listed in Table 6 are based on experience from the two multicentre children and adolescents clinical trials using ribavirin with interferon alfa-2b or peginterferon alfa-2b.
Slovenian: Seznam neželenih učinkov pri pediatrični populaciji v preglednici Neželeni učinki, o katerih so poročali in so navedeni v preglednici 6, temeljijo na izkušnjah iz dveh multicentričnih študij pri otrocih in mladostnikih, kjer so uporabljali ribavirin z interferonom alfa-2b ali peginterferonom alfa-2b.
English: Laguno M, Murillas J, Blanco J.L et al. AIDS 2004; 18(13): F27-F36.
Slovenian: AIDS 2004; 18(13): F27-F36.
English: Chest pain, oedema, pain, feeling cold
Slovenian: bolečine v prsih, edem, bolečine, občutek mraza
English: Myocardial infarction
Slovenian: miokardni infarkt
English: Hypotension
Slovenian: hipotenzija
English: The sustained response at the end of follow-up was significantly increased by the addition of ribavirin to interferon alfa-2b (41 % vs 16 %, p < 0.001).
Slovenian: Trajni odziv na koncu spremljanja bolnikov je bil bistveno večji (41 % proti 16 %, p < 0,001) zaradi dodatka ribavirina interferonu alfa-2b.
English: - Breast-feeding - History of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous six months (see section 4.4).
Slovenian: ne smete uvesti, dokler ne dobite negativnega izvida testa nosečnosti tik pred začetkom zdravljenja - Dojenje - Huda obstoječa srčna bolezen v anamnezi, vključno z nestabilno ali nenadzorovano srčno boleznijo v preteklih šestih mesecih (glejte poglavje 4.4) - Hemoglobinopatije (npr. talasemija, anemija srpastih celic)
English: Co-administration of ribavirin and didanosine is not recommended.
Slovenian: Sočasna uporaba ribavirina in didanozina ni priporočljiva.
English: Haematological abnormalities were more frequently reported in patients receiving ribavirin in combination with peginterferon alfa-2b when compared to patients receiving ribavirin in combination with interferon alfa-2b.
Slovenian: O hematoloških motnjah so poročali pogosteje pri bolnikih, ki so prejemali ribavirin v kombinaciji s peginterferonom alfa-2b, kot pri tistih, ki so prejemali ribavirin v kombinaciji z interferonom alfa-2b.
English: Ribavirin (1,000/1,200 mg) + interferon alfa-2b (3 MIU)
Slovenian: ribavirin (1.000/1.200 mg) + interferon alfa-2b (3 mio)
English: The adverse reactions listed in this section are primarily derived from clinical trials and/or as adverse drug reactions from spontaneous reports when ribavirin was used in combination with interferon alfa-2b or peginterferon alfa-2b.
Slovenian: Neželeni učinki, navedeni v tem poglavju, izvirajo v prvi vrsti iz kliničnih preskušanj in/ali spontano poročanih neželenih učinkov, ko je bil ribovirin uporabljeno v kombinaciji z interferonom alfa-2b ali peginterferonom alfa-2b.
English: While changes in laboratory values were observed in some patients treated with ribavirin used in combination with peginterferon alfa-2b in the clinical trial, values returned to baseline levels within a few weeks after the end of therapy.
Slovenian: Čeprav so v kliničnem preskušanju pri nekaterih bolnikih, ki so prejemali ribavirin v kombinaciji s peginterferonom alfa-2b, opazili spremembe laboratorijskih vrednosti, pa so se le-te povrnile na začetne vrednosti že v nekaj tednih po koncu zdravljenja.
English: HCV/HIV co-infected patients receiving peginterferon alfa-2b/ribavirin treatment and cART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients.
Slovenian: Bolniki, ki so sočasno okuženi z virusom HCV in HIV ter se zdravijo s peginterferonom alfa2b/ribavirinom in s terapijo cART, imajo lahko zvečano tveganje za nastanek hematoloških motenj (v obliki nevtropenije, trombocitopenije in anemije) v primerjavi s tistimi, ki so okuženi samo s HCV.
English: Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence, disturbance in attention, poor quality of sleep
Slovenian: hiperkinezija, tremor, disfonija, parestezije, hipoestezija, hiperestezija, motnje koncentracije, somnolenca, motnje pozornosti, slaba kakovost spanja
English: is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
Slovenian: je indicirano za kombinirano terapijo z interferonom alfa-2b za zdravljenje otrok, starih 3 leta ali več, ki imajo vse tipe predhodno nezdravljenega kroničnega hepatitisa C, razen genotipa 1, brez jetrne dekompenzacije in pozitiven izvid na RNA-HCV.
English: 6.6 Special precautions for disposal
Slovenian: 6.6 Posebni varnostni ukrepi za shranjevanje
English: Tachycardia, palpitations
Slovenian: tahikardija, palpitacije
English: 200 mg daily
Slovenian: 200 mg na dan
English: Ribavirin Teva Pharma B.V. is available in different pack sizes containing 14, 28, 42, 56, 84, 112, 140 or 168 tablets.
Slovenian: je na voljo v različnih velikostih pakiranj, ki vsebujejo 14, 28, 42, 56, 84, 112, 140 ali 168 tablet.
English: Contact your doctor immediately if you notice any of the following side effects occuring during combination treatment with other medicines: - chest pain or persistent cough; changes in the way your heart beats; fainting, - confusion, feeling depressed; suicidal thoughts or aggressive behaviour, attempt suicide, thoughts about threatening the life of others, - feelings of numbness or tingling, - trouble sleeping, thinking or concentrating, - severe stomach pain; black or tar-like stools; blood in stool or urine; lower back or side pain, - painful or difficult urination, - severe bleeding from your nose, - fever or chills beginning after a few weeks of treatment, - problems with your eyesight or hearing, - severe skin rash or redness.
Slovenian: Nemudoma se posvetujte s svojim zdravnikom, če opazite katerega koli od naslednjih neželenih učinkov med zdravljenjem v kombinaciji z drugimi zdravili: - bolečine v prsih ali trdovraten kašelj; spremembe srčnega utripa; omedlevica; - zmedenost, depresivnost; samomorilne misli ali agresivno vedenje, poskus samomora; misli kako ogroziti življenja drugih; - občutek odrevenelosti ali mravljincev; - težave s spanjem, razmišljanjem ali zbranostjo; - hude bolečine v želodcu; črno ali smolnato blato; kri v blatu ali urinu; bolečine v spodnjem delu hrbta ali ob strani; - hude krvavitve iz nosu; - zvišana telesna temperatura ali mrzlica, ki nastopi nekaj tednov po začetku zdravljenja; - težave z vidom ali sluhom; - hud kožni izpuščaj ali pordelost.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: Alopecia, rash
Slovenian: alopecija, izpuščaj
English: Ribavirin Dose (daily)
Slovenian: Odmerek ribavirina (dnevni)
English: • Ribavirin (1,000/1,200 mg/day) + interferon alfa-2b (3 MIU three times a week) (n = 505).
Slovenian:  ribavirin (1.000/1.200 mg/dan) + interferon alfa-2b (3 mio i.e. trikrat na teden) (n = 505).
English: Cardiomyopathy*, arrhythmia*
Slovenian: kardiomiopatija*, aritmije*
English: Reminder: Please read the “Do not take” section of the Package leaflet for the other medicines used in combination before you begin combination treatment with this medicine.
Slovenian: Opozorilo: Preberite tudi poglavje “Ne jemljite” v navodilih za druga zdravila, uporabljena v kombinaciji s tem zdravilom.
English: Face oedema
Slovenian: obrazni edem
English: Please refer to the corresponding SmPC of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with ribavirin.
Slovenian: Prosimo, glejte ustrezne povzetke glavnih značilnosti protiretrovirusnih zdravil, uporabljenih sočasno s terapijo za HCV, da bi se bolj zavedali in bi lahko obvladovali toksične učinke vsakega od teh zdravil ter potencialno prekrivanje njihovih toksičnih učinkov z ribavirinom.