FrancophonIA/ELRC3.0 huggingface dataset:
English: Decreases in haemoglobin, white blood cells, platelets, neutrophils and increase in bilirubin may require dose reduction or permanent discontinuation from therapy (see section 4.2).
Slovenian: Zaradi zmanjšanja vrednosti hemoglobina, levkocitov, trombocitov in nevtrofilcev ter povečanja vrednosti bilirubina je lahko potrebno bodisi zmanjšanje odmerka ali pa trajna ukinitev terapije (glejte poglavje 4.2).
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom,farmacevtom ali medicinsko sestro.
English: Weight loss and growth inhibition were very common during the treatment (at the end of treatment, mean decrease from baseline in weight and in height percentiles were of 15 percentiles and 8 percentiles, respectively) and growth velocity was inhibited (< 3rd percentile in 70 % of the patients).
Slovenian: Izguba telesne mase in zastoj rasti sta bila zelo pogosta med zdravljenjem (ob koncu zdravljenja je znašalo povprečno zmanjšanje telesne mase in višine glede na izhodiščno vrednost 15 percentilov oziroma 8 percentilov) in tudi njihova hitrost rasti je bila zmanjšana (upočasnila se je za do 3 percentile pri 70 % bolnikov).
English: Renal failure*, renal insufficiency*
Slovenian: odpoved ledvic*, insuficienca ledvic*
English: Please refer to the SmPC of (peg)interferon alfa for details on the recommendations of monitoring and management regarding the adverse reactions listed below before initiating therapy and other precautions associated with (peg)interferon alfa.
Slovenian: Preden začnete zdravljenje, prosimo, glejte povzetek glavnih značilnosti (peg)interferona alfa za podrobnosti o priporočilih za spremljanje in obvladovanje spodaj navedenih neželenih učinkov in upoštevajte druge previdnostne ukrepe povezane s (peg)interferonom alfa.
English: No pharmacokinetic interaction appears between ribavirin and hepatic function (see section 5.2).
Slovenian: Med ribavirinom in delovanjem jeter ni farmakokinetičnih interakcij (glejte poglavje 5.2).
English: Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Slovenian: sindrom Vogt-Koyanagi-Harada, sistemski eritematozni lupus, vaskulitis, akutne preobčutljivostne reakcije vključno z urtikarijo, angioedemom, bronhokonstrikcijo, anafilaksijo
English: CD4 lymphocytes decrease
Slovenian: Zmanjšanje števila limfocitov CD4:
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: ne smete uvesti, dokler ne dobite negativnega izvida testa nosečnosti tik pred začetkom zdravljenja.
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 non-responders.
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: No ribavirin effects were observed regarding neurobehavioural or reproductive development.
Slovenian: Poleg tega niso opazili nobenih učinkov ribavirina na razvoj živčevja ali reprodukcijskih organov ter na vedenje živali.
English: Anaemia a (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: If pregnancy does occur during treatment or within four months from stopping treatment, the patient must be advised of the significant teratogenic risk of ribavirin to the foetus (see section 4.4).
Slovenian: Če bolnica med zdravljenjem ali v roku štirih mesecev po koncu zdravljenja kljub temu zanosi, jo morate opozoriti na veliko teratogenost ribavirina za plod (glejte poglavje 4.4).
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 in ugotavljanje vpliva nadaljnje virološke negativnosti na klinične izide pri bolnikih, ki so imeli trajni odziv 24 tednov po 24- ali 48-tedenskem zdravljenju s peginterferonom alfa-2b in ribavirinom.
English: Renal failure, renal insufficiency*
Slovenian: odpoved ledvic, insuficienca ledvic*
English: - Pregnancy (see sections 4.4, 4.6 and 5.3).
Slovenian: (glejte poglavja 4.3, 4.4 in 5.3).
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Slovenian: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne East Sussex, BN22 9AG Velika Britanija
English: Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro.
Slovenian: Med farmakološke učinke ribavirina sodi tudi zvečanje količine fosforiliranih presnovkov purinskih nukleozidov in vitro.
English: Neuropathy, peripheral neuropathy
Slovenian: nevropatija, periferna nevropatija
English: In a clinical trial with 107 children and adolescent patients (3 to 17 years of age) treated with combination therapy of peginterferon alfa-2b and ribavirin, dose modifications were required in 25 % of patients, most commonly for anaemia, neutropenia and weight loss.
Slovenian: V kliničnem preskušanju pri 107 otrocih in mladostnikih (starih od 3 do 17 let), zdravljenih s kombinirano terapijo s peginterferonom alfa-2b in ribavirinom, je bila potrebna prilagoditev odmerka pri 25 % bolnikov, najpogosteje zaradi anemije, nevtropenije in izgube telesne mase.
English: - Genotoxicity: Ribavirin induces genotoxicity (see section 5.3).
Slovenian: - Genotoksičnost: Ribavirin povzroča genotoksične učinke (glejte poglavje 5.3).
English: In clinical trials C95-132 and I95-143, ribavirin + interferon alfa-2b combination therapy proved to be significantly more effective than interferon alfa-2b monotherapy (a doubling in sustained response).
Slovenian: V kliničnih preskušanjih C95-132 in I95-143 se je kombinirana terapija z ribavirinom in interferonom alfa-2b izkazala za statistično značilno bolj učinkovito od monoterapije z interferonom alfa-2b (podvojen trajni odziv).
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 97 % (95 % CI: 95-99 %) for patients receiving nonpegylated interferon alfa-2b (with or without ribavirin), and is 99 % (95 % CI: 98-100 %) for patients receiving pegylated interferon alfa-2b (with or without ribavirin).
Slovenian: Kaplan-Meierjeva ocena nadaljnjega neprekinjenega trajnega odziva v času 5 let je znašala 97 % (95 % IZ: 95-99 %) pri bolnikih, ki so prejemali nepegiliran interferon alfa-2b (z ali brez ribavirina), oziroma 99 % (95 % IZ: 98-100 %) pri tistih, ki so prejemali pegiliran interferon alfa-2b (z ali brez ribavirina).
English: Haemoglobin: Patients with History of Stable Cardiac Disease
Slovenian: Hemoglobin pri bolnikih z anamnezo stabilne srčne bolezni
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 2.200 ng/ml.
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: At least 5 years of long-term follow-up was completed after treatment in 462 patients and 327 patients, respectively.
Slovenian: Pri 462 bolnikih oziroma pri 327 bolnikih je bilo opravljeno najmanj 5-letno dolgoročno spremljanje.
English: Alopecia, pruritus, skin dry, rash
Slovenian: alopecija, pruritus, suha koža, izpuščaj
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 z ribavirinom v kombinaciji s peginterferonom alfa-2b ali interferonom alfa-2b so poročali o prevelikem odmerku 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: Seizure (convulsion)*
Slovenian: epileptični napadi (konvulzije)*
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: Arthralgia, myalgia, musculoskeletal pain
Slovenian: artralgija, mialgija, mišično-skeletne bolečine
English: Severe adverse reactions were reported in 7 % (8/107) of all subjects and included injection site pain (1 %), pain in extremity (1 %), headache (1 %), neutropenia (1 %), and pyrexia (4 %).
Slovenian: O hudih neželenih učinkih so poročali pri 7 % (8/107) vseh preiskovancev in mednje so sodili bolečina na mestu injiciranja (1 %), bolečina v udih (1 %), glavobol (1 %), nevtropenija (1 %) in zvišana telesna temperatura (4 %).
English: Ninety four of 107 children enrolled in the
Slovenian: Štiriindevetdeset od 107 otrok je bilo vključenih v 5-letno dolgoročno spremljevalno preskušanje.
English: Twenty four percent of children (11/46) treated for 24 weeks and 40 % of children (19/48) treated for 48 weeks had a > 15 percentile height for age decrease from pre-treatment to the end of 5 year long term follow up compared to pre-treatment baseline percentiles.
Slovenian: Štiriindvajsetim odstotkom otrok (11/46), zdravljenih 24 tednov, in 40 % otrok (19/48), zdravljenih 48 tednov, se je od časa pred zdravljenjem do konca 5-letnega dolgoročnega spremljanja telesna višina za starost zmanjšala za > 15 percentilov v primerjavi z izhodiščnim percentilom pred zdravljenjem.
English: Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and ribavirin when administered to paediatric patients with chronic hepatitis C
Slovenian: Srednja vrednost (% CV) farmakokinetičnih parametrov pri večkratnem odmerjanju interferona alfa-2b in ribavirina pediatričnim bolnikom s kroničnim hepatitisom C
English: If you are caring for a child and your doctor decides not to defer combination treatment with peginterferon alfa-2b or interferon alfa-2b until adulthood, it is important to understand that this combination therapy induces a growth inhibition that may be irreversible in some patients.
Slovenian: Če skrbite za otroka in se zdravnik odloči, da kombiniranega zdravljenja s peginterferonom alfa-2b ali interferonom alfa-2b ne bo odložil do odrasle dobe, morate vedeti, da to kombinirano zdravljenje povzroči zastoj rasti, ki je pri nekaterih bolnikih lahko ireverzibilen (neodpravljiv).
English: Ribavirin Teva Pharma B.V. 400 mg Tablets *Nb: for 800 mg daily dose, 2 x 200 mg tablets can be substituted for 1 x 400 mg tablet.
Slovenian: 400 mg tablete * pri dnevnih odmerkih 800 mgse lahko 2 x 200 mg tableti zamenjata z 1 x 400 mg tableto.
English: In case of serious adverse reaction potentially related to medicinal products used in combination with ribavirin, refer to the corresponding SmPC of these medicinal products as some combination regimens do not adhere to the ribavirin dose modification and/or discontinuation guidelines as described in
Slovenian: V primeru resnih neželenih učinkov, ki bi lahko bili povezani z zdravili, uporabljenimi v kombinaciji z ribavirinom, glejte ustrezne povzetke glavnih značilnosti teh zdravil, ker za nekatere kombinirane sheme ne veljajo smernice za odmerjanje in/ali prenehanje uporabe ribavirina, opisane v preglednici 2.
English: This myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of HCV antiviral therapy and concomitant azathioprine and did not recur upon reintroduction of either treatment alone (see section
Slovenian: Mielotoksičnost je bila reverzibilna v 4 do 6 tednih po prekinitvi protivirusne terapije za HCV in sočasnega azatioprina in se po ponovni uvedbi enega od obeh zdravljenj ni ponovila (glejte poglavje 4.5).
English: All but one of the paediatric subjects remained sustained virologic responders during long-term follow-up after completion of treatment with interferon alfa-2b plus ribavirin.
Slovenian: Pri vseh pediatričnih bolnikih razen enem se je ohranil trajni virološki odziv med dolgoročnim spremljanjem po zaključku zdravljenja z interferonom alfa-2b in ribavirinom.
English: Ribavirin Teva Pharma B.V. tablets are to be administered orally each day in two divided doses (morning and evening) with food.
Slovenian: naj bolnik jemlje peroralno vsak dan v dveh deljenih odmerkih (zjutraj in zvečer) s hrano.
English: P1.5/R Ribavirin (800 mg) + peginterferon alfa-2b (1.5 micrograms/kg) P0.5/R Ribavirin (1,000/1,200 mg) + peginterferon alfa-2b (1.5 to 0.5 microgram/kg) I/R
Slovenian: P1,5/R ribavirin (800 mg) + peginterferon alfa-2b (1,5 mikrogramov/kg) P0,5/R ribavirin (1.000/1.200 mg) + peginterferon alfa-2b (1,5 to 0,5 mikrogramov/kg) I/R
English: Bacterial infection (including sepsis), fungal infection, influenza, respiratory tract infection, bronchitis, herpes simplex, sinusitis, otitis media, rhinitis, urinary tract infection
Slovenian: bakterijska okužba (vključno s sepso), glivične okužbe, gripa, okužba zgornjih dihal, bronhitis, herpes simplex, sinusitis, otitis media, rinitis, okužba sečil
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 ribovirina, lahko poslabša delovanje srca in/ali že obstoječo srčno bolezen.
English: With zidovudine or stavudine, it is not certain if this medicine will change the way these medicines work.
Slovenian: Ni znano, ali lahko to zdravilo spremeni delovanje teh zdravil.
English: Upon cessation of treatment, essentially total recovery from ribavirin-induced testicular toxicity occurred within one or two spermatogenic cycles (see section 4.6).
Slovenian: Po koncu zdravljenja je prišlo v enem do dveh ciklusih spermatogeneze do praktično popolnega izginotja znakov testikularne toksičnosti ribavirina (glejte poglavje 4.6).
English: Hyperthyroidism, virilism
Slovenian: hipertiroidizem, virilizem
English: Dose modification for adverse reactions Dose modification for adults
Slovenian: Prilagoditev odmerka v primeru neželenih učinkov Prilagoditev odmerka pri odraslih
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 o njih poročali s pogostnostjo > 5 %: peroralna kandidoza (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: hearing or seeing images that are not present, heart attack, panic attack, hypersensitivity reaction to the medication inflammation of pancreas, pain in bone, diabetes mellitus, muscle weakness,
Slovenian: - slišati ali videti neobstoječe podobe, - srčni napad, napad panike, - preobčutljivostna reakcija na zdravila, - vnetje trebušne slinavke, bolečine v kosteh, sladkorna bolezen, - mišična šibkost.
English: Ribavirin Teva Pharma B.V. tablets are packaged in aluminium blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinyl Acetate (PVAc)
Slovenian: tablete v aluminijevem pretisnem omotu s polivinilklorid (PVC)/polietilen (PE)/polivinilacetatom (PVAc).
English: An increase in uric acid and indirect bilirubin values associated with haemolysis were also observed in some patients.
Slovenian: Pri nekaterih bolnikih so opažali tudi zvišanje vrednosti sečne kisline in indirektnega bilirubina v povezavi s hemolizo.
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: Genotip mio i.e.= milijonov mednarodnih enot; TNT = trikrat na teden 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: Table 8 Sustained virological response based on genotype after ribavirin in combination with peginterferon alfa-2b in HCV/HIV co-infected patients
Slovenian: Preglednica 8 Stalni virološki odziv glede na genotip po jemanju ribavirina v kombinaciji s peginterferonom alfa-2b pri bolnikih, sočasno okuženih s HCV in HIV
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: Therefore the use of zidovudine and ribavirin in combination with alpha interferons is not recommended.
Slovenian: Zato sočasno dajanje zidovudina in ribavirina v kombinirani terapiji z alfa interferoni ni priporočljivo.
English: Pericardial effusion*, pericarditis*
Slovenian: perikardni izliv*, perikarditis*
English: Table 7 Sustained response rates with ribavirin + peginterferon alfa-2b (by ribavirin dose [mg/kg], genotype and viral load)
Slovenian: Preglednica 7 Trajni virološki odziv pri uporabi ribavirin + peginterferon alfa-2b (glede na odmerek ribavirina [mg/kg], genotip in virusno obremenitev)
English: Eleven percent of children (5/46) treated for 24 weeks and 13 % of children (6/48) treated for 48 weeks were observed to have a decrease from pre-treatment baseline > 30 height for age percentiles to the end of the 5 year long term follow-up.
Slovenian: Pri enajstih odstotkih otrok (5/46), zdravljenih 24 tednov, in 13 % otrok (6/48), zdravljenih 48 tednov, so od časa pred zdravljenjem do konca 5-letnega dolgoročnega spremljanja opazili zmanjšanje > 30 percentilov telesne višine za starost.
English: When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients.
Slovenian: Pri odločitvi glede odložitve zdravljenja do odrasle dobe je pomembno upoštevati, da je kombinirana terapija povzročila zastoj rasti, ki je pri nekaterih bolnikih lahko ireverzibilen.
English: Paediatric patients (children 3 years of age and older and adolescents: Ribavirin Teva Pharma B.V.
Slovenian: Pediatrična populacija (otroci, stari 3 leta ali več, in mladostniki: Zdravilo Ribavirin Teva Pharma
English: Upon multiple dosing, ribavirin accumulates extensively in plasma with a six-fold ratio of multiple-dose 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: In patients co-infected with HCV/HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/µL.
Slovenian: Pri bolnikih sočasno okuženi s HCV in HIV, ki imajo število celic CD4 manjše od 200 celic/μl, je na voljo malo podatkov o učinkovitosti in varnosti zdravila (N = 25).
English: Additionally, patients receiving zidovudine with ribavirin in combination with alpha interferons could be at increased risk of developing anaemia (low number of red blood cells).
Slovenian: Pri bolnikih, zdravljenih s kombinirano terapijo interferonov alfa in ribavirina sočasno z zidovudinom, se lahko poveča verjetnost za razvoj anemije (majhno število rdečih krvnih celic).
English: Please refer to the corresponding SmPC of medicinal products that are used in combination with ribavirin for additional undesirable effects reported with these products.
Slovenian: Prosimo, glejte ustrezne povzetke glavnih značilnosti zdravil, uporabljenih v kombinaciji z ribovirinom, za dodatne neželene učinke, poročane pri teh zdravilih.
English: No interaction studies have been conducted with ribavirin and other medicinal products, except for peginterferon alfa-2b, interferon alfa-2b and antacids.
Slovenian: Ni bilo opravljenih nobenih študij medsebojnega delovanja ribavirina z drugimi zdravili, razen za peginterferon alfa-2b, interferon alfa-2b in antacidi.
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 of the 48-week interferon alfa-2b and ribavirin treatment.
Slovenian: Namen študije je bil opravljati letne ocene ohranjanja trajnega virološkega odziva in oceniti vpliv nadaljnjega negativnega izvida o navzočnosti virusa na klinični izid zdravljenja pri bolnikih, ki so pokazali trajni virološki odziv 24 tednov po 48-tedenskem zdravljenju z interferonom alfa-2b in ribavirinom.
English: Number of 200 mg tablets
Slovenian: Število 200 mg tablet
English: For use in patients with decompensated cirrhosis, see the corresponding SmPC of the medicinal products used in combination with ribavirin.
Slovenian: Za uporabo pri bolnikih z dekompenzirano cirozo jeter glejte ustrezne povzetke glavnih značilnosti zdravil, uporabljenih v kombinaciji z ribavirinom.
English: Alternating doses, 200 mg and 400 mg every other day
Slovenian: 30 do 50 ml/min izmenična odmerka 200 mg in 400 mg vsak drugi dan
English: Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Slovenian: čista aplazija eritrocitov, idiopatska trombocitopenična purpura, trombotična trombocitopenična purpura
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 (kot so težave z dihanjem, piskanje v pljučih ali koprivnica), nemudoma poiščite zdravniško pomoč.
English: Outer Carton for 14, 28, 42, 56, 84, 112, 140 and 168 film-coated tablets
Slovenian: škatla 14, 28, 42, 56, 84, 112, 140 in 168 filmsko obloženih tablet