FrancophonIA/ELRC3.0 huggingface dataset:
English: A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies and Vogt-Koyanagi-Harada syndrome (see also section 4.4).
Slovenian: Pri uporabi interferonov alfa so poročali o širokem razponu avtoimunih bolezni in drugih motenj imunskega izvora, vključno z motnjami žleze ščitnice, sistemskim eritematoznim lupusom, revmatoidnim artritisom (novonastalim ali poslabšanim), idiopatsko in trombotično trombocitopenično purpuro, vaskulitisom, nevropatijami, vključno z mononevropatijami in sindromom Vogt-KoyanagiHarada (glejte tudi poglavje 4.4).
English: ViraferonPeg monotherapy was not studied in HCV/HIV co-infected patients.
Slovenian: Monoterapije z zdravilom ViraferonPeg niso proučevali pri bolnikih, sočasno okuženih s HCV in HIV.
English: Haemolytic anaemia, leukopenia, thrombocytopenia, lymphadenopathy
Slovenian: hemolitična anemija, levkopenija, trombocitopenija, limfadenopatija
English: The powder and solvent are both contained in a two-chamber cartridge (Type I flint glass) separated by a bromobutyl rubber plunger.
Slovenian: Prašek in vehikel se nahajata v dvoprekatnem vložku (iz kristalnega stekla tipa I), ločena pa sta z batom iz bromobutilne gume.
English: Mitochondrial toxicity and lactic acidosis
Slovenian: Toksičnost za mitohondrije in laktacidoza
English: HCV-RNA negative or ≥ 1 log decrease in viral load
Slovenian: Negativna HCV-RNA ali zmanjšanje virusnega bremena za ≥ 1 log
English: In the ViraferonPeg combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: - ViraferonPeg (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511).
Slovenian: V kliničnem preskušanju kombiniranega zdravljenja z zdravilom ViraferonPeg je 1.530 predhodno nezdravljenih bolnikov eno leto prejemalo enega od naslednjih kombiniranih režimov zdravljenja: - ViraferonPeg (1,5 mikrograma/kg/teden) + ribavirin (800 mg/dan), (n = 511) - ViraferonPeg (1,5 mikrograma/kg/teden en mesec, potem pa 0,5 mikrograma/kg/teden
English: - Hypersensitivity to the active substance or to any interferon or to any of the excipients listed in section 6.1; - A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months (see section 4.4); - Severe, debilitating medical conditions; - Autoimmune hepatitis or a history of autoimmune disease; - Severe hepatic dysfunction or decompensated cirrhosis of the liver; - Pre-existing thyroid disease unless it can be controlled with conventional treatment; - Epilepsy and/or compromised central nervous system (CNS) function; - HCV/HIV patients with cirrhosis and a Child-Pugh score ≥ 6.
Slovenian: - preobčutljivost na učinkovino, katerega od interferonov ali katero koli pomožno snov, navedeno v poglavju 6.1, - anamneza hude obstoječe bolezni srca, vključno z nestabilno ali nenadzorovano boleznijo srca v preteklih šestih mesecih (glejte poglavje 4.4), - hude bolezni, ki bolnika izčrpavajo, - avtoimuni hepatitis ali avtoimuna bolezen v anamnezi, - huda jetrna okvara ali dekompenzirana jetrna ciroza, - obstoječa bolezen ščitnice, razen če jo je mogoče nadzorovati s konvencionalno terapijo, - epilepsija in/ali motnje delovanja osrednjega živčevja (CŽS), - bolniki, okuženi s HCV/HIV in s cirozo jeter ter z oceno ≥ 6 po Child-Pughu, - kombinacija zdravila ViraferonPeg s telbivudinom.
English: Long term maintenance monotherapy
Slovenian: Dolgoročna vzdrževalna monoterapija
English: Abnormal behaviour, depressed mood, emotional disorder, fear, nightmare Nervous system disorders
Slovenian: nenormalno vedenje, depresivno razpoloženje, čustvene motnje, strah, nočne more
English: Remove the needle guard.
Slovenian: • Odstranite pokrovček igle.
English: The intended dose of 1.5 g/kg of ViraferonPeg to be used in combination with ribavirin may be delivered in weight categories with the ViraferonPeg strengths according to Table 1.
Slovenian: Za načrtovanje odmerka zdravila ViraferonPeg 1,5 µg/kg za uporabo v kombinaciji z ribavirinom je lahko v pomoč preglednica 1 s kategorijami glede na telesno maso oz. jakost zdravila ViraferonPeg.
English: §, depression, aggression, affect lability, anger, agitation, anxiety, mood altered, restlessness, nervousness, insomnia
Slovenian: §, depresija, agresivnost, labilnost čustvovanja, jeza, vznemirjenost, anksioznost, spremenjeno razpoloženje, nemir, živčnost, nespečnost
English: Predictability of response and non-response in HCV/HIV co-infection - Early virological response by week 12, defined as a 2 log viral load decrease or undetectable levels of HCV-RNA, has been shown to be predictive for sustained response.
Slovenian: Napoved odzivnosti oziroma neodzivnosti pri bolnikih, ki imajo sočasno okužbo s HCV/HIVRaziskave so pokazale, da je zgodnji virološki odziv do 12. tedna zdravljenja, ki je opredeljen kot zmanjšanje virusnega bremena za 2 log enoti ali doseganje nemerljive vrednosti HCV-RNA, dober napovednik stalnega odziva na zdravljenje.
English: 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 jemanja ribavirina, čeprav natančen mehanizem tega pojava ni znan.
English: • Remove the needle cap. You may see some liquid trickle out of the needle (see Figure 7).
Slovenian: Iz igle se bo morda pocedilo nekaj tekočine (glejte sliko 7).
English: ViraferonPeg is indicated in a combination regimen with ribavirin for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C, previously untreated, without liver decompensation, and who are positive for HCV-RNA.
Slovenian: Zdravilo ViraferonPeg je indicirano za kombinirano zdravljenje z ribavirinom pri otrocih, starih 3 leta ali več, in mladostnikih, ki imajo predhodno nezdravljen kronični hepatitis C brez jetrne dekompenzacije in pozitiven izvid na HCV-RNA.
English: Ophthalmological disorders that have been reported rarely with alpha interferons include retinopathies (including macular oedema), retinal haemorrhages, retinal artery or vein occlusion, retinal exudates, loss of visual acuity or visual field, optic neuritis, and papilloedema (see section 4.4).
Slovenian: Med očesne bolezni, o katerih so poročali redko pri uporabi interferonov alfa, sodijo retinopatije (vključno z edemom makule), krvavitve v mrežnici, zamašitev mrežnične arterije ali vene, eksudati na mrežnici, izguba ostrine vida ali vidnega polja, optični nevritis in edem papile (glejte poglavje 4.4).
English: Your healthcare provider will instruct you how to self-inject this medicine.
Slovenian: Zdravstveni delavec vas bo naučil, kako si to zdravilo injicirate sami.
English: 9/l l
Slovenian: 9/l in
English: Solvent for ViraferonPeg Water for injections
Slovenian: Vehikel za ViraferonPeg voda za injekcije
English: Metabolic disturbances
Slovenian: bipolarna motnja
English: The data suggest that no alteration in ViraferonPeg dosage is necessary based on advancing age.
Slovenian: Ti podatki kažejo, da prilagajanje odmerka zdravila ViraferonPeg v višji starosti ni potrebno.
English: Any subject with missing data in and after the follow-up week 12 window was considered to be a non-responder at week 24 of follow-up.
Slovenian: Vsakega preiskovanca z manjkajočimi podatki v 12. tednu spremljanja in po njem so v 24. tednu spremljanja šteli med bolnike brez virološkega odziva.
English: Adults (bitherapy and monotherapy)
Slovenian: Odrasli (dvojna terapija in monoterapija)
English: Reconstituting ViraferonPeg powder for injection
Slovenian: Rekonstitucija praška ViraferonPeg za injekcije
English: This medicine, when given alone, is usually given at a dose of 0.5 or 1.0 microgram per kilogram of body weight once a week, for 6 months to 1 year.
Slovenian: Uporaba pri odraslih - zdravilo ViraferonPeg samo Kadar se to zdravilo uporablja samostojno, je odmerek običajno 0,5 ali 1,0 mikrogram na kilogram telesne mase enkrat na teden, 6 mesecev do 1 leto.
English: Elevation of blood concentrations of these medicines has been reported when administered in combination with other interferon preparations and therefore care should be taken.
Slovenian: Pri sočasni uporabi z drugimi zdravili z interferonom so poročali o zvišanih koncentracijah teh zdravil v krvi, zato je potrebna previdnost.
English: Excipients with known effect: Each pre-filled pen contains 40 mg of sucrose per 0.5 ml.
Slovenian: Pomožne snovi z znanim učinkom: En napolnjen injekcijski peresnik vsebuje 40 mg saharoze na 0,5 ml zdravila.
English: Interferon alfa-2b has been shown to be abortifacient in primates.
Slovenian: Pokazali so, da ima interferon alfa-2b pri primatih abortivni učinek.
English: In general, patients infected with genotype 4 are considered harder to treat and limited study data (n=66) indicate they are compatible with a duration of treatment with bitherapy as for genotype 1.
Slovenian: Omejeni podatki iz študije (n=66) kažejo, da so ti bolniki primerni za enako dolžino zdravljenja z dvojno terapijo kot pri genotipu 1.
English: - facial palsy (weakness and slumping on one side to the face), severe allergic reactions such as angioedema (an allergic skin disease characterized by patches of swelling involving the skin and its subcutaneous layers, the mucous membranes, and sometimes the internal organs), mania (excessive or unreasonable enthusiasm), pericardial effusion (a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself), Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), change in colour of the tongue.
Slovenian: - paraliza obraznega živca (šibkost in povešenje ene strani obraza), hude alergijske reakcije, kot je angioedem (alergijska reakcija na koži, za katero so značilne otekline kože in podkožja, sluznic in včasih notranjih organov), manija (prekomerno ali nerazumno navdušenje), perikardni izliv (nabiranje tekočine med perikardom (osrčnikom) in samim srcem), sindrom Vogt-Koyanagi-Harada (avtoimuna vnetna bolezen, ki prizadene oči, kožo in ušesne membrane ter ovojnice možganov in hrbtenjače), sprememba barve jezika.
English: After the needle is inserted, remove the hand used to pinch the skin and use it to hold the syringe barrel.
Slovenian: Ko je igla zabodena, spustite kožno gubo in z isto roko primite brizgo.
English: Injection site reaction
Slovenian: reakcija na mestu injiciranja
English: Adults - Duration of treatment - Naïve patients Tritherapy: Refer to the SmPC for boceprevir.
Slovenian: Odrasli - Trajanje zdravljenja - predhodno nezdravljeni bolniki Trojna terapija: glejte SmPC za boceprevir.
English: As with interferon alfa-2b, adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, receiving ViraferonPeg therapy require close monitoring.
Slovenian: Tako kot pri interferonu alfa-2b morate tudi pri zdravljenju z zdravilom ViraferonPeg odrasle bolnike s kongestivnim srčnim popuščanjem v anamnezi, miokardnim infarktom v anamnezi in/ali predhodnimi ali obstoječimi motnjami srčnega ritma skrbno spremljati.
English: In the ViraferonPeg monotherapy trial, a total of 916 naïve chronic hepatitis C patients were treated with ViraferonPeg (0.5, 1.0 or 1.5 micrograms/kg/week) for one year with a follow-up period of six months.
Slovenian: V raziskavi monoterapije z zdravilom ViraferonPeg je skupno 916 predhodno nezdravljenih bolnikov s kroničnim hepatitisom C eno leto prejemalo zdravilo ViraferonPeg v odmerku 0,5, 1,0 ali 1,5 mikrogramov/kg/teden, nato pa so jih spremljali še 6 mesecev.
English: The active substance is a covalent conjugate of recombinant interferon alfa-2b* with monomethoxy polyethylene glycol.
Slovenian: Učinkovina zdravila je kovalentni konjugat rekombinantnega interferona alfa-2b* z monometoksi polietilenglikolom.
English: Therefore, it is recommended that children and adolescent patients receiving ViraferonPeg/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped < 2 log10 compared to pretreatment or if they have detectable HCV-RNA at treatment week 24.
Slovenian: Zato je priporočljivo, da se otrokom in mladostnikom, ki prejemajo kombinacijo zdravila ViraferonPeg in ribavirina, terapija ukine, če jim vrednost HCV-RNA v 12. tednu upade za manj kot 2 log10 v primerjavi s stanjem pred zdravljenjem oziroma če imajo v krvi merljivo količino HCV-RNA v 24. tednu zdravljenja.
English: Interferon alfa-2b 3 MIU
Slovenian: Interferon alfa-2b (3 mio.
English: The vial, ampoule and injection materials intended for single use must be discarded.
Slovenian: Vialo, ampulo in injekcijski set za enkratno uporabo morate zavreči.
English: Table 14 Rates of response to retreatment in prior treatment failures Patients with undetectable HCV-RNA at treatment week 12 and SVR upon retreatment interferon alpha/ribavirin peginterferon alpha/ribavirin
Slovenian: Preglednica 14 Delež odziva na ponovno zdravljenje v primeru, da je bilo prejšnje zdravljenje neuspešno Bolniki z nemerljivo HCV-RNA v 12. tednu zdravljenja in trajnim virološkim odzivom (SVR) pri ponovnem zdravljenju interferon alfa/ribavirin peginterferon alfa/ribavirin celotna populacija*
English: I p = 0.0143 P 1.5/R vs. I/R
Slovenian: p < 0,001 P 1,5 vs. I p = 0,0143 P 1,5/R vs. I/R
English: Sustained Virologic Response (SVR) is defined as undetectable HCV-RNA at 24 weeks post-treatment (Table 14).
Slovenian: Trajni virološki odziv (SVR) je opredeljen kot nemerljiva vrednost HCV-RNA 24 tednov po zdravljenju (preglednica 14).
English: ViraferonPeg 1.0 microgram/kg
Slovenian: ViraferonPeg 1,0 mikrogram/kg
English: In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 micrograms/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Slovenian: V neprimerjalnem preskušanju je 235 bolnikov, ki so bili okuženi z virusom genotipa 1 in so imeli majhno virusno breme (< 600.000 i.e./ml), prejemalo zdravilo ViraferonPeg v odmerku 1,5 mikrograma/kg subkutano enkrat na teden v kombinaciji z ribavirinom v odmerku, izračunanem glede na telesno maso.
English: If you are very thin, you should only use the thigh for injection.
Slovenian: Če ste zelo suhi, si zdravilo vedno injicirajte le v stegno.
English: Dyspepsia, gastroesophageal reflux disease, stomatitis, mouth ulceration, glossodynia, gingival bleeding, constipation, flatulence, haemorrhoids, cheilitis, abdominal distension, gingivitis, glossitis, tooth disorder
Slovenian: dispepsija, gastroezofagealna refluksna bolezen, stomatitis, razjede v ustih, glosodinija, krvavitve iz dlesni, zaprtje, napenjanje, hemoroidi, heilitis, napihnjenost trebuha, gingivitis, glositis, bolezni zob
English: Musculoskeletal pain, pain in extremity, back pain
Slovenian: mišično-skeletne bolečine, bolečine v udih, bolečine v križu
English: - if you are a man who is taking ribavirin: do not have sex with a pregnant woman unless you use a condom.
Slovenian: Ne smete imeti spolnih odnosov z nosečo žensko brez uporabe kondoma.
English: Table 6 Adverse reactions reported in adults in clinical trials or through post-marketing surveillance in patients treated with peginterferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg + ribavirin
Slovenian: Preglednica 6 Neželeni učinki, o katerih so poročali v kliničnih preskušanjih ali pri spremljanju v obdobju trženja odraslih bolnikov, zdravljenih s peginterferonom alfa-2b, vključno z monoterapijo z zdravilom ViraferonPeg ali s kombinirano terapijo z zdravilom ViraferonPeg in ribavirinom
English: You might hear a soft sound when pushing on the needle.
Slovenian: Ko boste iglo potisnili, boste morda zaslišali tih zvok.
English: If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing upwards, until the bubbles disappear.
Slovenian: Narahlo trkajte po brizgi z iglo obrnjeno navpično navzgor, dokler mehurčki ne izginejo.
English: Change your injection site each time.
Slovenian: Vsakič uporabite drugo mesto injiciranja.
English: ViraferonPeg monotherapy dose reduction guidelines in adults
Slovenian: Smernice za zmanjšanje odmerka zdravila ViraferonPeg pri monoterapiji pri odraslih
English: 2 x baseline and > 10 x ULN
Slovenian: 2 x začetna vrednost in > 10 x ZMN
English: Hypotension, pallor
Slovenian: hipotenzija, bledica
English: Second dose reduction to ViraferonPeg 0.5 µg/kg
Slovenian: Drugo zmanjšanje odmerka zdravila ViraferonPeg na 0,5 µg/kg
English: Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during ViraferonPeg therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Slovenian: Psihiatrične motnje in bolezni osrednjega živčevja (CŽS) Med zdravljenjem z zdravilom ViraferonPeg in celo po ukinitvi zdravljenja, predvsem v 6-mesečnem obdobju spremljanja, so pri nekaterih bolnikih opažali hude učinke na CŽS, še posebej depresijo, samomorilne misli in poskus samomora.
English: Aplastic anaemia
Slovenian: aplastična anemija
English: Convulsion
Slovenian: konvulzije
English: Renal failure, renal insufficiency Reproductive system and breast disorders Common:
Slovenian: ledvična odpoved, ledvična insuficienca Motnje reprodukcije in dojk Pogosti:
English: Table 4 Effect of Peginterferon alfa-2b on Co-administered Medicines
Slovenian: Preglednica 4 Vpliv peginterferona alfa-2b na sočasno uporabljena zdravila
English: Use the reconstituted solution (solution you prepared by mixing the powder and the liquid in the prefilled pen) immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Slovenian: Po rekonstituciji raztopino (ki ste jo pripravili z mešanjem praška in tekočine v napolnjenem injekcijskem peresniku) uporabite takoj ali v roku 24 ur, če ste jo medtem shranili v hladilniku (2 °C - 8 °C).
English: In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of ViraferonPeg and ribavirin.
Slovenian: Poleg tega bi lahko med dolgotrajnim zdravljenjem s kombinacijo zdravila ViraferonPeg in ribavirina imela škodljiv vpliv na zobe in ustno sluznico tudi suha usta.
English: delusions, hallucination, - hypersensitivity reaction to the medication, heart attack, inflammation of the pancreas, pain in bone and diabetes mellitus, - cotton wool spots (white deposits on the retina).
Slovenian: halucinacije, - preobčutljivostna reakcija na zdravilo, srčni napad, vnetje trebušne slinavke, bolečine v kosteh in sladkorna bolezen, - spremembe na očesnem ozadju (belkaste lise na očesni mrežnici).
English: 25 % of subjects included nausea, chills, insomnia, anaemia, pyrexia, myalgia, asthenia, pain, alopecia, anorexia, weight decreased, depression, rash and irritability.
Slovenian: Dodatni neželeni učinki, o katerih so poročali pri več kot 25 % preiskovancev, so bili navzea, mrzlica, nespečnost, anemija, zvišana telesna temperatura, mialgija, astenija, bolečina, alopecija, anoreksija, zmanjšanje telesne mase, depresija, izpuščaj in razdražljivost.
English: 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent
Slovenian: 1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon 4 viale praška, 4 ampule vehikla
English: 9/l, and < 1.5 x 10
Slovenian: 9/l in < 1,5 x 10
English: Ribavirin capsules
Slovenian: Kapsule ribavirina
English: It is recommended that children and adolescent patients receiving ViraferonPeg/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped < 2 log10 compared to pretreatment or if they have detectable HCV-RNA at treatment week 24.
Slovenian: Priporočljivo je, da se otrokom in mladostnikom, ki prejemajo kombinacijo zdravila ViraferonPeg in ribavirina terapija ukine, če jim vrednost HCV-RNA v 12. tednu upade za manj kot 2 log10 v primerjavi s stanjem pred zdravljenjem oziroma če imajo v krvi merljivo količino HCV-RNA v 24. tednu zdravljenja.
English: Patients were randomized to receive either ViraferonPeg (1.5 µg/kg/week) plus ribavirin (800 mg/day) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Slovenian: Bolnike so naključno razporedili bodisi v skupino, ki je prejemala zdravilo ViraferonPeg (1,5 µg/kg/teden) in ribavirin (800 mg/dan), ali pa v skupino, ki je prejemala interferon alfa-2b (3 milijone i.e. trikrat na teden) in ribavirin (800 mg/dan) 48 tednov s 6-mesečnim obdobjem spremljanja po koncu zdravljenja.
English: Only 5 children and adolescents with Genotype 4 were treated in the ViraferonPeg/ribavirin clinical trial.
Slovenian: V kliničnem preskušanju zdravila ViraferonPeg in ribavirina so zdravili le 5 otrok in mladostnikov z genotipom 4.
English: If available, prescribers are advised to consult with a poison control centre (PCC).
Slovenian: Zdravnikom tudi priporočamo, da se posvetujejo z Centrom za zastrupitve, če le-ta obstaja.
English: Your healthcare provider will instruct you on how to give the injections.
Slovenian: Zdravstveni delavec vas bo naučil, kako si injicirati zdravilo.
English: Genotype 1  600,000 IU/ml
Slovenian: Genotip 1  600.000 i.e./ml vsi
English: Effect of Peginterferon alfa-2b on Co-administered Medicines
Slovenian: Vpliv peginterferona alfa-2b na sočasno uporabljena zdravila
English: - Insert the needle in the ampoule of solvent and withdraw the total amount of solvent.
Slovenian: - Vstavite iglo v ampulo z vehiklom in posesajte celotno količino vehikla iz nje.
English: More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses for oncology indications.
Slovenian: Pri nekaterih bolnikih, običajno starejših, ki so jih zdravili z večjimi odmerki za onkološke indikacije, so opažali znatnejšo otopelost in komo, vključno s primeri encefalopatije.
English: Visual disturbance, vision blurred, photophobia, conjunctivitis, eye irritation, lacrimal disorder, eye pain, dry eye
Slovenian: motnje vida, zamegljen vid, fotofobija, konjunktivitis, draženje očesa, težave s solznimi žlezami, bolečine v očesu, suho oko
English: Table 3b Reduced ViraferonPeg dose (0.25 g/kg) for the 0.5 g/kg monotherapy regimen in adults Body weight (kg)
Slovenian: Preglednica 3b Zmanjšani odmerek zdravila ViraferonPeg (0,25 g/kg) pri monoterapiji z 0,5 g/kg pri odraslih bolnikih
English: When used in combination with ribavirin, ViraferonPeg did not cause any effects not previously seen with either active substance alone.
Slovenian: Zdravilo ViraferonPeg v kombinaciji z ribavirinom ni povzročilo nobenih učinkov, ki ne bi že bili opisani pri ločeni uporabi vsake od teh dveh učinkovin.
English: Inject the solution by pushing the plunger all the way down gently.
Slovenian: Raztopino injicirajte tako, da bat previdno potisnete do konca.
English: The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Slovenian: Zaradi povečanega tveganja za anemijo torej sočasna uporaba ribavirina z zidovudinom ni priporočljiva (glejte poglavje 4.4).
English: Chest pain, chest discomfort, injection site pain, malaise, face oedema, oedema peripheral, feeling abnormal, thirst
Slovenian: bolečine v prsih, tiščanje v prsih, bolečina na mestu injiciranja, slabo počutje, obrazni edem, periferni edem, nenormalno počutje, žeja
English: Carton 150 micrograms
Slovenian: Škatla 150 mikrogramov
English: The pharmacokinetics of ViraferonPeg following a single subcutaneous dose of 1.0 microgram/kg were not affected by age.
Slovenian: Starost ni vplivala na farmakokinetiko zdravila ViraferonPeg po enkratnem subkutanem odmerku 1,0 mikrogram/kg.