FrancophonIA/ELRC3.0 huggingface dataset:
English: Pegasys is presented as a solution for injection in a pre-filled syringe (0.5 ml) with a separate injection needle.
Slovenian: Zdravilo Pegasys je na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi (0,5 ml).
English: Specific recommendations for management of treatment-emergent anaemia in adults are as follows: ribavirin should be reduced to 600 milligrams/day (200 milligrams in the morning and 400 milligrams in the evening) if either of the following apply: (1) a patient without significant cardiovascular disease experiences a fall in haemoglobin to < 10 g/dl and ≥ 8.5 g/dl, or (2) a patient with stable cardiovascular disease experiences a fall in haemoglobin by ≥ 2 g/dl during any 4 weeks of treatment.
Slovenian: (1) se pri bolniku brez pomembnega srčnožilnega obolenja pojavi zmanjšanje hemoglobina na < 10 g/dl in ≥ 8,5 g/dl ali (2) če se pri bolniku s stabilnim srčnožilnim obolenjem pojavi padec hemoglobina za ≥ 2 g/dl kadar koli med štiritedenskim zdravljenjem.
English: Hyperglycaemia, type 1 diabetes mellitus
Slovenian: Bolezni endokrinega sistema hipotiroidizem, hipertiroidizem diabetes diabetična ketoacidoza
English: Benzyl alcohol Sodium acetate Acetic acid Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid polisorbat 80 benzilalkohol natrijev acetat ocetna kislina voda za injekcije
English: OTHER
Slovenian: ALT
English: Ribavirin 1000/1200 mg 72 or 48 Weeks (N = 942) Pts with VR at Wk 12 a
Slovenian: 1000/1200 mg 72 tednov (n = 473)
English: In the investigator sponsored CHIPS study (Chronic Hepatitis C International Paediatric Study), 65 children and adolescents (6-18 years) with chronic HCV infection were treated with Pegasys 100 mcg/m2 sc once weekly and ribavirin 15 mg/kg/day for 24 weeks (genotypes 2 and 3) or 48 weeks
Slovenian: V raziskovalčevi študiji CHIPS (Chronic Hepatitis C International Pediatric Study) so 65 otrok in mladostnikov (starih 6 do 18 let) s kronično okužbo s HCV zdravili z zdravilom Pegasys
English: Pegasys 180 micrograms solution for injection Peginterferon alfa-2a
Slovenian: Pegasys 180 mikrogramov raztopina za injiciranje peginterferon alfa-2a
English: Pegasys 90 micrograms solution for injection in pre-filled syringe Pegasys 135 micrograms solution for injection in pre-filled syringe Pegasys 180 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Slovenian: Navodilo za uporabo Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi peginterferon alfa-2a
English: Liver and renal graft rejections have been reported with Pegasys, alone or in combination with ribavirin.
Slovenian: Pri zdravilu Pegasys, uporabljenem samostojno ali v kombinaciji z ribavirinom, so poročali o zavrnitvah jetrnih in ledvičnih presadkov.
English: Pegasys 180 micrograms solution for injection Each vial of 1 ml solution contains 180 micrograms peginterferon alfa-2a*.
Slovenian: Pegasys 180 mikrogramov raztopina za injiciranje Ena viala z 1 ml raztopine vsebuje 180 mikrogramov peginterferona alfa-2a*.
English: Pegasys 90 micrograms solution for injection in pre-filled syringe EU/1/02/221/017
Slovenian: Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/02/221/017
English: Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml * Pegasys 180 mcg & ribavirin 800 mg vs. Interferon alfa-2a 3 MIU & ribavirin 800 mg: Odds Ratio (95% CI) = 5.40 (3.42 to 8.54), P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0001 * Pegasys 180 mcg & ribavirin 800 mg vs. Pegasys 180 mcg:
Slovenian: *Zdravilo Pegasys 180 μg & ribavirin 800 mg v primerjavi z interferonom alfa-2a 3 mio i.e. & ribavirinom 800 mg: razmerje (95 % CI) = 5,40 (3,42 do 8,54), p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = < 0,0001 *Zdravilo Pegasys 180 μg & ribavirin 800 mg v primerjavi z zdravilom Pegasys 180 µg: razmerje (95 % CI) = 2,89 (1,93 do 4,32), p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = < 0,0001 *Interferon alfa-2a 3 mio i.e. & ribavirin 800 mg v primerjavi z zdravilom Pegasys 180 µg: razmerje (95 % CI) = 0,53 (0,33 do 0,85), p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = < 0,0084
English: Retinal haemorrhage
Slovenian: zamaščenost jeter
English: Table 9: Undesirable effects reported with Pegasys monotherapy for CHB or CHC or in combination with ribavirin for CHC patients in clinical trials and post marketing Body system Very common
Slovenian: Preglednica 9: Neželeni učinki, ki so se pojavili v kliničnih preskušanjih in po prihodu zdravila na trg pri samostojnem zdravljenju z zdravilom Pegasys pri bolnikih s CHB ali CHC ali v kombiniranem zdravljenju z ribavirinom pri bolnikih s CHC
English: Degree of abnormality Score Encephalopathy None Grade 1-2
Slovenian: Encefalopatija odsotna stopnja 1-2 stopnja 3-4*
English: Overall Sustained Response
Slovenian: Celokup en trajni odziv
English: Pegylated interferon Interferon plus ribavirin Pegylated interferon plus ribavirin
Slovenian: Pegasys 180 μg in ribavirin 1000/1200 mg 48 tednov interferon pegiliran interferon interferon in ribavirin pegiliran interferon in ribavirin
English: A total of 151 patients without advanced fibrosis were 2:1 randomized to Pegasys (group A, n=101) or untreated control (group B, n=50), respectively.
Slovenian: 151 bolnikov brez napredovale fibroze v razmerju 2:1 na skupino, ki je prejemala zdravilo Pegasys
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 180 µg PRE-FILLED SYRINGES (WITH BLUE BOX) - Multipack
Slovenian: ZUNANJA OVOJNINA- 12 x 180 µg NAPOLNJENE INJEKCIJSKE BRIZGE (Z MODRIM OKENCEM) - skupno pakiranje
English: ● Remove the needle guard from the syringe needle.
Slovenian: ● Z injekcijske igle snemite zaščito.
English: Tachycardia, oedema peripheral, palpitations,
Slovenian: Srčne bolezni tahikardija, periferni edem, palpitacije miokardni infarkt, kongestivno srčno popuščanje,
English: Thyroid function abnormalities or worsening of pre-existing thyroid disorders have been reported with the use of alfa interferons, including Pegasys.
Slovenian: obstaja povečano tveganje za nastanek novih ali poslabšanje že obstoječih psihiatričnih motenj, če jih zdravimo z interferonom alfa.
English: NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection
Slovenian: Pegasys 180 mikrogramov raztopina za injiciranje
English: The mean changes from baseline in height and weight for age Z-scores at Week 48 of treatment in study YV25718 were -0.07 and -0.21 (n=108 and n= 106 respectively) for Pegasys-treated patients as compared to -0.01 and -0.08 (n=47 each) in untreated patients.
Slovenian: -0,07 in -0,21 (n = 108 in n = 106) v primerjavi z -0,01 in -0,08 (n = 47 za vsako) pri nezdravljenih bolnikih.
English: Pegasys 135 micrograms solution for injection in pre-filled syringe EU/1/02/221/005
Slovenian: Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/02/221/005
English: Genotype 2 or 3 RVR Low viral load High viral load
Slovenian: Genotip 2 ali 3, nizko virusno breme in hiter virološki odziv**
English: 1 pre-filled syringe + 1 injection needle 90 micrograms/0.5 ml
Slovenian: 1 napolnjena injekcijska brizga + 1 injekcijska igla 90 mikrogramov/0,5 ml
English: ● if you think you are getting an infection (such as pneumonia) as when receiving Pegasys you may temporarily have a greater risk of getting an infection.
Slovenian: • če mislite, da ste dobili okužbo (kot je pljučnica).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 180 µg VIALS
Slovenian: ZUNANJA OVOJNINA - 4 x 180 µg VIALE
English: ● Hold the syringe with the needle in the vial pointing up, remove the syringe from the long needle while keeping the needle in the vial and without touching the tip of the syringe.
Slovenian: Snemite brizgo z dolge igle, igla pa naj ostane v viali.
English: Tooth extraction, cholecystectomy
Slovenian: Kirurški in drugi medicinski posegi ekstrakcija zoba, holecistektomija
English: Alopecia, dermatitis, pruritis, dry skin
Slovenian: Bolezni kože in podkožja alopecija, dermatitis, pruritus, suha koža psoriaza, urtikarija, ekcem,
English: 4 pre-filled syringes + 4 injection needles 135 micrograms/0.5 ml
Slovenian: 4 napolnjene injekcijske brizge + 4 injekcijske igle 135 mikrogramov/0,5 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 135 µg PRE-FILLED PENS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 12 x 135 µg NAPOLNJENI INJEKCIJSKI PERESNIKI
English: Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
Slovenian: Pri bolnikih, ki prejemajo zdravilo Pegasys v kombinaciji z ribavirinom, so poročali o zobnih in periodontalnih boleznih, ki lahko vodijo do izgube zob.
English: Roche Pharma AG Emil-Barell-Str. 1
Slovenian: Emil-Barell-Str. 1
English: NAME OF THE MEDICINAL PRODUCT Pegasys 90 micrograms solution for injection in pre-filled syringe Pegasys 135 micrograms solution for injection in pre-filled syringe Pegasys 180 micrograms solution for injection in pre-filled syringe
Slovenian: Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 180 µg PRE-FILLED PENS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 12 x 180 µg NAPOLNJENI INJEKCIJSKI PERESNIKI
English: Pegasys dose
Slovenian: Odmerek zdravila Pegasys
English: 1 pre-filled syringe + 1 injection needle 180 micrograms/0.5 ml
Slovenian: 1 napolnjena injekcijska brizga + 1 injekcijska igla 180 mikrogramov/0,5 ml
English: 1 x 200 mg tablets A.M.
Slovenian: 1 x 200-mg tableta zvečer
English: Fertility
Slovenian: lamivudin
English: * Similar to end point of HBV DNA < 10
Slovenian: * za HBeAg-pozitivne bolnike: HBV DNA < 10
English: 4 pre-filled syringes + 4 injection needles 180 micrograms/0.5 ml
Slovenian: 4 napolnjene injekcijske brizge + 4 injekcijske igle 180 mikrogramov/0,5 ml
English: 8) Dispose of pre-filled pen
Slovenian: 8) Odvrzite napolnjeni injekcijski peresnik
English: Your doctor has determined the exact dose of Pegasys, and will tell you how often to use it.
Slovenian: Vaš zdravnik je določil natančen odmerek zdravila Pegasys.
English: Back pain, arthritis, muscle weakness, bone pain, neck pain, musculoskelet al pain, muscle cramps
Slovenian: bolečina v kosteh, bolečina v vratu, mišičnoskeletna bolečina, mišični krči miozitis rabdomioliza
English: 1 pre-filled syringe + 1 injection needle 135 micrograms/0.5 ml
Slovenian: 1 napolnjena injekcijska brizga + 1 injekcijska igla 135 mikrogramov/0,5 ml
English: 1 ml of solution for injection in vial (Type I glass) with stopper (rubber butyl).
Slovenian: Viala (steklo tipa I) z zamaškom (butil guma) z 1 ml raztopine za injiciranje.
English: Pegasys 135 micrograms solution for injection in pre-filled pen Each pre-filled pen of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a*.
Slovenian: Pegasys 135 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku Vsak injekcijski peresnik z 0,5 ml raztopine vsebuje 135 mikrogramov peginterferona alfa-2a*.
English: Measuring the dose of Pegasys
Slovenian: Odmerjanje zdravila Pegasys
English: The pharmacokinetics of Pegasys were similar between healthy subjects and patients with hepatitis B or C. Comparable exposure and pharmacokinetic profiles were seen in cirrhotic (Child-Pugh Grade A) and non-cirrhotic patients.
Slovenian: Pri zdravih prostovoljcih in bolnikih s hepatitisom B ali C je bila farmakokinetika zdravila Pegasys podobna.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 6 x 180 µg PRE-FILLED SYRINGES (WITHOUT BLUE BOX)Multipack
Slovenian: ZUNANJA OVOJNINA- 6 x 180 µg NAPOLNJENE INJEKCIJSKE BRIZGE (BREZ MODREGA OKENCA) - skupno pakiranje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 6 x 135 µg PRE-FILLED SYRINGES (WITHOUT BLUE BOX)Multipack
Slovenian: ZUNANJA OVOJNINA - 6 x 135 µg NAPOLNJENE INJEKCIJSKE BRIZGE (BREZ MODREGA OKENCA) - skupno pakiranje
English: Pegasys 180 micrograms solution for injection in pre-filled syringe EU/1/02/221/007
Slovenian: Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/02/221/007
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, epistaksa
English: Renal insufficiency
Slovenian: Bolezni sečil ledvična insuficienca
English: Vertigo, earache
Slovenian: vročinski valovi, žeja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 90 µg PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA- 1 x 90 µg NAPOLNJENA INJEKCIJSKA BRIZGA
English: Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Pegasys skupaj z ribavirinom, so poročali o boleznih zob in dlesni, ki lahko vodijo do izgube zob.
English: Dysuria, incontinence, urinary tract disorder
Slovenian: Bolezni sečil disurija, inkontinenca, bolezen sečil
English: With respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1.
Slovenian: Za specifično aktivnost glede genotipa virusa hepatitisa C glejte poglavji 4.2 in 5.1.
English: Diabetes
Slovenian: hemoglobin
English: Syncope, migraine, memory impairment, weakness, hypoaesthesia hyperaesthesi a, paraesthesia, tremor, taste disturbance, nightmares, somnolence
Slovenian: Bolezni živčevja glavobol, omotica*, motnje koncentracije sinkopa, migrena, motnje spomina, oslabelost, hipestezija, hiperestezija, parestezija, tremor, motnje okusa,
English: Genotype 2 and 3 (N=96)
Slovenian: Genotip B (n = 21)
English: Metabolism and nutrition disorders Decreased appetite
Slovenian: Presnovne in prehranske motnje anoreksija dehidracija
English: Do not use Pegasys
Slovenian: Zdravila Pegasys ne dajemo
English: Upper respiratory infection, bronchitis, fungal infection of the mouth and herpes (a common recurring viral infection affecting the lips, mouth) Blood disorders: Low platelet count (affecting the clotting ability), anaemia (low red cell count) and enlarged lymph glands
Slovenian: Okužbe: glivične, virusne in bakterijske okužbe, okužba zgornjih dihal, bronhitis, glivična okužba v ustih in herpes (pogosta ponavljajoča se virusna okužba, ki prizadane ustnice in usta).
English: Gastrointestinal disorder
Slovenian: Injiciranje raztopine
English: MARKETING AUTHORISATION NUMBERS Pegasys 180 micrograms solution for injection EU/1/02/221/003
Slovenian: Pegasys 180 mikrogramov raztopina za injiciranje EU/1/02/221/003
English: Pegasys 180 micrograms solution for injection in pre-filled syringe Each syringe of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a*.
Slovenian: Pegasys 180 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku Vsak injekcijski peresnik z 0,5 ml raztopine vsebuje 180 mikrogramov peginterferona alfa-2a*.
English: HIV-HCV co-infected adult patients
Slovenian: Odrasli bolniki, sočasno okuženi s HIV in HCV
English: The possibility of shortening treatment duration to 16 weeks in genotype 2 or 3 patients was examined based on a sustained virological response observed in patients with rapid virological response by week 4 in study NV17317 (see Table 17).
Slovenian: V študiji NV17317 so proučevali možnost skrajšanja zdravljenja bolnikov, okuženih z genotipom 2 ali 3 na 16 tednov, glede na trajni virološki odziv, opažen pri bolnikih, ki so imeli hiter virološki odziv v
English: In the NV17424 (PEDS-C) study, previously untreated paediatric patients 5 to 17 years of age (55% <12 years old) with compensated CHC and detectable HCV RNA were treated with Pegasys 180 mcg x BSA/1.73 m2 once weekly for 48 weeks with or without ribavirin 15 mg/kg/day.
Slovenian: (55 % < 12 let) s kompenziranim CHC in merljivo koncentracijo HCV RNA, bili zdravljeni z zdravilom Pegasys 180 µg/1,73 m2 telesne površine (TP) enkrat tedensko, 48 tednov in ribavirinom
English: Suicidal ideation, hallucinations
Slovenian: nervoznost, zmanjšan libido misli o samomoru, halucinacije samomor,
English: Dose limiting toxicities were fatigue, elevated liver enzymes, neutropenia and thrombocytopenia, consistent with interferon therapy.
Slovenian: Neželeni posledični učinki zdravljenja z interferoni, ki so omejevali odmerke, so bili utrujenost, zvišane vrednosti jetrnih encimov, nevtropenija in trombocitopenija.
English: In subjects older than 62 years, the absorption of Pegasys after a single subcutaneous injection of 180 micrograms was delayed but still sustained compared to young healthy subjects (tmax of 115 hours vs. 82 hours, older than 62 years vs. younger, respectively).
Slovenian: Pri bolnikih, starejših od 62 let, je bil tmax 115 ur, pri mlajših pa 82 ur.
English: Pure red cell aplasia
Slovenian: okvara žil mrežnice,
English: In patients who develop evidence of hepatic decompensation during treatment, Pegasys should be discontinued.
Slovenian: Pri bolnikih, pri katerih se razvijejo ali poslabšajo oftalmološke motnje, je treba zdravljenje z zdravilom Pegasys prekiniti.
English: Consideration should be given to replacing zidovudine in a combination anti-retroviral therapy regimen if this is already established.
Slovenian: Če je bila ugotovljena anemija, je smiselno razmisliti o zamenjavi zidovudina v kombinaciji protivirusnih zdravil.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 135 µg PRE-FILLED SYRINGES
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 4 x 135 µg NAPOLNJENE INJEKCIJSKE BRIZGE
English: Reproductive system disorders: Impotence (inability to maintain an erection) General disorders: Chest pain, flu-like illness, malaise (not feeling well), lethargy, hot flushes, thirst
Slovenian: Splošne težave: bolečina v prsih, bolezen, podobna gripi, občutek slabosti (neugodno počutje), zaspanost, vročinski valovi, žeja.
English: Uncommon side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 100 people) are:
Slovenian: Občasni neželeni učinki pri kombiniranem zdravljenju zdravila Pegasys in ribavirina (pojavijo se lahko pri največ 1 od 100 bolnikov) so:
English: Moderate (ANC: 0.749 - 0.5 x 109/l) and severe (ANC: < 0.5 x 109/l) neutropenia was observed respectively in 24% (216/887) and 5% (41/887) of patients receiving Pegasys 180 micrograms and ribavirin 1000/1200 milligrams for 48 weeks.
Slovenian: 9/l) pa pri 5 % (41/887) bolnikov, ki so prejemali zdravilo Pegasys v odmerku 180 mikrogramov in ribavirin v odmerku 1000/1200 miligramov 48 tednov.
English: Collect the necessary items before beginning: Included in the pack:
Slovenian: Naslednje vrednosti lahko štejemo kot izhodiščne vrednosti ob začetku zdravljenja:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg VIAL
Slovenian: ZUNANJA OVOJNINA - 1 x 180 µg VIALA
English: Weekly dose (mcg)
Slovenian: Tedenski odmerek (mikrogrami)
English: Pegasys 180 micrograms solution for injection in pre-filled pen Each pre-filled pen of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a*.
Slovenian: Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Vsaka napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 180 mikrogramov peginterferona alfa2a*.
English: Hypertension, supraventricular arrhythmias, congestive heart failure, chest pain and myocardial infarction have been associated with alfa interferon therapies, including Pegasys.
Slovenian: Zdravljenje z interferoni, vključno z zdravilom Pegasys, povezujejo z neželenimi učinki, kot so hipertenzija, supraventrikularne aritmije, kongestivno srčno popuščanje, bolečina v prsih in miokardni infarkt.
English: Pegasys 135 micrograms solution for injection in pre-filled pen EU/1/02/221/011
Slovenian: Pegasys 135 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/02/221/011
English: Pegasys 180 micrograms solution for injection in pre-filled pen EU/1/02/221/014
Slovenian: Pegasys 180 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/02/221/014
English: COBAS AMPLICOR HBV MONITOR: HBV-DNA (IU/mL) = HBV-DNA
Slovenian: COBAS AMPLICOR HBV MONITOR: HBV-DNA (i.e./ml) = HBV-DNA (kopije/ml)/5,26 ** Bolnike, ki so prešli na zdravljenje z zdravilom Pegasys po glavnem obdobju opazovanja in pred 24. tedenom obdobja spremljanja,
English: Chronic hepatitis B in adult patients
Slovenian: Povzetek varnostnega profila Kronični hepatitis B pri odraslih bolnikih
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a.
Slovenian: Ena napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 90 mikrogramov peginterferona alfa-2a.
English: Digestive system disorders: Stomach ulcer, inflammation of the pancreas
Slovenian: Bolezni prebavil: razjeda na želodcu, vnetje trebušne slinavke.
English: NAME OF THE MEDICINAL PRODUCT Pegasys 90 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Slovenian: Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi peginterferon alfa-2a
English: NAME OF THE MEDICINAL PRODUCT Pegasys 135 micrograms solution for injection in pre-filled pen Peginterferon alfa-2a
Slovenian: Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi peginterferon alfa-2a
English: May cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Slovenian: Pri novorojenčkih in otrocih do 3. leta starosti lahko povzroči toksične in anafilaktične reakcije.
English: Very rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 10,000 people) are:
Slovenian: Zelo redki neželeni učinki pri kombiniranem zdravljenju zdravila Pegasys in ribavirina (pojavijo se lahko pri največ 1 od 10.000 bolnikov) so:
English: Group B** Untreated (N=50)
Slovenian: Genotip C (n = 34)
English: Rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 1000 people) are:
Slovenian: Redki neželeni učinki pri kombiniranem zdravljenju zdravila Pegasys in ribavirina (pojavijo se lahko pri največ 1 od 1000 bolnikov) so:
English: Flushing Hypertension Cerebral haemorrhage, vasculitis
Slovenian: mišičnoskeletna bolečina, mišični krči miozitis rabdomioliza
English: Female patients of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Slovenian: Med zdravljenjem in 4 mesece po končanem zdravljenju morajo bolnice v rodni dobi uporabljati učinkovito kontracepcijsko zaščito.
English: Nervous system disorders
Slovenian: Motnje jetrnega delovanja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 180 µg PRE-FILLED SYRINGES
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 4 x 180 µg NAPOLNJENI INJEKCIJSKI PERESNIKI
English: Thyroid function
Slovenian: Status ciroze
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 1 x 180 µg NAPOLNJENA INJEKCIJSKA BRIZGA
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pegasys 90 micrograms solution for injection in pre-filled syringe Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a*.
Slovenian: Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Vsaka napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 90 mikrogramov peginterferona alfa2a*.
English: Myositis
Slovenian: Okence
English: Musculoskeletal pain
Slovenian: Bolezni mišično-skeletnega sistema: vnetje mišic.