natgillin/translations-raw huggingface dataset:
For HBeAg-negative patients with HBV genotype D infection, HBsAg > 20,000 IU/mL or HBV DNA > 6.5 log10 IU/mL at Week 12 following commencement of treatment is associated with high likelihood of failure to achieve HBV-DNA <2,000 IU/mL and ALT normalization at Week 24 post treatment.
Pri HBeAg negativnih bolnikih, okuženih z virusom hepatitisa B genotipa D, HBsAg > 20.000 i.e./ml ali HBV DNA > 6,5 log10 i.e./ml v 12. tednu po začetku zdravljenja obstaja velika verjetnost nedoseganja HBV-DNA < 2000 i.e./ml in normalizacije ALT v 24. tednu po končanem zdravljenju.
There is limited experience with Pegasys in treating paediatric patients with CHC aged 3 to 5 years, or who have failed to be adequately treated previously.
Pri zdravljenju pediatričnih bolnikov s CHC, starih od 3 do 5 let, ali bolnikov, ki predhodno niso prejeli ustreznega zdravljenja, so na voljo le omejene izkušnje z zdravilom Pegasys.
Pegasys 90 micrograms solution for injection in pre-filled syringe The syringe is labeled with graduations corresponding to doses of 90 mcg, 65 mcg, 45 mcg, 30 mcg, 20 mcg and 10 mcg.
Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Na injekcijski brizgi so oznake za odmerke 90 mcg, 65 mcg, 45 mcg, 30 mcg, 20 mcg in 10 mcg.
Table 1: Dosing recommendations for combination therapy for adult patients with chronic hepatitis C
Preglednica 1: Priporočila odmerjanja pri kombiniranem zdravljenju odraslih bolnikov s kroničnim hepatitisom C
● Remove the needle guard.
● Snemite igelno zaščito.
Table 22: Serological, virological and biochemical responses in paediatric patients with chronic hepatitis B
Preglednica 22: Serološki, virološki in biokemijski odzivi pri pediatričnih bolnikih s CHB
● if you develop symptoms associated with a cold or other respiratory infection (such as cough, fever or any difficulty in breathing).
• če opazite spremembo vida, • če se pri vas razvijejo simptomi, povezani s prehladom ali drugo okužbo dihal (kot so kašelj,
A prolongation of the menstrual cycle has been seen with peginterferon alfa-2a in female monkeys (see section 5.3).
Pri uporabi peginterferona alfa-2a pri samicah opic so opazili podaljšanje menstrualnega cikla (glejte poglavje 5.3).
Hormone system disorders: Overactive and underactive thyroid gland
Bolezni endokrinega sistema: preveč aktivna in premalo aktivna žleza ščitnica.
All genotypes (N=101) Responder
Vsi genotipi (n = 101)
Available in packs of 1 or 4 vials.
Na voljo je pakiranje z 1 ali 4
Serum concentrations of theophylline should be monitored and appropriate dose adjustments of theophylline made for patients taking theophylline and Pegasys concomitantly.
Pri bolnikih, ki jemljejo teofilin sočasno z zdravilom Pegasys, moramo meriti serumske koncentracije teofilina in odmerek teofilina ustrezno prilagoditi.
Increases in ALT levels above baseline (BL) have been observed in patients treated with Pegasys, including patients with a virological response.
zdravljenih z zdravilom Pegasys, so opazili zvečanje koncentracij ALT nad izhodiščnimi vrednostmi (BL - baseline), vključno z bolniki z virološkim odzivom.
Ribavirin daily dose (Approx. 15 mg/kg/day)
Celoten odmerek (približno 15 mg/kg/dan)
• Pegasys 360 mcg/week for 12 weeks, followed by 180 mcg/week for a further 36 weeks
• zdravilo Pegasys 360 mikrogramov/teden 12 tednov, čemur je sledilo 180 mikrogramov/teden naslednjih 36 tednov,
In both studies the treatment duration was 48 weeks, with 24 weeks of treatment-free follow-up.
Zdravljenje je skupaj potekalo 48 tednov, po njegovem zaključku pa so bolnike še 24 tednov spremljali.
The posology of Pegasys in paediatric patients is based on the Body Surface Area (BSA).
Odmerjanje zdravila Pegasys pri pediatričnih bolnikih je odvisno od njihove telesne površine.
Table 15: Sustained virological response based on rapid viral response at week 4 for genotype 1 and 4 after Pegasys combination therapy with ribavirin in CHC patients
Preglednica 15: Trajni virološki odziv v povezavi s hitrim virološkim odzivom v 4. tednu za genotipa 1 in 4 po kombiniranem zdravljenju z zdravilom Pegasys in ribavirinom pri bolnikih s CHC
Table 13: Virological response in CHC patients Pegasys monotherapy
Preglednica 13: Virološki odziv pri bolnikih s CHC Samostojno zdravljenje z zdravilom Pegasys
Limited safety data are available in co-infected patients with CD4+ cell counts <200/µl.
Podatki o varnosti pri bolnikih, okuženih z obema virusoma in s številom celic CD4+, manjšim od 200/μl, so omejeni.
Psychiatric and nervous system disorders: Feeling depressed (feeling low, feeling bad about yourself or feeling hopeless), anxiety, inability to sleep, headache, difficulty concentrating and dizziness Breathing disorders: Cough, shortness of breath
Psihiatrične motnje in bolezni živčevja: depresija (občutek potrtosti, slab občutek o sebi ali občutek brezupa), tesnoba, nespečnost, glavobol, težave s koncentracijo in omotica.
Multipack: 12 (2 packs of 6) pre-filled syringes + 12 injection needles 180 micrograms/0.5 ml
Skupno pakiranje: 12 (2 pakiranji po 6) napolnjenih injekcijskih brizg + 12 injekcijskih igel 180 mikrogramov/0,5 ml
Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAgnegative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (ALT) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1).
Chronic Hepatitis B), ki so HBeAg (Hepatitis B envelope Antigen) pozitivni ali negativni, imajo kompenzirano jetrno bolezen, dokazano virusno replikacijo, zvišane vrednosti alanin-aminotransferaze (ALT) ali histološko potrjeno vnetje jeter in/ali fibrozo (glejte poglavji 4.4 in 5.1).
Patients infected with HCV genotype 2 or 3 who have detectable HCV RNA at week 4, regardless of pre-treatment viral load should receive 24 weeks of therapy.
Bolnike, okužene s HCV z genotipom 2 ali 3, ki imajo merljivo koncentracijo HCV RNA v 4. tednu, zdravimo 24 tednov, ne glede na virusno breme pred začetkom zdravljenja.
# p-value (vs. lamivudine) < 0.01 (stratified Cochran-Mantel-Haenszel test)
# p-vrednost (v primerjavi z lamivudinom) < 0,01 (stratificiran Cochran-Mantel-Haenszelov test) Histološki odziv je bil v vseh treh zdravljenih skupinah podoben v vseh študijah.
Common Uncommon Rare
Pogostnost neznana
There are no or limited amount of data from the use of peginterferon alfa-2a in pregnant women.
Podatkov o uporabi peginterferona alfa-2a pri nosečnicah ni oziroma so omejeni.
Genotype 2 or 3 without RVR**
Genotip 2 ali 3, brez hitrega virološkega odziva**
Withhold ribavirin
Odmerek ribavirina
High viral load = > 800,000 IU/ml, low viral load = ≤ 800,000 IU/ml.
Visoko virusno breme = > 800.000 i.e./ml, nizko virusno breme = ≤ 800.000 i.e./ml.
Pegasys given alone or in combination with ribavirin is usually given at a dose of 180 micrograms once a week.
Zdravilo Pegasys kot samostojno zdravilo ali v kombinaciji z ribavirinom običajno dajemo v odmerku 180 mikrogramov enkrat na teden.
Heart and blood vessel disorders: High blood pressure Breathing disorders: Wheezing
Srčne in žilne bolezni: visok krvni tlak.
• Pegasys 180 mcg/week for 72 weeks
• zdravilo Pegasys 180 mikrogramov/teden 72 tednov,
What you need to know before you use Pegasys
Kaj morate vedeti, preden boste uporabili zdravilo Pegasys Ne uporabljajte zdravila Pegasys, če:
● Place the needle firmly on the tip of the syringe (4).
● Iglo trdno namestite na vrh brizge (4).
As with other alfa interferons, prolongation of the menstrual cycle was observed following administration of peginterferon alfa-2a to female monkeys.
Kot pri drugih interferonih alfa so pri samicah opic pri jemanju peginterferona alfa-2a opazili podaljšanje menstrualnega cikla.
• Pegasys 360 mcg/week for 12 weeks, followed by 180 mcg/week for a further 60 weeks
• zdravilo Pegasys 360 mikrogramov/teden 12 tednov, čemur je sledilo 180 mikrogramov/teden naslednjih 60 tednov,
Psychiatric and nervous system disorders: Mood /emotion changes, aggression, nervousness, decreased sexual desire, poor memory, fainting, decreased muscle strength, migraine, numbness, tingling, burning sensation, tremor, changes in the sense of taste, nightmares, sleepiness Eye disorders: Blurry vision, eye pain, eye inflammation and dry eyes Ear disorders: ear pain
Psihiatrične motnje in bolezni živčevja: spremembe razpoloženja/občutkov, agresivnost, živčnost, zmanjšano spolno poželenje, slab spomin, omedlevica, zmanjšana mišična moč, migrena, otopelost, mravljinci, pekoč občutek, tremor, spremembe občutka okusa, nočne more, zaspanost.
For patients <75 kg and ≥75 kg, 1000 mg daily and 1200 mg daily of ribavirin, respectively, and regardless of genotype, should be administered.
Bolnikom, lažjim od 75 kg, dajemo 1000 mg dnevni odmerek, bolnikom s 75 kg ali več pa 1200 mg dnevni odmerek ribavirina, ne glede na genotip.
Group A (Pegasys treatment) (N=101)
Skupina A (zdravljenje z zdravilom Pegasys)
The following may be considered as baseline values for initiation of treatment: - Platelet count ≥ 90,000 cells/mm3 - ANC ≥ 1500 cells/mm3
- število trombocitov ≥ 90.000 celic/mm3, - ANC ≥ 1500 celic/mm3,
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 Pegasys and ribavirin.
Razen tega lahko imajo suha usta pri dolgotrajnem kombiniranem zdravljenju z zdravilom Pegasys in ribavirinom škodljiv vpliv na zobe in mukozne membrane v ustih.
Pulmonary symptoms, including dyspnoea, pulmonary infiltrates, pneumonia, and pneumonitis have been reported during therapy with Pegasys.
Med zdravljenjem z zdravilom Pegasys so poročali o pulmonalnih simptomih, kot so dispneja, pljučni infiltrati, pljučnica in pnevmonitis.
Overall, the safety profile for Pegasys in combination with ribavirin in prior non-responder patients was similar to that in naïve patients.
Celokupno je varnostni profil zdravljenja s kombinacijo zdravila Pegasys in ribavirina pri bolnikih, ki se na prejšnje zdravljenje niso odzvali, podoben kot pri bolnikih, ki se še niso zdravili.
Multipack: 12 (2 packs of 6) pre-filled syringes + 12 injection needles 135 micrograms/0.5 ml
Skupno pakiranje: 12 (2 pakiranji po 6) napolnjenih injekcijskih brizg + 12 injekcijskih igel 135 mikrogramov/0,5 ml
Plasma exposure of ribavirin did not appear to be affected by concomitant administration of nucleoside reverse transcriptase inhibitors (NRTIs).
Sočasno jemanje nukleozidnih zaviralcev reverzne transkriptaze (NRTIs) na plazemsko izpostavljenost ribavirinu ni vplivalo.
Pegasys 180 mcg Ribavirin 1000/1200 mg 48 weeks
Pegasys 180 µg in ribavirin 1000/1200 mg 48 tednov
Administration of Pegasys 180 micrograms once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that Pegasys has no effect on in vivo metabolic activity of cytochrome P450 3A4, 2C9, 2C19 and 2D6 isozymes.
Dajanje 180 mikrogramov zdravila Pegasys enkrat na teden 4 tedne pri zdravih moških prostovoljcih ni vplivalo na farmakokinetični profil mefenitoina, dapsona, debrisokina in tolbutamida.
Ribavirin had no significant effect on the initial viral kinetics over the first 4 to 6 weeks in patients treated with the combination of ribavirin and pegylated interferon alfa-2a or interferon alfa.
Ribavirin pri bolnikih, ki prejemajo kombinacijo ribavirina in pegiliranega interferona alfa-2a ali interferona alfa, na začetno kinetiko virusa med prvimi 4 do 6 tedni značilno ne vpliva.
Patients infected with HCV genotype 1 who have detectable HCV RNA at week 4 regardless of pre-treatment viral load should receive 48 weeks of therapy.
Bolnike, okužene s HCV genotipom 1, ki imajo merljivo koncentracijo HCV RNA v 4. tednu, zdravimo ne glede na virusno breme pred začetkom zdravljenja 48 tednov.
Myocardial infarction, congestive heart failure, cardiomyopat hy, angina, arrhythmia, atrial fibrillation, pericarditis, supraventricu lar tachycardia
kardiomiopatija, angina pektoris, aritmija, fibrilacija atrijev, perikarditis, supraventrikularna tahikardija
When used in combination with ribavirin, Pegasys did not cause any effects in monkeys not previously seen with either active substance alone.
Zdravilo Pegasys in ribavirin Ko so zdravilo Pegasys uporabili v kombinaciji z ribavirinom, zdravilo Pegasys pri opicah ni povzročilo nobenih dodatnih neželenih učinkov, ki jih prej ne bi videli pri posameznih učinkovinah.
Co-infected patients with advanced cirrhosis receiving HAART may also be at increased risk of hepatic decompensation and possibly death if treated with ribavirin in combination with interferons, including Pegasys.
Pri sočasno okuženih bolnikih z napredovalo cirozo, ki prejemajo HAART in se zdravijo z ribavirinom v kombinaciji z interferoni, vključno z zdravilom Pegasys, je tveganje za jetrno dekompenzacijo in možno smrt večje.
The response rate was lower in patients with no to minimal increase in ALT level at baseline (see Section 5.1).
Pri bolnikih, ki niso imeli zvišanih ravni ALT v izhodišču ali pa so bile te ravni zvišane minimalno, je bila stopnja odziva nižja (glejte poglavje 5.1).
3 MIU
3 mio i.e.
In a pharmacokinetic study of 24 HCV patients concomitantly receiving methadone maintenance therapy (median dose 95 mg; range 30 mg to 150 mg), treatment with Pegasys 180 micrograms sc once weekly for 4 weeks was associated with mean methadone levels that were 10% to 15% higher than at baseline.
V farmakokinetični študiji, v kateri je 24 bolnikov s HCV sočasno prejemalo vzdrževalno zdravljenje z metadonom (mediana odmerka 95 mg, razpon od 30 mg do 150 mg), je bilo zdravljenje z zdravilom Pegasys v odmerku 180 mikrogramov, danim subkutano enkrat na teden 4 tedne, povezano z 10 do 15
In the HALT-C study, patients with CHC and advanced fibrosis or cirrhosis who were non-responders to previous treatment with interferon alfa or pegylated interferon alfa monotherapy or in combination therapy with ribavirin were treated with Pegasys 180 mcg/week and ribavirin 1000/1200 mg daily.
V študiji HALT-C so bolnike s CHC in napredovalo fibrozo ali cirozo, ki se niso odzvali na prejšnje samostojno zdravljenje z interferonom alfa ali pegiliranim interferonom alfa oziroma zdravljenje v kombinaciji z ribavirinom, zdravili z zdravilom Pegasys 180 mikrogramov/teden in ribavirinom 1000/1200 mg na dan. Bolniki, pri katerih je bila po 20 tednih zdravljenja koncentracija HCV RNA nemerljiva, so nadaljevali z zdravljenjem s kombinacijo zdravila Pegasys in ribavirina.
In case of intolerance to ribavirin, Pegasys monotherapy should be continued.
Če bolnik ribavirina ne prenaša, moramo nadaljevati s samostojnim zdravljenjem z zdravilom Pegasys.
Predictability of response and non-response with Pegasys and ribavirin dual therapy - treatmentnaïve patients
Napoved odzivnosti in neodzivnosti pri dvojnem zdravljenju z zdravilom Pegasys in ribavirinom - že zdravljeni bolniki
● The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, acetic acid and water for injections.
• Pomožne snovi so: natrijev klorid, polisorbat 80, benzilalkohol, natrijev acetat, ocetna kislina in voda za injekcije.
HBV DNA response *
HBV DNA
Ischaemic colitis, tongue pigmentation
pankreatitis ishemični kolitis, pigmentacija jezika
Treatment with Pegasys should be discontinued immediately in patients with hepatic decompensation.
Pri bolnikih z jetrno dekompenzacijo je treba zdravljenje z zdravilom Pegasys takoj prekiniti.
Treatment should normally not be initiated if ALT is >10x ULN .
Zdravljenja normalno ne smemo začeti, če so vrednosti ALT
P=0.04 P=0.0002
p = 0,0002
Pegasys is presented as a solution for injection in a vial (1 ml).
Zdravilo Pegasys je na voljo v obliki raztopine za injiciranje v viali (1,0 ml).
Paediatric patients treated with Pegasys plus ribavirin combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline.
Pri pediatričnih bolnikih, ki so prejemali kombinirano zdravljenje z zdravilom Pegasys in ribavirinom, so po 48 tednih zdravljenja opazili zastoj v pridobivanju telesne mase in višine v primerjavi z izhodiščno vrednostjo.
For HCV monoinfected patients and HIV-HCV co-infected patients, for treatment regimens, duration of therapy and study outcome see Tables 13, 14, 15 and Table 21, respectively.
Sheme zdravljenja, trajanje zdravljenja in ugotovitve študij za bolnike, ki so okuženi le s HCV, in za bolnike, ki so sočasno okuženi s HIV in HCV, najdete v preglednicah 13, 14, 15 in 21.
Interferon alfa-2b 3 MIU
Interferon alfa-2b
● use if pre-filled pen appears to be damaged.
• uporabljajte napolnjenega injekcijskega peresnika, če se vam zdi poškodovan;
Based on the population pharmacokinetic model, the mean exposure (AUC) during the dosing interval for each BSA category was comparable with that observed in adults receiving 180 mcg fixed dosing.
(AUC) med intervali odmerjanja za vsako skupino telesne površine primerljiva s tisto pri odraslih, ki so prejemali 180-µg odmerek zdravila.
Thrombocytopenia Platelet 25,000 to <50,000 cells/mm3: 2 level adjustment.
Trombocitopenija Trombociti 25.000 do< 50.000 celic/mm3: zmanjšanje odmerka 2. stopnje.
Depression*, anxiety, insomnia*
Psihiatrične motnje depresija*, anksioznost,
● Remove the rubber cap from the syringe (3).
● Z injekcijske brizge odstranite gumijasti pokrovček (3).
Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Nemčija
Peginterferon alfa-2a
Interferon alfa-2a
Use of peginterferon as long term maintenance monotherapy (unapproved use) In a randomised, controlled US study (HALT-C) of HCV non-responder patients with varied degrees of fibrosis where 3.5 years of treatment with 90 micrograms/week of Pegasys monotherapy was studied, no significant reductions were observed in the rate of fibrosis progression or related clinical events.
Samostojna uporaba peginterferona za dolgotrajno vzdrževalno zdravljenje (neodobrena uporaba) V randomizirani, kontrolirani študiji (HALT-C), ki je potekala v ZDA, so bolniki s HCV in različnimi stopnjami fibroze, ki se na zdravljenje niso odzivali, 3,5 let prejemali 90 mikrogramov zdravila Pegasys na teden kot monoterapijo.
Overall Low viral load High viral load Genotype 1/4 Low viral load High viral load Genotype 2/3 Low viral load High viral load Cirrhosis Status Cirrhosis Noncirrhosis Best Response during Previous Treatment ≥2log10 decline in HCV RNA <2log10 decline in HCV RNA Missing best previous response
Brez ciroze Najboljši odziv med prejšnjim zdravljenjem ≥ 2 log10 znižanje HCV RNA < 2 log10 znižanje HCV RNA Brez podatka o prejšnjem najboljšem odzivu
Table 10: Adverse reactions reported among paediatric patients infected with HCV and assigned to Pegasys plus ribavirin in study NV17424
Preglednica 10: Neželeni učinki, poročani pri pediatričnih bolnikih, ki so bili okuženi z virusom HCV in so jim dodelili kombinaciji zdravila Pegasys in ribavirina v študiji
In CHC clinical trials with adult patients, isolated increases in ALT (≥ 10x upper limit of normal [ULN], or ≥ 2x BL for patients with a BL ALT ≥ 10x ULN) which resolved without dose-modification were observed in 8 of 451 patients treated with combination therapy.
Med kliničnimi preskušanji CHC pri odraslih bolnikih, so pri 8 od 451 bolnikov, ki so prejemali kombinirano zdravljenje, opazili posamezne primere zvišanja ALT (≥ 10-kratna zgornja referenčna vrednost (ULN - Upper Limit of Normal) ali ≥ 2-kratna BL pri bolnikih z BL ALT ≥ 10-kratna ULN),
The reversibility of growth inhibition is uncertain.
Ne moremo zagotovo reči, da je zastoj rasti reverzibilen.
The virological responses of HCV monoinfected patients treated with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load and in relation to genotype, pre-treatment viral load and rapid virological response at week 4 are summarised in Table 14 and Table 15, respectively.
Virološki odzivi bolnikov, okuženih le s HCV, ki so se zdravili z zdravilom Pegasys v kombinaciji z ribavirinom, so v odvisnosti od genotipa in virusnega bremena pred začetkom zdravljenja ter v odvisnosti od genotipa, virusnega bremena pred začetkom zdravljenja in hitrega virološkega odziva v 4. tednu, prikazani v preglednicah 14 in 15.
It is recommended that Pegasys pre-filled syringes be used for paediatric patients.
Za pediatrične bolnike je priporočljiva uporaba zdravila Pegasys v obliki napolnjenih injekcijskih brizg.
LVL = ≤ 800,000 IU/ml; HVL = > 800,000 IU/ml (a) It is presently not clear whether a higher dose of ribavirin (e.g.1000/1200 mg/day based on body weight) results in higher SVR rates than does the 800 mg/day, when treatment is shortened to 16 weeks.
Hiter virološki odziv = nemerljiva koncentracija HCV RNA v 4. tednu Za zdaj še ni jasno, če večji odmerek ribavirina (npr. 1000/1200 mg na dan glede na telesno maso) povzroči višji delež trajnega virološkega odziva kot odmerek 800 mg na dan, kadar je zdravljenje skrajšano na 16 tednov.
Contact your doctor or pharmacist if you need any help determining how to manage a missed dose of Pegasys.
Posvetujte se z zdravnikom ali farmacevtom, če potrebujete pomoč pri določanju dneva naslednjega odmerka.
Neoplasms benign and malignant disorders: Liver tumour Immune system disorders: Sarcoidosis (areas of inflamed tissue occurring throughout the body), inflammation of the thyroid
Bolezni imunskega sistema: sarkoidoza (področja vnetega kožnega tkiva po celem telesu), vnetje ščitnice.
Fluctuations in abnormalities of liver function tests are common in patients with CHC.
Delovanje jeter Pri bolnikih s CHC so fluktuacije patoloških rezultatov testov jetrnih funkcij pogoste.
Do not use this medicine if you notice the syringe or needle packaging is damaged, if the solution is cloudy or if it has floating particles or if the medicine is any colour besides colourless to light yellow.
Ne uporabljate tega zdravila, če ste opazili, da je ovojnina injekcijske brizge ali igle poškodovana, če je raztopina motna ali če vsebuje lebdeče delce in če je barva zdravila drugačna od brezbarvne do rahlo rumene barve.
Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorders, mania, confusion and alterations of mental status have been observed with alfa interferons.
(včasih proti drugim osebam, npr. razmišljanje o umoru), bipolarnimi motnjami razpoloženja, manijo, zmedenostjo in spremembami duševnega stanja.
MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/016
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/02/221/016
Ribavirin 800 mg 24 weeks
800 mg 24 tednov
Ribavirin 800 mg 48 weeks
800 mg 48 tednov
The virological responses of patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load for HIV-HCV coinfected patients are summarised below in Table 21.
Virološki odzivi bolnikov, zdravljenih le z zdravilom Pegasys, in bolnikov, ki so se zdravili z zdravilom Pegasys v kombinaciji z ribavirinom, so v povezavi z genotipom in virusnim bremenom pred začetkom zdravljenja za bolnike, okužene s HCV in HIV, prikazani v preglednici 21.
● the medicine is cloudy
• je zdravilo motno;
You or your partner must use an effective contraceptive during the time you are taking the treatment and for 7 months after stopping treatment.
Med zdravljenjem in 7 mesecev po končanem zdravljenju morate vi ali vaša partnerka uporabljati učinkovito kontracepcijo.
(copies/mL) / 5.26) ** Patients switched to Pegasys treatment post-principal observation period and before Week 24 follow-up were counted as non-responders.
** Bolnike, ki so prešli na zdravljenje z zdravilom Pegasys v obdobju po opazovanju and pred 24-tedenskim obdobjem spremljanja, štejemo kot neodzivne.