natgillin/translations-raw huggingface dataset:
The refore, each pen contains an excess amount of solvent and ViraferonPeg powder to ensure delivery of the labelled dose in 0.5 ml of ViraferonPeg, solution for injection.
Zato vsak peresnik vsebuje dodatno količino vehikla in praška ViraferonPeg, da zagotovimo dajanje odmerka, ki je naveden na nalepki, v 0, 5 ml zdravila ViraferonPeg, raztopina za injiciranje.
The reconstituted solution has a concentration of 80 micrograms in 0.5 ml.
Koncentracija rekonstituirane raztopine je 80 mikrogramov na 0, 5 ml.
162 1.
167 1.
ViraferonPeg 100 micrograms, powder and solvent for solution for injection in pre-filled pen
ViraferonPeg 100 mikrogramov, prašek in vehikel za raztopino za injiciranje v napolnjenem peresniku
Each pre-filled pen of ViraferonPeg 100 micrograms contains a sufficient amount of peginterferon alfa-2b as measured on a protein basis in a powder for solution for injection, and the corresponding amount of solvent, to provide 100 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Vsak napolnjen peresnik zdravila ViraferonPeg 100 mikrogramov vsebuje zadostno količino peginterferona alfa- 2b (merjeno glede na beljakovine) v prašku za raztopino za injiciranje in ustrezno količino vehikla, da vsebuje raztopina po rekonstituciji v skladu z navodili 100 mikrogramov v 0, 5 ml peginterferona alfa- 2b.
Dose to be administered ViraferonPeg should be administered as a once weekly subcutaneous injection.
168 Odmerek za injiciranje Zdravilo ViraferonPeg dajemo enkrat na teden v obliki subkutane injekcije.
163 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Kombinirana terapija ViraferonPeg 1, 5 mikrogramov/ kg na teden skupaj s kapsulami ribavirina.
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.
169 Raziskave so pokazale, da je zgodnji virološki odziv do 12. tedna zdravljenja, ki je opredeljen kot zmanjšanje virusnega bremena za 2 log točki ali doseganje nemerljive količine RNA virusa HCV v serumu, dober napovednik stalnega odziva na zdravljenje.
164 Duration of treatment - Retreatment Predictability of sustained virological response:
Trajanje zdravljenja - Ponovno zdravljenje Predvidljivost stalnega virološkega odziva:
165 Combination Therapy Dose Reduction Guidelines
170 Smernice za zmanjšanje odmerka pri kombinirani terapiji
(k g)
- -
ViraferonPeg Monotherapy Dose Reduction Guidelines
171 Smernice za zmanjšanje odmerka zdravila ViraferonPeg pri monoterapiji
166 Dose reduction for patients who use 0.5 μg/kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Zmanjšanje odmerka pri bolnikih, ki jemljejo 0, 5 μg/ kg zdravila ViraferonPeg v monoterapiji, mora biti doseženo z zmanjšanjem predpisanega volumna za pol.
(k g)
Enkrat na teden (ml)
Combination therapy:
172 Kombinirana terapija:
There are no apparent age-related effects on the pharmacok inetics of ViraferonPeg.
Ni vidnih učinkov starosti na farmakokinetiko zdravila ViraferonPeg.
in the previous six months (see section 4.4); 167
šestih mesecih (glejte poglavje 4. 4);
Current treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment.
Podatek o tem, ali je pred začetkom zdravljenja potrebna biopsija jeter, najdete v tekočih 173 smernicah za zdravljenje.
168 Hydration:
Hidracija:
In the presence of thyroid dysfunction, ViraferonPeg treatment may be continued if TSH levels can be maintained in the normal range by medication.
174 z zdravilom ViraferonPeg nadaljujete, če lahko ohranjate vrednosti TSH v normalnem razponu z zdravili.
169 Haematological abnormalities in HCV/HIV co-infected patients:
Hematološke motnje pri bolnikih, sočasno okuženih s HCV in HIV:
Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
175 povezana s povečano pogostnostjo zavrnitve ledvičnega presadka.
Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see ribavirin SPC).
176 mitohondrijske toksičnosti, še posebej v obliki laktacidoze in pankreatitisa, in nekateri od njih so vodili do bolnikove smrti (glejte SPC za ribavirin).
Adverse reactions reported in clinical trials or through post-marketing surveillance in patients treated with interferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg + ribavirin.
177 Preglednica 4 Neželeni učinki, o katerih so poročali v kliničnih preskušanjih ali v času postmarketinškega spremljanja bolnikov, zdravljenih z interferonom alfa- 2b, vključno z monoterapijo z zdravilom ViraferonPeg ali s kombinirano terapijo z zdravilom ViraferonPeg in ribavirinom
Frequency not known:
178 Pogostnost ni znana:
Sinusitis, bronchitis, dysphonia, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough 173
sinusitis, bronhitis, disfonija, epistaksa, rinitis, bolezni dihal, kongestija nosne sluznice, rinoreja, neproduktiven kašelj
Stevens Johnson syndrome, toxic epidermal necrolysis, injection site necrosis, erythema multiforme
Stevens- Johnsonov sindrom, toksična epidermalna nekroliza, nekroza na mestu injiciranja, multiformni eritem 179
174 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
V neki klinični raziskavi je imelo približno 1, 2% bolnikov, zdravljenih z zdravilom ViraferonPeg ali z interferonom alfa- 2b v kombinaciji z ribavirinom med zdravljenjem smrtno nevarne duševne pojave.
Mitochondrial toxicity:
180 Toksičnost za mitohondrije:
Although haematological toxicities of neutropenia, thrombocytopenia and aaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
Četudi se je hematološka toksičnost v obliki nevtropenije, trombocitopenije in anemije pogosteje pojavljala pri bolnikih, ki so bili sočasno okuženi s HCV in HIV, so lahko pri večini teh bolnikov toksične učinke odpravili s prilagoditvijo odmerka in je bila zaradi njih le redko potrebna predčasna ukinitev zdravila (glejte poglavje 4. 4).
175 Doses up to 10.5 times the intended dose have been reported.
Poročali so o zaužitju odmerkov tudi do 10, 5- kratnika odmerka, ki ga je bolnik nameraval vzeti.
176 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.
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.
In this trial, the combination of Viraferon Peg (1.5 micrograms/kg/week) and ribavirin was significantly more effective than the combination of interferon alfa-2b and ribavirin (Table 5), particularly in patients infected with Genotype 1 (Table 6).
V tej raziskavi je bila kombinacija zdravila ViraferonPeg (1, 5 mikrogramov/ kg/ teden in ribavirina statistično značilno bolj učinkovita od kombinacije interferona alfa- 2b in ribavirina (Preglednica 5), še posebej pri bolnikih, okuženih z genotipom 1 (Preglednica 6).
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
182 HCV genotip in virusna obremenitev na začetku sta prognostična dejavnika, za katera je znano, da vplivata na stopnjo odziva.
P 1.5 ViraferonPeg 1.5 micrograms/kg P 1.0 ViraferonPeg 1.0 microgram/kg P 0.5 ViraferonPeg 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/ R P 0.5/R I/R * **
P 1, 5/ R P 0, 5/ R I/ R * **
In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with ribavirin 800 mg –1,400 mg p.o. for 6 months (based on body weight, only three patients weighing > 105 kg, received the 1,400 mg dose) (Table 7).
183 V ločenem preskušanju je 224 bolnikov z genotipom 2 ali 3 prejemalo ViraferonPeg, 1, 5 mikrograma/ kg subkutano enkrat na teden, skupaj z ribavirinom od 800 mg do 1. 400 mg peroralno v času 6 mesecev (glede na telesno maso - 1. 400 mg za bolnike s telesno maso > 105 kg; vključeni so bili le 3 bolniki) (Preglednica 7).
178 Predictability of sustained virological response – Naïve patients Virological reponse 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 (Table 8).
Predvidljivost trajnega virološkega odziva - Nezdravljeni bolniki Pokazali so, da je virološki odziv do 12. tedna, opredeljen kot 2- log zmanjšanje virusne obremenitve ali nemerljive koncentracije HCV RNK, dober napovednik za trajen odziv (Preglednica 8).
Treatment ViraferonPeg 1.5 + ribavirin (> 10.6 mg/kg) 48-week treatment ViraferonPeg 1.5 + ribavirin 800-1,400 mg
184 + ribavirin (> 10, 6 mg/ kg) 48 - tedensko zdravljenje ViraferonPeg 1, 5
Genotype Viral response Sustained response Negative predictive value at week 12 1 Yes 75% (82/110) 71% (58/82) ---- No 25% (28/110) 0% (0/28) 100% 2 and 3 Yes 99% (213/215) 83% (177/213) ----
2 in 3
24-week treatment * reflects patients
da 99% (213/ 215)
No 1% (2/215) 50% (1/2) 50% with 12 week data available
* odziv pacienta po podatkih v 12- tednu zdravljenja
179 Table 9
Študija 11
Histological response Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51%).
185 Histološki odziv na zdravljenje V študiji 1 so biopsijo jeter opravili pred in po zdravljenju - na voljo so podatki za 210 od 412 preiskovancev (51%).
180 Table 10 Rates of Response to retreatment in prior treatment failures
Stopnje odziva na ponovno zdravljenje v primeru, da je bilo prejšnje zdravljenje neuspešno
181 Overall, approximately 36% (821/2,286) of patients had undetectable plasma HCV-RNA levels at Week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
Skupaj je imelo v 12. tednu zdravljenja približno 36% (821/ 2286) bolnikov nezaznavne koncentracije HCV- RNA v plazmi, kar so merili z raziskovalnim testom (meja detekcije 125 i. e. / ml).
Following subcutaneous administration, maximal serum concentrations occur between 15-44 hours post-dose, and are sustained for up to 48-72 hours post-dose.
187 Po subkutani uporabi nastopi največja plazemska koncentracija od 15 do 44 ur po odmerku in se ohrani do največ 48 do 72 ur po odmerku.
182 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Odmerek zdravila ViraferonPeg v monoterapiji je treba zmanjšati pri bolnikih z zmerno ali hudo ledvično okvaro (glejte poglavji 4. 2 in 4. 4).
Reproduction studies of ViraferonPeg have not been performed.
188 Reprodukcijske raziskave zdravila ViraferonPeg niso bile opravljene.
immediately, in -use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
shranjevanja med uporabo in pogoje shranjevanja pred uporabo odgovoren uporabnik in običajno ne sme presegati 24 ur pri temperaturi 2° C do 8 °C.
ViraferonPeg 100 micrograms is supplied as:
189 Zdravilo ViraferonPeg 100 mikrogramov je na voljo v naslednjih pakiranjih:
ViraferonPeg pre-filled pen contains a powder of peginterferon alfa-2b and a solvent for solution at a strength of 100 micrograms for single use.
Napolnjen peresnik ViraferonPeg vsebuje prašek peginterferona alfa- 2b in vehikel za pripravo raztopine v jakosti 100 mikrogramov za enkratno uporabo.
The reconstituted solution has a concentration of 100 micrograms in 0.5 ml.
Koncentracija rekonstituirane raztopine je 100 mikrogramov na 0, 5 ml.
10.
190 10.
185 1.
191 1.
ViraferonPeg 120 micrograms, powder and solvent for solution for injection in pre-filled pen
ViraferonPeg 120 mikrogramov, prašek in vehikel za raztopino za injiciranje v napolnjenem peresniku
Each pre-filled pen of ViraferonPeg 120 micrograms contains a sufficient amount of peginterferon alfa-2b as measured on a protein basis in a powder for solution for injection, and the corresponding amount of solvent, to provide 120 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Vsak napolnjen peresnik zdravila ViraferonPeg 120 mikrogramov vsebuje zadostno količino peginterferona alfa- 2b (merjeno glede na beljakovine) v prašku za raztopino za injiciranje in ustrezno količino vehikla, da vsebuje raztopina po rekonstituciji v skladu z navodili 120 mikrogramov v 0, 5 ml peginterferona alfa- 2b.
Dose to be administered ViraferonPeg should be administered as a once weekly subcutaneous injection.
192 Odmerek za injiciranje Zdravilo ViraferonPeg dajemo enkrat na teden v obliki subkutane injekcije.
186 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Kombinirana terapija ViraferonPeg 1, 5 mikrogramov/ kg na teden skupaj s kapsulami ribavirina.
In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ml) who become HCV-RN A negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i.e. overall 48 weeks treatment duration).
V podskupini bolnikov, ki so okuženi z virusom genotipa 1 in imajo majhno virusno obremenitev (< 600. 000 i. e. / ml) ter katerih izvidi na HCV- RNA postanejo negativni v 4. tednu zdravljenja in so še vedno negativni v 24. tednu zdravljenja, lahko zdravljenje bodisi ustavite po ciklusu terapije v 24. tednu, ali pa ga nadaljujete še za dodatnih 24 tednov (tako da bo skupno trajanje zdravljenja 48 tednov).
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.
193 Raziskave so pokazale, da je zgodnji virološki odziv do 12. tedna zdravljenja, ki je opredeljen kot zmanjšanje virusnega bremena za 2 log točki ali doseganje nemerljive količine RNA virusa HCV v serumu, dober napovednik stalnega odziva na zdravljenje.
187 Duration of treatment - Retreatment Predictability of sustained virological response:
Trajanje zdravljenja - Ponovno zdravljenje Predvidljivost stalnega virološkega odziva:
188 Combination Therapy Dose Reduction Guidelines
194 Smernice za zmanjšanje odmerka pri kombinirani terapiji
g/dl decrease in haemoglobin during any four week period during treatment (permanent dose reduction) -< 1.5 x 109/l -< 0.75 x 109/l 9
kateremkoli štiritedenskem obdobju med
Table 3a Dose modification guidelines for ViraferonPeg monotherapy
195 Preglednica 3a Smernice za prilagajanje odmerka za monoterapijo z zdravilom ViraferonPeg Laboratorijske
189 Dose reduction for patients who use 0.5 μg/kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Zmanjšanje odmerka pri bolnikih, ki jemljejo 0, 5 μg/ kg zdravila ViraferonPeg v monoterapiji, mora biti doseženo z zmanjšanjem predpisanega volumna za pol.
Use in hepatic impairment:
196 Uporaba pri jetrni okvari:
in the previous six months (see section 4.4); 190
šestih mesecih (glejte poglavje 4. 4);
Acute hypersensitivity:
197 Akutna preobčutljivost:
191 Hydration:
Hidracija:
Metabolic disturbances:
198 Presnovne motnje:
192 Haematological abnormalities in HCV/HIV co-infected patients:
Hematološke motnje pri bolnikih, sočasno okuženih s HCV in HIV:
Other:
199 Drugo:
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.
200 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.
Adverse reactions reported in clinical trials or through post-marketing surveillance in patients treated with interferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg + ribavirin.
201 Preglednica 4 Neželeni učinki, o katerih so poročali v kliničnih preskušanjih ali v času postmarketinškega spremljanja bolnikov, zdravljenih z interferonom alfa- 2b, vključno z monoterapijo z zdravilom ViraferonPeg ali s kombinirano terapijo z zdravilom ViraferonPeg in ribavirinom
Headache, mouth dry*
zmedenost, tremor, ataksija, nevralgija, vertigo, parestezije, hipoestezija, hiperestezija, hipertonija, migrena, povečano potenje
Frequency not known:
202 Pogostnost ni znana:
Sinusitis, bronchitis, dysphonia, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough 196
sinusitis, bronhitis, disfonija, epistaksa, rinitis, bolezni dihal, kongestija nosne sluznice, rinoreja, neproduktiven kašelj
Stevens Johnson syndrome, toxic epidermal necrolysis, injection site necrosis, erythema multiforme
Stevens- Johnsonov sindrom, toksična epidermalna nekroliza, nekroza na mestu injiciranja, multiformni eritem 203
197 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
V neki klinični raziskavi je imelo približno 1, 2% bolnikov, zdravljenih z zdravilom ViraferonPeg ali z interferonom alfa- 2b v kombinaciji z ribavirinom med zdravljenjem smrtno nevarne duševne pojave.
Mitochondrial toxicity:
204 Toksičnost za mitohondrije:
198 Doses up to 10.5 times the intended dose have been reported.
Poročali so o zaužitju odmerkov tudi do 10, 5- kratnika odmerka, ki ga je bolnik nameraval vzeti.
199 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.
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.
In the Viraferon Peg 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). • ViraferonPeg (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) + ribavirin (1,000/1,200 mg/day), (n = 514). • Interferon alfa-2b (3 MIU three times a week) + ribavirin (1,000/1,200 mg/day) (n = 505).
3- krat na teden) + ribavirin (1. 000/ 1. 200 mg/ dan) (n = 505).
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
206 HCV genotip in virusna obremenitev na začetku sta prognostična dejavnika, za katera je znano, da vplivata na stopnjo odziva.
P 1.5 ViraferonPeg 1.5 micrograms/kg P 1.0 ViraferonPeg 1.0 microgram/kg P 0.5 ViraferonPeg 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/R P 0.5/ R I/R * **
P 1, 5/ R P 0, 5/ R I/ R * **
In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with ribavirin 800 mg –1,400 mg p.o. for 6 months (based on body weight, only three patients weighing > 105 kg, received the 1,400 mg dose) (Table 7).
207 V ločenem preskušanju je 224 bolnikov z genotipom 2 ali 3 prejemalo ViraferonPeg, 1, 5 mikrograma/ kg subkutano enkrat na teden, skupaj z ribavirinom od 800 mg do 1. 400 mg peroralno v času 6 mesecev (glede na telesno maso - 1. 400 mg za bolnike s telesno maso > 105 kg; vključeni so bili le 3 bolniki) (Preglednica 7).
> 600,000 IU/ ml
83% (177/ 213)
93% (169/182)
(3 milijone i. e.
79% (143/182)
i. e. trikrat na teden) +
14%
(1, 5 µg/ kg / teden) +
(24/166)
trikrat na teden) +
≤ 600,000 IU/ml
µg/ teden) + ribavirin
93% (92/99)
ribavirin
86% (85/99)
Vredno
8% (7/91)
ribavirin
93% (77/83)
Vredn
In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
ost pa
201 Predictability of sustained virological response – Naïve patients Virological reponse 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 (Table 8).
mg) d
202 Table 9
Genotip 2, 3
203 Table 10 Rates of Response to retreatment in prior treatment failures
Stopnje odziva na ponovno zdravljenje v primeru, da je bilo prejšnje zdravljenje neuspešno
1
210
30.2 (343/1,135)
56, 6, 84, 0
23.0 (162/70 4)
27, 4, 92, 6
204 Overall, approximately 36% (821/2,286) of patients had undetectable plasma HCV-RNA levels at Week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
Skupaj je imelo v 12. tednu zdravljenja približno 36% (821/ 2286) bolnikov nezaznavne koncentracije HCV- RNA v plazmi, kar so merili z raziskovalnim testom (meja detekcije 125 i. e. / ml).
5.2 Pharmacokinetic properties
211 5. 2 Farmakokinetične lastnosti
205 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Odmerek zdravila ViraferonPeg v monoterapiji je treba zmanjšati pri bolnikih z zmerno ali hudo ledvično okvaro (glejte poglavji 4. 2 in 4. 4).
5.3 Preclinical safety data
212 5. 3 Predklinični podatki o varnosti
6.5 Nature and contents of container
213 6. 5 Vrsta ovojnine in vsebina
ViraferonPeg 120 micrograms is supplied as:
Zdravilo ViraferonPeg 120 mikrogramov je na voljo v naslednjih pakiranjih:
ViraferonPeg pre-filled pen contains a powder of peginterferon alfa-2b and a solvent for solution at a strength of 120 micrograms for single use.
Napolnjen peresnik ViraferonPeg vsebuje prašek peginterferona alfa- 2b in vehikel za pripravo raztopine v jakosti 120 mikrogramov za enkratno uporabo.
The reconstituted solution has a concentration of 120 micrograms in 0.5 ml.
Koncentracija rekonstituirane raztopine je 120 mikrogramov na 0, 5 ml.
208 1.
215 1.
ViraferonPeg 150 micrograms, powder and solvent for solution for injection in pre-filled pen
ViraferonPeg 150 mikrogramov, prašek in vehikel za raztopino za injiciranje v napolnjenem peresniku
Each pre-filled pen of ViraferonPeg 150 micrograms contains a sufficient amount of peginterferon alfa-2b as measured on a protein basis in a powder for solution for injection, and the corresponding amount of solvent, to provide 150 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Vsak napolnjen peresnik zdravila ViraferonPeg 150 mikrogramov vsebuje zadostno količino peginterferona alfa- 2b (merjeno glede na beljakovine) v prašku za raztopino za injiciranje in ustrezno količino vehikla, da vsebuje raztopina po rekonstituciji v skladu z navodili 150 mikrogramov v 0, 5 ml peginterferona alfa- 2b.
Dose to be administered ViraferonPeg should be administered as a once weekly subcutaneous injection.
216 Odmerek za injiciranje Zdravilo ViraferonPeg dajemo enkrat na teden v obliki subkutane injekcije.
209 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Kombinirana terapija ViraferonPeg 1, 5 mikrogramov/ kg na teden skupaj s kapsulami ribavirina.
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.
217 Raziskave so pokazale, da je zgodnji virološki odziv do 12. tedna zdravljenja, ki je opredeljen kot zmanjšanje virusnega bremena za 2 log točki ali doseganje nemerljive količine RNA virusa HCV v serumu, dober napovednik stalnega odziva na zdravljenje.
210 Duration of treatment - Retreatment Predictability of sustained virological response:
Trajanje zdravljenja - Ponovno zdravljenje Predvidljivost stalnega virološkega odziva:
211 Combination Therapy Dose Reduction Guidelines
218 Smernice za zmanjšanje odmerka pri kombinirani terapiji
Labora tory values
Laboratorijske