natgillin/translations-raw huggingface dataset:
Table 3a Dose modification guidelines for ViraferonPeg monotherapy
219 Preglednica 3a Smernice za prilagajanje odmerka za monoterapijo z zdravilom ViraferonPeg Laboratorijske
212 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:
220 Uporaba pri jetrni okvari:
in the previous six months (see section 4.4); 213
šestih mesecih (glejte poglavje 4. 4);
Acute hypersensitivity:
221 Akutna preobčutljivost:
214 Hydration:
Hidracija:
Metabolic disturbances:
222 Presnovne motnje:
215 Haematological abnormalities in HCV/HIV co-infected patients:
Hematološke motnje pri bolnikih, sočasno okuženih s HCV in HIV:
Other:
223 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.
224 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.
217 breast-feeding should be discontinued prior to initiation of treatment.
Zaradi nevarnosti neželenih učinkov pri dojenih dojenčkih naj matere dojenje prekinejo pred začetkom zdravljenja.
Adverse reactions reported in clinical trials or through post-marketing surveillance in patients treated with interferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg + ribavirin.
225 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:
226 Pogostnost ni znana:
Sinusitis, bronchitis, dysphonia, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough 219
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 227
220 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:
228 Toksičnost za mitohondrije:
CD4 lymphocytes decrease:Treatment with ViraferonPeg in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Zdravljenje z zdravilom ViraferonPeg v kombinaciji z ribavirinom je bilo povezano z zmanjšanjem absolutnega števila celic CD4+ v prvih 4 tednih, brez zmanjšanja odstotka celic CD4+.
222 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.
This study showed that Viraferon Peg was superior to interferon alfa-2b (Table 5).
Ta raziskava je potrdila, da je zdravilo ViraferonPeg boljše od interferona alfa- 2b (Preglednica 5).
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
230 HCV genotip in virusna obremenitev na začetku sta prognostična dejavnika, za katera je znano, da vplivata na stopnjo odziva.
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).
231 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).
224 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.
V neprimerjalnem preskušanju je 235 bolnikov, ki so bili okuženi z virusom genotipa 1 in so imeli majhno virusno obremenitev (< 600. 000 i. e. / ml), prejemalo ViraferonPeg v odmerku 1, 5 mikrograma/ kg subkutano enkrat na teden, v kombinaciji z ribavirinom v odmerku, izračunanem glede na telesno maso.
Table 8
232 Preglednica 8
Genotype Viral response Sustained response Negative predictive value at week 12
Negativna napovedna vrednost
ViraferonPeg 1.5 + ribavirin (> 10.6 mg/kg)
+ ribavirin (> 10, 6 mg/ kg)
48-week treatment ViraferonPeg 1.5
48 - tedensko zdravljenje ViraferonPeg 1, 5
+ ribavirin 800-1,400 mg
+ ribavirin 800 – 1. 400 mg
225 Table 9
Študija 11
Sustained virological response based on genotype after ViraferonPeg in combination with Ribavirin in HCV/HIV Co-infected patients Study 11 Study 22 ViraferonPeg Interferon ViraferonPeg Interferon (100 or alfa-2b (1.5 µg/kg/ alfa-2b 150c µg/week) (3 MIU TIW) week) + (3 MIU TIW) + + ribavirin + ribavirin ribavirin ribavirin p (800- (800- p (800 mg) (800 mg) valuea 1,200 mg) d 1,200 mg) d valueb
ViraferonPeg (100 or 150c
All Genotype 1, 4
alfa- 2b (3 milijone
226 Table 10 Rates of Response to retreatment in prior treatment failures
Stopnje odziva na ponovno zdravljenje v primeru, da je bilo prejšnje zdravljenje neuspešno
70.3 (5 2/74) 56.6, 84.0
70, 3 (52/ 74)
51.3 (176/3 43) 44.4, 58.3
51, 3 (176/ 343) 44, 4, 58, 3
227 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
235 5. 2 Farmakokinetične lastnosti
228 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
236 5. 3 Predklinični podatki o varnosti
The se studies were limited to four weeks due to the appearance of anti-interferon antibodies in most monkeys.
Trajanje teh raziskav je bilo omejeno na 4 tedne zaradi pojava protiteles proti interferonu pri večini opic.
immediately, in -use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 2 4 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.
6.5 Nature and contents of container
237 6. 5 Vrsta ovojnine in vsebina
ViraferonPeg 150 micrograms is supplied as:
Zdravilo ViraferonPeg 150 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 150 micrograms for single use.
Napolnjen peresnik ViraferonPeg vsebuje prašek peginterferona alfa- 2b in vehikel za pripravo raztopine v jakosti 150 mikrogramov za enkratno uporabo.
The reconstituted solution has a concentration of 150 micrograms in 0.5 ml.
Koncentracija rekonstituirane raztopine je 150 mikrogramov na 0, 5 ml.
231 ANNEX II
239 DODATEK II
232 A.
240 A.
SP (Brinny) Company Innishannon - County Cork Ireland
Industriepark 30 B- 2220 Heist- op- den- Berg Belgija
Industriepark 30 B-2220 Heist-op-den-Berg Belgium
Industriepark, 30 B- 2220 Heist- op- den- Berg Belgija
Summary of Product Characteristics, section 4.2).
Povzetek glavnih značilnosti zdravila, 4. 2).
233 ANNEX III
241 DODATEK III
234 A.
242 A.
235 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
243 PODATKI NA ZUNANJI OVOJNINI
ViraferonPeg 50 micrograms powder and solvent for solution for injection peginterferon alfa-2b
ViraferonPeg 50 mikrogramov, prašek in vehikel za raztopino za injiciranje peginterferon alfa- 2b
One vial of powder contains 50 micrograms of peginterferon alfa-2b and provides 50 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Ena viala praška vsebuje 50 mikrogramov peginterferona alfa- 2b in ima 50 mikrogramov/ 0, 5 ml peginterferona alfa- 2b po rekonstituciji v skladu s priporočili.
One ampoule of solvent contains 0.7 ml of water for injections.
Ena ampula vehikla vsebuje 0, 7 ml vode za injekcije.
1 vial of powder, 1 ampoule of solvent 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 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 50 micrograms/0.5 ml
1 viala praška, 1 ampula vehikla 1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon 4 viale praška, 4 ampule vehikla 4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi 6 vial praška, 6 ampul vehikla 12 vial praška, 12 ampule vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov 50 mikrogramov/ 0, 5 ml
Subcutaneous use Read the package leaflet before use.
Subkutana uporaba Pred uporabo preberite priloženo navodilo.
EXP After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Po rekonstituciji uporabite rekonstituirano raztopino takoj ali v roku 24 ur, če ste jo medtem shranili v hladilniku (2 °C – 8 °C).
236 9.
244 9.
EU/1/00/132/001 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/002 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/132/003 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/004 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/132/005 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/026 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 132/ 001 (1 viala praška, 1 ampula vehikla) EU/ 1/ 00/ 132/ 002 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon) EU/ 1/ 00/ 132/ 003 (4 viale praška, 4 ampule vehikla) EU/ 1/ 00/ 132/ 004 (4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi) EU/ 1/ 00/ 132/ 005 (6 vial praška, 6 ampul vehikla) EU/ 1/ 00/ 132/ 026 (12 vial praška, 12 ampule vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
237 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
245 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
ViraferonPeg 50 micrograms powder for injection SC
ViraferonPeg 50 mikrogramov prašek za injekcijo s. c.
238 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
246 PODATKI NA ZUNANJI OVOJNINI
ViraferonPeg 80 micrograms powder and solvent for solution for injection peginterferon alfa-2b
ViraferonPeg 80 mikrogramov, prašek in vehikel za raztopino za injiciranje peginterferon alfa- 2b
One vial of powder contains 80 micrograms of peginterferon alfa-2b and provides 80 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Ena viala praška vsebuje 80 mikrogramov peginterferona alfa- 2b in ima 80 mikrogramov/ 0, 5 ml peginterferona alfa- 2b po rekonstituciji v skladu s priporočili.
1 vial of powder, 1 ampoule of solvent 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 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 80 micrograms/0.5 ml
1 viala praška, 1 ampula vehikla 1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon 4 viale praška, 4 ampule vehikla 4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi 6 vial praška, 6 ampul vehikla 12 vial praška, 12 ampule vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov 80 mikrogramov/ 0, 5 ml
239 After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Po rekonstituciji uporabite rekonstituirano raztopino takoj ali v roku 24 ur, če ste jo medtem shranili v hladilniku (2 °C – 8 °C).
EU/1/00/132/006 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/007 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/132/008 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/009 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/132/010 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/027 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 132/ 006 (1 viala praška, 1 ampula vehikla) EU/ 1/ 00/ 132/ 007 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon) EU/ 1/ 00/ 132/ 008 (4 viale praška, 4 ampule vehikla) EU/ 1/ 00/ 132/ 009 (4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi) EU/ 1/ 00/ 132/ 010 (6 vial praška, 6 ampul vehikla) EU/ 1/ 00/ 132/ 027 (12 vial praška, 12 ampule vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
240 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
248 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
ViraferonPeg 80 micrograms powder for injection SC
ViraferonPeg 80 mikrogramov prašek za injekcijo s. c.
241 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
249 PODATKI NA ZUNANJI OVOJNINI
ViraferonPeg 100 micrograms powder and solvent for solution for injection peginterferon alfa-2b
ViraferonPeg 100 mikrogramov, prašek in vehikel za raztopino za injiciranje peginterferon alfa- 2b
One vial of powder contains 100 micrograms of peginterferon alfa-2b and provides 100 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Ena viala praška vsebuje 100 mikrogramov peginterferona alfa- 2b in ima 100 mikrogramov/ 0, 5 ml peginterferona alfa- 2b po rekonstituciji v skladu s priporočili.
1 vial of powder, 1 ampoule of solvent 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 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 100 micrograms/0.5 ml
1 viala praška, 1 ampula vehikla 1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon 4 viale praška, 4 ampule vehikla 4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi 6 vial praška, 6 ampul vehikla 12 vial praška, 12 ampule vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov 100 mikrogramov/ 0, 5 ml
242 9.
250 9.
EU/1/00/132/011 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/012 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/132/013 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/014 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/132/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 132/ 011 (1 viala praška, 1 ampula vehikla) EU/ 1/ 00/ 132/ 012 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon) EU/ 1/ 00/ 132/ 013 (4 viale praška, 4 ampule vehikla) EU/ 1/ 00/ 132/ 014 (4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi) EU/ 1/ 00/ 132/ 015 (6 vial praška, 6 ampul vehikla) EU/ 1/ 00/ 132/ 028 (12 vial praška, 12 ampule vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
243 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
251 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
ViraferonPeg 100 micrograms powder for injection SC
ViraferonPeg 100 mikrogramov prašek za injekcijo s. c.
244 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
252 PODATKI NA ZUNANJI OVOJNINI
ViraferonPeg 120 micrograms powder and solvent for solution for injection peginterferon alfa-2b
ViraferonPeg 120 mikrogramov, prašek in vehikel za raztopino za injiciranje peginterferon alfa- 2b
One vial of powder contains 120 micrograms of peginterferon alfa-2b and provides 120 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Ena viala praška vsebuje 120 mikrogramov peginterferona alfa- 2b in ima 120 mikrogramov/ 0, 5 ml peginterferona alfa- 2b po rekonstituciji v skladu s priporočili.
1 vial of powder, 1 ampoule of solvent 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 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 120 micrograms/0.5 ml
1 viala praška, 1 ampula vehikla 1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon 4 viale praška, 4 ampule vehikla 4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi 6 vial praška, 6 ampul vehikla 12 vial praška, 12 ampule vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov 120 mikrogramov/ 0, 5 ml
245 After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Po rekonstituciji uporabite rekonstituirano raztopino takoj ali v roku 24 ur, če ste jo medtem shranili v hladilniku (2 °C – 8 °C).
EU/1/00/132/016 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/017 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/132/018 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/019 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/132/020 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 132/ 016 (1 viala praška, 1 ampula vehikla) EU/ 1/ 00/ 132/ 017 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon) EU/ 1/ 00/ 132/ 018 (4 viale praška, 4 ampule vehikla) EU/ 1/ 00/ 132/ 019 (4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi) EU/ 1/ 00/ 132/ 020 (6 vial praška, 6 ampul vehikla) EU/ 1/ 00/ 132/ 029 (12 vial praška, 12 ampule vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
246 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
254 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
ViraferonPeg 120 micrograms powder for injection SC
ViraferonPeg 120 mikrogramov prašek za injekcijo s. c.
247 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
255 PODATKI NA ZUNANJI OVOJNINI
ViraferonPeg 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b
ViraferonPeg 150 mikrogramov, prašek in vehikel za raztopino za injiciranje peginterferon alfa- 2b
One vial of powder contains 150 micrograms of peginterferon alfa-2b and provides 150 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Ena viala praška vsebuje 150 mikrogramov peginterferona alfa- 2b in ima 150 mikrogramov/ 0, 5 ml peginterferona alfa- 2b po rekonstituciji v skladu s priporočili.
1 vial of powder, 1 ampoule of solvent 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 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 150 micrograms/0.5 ml
1 viala praška, 1 ampula vehikla 1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon 4 viale praška, 4 ampule vehikla 4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi 6 vial praška, 6 ampul vehikla 12 vial praška, 12 ampule vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov 150 mikrogramov/ 0, 5 ml
248 After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Po rekonstituciji uporabite rekonstituirano raztopino takoj ali v roku 24 ur, če ste jo medtem shranili v hladilniku (2 °C – 8 °C).
EU/1/00/132/021 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/022 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/132/023 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/024 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/132/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 132/ 021 (1 viala praška, 1 ampula vehikla) EU/ 1/ 00/ 132/ 022 (1 viala praška, 1 ampula vehikla, 1 injekcijska brizga, 2 injekcijski igli, 1 čistilni tampon) EU/ 1/ 00/ 132/ 023 (4 viale praška, 4 ampule vehikla) EU/ 1/ 00/ 132/ 024 (4 viale praška, 4 ampule vehikla, 4 injekcijske brizge, 8 injekcijskih igel, 4 čistilni tamponi) EU/ 1/ 00/ 132/ 025 (6 vial praška, 6 ampul vehikla) EU/ 1/ 00/ 132/ 030 (12 vial praška, 12 ampule vehikla, 12 injekcijskih brizg, 24 injekcijskih igel, 12 čistilnih tamponov)
249 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
257 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
ViraferonPeg 150 micrograms powder for injection SC
ViraferonPeg 150 mikrogramov prašek za injekcijo s. c.
250 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
258 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Solvent for ViraferonPeg Water for injections
Vehikel za ViraferonPeg Voda za injiciranje
251 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
259 PODATKI NA ZUNANJI OVOJNINI
Carton 50 micrograms powder and solvent for solution for injection
Škatla 50 mikrogramov prašek in vehikel za raztopino za injiciranje