natgillin/translations-raw huggingface dataset:
Creatinine ALT/AST
< 50 x 10 / l
> 2.0 mg/dl 2 x baseline and > 10 x ULN**
Bilirubin – direktni
Vial/Pen
> 4 mg/ dl
Dose (μg)
> 2, 0 mg/ dl
(μg/0.5 ml)
Jakost viale ali peresnika (μg/ 0, 5 ml)
(μg)
Dana količina (μg)
Table 3a Dose modification guidelines for ViraferonPeg monotherapy
29 Preglednica 3a Smernice za prilagajanje odmerka za monoterapijo z zdravilom ViraferonPeg Laboratorijske
28 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.
The 50 μg/0.5 ml vial must be used if necessary since the pen can only deliver a minimum volume of 0.3 ml.
Po potrebi uporabite viale s 50 μg/ 0, 5 ml, saj lahko s peresnikom injiciramo minimalni volumen 0, 3 ml.
For patients who use 1.0 μg/kg ViraferonPeg monotherapy, dose reduction may be accomplished by reducing the prescribed volume by one-half or by utilizing a lower dose strength as shown in Table 3b.
Za bolnike, ki jemljejo 1, 0 μg/ kg zdravila ViraferonPeg v monoterapiji, zmanjšanje odmerka dosežemo z zmanjšanjem predpisanega volumna za pol ali z uporabo manjše jakosti, kot je prikazano v Preglednici 3b.
Table 3b – Reduced ViraferonPeg Dose for the 1.0 μg/kg Monotherapy Regimen
Preglednici 3b – Zmanjšani odmerek zdravila ViraferonPeg za monoterapijo z 1, 0 μg/ kg
Dose (μg)
Enkrat na teden (ml)
Once Weekly
Injicirana količina
(μg/0.5 ml)
(μg/ 0, 5 ml)
Patients with severe renal dysfunction (creatinine clearance 15-29 ml/minute) should have the starting dose of ViraferonPeg reduced by 50%.
Pri bolnikih z zmernimi motnjami delovanja ledvic (očistek kreatinina od 30 do 50 ml/ minuto) začetni odmerek zdravila ViraferonPeg zmanjšajte za 25%, pri tistih s hudimi motnjami delovanja ledvic (očistek kreatinina od 15 do 29 ml/ minuto) pa morate začetni odmerek zdravila ViraferonPeg zmanjšati za 50%.
Data are not available for the use of ViraferonPeg in patients with creatinine clearance < 15 ml/minute (see section 5.2).
Ni podatkov o uporabi zdravila ViraferonPeg pri bolnikih z očistkom kreatinina < 15 ml/ minuto (glejte poglavje 5. 2).
Patients with creatinine clearance < 50 ml/minute must not be treated with ViraferonPeg in combination with ribavirin (see ribavirin SPC).
Bolnikov z očistkom kreatinina < 50 ml/ minuto ne smete zdraviti z zdravilom ViraferonPeg v kombinaciji z ribavirinom (glejte SPC za ribavirin).
Use in hepatic impairment:
30 Uporaba pri jetrni okvari:
- A history of severe pre-exist ing cardiac disease, including unstable or uncontrolled cardiac disease
- obstoječa huda bolezen srca, vključno z nestabilno ali nenadzorovano srčno boleznijo v preteklih
- Epilepsy and/or compromised central nervous system (CNS) function;
- epilepsija in/ ali motnje delovanja osrednjega živčevja (CŽS);
- Initiation of ViraferonPeg is contraindicated in HCV/HIV patients with cirrhosis and a Child-Pugh
- Uvedba zdravila ViraferonPeg je kontraindicirana pri bolnikih, ki so sočasno okuženi s HCV in
All patients in the chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i.e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Vsi bolniki iz raziskav kroničnega hepatitisa C so imeli jetrno biopsijo pred vključitvijo v raziskavo, vendar je v določenih primerih (npr. pri bolnikih z genotipom 2 in 3) zdravljenje možno brez histološke potrditve.
Acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been observed rarely during interferon alfa-2b therapy.
Če se
If such a reaction develops during treatment with ViraferonPeg, discontinue treatment and institute appropriate medical therapy immediately.
31 med zdravljenjem z zdravilom ViraferonPeg pojavi taka reakcija, morate takoj prekiniti zdravljenje in uvesti ustrezno medikamentozno terapijo.
As with interferon alfa-2b, patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, receiving ViraferonPeg therapy require close monitoring.
Kot pri interferonu alfa- 2b morate tudi pri zdravljenju z zdravilom ViraferonPeg bolnike s kongestivnim srčnim popuščanjem v anamnezi, miokardnim infarktom in/ ali preteklo ali sedanjo srčno aritmijo skrbno spremljati.
30 Hydration:
Hidracija:
HCV/HIV Co-infection Mitochondrial toxicity and lactic acidosis:
32 Sočasna okužba s HCV in HIV Toksičnost za mitohondrije in laktacidoza:
31 Haematological abnormalities in HCV/ HIV co-infected patients:
Hematološke motnje pri bolnikih, sočasno okuženih s HCV in HIV:
HCV/HIV co-infected patients receiving peginterferon alfa-2b/ribavirin treatment and HAART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients.
Bolniki, ki so sočasno okuženi z virusom HCV in HIV ter se zdravijo s peginterferonom alfa- 2b in ribavirinom in s terapijo HAART, imajo lahko povečano tveganje za nastanek hematoloških motenj (v obliki nevtropenije, trombocitopenije in anemije) v primerjavi s tistimi, ki so okuženi samo s HCV.
Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “Laboratory tests” and section 4.8).
Čeprav bi lahko pri večini teh bolnikov zmanjšali odmerek, je pri tej skupini bolnikov potrebno skrbno spremljanje hematoloških parametrov (glejte poglavje 4. 2, “ Laboratorijske preiskave ” v nadaljevanju in poglavje 4. 8).
In patients co-infected with HCV/HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/µl.
Pri bolnikih, ki so sočasno okuženi s HCV in HIV, so na voljo omejeni podatki o učinkovitosti in varnosti zdravila (N = 25) za tiste, ki imajo število celic CD4 manjše od 200 celic/ μl.
Other:
33 Drugo:
Caution should be used when admin istering peginterferon alfa-2b with medicinesmetabolised by CYP2D6 and CYP2C8/9, especially those with narrow therapeutic window, such as warfarin and phenytoin (CYP2C9) and flecainide (CYP2D6).
Pri uporabi peginterferona alfa- 2b z zdravili, ki se presnovijo s pomočjo CYP2D6 in CYP2C8/ 9, je potrebna previdnost, še posebej pri tistih z majhno terapevtsko širino, kot so varfarin in fenitoin (CYP2C9) ter flekainid (CYP2D6).
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.
34 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.
There are no adequate data from the use of interferon alfa-2b in pregnant women..
Ni zadostnih podatkov o uporabi interferona alfa- 2b pri nosečnicah.
ViraferonPeg is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus
Zdravilo ViraferonPeg lahko med nosečnostjo uporabljate le, če potencialne koristi upravičijo potencialno tveganje za plod.
Adverse reactions reported in clinical trials or through post-marketing surveillance in patients treated with interferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg + ribavirin.
35 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
Infections and infestations Very common:
Infekcijske in parazitske bolezni virusne okužbe * Zelo pogosti:
Cerebrovascular haemorrhage, cerebrovascular ischaemia, encephalopathy
možganskožilne krvavitve, možganskožilna ishemija,
Sinusitis, bronchitis, dysphonia, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough 35
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 37
36 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.
HCV/HIV co-infected patients For HCV/HIV co-infected patients receiving ViraferonPeg in combination with ribavirin, other undesirable effects (that were not reported in mono-infected patients) which have been reported in the larger studies with a frequency > 5% were: oral candidiasis (14%), lipodystrophy acquired (13%), CD4 lymphocytes decreased (8%), appetite decreased (8%), gamma-glutamyltransferase increased (9%), back pain (5%), blood amylase increased (6%), blood lactic acid increased (5%), cytolytic hepatitis (6%), lipase increased (6%) and pain in limb (6%).
Bolniki, ki so bili sočasno okuženi s HCV in HIV in so prejemali zdravilo ViraferonPeg v kombinaciji z ribavirinom, so imeli naslednje dodatne neželene učinke, ki jih niso opažali pri bolnikih z eno samo okužbo, v študijah pa so jih prijavljali s pogostnostjo > 5%: peroralna kandidiaza (14%), pridobljena lipodistrofija (13%), zmanjšano število limfocitov CD4 (8%), zmanjšan tek (8%), zvišana vrednost gama glutamiltransferaze (9%), bolečine v hrbtu (5%), zvišana vrednost amilaze v krvi (6%),
37 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.
38 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.
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
40 HCV genotip in virusna obremenitev na začetku sta prognostična dejavnika, za katera je znano, da vplivata na stopnjo odziva.
39
≤ 600. 000 i. e. / ml Genotip 1
Genotype 1
≤ > ≤
In the ViraferonPeg monotherapy study, the Quality of Life was generally less affected by 0.5 microgram/kg of ViraferonPeg than by either 1.0 microgram/kg of ViraferonPeg once weekly or 3 MIU of interferon alfa-2b three times a week.
V raziskavi monoterapije z zdravilom ViraferonPeg je bila kakovost življenja običajno manj zmanjšana pri bolnikih, ki so prejemali po 0, 5 mikrograma/ kg zdravila ViraferonPeg kot pri tistih, ki so prejemali bodisi 1, 0 mikrograma/ kg zdravila ViraferonPeg enkrat na teden ali 3 mio i. e. interferona alfa- 2b trikrat na teden.
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).
41 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).
Virologic Response at End of Treatment, Sustained Virologic Response and Relapse by HCV Genotype and Viral Load* ViraferonPeg 1.5 μg/kg once weekly plus Ribavirin 800-1,400 mg/day
Zdravljenje ViraferonPeg 1, 5
End
Genotip
of Treatment Response
Virusni odziv v 12. tednu
Sustained Virologic Response
Trajen odziv
Relapse
Negativna napovedna vrednost
All Subjects
+ ribavirin (> 10, 6 mg/ kg)
94
1
% (211/224)
da 75% (82/ 110)
81% (182/224)
71% (58/ 82)
12% (27/224)
ne 25% (28/ 110)
HCV 2 ≤ 600,000 IU/ml
0% (0/ 28)
100% (42/42) 100% (20/20)
100%
93% (39/42) 95% (19/20)
+ ribavirin 800 – 1. 400 mg
7% (3/42) 5% (1/20)
da 99% (213/ 215)
> 600,000 IU/ml
83% (177/ 213)
100% (22/22)
ne 1% (2/ 215)
91% (20/22)
50% (1/ 2)
9% (2/22)
Študija 11
HCV 3
alfa- 2b (3 milijone
93% (169/182)
ViraferonPeg
79% (143/182)
(3 milijone i. e.
14%
i. e. trikrat na teden) +
(24/166)
(1, 5 µg/ kg / teden) +
≤ 600,000 IU/ml
trikrat na teden) +
93% (92/99)
µg/ teden) + ribavirin
86% (85/99)
ribavirin
8% (7/91)
Vredno
> 600,000 IU/ml
ribavirin
93% (77/83)
ribavirin
70% (58/83)
(800- 1200
23% (17/75)
(800- 1200
* Any subject with an undetectable HCV-RNA level at the Follow-Up Week 12 visit and missing data at the Follow- Up Week 24 visit was considered a sustained responder.
st pb
The 6 month treatment duration in this trial was better tolerated than one year of treatment in the pivotal combination trial; for discontinuation 5% vs.
(800 mg)
49%.
(800 mg)
40 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
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
Table 8
mg) d
Predictability of sustained response by viral response at week 12 and genotype*
Vsi
Treatment ViraferonPeg 1.5 + ribavirin (> 10.6 mg/kg) 48-week treatment ViraferonPeg 1.5 + ribavirin 800-1,400 mg
27% (56/ 205) 20% (41/ 205) 0, 047 44% (23/ 52)
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) ----
21% (9/ 43)
24-week treatment
0, 017
No 1% (2/215) 50% (1/2) 50%
Genotip 1, 4 17% (21/ 125)
* reflects patients
6% (8/ 129)
with 12 week data available
0, 006 38% (12/ 32)
The negative predictive value for sustained response in patients treated with ViraferonPeg in monotherapy was 98%.
7% (2/ 27)
HCV/HIV Co-infected patients Two trials have been conducted in patients co-infected with HIV and HCV.
0, 007
41 Table 9
Genotip 2, 3
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
44% (35/ 80)
1 Carrat F, Bani-Sadr F, Pol S et al.
43 b: vrednost p pri testu hi- kvadrat c: preiskovanci s telesno maso < 75 kg so prejemali 100 µg zdravila ViraferonPeg na teden, preiskovanci s telesno maso ≥ 75 kg pa so prejemali 150 µg zdravila ViraferonPeg na teden d: odmerek ribavirina je znašal 800 mg za bolnike s telesno maso < 60 kg, 1000 mg za bolnike s telesno maso od 60 do 75 kg in 1200 mg za tiste s telesno maso > 75 kg 1 Carrat F, Bani- Sadr F, Pol S in sod.
42 Table 10 Rates of Response to retreatment in prior treatment failures
Stopnje odziva na ponovno zdravljenje v primeru, da je bilo prejšnje zdravljenje neuspešno
38.6 (17/44) 19.7, 57.5
44
Genotype 2/3 Genotype
56, 6, 84, 0
67.9 (74/109)
27, 4, 92, 6
70.3 (52/74) 56.6, 84.0
35, 0, 57, 0
53.6 (15/28)
Genotip
43 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
45 5. 2 Farmakokinetične lastnosti
44 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
46 5. 3 Predklinični podatki o varnosti
6.5 Nature and contents of container
47 6. 5 Vrsta ovojnine in vsebina
ViraferonPeg 80 micrograms is supplied as:
ViraferonPeg 80 mikrogramov je na voljo v naslednjih pakiranjih:
ViraferonPeg is supplied as a powder of peginterferon alfa-2b at a strength of 80 micrograms for single use.
ViraferonPeg je na voljo v obliki praška peginterferona alfa- 2b v jakosti 80 mikrogramov za enkratno uporabo.
The reconstituted solution has a concentration of 80 micrograms/0.5 ml.
Koncentracija rekonstituirane raztopine je 80 mikrogramov/ 0, 5 ml.
ViraferonPeg 100 micrograms powder and solvent for solution for injection
ViraferonPeg 100 mikrogramov, prašek in vehikel za raztopino za injiciranje
Each vial of ViraferonPeg, powder for solution for injection contains 100 micrograms of peginterferon alfa-2b as measured on a protein basis.
Vsaka viala zdravila ViraferonPeg, prašek za raztopino za injiciranje, vsebuje 100 mikrogramov peginterferona alfa- 2b, merjeno glede na beljakovine.
Each vial provides 100 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Po rekonstituciji v skladu z navodili vsebuje vsaka viala 100 mikrogramov/ 0, 5 ml peginterferona alfa- 2b.
For more information, see section 5.1. *produced by rDNA technology in E.coli cells harbouring a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes
Za dodatne informacije glejte poglavje 5. 1. * izdelan s tehnologijo rekombinantne DNA na celicah E. coli, v katere so z genetskim inženiringom vstavili plazmidni hibrid z genom za interferon alfa- 2b iz človeških levkocitov
Dose to be administered ViraferonPeg should be administered as a once weekly subcutaneous injection.
50 Odmerek za injiciranje Zdravilo ViraferonPeg dajemo enkrat na teden v obliki subkutane injekcije.
48 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-RN A, has been shown to be predictive for sustained response.
51 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.
49 Duration of treatment - Retreatment Predictability of sustained virological response:
Trajanje zdravljenja - Ponovno zdravljenje Predvidljivost stalnega virološkega odziva:
50 Combination Therapy Dose Reduction Guidelines
52 Smernice za zmanjšanje odmerka pri kombinirani terapiji
- < 50 x 10 /l - - > 5 mg/dl -
< 1, 5 x 109/ l < 0, 75 x 109/ l 9
(μ g/0.5 ml)
Jakost viale ali peresnika (μg/ 0, 5 ml)
Table 3a Dose modification guidelines for ViraferonPeg monotherapy
53 Preglednica 3a Smernice za prilagajanje odmerka za monoterapijo z zdravilom ViraferonPeg Laboratorijske
51 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.
(μ g/0.5ml)
(μg/ 0, 5 ml)
Use in hepatic impairment:
54 Uporaba pri jetrni okvari:
Acute hypersensitivity:
55 Akutna preobčutljivost:
Acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been observed rarely during interferon alfa-2b therapy.
Med zdravljenjem z interferonom alfa- 2b so redko opažali akutne preobčutljivostne reakcije (npr. urtikarijo, angioedem, bronhokonstrikcijo, anafilaktične reakcije).
If such a reaction develops during treatment with ViraferonPeg, discontinue treatment and institute appropriate medical therapy immediately.
Če se med zdravljenjem z zdravilom ViraferonPeg pojavi taka reakcija, morate takoj prekiniti zdravljenje in uvesti ustrezno medikamentozno terapijo.
53 Hydration:
Hidracija:
Infrequently, patients treated for chronic hepatitis C with interferon alpha have developed thyroid abnormalities, ei ther hypothyroidism or hyperthyroidism.
Redko se lahko pri bolnikih zdravljenih z interferonom alfa- 2b zaradi kroničnega hepatitisa C pojavijo motnje delovanja žleze ščitnice - hipertiroza ali hipotiroza.
Metabolic disturbances:
56 Presnovne motnje:
HCV/HIV Co-infection Mitochondrial toxicity and lactic acidosis:
Sočasna okužba s HCV in HIV Toksičnost za mitohondrije in laktacidoza:
54 Haematological abnormalities in HCV/HIV co-infected patients:
Hematološke motnje pri bolnikih, sočasno okuženih s HCV in HIV:
Other:
57 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.
58 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.
59 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:
60 Pogostnost ni znana:
Sinusitis, bronchitis, dysphonia, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough 58
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 61
59 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:
62 Toksičnost za mitohondrije:
60 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.
61 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.
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
64 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 * **