natgillin/translations-raw huggingface dataset:
Headache, dizziness Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
glavobol, omotica hiperkinezija, tremor, disfonija, parestezije, hipoestezija, hiperestezija, zmanjšana koncentracija, somnolenca
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased
alopecija, izpuščaj preobčutljivostne reakcije na svetlobo, makulopapulozni izpuščaj, ekcem, akne, kožne bolezni, bolezni nohtov, obarvanje kože, pruritus, suha koža, eritem, podplutbe, povečano potenje
Chest pain, asthenia, oedema, injection site pain
ženske: amenoreja, menoragija, motnje menstruacije, bolezni vagine moški: bolečine v modih vnetje na mestu injiciranja, reakcija na mestu injiciranja, utrujenost, mrzlica, zvišana telesna temperatura§, gripi podobni simptomi§, splošno slabo počutje, razdražljivost, bolečine v prsih, astenija, edem, bolečine na mestu injiciranja
Growth rate decrease (height and/or weight decrease for age)§
zmanjšana rast (premajhna telesna višina in/ ali masa glede na starost) §
Common: § See section 4.4
Pogosti: § glejte poglavje 4. 4
Immunostimulants, cytokines and immunomodulators, interferons, interferon alfa-2b, ATC code:
Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, citokini in imunomodulatorji, interferoni, interferon alfa- 2b, oznaka ATC:
IntronA is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques.
IntronA je sterilna, stabilna oblika visokoprečiščenega interferona alfa- 2b, ki ga izdelujemo s tehnikami rekombinantne DNA.
Recombinant interferon alfa-2b is a water-soluble protein with a molecular weight of approximately 19,300 daltons.
Rekombinantni interferon alfa- 2b je vodotopna beljakovina z molekulsko maso približno 19. 300 daltonov.
It is obtained from a clone of E. coli, which harbours a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
Pridobiva se iz klona E. coli, v katerega je vgrajen plasmidni hibrid izdelan z genetskim inženiringom, ki vsebuje gen za interferon alfa- 2b iz človeških levkocitov.
The activity of IntronA is expressed in terms of IU, with 1 mg of recombinant interferon alfa-2b protein corresponding to 2.6 x l08 IU.
Aktivnost zdravila IntronA izražamo v i. e., pri čemer 1 mg rekombinantne beljakovine interferona alfa- 2b ustreza 2, 6 x 108 i. e.
International Units are determined by comparison of the activity of the recombinant interferon alfa-2b with the activity of the international reference preparation of human leukocyte interferon established by the World Health Organisation.
Število mednarodnih enot se določi s primerjavo aktivnosti rekombinantnega interferona alfa- 2b z aktivnostjo mednarodnega referenčnega pripravka interferona iz človeških levkocitov, ki ga je uvedla Svetovna zdravstvena organizacija.
The interferons are a family of small protein molecules with molecular weights of approximately 15,000 to 21,000 daltons.
Interferoni so skupina majhnih beljakovinskih molekul z molekulsko maso približno 15. 000 do 21. 000 daltonov.
IntronA has been classified as recombinant interferon alfa-2b.
IntronA je opredeljen kot rekombinantni interferon alfa- 2b.
 15 The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Izsledki številnih raziskav kažejo, da sproži interferon po vezavi na celično membrano zapleteno kaskado znotrajceličnih procesov, med drugim indukcijo nekaterih encimov.
Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and human cell culture systems as well as human tumour xenografts in animals.
Rekombinantni interferon alfa- 2b je v raziskavah na živalskih in človeških celičnih kulturah, pa tudi na človeških tumorskih ksenopresadkih na živalih, pokazal antiproliferativne učinke.
Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Rekombinantni interferon alfa- 2b tudi zavira replikacijo virusov in vitro in in vivo.
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
Četudi natančen mehanizem delovanja rekombinantnega interferona alfa- 2b proti virusom ni znan, kaže, da spremeni presnovo celice gostiteljice.
Chronic hepatitis B:
16 Kronični hepatitis B:
Current clinical experience in patients who remain on interferon alfa-2b for 4 to 6 months indicates that therapy can produce clearance of serum HBV-DNA.
Sedanje klinične izkušnje pri bolnikih, ki se zdravijo z interferonom alfa- 2b 4 do 6 mesecev, kažejo, da lahko s terapijo dosežemo očistek serumske HBV- DNA.
In adult patients with loss of HBeAg and HBV-DNA, a significant reduction in morbidity and mortality has been observed.
Pri odraslih bolnikih z izgubo HBeAg in HBV- DNA so ugotavljali znatno zmanjšanje obolevnosti in umrljivosti.
Interferon alfa-2b (6 MIU/m2 3 times a week for 6 months) has been given to children with chronic active hepatitis B.
Interferon alfa- 2b (6 mio. i. e. / m2 trikrat na teden 6 mesecev) so uporabljali pri otrocih s kroničnim aktivnim hepatitisom B.
Because of a methodological flaw, efficacy could not be demonstrated.
Zaradi pomanjkljivosti metodologije ni bilo mogoče dokazati učinkovitosti zdravila.
Moreover children treated with interferon alfa-2b experienced a reduced rate of growth and some cases of depression were observed.
Poleg tega so pri otrocih, zdravljenih interferonom alfa- 2b, opažali zmanjšano hitrost rasti in v nekaterih primerih depresijo.
Chronic hepatitis C:
Kronični hepatitis C:
In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is 47%.
Pri odraslih bolnikih, ki so prejemali interferon v kombinaciji z ribavirinom je bil trajen virološki odziv 47%.
Superior efficacy has been demonstrated with the combination of pegylated interferon with ribavirin (sustained response rate of 61% achieved in a study performed in naïve patients with a ribavirin dose > 10.6 mg/kg, p < 0.01).
Boljša učinkovitost pa se je pokazala pri uporabi pegiliranega interferona z ribavirinom (v študiji, opravljeni pri bolnikih, ki še niso prejemali tega zdravila, je bil z uporabo ribavirina v odmerku > 10, 6 mg/ kg, p < 0, 01 61% dosežen trajen virološki odziv na zdravljenje).
IntronA alone or in combination with ribavirin has been studied in 4 randomised Phase III clinical trials in 2,552 interferon-naïve patients with chronic hepatitis C.
Zdravilo IntronA v monoterapiji ali v kombinaciji z ribavirinom so raziskovali v 4 randomiziranih kliničnih raziskavah tretje faze pri 2. 552 bolnikih, ki še niso bili zdravljeni z interferonom in so imeli kronični hepatitis C.
The trials compared the efficacy of IntronA used alone or in combination with ribavirin.
V teh raziskavah so primerjali učinkovitost zdravila IntronA v monoterapiji ali v kombinaciji z ribavirinom.
Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 100 copies/ml), a liver biopsy consistent with a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Bolniki, primerni za vključitev v te raziskave, so imeli kronični hepatitis C, ki je bil potrjen s pozitivnim izvidom testa polimerazne verižne reakcije za HCV- RNA (PCR) (> 100 kopij/ ml), izvidom jetrne biopsije, ki je histološko potrdil diagnozo kroničnega hepatitisa brez drugega vzroka za kronični hepatitis, ter nenormalno serumsko vrednostjo ALT.
IntronA was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with ribavirin.
Zdravilo IntronA so dajali bolnikom v odmerku 3 mio. i. e. trikrat na teden, v monoterapiji ali v kombinaciji z ribavirinom.
Sustained virologic response rates for treatment groups treated for one year with IntronA alone or in combination with ribavirin (from two studies) are shown in Table 3.
Pogostnosti ohranjenega virološkega odziva za terapevtske skupine, zdravljene eno leto z zdravilom IntronA v monoterapiji ali v kombinaciji z ribavirinom (iz dveh raziskav) so podane v preglednici 3.
The increased response rate to the combination of IntronA + ribavirin, compared with IntronA alone, is maintained across all subgroups.
Povečana pogostnost odziva na kombinacijo zdravila IntronA in ribavirina, v primerjavi s samim zdravilom IntronA, se ohrani v vseh podskupinah.
The relative benefit of combination therapy with IntronA + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3).
Relativna koristnost kombinirane terapije z zdravilom IntronA in ribavirinom je še posebej pomembna za podskupino bolnikov, ki jih je najtežje zdraviti (genotip 1 in velika virusna obremenitev) (Preglednica 3).
 16 Response rates in these trials were increased with compliance.
Pogostnosti odziva v teh raziskavah so se povečevale z zdravljenjem po predpisih.
32% in trial C/I98-580).
Ne glede na genotip so imeli bolniki, ki so prejemali IntronA skupaj z ribavirinom in so prejeli  80% terapije, večji ohranjen odziv 6 mesecev po enoletnem zdravljenju kot tisti, ki so prejeli < 80% terapije (56% v primerjavi z 32% v raziskavi C/ I98- 580).
virologic response rates with IntronA + ribavirin (one year of treatment) by genotype and viral load
Pogostnosti ohranjenega virološkega odziva pri uporabi zdravila IntronA in ribavirina (enoletno zdravljenje) glede na genotip in virusno obremenitev
Genotype 1
17 Genotip 1
 2 million copies/ml Genotype 1
 2 milijona kopij/ ml Genotip 1
> 2 million copies/ml
> 2 milijona kopij/ ml
I IntronA (3 MIU 3 times a week) I/R IntronA (3 MIU 3 times a week) + ribavirin (1,000/1,200 mg/day)
I IntronA (3 mio i. e. trikrat na teden) I/ R IntronA (3 mio i. e. trikrat na teden) + ribavirin (1. 000/ 1. 200 mg/ dan)
HCV/HIV Co-infected patients Two trials have been conducted in patients co-infected with HIV and HCV.
Bolniki, sočasno okuženi z virusoma HCV in HIV Opravljeni sta bili dve preskušanji pri bolnikih, ki so bili sočasno okuženi z virusoma HCV in HIV.
Overall, in both studies, patients who received IntronA plus ribavirin, were less likely to respond than patients who received pegylated interferon alfa-2b with ribavirin.
Na splošno so v obeh študijah opazili, da je bila pri bolnikih, ki so prejemali zdravilo IntronA z ribavirinom, manjša verjetnost za odziv kot pri tistih, ki so prejemali pegiliran interferon alfa- 2b z ribavirinom.
Patients were randomized to receive either pegylated interferon alfa-2b (1.5 µg/kg/week) plus ribavirin (800 mg/day) or IntronA (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Bolnike so naključno razporedili bodisi v skupino, ki je prejemala pegiliran interferon alfa- 2b (v odmerku 1, 5 µg/ kg/ teden) z ribavirinom (v odmerku 800 mg/ dan) ali pa v skupino, ki je prejemala zdravilo IntronA (3 mio i. e. trikrat na teden) z ribavirinom (v odmerku 800 mg/ dan), v času 48 tednov, z nadaljnjim 6- mesečnim obdobjem spremljanja bolnikov.
Patients were randomized to receive either pegylated interferon alfa-2b (100 or 150 µg /week based on weight) plus ribavirin (800-1,200 mg/day based on weight) or IntronA (3 MIU TIW) plus ribavirin (800-1,200 mg/day based on weight).
Bolnike so naključno razporedili bodisi v skupino, ki je prejemala pegiliran interferon alfa- 2b (v odmerkih 100 ali 150 µg/ teden, odvisno od telesne mase) z ribavirinom (v odmerku 800- 1. 200 mg/ dan, odvisno od telesne mase) ali pa v skupino, ki je prejemala zdravilo IntronA (3 m. i. e. trikrat na teden) z ribavirinom (v odmerku 800- 1. 200 mg/ dan, odvisno od telesne mase).
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Zdravljenje je trajalo 48 tednov, z nadaljnjim 6- mesečnim obdobjem spremljanja bolnikov, razen pri tistih, ki so bili okuženi z genotipoma 2 ali 3 in so imeli virusno breme < 800. 000 i. e. / ml (Amplicor) - njih so zdravili 24 tednov z nadaljnjim 6- mesečnim obdobjem spremljanja.
Table 4
Preglednica 4 Trajni virološki odziv glede na genotip po uporabi zdravila IntronA v kombinaciji z ribavirinom, v primerjavi z uporabo pegiliranega interferona alfa- 2b v kombinaciji z ribavirinom pri bolnikih, ki so bili sočasno okuženi z virusoma HCV in HIV
Sustained virological response based on genotype after IntronA in combination with ribavirin versus pegylated interferon alfa-2b in combination with ribavirin in HCV/HIV co-infected patients Study 11 Study 22 pegylated pegylated interferon interferon alfa-2b alfa-2b (100 IntronA (1.5 µg/kg/ IntronA or (3 MIU TIW) week) + (3 MIU TIW) + 150c µg/week) + ribavirin ribavirin ribavirin p + ribavirin (800- p (800 mg) (800 mg) valuea (800- 1,200 mg)d valueb
pa

mg) d
17 1,200 mg)d
1. 200 mg) d
All Genotype 1, 4
Vsi
27% (56/205) 20% (41/205) 0.047 44% (23/52) 21% (9/43) 17% (21/125) 6% (8/129) 0.006 38% (12/32) 7% (2/27)
(23/ 52) Genotipa 1, 17% (21/ 125)
Genotype 2, 3
44% (35/ 80)
MIU = million international units; TIW = three times a week. a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week pegylated interferon alfa-2b and subjects ≥ 75 kg received 150 µg/week pegylated interferon alfa-2b. d: ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Odmerki ribavirina so bili naslednji:
1 Carrat F, Bani-Sadr F, Pol S et al.
1 Carrat F, Bani- Sadr F, Pol S in sod.
2 Laguno M, Murillas J, Blanco J.L et al.
2 Laguno M, Murillas J, Blanco J. L in sod.
Relapse patients:
Bolniki s ponovitvijo oz. relapsom bolezni:
A total of 345 interferon alpha relapse patients were treated in two clinical trials with IntronA monotherapy or in combination with ribavirin.
Skupaj 345 bolnikov z interferon alfa relapsom je bilo zdravljenih v dveh kliničnih raziskavah z zdravilom IntronA, v monoterapiji ali v kombinaciji z ribavirinom.
4.7%).
Pri teh bolnikih je dodatek ribavirina zdravilu IntronA povečal učinkovitost samega zdravila IntronA v monoterapiji kroničnega hepatitisa C za kar 10- krat (48, 6% v primerjavi s 4, 7%).
This enhancement in efficacy included loss of serum HCV (< 100 copies/ml by PCR), improvement in hepatic inflammation, and normalisation of ALT, and was sustained when measured 6 months after the end of treatment.
Ta okrepitev učinkovitosti je vključevala odsotnost HCV v serumu (< 100 kopij/ ml pri PCR), izboljšanje vnetja jeter in normalizacijo ALT in je bila še ohranjena ob merjenju 6 mesecev po koncu terapije.
Long-Term efficacy data In a large study, 1,071 patients were enrolled after treatment in a prior non pegylated interferon alfa-2b or non pegylated interferon alfa-2b/ribavirin study to evaluate the durability of sustained virologic response and assess the impact of continued viral negativity on clinical outcomes.
Dolgoročni podatki o učinkovitosti V veliko študijo so vključili skupaj 1. 071 bolnikov, ki so bili predhodno vključeni v študijo z nepegiliranim interferonom alfa- 2b ali z nepegiliranim interferonom alfa- 2b in ribavirinom, da bi ovrednotili trajanje stalnega virološkega odziva in ocenili vpliv nadaljnjih negativnih izvidov določanja virusa na klinične izide.
The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 97% with a 95% Confidence Interval of [95%, 99%].
Kaplan- Meierjeva ocena ohranjanja stalnega virološkega odziva v obdobju 5 let za vse bolnike znaša 97%, s 95% intervalom zaupanja [95%, 99%].
SVR after treatment of chronic HCV with non pegylated interferon alfa-2b (with or without ribavirin) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical'cure' from chronic HCV.
Stalni virološki odziv po zdravljenju kronične okužbe z virusom hepatitisa C z nepegiliranim interferonom alfa- 2b (z ali brez ribavirina) vodi dodolgotrajnega očistkavirusa ter tako odpravi jetrno okužbo in omogoči klinično » ozdravitev « kronične okužbe z virusom hepatitisa C.
However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
To pa ne pomeni, da ne bo prišlo do jetrnih dogodkov pri bolnikih s cirozo (vključno s hepatokarcinomom).
Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCV-RNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received IntronA 3 MIU/m2 3 times a week plus ribavirin 15 mg/kg per day for 1 year followed by 6 months follow-up after-treatment.
Otroci in mladostniki, stari od 3 do 16 let in s kompenziranim kroničnim hepatitisom C in merljivimi količinami HCV RNA (kar je ocenil osrednji laboratorij z uporabo raziskovalnega testa RT- PCR), so bili vključeni v dve multicentrični preskušanji in so zdravilo IntronA prejemali v odmerku 3 mio i. e. / m2 trikrat na teden skupaj z ribavirinom v 15 mg/ kg na dan v času enega leta, čemur je sledilo 6 - mesečno spremljanje po zdravljenju.
57% male, 80% Caucasian, and 78% genotype 1,64%  12 years of age.
V študijo je bilo vključenih 118 bolnikov; od tega je bilo 57% moških, 80% bolnikov bele rase, 78% bolnikov z genotipom 1 in 64% otrok, starih  12 let.
The population enrolled mainly consisted in children with mild to moderate hepatitis C.
Populacija je vključevalapredvsem otroke z blagim do zmernim hepatitisom C.
Sustained virological response rates in children and adolescents were similar to those in adults.
Delež trajenega virološkega odziva pri otrocih in mladostnikih je bil podoben tistemu pri odraslih.
Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Zaradi pomanjkanja podatkov pri otrocih s hudim napredovanjem bolezni in možnostjo pojava neželenih učinkov je potrebno pred uporabo kombinacije ribavirina in interferona alfa- 2b v tej populaciji skrbno pretehtati razmerje med koristnostjo zdravljenja in tveganjem.
Study results are summarized in Table 5.
(glejte poglavja 4. 1, 4. 4 in 4. 8).
Table 5.
Povzetek izsledkov študije je podan v Preglednici 5.
Virological response in previously untreated paediatric patients IntronA 3 MIU/m2 3 times a week + ribavirin 15 mg/kg/day
Virološki odziv pri predhodno nezdravljenih pediatričnih bolnikih IntronA 3 mio i. e. / m2 3 – krat na teden + ribavirin 15 mg/ kg/ dan
 18 Overall Response1 (n=118)
Skupni odziv1 (n=118)
Genotype 2/3/4 (n=26) *Number (%) of patients
Genotip 2/ 3/ 4 (n=26) * Število (%) bolnikov
Defined as HCV-RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period
Opredeljeno kot vrednost HCV- RNA pod mejo detekcije z uporabo raziskovalnega testa RT- PCR ob koncu zdravljenja in v obdobju spremljanja bolnikov.
The pharmacokinetics of IntronA were studied in healthy volunteers following single 5 million IU/m2 and 10 million IU doses administered subcutaneously, at 5 million IU/m2 administered intramuscularly and as a 30-minute intravenous infusion.
Farmakokinetiko zdravila IntronA so raziskovali pri zdravih prostovoljcih po enkratnih subkutanih odmerkih po 5 milijonov i. e. / m2 in 10 milijonov i. e., po intramuskularnem dajanju 5 milijonov i. e. / m2 in po 30- minutni intravenski infuziji.
C max occurred three to 12 hours after the lower dose and six to eight hours after the higher dose.
C max je bila dosežena 3 do 12 ur po manjšem odmerku in 6 do 8 ur po večjem odmerku.
The elimination half-lives of interferon injections were approximately two to three hours, and six to seven hours, respectively.
Razpolovna doba eliminacije interferona po injiciranju je bila približno 2 do 3 ure oz.
Serum levels were below the detection limit 16 and 24 hours, respectively, post-injection.
24 ur po injiciranju.
Both subcutaneous and intramuscular administration resulted in bioavailabilities greater than 100%.
Tako pri subkutani uporabi kot pri intramuskularni uporabi je bila biološka uporabnost zdravila večja od 100%.
After intravenous administration, serum interferon levels peaked (135 to 273 IU/ml) by the end of the infusion, then declined at a slightly more rapid rate than after subcutaneous or intramuscular administration of medicinal product, becoming undetectable four hours after the infusion.
Po intravenski uporabi so bile največje serumske koncentracije interferona (od 135 do 273 i. e. / ml) dosežene ob koncu infuzije, potem pa so upadale nekoliko hitreje kot po subkutani ali intramuskularni uporabi zdravila in 4 ure po infuziji več niso bile merljive.
Multiple-dose pharmacokinetic properties for IntronA injection and ribavirin capsules in children and adolescents with chronic hepatitis C, between 5 and 16 years of age, are summarized in Table 6.
Farmakokinetične lastnosti pri večkratnem odmerjanju zdravila IntronA injekcije in kapsul ribavirina pri otrocih in mladostnikih s kroničnim hepatitisom C v starosti od 5 do 16 let so povzete v Preglednici 6.
 19 Table 6.
Preglednica 6.
Mean (% CV) multiple-dose pharmacokinetic parameters for IntronA and ribavirin capsules when administered to children or adolescents with chronic hepatitis C
Srednja vrednost (% CV) farmakokinetičnih parametrov pri večkratnem odmerjanju zdravila IntronA in kapsul ribavirina otrokom ali mladostnikom s kroničnim hepatitisom C IntronA
IntronA
3 mio i. e. / m2 3- krat na teden
15 mg/kg/day as 2 divided doses (n = 17)
15 mg/ kg na dan v obliki
3 MIU/m2 3 times a week (n = 54)
2 deljenih odmerkov (n = 17)
max (ng/ml) AUC*
3. 275 (25)
3,275 (25) 29,774 (26)
29. 774 (26)
Apparent clearance l/hr/kg
Navidezni očistek l/ h/ kg
*AUC 12 (ng.hr/ml) for ribavirin; AUC 0-24 (IU.hr/ml) for IntronA
* AUC 12 (ng x h/ ml) za ribavirin; AUC 0- 24 (i. e. x h/ ml) za IntronA
Interferon neutralising factor assays were performed on serum samples of patients who received IntronA in Schering-Plough monitored clinical trials.
Testi za določanje nevtralizacijskega faktorja za interferon so bili opravljeni na vzorcih seruma pri bolnikih, ki so prejeli zdravilo IntronA v kliničnih raziskavah, ki so potekale pod nadzorom družbe Schering- Plough.
The clinical incidence of neutralising factors developing in cancer patients treated systemically is 2.9% and in chronic hepatitis patients is 6.2%.
Klinična incidenca nevtralizacijskih faktorjev, ki se pojavijo pri sistemsko zdravljenih bolnikih z rakavimi boleznimi, je 2, 9%, pri bolnikih s kroničnim hepatitisom pa 6, 2%.
The detectable titres are low in almost all cases and have not been regularly associated with loss of response or any other autoimmune phenomenon.
20 Merljivi titri so majhni skoraj v vseh primerih in jih niso redno povezovali s prenehanjem odziva ali s kakršnimkoli drugim avtoimunskim pojavom.
Injections of human recombinant interferon alfa-2b for up to three months have shown no evidence of toxicity in mice, rats, and rabbits.
Po injiciranju človeškega rekombinantnega interferona alfa- 2b do 3 mesece niso opažali nobenih znakov toksičnosti zdravila pri miših, podganah in kuncih.
Daily dosing of cynomolgus monkeys with 20 x 106 IU/kg/day for 3 months caused no remarkable toxicity.
Vsakodnevno odmerjanje zdravila pri opicah vrste cynomolgus v odmerku 20 x 106 i. e. / kg na dan 3 mesece ni povzročilo izrazitejše toksičnosti.
Toxicity was demonstrated in monkeys given 100 x 106 IU/kg/day for 3 months.
Raziskave pa so pokazale toksičnost interferona pri opicah, ki so prejemale 100 x 106 i. e. / kg na dan 3 mesece.
In studies of interferon use in non-human primates, abnormalities of the menstrual cycle have been observed (see section 4.4).
V predkliničnih raziskavah uporabe interferona pri nečloveških primatih so opažali motnje menstrualnega ciklusa (glejte poglavje 4. 4).