natgillin/translations-raw huggingface dataset:
The interferons are a family of small protein molecules with molecular weights of approximately 15,000 to na
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. če
21,000 daltons.
Interferoni so skupina majhnih beljakovinskih molekul z molekulsko maso približno 15. 000 do 21. 000 daltonov.
They are produced and secreted by cells in response to viral infections or various synthetic and biological inducers.
Izdelujejo in izločajo jih telesne celice v odziv na virusno okužbo ali različne sintetične on
Three major classes of interferons have been identified: alpha, beta and gamma.
ali biološke induktorje.
These three main classes are themselves not homogeneous and may contain several different molecular i dic
Pri človeku so tako ugotovili uk
More than 14 genetically distinct human alpha interferons have been identified.
več kot 14 genetsko različnih alfa interferonov.
Me
Viraferon je opredeljen kot rekombinantni interferon alfa - 2b.
Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface.
Interferoni delujejo na celice tako, da se vežejo na specifične membranske receptorje na celični površini. ks
Studies with other interferons have demonstrated species specificity.
specifičnost.
93 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.
It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus-infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
98 okuženih z virusi, supresijo celične proliferacije in različnimi oblikami imunomodulacijskega delovanja, kot je npr. okrepitev fagocitne aktivnosti makrofagov in povečanje specifične citotoksičnosti limfocitov za tarčne celice.
ed 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.
ie človeških tumorskih ksenopresadkih na živalih, pokazal antiproliferativne učinke.
s ori Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Četudi natančen
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
r mehanizem delovanja rekombinantnega interferona alfa- 2b proti virusom ni znan, kaže, da spremeni
uth Chronic hepatitis B:
eg Kronični hepatitis B:
Current clinical experience in patients who remain on interferon alfa-2b for 4 to 6 months indicates that
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.
An improvement in liver histology has been observed.
Opažali so tudi izboljšanje histološkega izvida
ge Interferon alfa-2b (6 MIU/ m2 3 times a week for 6 months) has been given to children with chronic active hepatitis B.
sťo Interferon alfa- 2b (6 mio i. e. / m2 trikrat na teden 6 mesecev) so uporabljali pri otrocih s kroničnim aktivnim hepatitisom B.
Moreover children treated lon 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. no Kronični hepatitis C:
In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is no
Pri odraslih bolnikih, ki so prejemali interferon v kombinaciji z ribavirinom je bil trajen virološki odziv lat
47%.
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). t uc
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 up
Viraferon 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 Viraferon 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 no
Efficacy was defined as sustained virologic response, rod
Učinkovitost so opredelili kot ohranjen virološki odziv 6 mesecev po koncu zdravljenja.
6 months after the end of treatment.
Bolniki, primerni za vključitev v te raziskave, so imeli kronični če
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. lp
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. on
Viraferon was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with na
Zdravilo Viraferon so dajali bolnikom v odmerku 3 mio i. e. trikrat na teden, v monoterapiji ali v kombinaciji z ribavirinom.
The majority of patients in these clinical trials were treated for one year.
Vse bolnike so uk
All patients were followed for an additional 6 months after the end of treatment for the determination of sustained virologic response.
spremljali še nadaljnjih 6 mesecev po koncu zdravljenja, da so ugotavljali ohranjen virološki odziv.
Sustained virologic response rates for treatment groups treated for one year with Viraferon alone or in i dic
Pogostnosti ohranjenega virološkega odziva za terapevtske skupine, zdravljene eno leto z zdravilom Viraferon v monoterapiji ali v kombinaciji z ribavirinom (iz dveh raziskav) so podane v preglednici 3. ks
HCV genotype and baseline virus load are prognostic Me
HCV genotip in Lie
factors which are known to affect response rates.
virusna obremenitev na začetku zdravljenja sta znana prognostične dejavnika, ki vplivata na pogostnost odziva.
Response rates in these trials were increased with compliance.
99 Pogostnosti odziva v teh raziskavah so se povečevale z boljšim sodelovanje bolnika.
Regardless of genotype, patients who received Viraferon in combination with ribavirin and received ≥ 80% of their treatment had a higher sustained
Ne glede na genotip so imeli bolniki, ki so prejemali Viraferon 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).
Table 3
ie Preglednica 3:
HCV Genotype
ác I/ R I/ R HCV Genotip
N=505
r N=505 N=505 N=503
C95-132/ I95-143 C95-132/ I95-143
ist C/ I98- 580 C95- 132/ I95- 143 C95- 132/ I95- 143
s All Genotypes
Vsi genotipi
ori Genotype 1
eg Genotip 1
uth Genotype 1 ≤ 2 million
ur Genotip 1 ≤ 2 milijona
ra copies/ ml Genotype 1 > 2 million
sťo kopij/ ml Genotip 1 > 2 milijona kopij/ ml
ge copies/ ml
79%
I Viraferon (3 MIU 3 times a week) I/ R Viraferon (3 MIU 3 times a week) + ribavirin (1,000/ 1,200 mg/ day) no
I Viraferon (3 mio i. e. trikrat na teden) I/ R Viraferon (3 mio i. e. trikrat na teden) + ribavirin (1. 000/ 1. 200 mg/ dan) up
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 Viraferon plus ribavirin, were less likely to respond than patients who received pegylated t
Na splošno so v obeh študijah opazili, da je bila pri bolnikih, ki so prejemali zdravilo Viraferon z ribavirinom, no
interferon alfa-2b with ribavirin.
manjša verjetnost za odziv kot pri tistih, ki so prejemali pegiliran interferon alfa- 2b z ribavirinom.
The response to treatment in both of these trials is presented in Table 4. uc
Odzivi na zdravljenje v obeh opravljenih študijah so podani v Preglednici 4.
Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
odraslih bolnikov s kroničnim hepatitisom C, ki so bili sočasno okuženi z virusom HIV.
Patients were randomized to receive either pegylated interferon alfa-2b (1.5 µg/ kg/ week) plus ribavirin (800 mg/ day) or Viraferon (3 MIU TIW) rod
Bolnike so naključno razporedili bodisi v skupino, ki je prejemala pegiliran interferon alfa- 2b (v odmerku on
plus ribavirin (800 mg/ day) for 48 weeks with a follow-up period of 6 months.
Študija 2 pa (P02080) je bila randomizirana uk
Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
enocentrična študija, v katero je bilo vključenih 95 predhodno nezdravljenih odraslih bolnikov s kroničnim hepatitisom C, ki so bili sočasno okuženi z virusom HIV.
Patients were randomized to receive either pegylated interferon alfa-2b (100 lp
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 ks
or 150 µg / week based on weight) plus ribavirin (800-1,200 mg/ day based on weight) or Viraferon (3 MIU TIW) plus ribavirin (800-1,200 mg/ day based on weight).
je prejemala zdravilo Viraferon (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 na
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 Lie
< 800,000 IU/ ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period. i
< 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 Viraferon 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
dic
100
pegylated
Študija 22
interferon
interferon alfa- 2b
interferon
pegiliran
or
150c µg /
Viraferon
interferon
(1.5 µg/ kg/
(3 m. i. e.
150c µg/ week) (3 MIU TIW)
teden) +
week) +
trikrat na
MIU TIW) +
teden) +
+ ribavirin + ribavirin
na teden) +
ribavirin
r Vrednost
p
1. 200 mg) d
(800 mg) (800 mg)
Vsi
value a
27% (56/ 205)
1,200 mg)
44%
95 All Genotype 1, 4
Genotipa 1,
0.047 0.006
7% (2/ 27)
44% (23/ 52) 38% (12/ 32)
(12/ 32)
0.017 0.007
ur
MIU = million international units; TIW = three times a week.
m. i. e. = milijonov mednarodnih enot; TIW = trikrat na teden
ed 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.
Odmerki ribavirina so bili naslednji:
s 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.
800 mg za bolnike < 60 kg, 1. 000 mg za tiste s telesno maso od 60 do 75 kg in 1. 200 mg za bolnike s telesno maso > 75 kg.
ori 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.
2839- 2848. lat 2 Laguno M, Murillas J, Blanco J. L in sod.
F27-F36.
F27- F36. up
uth Relapse patients:
Bolniki s ponovitvijo oz. relapsom bolezni:
In these patients, the addition of ribavirin to
Skupaj 345 bolnikov z interferon alfa relapsom je bilo zdravljenih v dveh kliničnih raziskavah z zdravilom Viraferon, v monoterapiji ali v kombinaciji z ribavirinom.
ra Viraferon increased by as much as 10-fold the efficacy of Viraferon used alone in the treatment of chronic hepatitis C (48.6% vs.
Pri teh bolnikih je dodatek ribavirina zdravilu Viraferon povečal učinkovitost samega zdravila Viraferon v monoterapiji kroničnega hepatitisa C za kar 10- krat (48, 6% v primerjavi s 4, 7%).
4.7%).
Ta no
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
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. če
ge measured 6 months after the end of treatment.
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 on
Long-Term efficacy data lon 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.
ovrednotili trajanje stalnega virološkega odziva in ocenili vpliv nadaljnjih negativnih izvidov določanja virusa na klinične izide.
462 patients completed at least 5 years of long-term follow-up and only 12 sustained responders' out of 492 relapsed during this study. no
Pri 462 bolnikih se je zaključilo najmanj 5 letno dolgoročno spremljanje in le pri uk
SVR after treatment of chronic HCV with non pegylated interferon alfa-2b (with or without ribavirin) results t
Stalni virološki odziv po zdravljenju kronične okužbe z virusom hepatitisa C z nepegiliranim interferonom ks
in long-term clearance of the virus providing resolution of the hepatic infection and clinical'cure 'from uc
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). rod
Lie
multicentre trials and received Viraferon 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 Viraferon prejemali v odmerku 3 mio i. e. / m2 trikrat na teden skupaj z ribavirinom v odmerku 15 mg/ kg na dan v času enega leta, čemur je sledilo 6 - 101 mesečno spremljanje po zdravljenju.
The population enrolled mainly consisted in na
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.
children with mild to moderate hepatitis C.
Populacija je vključevalapredvsem otroke z blagim do zmernim hepatitisom C.
Due to the lack of data in children with severe progression of the disease, and i
Zaradi pomanjkanja podatkov pri otrocih s hudim napredovanjem bolezni in možnostjo pojava neželenih učinkov je potrebno pred uporabo
the potential for undesirable effects, the benefit/ risk of the combination of ribavirin and interferon alfa-2b dic
ie kombinacije ribavirina in interferona alfa- 2b v tej populaciji skrbno pretehtati razmerje med koristnostjo zdravljenja in tveganjem.
needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
(glejte poglavja 4. 1, 4. 4 in 4. 8).
Me
ác Povzetek izsledkov študije je podan v Preglednici 5.
Table 5.
r ist Preglednica 5.
Virological response in previously untreated paediatric patients Viraferon 3 MIU/ m2 3 times a week + ribavirin 15 mg/ kg/ day
Virološki odziv pri predhodno nezdravljenih pediatričnih bolnikih Viraferon 3 mio i. e. / m2 3 – krat na teden
Overall Response1 (n=118)
ur Skupni odziv1 (n=118)
Genotype 2/ 3/ 4 (n=26) *Number (%) of patients
sťo 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 obdobju spremljanja bolnikov.
ed 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti lat
The pharmacokinetics of Viraferon were studied in healthy volunteers following single 5 million IU/ m2 and
Farmakokinetiko zdravila Viraferon so raziskovali pri zdravih prostovoljcih po enkratnih subkutanih up
s 10 million IU doses administered subcutaneously, at 5 million IU/ m2 administered intramuscularly and as a
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.
The elimination half-lives of interferon injections were approximately two
Razpolovna doba eliminacije interferona po injiciranju je bila približno 2 no
uth to three hours, and six to seven hours, respectively.
6 do 7 ur.
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%. če
ra 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
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.
The elimination half-life was approximately two hours.
Razpolovna doba eliminacije je bila približno 2 on
lon
uri.
Urine levels of interferon were below the detection limit following each of the three routes of administration.
Koncentracija interferona v seču je bila pod mejo detekcije pri vseh treh omenjenih načinih uporabe uk
Multiple-dose pharmacokinetic properties for Viraferon injection and ribavirin capsules in children and adolescents with chronic hepatitis C, between 5 and 16 years of age, are summarized no
Farmakokinetične lastnosti pri večkratnem odmerjanju zdravila Viraferon injekcije ks
in Table 6.
in kapsul ribavirina pri otrocih in mladostnikih s kroničnim hepatitisom C v starosti od 5 do 16 let so povzete v Preglednici 6.
The pharmacokinetics of Viraferon and ribavirin (dose-normalized) are similar in adults and children or adolescents. t
Lie
Mean (% CV) multiple-dose pharmacokinetic parameters for Viraferon and ribavirin uc
Srednja vrednost (% CV) farmakokinetičnih parametrov pri večkratnem odmerjanju zdravila Viraferon in kapsul ribavirina otrokom ali mladostnikom s kroničnim hepatitisom C Viraferon
Viraferon
3 mio i. e. / m2 3- krat na teden
15 mg/ kg/ day as 2 divided
15 mg/ kg na dan v obliki
3 MIU/ m2 3 times a week
2 deljenih odmerkov
(n = 17)
102 (n = 17)
clearance l/ hr/ kg na
Navidezni očistek l/ h/ kg
*AUC12 (ng. hr/ ml) for ribavirin; AUC0-24 (IU. hr/ ml) for Viraferon i
ác * AUC12 (ng x h/ ml) za ribavirin; AUC0- 24 (i. e. x h/ ml) za Viraferon
Interferon neutralising factor assays were performed on serum samples of patients who received Viraferon in dic
r Testi za določanje nevtralizacijskega faktorja za interferon so bili opravljeni na vzorcih seruma pri
Schering-Plough monitored clinical trials.
ist bolnikih, ki so prejeli zdravilo Viraferon 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%.
Merljivi titri so majhni skoraj v vseh primerih in jih niso redno povezovali s prenehanjem odziva ali s kakršnimkoli drugim avtoimunskim pojavom.
The detectable titres are low in almost Me
Pri bolnikih s hepatitisom niso opažali prenehanja
In patients with hepatitis, no loss of response was observed apparently due to the low titres.
ur odzivnosti, kar naj bi bilo posledica majhnih titrov.
Although interferon is generally recognised as being species specific, toxicity studies in animals were conducted.
sťo Četudi interferon na splošno šteje za vrstno specifičnega, so bile opravljene predklinične raziskave toksičnosti na živalih.
Daily dosing of cynomolgus monkeys with 20 x 106 IU/ kg/ day
Vsakodnevno odmerjanje no 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 lat 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 up
Results of animal reproduction studies indicate that recombinant interferon alfa-2b was not teratogenic in rats
Izsledki reprodukcijskih raziskav na živalih kažejo, da rekombinantni interferon alfa- 2b ni teratogen za podgane in kunce in da ne vpliva negativno na nosečnost, razvoj ploda ali reprodukcijsko sposobnost no
ed or rabbits, nor did it adversely affect pregnancy, foetal development or reproductive capacity in offspring of treated rats.
Za interferon alfa- 2b so raziskave pokazale, da povzroča splav pri opicah rhesus (Macaca mulatta), če ga prejemajo v odmerku, ki je 90 oz.
Interferon alfa-2b has been shown to have abortifacient effects in Macaca mulatta (rhesus monkeys) at 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/ m2.
Splav so opažali v vseh skupinah po če
s Abortion was observed in all dose groups (7.5 million, 15 million and 30 million IU/ kg), and was statistically
velikosti odmerka (7, 5 milijonov, 15 milijonov in 30 milijonov i. e. / kg), in je bil v primerjavi s kontrolno skupino statistično značilno pogostejši pri skupinah s srednjimi in velikimi odmerki (ki so ustrezali 90 oz.
ori significant versus control at the mid- and high-dose groups (corresponding to 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/ m2).
Tudi za on
High doses of other forms of interferons alpha and beta are known to produce dose-related anovulatory and abortifacient effects in rhesus
velike odmerke drugih oblik interferonov alfa in beta je znano, da povzročijo od odmerka odvisne učinke v smislu izgube ovulacije ali splava pri opicah rhesus. uk
uth monkeys.
Raziskave mutagenosti interferona alfa- 2b niso pokazale nobenih neželenih dogodkov.
Mutagenicity studies with interferon alfa-2b revealed no adverse events.
Študije za proučevanje učinkov zdravljenja z interferonom alfa- 2b na rast, razvoj, spolno zorenje in ks
ra No studies have been conducted in juvenile animals to examine the effects of treatment with interferon alfa- 2b on growth, development, sexual maturation, and behaviour (see section 4.4 and Rebetol SPC if Viraferon
Lie
6.1 List of excipients no
6. 1 Seznam pomožnih snovi