natgillin/translations-raw huggingface dataset:
No interaction studies have been conducted with Rebetol and other medicinal products, except for interferon alfa-2b and antacids.
Ni bilo nobenih študij medsebojnega delovanja zdravila Rebetol z drugimi zdravili, razen za interferon alfa- 2b in antacide.
No pharmacokinetic interactions were noted between Rebetol and interferon alfa-2b in a multiple-dose pharmacokinetic study.
V farmakokinetični študiji večkratnega odmerjanja niso beležili nobenih farmakokinetičnih interakcij med zdravilom Rebetol in interferonom alfa- 2b.
The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium, aluminium and simethicone; AUCtf decreased 14%.
Vrednost AUCtf se je zmanjšala za 14%.
It is possible that the decreased bioavailability in this study was due to delayed transit of ribavirin or modified pH.
Možno je, da je bila zmanjšana biološka uporabnost v tej študiji posledica zapoznelega prehajanja ribavirina ali spremenjenega pH.
This interaction is not considered to be clinically relevant.
Ta interakcija ne šteje za klinično pomembno.
Nucleoside analogues:
Nukleozidni analogi:
Use of nucleoside analogs, alone or in combination with other nucleosides, has resulted in lactic acidosis.
Uporaba nukleozidnih analogov, bodisi samostojno ali v kombinaciji z drugimi nukleozidi, je povzročila laktacidozo.
Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro.
Farmakološko ribavirin poveča raven fosforiliranih presnovkov purinskih nukleozidov in vitro.
This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Ta učinek bi lahko povečal tveganje za pojav laktacidoze, ki jo povzročijo analogi purinskih nukleozidov (npr. didanozin ali abakavir).
Co-administration of Rebetol and didanosine is not recommended.
Sočasno dajanje zdravila Rebetol z didanozinom ni priporočljivo.
Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see section 4.4).
Poročali so o primerih mitohondrijske toksičnosti, še posebej o laktacidozi in pankreatitisu, z nekaj smrtnimi primeri (glejte poglavje 4. 4).
The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Zaradi povečanega tveganja za anemijo torej sočasna uporaba ribavirina z zidovudinom ni priporočljiva (glejte poglavje 4. 4).
Consideration should be given to replacing zidovudine in a combination anti-retroviral treatment (ART)regimen if this is already established.
Premislite, ali bi bilo treba pri zdravljenju z uveljavljeno kombinirano protivirusno shemo (ART) morda zamenjati zidovudin.
Any potential for interactions may persist for up to two months (five half-lives for ribavirin) after cessation of Rebetol therapy due to the long half-life (see section 5.2).
Zaradi dolge razpolovne dobe lahko pride do medsebojnega delovanja z drugimi zdravili še do dva meseca (5 razpolovnih dob ribavirina) po koncu terapije z zdravilom Rebetol (glejte poglavje 5. 2).
In animal studies, ribavirin produced reversible effects on spermatogenesis (see
poglavje 5. 3).
Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, male patients and their female partners of childbearing age must be counseled to each use an effective contraceptive during treatment with Rebetol and for seven months after treatment.
Četudi podatki o približno 300 prospektivno spremljanih nosečnostih z izpostavljenostjo očeta ribavirinu niso pokazali ne povečanega tveganja za pojav malformacij v primerjavi s splošno populacijo ne specifičnega vzorca malformacij, morate moškim bolnikom in njihovim partnerkam v rodni dobi svetovati, naj oba uporabljata učinkovito kontracepcijo med zdravljenjem z zdravilom Rebetol in še sedem mesecev po koncu zdravljenja.
It is not known whether ribavirin is excreted in human milk.
Ni znano, ali se ribavirin pri ljudeh izloča v materino mleko pri človeku.
Because of the potential for adverse reactions in nursing infants, nursing must be discontinued prior to initiation of treatment.
Zaradi nevarnosti za pojav neželenih reakcij pri dojenčkih mora mati prenehati z dojenjem pred uvedbo zdravljenja
Rebetol has no or negligible influence on the ability to drive or use machines; however, interferon alfa-2b used in combination may have an effect.
Rebetol nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji, interferon alfa- 2b uporabljen v kombinirani terapiji pa ima lahko tovrsten učinek.
Thus, patients who develop fatigue, somnolence, or confusion during treatment must be cautioned to avoid driving or operating machinery.
Bolnike, ki med zdravljenjem postanejo utrujeni, zaspani ali zmedeni, morate torej opozoriti, da ne smejo voziti ali upravljati s stroji.
Children and adolescents in clinical trials:
Otroci in mladostniki v kliničnih preskušanjih:
Reported adverse reactions listed in Table 3 are based on experience from paediatric clinical trials.
Prijavljeni neželeni učinki, ki so navedeni v Preglednici 3, temeljijo na izkušnjah iz pediatričnih kliničnih preskušanj.
Adverse reactions reported at a ≥ 10% incidence in paediatric trials were previously reported in adults (Table 4) and are not repeated in the paediatric table.
Neželeni učinki, o katerih so poročali v kliničnih preskušanjih in jih niso opisovali prej z incidenco ≥ 10% pri otrocih in mladostnikih, so navedeni v Preglednici 4.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10);
Neželeni učinki so navedeni po organskih sistemih, z naslednjimi kategorijami pogostnosti: zelo pogosti
32 common (≥1/100 to < 1/10).
33 (≥1/ 10); pogosti (od ≥1/ 100 do < 1/ 10).
Adverse reactions very commonly and commonly reported during clinical trials of Rebetol with interferon alfa-2b injection in paediatric patients
Preglednica 3 Neželeni učinki, ki so jih zelo pogosto ali pogosto prijavljali med kliničnimi preskušanji zdravila Rebetol z interferonom alfa- 2b za injiciranje pri pediatričnih bolnikih
Viral infection, pharyngitis Fungal infection, bacterial infection, pulmonary infection, otitis media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis
Virusne okužbe, faringitis Glivične okužbe, bakterijske okužbe, pljučne okužbe, otitis media, zobni absces, herpes simpleks, okužbe sečil, vaginitis, gastroenteritis
Depression, insomnia, emotional lability Suicidal ideation, aggressive reaction, confusion, behaviour disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy
Depresija, nespečnost, čustvena nestabilnost samomorilne misli, agresivno odzivanje, zmedenost, vedenjske motnje, vznemirjenost, somnambulizem, tesnoba, živčnost, motnje spanja, nenormalne sanje, apatičnost
Headache, dizziness Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
Glavobol, omotica Hiperkinezija, tremor, disfonija, parestezije, hipoestezija, hiperestezija, motnje koncentracije, somnolenca
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased 33
Alopecija, izpuščaj Preobčutljivostne reakcije na svetlobo, makulopapulozni izpuščaj, ekcem, akne, kožne bolezni, bolezni nohtov, obarvanje kože, pruritus, suha koža, eritem, podplutbe,
Very common:
34 povečano potenje Bolezni mišično- skeletnega sistema in vezivnega tkiva Zelo pogosti:
Male: testicular pain
Ženske: amenoreja, menoragija, menstrualne motnje, bolezni nožnice Moški: bolečine v testisih
Injection site inflammation, injection site reaction, fatigue, rigors, fever, influenza-like symptoms, malaise, irritability
Vnetje na mestu injiciranja, reakcija na mestu injiciranja, utrujenost, mrzlica, zvišana telesna temperatura, gripi podobni simptomi, bolehnost, razdražljivost
Chest pain, asthenia, oedema, injection site pain
Bolečine v prsih, astenija, edem, bolečine na mestu injiciranja
Common:
Poškodbe in zastrupitve in zapleti pri posegih Pogosti:
Skin laceration
Laceracije kože
Adverse reactions reported with a > 10% incidence in adult patients treated with ribavirin capsules in combination with interferon alfa-2b or pegylated interferon alfa-2b for one year have also been reported in children and adolescents.
Neželeni učinki z incidenco > 10%, o katerih so poročali pri odraslih bolnikih, ki so se eno leto zdravili s kapsulami ribavirina v kombinaciji z interferonom alfa- 2b ali pegiliranim interferonom alfa - 2b, so bili opisani tudi pri otrocih in mladostnikih.
The side effect profile was also similar at the lower incidences.
Profil neželenih učinkov je bil podoben tudi pri nižjih incidencah.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known.
Neželeni učinki so navedeni po organskih sistemih, z naslednjimi kategorijami pogostnosti: zelo pogosti (≥1/ 10), pogosti (od ≥1/ 100 do < 1/ 10), občasni (od ≥1/ 1000 do < 1/ 100), redki (od ≥ 1/ 10. 000 do < 1/ 1000), zelo redki (< 1/ 10 000), neznana.
Anaemia, neutropenia Thrombocytopenia, lymphadenopathy, lymphopenia Aplastic anaemia* Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Anemije, nevtropenija Trombocitopenija, limfadenopatija, limfopenija Aplastična anemija * Izolirana aplazija eritrocitov, idiopatska trombocitopenična
Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Sarkoidoza * Sindrom Vogt- Koyanagi- Harada, sistemski lupus eritematozus, revmatoidni artritis (nov pojav ali poslabšanje obstoječega), vaskulitis, akutne preobčutljivostne reakcije vključno z urtikarijo, angioedem, bronhokonstrikcija, anafilaksija
Anorexia Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite, thirst
Anoreksija Hiperglikemija, hiperurikemija, hipokalcemija, dehidracija, povečan tek, žeja
Suicide attempts Hallucination Suicide* Mental status change
Poskus samomora Halucinacije Samomor * Spremembe duševnega stanja
Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis* 35
Pljučni infiltrati *, pnevmonitis *, intersticijski pnevmonitis *
Alopecia, pruritus, skin dry, rash Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, dermatitis, acne, furunculosis*, erythema, skin disorder, bruise, sweating increased, abnormal hair texture, nail disorder*
Alopecija, pruritus, suha koža, izpuščaj Psoriaza, poslabšanje psoriaze, ekcem, preobčutljivostne reakcije na svetlobo, makulopapulozni izpuščaj, eritematozni izpuščaj, dermatitis, akne, furunkuloza *, eritem, kožne bolezni, podplutbe, povečano potenje, nenormalna tekstura las, bolezni nohtov *
conditions Injection site inflammation, injection site reaction, fatigue, rigors, fever, flu-like symptoms, asthenia, irritability
Vnetje na mestu injiciranja, reakcija na mestu injiciranja, utrujenost, mrzlica, zvišana telesna temperatura, gripi podobni simptomi, astenija, razdražljivost
Common:
Pogosti: * Ker ribavirin vedno predpisujejo skupaj
Weight decrease Cardiac murmur, urine abnormal
Hujšanje šum na srcu *, nenormalen seč z zdravili, ki vsebujejo interferon alfa, in ker našteti neželeni učinki temeljijo na
An increase in uric acid and indirect bilirubin values associated with haemolysis was observed in some patients treated with Rebetol used in combination with interferon alfa-2b in clinical trials, but values returned to baseline levels by four weeks after the end of therapy.
37 Pri nekaterih bolnikih, zdravljenih z zdravilom Rebetol v kombinaciji z interferonom alfa- 2b v kliničnih preskušanjih, so opažali povečanje vrednosti sečne kisline in indirektnega bilirubina zaradi hemolize, vendar so se vrednosti povrnile na začetno raven v štirih tednih po koncu terapije.
In clinical trials with Rebetol used in combination with interferon alfa-2b, the maximum overdose reported was a total dose of 10 g of Rebetol (50 x 200 mg capsules) and 39 MIU of interferon alfa-2b (13 subcutaneous injections of 3 MIU each) taken in one day by a patient in an attempt at suicide.
V kliničnih preskušanjih zdravila Rebetol v kombinaciji z interferonom alfa- 2b je bilo največje preveliko odmerjanje skupni odmerek 10 g zdravila Rebetol (50 x 200 mg kapsul) in 39 mio i. e. interferona alfa- 2b (13 subkutanih injekcij po 3 mio i. e. vsaka), ki ga je v enem dnevu vzel bolnik v poskusu samomora.
Direct acting antivirals, nucleosides and nucleotides (excl. reverse transcriptase inhibitors), ATC code:
Neposredno delujoča zdravila proti virusnim okužbam, nukleozidi in nukleotidi (z izjemo zaviralcev reverzne transkriptaze), oznaka ATC:
Ribavirin (Rebetol) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Ribavirin (Rebetol) je sintetični nukleozidni analog, ki je pokazal aktivnost proti nekaterim RNA in DNA virusom in vitro.
The mechanism by which Rebetol in combination with interferon alfa-2b exerts its effects against HCV is unknown.
Mehanizem delovanja, s katerim zdravilo Rebetol v kombinaciji z interferonom alfa- 2b deluje proti HCV, ni znan.
Oral formulations of Rebetol monotherapy have been investigated as therapy for chronic hepatitis C in several clinical trials.
Peroralne pripravke zdravila Rebetol v monoterapiji so proučevali v večih kliničnih preskušanjih kot terapijo za kronični hepatitis C.
Results of these investigations showed that Rebetol monotherapy had no effect on eliminating hepatitis virus (HCV-RNA) or improving hepatic histology after six to 12 months of therapy and six months of follow-up.
Izsledki teh raziskav so pokazali, da monoterapija z zdravilom Rebetol ni imela nobenega učinka na odpravo virusa hepatitisa (HCV- RNA) ali na izboljšanje jetrnega histološkega izvida po šestih do dvanajstih mesecih terapije in šestih mesecih spremljanja bolnikov.
Rebetol clinical trials in children and adolescents:
Klinična preskušanja zdravila Rebetol otrocih in mladostnikih:
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 Rebetol 15 mg/kg per day plus interferon alfa-2b 3 MIU/m2 three times a week 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 Rebetol prejemali v odmerku 15 mg/ kg na dan skupaj z interferonom alfa- 2b v odmerku 3 mio i. e. / m2 trikrat na teden 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 vključevala predvsem otroke z blagim do zmernim hepatitisom C.
Sustained virological response rates in children and adolescents were similar to those in adults (see Table 5).
Delež trajnega virološkega odziva pri otrocih in mladostnikih je bil podoben tistemu pri odraslih (glejte Preglednico 5).
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( glejte poglavja 4. 1, 4. 4 in 4. 8).
Virological response: previously untreated children and adolescents Rebetol 15 mg/kg/day + interferon alfa-2b 3 MIU/m2 3 times a week
Virološki odziv: predhodno nezdravljeni otroci in mladostniki Rebetol 15 mg/ kg na dan + interferon alfa- 2b 3 mio i. e. / m2 3- krat na teden
Genotype 2/3/4 (n=26) *Number (%) of patients
Genotipi 2, 3 in 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 v obdobju spremljanja bolnikov.
5.2 Pharmacokinetic properties
38 5. 2 Farmakokinetične lastnosti
Multiple-dose pharmacokinetic properties for Rebetol capsules and interferon alfa-2b 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 Rebetol kapsule in interferona alfa- 2b pri otrocih in mladostnikih s kroničnim hepatitisom C v starosti od 5 do 16 let so povzete v Preglednici 6.
Rebetol capsules when administered to children or adolescents with chronic hepatitis C PARAMETER
Preglednica 6 Srednja vrednost (% CV) farmakokinetičnih parametrov pri večkratnem odmerjanju interferona alfa- 2b in zdravila Rebetol kapsule zdravila otrokom ali mladostnikom s kroničnim hepatitisom C
15 mg/kg/day as 2 divided doses (n = 17)
3 mio i. e. / m2 3- krat na teden
3 MIU/m2
PARAMETER
3 times a week (n = 54)
15 mg/ kg/ dan v 2 deljenih odmerkih (n = 17)
AUC* clearance l/hr/kg
Navidezni očistek l/ h/ kg
622 (48) Not done
ni bil izmerjen
*AUC12 (ng.hr/ml) for Rebetol; AUC0-24 (IU.hr/ml) for interferon alfa-2b
* AUC12 (ng. h/ ml) za zdravilo Rebetol; AUC0- 24 (i. e. h/ ml) za interferon alfa- 2b
Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax= 1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively).
Ribavirin se hitro absorbira po zaužitju enkratnega odmerka (srednji Tmax = 1, 5 ure), čemur sledita hitra faza porazdelitve in faza podaljšanega izločanja (razpolovna doba absorpcije, porazdelitve in izločanja po enkratnem odmerku je 0, 05, 3, 73 in 79 ur).
There is a linear relationship between dose and AUCtf following single doses of 200-1,200 mg ribavirin.
Po enkratnih odmerkih od 200 do 1. 200 mg ribavirina je odvisnost AUCtf od odmerka linearna.
Volume of distribution is approximately 5,000 l.
Volumen porazdelitve je približno 5. 000 l.
Ribavirin has been shown to produce high inter- and intra-subject pharmacokinetic variability following single oral doses (intrasubject variability of approximately 30% for both AUC and Cmax), which may be due to extensive first pass metabolism and transfer within and beyond the blood compartment.
To je lahko posledica obsežne presnove pri prvem prehodu skozi jetra in porazdelitve v okviru krvnega razdelka in iz njega.
Ribavirin transport in non-plasma compartments has been most extensively studied in red cells, and has been identified to be primarily via an es-type equilibrative nucleoside transporter.
Prehajanje ribavirina v neplazemskih razdelkih so najobsežneje proučevali na eritrocitih in ugotovili, da poteka predvsem po tipu ekvilibracijskega nukleozidnega prenašalca tipa es.
1) a reversible phosphorylation pathway; 2) a degradative pathway involving deribosylation and amide hydrolysis to yield a triazole carboxyacid metabolite.
1) reverzibilno fosforilacijsko pot ter 2) razgradno pot, ki obsega deribozilacijo in amidno hidrolizo in tvori triazolski karboksikislinski presnovek.
Both ribavirin and its triazole, carboxamide and triazole carboxylic acid metabolites are also excreted renally.
Tako ribavirin kot njegovi triazolski karboksamidni in triazolski karboksikislinski presnovki se izločajo tudi prek ledvic.
Following oral dosing with 600 mg BID, steady-state was reached by approximately four weeks, with mean steady state plasma concentrations approximately 2,200 ng/ml.
Po peroralnem odmerjanju ribavirina 600 mg dvakrat na dan je bilo stanje dinamičnega ravnovesja doseženo v približno štirih tednih; srednja plazemska koncentracija v stanju dinamičnega ravnovesja je bila približno 2. 200 ng/ ml.
Upon discontinuation of dosing the half-life was approximately 298 hours, which probably reflects slow elimination from non-plasma compartments.
Po prekinitvi odmerjanja je bila razpolovna doba približno 298 ur, kar je verjetno odraz počasnega izločanja zdravila iz neplazemskih razdelkov.
It is possible that the increased bioavailability in this study was due to delayed transit of ribavirin or modified pH.
Mogoče je, da je bila povečana biološka uporabnost v tej raziskavi posledica zapoznelega prehajanja ribavirina ali spremenjenega pH.
The clinical relevance of results from this single dose study is unknown.
Klinična pomembnost izsledkov te študije z enkratnim odmerkom ni
In the pivotal clinical efficacy trial, patients were instructed to take ribavirin with food to achieve the maximal plasma concentration of ribavirin.
V osrednjem preskušanju klinične učinkovitosti so bolnikom naročili, naj za doseganje kar največje plazemske koncentracije ribavirina zdravilo jemljejo sočasno s hrano.
Anaemia occurs shortly after initiation of dosing,but is rapidly reversible upon cessation of treatment.
Anemija se pojavi kmalu po začetku jemanja zdravila, vendar je hitro reverzibilna po koncu zdravljenja.
In 3-and 6-month studies in mice to investigate ribavirin-induced testicular and sperm effects, abnormalities in sperm occurred at doses of 15 mg/kg and above.
V 3 - in 6- mesečni študiji na miših za proučevanje učinkov ribavirina na testise in spermo so se anomalije sperme pojavile pri odmerku 15 mg/ kg in več.
Upon cessation of treatment, essentially total recovery from ribavirin-induced testicular toxicity occurred within one or two spermatogenic cycles.
Po koncu zdravljenja je prišlo v enem do dveh ciklusih spermatogeneze do praktično popolnega izginotja znakov testikularne toksičnosti ribavirina.
Genotoxic activity was observed in the mouse lymphoma assay, and at doses of 20-200 mg/kg in a mouse micronucleus assay.
Njegovo genotoksično delovanje so beležili tudi v testu na celicah mišjega limfoma in v testu na mišjih mikronukleusih pri odmerkih od 20 do 200 mg/ kg.
Conventional carcinogenicity rodent studies with low exposures compared to human exposure under therapeutic conditions (factor 0.1 in rats and 1 in mice) did not reveal tumorigenicity of ribavirin.
Konvencionalne študije kancerogenosti pri glodalcih z majhnimi izpostavljenostmi v primerjavi z izpostavljenostjo pri človeku v terapevtskih pogojih (faktor 0, 1 pri podganah in 1 pri miših) niso pokazale nobene tumorogenosti ribavirina.
In addition, in a 26 week carcinogenicity study using the heterozygous p53(+/-) mouse model, ribavirin did not produce tumours at the maximally tolerated dose of 300 mg/kg (plasma exposure factor approximately 2.5 compared to human exposure).
Poleg tega v 26- tedenski raziskavi kancerogenosti z uporabo heterozigotnega mišjega modela p53( + / -) ribavirin ni povzročil nastanka tumorjev pri največjem odmerku, ki so ga živali še prenašale, 300 mg/ kg (faktor plazemske izpostavljenosti približno 2, 5- večji od izpostavljenosti pri človeku).
When used in combination with interferon alfa-2b, ribavirin did not cause any effects not previously seen with either active substance alone.
Ribavirin v kombinaciji s peginterferonom alfa- 2b ali interferonom alfa - 2b ni povzročil nobenih učinkov, ki ne bi že bili opisani v zvezi s samostojno uporabo vsake od obeh