natgillin/translations-raw huggingface dataset:
Derudover forekom lidelser på injektionsstedet, feber, anoreksi, opkastning og emotionel labilitet hyppigere hos 13 børn og unge sammenlignet med voksne patienter.
In addition, injection site disorders, fever, anorexia, vomiting, and emotional lability occurred more frequently in children and adolescents compared to adult patients.
Dosisjusteringer var nødvendige hos 30% af patienterne, mest almindeligt for anæmi og neutropeni.
Dose modifications were required in 30% of patients, most commonly for anaemia and neutropaenia.
Følgende kategorier er anvendt: meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10).
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100, < 1/10).
Bivirkninger rapporteret som værende meget almindelige eller almindelige i kliniske undersøgelser hos børn Meget almindelig (≥1/ 10) - Almindelig (≥1/ 100, < 1/ 10) Systemorganklasser Infektioner og parasitære sygdomme
Table 2 Adverse reactions very commonly and commonly reported in paediatric clinical trials  13 Very common (≥1/10) - Common (≥1/100, < 1/10) System Organ Class Infection and infestations
Virusinfektion, pharyngitis Svampeinfektion, bakteriel infektion, pulmonal infektion, otitis media, tand absces, herpes simplex, urinvejsinfektion, vaginitis, gastroenteritis
Viral infection, pharyngitis Fungal infection, bacterial infection, pulmonary infection, otitis media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis
Almindelig: § Psykiske forstyrrelser
Common: § Psychiatric disorders
Anoreksi Hypertriglyceridæmi§, hyperurikæmi, øget appetit
Anorexia Hypertriglyceridemia§, hyperuricemia, increased appetite
Nervesystemet§
Common: § Nervous system disorders
Hovedpine, svimmelhed, Hyperkinesi, tremor, dysfoni, parestesi, hypoestesi, hyperestesi, koncentrationsbesvær, søvnighed
Headache, dizziness Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
14 Lever og galdeveje Almindelig:
Common:
Alopeci, udslæt Fotosensitivitets reaktioner, makulopapulært udslæt, eksem, akne, hudlidelse, neglelidelse, pigmentforandringer, pruritus, tør hud, erythem, blå mærker, øget svedtendens
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased
Almene symptomer og reaktioner på administartionsstedet
General disorders and administration site conditions
Kvinder: amenorré, menoragi, menstruations forstyrrelser, vaginale problemer Mænd: testikelsmerter
Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder Male: testicular pain
Fald i væksthastighed (højde og/ eller vægtfald i forhold til alder) §
Growth rate decrease (height and/or weight decrease for age)§
4. 4
Common: § See section 4.4
Immunstimulerende midler, cytokiner og immunmodulatorer, interferoner, interferon alfa- 2b, ATC- kode:
Immunostimulants, cytokines and immunomodulators, interferons, interferon alfa-2b, ATC code:
IntronA er en steril, stabil, formulering af højt oprenset interferon alfa- 2b produceret ved rekombinant DNA- teknik.
IntronA is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques.
Rekombinant interferon alfa- 2b er et vandopløseligt protein med en molekylvægt på cirka 19. 300 daltons.
Recombinant interferon alfa-2b is a water-soluble protein with a molecular weight of approximately 19,300 daltons.
Det fås fra en klon af E. coli, som huser et genetisk fremstillet plasmid, hybridiseret med et interferon alfa- 2b gen fra humane leukocytter.
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.
Aktiviteten af IntronA udtrykkes i IE, med 1 mg af rekombinant interferon alfa- 2b protein svarende til 2, 6 x 108 IE.
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.
Internationale enheder fastsættes ved at sammenligne aktiviteten af rekombinant interferon alfa- 2b med aktiviteten af den internationale referencestandard af human leukocyt interferon fastsat af verdenssundhedsorganisationen WHO.
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.
15 Interferoner er en familie af små proteinmolekyler med molekylevægte på cirka 15. 000- 21. 000 daltons.
The interferons are a family of small protein molecules with molecular weights of approximately 15,000 to 21,000 daltons.
Alfa, beta og gamma.
Three major classes of interferons have been identified: alpha, beta and gamma.
IntronA er blevet klassificeret som rekombinant interferon alfa- 2b.
IntronA has been classified as recombinant interferon alfa-2b.
Resultaterne af adskillige undersøgelser antyder, at når interferon er bundet til cellemembranen starter en kompleks sekvens af intracellulære reaktioner, som omfatter induktion af visse enzymer.
 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.
Rekombinant interferon alfa- 2b har vist antiproliferative effekter i undersøgelser under anvendelse af både animale og humane cellekultursystemer, såvel som humane tumor xentotransplantater på dyr.
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.
Rekombinant interferon alfa- 2b hæmmer også viral replikation in vitro og in vivo.
Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Skønt den nøjagtige antivirale virkningsmekanisme af rekombinant alfa- 2b er ukendt, synes det at ændre værtscellemetabolismen.
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
Nuværende kliniske erfaringer med patienter, som forbliver i interferon alfa- 2b behandling i 4 til 6 måneder, viser, at behandlingen kan give elimination af serum HBV- DNA.
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.
Hos voksne patienter med nedsættelse af HbeAg og HBV- DNA er set en signifikant reduktion i morbiditet og mortalitet.
In adult patients with loss of HBeAg and HBV-DNA, a significant reduction in morbidity and mortality has been observed.
Interferon alfa- 2b (6 MIE/ m2 3 gange om ugen i 6 måneder) er blevet givet til børn med kronisk aktiv hepatitis B.
Interferon alfa-2b (6 MIU/m2 3 times a week for 6 months) has been given to children with chronic active hepatitis B.
På grund af en metodesvaghed, kunne effekt ikke påvises.
Because of a methodological flaw, efficacy could not be demonstrated.
Herudover fik børn behandlet med interferon alfa- 2b en nedsat væksthastighed og nogle tilfælde af depression sås.
Moreover children treated with interferon alfa-2b experienced a reduced rate of growth and some cases of depression were observed.
Kronisk hepatitis C:
Chronic hepatitis C:
Hos voksne patienter, som modtager interferon i kombination med ribavirin, er den opnåede vedvarende respons rate 47%.
In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is 47%.
Bedre effekt er blevet demonstreret med kombinationen af pegyleret interferon med ribavirin (vedvarende respons rate 61% opnået i en undersøgelse udført hos naive patienter med en ribavirin dosis > 10, 6 mg/ kg, p < 0, 01).
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).
IntronA alene eller i kombination med ribavirin er blevet undersøgt i 4 randomiserede fase III kliniske undersøgelser hos 2. 552 interferon- naive patienter med kronisk hepatitis C.
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.
Undersøgelserne sammenlignede effekten af IntronA anvendt alene eller i kombination med ribavirin.
The trials compared the efficacy of IntronA used alone or in combination with ribavirin.
Patienter, der kunne indgå i disse undersøgelser, havde kronisk hepatitis C bekræftet ved en positiv HCV- RNA polymerasekædereaktions assay (PCR) (> 100 kopier/ ml), en leverbiopsi i overensstemmelse med en histologisk diagnose med kronisk hepatitis uden anden årsag til den kroniske hepatitis, og abnorm serum ALAT.
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.
16 IntronA blev indgivet i en dosis på 3 MIE 3 gange om ugen som monoterapi eller i kombination med ribavirin.
IntronA was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with ribavirin.
Samtidig indgift af IntronA med ribavirin øgede effekten af IntronA til mindst det dobbelte ved behandling af kronisk heptatitis C hos naive patienter.
Co-administration of IntronA with ribavirin increased the efficacy of IntronA by at least two fold for the treatment of chronic heptatitis C in naïve patients.
Responsrater i disse undersøgelser steg med compliance.
 16 Response rates in these trials were increased with compliance.
Uafhængigt af genotype havde patienter, som fik IntronA i kombination med ribavirin og fik  80% af deres behandling, et højere vedvarende respons 6 måneder efter 1 års behandling end dem, der anvendte < 80% af deres behandling (56% mod 32% i undersøgelse C/ I98- 580).
32% in trial C/I98-580).
Vedvarende virologiske responsrater med IntronA + ribavirin (et års behandling) efter genotype og virusmængde
virologic response rates with IntronA + ribavirin (one year of treatment) by genotype and viral load
HCV Genotype
HCV Genotype
Genotype 1
Genotype 1
 2 millioner kopier/ ml Genotype 1
 2 million copies/ml Genotype 1
> 2 millioner kopier/ ml
> 2 million copies/ml
Genotype 2/ 3
Genotype 2/3
I IntronA (3 MIE 3 gange om ugen) I/ R IntronA (3 MIE 3 gange om ugen) + ribavirin (1. 000/ 1. 200 mg/ dag)
I IntronA (3 MIU 3 times a week) I/R IntronA (3 MIU 3 times a week) + ribavirin (1,000/1,200 mg/day)
Samtidig infektion med HCV/ HIV Der har været udført to undersøgelser af patienter med samtidig infektion af HIV og HCV.
HCV/HIV Co-infected patients Two trials have been conducted in patients co-infected with HIV and HCV.
I begge undersøgelser var patienter, der fik IntronA plus ribavirin overordnet mindre tilbøjelige til at respondere end patienter, der fik pegyleret interferon alfa- 2b med ribavirin.
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.
Patienterne blev randomiseret til enten at få pegyleret interferon alfa 2b (1, 5 µg/ kg/ uge) plus ribavirin (800 mg/ dag) eller IntronA (3 MIE TIW) plus ribavirin (800 mg/ dag) i 48 uger med en opfølgningsperiode på 6 måneder.
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.
Patienterne blev randomiseret til at få enten pegyleret interferon alfa- 2b (100 eller 150 µg / uge baseret på vægt) plus ribavirin (800 - 1. 200 mg/ dag baseret på vægt) eller IntronA (3 MIE TIW) plus ribavirin (800- 1. 200 mg/ dag baseret på vægt).
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).
17 af de patienter, der var inficeret med genotype 2 og 3 og viral load < 800. 000 IE/ ml (Amplicor), som blev behandlet i 24 uger med en opfølgningsperiode på 6 måneder.
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.
Vedvarende virologisk respons baseret på genotype efter IntronA i kombination med ribavirin versus pegyleret interferon alfa- 2b i kombination med ribavirin hos patienter med samtidig infektion af HCV/ HIV Undersøgelse 11 Undersøgelse 22 pegyleret pegyleret interferon interferon alfa- 2b (100 alfa- 2b eller IntronA (1, 5 µg/ kg / IntronA 150c µg/ uge) (3 MIE TIW) uge) + (3 MIE TIW) + + ribavirin + ribavirin ribavirin ribavirin p (800 - (800 - p (800 mg) (800 mg) værdi a 1. 200 mg) d 1. 200 mg) d værdib
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
Alle

Genotype 1, 17% (21/ 125) 4
17 1,200 mg)d
6% (8/ 129)
All Genotype 1, 4
0, 006 38% (12/ 32)
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)
0, 007
Genotype 2, 3
Genotype 2, 44% (35/ 80) 3
44% (35/80) 43% (33/76) 0.88 53% (10/19) 47% (7/15)
MIE = millioner internationale enheder; TIW = tre gange ugentlig. a: p værdi baseret på Cochran- Mantel Haenszel Chi kvadrat- test. b: p værdi baseret på chi- kvadrat- test. c: forsøgspersoner < 75 kg fik 100 µg/ uge pegyleret interferon alfa- 2b og forsøgspersoner ≥ 75 kg fik 150 µg/ uge pegyleret interferon alfa- 2b. d: ribavirin dosering var 800 mg for patienter < 60 kg, 1. 000 mg for patienter 60- 75 kg og 1. 200 mg for patienter > 75 kg.
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.
Relaps patienter:
Relapse patients:
I alt 345interferon alfa relaps patienter blev behandlet i to kliniske undersøgelser med IntronA monoterapi eller i kombination med ribavirin.
A total of 345 interferon alpha relapse patients were treated in two clinical trials with IntronA monotherapy or in combination with ribavirin.
Hos disse patienter øgede supplement af ribavirin til IntronA helt op til 10 gange effekten af IntronA anvendt alene i behandlingen af kronisk hepatitis C (48, 6% mod 4, 7%).
4.7%).
Denne forøgelse af effekten omfattede tab af serum HCV (< 100 kopier/ ml ved PCR), forbedring i leverinflammation og normalisering af ALAT, og var opretholdt ved måling 6 måneder efter afsluttet behandling.
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.
Langtidsdata I en stor undersøgelse, blev 1. 071 patienter inkluderet efter behandling i en tidligere ikke pegyleret interferon alfa- 2b eller ikke pegyleret interferon alfa- 2b/ ribavirin undersøgelse for at evaluere varigheden af vedvarende virologisk respons og bestemme virkningen af fortsat viral negativitet på kliniske resultater.
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.
Kaplan- Meier estimatet for fortsat vedvarende respons over 5 år for alle patienter er 97% med et 95% konfidensinterval på [95%, 99%].
The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 97% with a 95% Confidence Interval of [95%, 99%].
SVR efter behandling af kronisk HCV med ikke pegyleret interferon alfa- 2b (med eller uden ribavirin) resulterer i langtidsclearance af virus hvilket medfører resolution af den hepatiske infektion og klinisk 'helbredelse' af kronisk HCV.
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.
Børn og unge i alderen 3 til 16 år med kompenseret kronisk hepatitis C og påviselig HCV RNA (målt hos et centralt laboratorium ved brug af en forskningsbaseret RT- PCR analyse) blev inkluderet i to multicenter undersøgelser og fik IntronA 3 MIE/ m2 tre gange om ugen plus ribavirin 15 mg/ kg per dag i 1 år efterfulgt af 6 måneders opfølgning efter behandling.
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.
I alt 118 patienter blev inkluderet:
A total of 118 patients were enrolled:
57% mænd, 80% kaukasiske og 78% genotype 1, 64% i alderen  12 år.
57% male, 80% Caucasian, and 78% genotype 1,64%  12 years of age.
Den inkluderede population 18 bestod hovedsageligt af børn med mild til moderat hepatitis C.
The population enrolled mainly consisted in children with mild to moderate hepatitis C.
Vedvarende virologiske responsrater hos børn og unge svarede til dem, der sås hos voksne.
Sustained virological response rates in children and adolescents were similar to those in adults.
4. 1, 4. 4 og 4. 8).
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).
Virologisk respons hos tidligere ubehandlede pædiatriske patienter IntronA 3 MIE/ m2 3 gange om ugen + ribavirin 15 mg/ kg/ dag
Virological response in previously untreated paediatric patients IntronA 3 MIU/m2 3 times a week + ribavirin 15 mg/kg/day
Samlet respons1 (n=118)
 18 Overall Response1 (n=118)
Genotype 1 (n=92)
Genotype 1 (n=92)
Genotype 2/ 3/ 4 (n=26) * Antal (%) patienter
Genotype 2/3/4 (n=26) *Number (%) of patients
Defineret som HCV RNA under detektionsgrænsen ved brug af en forskningsbaseret RT- PCR analyse ved afslutningen af behandlingen og under opfølgningsperioden
Defined as HCV-RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period
Farmakokinetikken af IntronA blev undersøgt hos raske forsøgspersoner efter enkeltdoser på 5 millioner IE/ m2 og 10 millioner IE indgivet subkutant, ved doser på 5 millioner IE/ m2 indgivet intramuskulært og som en 30 minutters intravenøs infusion.
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.
C max sås tre til 12 timer efter den laveste dosis og seks til otte timer efter den højeste dosis.
C max occurred three to 12 hours after the lower dose and six to eight hours after the higher dose.
Eliminationshalveringstiden af interferon- injektioner var henholdsvis cirka to til tre timer og seks til syv timer.
The elimination half-lives of interferon injections were approximately two to three hours, and six to seven hours, respectively.
Både subkutan og intramuskulær indgift gav en biotilgængelighed på mere end 100%.
Both subcutaneous and intramuscular administration resulted in bioavailabilities greater than 100%.
Efter intravenøs indgift sås det maksimale interferonniveau (135- 273 IE/ ml) ved slutningen af infusionen, og herefter faldt det med en lidt hurtigere hastighed end efter subkutan eller intramuskulær indgift, idet det ikke kunne påvises fire timer efter infusion.
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.
Flerdosis farmakokinetiske egenskaber for IntronA injektionsvæske og ribavirin kapsler hos børn og unge med kronisk hepatitis C i alderen 5 til 16 år er opsummeret i Tabel 6.
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.
Farmakokinetikken for IntronA og ribavirin (dosis- normaliseret) er ens hos voksne og børn eller unge.
The pharmacokinetics of IntronA and ribavirin (dose-normalized) are similar in adults and children or adolescents.
Tabel 6.
 19 Table 6.
Gennemsnitlig (% CV) flerdosis farmakokinetiske parametre for IntronA og ribavirin kapsler ved indgift til børn eller unge med kronisk hepatitis C
Mean (% CV) multiple-dose pharmacokinetic parameters for IntronA and ribavirin capsules when administered to children or adolescents with chronic hepatitis C
PARAMETER
Parameter
fordelt på 2 doser (n = 17)
15 mg/kg/day as 2 divided doses (n = 17)
gange om ugen (n = 54)
3 MIU/m2 3 times a week (n = 54)
T max (timer)
T max (hr)
C max (ng/ ml)
C
3. 275 (25)
max (ng/ml) AUC*
29. 774 (26)
3,275 (25) 29,774 (26)
Tilsyneladende clearance l/ time/ kg
Apparent clearance l/hr/kg
* AUC 12 (ng. time/ ml) for ribavirin; AUC 0- 24 (IE. time/ ml) for IntronA
*AUC 12 (ng.hr/ml) for ribavirin; AUC 0-24 (IU.hr/ml) for IntronA
Interferonneutraliserende faktorer er
Interferon neutralising factor assays were performed on serum samples of patients who received IntronA in Schering-Plough monitored clinical trials.
19 antistoffer, som neutraliserer den antivirale virkning af interferon.
Interferon neutralising factors are antibodies which neutralise the antiviral activity of interferon.
Den kliniske hyppighed af neutraliserende faktorer, som udvikledes hos cancerpatienter, der blev behandlet systemisk, var 2, 9% og hos patienter med kronisk hepatitis 6, 2%.
The clinical incidence of neutralising factors developing in cancer patients treated systemically is 2.9% and in chronic hepatitis patients is 6.2%.
Injektioner med human rekombinant interferon alfa- 2b i op til tre måneder har ikke vist tegn på toksicitet hos mus, rotter og kaniner.
Injections of human recombinant interferon alfa-2b for up to three months have shown no evidence of toxicity in mice, rats, and rabbits.
Daglige doser til cynomolgus aber med 20 x 106 IE/ kg/ dag i 3 måneder forårsagede ingen mærkbar toksicitet.
Daily dosing of cynomolgus monkeys with 20 x 106 IU/kg/day for 3 months caused no remarkable toxicity.
Toksicitet blev påvist i aber, der fik 100 x 106 IE/ kg/ dag i 3 måneder.
Toxicity was demonstrated in monkeys given 100 x 106 IU/kg/day for 3 months.
4. 4).
In studies of interferon use in non-human primates, abnormalities of the menstrual cycle have been observed (see section 4.4).