natgillin/translations-raw huggingface dataset:
MIE = millioner internationale enheder; TIW = tre gange ugentlig. a: p- værdi baseret på Cochran- Mantel Haenszel Chi square- test. b: p værdi baseret på chi- square test. c: forsøgspersoner < 75 kg fik 100 µg/ uge peginterferon alfa- 2b og forsøgspersoner ≥ 75 kg fik 150 µg/ uge peginterferon alfa- 2b. d:
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 peginterferon alfa-2b and subjects ≥ 75 kg received 150 µg/week peginterferon alfa-2b. d:
Rebetol dosis var 800 mg for patienter < 60 kg, 1. 000 mg for patienter 60- 75 kg, og 1. 200 mg for patienter > 75 kg.
Rebetol dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Både Metavirscore og Ishakgraden faldt blandt de forsøgspersoner, der blev behandlet med Rebetol i kombination med peginterferon alfa- 2b.
Both the Metavir score and Ishak grade decreased among subjects treated with Rebetol in combination with peginterferon alfa-2b.
Dette fald var signifikant blandt de responderende (- 0, 3 for Metavir og - 1, 2 for Ishak) og stabile (- 0, 1 for Metavir og - 0, 2 for Ishak) blandt de ikke- responderende.
This decline was significant among responders (-0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among non- responders.
Patienter som ikke har responderet på tidligere behandling Genbehandling af patienter hvor behandling med peginterferon alfa 2b i kombination med Rebetol tidligere har været uden effekt (relaps og non responder patienter) 2. 293 patienter i en ikke sammenligningsundersøgelse, som havde moderat til svær fibrose, hvor tidligere behandling med kombinationen af alfa interferon/ ribavirin var uden effekt, blev behandlet
Previous treatment failure patients Retreatment of prior treatment failures (relapse and non-responder patients) with peginterferon alfa- 2b in combination with Rebetol In a non-comparative trial, 2,293 patients with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with peginterferon alfa 2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted Rebetol.
Patienter som var HCV- RNA negative ved afslutningen af en 12 ugers behandling fortsatte behandlingen i alt 48 uger og blev overvåget i de næste 24 uger efter behandlingen var afsluttet.
Patients who were HCV-RNA negative at Treatment Week 12 continued treatment for 48 weeks and were followed for 24 weeks post-treatment.
12 ugers respons på behandlingen blev defineret som ikke- målbart HCV- RNA efter 12 ugers behandling.
Response Week 12 was defined as undetectable HCV- RNA after 12 weeks of treatment.
Sustained virologisk respons (SVR) er defineret som ikke- målbart HCV- RNA 24 uger efter endt behandling (Tabel 10).
Sustained Virologic Response (SVR) is defined as undetectable HCV-RNA at 24 weeks post-treatment (Table 10).
Tabel 10 Responsrater på genbehandling af patienter som ikke har responderet på tidligere behandling
Table 10 Rates of Response to retreatment in prior treatment failures
Patienter med ikke- målbart HCV- RNA efter 12 ugers behandling og SVR lige efter genbehandling Samlet
Patients with undetectable HCV–RNA 19 at treatment Week 12 and SVR upon retreatement Overall
Overordnet respons Tidligere respons
Overall Prior Response
38, 6 (549/ 1. 423)
38.6 (549/1,423) 59.4 (326/549) 54.0,64.8
59, 4 (326/ 549) 54, 0, 64, 8
31.5 (272/863) 50.4 (137/272) 42.6, 58.2
31, 5 (272/ 863) 50, 4 (137/ 272) 42, 6, 58, 2
21.7 (497/2,293) 19.5, 23.9
21, 7 (497/ 2. 293) 19, 5, 23, 9
Relapse
Tilbagefald
67.7 (203/300)
67, 7 (203/ 300)
59.6 (121/203) 50.7, 68.5
59, 6 (121/ 203) 50, 7, 68, 5
58.1 (200/344)
58, 1 (200/ 344) 52, 5 (105/ 200) 43, 4, 61, 6
52.5 (105/200) 43.4, 61.6
59, 7 (129/ 216)
59.7 (129/216)
51, 2 (66/ 129) 39, 8, 62, 5
51.2 (66/129) 39.8, 62.5
48, 6 (122/ 251) 44, 3 (54/ 122) 32, 7, 55, 8
44.3 (54/122) 32.7, 55.8
75, 6 (96/ 127) 63, 5 (61/ 96) 50, 9, 76, 2
75.6 (96/127) 63.5 (61/96) 50.9, 76.2
4 METAVIR Fibrose score
42.5 (17/40)
42, 5 (17/ 40)
70.6 (12/17) 42.1, 99.1
70, 6 (12/ 17) 42, 1, 99, 1
44.4 (12/27) 50.0 (6/12) 12.8, 87.2
44, 4 (12/ 27) 50, 0 (6/ 12) 12, 8, 87, 2
28.4 (19/67) 14.2, 42.5
28, 4 (19/ 67) 14, 2, 42, 5
METAVIR Fibrosis score
32, 4 (78/ 241) 51, 3 (40/ 78) 36, 7, 65, 9
32.4 (78/241)
21, 9 (147/ 672) 17, 8, 26, 0
51.3 (40/78) 36.7, 65.9
F4 Baseline virus - mængder
21.9 (147/672) 17.8, 26.0
HVL (< 600. 000 IU/ ml)
Baseline Viral Load HVL (> 600,000 IU/ml)
Non- responders defineres som serum/ plasma- HCV- RNA- positive ved afslutning af mindst 12 ugers behandling.
Non-responder defined as serum/plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment.
20 HCV- RNA- serum måles ved et videnskabeligt baseret kvantitativt polymerase- kædereaktions- assay på et centralt laboratorium * Hensigt til at behandle- populationen inkluderer 7 patienter, hvor mindst 12 ugers tidligere behandling ikke er bekræftet.
Plasma HCV-RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory * Intent to treat population includes 7 patients for whom at least 12 weeks of prior therapy could not be confirmed.
36% (821/ 2. 286) af patienterne ikke målbart HCV- RNA plasma niveau i den 12. behandlings uge, målt ved hjælp af en videnskabelig baseret test (detektionsgrænse 125 IE/ ml).
Overall, approximately 36% (821/2,286) of patients had undetectable plasma HCV-RNA levels at Week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
I denne undergruppe opretholdt 56% (463/ 823) den virulogiske respons rate.
In this subgroup, there was a 56% (463/823) sustained virological response rate.
For patienter som tidligere har været behandlet med ikke pegyleret interferon eller pegyleret interferon og som har været negative i 12. behandlings uge, var den fortsatte responsrate henholdsvis 59% og 50%.
For patients with prior failure on therapy with nonpegylated interferon or pegylated interferon and negative at Week 12, the sustained response rates were 59% and 50%, respectively.
Genbehandling af relaps patienter med Rebetol og interferon alfa- 2b kombinations behandling To undersøgelser vurderede anvendelsen af Rebetol + interferon alfa- 2b kombinationsbehandling hos relaps patienter (C95- 144 og I95- 145); 345 patienter med kronisk hepatitis, som havde fået relaps efter tidligere interferonbehandling, blev behandlet i seks måneder med en seks måneders opfølgning.
Retreatment of relapse patients with Rebetol and interferon alfa-2b combination treatment Two trials examined the use of Rebetol and interferon alfa-2b combination treatment in relapse patients (C95-144 and I95-145); 345 chronic hepatitis patients who had relapsed after previous interferon treatment were treated for six months with a six month follow-up.
Kombinationsbehandling med Rebetol + interferon alfa- 2b resulterede i et vedvarende virologisk respons, der var ti gange større end ved interferon alfa- 2b alene (49% mod 5%, p < 0, 0001).
Combination therapy with Rebetol and interferon alfa-2b resulted in a sustained virological response that was ten-fold higher than that with interferon alfa-2b alone (49% vs 5%, p < 0.0001).
Den gavnlige effekt blev opretholdt uafhængigt af standardforudsigelser om respons på interferon alfa- 2b såsom virusmængde, HCV genotype og histologisk stadie.
This benefit was maintained irrespective of standard predictors of response to interferon alfa-2b such as virus level, HCV genotype and histological staging.
Langtidsvirkningsfulde data To store undersøgelser med langtidsopfølgning inkluderede 1. 071 patienter og 567 patienter efter behandling i tidligere undersøgelser med henholdsvis non- pegyleret interferon alfa- 2b (med eller uden Rebetol) og pegyleret interferon alfa- 2b (med eller uden Rebetol).
Long-term efficacy data Two large long-term follow-up studies enrolled 1,071 patients and 567 patients after treatment in prior studies with nonpegylated interferon alfa-2b (with or without Rebetol) and pegylated interferon alfa- 2b (with or without Rebetol), respectively.
Kun henholdsvis 12 ud af 492 vedvarende responders og 3 ud af 366 vedvarende responders fik tilbagefald i undersøgelserne.
12 out of 492 sustained responders and only 3 out of 366 sustained responders relapsed, respectively, in the studies.
Kaplan- Meier estimatet for fortsat vedvarende respons over 5 år er 97% (95% CI:
The Kaplan-Meier estimate for continued sustained response over 5 years is 97% (95% CI:
95- 99%) for patienter, der fik non- pegyleret interferon alfa 2b (med eller uden Rebetol), og det er 99% (95% CI:
95-99%) for patients receiving nonpegylated interferon alfa-2b (with or without Rebetol), and is 99% (95% CI:
98- 100%) for patienter, der fik pegyleret interferon alfa- 2b (med eller uden Rebetol).
98-100%) for patients receiving pegylated interferon alfa-2b (with or without Rebetol).
SVR efter behandling af kronisk HCV med interferon alfa- 2b (pegyleret eller non- pegyleret, med eller uden Rebetol) 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 interferon alfa-2b (pegylated and nonpegylated,with or without Rebetol) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical'cure' from chronic HCV.
Rebetol kliniske undersøgelser hos børn og unge:
Rebetol clinical trials in children and adolescents:
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 Rebetol 15 mg/ kg per dag plus interferon alfa- 2b 3 MIE/ m2 tre gange om ugen 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 Rebetol 15 mg/kg per day plus interferon alfa-2b 3 MIU/m2 3 times a week for 1 year followed by 6 months follow-up after treatment.
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.
Undersøgelses resultater er summerede i Tabel 11.
Study results are summarized in Table 11.
21 Tabel 11
Table 11.
Tidligere ubehandlede børn og unge Rebetol 15 mg/ kg/ dag + interferon alfa- 2b 3 MIE/ m2 3 gange om ugen
Virological response in previously untreated children and adolescents Rebetol 15 mg/kg/day + interferon alfa-2b 3 MIU/m2 3 times a week
Genotype 2/ 3/ 4 (n=26) * Antal (%) patienter
21 Genotype 2/3/4 (n=26) * Number (%) of patients
0, 05, 3, 73 og 79 timer).
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).
Absorptionen er omfattende med omkring 10% af en radioaktivt mærket dosis udskilt i fæces.
Absorption is extensive with approximately 10% of a radiolabelled dose excreted in the faeces.
Den absolutte bioavailabilitet er imidlertid omkring 45% - 65%, hvilket synes at skyldes first pass metabolisme.
However, absolute bioavailability is approximately 45 %-65%, which appears to be due to first pass metabolism.
Der er en lineær relation mellem dosis og AUCtf efter enkelte doser på 200- 1. 200 mg ribavirin.
There is a linear relationship between dose and AUCtf following single doses of 200-1,200 mg ribavirin.
Fordelingsvolumen er cirka 5. 000 liter.
Volume of distribution is approximately 5,000 l.
Det er vist for ribavirin, at det kan give høj inter - og intrapersonvariabilitet efter enkelte orale doser (intrapersonvariabilitet på cirka 30% for både AUC og Cmax), hvilket kan skyldes stor first pass metabolisme og overførsel inden for og uden for blodfordelingsrummet.
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.
Ribavirin transport i non- plasmacompartments er blevet meget omfattende undersøgt i røde blodlegemer og er blevet identificeret til hovedsageligt at foregå via en es- type equilibrativ nukleosid transporter.
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.
Forholdet blod: plasma ribavirinkoncentrationer er cirka 60: 1; det overskydende ribavirin i blodet er til stede som ribavirinnukleotider afsondret i erytrocytter.
The ratio of whole blood:plasma ribavirin concentrations is approximately 60: 1; the excess of ribavirin in whole blood exists as ribavirin nucleotides sequestered in erythrocytes.
Ribavirin har to metaboliseringsveje:
Ribavirin has two pathways of metabolism:
1) en reversibel phosphorylering; 2) en nedbrydning, der involverer deribosylation og amidhydrolyse til at danne en triazolcarboxylsyremetabolit.
1) a reversible phosphorylation pathway; 2) a degradative pathway involving deribosylation and amide hydrolysis to yield a triazole carboxyacid metabolite.
Både ribavirin og dets triazolcarboxamid - og triazolcarboxylsyremetabolitter udskilles renalt.
Both ribavirin and its triazole carboxamide and triazole carboxylic acid metabolites are also excreted renally.
Efter peroral dosering med 600 mg to gange daglig blev steady- state nået efter cirka fire uger med gennemsnitlige steady- state plasmakoncentrationer omkring 2. 200 ng/ ml.
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.
Efter ophørt dosering var halveringstiden cirka 298 timer, hvilket sandsynligvis afspejler langsom elimination fra non - plasma compartments.
Upon discontinuation of dosing the half-life was approximately 298 hours, which probably reflects slow elimination from non-plasma compartments.
Effekt af fødeindtagelse:
Food effect:
Bioavailabiliteten af en enkelt oral dosis ribavirin forøgedes ved samtidig indtagelse af et måltid med højt fedtindhold (AUCtf og Cmax steg begge med 70%).
The bioavailability of a single oral dose of ribavirin was increased by co-administration of a high fat meal (AUCtf and Cmax both increased by 70%).
Enkeltdosis ribavirin farmakokinetik var ændret (øget AUCtf og Cmax) hos patienter med nedsat nyrefunktion sammenlignet med kontrolpersoner (creatinin clearance > 90 ml/ minut).
Single-dose ribavirin pharmacokinetics were altered (increased AUCtf and Cmax) in patients with renal dysfunction compared with control subjects (creatinine clearance > 90 ml/minute).
22 Leverfunktion:
Hepatic function:
Enkeltdosis farmakokinetik for ribavirin hos patienter med let, moderat eller svær leverfunktionsnedsættelse (Child- Pugh Classification A, B eller C) svarer til værdier for normale kontroller.
Single-dose pharmacokinetics of ribavirin in patients with mild, moderate or severe hepatic dysfunction (Child-Pugh Classification A, B or C) are similar to those of normal controls.
Ældre patienter (i alderen ≥ 65 år):
Elderly patients (≥ 65 years of age):
Den fremkomne clearance model viste, at kropsvægt, køn, alder og serum creatinin var de vigtigste covariate.
The clearance model developed showed that body weight, gender, age, and serum creatinine were the main covariates.
For mænd var clearance cirka 20% højere end for kvinder.
For males, clearance was approximately 20% higher than 22 for females.
Flerdosis farmakokinetiske egenskaber for Rebetol kapsler og interferon alfa- 2b hos børn og unge med kronisk hepatitis C i alderen 5 til 16 år er opsummeret i Tabel 12.
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 12.
Farmakokinetikken for Rebetol og interferon alfa- 2b (dosis- normaliseret) er ens hos voksne og børn eller unge.
The pharmacokinetics of Rebetol and interferon alfa-2b (dose-normalized) are similar in adults and children or adolescents.
Tabel 12
Table 12.
og Rebetol kapsler ved indgift til børn eller unge med kronisk hepatitis C
Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and Rebetol capsules when administered to children or adolescents with chronic hepatitis C
15 mg/ kg/ dag
15 mg/kg/day as 2 divided doses (n = 17)
fordelt på 2 doser (n = 17)
3 MIU/m2
3 MIE/ m2 3 gange om ugen (n = 54)
3 times a week (n = 54)
3. 275 (25)
3,275 (25)
29. 774 (26)
29,774 (26)
Tilsyneladende clearance l/ time/ kg
clearance l/hr/kg
* AUC12 (ng. time/ ml) for Rebetol; AUC0- 24 (IE. time/ ml) for interferon alfa- 2b
*AUC12 (ng.hr/ml) for Rebetol; AUC0-24 (IU.hr/ml) for interferon alfa-2b
Dette viste sig efterfølgende som mindre fald i kropsvægt, crown- rump længde og knoglelængde.
In a juvenile rat toxicity study, pups dosed from postnatal day 7 to 63 with 10, 25 and 50 mg/kg of ribavirin demonstrated a dose-related decrease in overall growth, which was subsequently manifested as slight decreases in body weight, crown-rump length and bone length.
I 3 og 6 måneders undersøgelser på mus for at undersøge ribavirin induceret testis - og sædcellepåvirkninger forekom abnormaliteter i sædceller ved doser på 15 mg/ kg og derover.
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.
Disse doser til dyr giver systemiske eksponeringer et godt stykke under dem, der opnås hos mennesker ved
These doses in animals produce systemic exposures well below those achieved in humans at therapeutic doses.
4. 6).
Upon cessation of treatment, essentially total recovery from ribavirin-induced testicular toxicity occurred within one or two spermatogenic cycles (see section 4.6).
Ribavirin var aktiv i Balb/ 3T3 in vitro Transformation Assay.
Ribavirin was active in the Balb/3T3 in vitro Transformation Assay.
Genotoksisk aktivitet sås i mus lymfomtest og ved doser på 20 - 200 mg/ kg i en mus mikronucleusprøve.
Genotoxic activity was observed in the mouse lymphoma assay, and at doses of 20-200 mg/kg in a mouse micronucleus assay.
Ribavirin blev ikke fundet tumorfremkaldende i konventionelle carcinogenicitetsundersøgelser på gnavere med lav eksposition sammenlignet med human eksponering under terapeutiske omstændigheder (faktor 0, 1 i rotter og 1 i mus).
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.
Derudover fremkaldte ribavirin ikke tumorer i en 26 ugers carcinogenicitetsundersøgelse med den heterozygote p53( + / -) musemodel og den maksimale tolererede dosis på 300 mg/ kg (plasma ekspositionsfaktor cirka 2, 5 sammenlignet med human eksponering).
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
Ribavirin og interferon alfa- 2b:
Ribavirin plus interferon alfa-2b:
Ved anvendelse i kombination med peginterferon alfa- 2b eller interferon alfa- 2b forårsagede ribavirin ikke nogen virkninger, som ikke tidligere var set med hvert aktivt stof alene.
When used in combination with peginterferon alfa-2b or interferon alfa-2b, ribavirin did not cause any effects not previously seen with either active substance alone.
Mikrokrystallinsk cellulose, Lactosemonohydrat, Croscarmellosenatrium, Magnesiumstearat.
Microcrystalline cellulose, Lactose monohydrate, Croscarmellose sodium, Magnesium stearate.
Gelatine, Titandioxid.
Gelatine, Titanium dioxide.
Kapselprægning:
Capsule imprint:
Shellac, Propylenglycol, Ammoniumhydroxid, Farvestof (E 132).
Shellac, Propylene glycol, Ammonium hydroxide, Colouring agent (E 132).
Ribavirin kapsler er pakket i blisterpakninger, som består af polyvinylklorid (PVC) / polyethylen (PE) / polyvinyliden klorid (PVdC).
Ribavirin capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC).
24 Pakninger á 84, 112, 140 og 168 kapsler.
Packs of 84, 112, 140 and 168 capsules.
SP Europe 73, rue de Stalle B- 1180 Bruxelles Belgien
SP Europe 73, rue de Stalle B-1180 Bruxelles 24 Belgium
7. maj 1999 Dato for seneste fornyelse:
7 May 1999 Date of last renewal:
02. september 2004
02 September 2004
Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Rebetol 40 mg/ ml oral opløsning
Rebetol 40 mg/ml oral solution
Hver ml oral opløsning indeholder 40 mg ribavirin.
Each ml of oral solution contains 40 mg of ribavirin.
Rebetol indeholder 142 mg sorbitol og 300 mg saccharose per ml.
Rebetol contains 142 mg of sorbitol and 300 mg of sucrose per ml.
Rebetol er beregnet til anvendelse, i kombination med interferon alfa- 2b, til behandling af børn og unge i alderen 3 år eller ældre, som lider af tidligere ubehandlet kronisk hepatitis C uden leverdekompensation, og som er positive med hensyn til serum HCV- RNA.
Rebetol is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
4. 4, 4. 8 og 5. 1).
The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (See sections 4.4, 4.8 and 5.1).
Der er ingen information om sikkerhed eller effekt hos børn eller unge ved anvendelse af Rebetol med pegylerede eller andre former af interferon (det vil sige foruden alfa- 2b).
There is no safety or efficacy information in children or adolescents on the use of Rebetol with pegylated or other forms of interferon (i.e., not alfa-2b).
Dosis, der skal indgives Rebetol oral opløsning leveres i en koncentration på 40 mg/ ml.
Dose to be administered Rebetol oral solution is supplied in a concentration of 40 mg/ml.
Børn i alderen 3 år eller ældre samt unge:
Children 3 years of age or older and adolescents:
Rebetol oral opløsning indtages fordelt på to doser (morgen og aften) samtidig med et måltid.
Rebetol oral solution is administered in two divided doses (morning and evening) with food.
I kliniske undersøgelser udført i denne population, blev Ribavirin brugt i en dosis af 15 mg/ kg/ dag (Tabel 1).
In clinical studies performed in this population ribavirin was used in a dose of 15 mg/kg/day (Table 1).
Rebetol skal anvendes i kombination med interferon alfa- 2b injektionsvæske, opløsning, givet i en dosis på 3 millioner internationale enheder (MIE) / m2 tre gange ugentligt.
Rebetol must be used in combination with interferon alfa-2b solution for injection, administered at a dose of 3 million international units (MIU)/m2 three times a week.
26
26 Please refer also to the interferon alfa-2b Summary of Product Characteristics (SPC).
Rebetol oral opløsning - Pædiatrisk dosering
Rebetol Oral Solution - Paediatric Dosage
Afmålt dosis
Measured Dose
(morgen / aften)
(Morning / Evening)
Patienter, der vejer > 47 kg og desuden er i stand til at synke kapsler, kan tage den ækvivalente dosis ribavirin 200 mg kapsler fordelt på to doser (se venligst SPC for ribavirin kapsler).
Patients who weigh > 47 kg and are able to swallow capsules may take the equivalent dose of ribavirin 200 mg capsules in two divided doses (Please see SPC for ribavirin capsules).
Behandlingsvarighed Genotype 1:
Duration of treatment Genotype 1.