natgillin/translations-raw huggingface dataset:
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.
Pri bolnikih z blagimi, zmernimi ali hudimi motnjami delovanja jeter (A, B ali C po Child- Pughu) je farmakokinetika enkratnih odmerkov ribavirina podobna kot pri normalnih preiskovancih iz kontrolne skupine.
Elderly patients (≥ 65 years of age):
Starejši bolniki (≥ 65 let starosti):
The clearance model developed showed that body weight, gender, age, and serum creatinine were the main covariates.
Razviti model očistka je pokazal, da so glavne
For males, clearance was approximately 20% higher than 22 for females.
Pri moških je bil očistek približno 20% večji kot pri ženskah.
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.
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 12.
The pharmacokinetics of Rebetol and interferon alfa-2b (dose-normalized) are similar in adults and children or adolescents.
Farmakokinetika zdravila Rebetol in interferona alfa- 2b (z normaliziranim odmerkom) je podobna pri odraslih in otrocih ali mladostnikih.
Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and Rebetol capsules when administered to children or adolescents with chronic hepatitis C
Srednja vrednost (% CV) farmakokinetičnih parametrov pri večkratnem odmerjanju interferona alfa- 2b in zdravila Rebetol kapsule otrokom ali mladostnikom s kroničnim hepatitisom C
3 MIU/m2
2 deljenih odmerkov (n = 17)
clearance l/hr/kg
Navidezni očistek l/ h/ kg
*AUC12 (ng.hr/ml) for Rebetol; AUC0-24 (IU.hr/ml) for interferon alfa-2b
* AUC12 (ng x h/ ml) za Rebetol; AUC0- 24 (i. e. x h/ ml) za interferon alfa- 2b
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.
V študiji toksičnosti zdravila za podganje mladiče so pri mladičih, ki so jim 7. do 63. dne po rojstvu dajali odmerke 10, 25 in 50 mg/ kg ribavirina, so ugotovili od odmerka odvisno splošno zmanjšanje rasti, ki se je kasneje pokazalo kot rahlo zmanjšanje telesne mase, razdalje od temena do trtice in dolžine kosti.
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 (see section 4.6).
Po koncu zdravljenja je prišlo v enem do dveh ciklusih spermatogeneze do praktično popolnega izginotja znakov testikularne toksičnosti ribavirina (glejte poglavje 4. 6).
Ribavirin was active in the Balb/3T3 in vitro Transformation Assay.
Ribavirin se je izkazal za aktivnega v transformacijskem testu na celicah Balb/ 3T3 in vitro.
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 pri odmerkih od 20 do 200 mg/ kg v testu na mišjih mikronukleusih.
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.
24 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
Poleg tega v 26- tedenski študiji 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).
Ribavirin plus interferon alfa-2b:
Ribavirin in interferon alfa- 2b:
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.
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 obeh učinkovin.
Microcrystalline cellulose, Lactose monohydrate, Croscarmellose sodium, Magnesium stearate.
Mikrokristalna celuloza, laktoza monohidrat, premrežen natrijev karmelozat, magnezijev stearat.
Gelatine, Titanium dioxide.
Želatina, titanov dioksid.
Shellac, Propylene glycol, Ammonium hydroxide, Colouring agent (E 132).
Napis na kapsuli: šelak, propilenglikol, amonijev hidroksid, barvilo (E 132).
Ribavirin capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC).
Ribavirin kapsule so pakirane v pretisne omote iz polivinilklorida (PVC) / polietilena (PE) / polivinilidenklorida (PVdC).
SP Europe 73, rue de Stalle B-1180 Bruxelles 24 Belgium
SP Europe 73, rue de Stalle B- 1180 Bruxelles Belgija
84 hard capsules 112 hard capsules 140 hard capsules 168 hard capsules
84 trde kapsule 112 trde kapsule 140 trde kapsule 168 trde kapsule
7 May 1999 Date of last renewal:
7. maj 1999 Datum zadnjega podaljšanja dovoljenja:
02 September 2004
2. september, 2004
Rebetol 40 mg/ml oral solution
Rebetol 40 mg/ ml peroralna raztopina
Each ml of oral solution contains 40 mg of ribavirin.
1 mililiter peroralne raztopine vsebuje 40 mg ribavirina.
Clear, colourless to pale or light yellow oral solution
Bistra, brezbarvna do bleda ali svetlo rumena peroralna raztopina
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.
Zdravilo Rebetol je namenjeno uporabi v kombinirani terapiji z interferonom alfa- 2b za zdravljenje otrok, starih 3 leta ali več, ki imajo predhodno nezdravljen kronični hepatitis C brez jetrne dekompenzacije in pozitiven izvid na serumsko HCV RNA.
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).
Pri tem morate pretehtati pričakovano korist zdravljenja v primerjavi z izsledki o varnosti zdravila pri pediatričnih bolnikih v kliničnih preskušanjih (glejte poglavja 4. 4, 4. 8 in 5. 1).
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).
Ni podatkov o varnosti ali učinkovitosti uporabe zdravila Rebetol pri otrocih ali mladostnikih skupaj s pegiliranimi ali drugimi oblikami interferona (tj. ne alfa- 2b).
Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C.
Zdravljenje sme uvesti in spremljati le zdravnik z izkušnjami iz zdravljenja kroničnega hepatitisa C.
Dose to be administered Rebetol oral solution is supplied in a concentration of 40 mg/ml.
Odmerek Rebetol peroralna raztopina je na voljo v koncentraciji 40 mg/ ml.
Children 3 years of age or older and adolescents:
Otroci, stari 3 leta ali starejši in mladostniki:
Rebetol oral solution is administered in two divided doses (morning and evening) with food.
Zdravilo Rebetol peroralna raztopina dajemo v dveh deljenih odmerkih s hrano (zjutraj in zvečer).
In clinical studies performed in this population ribavirin was used in a dose of 15 mg/kg/day (Table 1).
V kliničnih študijah izvajanih s to poulacijo se je ribavirin uporabljal v odmerku 15 mg/ kg/ dan (Preglednica 1).
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.
Zdravilo Rebetol uporabljajte skupaj z interferonom alfa- 2b raztopino za injiciranje, v odmerku 3 milijone mednarodnih enot (mio i. e.) / m2 trikrat na teden.
26 Please refer also to the interferon alfa-2b Summary of Product Characteristics (SPC).
Preberite tudi Povzetek glavnih značilnosti zdravila (SPC) za interferon alfa- 2b.
Table 1
27
Rebetol Oral Solution - Paediatric Dosage
Preglednica 1
Body Weight (kg)
Rebetol peroralna raztopina – Odmerjanje pri pediatričnih bolnikih
Measured Dose
Telesna masa (kg)
(Morning / Evening)
Izmerjeni odmerek (zjutraj / zvečer)
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).
Bolniki, ki tehtajo > 47 kg in lahko pogoltnejo kapsule, lahko zaužijejo enakovreden 200 mg odmerek ribavirina tudi v obliki kapsul, v dveh deljenih odmerkih (glejte SPC za ribavirin kapsule).
Duration of treatment Genotype 1.
Dolžina zdravljenja Genotip 1:
Patients who fail to achieve virological response at 6 months are highly unlikely to become sustained virological responders (negative predictive value 96%).
Pri bolnikih, ki niso dosegli virološkega odziva do 12. tedna, je zelo majhna verjetnost, da bodo postali stalno virološko odzivni (negativna napovedna vrednost 96%).
Virological response is defined as absence of detectable HCV-RNA at 12 weeks of treatment.
Virološki odziv je opredeljen kot odsotnost merljive vrednosti HCV- RNA v 12. tednu zdravljenja.
Dose modification If severe adverse reactions or laboratory abnormalities develop during therapy with Rebetol oral solution and interferon alfa-2b, modify the dosages of each product if appropriate, until the adverse reactions abate.
Prilagoditev odmerka Če se med zdravljenjem z zdravilom Rebetol peroralna raztopina in interferonom alfa- 2b pojavijo hujše neželene reakcije ali nenormalni izvidi laboratorijskih preiskav, odmerek vsakega zdravila po potrebi prilagajajte, dokler neželene reakcije ne izginejo.
Guidelines were developed in clinical trials for dose modification (see Dosage modification guidelines, Table 2).
V kliničnih preskušanjih so pripravili smernice za prilagajanje odmerka (glejte Smernice za prilagajanje odmerka, Preglednica 2).
The potential negative impact of ribavirin dose reduction on efficacy results could not be ruled out.
Ker je upoštevanje terapije lahko pomembno za izid zdravljenja, naj bo odmerek čimbliže priporočenemu standardnemu odmerku, saj ni mogoče izključiti morebitnega negativnega vpliva zmanjšanja odmerka ribavirina na učinkovitost zdravljenja.
Dosage modification guidelines for children and adolescents Reduce only Rebetol Reduce only interferon
Smernice za prilagajanje odmerka za otroke in mladostnike Zmanjšajte le odmerek Zmanjšajte le odmerek
Discontinue
Laboratorijske
Laboratory Values
zdravila Rebetol
dose to 7.5 mg/kg* per
interferona alfa- 2b
alfa-2b dose
kombinirano
combination therapy
na 7, 5 mg/ kg * na dan,
day, if:
če je:
to one-half dose, if:
na polovico odmerka, če je:
if:
terapijo, če je:
Haemoglobin
Hemoglobin Levkociti Nevtrofilci
< 10 g/dl
10 g/ dl - -
< 8.5 g/dl
- < 1, 5 x 109/ l < 0, 75 x 109/ l 9
White blood cells Neutrophils Platelets Bilirubin – Direct
< 8, 5 g/ dl < 1, 0 x 109/ l < 0, 5 x 109/ l < 50 x 109/ l
- - - -
Trombociti
< 1.5 x 109/l < 0.75 x 109/l < 80 x 109/l -
-
Bilirubin – Indirect
< 80 x 10 / l
> 5 mg/ dl
2, 5 x ZMN **
-
>
> 5 mg/dl
5 mg/ dl
(for > 4 weeks)
> 5 mg/ dl (za > 4 tedne)
2
2 x začetna vrednost
aminotransferase/ aspartate aminotransferase (ALT/AST)
aminotransferaza /
> 10 x ULN**
in
Children and adolescent patients whose dose of Rebetol is reduced to 7.5 mg/kg per day receive the dose in two divided amounts, in the morning and the evening ** Upper limit of normal
> 10 x ZMN ** aspartat aminotransferaza (ALT/ AST) * Otroci in mladostniki, pri katerih je bil odmerek zdravila Rebetol zmanjšan na 7, 5 mg/ kg na dan, naj prejmejo odmerek v dveh deljenih odmerkih, zjutraj in zvečer ** Zgornja meja normale
Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of Rebetol.
Zato je priporočljivo, da pri vseh bolnikih pred uvedbo zdravila Rebetol ovrednotite delovanje ledvic.
Patients with creatinine clearance < 50 ml/minute must not be treated with Rebetol (see section 4.3).
Bolnikov, pri katerih je očistek kreatinina < 50 ml/ min, ne smete zdraviti z zdravilom Rebetol (glejte poglavje 4. 3).
If serum creatinine rises to > 2 mg/dl (see Table 2), Rebetol and interferon alfa-2b must be discontinued.
Če je vrednost kreatinina v serumu > 2 mg/ dl (glejte Preglednico 2), prekinite zdravljenje z zdravilom Rebetol in interferon alfa- 2b.
Patients co-infected with HCV/HIV:
Bolniki, ki imajo sočasno okužbo s HCV/ HIV:
Patients taking NRTI treatment in association with ribavirin and interferon alfa-2b or peginterferon alfa-2b may be at increased risk of mitochondrial toxicity, lactic acidosis and hepatic decompensation (see section 4.4).
Bolniki, ki jemljejo terapijo NRTI skupaj z ribavirinom in interferonom alfa- 2b ali peginterferonom alfa- 2b, imajo lahko povečano tveganje za nastanek mitohondrijske toksičnosti, laktacidoze in jetrne dekompenzacije (glajte poglavje 4. 4).
In females of childbearing potential, Rebetol must not be
4. 3 Kontraindikacije
initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
ne smete uvesti, dokler ne dobite negativnega izvida testa nosečnosti tik pred začetkom zdravljenja;
- Women who are breast-feed ing.
- Doječe matere;
with creatinine clearance < 50 ml/minute and/or on haemodialysis.
kreatinina < 50 ml/ min in/ ali hemodializo;
- Severe hepatic dysfunction or decompensated cirrhosis of the liver.
- Huda jetrna okvara ali dekompenzirana jetrna ciroza;
Because of co-administration with interferon alfa-2b:
Zaradi sočasne uporabe interferona alfa- 2b pa še:
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Rebetol combination therapy with interferon alfa-2b, and even after treatment discontinuation mainly during the 6-month follow-up period.
Pri nekaterih bolnikih so med kombinirano terapijo z zdravilom Rebetol in interferonom alfa- 2b opažali hude učinke na CŽS, še posebej depresijo, samomorilne misli in tudi poskus samomora, celo po ukinitvi zdravljenja, predvsem v 6- mesečnem obdobju spremljanja.
Among children and adolescents, treated with Rebetol in combination with interferon alfa-2b, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% versus 1%) during treatment and during the 6-month follow-up after treatment.
Tako kot pri odraslih bolnikih so tudi pri otroci in mladostniki
As in adult patients, 28 children and adolescents experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence).
29 opazili druge psihiatrične neželene dogodke (npr. depresijo, čustveno labilnost in zaspanost).
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Rebetol and interferon alfa-2b be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Če psihiatrični simptomi ne prenehajo ali se celo poslabšajo, ali če ugotovite, da ima bolnik samomorilne misli, je priporočljivo, da prekinete zdravljenje z zdravilom Rebetolom in interferonom alfa- 2b in bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
Based on results of clinical trials, the use of ribavirin as monotherapy is not effective and Rebetol must not be used alone.
Na podlagi izsledkov kliničnih preskušanj vemo, da ribavirin v obliki monoterapije ni učinkovit, zato zdravila Rebetol ne smete uporabljati samostojno.
The safety and efficacy of this combination have been established only using ribavirin together with interferon alfa-2b.
Varnost in učinkovitost te kombinacije je bila ugotovljena le pri uporabi ribavirina skupaj z interferonom alfa- 2b.
A decrease in haemoglobin levels to < 10 g/dl was observed in up to 14% of adult patients and in 7% of children and adolescents treated with Rebetol in combination with peginterferon alfa-2b (adults only) or interferon alfa-2b (adult, children and adolescents) in clinical trials.
V kliničnih preskušanjih so pri do 14% odraslih bolnikov in 7% otrok in mladostnikov, zdravljenih z zdravilom Rebetol v kombinaciji s peginterferonom alfa- 2b (le odrasli bolniki) ali z interferonom alfa- 2b (odrasli, otroci in mladostniki), opažali zmanjšanje vrednosti hemoglobina na < 10 g/ dl.
Although ribavirin has no direct cardiovascular effects, anaemia associated with Rebetol may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease or both.
Čeprav ribavirin nima neposrednih srčnožilnih učinkov, lahko anemija zaradi zdravila Rebetol povzroči poslabšanje delovanja srca, poslabšanje simptomov koronarne bolezni ali oboje.
Thus, Rebetol must be administered with caution to patients with pre-existing cardiac disease (see section 4.3).
Zato zdravilo Rebetol uporabljajte previdno pri bolnikih z obstoječo boleznijo srca (glejte poglavje 4. 3).
Cardiac status must be assessed before start of therapy and monitored clinically during therapy; if any deterioration occurs, therapy must be stopped.
Če se pojavi kakršnokoli poslabšanje, zdravljenje prekinite.
Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders must be closely monitored.
Odrasle bolnike s kongestivnim srčnim popuščanjem ali miokardnim infarktom v anamnezi in/ ali s predhodnimi ali obstoječimi motnjami srčnega ritma morate strogo nadzorovati.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of therapy.
Srčne aritmije (predvsem supraventrikularne) se običajno odzovejo na konvencionalno terapijo, vendar lahko zahtevajo prekinitev zdravljenja.
There are no data in children and adolescents with a history of cardiac disease.
Ni podatkov otrocih in mladostnikih s srčno boleznijo v anamnezi.
If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Rebetol must be discontinued immediately and appropriate medical therapy instituted.
Če se razvije akutna preobčutljivostna reakcija (npr. urtikarija, angioedem, bronhokonstrikcija, anafilaksija), zdravilo Rebetol takoj ukinite in uvedite ustrezno zdravljenje.
Any patient developing significant liver function abnormalities during treatment must be monitored closely.
Vsakega bolnika, pri katerem se med zdravljenjem pojavijo pomembne motnje delovanja jeter, skrbno nadzorujte.
29 Supplemental monitoring specific for children and adolescents
Dodatno spremljanje posebej za otroke in mladostnike
During a 1-year course of therapy there was a decrease in the rate of linear growth (mean percentile decrease of 9%) and a decrease in the rate of weight gain (mean percentile decrease of 13%).
Med enoletno terapijo so ugotovili zmanjšanje hitrosti linearne rasti (9% srednje percentilno zmanjšanje) in zmanjšanje hitrosti prirastka telesne mase (13% srednje percentilno zmanjšanje).
Therefore, the risk/benefit of the combined use of Rebetol and interferon alfa-2b should be assessed in young children prior to the initiation of therapy.
Zato je treba pred začetkom zdravljenja oceniti razmerje med tveganji in koristmi kombinirane uporabe zdravila Rebetol in interferona alfa- 2b pri majhnih otrocih.
Thyroid Monitoring:
Spremljanje delovanja ščitnice:
Children and adolescents patients should be monitored every 3 months for evidence of thyroid dysfunction (e.g.
Otroke in mladostnike morate spremljati na vsake 3 mesece glede morebitnih znakov motenj delovanja žleze ščitnice (npr.
HCV/HIV Co-infection:
Sočasna okužba z virusom HCV/ HIV:
Caution should be taken in HIV-positive subjects co-infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa-2b/ribavirin treatment.
Pri bolnikih s pozitivnim izvidom na HIV in sočasno okužbo s HCV, ki prejemajo zaviralec nukleozidne reverzne transkriptaze (NRTI – » nucleoside reverse transcriptase inhibitor «) v povezavi z zdravljenjem z interferonom alfa- 2b in ribavirinom, je potrebna previdnost (posebno ddI in d4T).
In particular, co-administration of Rebetol and didanosine is not recommended due to the risk of mitochondrial toxicity (see section 4.5).
Zaradi možnosti razvoja mitohondrijske toksičnosti, še posebej ni priporočljivo sočasno dajanje zdravila Rebetol z didanozinom( glejte poglavje 4. 5).
Moreover, co-administration of Rebetol and stavudine should be avoided to limit the risk of overlapping mitochondrial toxicity.
Poleg tega se je treba izogibati sočasni uporabi zdravila Rebetol in stavudina, da omejimo tveganje mitohondrijske toksičnosti zaradi prekrivanja učinkov obeh zdravil.
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Rebetol and interferon alfa-2b combination therapy.
Pri bolnikih, ki so prejemali zdravilo Rebetol in interferon alfa - 2b v kombinirani terapiji, so poročali o zobnih boleznih in boleznih parodoncija, ki lahko vodijo do izgube zob.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Rebetol and interferon alfa-2b.
Poleg tega bi lahko med dolgotrajnim zdravljenjem s kombinacijo zdravila zdravilo Rebetol in interferona alfa- 2b imela škodljiv vpliv na zobe in ustno sluznico tudi suha usta.
Standard haematological tests and blood chemistries (complete blood count [CBC] and differential, platelet count, electrolytes, serum creatinine, liver function tests, uric acid) must be conducted in all patients prior to initiating therapy.
Pred začetkom zdravljenja pri vseh bolnikih opravite standardne hematološke in biokemične preiskave krvi (celotno krvno sliko z diferencialno krvno sliko, število trombocitov, določanje vrednosti elektrolitov in serumskega kreatinina, jetrne funkcijske teste, določanje vrednosti sečne kisline).
Acceptable baseline values that may be considered as a guideline prior to initiation of Rebetol therapy in children and adolescents:
Sprejemljive začetne vrednosti, ki lahko služijo kot smernice pred uvedbo terapije z zdravilom Rebetol pri otrocihh in mladostnikih:
Haemoglobin Platelets Neutrophil Count
≥ 11 g/ dl (deklice); ≥ 12 g/ dl (fantki) hemoglobin ≥ 100 000/ mm3 trombociti
≥ 11 g/dl (females); ≥ 12 g/dl (males) ≥ 100,000/mm3 ≥ 1,500/mm3
31 ≥ 1 500/ mm3 število nevtrofilcev
30 Laboratory evaluations are to be conducted at weeks 2 and 4 of therapy, and periodically thereafter as clinically appropriate.
Laboratorijske preiskave opravite v 2. in 4. tednu zdravljenja in po potrebi tudi občasno kasneje, glede na klinično stanje bolnika.
Uric acid may increase with Rebetol due to haemolysis; therefore, the potential for development of gout must be carefully monitored in pre-disposed patients.
Zato pri k temu nagnjenih bolnikih skrbno spremljajte možnost nastanka protina.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency should not take this medicine.
Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/ galaktoze ali pomanjkanjem saharoza- izomaltaze ne smejo jemati tega zdravila.
There is no evidence from toxicity studies that ribavirin induces liver enzymes.
Študije toksičnosti niso pokazale nobenih znakov, da bi ribavirin morda induciral jetrne encime.