natgillin/translations-raw huggingface dataset:
HCV/ HIV Co-infection The recommended duration of dosing for HCV/ HIV co-infected patients is 48 weeks, regardless of genotype.
Sočasna okužba s HCV in HIV Priporočena dolžina zdravljenja pri bolnikih, ki so sočasno okuženi s HCV in HIV, znaša 48 tednov, ne glede na genotip.
Predictability of response and non-response in HCV/ HIV Co-infection Early virological response by Week 12, defined as a 2 log viral load decrease or undetectable levels of HCV-RNA, has been shown to be predictive for sustained response.
Napovedovanje odziva oziroma odsotnosti odziva na zdravljenje pri bolnikih, ki imajo sočasno okužbo
The negative predictive value for sustained response in HCV/ HIV co-infected patients treated with Rebetol in combination with peginterferon alfa-2b was 99% (67/ 68; Study 1) (see section 5.1).
3 s HCV in HIV Raziskave so pokazale, da je zgodnji virološki odziv do 12. tedna zdravljenja, ki je opredeljen kot zmanjšanje virusnega bremena za 2 log točki ali doseganje nemerljive količine RNA virusa HCV v serumu, dober napovednik stalnega odziva na zdravljenje.
A positive predictive value of 50% (52/ 104; Study 1) was observed for HCV/ HIV co-infected patients receiving combination therapy.
Negativna napovedna vrednost stalnega virološkega odziva pri bolnikih, ki so bili sočasno okuženi s HCV in HIV in so se zdravili z zdravilom Rebetol v kombinaciji s peginterferonom alfa- 2b, je bila 99% (67/ 68, študija 1) (glejte poglavje 5. 1), medtem ko so 50% pozitivno napovedno vrednost (52/ 104, študija 1) opazili pri bolnikih, ki so bili sočasno okuženi s HCV in HIV in so prejemali kombinirano terapijo.
3 Duration of treatment - Retreatment Predictability of sustained virological response:
Trajanje zdravljenja - Ponovno zdravljenje Predvidljivost stalnega virološkega odziva:
All patients, irrespective of genotype, who have demonstrated serum HCV-RNA below the limits of detection at Week 12 should receive 48 weeks of therapy.
Vsi bolniki ne glede na genotip, ki so imeli v 12. tednu serumsko vrednost HCV- RNA pod mejo detekcije, morajo prejemati terapijo 48 tednov.
Retreated patients who fail to achieve virological response at Week 12 are unlikely to become sustained virological responders after 48 weeks of therapy (see also section 5.1).
Pri ponovno zdravljenih bolnikih, ki v 12. tednu niso imeli virološkega odziva, pa je malo verjetno, da bodo po 48 tednih zdravljenja dosegli stalni virološki odziv (glejte tudi poglavje 5. 1).
Retreatment duration greater than 48 weeks in non-responder patients with genotype 1 has not been studied with pegylated interferon alfa-2b and ribavirin combination therapy.
Pri bolnikih z genotipom 1, ki se niso odzvali na prejšnje zdravljenje, še niso proučili trajanja ponovnega zdravljenja, ki bi bilo daljše od 48 tednov, pri kombinirani terapiji s pegiliranim interferonom alfa- 2b in ribavirinom.
Rebetol Capsules in combination with interferon alfa-2b:
Rebetol kapsule v kombinaciji z interferonom alfa- 2b:
Duration of treatment:
Dolžina zdravljenja:
During those clinical trials in which patients were treated for one year, patients who failed to show a virological response after six months of treatment (HCV-RNA below lower limit of detection) were unlikely to become sustained virological responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment). • Genotype 1:
V kliničnih preskušanjih, v katerih so bolnike zdravili eno leto, se je izkazalo, da je pri bolnikih, pri katerih po šestih mesecih zdravljenja ni virološkega odziva (HCV- RNA pod spodnjo mejo detekcije), zelo malo verjetno, da bodo razvili trajen virološki odziv (HCV- RNA pod spodnjo mejo detekcije šest mesecev po prekinitvi zdravljenja). • Genotip 1:
Treatment should be continued for another six month period (i. e., a total of one year) in patients who exhibit negative HCV-RNA after six months of treatment. • Genotypes Non-1:
Pri bolnikih, ki imajo po šestih mesecih zdravljenja negativno vrednost HCV- RNA, morate z zdravljenjem nadaljevati še šest mesecev (tj. skupaj eno leto). • Genotipi ne- 1:
The decision to extend therapy to one year in patients with negative HCV- RNA after six months of treatment should be based on other prognostic factors (e. g., age > 40 years, male gender, bridging fibrosis).
Odločitev o podaljšanju terapije na eno leto pri bolnikih z negativno vrednostjo HCV- RNA po šestih mesecih zdravljenja mora temeljiti na drugih prognostičnih dejavnikih (npr. starost > 40 let, moški spol, premostitvena fibroza).
Children aged three years and older, and adolescents:
Otroci, stari tri leta in več in mladostniki:
(for patients who weigh < 47 kg, or are unable to swallow capsules, please refer to the SPC for ribavirin 40 mg/ ml oral solution).
(za bolnike, ki tehtajo < 47 kg ali ne morejo pogoltniti kapsule, glejte SPC za ribavirin 40 mg/ ml peroralna raztopina).
In clinical studies performed in this population ribavirin and interferon alfa-2b were used in doses of 15 mg/ kg/ day and 3 MIU/ m2 three times a week respectively (Table 2).
(Preglednica 2).
Rebetol capsules are to be administered orally each day in two divided doses with food (morning and evening).
Rebetol kapsule se uporabljajo peroralno vsak dan v dveh deljenih odmerkih s hrano (zjutraj in zvečer).
Rebetol paediatric dose based on body weight
Odmerek zdravila Rebetol za otroke na podlagi telesne mase
Patient weight (kg) 47 - 49 50 - 65
Telesna masa bolnika (kg)
Daily Rebetol dose 600 mg 800 mg
Dnevni odmerek zdravila Rebetol
Number of 200 mg capsules 3 capsules a 4 capsules b
Število 200 mg kapsul 3 kapsule a
Refer to adult dosing table (Table 1)
Glede na tableo odmerjanja za odrasle( Preglednica 1)
1 morning, 2 b
1 zjutraj, 2 zvečer b:
2 morning, 2
2 zjutraj, 2 zvečer
Duration of treatment in children and adolescents Genotype 1:
Dolžina zdravljenja pri otrocih in mladostnikih Genotip 1:
The recommended duration of treatment is 1 year.
Priporočena dolžina zdravljenja je 1 leto.
Virological response is defined as absence of detectable HCV-RNA at Week 12 of treatment.
Virološki odziv je opredeljen kot odsotnost merljive vrednosti HCV- RNA v 12. tednu zdravljenja.
Genotype 2 or 3:
Genotip 2 or 3:
Dose modification for all patients If severe adverse reactions or laboratory abnormalities develop during therapy with Rebetol and peginterferon alfa-2b or interferon alfa-2b, modify the dosages of each product if appropriate, until the adverse reactions abate.
4 Prilagajanje odmerka za vse bolnike Če se med zdravljenjem z zdravilom Rebetol in peginterferonom alfa- 2b ali interferonom alfa- 2b pojavijo hude 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 3).
V kliničnih preskušanjih so pripravili smernice za prilagajanje odmerka (glejte Smernice za prilagajanje odmerka, Preglednica 3).
As adherence might be of importance for outcome of therapy, the dose should be kept as close as possible to the recommended standard dose.
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.
The potential negative impact of ribavirin dose reduction on efficacy results could not be ruled out.
Preglednica 3 Smernice za prilagajanje odmerka
Table 3
Zmanjšajte le dnevni
Dosage modification guidelines Reduce only Rebetol Reduce only
Zmanjšajte le odmerek
Discontinue
Prekinite
Laboratory Values
Laboratorijske
daily dose adult to
odmerek zdravila
4
vrednosti
peginterferon alfa-2b
Rebetol za odrasle na
combination therapy
(odrasli) ali interferona
600 mg/ day*,
600 mg/ dan *, za
(adult) or interferon alfa-
alfa- 2b (odrasli in otroci)
if:
otroke na
paediatric to 7.5 mg/ kg, if:
7, 5 mg/ kg če:
to one-half dose, if:
na polovico odmerka, če:
Haemoglobin
Hemoglobin Hemoglobin pri:
≥ 2 g/ dl 4
≥ 2 g/ dl zmanjšanje vrednosti hemoglobina med
decrease in haemoglobin during any week period during treatment (permanent dose reduction)
bolnikih s stabilno
< 12 g/ dl after 4 weeks of dose reduction
< 12 g/ dl po 4
White blood cells Neutrophils
srčno boleznijo v
- < 1.5 x 109/ l - < 0.75 x 109/ l
katerimkoli 4- tedenskim obdobjem med
< 1.0 x 109/ l < 0.5 x 109/ l
tednih zmanjševanja
Platelets
anamnezi
-
odmerka
Adult < 50 x 109/ l
Levkociti Nevtrofilci
Adult < 25 x 109/ l
< 1, 5 x 109/ l < 0, 75 x 109/ l
Paediatric < 80 x 109/ l
< 1, 0 x 109/ l < 0, 5 x 109/ l
Paediatric
Trombociti
< 50 x 109/ l
Odrasli < 50 x 109/ l Otroci < 80 x 109/ l
Adult > 4 mg/ dl
Odrasli > 4 mg/ dl (za > 4 tedne) Otroci > 5 mg/ dl (za > 4 tedne)
Alanine
Alanin - aminotransferaza / Aspartat - aminotransferaza (ALT/ AST)
> 10 x ULN**
x začetna vrednost in > 10 x ZMN **
The pharmacokinetics of ribavirin are altered in patients with renal dysfunction due to reduction of apparent clearance in these patients (see section 5.2).
Farmakokinetika ribavirina je spremenjena pri bolnikih z motnjami delovanja ledvic zaradi zmanjšanja navideznega očistka pri teh bolnikih (glejte poglavje 5. 2).
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 pričetkom jemanja 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 (Table 3), Rebetol and peginterferon alfa-2b/ interferon alfa-2b must be discontinued.
Če se vrednost kreatinina v serumu zviša nad 2 mg/ dl (glejte Preglednico 3), morate zdravljenje z zdravili Rebetol in peginterferon alfa- 2b oz. interferon alfa- 2b prekiniti.
Therefore, no dose adjustment of Rebetol is required in patients with hepatic impairment.
Med ribavirinom in delovanjem jeter ni farmakokinetičnih interakcij (glejte poglavje 5. 2), zato pri bolnikih z jetrno okvaro ni potrebno prilagajanje odmerka zdravila Rebetol.
Use in the elderly (≥ 65 years of age):
5 Uporaba pri starejših bolnikih (starost ≥ 65 let):
However, as in younger patients, renal function must be determined prior to administration of Rebetol (see section 5.2).
Kot pri mlajših bolnikih pa morate pred začetkom uporabe zdravila Rebetol opraviti preiskave delovanja ledvic (glejte poglavje 5. 2).
Use in patients under the age of 18 years:
Uporaba pri bolnikih, mlajših od 18 let:
Rebetol as capsules or oral solution may be used in combination with interferon alfa-2b in children (3 years of age and older) and adolescents.
Rebetol kapsule ali peroralna raztopina se lahko uporablja v kombinaciji z interferonom alfa- 2b pri otrocih (starost 3 leta in več) in mladostnikih.
The selection of formulation is based on individual characteristics of the patient (see section 4.1).
Farmacevtsko obliko izberemo glede na specifične lastnosti posameznega bolnika (glejte poglavje 4. 1.).
Safety and effectiveness of Rebetol with pegylated or other forms of interferon (i. e. not alfa-2b) in these patients have not been evaluated.
Varnosti in učinkovitosti zdravila Rebetol s pegilirano ali drugo obliko interferona (tj. ne alfa- 2b) pri teh bolnikih niso ovrednotili.
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 5 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).
Rebetol must not be initiated until a report of a
4. 3 Kontraindikacije
negative pregnancy test has been obtained immediately prior to initiation of therapy.
dokler ne dobite negativnega izvida testa nosečnosti tik pred začetkom zdravljenja;
- Women who are breast-feeding.
- Doječe matere;
- A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease,
- Hude obstoječe srčne bolezni v anamnezi, vključno z nestabilno ali nenadzorovano srčno boleznijo
in the previous six months (see section 4.4).
v preteklih šestih mesecih (glejte poglavje 4. 4.);
- Severe, debilitating medical conditions, including patients with chronic renal failure, patients
- Hude bolezni, ki bolnika onesposobijo, vključno s kronično ledvično odpovedjo in očistkom
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.
- Hude motnje delovanja jeter ali dekompenzirana jetrna ciroza;
- Haemoglobinopathies (e. g., thalassemia, sickle-cell anaemia).
- Hemoglobinopatije (npr. talasemija, anemija srpastih celic);
- Initiation of peginterferon alfa-2b is contraindicated in HCV/ HIV patients with cirrhosis and a
- Uvedba peginterferona alfa- 2b je kontraindicirana pri bolnikih, ki so sočasno okuženi s HCV in
Child-Pugh score ≥ 6.
HIV ter imajo cirozo jeter z oceno ≥ 6 po Child- Pughu.
ideation, or suicide attempt.
depresija, samomorilne misli ali poskus samomora.
Because of co-administration with peginterferon alfa-2b or interferon alfa-2b:
Zaradi sočasne uporabe peginterferona alfa- 2b ali interferona alfa- 2b pa še:
- Autoimmune hepatitis; or history of autoimmune disease.
- avtoimunski hepatitis ali avtoimunska bolezen v anamnezi.
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Rebetol combination therapy with peginterferon alfa-2b or 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 peginterferonom alfa- 2b ali 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.
Pri otrocih in mladostnikih zdravljenih z zdravilom Rebetol v kombinaciji z interferonom alfa- 2b, so pogosteje poročali o samomorilnih mislih ali poskusu samomora kot pri odraslih (2, 4% v primerjavi z 1%) med zdravljenjem in v času 6- mesečnega spremljanja bolnikov po zdravljenju.
Other CNS effects including aggressive behaviour (sometimes directed against others), confusion and alterations of mental status have been observed with alpha interferons.
Opažali so tudi druge učinke interferonov alfa na CŽS, vključno z agresivnostjo (ki je včasih usmerjena proti drugim), zmedenostjo in spremembami duševnega statusa.
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Rebetol and peginterferon alfa-2b or 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 peginterferonom alfa- 2b ali interferonom alfa- 2b in bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
Patients with existence of or history of severe psychiatric conditions:
6 Bolniki s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi:
If treatment with Rebetol in combination with peginterferon alfa-2b or interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Če ocenite, da je potrebno zdravljenje z zdravilom Rebetol v kombinaciji s peginterferonom alfa- 2b ali interferonom alfa- 2b pri odraslih bolnikih s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi, ga smete uvesti šele potem, ko ste zagotovili ustrezno individualno diagnostično in terapevtsko obravnavo psihiatrične motnje.
The use of Rebetol and interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Uporaba zdravila Rebetol in interferona alfa- 2b pri otrocih in mladostnikih s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi je kontraindicirana (glejte poglavje 4. 3).
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 ga ne smete uporabljati samostojno.
The safety and efficacy of this combination have been established only using ribavirin capsules together with peginterferon alfa-2b or interferon alfa-2b solution for injection.
Varnost in učinkovitost te kombinacije je bila ugotovljena le pri uporabi kapsul ribavirina skupaj s peginterferonom alfa- 2b ali interferonom alfa- 2b raztopina za injiciranje.
All patients in the chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i. e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Pri vseh bolnikih v študijah kroničnega hepatitisa C so opravili jetrno biopsijo pred vključitvijo v študijo, toda v nekaterih primerih (tj. pri bolnikih z genotipoma 2 in 3), je lahko zdravljenje možno brez histološke potrditve.
6 Current treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment.
Pri odločanju, ali je pred začetkom zdravljenja potrebna jetrna biopsija, upoštevajte tekoče terapevtske smernice.
Teratogenic risk:
Nevarnost teratogenosti:
Female patients:
Bolnice:
Rebetol must not be used by women who are pregnant (see section 4.3).
Nosečnice ne smejo uporabljati zdravila Rebetol (glejte poglavje 4. 3).
Extreme care must be taken to avoid pregnancy in female patients (see sections 4.6 and 5.3).
Izjemno skrbno moramo paziti, da preprečimo zanositev bolnice med zdravljenjem (glejte poglavji 4. 6 in 5. 3).
Male patients and their female partners:
Bolniki in njihove partnerke:
Extreme care must be taken to avoid pregnancy in partners of male patients taking Rebetol (see sections 4.6 and 5.3).
Izjemno skrbno moramo paziti, da preprečimo zanositev pri partnerkah moških bolnikov, ki jemljejo zdravilo Rebetol (glejte poglavji 4. 6 in 5. 3).
Haemolysis:
Hemoliza:
A decrease in haemoglobin levels to < 10 g/ dl was observed in up to 14% of adult patients and 7% of children and adolescents treated with Rebetol in combination with peginterferon alfa-2b (adults only) or interferon alfa-2b (adults and children or 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 (samo odrasli) ali interferonom alfa- 2b (odrasli in otroci ali 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 morate zdravilo Rebetol pri bolnikih z obstoječo boleznijo srca uporabljati previdno (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 (see section 4.2).
Če se pojavi kakršnokoli poslabšanje, morate zdravljenje prekiniti (glejte poglavje 4. 2).
Cardiovascular:
Srčnožilni učinki:
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.
Acute hypersensitivity:
Akutna preobčutljivost:
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, anafilaksa), morate jemanje zdravila Rebetol takoj prekiniti in uvesti ustrezno zdravljenje.
Ocular changes:
Očesne spremembe:
Retinopathy including retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction which may result in loss of vision have been reported in rare instances with combination therapy with alpha interferons.
V redkih primerih so pri takšni kombinirani terapiji z interferoni alfa poročali o retinopatiji, vključno z mrežničnimi krvavitvami, mehkimi eksudati, edemom papile, nevropatijo vidnega živca in zamašitvijo mrežnične arterije ali vene, ki lahko povzroči izgubo vida.
Patients with preexisting ophthalmologic disorders (e. g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during combination therapy with alpha interferons.
Bolniki z obstoječimi očesnimi boleznimi (npr. diabetična ali hipertenzivna retinopatija) bi morali imeti med kombinirano terapijo z interferoni alfa občasno oftalmološki pregled.
Liver function:
Delovanje jeter:
Supplemental monitoring specific for children and adolescents
7 Dodatno spremljanje posebej za otroke in mladostnike
In addition, preclinical juvenile toxicity results have demonstrated a minor, dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3).
Pri novorojenih podganjih mladičih, ki so jim dajali odmerke ribavirina, so ugotovili manjše, od odmerka odvisno splošno zmanjšanje rasti, ki se je kasneje pokazalo kot rahlo zmanjšanje telesne mase, razdalje od temena do trtice in dolžine kosti (glejte poglavje 5. 3).
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.
Physicians are advised to monitor the growth of children taking Rebetol in combination with interferon alfa-2b.
Zdravnikom torej svetujemo, naj spremljajo rast otrok, ki jemljejo zdravilo Rebetol v kombinaciji z interferonom alfa- 2b.
7 Thyroid Monitoring:
Spremljanje delovanja ščitnice:
Approximately 12% of children treated with Rebetol and interferon alfa-2b developed increase in TSH.
Pri približno 12% otrok, zdravljenih z zdravilom Rebetol in interferonom alfa- 2b, se je pojavilo povečanje TSH.
Prior to initiation of interferon alfa-2b therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Pred uvedbo terapije z interferonom alfa- 2b morate ovrednotiti vrednost TSH in morebitne motnje v delovanju ščitnice, ki jih ugotovite v tem času, zdraviti z ustaljeno terapijo.
Interferon alfa-2b therapy may be initiated if TSH levels can be maintained in the normal range by medication.
Terapijo z interferonom alfa- 2b lahko uvedete, če boste lahko z zdravili ohranjali vrednost TSH v normalnem razponu.
Thyroid dysfunction during treatment with Rebetol and interferon alfa-2b has been observed.
Med zdravljenjem z zdravilom Rebetol in interferonom alfa- 2b so opažali motnje delovanja žleze ščitnice.