natgillin/translations-raw huggingface dataset:
This regimen must be maintained unless the disease progresses rapidly or severe intolerance is manifested.
Ta režim zdravljenja vzdržujte, razen če bolezen hitro napreduje ali če bolnik zelo slabo prenaša zdravilo.
 4 Chronic Myelogenous Leukaemia:
Kronična mieloična levkemija:
The recommended dosage of IntronA is 4 to 5 million IU/ m2 administered daily subcutaneously.
Priporočeni odmerek zdravila IntronA je 4 do 5 milijonov i. e. / m2 dnevno in se injicira subkutano.
Some patients have been shown to benefit from IntronA 5 million IU/ m2 administered daily subcutaneously in association with cytarabine (Ara-C) 20 mg/ m2 administered daily subcutaneously for 10 days per month (up to a maximum daily dose of 40 mg).
Pri nekaterih bolnikih so ugotavljali koristi pri subkutanem odmerku 5 milijonov i. e. / m2 zdravila IntronA dnevno, danem skupaj s citarabinom (Ara- C) v subkutanem odmerku 20 mg/ m2 dnevno, 10 dni na mesec (do največjega dnevnega odmerka 40 mg).
When the white blood cell count is controlled, administer the maximum tolerated dose of IntronA (4 to 5 million IU/ m2 daily) to maintain haematological remission.
Ko bo število levkocitov pod nadzorom, dajte bolniku največji odmerek zdravila IntronA, ki ga še prenaša (4 do 5 milijonov i. e. / m2 na dan) za ohranjanje hematološke remisije.
IntronA treatment must be discontinued after 8 to 12 weeks of treatment if at least a partial haematological remission or a clinically meaningful cytoreduction has not been achieved.
Terapijo z zdravilom IntronA morate prekiniti po 8 do 12 tednih, če niste dosegli vsaj delne hematološke remisije ali klinično pomembnega zmanjšanja števila celic.
Maintenance therapy:
Vzdrževalna terapija:
In patients who are in the plateau phase (more than 50% reduction of myeloma protein) following initial induction chemotherapy, interferon alfa-2b may be administered as monotherapy, subcutaneously, at a dose of 3 million IU/ m2 three times a week (every other day).
Pri bolnikih v fazi platoja (več kot 50% zmanjšanje količine mielomskega proteina) lahko po začetni indukcijski kemoterapiji dajete interferon alfa- 2b subkutano kot monoterapijo v odmerku 3 milijoni i. e. / m2 trikrat na teden (vsak drugi dan).
Adjunctively with chemotherapy, interferon alfa-2b may be administered subcutaneously, at a dose of 5 million IU three times a week (every other day) for a duration of 18 months.
Dodatno h kemoterapiji lahko bolniku subkutano dajete še interferon alfa- 2b v odmerku 5 milijonov i. e. trikrat na teden (vsak drugi dan) v času 18 mesecev.
CHOP-like regimens are advised, but clinical experience is available only with CHVP (combination of cyclophosphamide, doxorubicin, teniposide and prednisolone).
Svetujemo uporabo sheme, podobne shemi CHOP, klinične izkušnje pa so na voljo le za shemo CHVP (kombinacija ciklofosfamida, doksorubicina, tenipozida in prednizolona).
Carcinoid Tumour:
Karcinoidni tumorji:
The usual dose is 5 million IU (3 to 9 million IU) administered subcutaneously three times a week (every other day).
(3 do 9 milijonov i. e.), dan subkutano trikrat na teden (vsak drugi dan).
Patients with advanced disease may require a daily dose of 5 million IU.
Pri bolnikih z napredovano boleznijo je lahko potreben odmerek 5 milijonov i. e. na dan.
Therapy may continue for as long as the patient responds to interferon alfa-2b treatment.
Zdravljenje lahko nadaljujete vse dokler se bolnik še odziva na interferon alfa- 2b.
As induction therapy, interferon alfa-2b is administered intravenously at a dose of 20 million IU/ m2 daily for five days a week for a four-week period; the calculated interferon alfa-2b dose is added to sodium chloride 9 mg/ ml (0.9%) solution for injection and administered as a 20- minute infusion (see section 6.6).
Izračunani odmerek interferona alfa- 2b dodajte natrijevemu kloridu 9 mg/ ml (0, 9%) raztopini za injekcije in ga dajte bolniku v 20- minutni infuziji (glejte poglavje 6. 6).
As maintenance treatment, the recommended dose is 10 million IU/ m2 administered subcutaneously three days a week (every other day) for 48 weeks.
Za vzdrževalno zdravljenje je priporočeni odmerek 10 milijonov i. e. / m2, dan subkutano 3 dni na teden (vsak drugi dan) v času 48 tednov.
If severe adverse events develop during interferon alfa-2b treatment, particularly if granulocytes decrease to< 500/mm3 or alanine aminotransferase/aspartate aminotransferase (ALT/AST) rises to> 5 x upper limit of normal, discontinue treatment temporarily until the adverse event abates.
Če se med zdravljenjem z interferonom alfa- 2b pojavijo hudi neželeni dogodki, še posebej če število granulocitov pade na < 500/ mm3 ali če vrednost alanin- aminotransferaze/ aspartat- aminotransferaze (ALT/ AST) naraste na > 5- kratno zgornjo mejo normale, začasno prekinite zdravljenje, dokler se neželeni dogodek ne ublaži.
Interferon alfa-2b treatment is to be restarted at 50% of the previous dose.
Zdravljenje z interferonom alfa- 2b ponovno uvedite z le 50% prejšnjega odmerka.
If intolerance persists after dose adjustment or if granulocytes decrease to< 250/mm3 or ALT/AST rises to> 10 x upper limit of normal, discontinue interferon alfa-2b therapy.
Če je intoleranca trdovratna tudi po prilagoditvi odmerka ali če število granulocitov upade na < 250/ mm3 ali se vrednost ALT/ AST zviša na > 10- kratno zgornjo mejo normale, prekinite terapijo z interferonom alfa- 2b.
Although the optimal (minimum) dose for full clinical benefit is unknown, patients must be treated at the recommended dose, with dose reduction for toxicity as described.
Četudi optimalni (minimalni) odmerek za doseganje polnega kliničnega učinka ni znan, morate bolnike zdraviti s priporočenimi odmerki, z opisanim zmanjšanjem odmerka v primeru toksičnosti.
- Hypersensitivity to the active substance or to any of the excipients.
- Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov,
- A history of severe pre-existing cardiac disease, e. g., uncontrolled congestive heart failure,
- Anamneza hude obstoječe srčne bolezni, npr. nekontrolirano kongestivno srčno popuščanje,
recent myocardial infarction, severe arrhythmic disorders.
nedavni miokardni infarkt, hude aritmije,
- Severe renal or hepatic dysfunction; including that caused by metastases.
- Huda ledvična ali jetrna insuficienca, vključno z insuficienco, ki nastane kot posledica metastaz,
- Epilepsy and/ or compromised central nervous system (CNS) function (see section 4.4).
- Epilepsija in/ ali moteno delovanje osrednjega živčevja (CŽS) (glejte poglavje 4. 4),
- Chronic hepatitis with decompensated cirrhosis of the liver.
- Kronični hepatitis z dekompenzirano jetrno cirozo,
- Chronic hepatitis in patients who are being or have been treated recently with
- Kronični hepatitis pri bolnikih, ki se zdravijo ali so se nedavno zdravili z imunosupresivi, razen
immunosuppressive agents excluding short term corticosteroid withdrawal.
kratkotrajne ukinitve kortikosteroidov,
- Autoimmune hepatitis; or history of autoimmune disease; immunosuppressed transplant
- Avtoimunski hepatitis ali avtoimunska bolezen v pretekli anamnezi, imunosuprimirani bolniki
recipients.
po transplantaciji,
- Pre-existing thyroid disease unless it can be controlled with conventional treatment.
- Obstoječa bolezen ščitnice, razen če jo je mogoče nadzirati s konvencionalno terapijo.
 5 Children and adolescents:
Otroci in mladostniki:
- Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal
- Obstoječa huda duševna bolezen ali huda duševna bolezen v anamnezi, še posebej huda
ideation or suicide attempt.
depresija, samomorilne misli ali poskus samomora.
Combination therapy with ribavirin:
Kombinirana terapija z ribavirinom:
Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Glejte tudi SPC za ribavirin, če uporabljate interferon alfa- 2b v kombinaciji z ribavirinom pri bolnikih s kroničnim hepatitisom C.
Psychiatric and central nervous system (CNS):
Psihiatrične motnje in centralni živčni sistem (CŽS):
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during IntronA therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Med terapijo z zdravilom IntronA so pri nekaterih bolnikih 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 IntronA in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6-month follow-up after treatment.
Pri otrocih in mladostnikih 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.
As in adult patients, children and adolescents experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence).
Tako kot pri odraslih bolnikih so tudi pri otroci in mladostniki opazili druge psihiatrične neželene dogodke (npr. depresijo, čustveno labilnost in zaspanost).
Other CNS effects including aggressive behaviour (sometimes directed against others), bipolar disorders, mania, confusion and alterations of mental status have been observed with alpha interferons.
Opažali so tudi druge učinke interferona alfa na CŽS, vključno z agresivnostjo (ki je včasih usmerjena proti drugim), bipolarno motnjo, manijo, zmedenostjo in spremembami duševnega statusa.
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with IntronA 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 IntronA in bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
If treatment with 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 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 interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Uporaba interferona alfa- 2b pri otrocih in mladostnikih s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi je kontraindicirana (glejte poglavje 4. 3).
Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during IntronA therapy.
Redko so med terapijo z zdravilom IntronA opažali akutne preobčutljivostne reakcije na interferon alfa- 2b (npr. urtikarijo, angioedem, bronhokonstrikcijo, anafilaktične reakcije).
Moderate to severe adverse experiences may require modification of the patient's dosage regimen, or in some cases, termination of IntronA therapy.
Pri zmernih do hudih neželenih učinkih je lahko potrebna prilagoditev režima odmerjanja, v nekaterih primerih pa tudi prekinitev terapije z zdravilom IntronA.
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out.
6 Četudi je zvišana telesna temperatura lahko povezana z gripoznim sindromom, ki je pogost med zdravljenjem z interferonom, morate najprej izključiti druge vzroke za trdovratno zvišanje telesne temperature.
IntronA must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e. g., chronic obstructive pulmonary disease) or diabetes mellitus prone to ketoacidosis.
Zdravilo IntronA morate uporabljati previdno pri bolnikih z izčrpujočimi boleznimi in motnjami, npr. pri tistih s pljučno boleznijo v anamnezi (npr. kronična obstruktivna pljučna bolezen) ali sladkorna bolezen z nagnjenostjo h ketoacidozi.
Caution must be observed also in patients with coagulation disorders (e. g., thrombophlebitis, pulmonary embolism) or severe myelosuppression.
Previdnost je potrebna tudi pri bolnikih z motnjami koagulacije (npr. tromboflebitisom, pljučno embolijo) ali hudo mielosupresijo.
 6 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
Pri bolnikih, zdravljenih z interferonom alfa, vključno s tistimi, ki so zdravljeni z zdravilom IntronA, so redko opažali pljučne infiltrate, pnevmonitis in pljučnico, ki so občasno vodili celi do smrti bolnika.
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.5).
O teh simptomih so poročali pogosteje pri sočasni uporabi kitajskega zeliščnega pripravka shosaikoto in interferona alfa (glejte poglavje 4. 5).
Ocular adverse events (see section 4.8) including retinal haemorrhages, cotton wool spots, and retinal artery or vein obstruction have been reported in rare instances after treatment with alpha interferons.
V redkih primerih so po zdravljenju z alfa interferoni poročali o očesnih neželenih dogodkih (glejte poglavje 4. 8), npr. krvavitvah v mrežnico, bombažu podobnih lisah in zamašitvi mrežnične arterije ali vene.
Periodic visual examinations during IntronA therapy are recommended particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Med zdravljenjem z zdravilom IntronA priporočamo redne preglede vida, še posebej pri tistih z boleznimi, ki so lahko povezane z retinopatijo, npr. sladkorna bolezen ali hipertenzija.
Very rarely, seizures have occurred with high doses of IntronA.
Zelo redko so pri uporabi velikih odmerkov zdravila IntronA nastopile konvulzije.
Adult patients with a history of congestive heart failure, myocardial infarction and/ or previous or current arrhythmic disorders, who require IntronA therapy, must be closely monitored.
Odrasle bolnike s kongestivnim srčnim popuščanjem ali miokardnim infarktom v pretekli anamnezi in/ ali s predhodnimi ali obstoječimi aritmijami, ki potrebujejo terapijo z zdravilom IntronA, morate skrbno spremljati.
It is recommended that those patients who have pre-existing cardiac abnormalities and/ or are in advanced stages of cancer have electrocardiograms taken prior to and during the course of treatment.
Priporočamo, da pri bolnikih z obstoječimi srčnimi motnjami in/ ali tistih, ki so v napredovalih stadijih maligne bolezni, posnamete EKG pred in po terapiji.
Monitoring of lipid levels is, therefore, recommended.
Opisali so hipertrigliceridemijo in poslabšanje hipertrigliceridemije, ki je bilo včasih hudo, zato priporočamo spremljanje lipidov v krvi.
Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of IntronA in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Zaradi poročil, da je interferon alfa poslabšal obstoječo psoriazo in sarkoidozo, priporočamo, da pri bolnikih s psoriazo in sarkoidozo IntronA uporabljate le, če njegove morebitne koristi odtehtajo možno tveganje.
Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also section 4.4 Chronic hepatitis C, Monotherapy (thyroid abnormalities) and section 4.8).
7 preiskati ter pri njih ponovno oceniti razmerje med koristmi in tveganji nadaljnje terapije z interferonom (glejte tudi poglavji 4. 4 Kronični hepatitis C, monoterapija (ščitnične motnje) in 4. 8).
Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with chronic hepatitis C treated with interferon.
Pri bolnikih s kroničnim hepatitisom C, ki so se zdravili z interferonom, so poročali o primerih sindroma Vogt- Koyanagi- Harada (VKH).
If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8).
Če sumite na sindrom VKH, morate bolniku ukiniti protivirusno zdravljenje in se posvetovati glede uvedbe kortikosteroidne terapije (glejte poglavje 4. 8).
Discontinue treatment with IntronA in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation.
Pri bolnikih s kroničnim hepatitisom, pri katerih ugotavljate podaljšanje parametrov koagulacije, ki bi lahko kazalo na jetrno dekompenzacijo, prekinite terapijo z zdravilom IntronA.
 7 Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/ repeated receipt of human plasma-derived albumin.
Pri bolnikih, ki redno ali večkrat prejemajo albumin iz človeške plazme, po potrebi uvedite ustrezno cepljenje (hepatitis A in B).
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
Med standardne ukrepe za preprečevanje okužb kot posledica uporabe zdravil, izdelanih iz človeške krvi ali plazme, sodijo selekcija darovalcev, presejalno testiranje posameznih darovanih enot in skupne količine zbrane plazme na specifične markerje okužbe in uporaba učinkovitih proizvodnih postopkov za inaktivacijo oz. odstranjevanje virusov.
It is strongly recommended that every time that IntronA is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Močno priporočamo, da ob vsakem dajanju zdravila IntronA bolniku zapišete ime in številko serije zdravila, da bi ohranili sledljivost med bolnikom in serijo zdravila.
Also see ribavirin SPC if IntronA is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Če boste IntronA uporabljali skupaj z ribavirinom pri bolnikih s kroničnim hepatitisom C, glejte tudi SPC za ribavirin.
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, vključenih v raziskave kroničnega hepatitisa C, so pred vključitvijo v raziskavo opravili jetrno biopsijo, vendar je v določenih primerih (npr. pri bolnikih z genotipoma 2 in 3), zdravljenje možno tudi brez histološke potrditve.
Infrequently, adult patients treated for chronic hepatitis C with IntronA developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
V redkih primerih so se pri odraslih bolnikih, zdravljenih z zdravilom IntronA zaradi kroničnega hepatitisa C, pojavile ščitnične motnje, bodisi hipotiroza ali hipertiroza.
In clinical trials using IntronA therapy, 2.8% patients overall developed thyroid abnormalities.
V kliničnih raziskavah terapije z zdravilom IntronA so se pri 2, 8% vseh bolnikov pojavile ščitnične motnje.
The mechanism by which IntronA may alter thyroid status is unknown.
Mehanizem, prek katerega lahko IntronA vpliva na ščitnico, ni znan.
In the presence of thyroid dysfunction, IntronA treatment may be continued if TSH levels can be maintained in the normal range by medication.
V primeru motenj delovanja žleze ščitnice lahko terapijo z zdravilom IntronA nadaljujete, če boste lahko z zdravili ohranjali koncentracijo TSH v normalnem razponu vrednosti.
Discontinuation of IntronA therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and adolescents, Thyroid monitoring).
Motnje delovanja žleze ščitnice, ki so se pojavile med terapijo z zdravilom IntronA, niso minile ob prekinitvi terapije (glejte tudi Otroci in mladostniki, Spremljanje delovanja ščitnice).
Supplemental monitoring specific for children and adolescents Thyroid Monitoring:
Dodatno spremljanje delovanja posebej za otroke in mladostnike Spremljanje ščitnice:
Approximately 12% of children treated with interferon alfa-2b and ribavirin developed increase in TSH.
Pri približno 12% otrok, zdravljenih z interferonom alfa- 2b in ribavirin, se je pojavilo povečanje TSH.
Another 4% had a transient decrease below the lower limit of normal.
Dodatnih 4% je imelo prehodno zmanjšanje pod spodnjo mejo normale.
Prior to initiation of IntronA therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Pred uvedbo terapije z zdravilom IntronA - morate ovrednotiti vrednost TSH in morebitne motnje v delovanju ščitnice, ki jih ugotovite v tem času, zdraviti z ustaljeno terapijo.
IntronA therapy may be initiated if TSH levels can be maintained in the normal range by medication.
Terapijo z zdravilom IntronA lahko uvedete, če boste lahko z zdravili ohranjali vrednost TSH v normalnem razponu.
Thyroid dysfunction during treatment with interferon alfa-2b and ribavirin has been observed.
Med zdravljenjem z interferonomom alfa- 2b in ribavirinom so opažali motnje delovanja žleze ščitnice.
If thyroid abnormalities are detected, the patient’ s thyroid status should be evaluated and treated as clinically appropriate.
Če 8 ugotovite motnje v delovanju žleze ščitnice, ovrednotite bolnikov ščitnični status in ga zdravite, kot je klinično ustrezno.
Children and adolescents 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.
Growth and Development:
Rast in razvoj:
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%).
V času 1- letne terapije je prišlo do zmanjšanja hitrosti linearne rasti (srednje percentilno zmanjšanje 9%) in zmanjšanja hitrosti pridobivanja telesne mase (srednje percentilno zmanjšanje 13%).
A general reversal of these trends was noted during the 6 months follow- up post treatment.
V času 6- mesečnega spremljanja po zdravljenju so opazili splošni obrat teh trendov.
However, based on interim data from a long-term follow-up study, 12 (14%) of 84 children had a > 15 percentile decrease in rate of linear growth, of whom 5 (6 %)children had a > 30 percentile decrease despite being off treatment for more than 1 year.
Vendar pa je na podlagi vmesnih podatkov iz dolgoročne študije spremljanja bolnikov po zdravljenju imelo 12 (14%) od 84 otrok > 15 percentilno zmanjšanje hitrosti linearne rasti, od tega je imelo 5 (6%) otrok > 30 percentilno zmanjšanje kljub temu, da terapije niso prejemali že več kot 1 leto.
In addition, preclicinal 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  8 interferon alfa-2b and ribavirin 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 interferona alfa- 2b in ribavirina pri majhnih otrocih.
Physicians are advised to monitor the growth of children taking ribavirin in combination with interferon alfa-2b.
Zdravnikom torej svetujemo, naj spremljajo rast otrok, ki jemljejo ribavirin v kombinaciji z interferonom alfa- 2b.