natgillin/translations-raw huggingface dataset:
If thyroid abnormalities are detected, the patient ’ s thyroid status should be evaluated and treated as clinically appropriate.
Če ugotovite motnje v delovanju žleze ščitnice, ovrednotite bolnikov ščitnični status in ga zdravite, kot je klinično ustrezno.
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:
Pri bolnikih, pozitivnih na HIV, ki se zdravijo po shemi NRTI, mora zdravnik skrbno spremljati pokazatelje mitohondrijske toksičnosti in laktacidoze pri sočasnem zdravljenju z ribavirinom:
- co-administration of Rebetol and didanosine is not recommended due to the risk of
- zaradi možnosti razvoja mitohondrijske toksičnosti, še posebej ni priporočljivo sočasno dajanje
mitochondrial toxicity (see section 4.5).
zdravila Rebetol z didanozinom( glejte poglavje 4. 5).
- co-administration of Rebetol and stavudine should be avoided to limit the risk of overlapping
- izogibati se je treba sočasni uporabi zdravila Rebetol in stavudina, da omejimo tveganje
mitochondrial toxicity.
mitohondrijske toksičnosti zaradi prekrivanja učinkov obeh zdravil.
Hepatic decompensation in HCV/ HIV co-infected patients with advanced cirrhosis:
Jetrna dekompenzacija pri bolnikih, ki so sočasno okuženi s HCV in HIV in imajo napredovalo cirozo jeter:
Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death.
Sočasno okuženi bolniki z napredovalo cirozo, ki prejemajo terapijo HAART, imajo lahko povečano tveganje za nastanek jetrne dekompenzacije in smrt.
Co-infected patients receiving both antiretroviral (ARV) and anti-hepatitis treatment should be closely monitored, assessing their Child-Pugh score during treatment.
Sočasno okužene bolnike, ki prejemajo tako antiretrovirusno zdravljenje (ARV) kot zdravljenje hepatitisa, je treba skrbno spremljati in jim določati oceno po Child- Pughu v teku zdravljenja.
Haematological abnormalities in HCV/ HIV co-infected patients:
Hematološke motnje pri bolnikih, sočasno okuženih s HCV in HIV:
HCV/ HIV co-infected patients receiving peginterferon alfa-2b/ ribavirin treatment and HAART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients.
Bolniki, ki so sočasno okuženi z virusom HCV in HIV ter se zdravijo s peginterferonom alfa - 2b/ ribavirinom in s terapijo HAART, imajo lahko povečano tveganje za nastanek hematoloških motenj (v obliki nevtropenije, trombocitopenije in anemije) v primerjavi s tistimi, ki so okuženi samo s HCV.
Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “ Laboratory tests” and section 4.8).
8 spremljanje hematoloških parametrov (glejte poglavje 4. 2, “ Laboratorijske preiskave ” v nadaljevanju in poglavje 4. 8).
Patients treated with ribavirin and zidovudine are at increased risk of developing anaemia; therefore, the concomitant use of ribavirin with zidovudine is not recommended (see section 4.5).
Bolniki, zdravljeni z ribavirinom in zidovudinom, imajo povečano tveganje za pojav anemije, zato pri njih sočasna uporaba ribavirina in zidovudina ni priporočljiva (glejte poglavje 4. 5).
In patients co-infected with HCV/ HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/ µl.
Pri bolnikih, ki so sočasno okuženi s HCV in HIV, so na voljo omejeni podatki o učinkovitosti in varnosti zdravila (N = 25) za tiste, ki imajo število celic CD4 manjše od 200 celic/ μl.
Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Rebetol and peginterferon alfa-2b.
Preberite si tudi ustrezne Povzetke glavnih značilnosti zdravila za protiretrovirusna zdravila, ki jih bo bolnik jemal skupaj s terapijo za HCV, da bi se bolj zavedali in bi lahko zdravili toksične učinke vsakega od teh zdravil ter da bi se zavedali potencialnega prekrivanja njihovih toksičnih učinkov z zdravilom Rebetol v kombinaciji s peginterferonom alfa- 2b.
In addition, dry mouth could have a damaging effect on teeth and mucous
Pri bolnikih, ki so prejemali zdravilo Rebetol in peginterferon alfa- 2b ali interferon alfa- 2b v kombinirani terapiji, so poročali o zobnih boleznih in boleznih parodoncija, ki lahko vodijo do izgube zob.
8 membranes of the mouth during long-term treatment with the combination of Rebetol and peginterferon alfa-2b or interferon alfa-2b.
Poleg tega bi lahko med dolgotrajnim zdravljenjem s kombinacijo zdravila zdravilo Rebetol in peginterferona alfa- 2b ali interferona alfa- 2b imela škodljiv vpliv na zobe in ustno sluznico tudi suha usta.
Laboratory tests:
Laboratorijske preiskave:
Acceptable baseline values that may be considered as a guideline prior to initiation of Rebetol therapy:
Sprejemljive začetne vrednosti, ki lahko služijo kot smernice pred uvedbo terapije z zdravilom Rebetol:
Adult: ≥ 12 g/dl (females); ≥ 13 g/dl (males) Paediatric: ≥ 11 g/dl (females); ≥ 12 g/dl (males)
• Odrasli ≥12 g/ dl (ženske); ≥13 g/ dl (moški) hemoglobin Otroci ≥11 g/ dl (ženske); ≥12 g/ dl (moški ≥100. 000/ mm3 • trombociti ≥1. 500/ mm3 • število nevtrofilcev
For females of childbearing potential:
Ženske v rodni dobi:
Female patients must have a routine pregnancy test performed monthly during treatment and for four months thereafter.
Bolnice morajo rutinsko opravljati nosečnostni test vsak mesec med zdravljenjem in še štiri mesece po njem.
Female partners of male patients must have a routine pregnancy test performed monthly during treatment and for seven months thereafter (see section 4.6).
Partnerke bolnikov morajo rutinsko opravljati nosečnostni test vsak mesec med zdravljenjem in še sedem mesecev po njem (glejte poglavje 4. 6).
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 morate pri k temu nagnjenih bolnikih skrbno spremljati možnost nastanka protina.
Use in patients with rare hereditary disorders:
Uporaba pri bolnikih z redkimi dednimi boleznimi:
Each Rebetol capsule contains 40 mg of lactose.
Vsaka kapsula zdravila Rebetol vsebuje 40 mg laktoze.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
No interaction studies have been conducted with Rebetol and other medicinal products, except for peginterferon alfa-2b, interferon alfa-2b and antacids.
Ni bilo opravljenih nobenih študij medsebojnega delovanja zdravila Rebetol z drugimi zdravili, razen za peginterferon alfa- 2b, interferon alfa- 2b in antacide.
Interferon alfa-2b:
9 Interferon alfa- 2b:
No pharmacokinetic interactions were noted between Rebetol and peginterferon alfa-2b or interferon alfa-2b in a multiple-dose pharmacokinetic study.
V farmakokinetični študiji večkratnih odmerkov niso beležili nobenih farmakokinetičnih interakcij med zdravilom Rebetol in peginterferonom alfa- 2b ali interferonom alfa - 2b.
Antacid:
Antacidi:
The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14%.
Vrednost AUCtf se je zmanjšala za 14%.
Nucleoside analogs:
Nukleozidni analogi:
Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see section 4.4).
Objavljena so bila poročila o primerih toksičnosti za mitohondrije, še posebej v obliki laktacidoze in pankreatitisa, in nekateri od njih so vodili do bolnikove smrti (glejte poglavje 4. 4).
The concomitant use of
Kadar je bil zidovudin vključen v shemo zdravljenja okužbe s HIV, so poročali o poslabšanju anemije zaradi jemanja ribavirina, čeprav natančen mehanizem tega pojava ni znan.
9 ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Zaradi povečanega tveganja za anemijo torej sočasna uporaba ribavirina z zidovudinom ni priporočljiva (glejte poglavje 4. 4).
Any potential for interactions may persist for up to two months (five half-lives for ribavirin) after cessation of Rebetol therapy due to the long half-life (see section 5.2).
Zaradi dolge razpolovne dobe lahko do medsebojnega delovanja pride še do dva meseca (5 razpolovnih dob ribavirina) po koncu terapije z zdravilom Rebetol (glejte poglavje 5. 2).
The re is no evidence that ribavirin interacts with non-nucleoside reverse transcriptase inhibitors or protease inhibitors.
Ni dokazov o medsebojnem delovanju ribavirina z nenukleozidnimi zaviralci reverzne transkriptaze ali zaviralci proteaz.
The use of Rebetol is contraindicated during pregnancy.
Uporaba zdravila Rebetol je kontraindicirana v času nosečnosti.
- Fertility:
- Plodnost:
In animal studies, ribavirin produced reversible effects on spermatogenesis (see section
V študijah na živalih je ribavirin povzročil reverzibilne učinke na spermatogenezo (glejte
5.3).
poglavje 5. 3).
- Teratogenicity:
- Teratogenost:
Significant teratogenic and/or embryocidal potential have been demonstrated for
Za ribavirin je bil dokazan pomemben teratogeni in/ ali embriocidni potencial pri
ribavirin in all animal species in which adequate studies have been conducted, occurring at doses as low as one twentieth of the recommended human dose (see section 5.3).
Tovrstni učinki so se pojavili že pri tako majhnih odmerkih kot je ena dvajsetina priporočenega odmerka za človeka (glejte poglavje 5. 3).
- Genotoxicity:
- Genotoksičnost:
Ribavirin induces genotoxicity (see section 5.3).
Ribavirin povzroča genotoksične učinke (glejte poglavje 5. 3).
Rebetol must not be used by females who are pregnant (see sections 4.3, 4.4 and 5.3).
Nosečnice ne smejo uporabljati zdravila Rebetol (glejte poglavja 4. 3, 4. 4 in 5. 3).
Rebetol therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Zdravljenja z zdravilom Rebetol ne smete uvesti, dokler ne dobite negativnega izvida nosečnostnega testa tik pred začetkom zdravljenja.
Females of childbearing potential and their partners must each use an effective contraceptive during treatment and for four months after treatment has been concluded; routine monthly pregnancy tests must be performed during this time (see section 4.4).
V tem času morate vsak mesec rutinsko opravljati nosečnostni test (glejte poglavje 4. 4).
Extreme care must be taken to avoid pregnancy in partners of male patients taking Rebetol (see sections 4.3, 4.4 and 5.3).
Izjemno skrbno moramo paziti, da preprečimo zanositev pri partnerkah moških bolnikov, ki jemljejo zdravilo Rebetol (glejte poglavja 4. 3, 4. 4 in 5. 3).
Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, male patients and their female partners of childbearing age must be counseled to each use an effective contraceptive during treatment with Rebetol and for seven months after treatment Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.
Moškim z nosečo partnerko naročite, naj uporabljajo kondom, da se čimbolj zmanjša prehajanje ribavirina v partnerko.
Because of the potential for adverse reactions in nursing infants, nursing must be discontinued prior to initiation of treatment.
Zaradi nevarnosti za pojav neželenih reakcij pri dojenčkih mora mati prenehati z dojenjem pred pričetkom zdravljenja.
Rebetol has no or negligible influence on the ability to drive and use machines; however, peginterferon alfa-2b or interferon alfa-2b used in combination may have an effect.
Rebetol nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji, peginterferon alfa- 2b ali interferon alfa- 2b uporabljen v kombinirani terapiji pa imata lahko tovrsten učinek.
10 The safety of Rebetol capsules is evaluated from data from three clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied Rebetol in combination with interferon alfa-2b, one trial studied Rebetol in combination with peginterferon alfa-2b.
V dveh preskušanjih so raziskovali Rebetol v kombinaciji z interferonom alfa- 2b, v eni pa Rebetol v kombinaciji s peginterferonom alfa- 2b.
Patients who are treated with interferon alfa-2b and ribavirin after previous relapse from interferon therapy or who are treated for a shorter period are likely to have an improved safety profile than that described below.
Pri bolnikih, ki se zdravijo z interferonom alfa- 2b in ribavirinom po predhodni ponovitvi bolezni po terapiji z interferonom, ali pri tistih, ki se zdravijo krajši čas, bo varnostni profil verjetno boljši od spodaj opisanega.
The adverse reactions listed in Table 4 are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use.
Neželeni učinki, ki so navedeni v Preglednici 4, so povzeti iz izkušenj, zbranih v kliničnih preskušanjih pri odraslih bolnikih, ki se še niso zdravili s tem zdravilom in so jih z njim zdravili eno leto, ter iz postmarketinške uporabe zdravila.
Also, refer to peginterferon alfa-2b and interferon alfa-2b SPCs for adverse reactions that may be attributable to interferon monotherapy.
Za neželene učinke, ki bi jih lahko pripisali monoterapiji z interferonom, si preberite SPC- ja za peginterferon alfa- 2b in interferon alfa - 2b.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known.
Neželeni učinki so navedeni po organskih sistemih, z naslednjimi kategorijami pogostnosti: zelo pogosti (≥1/ 10), pogosti (od ≥1/ 100 do < 1/ 10), občasni (od ≥1/ 1000 do < 1/ 100), redki (od ≥ 1/ 10. 000 do < 1/ 1000), zelo redki (< 1/ 10. 000), neznana.
Table 4
Preglednica 4 Neželeni učinki, o katerih so poročali med kliničnimi preskušanji ali v okviru postmarketinških izkušenj z uporabo zdravila Rebetol skupaj s pegiliranim interferonom alfa- 2b ali interferonom alfa- 2b za injiciranje
System Organ Class and infestations
Razvrstitev po organskih sistemih
Very common:
Infekcijske in parazitske bolezni Zelo pogosti:
Pneumonia*
Virusne okužbe, faringitis Glivične okužbe, otitis media, herpes simpleks, okužbe sečil Pljučnica *
Neoplasm unspecified
Neopredeljene novotvorbe
Anaemia, neutropenia Thrombocytopenia, lymphadenopathy, lymphopenia Aplastic anaemia* Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Anemije, nevtropenija Trombocitopenija, limfadenopatija, limfopenija Aplastična anemija * Izolirana aplazija eritrocitov, idiopatska trombocitopenična purpura, trombotska trombocitopenična purpura
Sarcoidosis* Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Sindrom Vogt- Koyanagi- Harada, sistemski lupus eritematozus, revmatoidni artritis (nov pojav ali poslabšanje obstoječega), vaskulitis, akutne preobčutljivostne reakcije vključno z urtikarijo, angioedem, bronhokonstrikcija, anafilaksija
Hypothyroidism, hyperthyroidism Diabetes
Hipotiroidizem, hipertiroidizem Sladkorna bolezen
Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite, thirst
Anoreksija Hiperglikemija, hiperurikemija, hipokalcemija, dehidracija, povečan tek, žeja
Hypertriglyceridemia*
Hipertrigliceridemija *
Depression, insomnia, anxiety, emotional lability Suicidal ideation, psychosis, aggressive behaviour, confusion, agitation, nervousness, sleep disorder, abnormal dreaming, abnormal crying, apathy, decreased libido
Depresija, nespečnost, tesnoba, čustvena nestabilnost Samomorilne misli, psihoza, agresivno vedenje, zmedenost, vznemirjenost, živčnost, motnje spanja, nenormalne sanje, nenormalen jok, apatičnost, zmanjšana spolna sla
Suicide* Mental status change
Poskus samomora Halucinacije Samomor * Spremembe duševnega stanja
Headache, dizziness, dry mouth, concentration impaired Ataxia, tremor, paresthaesia, dysphonia, taste loss, hypoaesthesia, hyperaesthesia, somnolence, migraine, hypertonia, dysgeusia
Glavobol, omotica, suha usta, zmanjšana koncentracija Ataksija, tremor, parestezije, disfonija, izguba okusa, hipoestezija, hiperestezija, somnolenca, migrena, hipertonija, disgevzija
Seizure (convulsion)*, peripheral neuropathy* Cerebrovascular haemorrhage*, cerebrovascular ischaemia*, encephalopathy*, polyneuropathy*
Epileptični napadi (konvulzije) *, periferna nevropatija * Cerebrovaskularne krvavitve *, cerebrovaskularna ishemija *, encefalopatija *, polinevropatija *
Facial palsy, neuropathies (including mononeuropathies)
Paraliza obraznega živca, nevropatije (vključno z mononevropatijami)
Blurred vision, conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder
Zamegljen vid, konjunktivitis, očesne bolečine, motnje vida, bolezni solzne žleze
Retinal haemorrhages*, retinopathies (including macular oedema)*, retinal artery obstruction*, retinal vein obstruction*, optic neuritis*, papilloedema*, loss of visual acuity or visual field*, cotton wool spots*
Mrežnične krvavitve *, retinopatije (vključno z edemom makule) *, zamašitev mrežnične arterije *, zamašitev mrežnične vene *, nevritis vidnega živca *, edem papile *, zmanjšanje ostrine vida ali zmanjšanje vidnega polja *, mehki eksudati *
Ear and labyrinth disorders
Ušesne bolezni, vključno z motnjami labirinta Pogosti:
Vertigo, hearing impairment/loss, tinnitus, earache
Vrtoglavica, poslabšanje sluha ali izguba sluha, tinitus, ušesne bolečine
Palpitation, tachycardia Cardiomyopathy*, arrhythmia* Myocardial infarction*, cardiac ischaemia*
Palpitacije, tahikardija Kardiomiopatija *, aritmije * Miokardni infarkt *, srčna ishemija *
Hypotension, hypertension, syncope, flushing Peripheral ischaemia*
Hipotenzija, hipertenzija, sinkopa, pordelost Periferna ishemija *
Dyspnoea, coughing Sinusitis, bronchitis, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough
Dispneja, kašelj Sinusitis, bronhitis, epistaksa, rinitis, motnje dihanja, kongestija nosne sluznice, rinoreja, neproduktiven kašelj
Very rare:
12 Zelo redki:
Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis*
Pljučni infiltrati *, pnevmonitis *, intersticijski pnevmonitis *
Diarrhoea, vomiting, nausea, abdominal pain Ulcerative stomatitis, stomatitis, colitis, upper right quadrant pain, dyspepsia, gastroesophogeal reflux*, glossitis, gingival bleeding, gingivitis, loose stools, constipation, flatulence
Driska, bruhanje, slabost, trebušne bolečine Ulcerozni stomatitis, stomatitis, kolitis, bolečine v zgornjem desnem kvadrantu trebuha, dispepsija, gastroezofagealni refluks *, glositis, krvavitve iz dlesni, gingivitis, mehko blato, zaprtje, napenjanje
Pancreatitis* Ischaemic colitus*, ulcerative colitus* Periodontal disorder, dental disorder
Pankreatitis * Ishemični kolitis *, ulcerozni kolitis * Parodontalne bolezni, zobne bolezni
Hepatomegaly, jaundice, hyperbilirubinemia* Hepatotoxicity (including fatalities)*
Hepatomegalija, zlatenica, hiperbilirubinemija * Hepatotoksičnost (vključno s smrtnimi primeri) *
Skin and subcutaneous tissue disorders Very common:
Zelo pogosti:
Alopecia, pruritus, skin dry, rash Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, dermatitis, acne, furunculosis*, erythema, skin disorder, bruise, sweating increased, abnormal hair texture, nail disorder* 12
Alopecija, pruritus, suha koža, izpuščaj Psoriaza, poslabšanje psoriaze, ekcem, preobčutljivostne reakcije na svetlobo, makulopapulozni izpuščaj, eritematozni izpuščaj, dermatitis, akne, furunkuloza *, eritem, kožne bolezni, podplutbe, povečano potenje, nenormalna tekstura las, bolezni nohtov *
Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme*
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Musculoskeletal and connective tissue disorders
Stevens- Johnsonov sindrom *, toksična epidermalna nekroliza *, multiformni eritem *
Arthralgia, myalgia, musculoskeletal pain Arthritis Rhabdomyolysis*, myositis*
Artralgija, mialgija, mišično- skeletne bolečine Artritis Rabdomioliza *, miozitis *
Micturition frequency, polyuria Renal failure*, renal insufficiency* Nephrotic syndrome*
Motnje reprodukcije in dojk
Reproductive system and breast disorders
Pogosto uriniranje, poliurija Ledvična odpoved *, ledvična insuficienca * Nefrotski sindrom *
Male: impotence, prostatitis Sexual dysfunction (not specified)*
Moški: impotenca, prostatitis Spolne motnje (neopredeljene) *
Injection site inflammation, injection site reaction, fatigue, rigors, fever, flu-like symptoms, asthenia, irritability
Vnetje na mestu injiciranja, reakcija na mestu injiciranja, utrujenost, mrzlica, zvišana telesna temperatura, gripi podobni simptomi, astenija, razdražljivost
Chest pain, peripheral oedema, malaise, injection site pain, face oedema*
Bolečine v prsih, periferni edem, bolehnost, bolečine na mestu injiciranja, obrazni edem *
Common:
Pogosti: * Ker ribavirin vedno predpisujejo skupaj z zdravili, ki
Weight decrease Cardiac murmur, urine abnormal
Hujšanje šum na srcu *, nenormalen seč vsebujejo interferon alfa, in ker našteti neželeni učinki temeljijo na
* Since ribavirin is always prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using ribavirin in combination with interferon alfa-2b (pegylated or nonpegylated).
postmarketinških izkušnjah in ne omogočajo natančne opredelitve pogostnosti, so zgoraj navedene pogostnosti vzete iz kliničnih preskušanj z uporabo ribavirina v kombinaciji z interferonom alfa- 2b (pegiliranim ali nepegiliranim).
A reduction in haemoglobin concentrations by > 4 g/dl was observed in 30% of patients treated with Rebetol and peginterferon alfa-2b and 37% of patients treated with Rebetol + interferon alfa-2b.
Zmanjšanje koncentracije hemoglobina za > 4 g/ dl so opazili pri 30% bolnikov, ki so prejemali Rebetol + peginterferon alfa- 2b, ter pri 37% bolnikov, ki so prejemali Rebetol + interferon alfa- 2b.
Haemoglobin levels dropped below 10 g/dl in up to 14% of adult patients and 7% of children and adolescents treated with Rebetol in combination with either peginterferon alfa-2b (adults only) or interferon alfa-2b.
Pri do 14% odraslih bolnikov in 7% otrok in mladostnikov, zdravljenih z zdravilom Rebetol v
Most cases of anaemia, neutropaenia, and thrombocytopaenia were mild (WHO grades 1 or 2).
13 kombinaciji bodisi s peginterferonom alfa- 2b (samo odrasli) ali z interferonom alfa- 2b, se je vrednost hemoglobina znižala pod 10 g/ dl.
There were some cases of more severe neutropenia in patients treated with Rebetol in combination with peginterferon alfa-2b (WHO grade 3:
Bilo je tudi nekaj primerov hujše nevtropenije (3. stopnje po WHO:
39 of 186 [21%]; and WHO grade 4:
39 od 186 [21%] in 4. stopnje po WHO: