natgillin/translations-raw huggingface dataset:
What IntronA is and what it is used for What you need to know before you use IntronA How to use IntronA
Kaj je zdravilo IntronA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo IntronA Kako uporabljati zdravilo IntronA Možni neželeni učinki
if you have received an organ transplant, either kidney or liver, interferon treatment may increase the risk of rejection.
če ste prejemnik presajenega organa, bodisi ledvice ali jeter, lahko zdravljenje z interferonom poveča tveganje za njegovo zavrnitev.
Standard haematological tests and blood chemistries (complete blood count and differential, platelet count, electrolytes, liver enzymes, serum protein, serum bilirubin and serum creatinine) are to be conducted in all patients prior to and periodically during systemic treatment with IntronA.
Standardne hematološke preiskave in biokemične preiskave krvi (celotna krvna slika in diferencialna krvna slika, število trombocitov, določanje elektrolitov, jetrnih encimov, serumskih beljakovin, bilirubina v serumu in serumskega kreatinina) morate opraviti pri vseh bolnikih, in sicer pred terapijo z zdravilom IntronA in redno med sistemsko terapijo z njim.
Your doctor has prescribed IntronA specifically for you and your current condition; do not share this medicine with anyone else.
Zdravnik je zdravilo IntronA predpisal prav vam in za vaše trenutne zdravstvene težave, zato ga ne smete dati drugim.
Detailed instructions for subcutaneous administration are provided with this leaflet (see section “HOW TO SELF INJECT INTRONA” at the end of the leaflet).
Podrobna navodila za podkožno injiciranje so priložena temu navodilu (glejte poglavje “KAKO SI LAHKO SAMI INJICIRATE ZDRAVILO INTRONA” - na koncu navodil).
These undesirable effects have also been reported with IntronA alone.
O teh neželenih učinkih so poročali tudi pri monoterapiji z zdravilom IntronA.
The mechanism by which IntronA may alter thyroid status is unknown.
Mehanizem, prek katerega lahko zdravilo IntronA vpliva na ščitnico, ni znan.
In these patients, the addition of ribavirin to IntronA increased by as much as 10-fold the efficacy of IntronA used alone in the treatment of chronic hepatitis C (48.6 % vs. 4.7 %).
Pri teh bolnikih je dodatek ribavirina zdravilu IntronA povečal učinkovitost zdravila IntronA v monoterapiji kroničnega hepatitisa C za kar 10-krat (48,6 % v primerjavi s 4,7 %).
Interferon neutralising factor assays were performed on serum samples of patients who received IntronA in Schering-Plough monitored clinical trials.
Testi za določanje nevtralizacijskega faktorja za interferon so bili opravljeni na vzorcih seruma pri bolnikih, ki so prejeli zdravilo IntronA v kliničnih preskušanjih, ki so potekala pod nadzorom družbe Schering-Plough.
Hairy cell leukaemia Treatment of patients with hairy cell leukaemia.
Dlakastocelična levkemija Zdravljenje bolnikov z dlakastocelično levkemijo.
Children and adolescent population
Otroci in mladostniki
In particular, decrease in mean height percentile from baseline to the end of the longterm follow-up was most prominent in prepubertal age children (see section 4.4).
Zmanjšanje srednjega percentila višine od začetka zdravljenja do konca dolgoročnega spremljanja bolnikov pa je bilo najbolj izrazito pri otrocih pred puberteto (glejte poglavje 4.4).
If necessary, an inter-disciplinary approach including a mental health care provider or addiction specialist should be considered to evaluate, treat and follow the patient.
Če je potrebno, uporabite interdisciplinarni pristop z vključitvijo specialista s področja duševnega zdravja ali odvisnosti, za oceno stanja, zdravljenje in spremljanje takega bolnika.
Hypotension may occur during IntronA therapy or up to two days post-therapy and may require supportive treatment.
Med terapijo z zdravilom IntronA ali do dva dni po prenehanju terapije lahko nastopi hipotenzija, zaradi katere je lahko potrebna podporna terapija.
Therefore, it is recommended that children and adolescent patients receiving IntronA/ribavirin combination be discontinued from therapy if their week 12 HCV-RNA dropped < 2 log10 compared to pretreatment, or if they have detectable HCV-RNA at treatment week 24.
Zato je priporočljivo, da otrokom in mladostnikom, ki prejemajo kombinacijo zdravila IntronA in ribavirina, zdravljenje ukinete, če jim vrednost HCV-RNA v 12. tednu upade za < 2 log10 v primerjavi s stanjem pred zdravljenjem ali če imajo v krvi merljivo količino HCV-RNA v 24. tednu zdravljenja.
Any patient complaining of changes in visual acuity or visual fields, or reporting other ophthalmologic symptoms during treatment with IntronA, must have a prompt and complete eye examination.
Vsi bolniki, ki tožijo o spremembah ostrine vida ali vidnega polja ali ki imajo druge oftalmološke simptome med zdravljenjem z zdravilom IntronA, morajo biti takoj poslani na celoten oftalmološki pregled.
During ALT flare, the following liver function tests must be monitored at two-week intervals: ALT, prothrombin time, alkaline phosphatase, albumin and bilirubin.
Med povečanjem vrednosti ALT morate na vsaka dva tedna opravljati naslednje preiskave delovanja jeter: določanje vrednosti ALT, protrombinskega časa, alkalne fosfataze, albumina in bilirubina.
Driving and using machines Do not drive or use machines if you become drowsy, tired, or confused from using this medicine.
Vpliv na sposobnost upravljanja vozil in strojev Če postanete zaradi tega zdravila zaspani, utrujeni ali zmedeni, ne vozite in ne upravljajte strojev.
In general, the adverse reaction profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric- specific concern regarding growth inhibition as decrease in height percentile (mean percentile decrease of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment.
Na splošno je bil profil neželenih učinkov v omejeni proučevani populaciji otrok in mladostnikov podoben kot pri odraslih, čeprav obstaja za pediatrične bolnike še posebna skrb glede zastoja rasti, saj so med zdravljenjem opazili zmanjšanje percentila višine (srednje zmanjšanje za 9 percentilov) in percentila telesne mase (srednje zmanjšanje za 13 percentilov).
Insert the needle into the vial containing the IntronA solution and inject air into the vial.
Vstavite iglo v vialo z raztopino zdravila IntronA in injicirajte zrak v vialo.
Any patient developing liver function abnormalities during treatment with IntronA must be monitored closely and treatment discontinued if signs and symptoms progress.
Vse bolnike, pri katerih se med zdravljenjem z zdravilom IntronA pojavijo motnje delovanja jeter, morate natančno spremljati in zdravljenje prekiniti, če se znaki in simptomi slabšajo.
Clinical experience indicates that a haematological and cytogenetic major/minor response is obtainable in the majority of patients treated.
Klinične izkušnje kažejo, da je pri večini zdravljenih bolnikov možno doseči večji ali manjši hematološki in citogenetski odziv.
Patients with debilitating medical conditions
Bolniki z izčrpavajočimi bolezenskimi stanji
Due to the lack of data in these two multicentre trials for children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Zaradi pomanjkanja podatkov v teh dveh multičentričnih preskušanjih pri otrocih s hudim napredovanjem bolezni in možnostjo pojava neželenih učinkov je potrebno pred uporabo kombinacije ribavirina in interferona alfa-2b v tej populaciji skrbno pretehtati razmerje med koristnostjo zdravljenja in tveganjem (glejte poglavja 4.1, 4.4 in 4.8).
Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Rekombinantni interferon alfa-2b zavira tudi replikacijo virusov in vitro in in vivo.
Results of animal reproduction studies indicate that recombinant interferon alfa-2b was not teratogenic in rats or rabbits, nor did it adversely affect pregnancy, foetal development or reproductive capacity in offspring of treated rats.
Izsledki študij o vplivu na sposobnost razmnoževanja na živalih kažejo, da rekombinantni interferon alfa-2b ni bil teratogen za podgane in kunce in da ni negativno vplival na brejost, razvoj ploda ali na sposobnost razmnoževanja potomcev zdravljenih podgan.
Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Bacterial infection
faringitis*, virusna okužba* bronhitis, sinusitis, herpes simpleks (rezistenca), rinitis bakterijska okužba pljučnica
For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue IntronA therapy.
Pri vseh bolnikih velja, da če po 3 do 4 mesecih zdravljenja ne ugotovite nobenega izboljšanja serumske vrednosti HBV-DNA (ob največjem odmerku, ki ga bolnik še prenaša), morate terapijo z zdravilom IntronA ukiniti.
Any thyroid abnormality detected at that time must be treated with conventional therapy.
Vse motnje v delovanju ščitnice, ki jih takrat ugotovite, morate zdraviti s konvencionalno terapijo.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100, <1/10).
V posameznih organskih sistemih so neželeni učinki razvrščeni po pogostnosti v naslednji dve kategoriji: zelo pogosti (≥1/10), pogosti (≥1/100, <1/10).
It is obtained from a clone of E. coli, which harbours a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
Pridobiva se iz klona E. coli, v katerega je vgrajen plasmidni hibrid, izdelan z genetskim inženiringom, ki vsebuje gen za interferon alfa-2b iz človeških levkocitov.
(affects less than 1 user in 10,000)
(pojavijo se pri manj kot 1 bolniku od 10.000 bolnikov)
In a large study, 1,071 patients were enrolled after treatment in a prior non-pegylated interferon alfa2b or non-pegylated interferon alfa-2b/ribavirin study to evaluate the durability of sustained virologic response and assess the impact of continued viral negativity on clinical outcomes.
V veliko študijo so vključili skupaj 1.071 bolnikov, ki so bili predhodno vključeni v študijo z nepegiliranim interferonom alfa-2b ali z nepegiliranim interferonom alfa-2b in ribavirinom, da bi ovrednotili trajanje trajnega virološkega odziva in ocenili vpliv nadaljnjih negativnih izvidov določanja virusa na klinične izide.
The side effect may develop at various time points during treatment, typically several months after starting treatment with IntronA.
Neželeni učinek se lahko pojavi ob različnih časovnih točkah zdravljenja, običajno nekaj mesecev po začetku zdravljenja z zdravilom IntronA.
The dosage will vary according to the disease being treated.
Odmerki zdravila IntronA se razlikujejo glede na bolezen, ki jo zdravimo.
If you are exceptionally thin, use only the thigh or outer surface of the arm for injection.
Če ste izjemno suhi, za mesto injiciranja izberite le stegno ali zunanjo površino roke.
The pharmacokinetics of IntronA were studied in healthy volunteers following single 5 million IU/m and 10 million IU doses administered subcutaneously, at 5 million IU/m2 administered intramuscularly and as a 30-minute intravenous infusion.
Farmakokinetiko zdravila IntronA so raziskovali pri zdravih prostovoljcih po enkratnih subkutanih odmerkih po 5 milijonov i.e./m2 in 10 milijonov i.e., po intramuskularnem dajanju 5 milijonov i.e./m in po 30-minutni intravenski infuziji.
When IntronA is used with hydroxyurea, the frequency and severity of cutaneous vasculitis may be increased.
Pri uporabi zdravila IntronA skupaj s hidroksisečnino se lahko poveča pogostnost in resnost kožnega vaskulitisa.
With one hand, pinch a fold of loose skin.
Z eno roko oblikujte kožno gubo.
What IntronA looks like and contents of the pack
Izgled zdravila IntronA in vsebina pakiranja
During combination therapy for up to 48 weeks with IntronA and ribavirin, growth inhibition was observed that resulted in reduced final adult height in some patients.
V času kombinirane terapije z zdravilom IntronA in ribavirinom, ki je trajala do 48 tednov, so opazili zastoj rasti, ki je imel pri nekaterih bolnikih za posledico manjšo končno telesno višino.
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/mL (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Zdravljenje je trajalo 48 tednov, z nadaljnjim 6-mesečnim obdobjem spremljanja bolnikov, razen pri tistih, ki so bili okuženi z genotipoma 2 ali 3 in so imeli virusno breme < 800.000 i.e./ml (Amplicor) - njih so zdravili 24 tednov z nadaljnjim 6-mesečnim obdobjem spremljanja.
When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients.
Pri odločitvi glede odložitve zdravljenja do odrasle dobe je pomembno upoštevati, da je kombinirana terapija povzročila zastoj rasti, ki je imel pri nekaterih bolnikih za posledico manjšo končno telesno višino.
It is important to consider that the combination therapy induced a growth inhibition that resulted in reduced final adult height in some patients.
Pomembno je upoštevati, da je kombinirana terapija povzročila zastoj rasti, ki je imel pri nekaterih bolnikih za posledico manjšo končno telesno višino.
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).
Bolnike z znaki ali simptomi, ki bi lahko bili združljivi z avtoimuno boleznijo, morate skrbno preiskati ter pri njih ponovno oceniti razmerje med koristmi in tveganji nadaljnje terapije z interferonom (glejte tudi poglavji 4.4 Kronični hepatitis C, monoterapija (motnje ščitnice) in 4.8).
Take the needle and place it firmly onto the tip of the syringe.
Vzemite iglo in jo trdno pričvrstite na vrh brizge.
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 že obstoječimi srčnimi motnjami in/ali tistih, ki so v napredovalih stadijih maligne bolezni, EKG posnamete pred in po terapiji.
IntronA is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for hepatitis C virus RNA (HCV-RNA) (see section 4.4).
Zdravilo IntronA je indicirano za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki imajo povečane vrednosti transaminaz brez dekompenzacije jeter in pozitiven izvid RNA virusa hepatitisa C (HCV-RNA) (glejte poglavje 4.4).
Increase in serum ALT/AST (SGPT/SGOT) levels have been noted as an abnormality in some non-hepatitis subjects and also in some patients with chronic hepatitis B coincident with clearance of viral DNAp.
Povečanje serumske vrednosti ALT/AST (SGPT/SGOT) so opažali kot motnjo pri nekaterih osebah brez hepatitisa in tudi pri nekaterih bolnikih s kroničnim hepatitisom B skladno z očistkom virusne DNAp.
- 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, ki imajo ali so kdaj imeli hude psihiatrične motnje, je kontraindicirana (glejte poglavje 4.3).
If adverse events develop during the course of treatment with IntronA for any indication, modify the dose or discontinue therapy temporarily until the adverse events abate.
Če se v teku zdravljenja z zdravilom IntronA za katerokoli od indikacij pojavijo neželeni učinki, prilagodite odmerjanje ali začasno ukinite zdravljenje, dokler neželeni učinki ne izzvenijo.
Children and adolescent population: Growth and development (chronic hepatitis C) During the course of interferon (standard and pegylated)/ribavirin combination therapy lasting up to 48 weeks in patients ages 3 through 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1).
Otroci in mladostniki: Rast in razvoj (kronični hepatitis C) Med kombinirano terapijo z interferonom (standardnim in pegiliranim) ter ribavirinom, ki je trajala do 48 tednov, sta bila pri bolnikih, starih od 3 do 17 let, hujšanje in zastoj rasti pogosta (glejte poglavji 4.8 in 5.1).
Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “How to self inject IntronA”).
Natančna navodila za subkutano uporabo zdravila so opisana v navodilu za uporabo (v poglavju "Kako si sami injicirate zdravilo IntronA").
Sustained virologic response rates for treatment groups treated for one year with IntronA alone or in combination with ribavirin (from two studies) are shown in Table 3.
Deleži trajnega virološkega odziva po terapevtskih skupinah, zdravljenih eno leto z zdravilom IntronA v monoterapiji ali v kombinaciji z ribavirinom (iz dveh raziskav), so podani v preglednici 3.
Remove the needle from the vial and check for air bubbles in the syringe.
Iglo izvlecite iz viale in preverite, ali so v brizgi morda zračni mehurčki.
The adverse reactions listed in Table 1 are based on experience from clinical trials and post-marketing.
Neželeni učinki, podani v Preglednici 1, so povzeti iz kliničnih preskušanj in iz obdobja trženja.
Your doctor has determined the exact dosage for administration of IntronA according to your individual needs.
Odmerek zdravila IntronA je zdravnik določil natančno glede na vaše individualne potrebe.
Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
Videti je bilo, da so kardiovaskularni (KVS) neželeni učinki, še posebej aritmija, odvisni predvsem od obstoječe KVS bolezni in predhodne terapije s kardiotoksičnimi snovmi (glejte poglavje 4.4).
A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1,64 %  12 years of age.
V študijo je bilo vključenih skupno 118 bolnikov; od tega je bilo 57 % moških, 80 % bolnikov bele rase, 78 % bolnikov z genotipom 1 in 64 % otrok, starih  12 let.
Children and adolescents should be monitored every 3 months for evidence of thyroid dysfunction (e.g. TSH).
Otroke in mladostnike je treba spremljati na vsake 3 mesece in pri njih iskati morebitne znake motenj delovanja ščitnice (npr. spremembe vrednosti TSH).
Twenty (21 %) of 97 children had a > 15 percentile decrease in height percentile, of whom 10 of the 20 children had a > 30 percentile decrease in their height percentile from the start of treatment to the end of long-term follow-up (up to 5 years).
Pri dvajsetih otrocih (21 %) od skupaj 97 otrok se je od začetka zdravljenja do konca dolgoročnega spremljanja bolnikov (do 5 let) percentil telesne višine zmanjšal za > 15 percentilov, pri 10 od teh 20 otrok pa se je percentil telesne višine zmanjšal za > 30 percentilov.
Adverse experiences including prolongation of coagulation markers and liver abnormalities Moderate to severe adverse experiences may require modification of the patient's dose regimen, or in some cases, termination of IntronA therapy.
Neželeni učinki vključno s podaljšanimi parametri koagulacije in jetrnimi nepravilnostmi Pri zmernih do hudih neželenih učinkih je lahko potrebna prilagoditev režima odmerjanja, v nekaterih primerih pa tudi prekinitev terapije z zdravilom IntronA.
Patients predisposed to the development of autoimmune disorders may be at increased risk.
Bolniki, ki so nagnjeni k nastanku avtoimunih bolezni, so lahko bolj ogroženi zaradi tega.
Prior to initiation of IntronA therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
Pred uvedbo terapije z zdravilom IntronA za zdravljenje kroničnega hepatitisa C določite serumsko koncentracijo tirotropnega hormona (TSH).
Treatment of high tumour burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen.
Zdravljenje folikularnega limfoma z veliko tumorsko obremenitvijo kot dodatno zdravljenje ob ustrezni kombinirani uvajalni kemoterapiji, kot je shema, podobna CHOP zdravljenju.
Measuring the dose of IntronA
Merjenje odmerka zdravila IntronA
Females of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Ženske v rodni dobi morajo učinkovito kontracepcijo uporabljati med zdravljenjem in še 4 mesece po zaključku zdravljenja.
HCV infected patients having a co-occurring substance use disorder (alcohol, cannabis, etc) are at an increased risk of developing psychiatric disorders or exacerbation of already existing psychiatric disorders when treated with alpha interferon.
Pri bolnikih, okuženih s HCV, ki sočasno uživajo tudi opojne substance (alkohol, marihuano, itd.), je med zdravljenjem z interferonom alfa povečano tveganje za pojav psihiatričnih motenj ali za poslabšanje že obstoječih psihiatričnih motenj.
This syndrome is a granulomatous inflammatory disorder affecting the eyes, auditory system, meninges, and skin.
To je granulomatozna vnetna bolezen, ki prizadene oči, slušni aparat, možganske ovojnice in kožo.
§, sepsis Hepatitis B reactivation in HCV/HBV co-infected patients
§, sepsa reaktivacija hepatitisa B pri bolnikih, sočasno okuženih s HCV/HBV
The adverse reactions listed in Table 2 are based on experience from the two multicentre children and adolescent clinical trials.
Neželeni učinki, ki so navedeni v Preglednici 2, so povzeti iz dveh multicentričnih kliničnih preskušanj pri otrocih in mladostnikih.
§, retinopathies (including macular oedema), retinal artery or vein obstruction
§, retinopatija (vključno z edemom makule), zamašitev mrežnične arterije ali vene
In clinical trials conducted in the hepatitis C population, patients were treated with IntronA alone or in combination with ribavirin for one year.
V kliničnih preskušanjih pri skupini bolnikov s hepatitisom C so bolnike eno leto zdravili z zdravilom IntronA samim ali v kombinaciji z ribavirinom.
Chronic hepatitis C in children and adolescent population Three clinical trials have been conducted in children and adolescents; two with standard interferon and ribavirin and one with pegylated interferon and ribavirin.
Opravljena so bila tri klinična preskušanja pri otrocih in mladostnikih, dva s standardnim interferonom in ribavirinom in eno s pegiliranim interferonom in ribavirinom.
IntronA solution for injection or infusion may be injected directly after withdrawal of the appropriate doses from the vial with a sterile injection syringe.
IntronA raztopino za injiciranje ali infundiranje lahko injicirate takoj, ko iz viale s sterilno injekcijsko brizgo posesate ustrezni odmerek.
If persistent or recurrent intolerance develops following adequate dose adjustment, or disease progresses, discontinue treatment with IntronA.
Če se po ustrezni prilagoditvi odmerka pojavi trdovratna ali ponavljajoča intoleranca za zdravilo ali če bolezen napreduje, ukinite terapijo z zdravilom IntronA.
Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels.
Med klinično pomembna odstopanja laboratorijskih vrednosti, ki se najpogosteje pojavijo pri odmerkih, večjih od 10 milijonov i.e. na dan, sodijo zmanjšanje števila granulocitov in levkocitov, zmanjšanje vrednosti hemoglobina in števila trombocitov, povečanje vrednosti alkalne fosfataze, LDH, serumskega kreatinina in dušika sečnine v serumu.