natgillin/translations-raw huggingface dataset:
Seventy percent (68/97) of all enrolled subjects completed this study of which 75 % (42/56) were sustained responders.
70 % (68/97) vseh v študijo vključenih preizkušancev je študijo dokončalo in od tega jih je 75 % (42/56) doseglo trajni virološki odziv.
IntronA is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Zdravilo IntronA uporabljajte v času nosečnosti le, če njegove potencialne koristi upravičijo potencialno tveganje za plod.
If you have the impression that the effect of IntronA is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila IntronA premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
If the solution is cold, warm the syringe between your palms.
Če je raztopina hladna, brizgo ogrejte v dlaneh.
Pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Pljučna arterijska hipertenzija - bolezen, ki povzroči hudo zoženje krvnih žil v pljučih, katerega posledica je visok krvni tlak v žilah, po katerih kri teče iz srca v pljuča.
a: Response to treatment was defined as undetectable HCV-RNA at 24 weeks post-treatment, lower limit of detection=125 IU/mL.
a: Odziv na zdravljenje je bil opredeljen kot nemerljiva vrednost HCV-RNA v 24. tednu po zdravljenju, spodnja meja detekcije = 125 i.e./ml.
Moderate and usually reversible reduction in all three blood elements-white blood cells, red blood cells and platelets, has been reported.
Poročali so o zmernem in ponavadi reverzibilnem zmanjšanju števila vseh treh vrst krvnih celic- belih krvnih celic, rdečih krvnih celic in celic za strjevanje krvi.
Psychiatric and central nervous system:
Psihiatrične motnje in centralni živčni sistem:
If intolerance persists after dose adjustment or if granulocytes decrease to < 250/mm
Če intoleranca traja tudi po prilagoditvi odmerka ali če število granulocitov upade na < 250/mm
Moreover children treated with interferon alfa-2b experienced a reduced rate of growth and some cases of depression were observed.
Poleg tega so pri otrocih, zdravljenih interferonom alfa-2b, opazili zmanjšano hitrost rasti in nekaj primerov depresije.
As maintenance therapy in patients who have achieved objective remission (more than 50 % reduction in myeloma protein) following initial induction chemotherapy.
Kot vzdrževalno zdravljenje pri bolnikih, pri katerih je bila dosežena objektivna remisija (več kot 50 % zmanjšanje količine mielomskega proteina) po začetni uvajalni kemoterapiji.
There are no data in children or adolescents with a history of cardiac disease.
Podatkov o otrocih in mladostnikih s srčno boleznijo v anamnezi ni.
However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
To pa ne izključuje pojava jetrnih dogodkov pri bolnikih s cirozo (vključno s hepatokarcinomom).
All patients in these trials received 3 MIU of IntronA three times a week.
Vsi bolniki v teh preskušanjih so prejemali 3 milijone i.e. zdravila IntronA trikrat na teden.
The pharmacokinetics of IntronA and ribavirin (dose-normalized) are similar in adults and children or adolescents.
Farmakokinetika zdravila IntronA in ribavirina (z normaliziranim odmerkom) je podobna pri odraslih in otrocih ali mladostnikih.
Do not use this medicine after the expiry date which is stated on the package.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Genotype 1  2 million copies/mL Genotype 1 > 2 million copies/mL
Genotip 1  2 milijona kopij/ml Genotip 1 > 2 milijona kopij/ml
- if you have hepatitis and have been treated recently with medicines that suppress the immune system (other than short-term treatment with cortisone-type medicine).
- če imate hepatitis in ste se nedavno zdravili z zdravili, ki zavirajo imunski sistem (razen kratkotrajnega zdravljenja z zdravili, kot je kortizon).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V posameznih skupinah glede pogostnosti so neželeni učinki navedeni po padajoči resnosti.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Cases of stroke (cerebrovascular events) have been reported.
Poročali so o primerih možganske kapi (cerebrovaskularni dogodki).
Long-term efficacy data
Dolgoročni podatki o učinkovitosti
For multidose vials, be sure to return the vial to the refrigerator.
Pri uporabi viale z več odmerki ne pozabite viale po uporabi vrniti nazaj v hladilnik.
If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Če vaša partnerka trenutno ni noseča, a je v rodni dobi, mora opraviti nosečnostni test vsak mesec med vašim zdravljenjem in še 7 mesecev po koncu zdravljenja.
Response rates in these trials were increased with compliance.
Deleži odziva v teh raziskavah so se povečevali s komplianco zdravljenja.
Warnings and precautions Talk to your doctor, pharmacist or nurse before using IntronA - if you are pregnant or planning to become pregnant (see section “Pregnancy and breast-feeding”).
Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila IntronA se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro - če ste noseči ali načrtujete nosečnost (glejte poglavje “Nosečnost in dojenje”).
If the product is not used during the seven-day period, it cannot be put back in the refrigerator for a new storage period and must be discarded.
Če zdravila ne porabite v teh 7 dneh, ga ne smete postaviti nazaj v hladilnik za naslednje obdobje shranjevanja, ampak ga morate zavreči.
Pharmacotherapeutic group: interferon alfa-2b, ATC code: L03A B05
Farmakoterapevtska skupina: interferon alfa-2b, oznaka ATC: L03A B05
The response to treatment in both of these trials is presented in Table 4.
Odzivi na zdravljenje v obeh študijah so podani v Preglednici 4.
Growth rate decrease (height and/or weight decrease for age)
zmanjšana rast (premajhna telesna višina in/ali masa glede na starost)
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden začnete uporabljati to zdravilo.
- if you notice unusual bleeding or bruising check with your doctor immediately.
- če opazite nenavadne krvavitve ali podplutbe, se nemudoma posvetujte z zdravnikom.
All patients were followed for an additional 6 months after the end of treatment for the determination of sustained virologic response.
Vse bolnike so spremljali še nadaljnjih 6 mesecev po koncu zdravljenja, da so ugotavljali trajen virološki odziv.
Please make sure to select an appropriate dose form and strength.
Prosimo, pozorno izberite primerno obliko in jakost.
You should brush your teeth thoroughly twice daily and have regular dental examinations.
Temeljito si morate ščetkati zobe dvakrat na dan in redno hoditi na pregled k zobozdravniku.
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 po 8 do 12 tednih prekiniti, če niste dosegli vsaj delne hematološke remisije ali klinično pomembnega zmanjšanja števila celic.
Therefore, the combination of IntronA with telbivudine is contraindicated (see section 4.3).
Kombinacija zdravila IntronA in telbivudina je zato kontraindicirana (glejte poglavje 4.3).
If you are scheduled to inject this medicine every day, and you accidentally missed a full day's dose, continue treatment at the usual dose the following day.
Če si zdravilo injicirate vsak dan in ste nehote pozabili celodnevni odmerek, naslednji dan nadaljujte zdravljenje z običajnim odmerkom.
What you need to know before you use IntronA
Kaj morate vedeti, preden boste uporabili zdravilo IntronA
If you forget to use IntronA
Če ste pozabili uporabiti zdravilo IntronA
Any unused medicine must be discarded after withdrawal of the dose.
Neporabljeno zdravilo je potrebno zavreči potem, ko vzamete odmerek.
Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with IntronA.
Narkotike, hipnotike ali sedative morate pri sočasni uporabi z zdravilom IntronA uporabljati previdno.
A major cytogenetic response is defined by < 34 % Ph+ leukaemic cells in the bone marrow, whereas a minor response is  34 %, but < 90 % Ph+ cells in the marrow.
Večji citogenetski odziv je opredeljen kot < 34 % Ph+ levkemičnih celic v kostnem mozgu, manjši pa kot  34 %, vendar z < 90 % Ph+ celic v kostnem mozgu.
Patients with psoriasis and sarcoidosis
Bolniki s psoriazo in sarkoidozo
Preparation of IntronA for intravenous infusion: The infusion is to be prepared immediately prior to use.
Priprava zdravila IntronA za intravensko infundiranje: Infuzijo morate pripraviti tik pred uporabo.
Immediately contact the doctor or seek emergency treatment if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others.
Takoj pokličite zdravnika ali poiščite nujno medicinsko pomoč, če otrok kaže kakršne koli neobičajne vedenjske znake, se počuti depresivno ali če otrok želi škodovati sebi ali drugim.
Be sure the solution is at room temperature up to 25°C.
Raztopina mora biti na sobni temperaturi do 25 °C.
Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96 %).
Pri bolnikih, ki niso dosegli virološkega odziva v 12. tednu, je zelo majhna verjetnost, da bodo dosegli trajen virološki odziv (negativna napovedna vrednost 96 %).
IntronA 3 MIU/m 2 3 times a week (n = 54)
IntronA 3 mio i.e./m 2 3-krat na teden (n = 54)
A five-year long-term, observational, follow-up study enrolled 97 paediatric chronic hepatitis C patients after treatment in the standard interferon multicentre trials.
V petletno dolgoročno opazovalno študijo za spremljanje bolnikov so vključili 97 pediatričnih bolnikov s kroničnim hepatitisom C po zdravljenju v okviru multicentričnih preskušanj s standardnim interferonom.
It is recommended that patients be treated with IntronA alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Priporočamo, da bolnike zdravite z zdravilom IntronA samim najmanj 3 do 4 mesece, potem pa določite stanje HCV-RNA.
Your doctor will monitor you for signs and symptoms of these conditions (Please be sure to read the ribavirin Patient Leaflet also).
Zdravnik vas bo spremljal, da ugotovi morebitne znake in simptome teh motenj (Preberite si tudi Navodilo za uporabo za ribavirin).
The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 97 % with a 95 % Confidence Interval of [95 %, 99 %].
Kaplan-Meierjeva ocena ohranjanja trajnega virološkega odziva v obdobju 5 let za vse bolnike znaša 97 %, s 95 % intervalom zaupanja [95 %, 99 %].
If you are prescribed IntronA in combination with ribavirin, ribavirin can be very damaging to an unborn baby, thus both female and male patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur: - if you are a girl or a woman of childbearing age, you must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Če vam zdravnik predpiše IntronA v kombinaciji z ribavirinom, je ribavirin lahko zelo škodljiv za nerojenega otroka, zato morajo tako bolnice kot bolniki upoštevati posebne previdnostne ukrepe glede spolnih odnosov, če obstaja kakršna koli možnost za zanositev: - če ste dekle ali ženska v rodni dobi, mora biti nosečnostni test pri vas negativen pred zdravljenjem, vsak mesec med zdravljenjem in še 4 mesece po zaključku zdravljenja.
Regardless of genotype, patients who received IntronA in combination with ribavirin and received  80 % of their treatment had a higher sustained response 6 months after 1 year of treatment than those who took < 80 % of their treatment (56 % vs. 32 % in trial C/I98-580).
Ne glede na genotip so imeli bolniki, ki so prejemali IntronA skupaj z ribavirinom in so prejeli  80 % terapije, večji trajen odziv 6 mesecev po enoletnem zdravljenju kot tisti, ki so prejeli < 80 % terapije (56 % v primerjavi z 32 % v raziskavi C/I98-580).
If this is a multidose vial, you will only have to remove the cap when preparing the first dose.
Če gre za vialo z več odmerki, je treba kapico sneti le pri pripravi prvega odmerka.
The mechanism behind these events is not known (see sections 4.3, 4.4 and 4.5 of the telbivudine SPC).
Mehanizem nastanka periferne nevropatije ni znan (glejte poglavja 4.3, 4.4 in 4.5 v SPC-ju za telbivudin).
If you have them, you may have had a serious allergic reaction to IntronA.
Če jih imate, je možno, da imate resno alergijsko reakcijo na zdravilo IntronA.
If the medicine is not used during the seven-day period, it should be discarded.
Če zdravila v teh 7 dneh ne uporabite, ga morate zavreči.
- if you have poor kidney or liver function.
- če vam ledvice ali jetra slabo delujejo.
Women of childbearing potential/contraception in males and females Women of childbearing potential have to use effective contraception during treatment.
Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženske v rodni dobi morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
Other medicines and IntronA
Druga zdravila in zdravilo IntronA
If you use more IntronA than you should Contact your doctor or healthcare professional as soon as possible.
Če ste uporabili večji odmerek zdravila IntronA, kot bi smeli Čim prej pokličite zdravnika ali drugega zdravstvenega delavca.
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.
462 patients completed at least 5 years of long-term follow-up and only 12 sustained responders' out of 492 relapsed during this study.
Pri 462 bolnikih se je zaključilo najmanj 5 letno dolgoročno spremljanje in le pri 12 bolnikih s trajnim virološkim odzivom od skupaj 492 bolnikov je prišlo do ponovitve bolezni v času te študije.
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 že obstoječo psoriazo in sarkoidozo, priporočamo, da pri bolnikih s psoriazo in sarkoidozo zdravilo IntronA uporabljate le, če njegove morebitne koristi odtehtajo možno tveganje.
Any size vial may be used to measure the required dose; however, final concentration of interferon in sodium chloride solution must be not less than 0.3 million IU/mL.
Za odmerjanje potrebnega odmerka se lahko uporabi katerakoli velikost viale, vendar končna koncentracija interferona v raztopini natrijevega klorida ne sme biti manjša od 0,3 milijona i.e./ml.
It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus-infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Menijo, da je ta proces vsaj deloma odgovoren za različne celične odzive na interferon, vključno z zavoro replikacije virusov v celicah okuženih z virusi, supresijo celične proliferacije in oblikami imunomodulacijskega delovanja, kot je okrepitev fagocitne aktivnosti makrofagov in povečanje specifične citotoksičnosti limfocitov za tarčne celice.
Your doctor will determine the exact dosage schedule and regimen according to your needs.
Natančen odmerek in režim odmerjanja zdravil bo določil zdravnik glede na vaše potrebe.
Tell your doctor if you are taking theophylline or aminophylline for asthma, and about all other medicines you are taking, or have taken recently, even those not prescribed, as the dose of some medicines may have to be adjusted while you are treated with IntronA.
Zdravniku povejte, če jemljete teofilin ali aminofilin za astmo, pa tudi za vsa druga zdravila, ki jih jemljete ali ste jih jemali nedavno, tudi za tista, ki ste jih dobili brez recepta, saj je lahko med zdravljenjem z zdravilom IntronA potrebna prilagoditev odmerka nekaterih zdravil.
- if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing, or hives) while on this medicine seek medical help immediately.
- če se med jemanjem tega zdravila pojavijo simptomi hude alergijske reakcije (npr. težave z dihanjem, piskanje v pljučih ali koprivnica), nemudoma poiščite zdravniško pomoč.
*AUC12 (ng.hr/mL) for ribavirin; AUC0-24 (IU.hr/mL) for IntronA
*AUC12 (ng x h/ml) za ribavirin; AUC0-24 (i.e. x h/ml) za IntronA
With your other hand hold the syringe as you would a pencil.
Z drugo držite brizgo kot svinčnik.
If such a reaction develops, discontinue the medicine and institute appropriate medical therapy.
Če se takšna reakcija pojavi, prekinite zdravljenje in uvedite ustrezno medikamentozno terapijo.
If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Če pride do te reakcije, si potem zagotovo temeljito sperite usta.
Turn the vial and the syringe upside down in one hand.
Vialo in brizgo obrnite tako, da je viala zgoraj, in ju držite v eni roki.
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 (tj. pri bolnikih z genotipoma 2 in 3), zdravljenje možno tudi brez histološke potrditve.
Remove the needle guard without touching the needle, and fill the syringe with air by pulling the plunger to the level that represents your dose as prescribed by your doctor.
Z igle snemite zaščitni pokrovček, ne da bi se je dotaknili, in brizgo napolnite z zrakom tako, da bat potegnete nazaj do črte, ki predstavlja odmerek zdravila, ki vam ga je predpisal zdravnik.
Examine the solution prior to administration: it should be clear and colourless.
Pred uporabo raztopino preglejte: biti mora bistra in brezbarvna.
3 or alanine aminotransferase/aspartate aminotransferase (ALT/AST) rises to > 5 x upper limit of normal, discontinue treatment temporarily until the adverse event abates.
3 ali če vrednost alanin-aminotransferaze/aspartat-aminotransferaze (ALT/AST) naraste na > 5-kratno zgornjo mejo normale, začasno prekinite zdravljenje, dokler neželeni učinek ne izzveni.
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
Čeprav natančen protivirusni način delovanja rekombinantnega interferona alfa-2b ni znan, kaže, da spremeni presnovo celice gostiteljice.
In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is 47 %.
Pri odraslih bolnikih, ki so prejemali interferon v kombinaciji z ribavirinom, je delež trajnega virološkega odziva 47 %.
The increased response rate to the combination of IntronA + ribavirin, compared with IntronA alone, is maintained across all subgroups.
Povečan delež odziva na kombinacijo zdravila IntronA in ribavirina v primerjavi s samim zdravilom IntronA se ohranja v vseh podskupinah.
IntronA must be used with caution in fertile men.
Zdravilo IntronA uporabljajte previdno pri plodnih moških.
A clinical trial investigating the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of developing peripheral neuropathy.
Klinično preskušanje, v katerem so proučevali uporabo kombinacije telbivudina, v odmerku 600 mg na dan, in pegiliranega interferona alfa-2a, v odmerku 180 mikrogramov subkutano enkrat na teden, je pokazalo, da je ta kombinacija povezana s povečanim tveganjem za pojav periferne nevropatije.
IntronA is used in adult patients to treat certain disorders that affect the blood, bone marrow, lymph glands, or skin and may extend into the body.
Zdravilo IntronA se uporablja pri odraslih bolnikih za zdravljenje določenih bolezni, ki prizadenejo kri, kostni mozeg, limfne žleze ali kožo, in se lahko razširijo po telesu.
They exhibit selectivity for human but not murine interferons, suggesting species specificity.
Selektivni so za človeške, ne pa tudi za glodalske interferone, kar kaže na vrstno specifičnost.
Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated.
Sedanje klinične izkušnje kažejo, da vzdrževalno zdravljenje z interferonom alfa-2b podaljša fazo platoja, vendar učinek na skupno preživetje ni bil dokončno dokazan.
- if you develop symptoms associated with a cold or other respiratory infection, such as fever, cough, or any difficulty in breathing, tell your doctor.
- če se pri vas pojavijo simptomi, povezani s prehladom ali drugimi okužbami dihal, kot so zvišana telesna temperatura, kašelj ali kakršne koli težave z dihanjem, obvestite zdravnika.
In patients with hepatitis, no loss of response was observed apparently due to the low titres.
Pri bolnikih s hepatitisom niso opažali prenehanja odzivnosti, očitno zaradi majhnih titrov.
If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.
Če rentgenogram pokaže pljučne infiltrate ali znake motenj pljučne funkcije, morate bolnika skrbno nadzorovati in po potrebi ukiniti interferon alfa.
Effect on fertility Interferon may impair fertility (see section 4.6 and section 5.3).
Vpliv na plodnost Interferon lahko zmanjša plodnost (glejte poglavji 4.6 in 5.3).
- if you have a history of autoimmune disease, or have had an organ transplant and are taking medicine that suppresses your immune system (your immune system helps protect you from infection).
- če ste imeli kdaj v preteklosti avtoimuno bolezen ali ste prejemnik presajenega organa in jemljete zdravila, ki zavirajo imunski sistem (imunski sistem pomaga ščititi telo pred okužbami).
IntronA (interferon alfa-2b) modifies the response of the body's immune system to help fight infections and severe diseases.
Zdravilo IntronA (interferon alfa-2b) spremeni imunski odziv telesa in pomaga pri obrambi proti okužbam in hudim boleznim.
Patients are to be advised that they may develop fatigue, somnolence, or confusion during treatment with IntronA, and therefore it is recommended that they avoid driving or operating machinery.
Bolnike poučite, da bodo med zdravljenjem z zdravilom IntronA lahko utrujeni, zaspani ali zmedeni in da je zato priporočljivo, da se izogibajo vožnji ali upravljanju strojev.
The population enrolled mainly consisted in children with mild to moderate hepatitis C. In the two multicentre trials sustained virological response rates in children and adolescents were similar to those in adults.
Populacija je vključevala predvsem otroke z blagim do zmernim hepatitisom C. V dveh multicentričnih preskušanjih je bil delež trajnega virološkega odziva pri otrocih in mladostnikih podoben tistemu pri odraslih.
IntronA increases the risk of liver decompensation and death in patients with cirrhosis.
Zdravilo IntronA poveča tveganje za jetrno dekompenzacijo in smrt pri bolnikih s cirozo.
Rarely reported side effects: pneumonia.
Redko poročani neželeni učinki: pljučnica.