FrancophonIA/ELRC3.0 huggingface dataset:
English: The dispersion is slightly cloudy, with a cream-to-pink colour.
Slovenian: disperzija za infundiranje Rahlo motna disperzija kremasto do rožnate barve.
English: Serious infections including sepsis have been observed in patients treated with Provenge.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Provenge, so poročali o hudih okužbah, vključno s sepso.
English: In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the Provenge group.
Slovenian: V kontroliranih kliničnih preskušanjih so pri 3,5 % bolnikov iz skupine z zdravilom Provenge poročali o hudi (3. stopnje) akutni reakciji na infundiranje.
English: • shortness of breath, wheezing, dizziness, rash, or fever.
Slovenian: • zasoplost, sopenje, omotica, izpuščaj ali zvišana telesna temperatura
English: After the infusion
Slovenian: Po infundiranju
English: • If the infusion of Provenge must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (25°C) for more than 3 hours.
Slovenian: • Če je treba infundiranje zdravila Provenge prekiniti, se ne sme ponovno začeti, če je infuzijska vrečka stala pri sobni temperaturi (25°C) več kot 3 ure.
English: Summary of safety profile
Slovenian: Povzetek rezultatov študije
English: • It must be ensured that the Final Product Disposition Notification form containing the patient identifiers, expiration date and time, and the disposition status (approved for infusion or rejected), has been received from the market authorisation holder.
Slovenian: • Zagotoviti je treba, da ste od imetnika dovoljenja za promet z zdravilom prejeli obrazec z obvestilom o končnem razpolaganju z zdravilom, ki vsebuje podatke za bolnikovo identifikacijo, datum in čas poteka roka uporabnosti in stanje razpolaganja (odobreno za
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti anemija*
English: The MAH shall ensure that all healthcare professionals who are expected to prescribe or use Provenge are provided with the following items:
Slovenian: da bodo predpisovali ali uporabljali zdravilo Provenge, da na razpolago naslednje postavke
English: In clinical study D9902B (IMPACT), 237 out of the 512 patients randomized were evaluated for the development of humoral or cellular immune responses (T cell proliferation and gamma-interferon
Slovenian: (IMPACT) je bilo ocenjenih 237 od 512 randomiziranih bolnikov glede razvoja humoralnega ali celičnega imunskega odgovora (proliferacija T-celic in gama-interferona (γIFN) ELISPOT) v ciljne antigene ob izhodišču, in v 6., 14. in 26. tednu.
English: The bag should be removed from the insulated polyurethane container and inspected for leaks, external damage, foreign particulate matter, or clumps/clots.
Slovenian: Vrečko vzemite iz izoliranega poliuretanskega vsebnika in preglejte, ali pušča, ima vidne poškodbe,
English: In controlled clinical trials, 23.8% of patients in the Provenge group required opioids (a single dose of pethidine) on the day of infusion for infusion reactions compared with 2.4% of patients in control group (see sections 4.2 and 4.4).
Slovenian: potrebni opioidi (enojni odmerek pethidina) na dan infundiranja zaradi reakcije na infuzijo v primerjavi z 2,4 % bolnikov v kontrolni skupini (glejte poglavji 4.2 in 4.4).
English: Gently mix and re-suspend the contents of the bag, inspecting for clumps and clots.
Slovenian: Vsebino vrečke nežno premešajte in ponovno suspendirajte ter preverite, ali vsebuje grudice ali strdke.
English: Provenge is used as treatment for prostate cancer that has spread outside of the prostate but not to the liver, lung or brain, and no longer responds to medicines that lower the levels of the male hormone testosterone in patients who are not considered appropriate for treatment with chemotherapy.
Slovenian: pljuča ali možgane, in ki se na zdravila, ki znižujejo raven moškega hormona testosterona, več ne odziva,
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih zelo pogosti citratna toksičnost*
English: IgG) responses against both PAP-GM-CSF and the PAP antigens were observed in the Provenge group through the follow up period.
Slovenian: PAP-GM-CSF in PAP so opazili v skupini z zdravilom Provenge v času spremljanja.
English: To be taken into consideration by patients with reduced kidney function or on a controlled potassium diet.
Slovenian: To je treba upoštevati pri bolnikih z zmanjšanim delovanjem ledvic ali pri bolnikih na dieti z nadziranim vnosom kalija.
English: If the infusion of Provenge must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (25°C) for more than 3 hours.
Slovenian: Če je treba infundiranje zdravila Provenge prekiniti, se ga ne sme nadaljevati, če je infuzijska vrečka stala pri sobni temperaturi (25 °C) več kot 3 ure.
English: Before handling or administering Provenge
Slovenian: Navodila za ravnanje Pred ravnanjem z zdravilom ali dajanjem zdravila Provenge
English: Acute infusion reactions have been observed in patients treated with Provenge.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Provenge, so poročali o akutnih reakcijah na infundiranje.
English: - tingling, numbness or abnormal sensation (paraesthesia) around lips, in mouth, or in the arms and/or legs during the leukapheresis procedure - muscle spasms, chest pain, and low blood pressure during the leukapheresis procedure
Slovenian: - boleči sklepi ali bolečine v sklepih (artralgija) - zbadanje, omrtvelost ali nenormalna občutenja (parestezija) okoli ustnic, v ustih ali v rokah - mišični spazmi, bolečine v prsnem košu in nizek krvni tlak med postopkom levkafereze (ki jih povzroči zdravilo (citrat), ki se ga uporablja za preprečevanje strjevanja krvi) - anemija (zmanjšano število rdečih krvnih celic) zaradi postopka levkafereze Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: To be taken into consideration by patients with heart conditions or those on a controlled sodium diet.
Slovenian: To morajo upoštevati bolniki z boleznimi srca ali bolniki, ki so na dieti z nadzorovanim vnosom natrija.
English: Shelf life and special precautions for storage
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE
English: If not used immediately, in use storage times and conditions should not exceed 3 hours at room temperature (25°C).
Slovenian: Če se zdravilo ne uporabi takoj, se lahko shrani za največ 3 ure pri sobni temperaturi (25 °C).
English: To be taken into consideration by patients on a controlled sodium diet.
Slovenian: To je treba upoštevati pri bolnikih na dieti z nadziranim vnosom natrija.
English: • The Final Product Disposition Notification form is marked REJECTED.
Slovenian: • je na obrazcu z obvestilom o končnem razpolaganju z zdravilom zdravilo označeno kot
English: Acute infusion reactions such as chills, fatigue, fever, nausea, and joint ache were frequently observed in clinical studies.
Slovenian: V kliničnih študijah so pogosto opazili akutne reakcije na infundiranje, kot so mrzlica, utrujenost, zvišana telesna temperature, navzea in bolečine v sklepih.
English: • It must be ensured that the patient's identity matches the essential unique patient information on the Provenge bag and the Final Product Disposition Notification form.
Slovenian: • Zagotoviti je treba, da se identiteta bolnika ujema z bistveno edinstveno informacijo o bolniku na vrečki z zdravilom Provenge in na obrazcu z obvestilom o končnem razpolaganju z
English: Provenge treatment checklists
Slovenian: Kontrolne sezname za zdravljenje z zdravilom Provenge 4.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
English: You may need to have further CBC tests during your treatment in line with local or country-wide practices.
Slovenian: Morda bodo v skladu z lokalno ali državno prakso med zdravljenjem potrebne dodatne preiskave celotne krvne slike.
English: Provenge has a shelf life of 18 hours in the insulated container that is shipped to the medical facility where the infusion will be administered.
Slovenian: Rok uporabnosti in posebni previdnostni ukrepi za shranjevanje zdravila: Rok uporabnosti zdravila Provenge je 18 ur v izoliranem vsebniku, poslanem na zdravstveni center, v katerem bo infundiranje potekalo.
English: One bag containins autologous peripheral blood mononuclear cells activated with PAP-GM-CSF, including a minimum of 50 x 106 autologous CD54+ cells.
Slovenian: Ena vrečka vsebuje so avtologne mononuklearne celice iz periferne krvi, aktivirane s PAP-GM-CSF), od tega najmanj 50 x 106 avtolognih CD54+ celic.
English: • It must be ensured that the patient's identity matches the essential unique patient information on the Provenge bag and on the Final Product Disposition form.
Slovenian: • Zagotoviti je treba, da se identiteta bolnika ujema z bistveno edinstveno informacijo o bolniku na vrečki z zdravilom Provenge in na obrazcu z obvestilom o končnem razpolaganju z zdravilom.
English: Vital signs should be taken at least 30 minutes prior to and 30 minutes following each infusion.
Slovenian: Vsaj 30 minut pred infundiranjem in še
English: Prior to launch of Provenge in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational materials with the National Competent Authority.
Slovenian: Pred lansiranjem zdravila Provenge v vsaki državi članici mora imetnik dovoljenja za promet z zdravilom
English: Respiratory, thoracic, and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora hipoksija sopenje dispneja bronhospazem
English: This medicinal product contains approximately 800 mg of sodium and 45 mg of potassium per infusion.
Slovenian: Pomožne snovi z znanim učinkom Ena infuzija vsebuje približno 800 mg natrija in 45 mg kalija.
English: One bag contains autologous peripheral blood mononuclear cells activated with PAP-GM-SF (prostatic acid phosphatase-granulocyte macrophage-colony stimulating factor), including a minimum of 50 x 106 autologous CD54+ cells.
Slovenian: Ena vrečka vsebuje avtologne mononuklearne celice iz periferne krvi, aktivirane s PAP-GM-CSF (prostatičnim kislim granulocitne in makrofagne kolonije stimulirajočim faktorjem), od tega vsaj 50 x 106 avtolognih CD54+ celic.
English: Precautions to be taken before handling or administering the medicinal product Provenge is not tested for transmissible infectious diseases and hence may carry the risk of transmitting infectious diseases to healthcare professionals handling the product.
Slovenian: Zdravilo Provenge ni bilo testirano za povzročitelje nalezljivih bolezni, zato lahko predstavlja tveganje,
English: Eosinophilia
Slovenian: Bolezni sečil hematurija
English: Excipients with known effect
Slovenian: Z infundiranjem povezani neželeni učinki
English: The active substance is autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (prostatic acid phosphatase-granulocyte macrophage-colony stimulating factor), including a minimum of 50 x 106 autologous CD54+ cells.
Slovenian: Zdravilna učinkovina so avtologne mononuklearne celice iz periferne krvi, aktivirane s PAP-GM-CSF (prostatičnim kislim granulocitne in makrofagne kolonije stimulirajočim faktorjem), od tega vsaj 50 x 106 avtolognih CD54
English: Cerebrovascular accident Transient ischaemic attack Tremor
Slovenian: Bolezni živčevja omotica parestezija* oralna parestezija* glavobol cerebrovaskularni dogodek prehodna ishemična ataka tremor hipoestezija kompresija hrbtenjače sinkopa cerebralni infarkt
English: In controlled clinical trials, 23.8% of patients treated with Provenge required opioids (a single dose of pethidine) on the day of infusion for infusion reactions (see sections 4.4 and 4.8).
Slovenian: potrebni opioidi (enojni odmerek pethidina) na dan infundiranja zaradi reakcije na infuzijo (glejte poglavji 4.4 in 4.8).
English: To submit the results from study P-11, a randomised, double-blind trial evaluating Provenge versus placebo in patients with non-metastatic prostate cancer who experience PSA elevation following radical prostatectomy
Slovenian: Provenge v primerjavi s placebom pri bolnikih z nemetastatskim rakom prostate, pri katerih je prišlo po radikalni prostatektomiji do zvišanih ravni PSA
English: Exp.
Slovenian: celic.
English: Keep this leaflet.
Slovenian: Ne obsevajte.
English: Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T).
Slovenian: Avtologne mononuklearne celice iz periferne krvi, aktivirane s prostatičnim kislim, granulocitne in makrofagne kolonije stimulirajočim faktorjem (PAP-GM-CSF, prostatic acid phosphatase-granculocyte macrophage-colony stimulating factor) (Sipuleucel-T).
English: Gastrointestinal disorders
Slovenian: Dokumentacijo za vzdrževanje katetrov za aferezo
English: • An infection which affects your whole body (e.g., sepsis, seen as high temperature, increased heart rate or breathing)
Slovenian: Pred začetkom uporabe se posvetujte z zdravnikom, če imate katerega od spodaj navedenih stanj, saj vas bodo morali skrbno nadzirati med infundiranjem in po njem: • okužba, ki je prizadela celo telo (npr. sepsa, ki se kaže kot zvišana telesna temperatura, hitrejši srčni utrip ali hitrejše dihanje)
English: Immunocompromised patients
Slovenian: Starejši bolniki
English: Tests
Slovenian: Zdravila
English: The potassium content per infusion should be taken into account if administered to patients with renal impairment and/or those on a controlled potassium diet. Hyperkalaemia should be corrected prior to Provenge administration (see section 4.4).
Slovenian: Vsebnost kalija na infuzijo je treba upoštevati pri dajanju zdravila bolnikom z ledvično okvaro in/ali tistim na dieti z nadziranim vnosom kalija.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING INFUSION BAG
Slovenian: PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI INFUZIJSKA VREČKA
English: Provenge has not been investigated in patients with hepatic impairment.
Slovenian: Zdravila Provenge pri bolnikih z okvarjenim delovanjem jeter niso preučili.
English: Cases in which Provenge cannot be infused
Slovenian: Provenge, ki mu je pretekel rok veljavnosti, ne infundirajte.
English: Pregnancy, breast-feeding and fertility Provenge is for use in men only.
Slovenian: Nosečnost, dojenje in plodnost
English: Thrombocytopenia*
Slovenian: pogosti trombocitopenija* eozinofilija
English: Pharmaceutical Form Route of Administration
Slovenian: Farmacevtska oblika Pot uporabe Ovojnina
English: It is available as tablets (375 mg).
Slovenian: Na voljo je v obliki tablet (375 mg).
English: What measures are being taken to ensure the safe use of Incivo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Incivo?
English: The full EPAR for Incivo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Incivo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In addition, treatment could be shortened for many patients and the benefits could be seen across different patient types with different degrees of liver damage.
Slovenian: Poleg tega se lahko zdravljenje pri številnih bolnikih tudi skrajša, koristi pa so vidne pri različnih vrstah bolnikov z različnimi stopnjami okvare jeter.
English: The European Commission granted a marketing authorisation valid throughout the European Union
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Incivo, veljavno po vsej Evropski uniji, odobrila
English: The company that markets Incivo will provide all doctors who are expected to prescribe it with an educational pack containing important safety information on the main risks with Incivo, in particular the risk of rash and severe skin reactions.
Slovenian: Družba, ki trži zdravilo Incivo, bo vsem zdravnikom, za katere se pričakuje, da bodo predpisovali to zdravilo, zagotovila izobraževalno gradivo s pomembnimi varnostnimi informacijami glede glavnih tveganj, povezanih z zdravilom Incivo, zlasti glede tveganja za pojav izpuščajev in hudih kožnih
English: This is a summary of the European public assessment report (EPAR) for Incivo.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Incivo.
English: The Committee noted that the main risks identified were severe rash and the possibility of the virus developing drug resistance, but considered that these risks were manageable.
Slovenian: Odbor je menil, da sta glavni ugotovljeni tveganji pojav hudih izpuščajev in možnost, da virus razvije odpornost na zdravilo, vendar je menil, da sta ti tveganji obvladljivi.
English: What benefit has Incivo shown during the studies?
Slovenian: Kakšne koristi je zdravilo Incivo izkazalo med študijami?
English: It blocks the action of an enzyme called NS3-4A protease in the hepatitis C virus, which is essential for its life cycle.
Slovenian: Zavira delovanje encima, imenovanega proteaza NS3-4A, pri virusu hepatitisa C, ki je nujen za njegov življenjski cikel.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Incivo, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev
English: For more information about treatment with Incivo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Incivo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This stops the hepatitis C virus from replicating in the infected host cells of the body.
Slovenian: To virusu hepatitisa C preprečuje razmnoževanje v okuženih gostiteljskih celicah telesa.
English: What is the risk associated with Incivo?
Slovenian: Kakšna tveganja so povezana z zdravilom Incivo?
English: The CHMP therefore concluded that the benefits of Incivo were greater than its risks, and recommended it be granted marketing authorisation.
Slovenian: Zato je zaključil, da so koristi zdravila Incivo večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: When Incivo is added to peginterferon alfa and ribavirin (the current standard treatment for hepatitis C) this increases the likelihood of the virus being killed.
Slovenian: Kadar se zdravilo Incivo dodaja peginterferonu alfa in ribavirinu (trenutnemu standardnemu zdravljenju hepatitisa C), to povečuje verjetnost uničenja virusa.
English: Incivo must not be used in patients who are hypersensitive (allergic) to telaprevir or any of the other ingredients.
Slovenian: Zdravila Incivo ne smejo uporabljati bolniki, ki so preobčutljivi za (alergični na) telaprevir ali katero koli drugo sestavino zdravila.
English: The most common side effects with Incivo (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), nausea (feeling sick), diarrhoea, vomiting, haemorrhoids (piles), proctalgia (anal pain), pruritus (itching) and rash.
Slovenian: Najpogostejši neželeni učinki zdravila Incivo (opaženi pri več kot 1 bolniku od 10) so anemija (nizko število rdečih krvnih celic), navzeja (slabost), driska, bruhanje, hemoroidi, proktalgija (bolečine v zadnjiku), pruritus (srbečica) in izpuščaji.
English: In all three studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus six months after the end of
Slovenian: V vseh treh študijah je bilo glavno merilo učinkovitosti število bolnikov, pri katerih krvne preiskave šest mesecev po koncu zdravljenja niso pokazale znakov virusa hepatitisa C.
English: It is used in adults who have compensated liver disease (when the liver is damaged but is still functioning normally) including cirrhosis (scarring of the liver) either in previously untreated patients or in those who have already been treated with interferon alfa.
Slovenian: Uporablja se pri odraslih bolnikih s kompenzirano boleznijo jeter (kadar so jetra poškodovana, vendar še vedno normalno delujejo), vključno s cirozo (brazgotinjenjem jeter), in sicer pri bolnikih, ki še niso bili zdravljeni, ali bolnikih, ki so že bili zdravljeni z interferonom alfa.
English: Incivo was investigated in three main studies in patients infected with hepatitis C. The first study involved 1,095 previously untreated patients, and the second study involved 663 patients who had already been treated with peginterferon alfa and ribavirin but were still infected.
Slovenian: Zdravilo Incivo so raziskovali v treh glavnih študijah pri bolnikih, okuženih s hepatitisom C. V prvi študiji je sodelovalo 1 095 predhodno nezdravljenih bolnikov, v drugi pa 663 bolnikov, ki so se že zdravili s peginterferonom alfa in ribavirinom, vendar so bili še vedno okuženi.
English: The active substance in Incivo, telaprevir, is a protease inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Incivo, telaprevir, je zaviralec proteaze.
English: A third study in previously untreated patients compared the effects of giving peginterferon alfa and ribavirin for different lengths of time (either six months or one year) together with three months of Incivo treatment.
Slovenian: V tretji študiji so pri predhodno nezdravljenih bolnikih primerjali učinke jemanja peginterferona alfa in ribavirina v različno dolgih obdobjih (šest mesecev ali eno leto) skupaj s tremi meseci zdravljenja z zdravilom Incivo.
English: Three Incivo tablets should be swallowed whole twice a day with food for a period of 12 weeks.
Slovenian: Tri tablete zdravila Incivo je treba jemati 12 tednov, in sicer jih je treba pogoltniti cele s hrano dvakrat na dan. Druga možnost je jemanje tablet Incivo s hrano vsakih osem ur.
English: Incivo must not be given in combination with several other medicines, including those which are affected by or affect the CYP3A gene and Class Ia or III antiarrhythmics.
Slovenian: Zdravilo Incivo se ne sme jemati v kombinaciji z več drugimi zdravili, vključno s tistimi, na katera učinkujejo gen CYP3A in antiaritmiki razreda Ia ali III, oziroma tistimi, ki učinkujejo na gen CYP3A in antiaritmike razreda Ia ali III. Za celoten seznam omejitev glejte navodilo
English: Incivo is a medicine that contains the active substance telaprevir.
Slovenian: Incivo je zdravilo, ki vsebuje zdravilno učinkovino telaprevir.
English: How does Incivo work?
Slovenian: Kako zdravilo Incivo deluje?
English: Treatment with Incivo should be started and monitored by a doctor experienced in managing chronic
Slovenian: Zdravljenje z zdravilom Incivo naj uvede in spremlja zdravnik z izkušnjami pri zdravljenju okužb s
English: Incivo is used to treat chronic (long term) hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in combination with two other medicines, peginterferon alfa and ribavirin.
Slovenian: Zdravilo Incivo se uporablja za zdravljenje kroničnega (dolgotrajnega) hepatitisa C (bolezni jeter zaradi okužbe z virusom hepatitisa C) v kombinaciji z dvema drugima zdraviloma, peginterferonom alfa in
English: Treatment with ribavirin and peginterferon alfa will continue for a longer period, based on whether the patient has been treated before and test results during their Incivo treatment.
Slovenian: Zdravljenje z ribavirinom in peginterferonom alfa se nadaljuje dlje časa glede na to, ali je bolnik že bil zdravljen, in glede na izvide preiskav med zdravljenjem z zdravilom Incivo.
English: In the first study, when Incivo was given for three months, 75% of patients tested negative for hepatitis C compared with 44% of patients receiving placebo.
Slovenian: V prvi študiji, v kateri so zdravilo Incivo dajali tri mesece, je bil pri 75 % bolnikov izvid za hepatitis C negativen v primerjavi s 44 % bolnikov, ki so prejemali placebo.
English: How has Incivo been studied?
Slovenian: Kako je bilo zdravilo Incivo raziskano?