FrancophonIA/ELRC3.0 huggingface dataset:
English: • Infusion must begin prior to the expiration date and time indicated on the Final Product Disposition Notification form and bag label.
Slovenian: • Infuzija se mora začeti pred datumom in časom poteka roka uporabnosti, navedenega na obvestilu o končnem razpolaganju z zdravilom in nalepki vrečke.
English: Prior to the first leukapheresis proceedure, a complete blood count (CBC) test should be performed.
Slovenian: Pred prvim postopkom levkafereze je treba opraviti preiskavo celotne krvne slike.
English: Disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: What Provenge looks like and contents of the pack Provenge is a slightly cloudy dispersion of cream-to-pink colour and is supplied in a plastic bag with 3 sample ports.
Slovenian: Izgled zdravila Provenge in vsebina pakiranja Zdravilo Provenge je rahlo motna disperzija kremne do rožnate barve, dobavljena v plastični vrečki s
English: Provenge has moderate influence on the ability to drive and use machines, as it may cause fatigue, dizziness, syncope, chills, and headache.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Provenge ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji, saj lahko povzroči utrujenost, omotico, sinkopo, mrzlico in glavobol.
English: To conduct study P12-1 to evaluate characteristics predictive of a positive imaging study for distant metastases in patients with castrate-resistant prostate cancer.
Slovenian: Da izvede študijo P12-1, s katero se vrednoti zmožnost za napoved pozitivnega rezultata pri preslikovanju razsejanih metastaz pri bolnikih z na kastracijo odpornim rakom prostate.
English: If your infusion of Provenge has to be interrupted for any reason, your doctor will not be able to restart the infusion if the medicine has been at room temperature for more than 3 hours.
Slovenian: Če je treba infundiranje zdravila Provenge zaradi katerega koli razloga prekiniti, vaš zdravnik z infundiranjem ne bo mogel nadaljevati, če je bilo zdravilo več kot 3 ure pri sobni temperaturi.
English: However, as Provenge is an autologous product, a positive test does not preclude the manufacture of the product.
Slovenian: Vendar pa je zdravilo Provenge avtologno zdravilo, zato pozitivni test ne prepreči izdelave zdravila.
English: Study D9901 was a randomised, double-blind, controlled, multicentre trial in patients with metastatic castrate resistant prostate cancer and no cancer-related pain.
Slovenian: Podporne študije Študija D9901 je bilo randomizirano, dvojno slepo, kontrolirano, multicentrično preskušanje pri bolnikih z metastatskim, na kastracijo odpornim rakom prostate brez bolečin, povezanih z rakom.
English: Patients with renal impairment and/or hyperkalaemia The content of sodium and potassium per infusion should be taken into account if administered in patients with cardiovascular diseases and/or renal impairment.
Slovenian: Bolniki z okvaro ledvic in/ali hiperkaliemijoVsebnost natrija in kalija na infuzijo je treba upoštevati pri dajanju zdravila bolnikom s kardiovaskularno boleznijo in/ali ledvično okvaro.
English: If you miss an appointment and you cannot be given your Provenge infusion, it will no longer be usable.
Slovenian: Če se termina ne boste držali in tako infuzije zdravila Provenge ne boste mogli prejeti, bo zdravilo postalo neuporabno.
English: Do not initiate infusion if expired, after 3 hours at room temperature (25°C), or if particles/clumps are visible despite gentle manual mixing.
Slovenian: Če je potekel rok uporabnosti, po 3 urah pri sobni temperaturi (25°C) ali če so kljub nežnemu ročnemu mešanju prisotni delci/grudice, zdravila ne infundirajte.
English: During or within 24 hours of the infusion, you may develop very common symptoms such as chills, fever, tiredness, feeling weak, headache, feeling sick (nausea), being sick (vomiting), muscle ache, and dizziness,.
Slovenian: Med infundiranjem ali v 24 urah po njem se bodo morda pojavili zelo pogosti simptomi, na primer mrzlica, zvišana telesna temperatura, utrujenost, občutek šibkosti, glavobol, občutek slabosti (navzea),
English: Submission of study protocol within 1 month of authorisation
Slovenian: Protokol študije predložiti najkasneje 1 mesec po izdaji dovoljenja za promet z zdravilomletno obveščanje o napredovanju študije
English: Your doctor will give you a schedule for your cell collection and infusion appointments.
Slovenian: Vaš zdravnik vam bo izročil načrt za odvzem celic in obisk zaradi infundiranja.
English: When given as a drip (infusion) into your vein, Provenge works by teaching your immune cells to recognise and attack prostate cancer cells.
Slovenian: Provenge deluje tako, da nauči vaše imunske celice, da prepoznavajo in napadajo celice raka prostate.
English: The IMPACT study was a randomised, double-blind, controlled, multicentre trial in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.
Slovenian: Študija IMPACT je bilo randomizirano, dvojno slepo, kontrolirano, multicentrično preskušanje pri bolnikih z asimptomatskim ali minimalno simptomatskim metastatskim, na kastracijo odpornim rakom prostate.
English: Provenge is not tested for transmissible infectious agents.
Slovenian: Zdravilo Provenge ni bilo testirano za povzročitelje nalezljivih bolezni.
English: Patients with renal impairment and/or hyperkalaemia and/or on a controlled potassium diet Provenge has not been investigated in patients with renal impairment.
Slovenian: Bolniki z okvaro ledvic in/ali hiperkaliemijo in/ali bolniki na dieti z nadziranim vnosom kalija Zdravila Provenge pri bolnikih z okvarjenim delovanjem ledvic niso preučili.
English: Preparing the infusion Take care to ensure aseptic handling when preparing the infusion.
Slovenian: Pri pripravi infuzije zagotovite aseptično ravnanje.
English: For full instructions on the preparation and handling of Provenge, see section 6.6.
Slovenian: Za celotna navodila o pripravi zdravila Provenge in rokovanju z njim glejte poglavje 6.6. 4.3 Kontraindikacije
English: The study should provide a summary of baseline patient characteristics including PSA and
Slovenian: Študija mora vsebovati povzetek glavnih značilnosti pacientov na
English: Reports of serious infection have been received in post-marketing surveillance including devicerelated infection, device-related sepsis, pneumonia, sepsis, bacteraemia, and urinary tract infection.
Slovenian: Poročila o resnih okužbah, prejeta v obdobju trženja, so vključevala okužbe, povezane s pripomočkom, sepso, povezano s pripomočkom, pljučnico, sepso, bakteriemijo in okužbo sečil.
English: What Provenge contains
Slovenian: Kaj vsebuje zdravilo Provenge
English: Patient leukapheresis material is tested for transmissible infectious agents in line with applicable member state requirements.
Slovenian: Material iz bolnikove levkafereze se testira za povzročitelje nalezljivih bolezni v skladu z upoštevanimi zahtevami držav članic.
English: Additionally, there have been reports of thrombocytopenia received in spontaneous post-marketing reporting that have been temporally associated with leukapheresis.
Slovenian: Iz spontanega poročanja v obdobju trženja zdravila so bila prejeta so tudi poročila o trombocitopeniji, ki so bila začasno povezana z levkaferezo.
English: Each dose of Provenge is preceded by a standard leukapheresis procedure approximately 3 days prior to the scheduled infusion date.
Slovenian: Vsak odmerek zdravila Provenge sledi standardnemu postopku levkafereze približno 3 dni pred načrtovanim datumom infundiranja.
English: Provenge is intended solely for autologous use.
Slovenian: Zdravilo Provenge je namenjeno izključno avtologni uporabi.
English: • approximately 45 mg potassium per infusion.
Slovenian: • približno 45 mg kalija na infuzijo.
English: Appropriate precautions should be employed when handling Provenge (see section 4.4).
Slovenian: Pri rokovanju z zdravilom Provenge je treba upoštevati ustrezne previdnostne ukrepe (glejte poglavje 4.4).
English: Acute infusion reactions (reported within 1 day of infusion) included, but were not limited to, fever, chills, respiratory events (dyspnoea, hypoxia, and bronchospasm), nausea, vomiting, fatigue, hypertension, and tachycardia.
Slovenian: Akutne reakcije na infundiranje (o njih so poročali v 1 dnevu od infundiranja) so med drugim vključevale zvišano telesno temperaturo, mrzlico, respiratorne dogodke (dispneja, hipoksija in bronhospazem), navzeo, bruhanje, utrujenost, hipertenzijo in tahikardijo.
English: In controlled clinical trials, 71.2% of patients in the Provenge group developed an acute infusion reaction.
Slovenian: Akutna reakcija na infundiranje V kontroliranih kliničnih preskušanjih se je pri 71,2 % bolnikov v skupini z zdravilom Provenge razvila akutna reakcija na infundiranje.
English: • Contents of the bag will be slightly cloudy, with a cream to pink colour.
Slovenian: • Vsebina vrečke je rahlo motna in kremne do rožnate barve.
English: Each dose of Provenge requires a standard leukapheresis procedure approximately 3 days prior to the infusion.
Slovenian: Za vsak odmerek zdravila Provenge je potreben standardni postopek levkafereze približno 3 dni pred infundiranjem.
English: Preparing the infusion • Take care to ensure aseptic handling when preparing the infusion.
Slovenian: • Pri pripravi infuzije zagotovite aseptično ravnanje.
English: • approximately 800 mg sodium per infusion.
Slovenian: • približno 800 mg natrija na infuzijo.
English: If you need more information on the testing of your blood please ask your doctor or nurse.
Slovenian: Če potrebujete več informacij o krvnih preiskavah, se posvetujte z zdravnikom ali medicinsko sestro.
English: Posology One dose of Provenge contains a minimum of 50 x 106 autologous CD54+ cells activated with
Slovenian: Odmerjanje En odmerek zdravila Provenge vsebuje najmanj 50 x 106 avtolognih celic CD54+, aktiviranih s
English: The most commonly reported adverse reactions are chills, fatigue, pyrexia, nausea, arthralgia, headache, and vomiting.
Slovenian: Najpogosteje poročani neželeni učinki so mrzlica, utrujenost, pireksija, navzea, artralgija, glavobol in bruhanje.
English: Visit 5 - Blood cell collection (leukapheresis)
Slovenian: 5. obisk - odvzem krvnih celic (levkafereza)
English: Dispersion for infusion.
Slovenian: disperzija za infundiranje
English: EXPIRY DATE
Slovenian: • kap v anamnezi
English: This medicinal product contains approximately 800 mg sodium per infusion.
Slovenian: To zdravilo vsebuje približno 800 mg natrija na infuzijo.
English: Visit 3 - Blood cell collection (leukapheresis)
Slovenian: 3. obisk - odvzem krvnih celic (levkafereza)
English: Hyperkalaemia should be corrected prior to Provenge administration (see section 4.2).
Slovenian: Hiperkaliemijo je treba pred začetkom uporabe zdravila Provenge popraviti (glejte poglavje 4.2).
English: Accordingly, healthcare professionals should employ appropriate precautions when handling leukapheresis material or Provenge.
Slovenian: Zdravstveno osebje mora zato pri rokovanju z levkafereznim materialom ali zdravilom Provenge uporabljati ustrezne previdnostne ukrepe.
English: • Upon completion of the infusion, the patient specific label on the infusion bag should be removed and adhered to the patient file.
Slovenian: • Po končanem infundiranju je treba nalepko na infuzijski vrečki, specifično za bolnika, odlepiti in nalepiti v bolnikovo kartoteko.
English: To mitigate such reactions, premedication, consisting of paracetamol and an antihistamine was administered in clinical studies prior to infusion.
Slovenian: Za lajšanje teh reakcij so v kliničnih študijah pred infundiranjem bolniki prejeli premedikacijo, ki je vsebovala paracetamol in antihistaminik.
English: Patients with positive serology tests for human immunodeficiency virus [HIV] 1 and 2, human T cell lymphotropic virus [HTLV] 1, and hepatitis B and C were excluded from controlled clinical trials.
Slovenian: celični limfotropni virus [HTLV]-1 in virus hepatitisa B in C so bili iz kontroliranih kliničnih preskušanj izločeni.
English: Embolic and thrombotic events Provenge should be used with caution in patients with a history of embolic and thrombotic disorders.
Slovenian: Embolični in trombotični dogodki Pri bolnikih z emboličnimi in trombotičnimi dogodki v anamnezi je treba zdravilo Provenge uporabljati previdno.
English: Therefore patient leukapheresis material and Provenge may carry the risk of transmitting infectious diseases to healthcare professionals handling the product.
Slovenian: Material iz bolnikove levkafereze zato lahko predstavlja tveganje, da se zdravstveno osebje, ki z njim rokuje, naleze kužnih bolezni.
English: Pregnancy Provenge is not intended for use in women.
Slovenian: Zdravilo Provenge ni namenjeno ženskam.
English: - decrease of platelets in the blood due to the leukapheresis procedure Uncommon side effects (may affect up to 1 in 100 patients - severe infection in the blood from a contaminated catheter (catheter sepsis) - infection from a contaminated catheter (catheter-related infection) - skin infection of the area where the infusion drip was inserted
Slovenian: - huda okužba krvi (sepsa) - huda okužba krvi zaradi kontaminacije katetra (sepsa zaradi katetra) - okužba zaradi kontaminacije katetra (okužba zaradi katetra) - okužba predela kože, kjer je vstavljena infuzija
English: Sodium chloride Sodium lactate Potassium chloride Calcium chloride
Slovenian: natrijev klorid natrijev laktat kalijev klorid kalcijev klorid
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 4.2 and 4.8).
Slovenian: V kontroliranih kliničnih preskušanjih so bili pri 23,8 % bolnikov, zdravljenih z zdravilom Provenge, potrebni opioidi (enojni odmerek pethidina) na dan infundiranja zaradi reakcije na infuzijo (glejte poglavji 4.2 in 4.8).
English: Additional CBC tests may be performed in accordance with local requirements.
Slovenian: Dodatne preiskave celotne krvne slike se opravijo v skladu z lokalnimi zahtevami.
English: Fertility Effect on male fertility is not known.
Slovenian: Učinek na sposobnost razmnoževanja pri moških ni znan.
English: Handling precautions for control of infectious disease Provenge is prepared from human blood of the specific patient and is not tested for transmissible infectious agents.
Slovenian: Zdravilo Provenge se pripravlja iz človeške krvi specifičnega bolnika in se na povzročitelje nalezljivih bolezni ne testira.
English: Accordingly, healthcare professionals should employ appropriate precautions when handling leukapheresis material or Provenge (see section 4.4).
Slovenian: Zato mora zdravstveno osebje, ko rokuje z materialom levkafereze ali zdravilom Provenge (glejte poglavje 4.4), uporabljati ustrezne previdnostne ukrepe.
English: • Specific handling and administration requirements for Provenge
Slovenian: • Posebne zahteve glede ravnanja z zdravilom Provenge in njegovo uporabo
English: Reactions included chills, fever, fatigue, asthenia, dyspnoea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting.
Slovenian: Reakcije so vključevale mrzlico, zvišano telesno temperaturo, utrujenost, astenijo, dispnejo, hipoksijo, bronhospazem, omotico, glavobol, hipertenzijo,
English: If not used immediately, in-use storage times and conditions should not exceed 3 hours at room temperature (25°C).
Slovenian: Čas shranjevanja zdravila, ki se ne uporabi takoj, ne sme biti daljši kot 3 ure pri sobni temperaturi (25°C).
English: Steps before Provenge treatment
Slovenian: Koraki pred zdravljenjem z zdravilom Provenge 1.
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Slovenian: V nadaljevanju je seznam neželenih učinkov na podlagi izkušenj iz kliničnih preskušanj in obdobja trženja zdravila, razvrščen po organskih sistemih in pogostnosti pojava: zelo pogosti (≥1/10), pogosti
English: In post-marketing experience of greater than 5,000 patients treated, this incidence is approximately 19% (see section 4.4).
Slovenian: V izkušnjah iz obdobja trženja z več kot 5.000 zdravljenimi bolniki je bila ta incidenca približno 19 %
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot /COI {lot number/chain of identity} First Name, Middle Initial, Last Name {patient name} DOB {patient date of birth}
Slovenian: ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV Serija/COI {številka serije/neprekinjena veriga identitete} Ime, priimek {bolnikovo ime}
English: Gently mix and re-suspend the contents of the bag, inspecting for particles, clumps or clots.
Slovenian: Vsebino vrečke nežno premešajte in ponovno suspendirajte ter preverite, ali vsebuje delce, grudice ali strdke.
English: Cerebral infarction
Slovenian: Možganska kap
English: Therefore, patient leukapheresis material and Provenge may carry the risk of transmitting infectious viruses (HIV 1 and 2, hepatitis B and C) to healthcare professionals handling the product.
Slovenian: Zato lahko bolnikov levkaferezni material za zdravstveno osebje, ki ravna z zdravilom, predstavlja tveganje za prenos kužnih virusov (HIV 1 in 2, hepatitisa B in C).
English: Driving and using machines You may feel tired, faint, or dizzy or have a headache or chills after receiving your Provenge infusion.
Slovenian: Po infundiranju zdravila Provenge boste morda čutili utrujenost, vrtoglavico ali omotičnost, ali pa boste imeli glavobol ali mrzlico.
English: Peripheral blood mononuclear cells collected from the patients are cultured with PAP-GM-CSF, a fusion protein consisting of PAP linked to granulocyte-macrophage colony-stimulating factor (GM-CSF) an immune cell activator.
Slovenian: Mononuklearne celice iz bolnikom odvzete periferne krvi se vzgajajo s PAP-GM-CSF, ki je fuzijski protein, sestavljen iz PAP, vezanega na granulocitne makrofagne kolonije spodbujajoči faktor
English: NAME OF THE MEDICINAL PRODUCT PROVENGE 50 x 106 CD54+ cells/250 mL dispersion for infusion.
Slovenian: IME ZDRAVILA Provenge 50 x 106 CD54+ celic/250 ml disperzija za infundiranje
English: - rash, including raised itchy rash (urticaria), or itching
Slovenian: - izpuščaj, vključno z dvignjenim srbečim izpuščajem (urtikarijo) ali srbenje
English: Do not
Slovenian: Neobsevajte.
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 (see section 6.3).
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 (glejte poglavje 6.3).
English: If you have severe reactions during the infusion your doctor may either slow down the infusion or stop it. You may also be given other medicines if needed.
Slovenian: Če imate med infundiranjem hudo reakcijo, lahko vaš zdravnik infundiranje upočasni ali prekine.
English: - anaemia (decrease in number of red blood cells) due tothe leukapheresis procedure
Slovenian: - kri v urinu - nelagodje v prsnem košu - zmanjšanje števila trombocitov v krvi zaradi postopka levkafereze
English: • not enough of the right type of cells to manufacture the medicine.
Slovenian: • težava pri odvzemu vaših krvnih celic za izdelavo zdravila Provenge • nezadostno število celic pravilne vrste za izdelavo zdravila
English: Name and address of the manufacturer of the biological active substance
Slovenian: ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca biološke zdravilne učinkovine
English: In some cases, the patient may be unable to receive a scheduled infusion of Provenge.
Slovenian: Primeri, v katerih zdravila Provenge ni mogoče infundirati V nekaterih primerih bolnik morda ne bo mogel prejeti načrtovane infuzije zdravila Provenge.
English: - increase in a type of white blood cells called eosinophils - infusion site reaction (a reaction of the skin area where the infusion drip was inserted)
Slovenian: - reakcija na mestu infundiranja (reakcija na predelu kože, kjer je bila vstavljena kapalna infuzija)
English: PAP-GM-CSF were observed in cells collected from peripheral blood of patients through the follow-up period in the Provenge treatment group but not in controls.
Slovenian: Proliferativni odgovor T-celic in γIFN ELISPOT na PAP in PAP-GM-CSF so opazili v celicah, odvzetih iz periferne krvi bolnikov v času spremljanja v skupini, zdravljeni z zdravilom Provenge, ne pa tudi pri kontrolah.
English: In controlled clinical trials, infection occurred in 27.5% of subjects in the Provenge group and 27.7% of subjects in the control group.
Slovenian: V kontroliranih kliničnih preskušanjih se je okužba pojavila pri 27,5 % oseb v skupini z zdravilom
English: Update on study outcome annually Final study report by 31 December 2019
Slovenian: Končno poročilo o študiji do 31. decembra 2019
English: In the event of an acute infusion reaction, the infusion may be interrupted or slowed, depending on the severity of the reaction.
Slovenian: V primeru akutne reakcije na infundiranje se lahko, odvisno od resnosti reakcije, infuzija prekine ali ustavi.
English: What you need to know before you are given Provenge
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Provenge Ne uporabljajte zdravila Provenge
English: Store the bag in the insulated container to maintain the correct storage temperature (2°C-8°C) until infusion.
Slovenian: Vrečko shranjujte v izoliranem vsebniku za ohranjanje pravilne temperature shranjevanja (2 °C-8 °C) do infundiranja.
English: In controlled clinical trials, the dosing interval range was 115 weeks (see section 5.1).
Slovenian: V kontroliranih kliničnih preskušanjih je razpon intervala odmerjanja 1-15 tednov
English: Contents of the bag will be slightly cloudy, with a cream to pink colour.
Slovenian: Vsebina vrečke je rahlo motna in kremaste do rožnate barve.
English: Hyperhidrosis Pruritus Urticaria
Slovenian: Bolezni kože in podkožja izpuščaj hiperhidroza pruritus urtikarija
English: Visit 4 - Provenge infusion
Slovenian: 4. obisk - infundiranje zdravila Provenge
English: Visit 6 - Provenge infusion
Slovenian: 6. obisk - infundiranje zdravila Provenge
English: To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Slovenian: To morajo upoštevati bolniki z zmanjšanim delovanjem ledvic ali bolniki, ki so na dieti z nadzorovanim vnosom kalija.
English: Atrial fibrillation Myocardial infarction Myocardial ischaemia
Slovenian: Bolezni srca atrijska fibrilacija miokardni infarkt miokardna ishemija
English: Catheter sepsis Catheter related infection Catheter site infection Sepsis
Slovenian: Infekcijske in parazitske bolezni pogosti bakteriemija občasni sepsa zaradi katetra s katetrom povezane okužbe okužba mesta katetra sepsa
English: The product also contains approximately 45 mg potassium per infusion.
Slovenian: Zdravilo vsebuje približno 45 mg kalija na infuzijo.
English: Visit 2 - Provenge infusion
Slovenian: 2. obisk - infundiranje zdravila Provenge
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija mialgija mišični spazmi*
English: • Training completion form as agreed with the national competent authority
Slovenian: Izobraževalno gradivo za zdravstvene delavce bo vključevalo naslednje ključne postavke: • Obrazec za zaključeno usposabljanja, kot je dogovorjeno s pristojnim državnim organom
English: Before infusion, it must be confirmed that the patient's identity matches the essential unique patient information on the Provenge bag and on the Final Product Disposition Notification form.
Slovenian: Pred infundiranjem je treba potrditi, 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.