natgillin/translations-raw huggingface dataset:
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.
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).
Driving and using machines You may feel tired, faint, or dizzy or have a headache or chills after receiving your Provenge infusion.
Po infundiranju zdravila Provenge boste morda čutili utrujenost, vrtoglavico ali omotičnost, ali pa boste imeli glavobol ali mrzlico.
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.
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
NAME OF THE MEDICINAL PRODUCT PROVENGE 50 x 106 CD54+ cells/250 mL dispersion for infusion.
IME ZDRAVILA Provenge 50 x 106 CD54+ celic/250 ml disperzija za infundiranje
- rash, including raised itchy rash (urticaria), or itching
- izpuščaj, vključno z dvignjenim srbečim izpuščajem (urtikarijo) ali srbenje
Do not
Neobsevajte.
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).
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).
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.
Če imate med infundiranjem hudo reakcijo, lahko vaš zdravnik infundiranje upočasni ali prekine.
- anaemia (decrease in number of red blood cells) due tothe leukapheresis procedure
- kri v urinu - nelagodje v prsnem košu - zmanjšanje števila trombocitov v krvi zaradi postopka levkafereze
• not enough of the right type of cells to manufacture the medicine.
• težava pri odvzemu vaših krvnih celic za izdelavo zdravila Provenge • nezadostno število celic pravilne vrste za izdelavo zdravila
Name and address of the manufacturer of the biological active substance
ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca biološke zdravilne učinkovine
In some cases, the patient may be unable to receive a scheduled infusion of Provenge.
Primeri, v katerih zdravila Provenge ni mogoče infundirati V nekaterih primerih bolnik morda ne bo mogel prejeti načrtovane infuzije zdravila Provenge.
- 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)
- reakcija na mestu infundiranja (reakcija na predelu kože, kjer je bila vstavljena kapalna infuzija)
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.
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.
In controlled clinical trials, infection occurred in 27.5% of subjects in the Provenge group and 27.7% of subjects in the control group.
V kontroliranih kliničnih preskušanjih se je okužba pojavila pri 27,5 % oseb v skupini z zdravilom
Update on study outcome annually Final study report by 31 December 2019
Končno poročilo o študiji do 31. decembra 2019
In the event of an acute infusion reaction, the infusion may be interrupted or slowed, depending on the severity of the reaction.
V primeru akutne reakcije na infundiranje se lahko, odvisno od resnosti reakcije, infuzija prekine ali ustavi.
What you need to know before you are given Provenge
Kaj morate vedeti, preden boste dobili zdravilo Provenge Ne uporabljajte zdravila Provenge
Store the bag in the insulated container to maintain the correct storage temperature (2°C-8°C) until infusion.
Vrečko shranjujte v izoliranem vsebniku za ohranjanje pravilne temperature shranjevanja (2 °C-8 °C) do infundiranja.
In controlled clinical trials, the dosing interval range was 115 weeks (see section 5.1).
V kontroliranih kliničnih preskušanjih je razpon intervala odmerjanja 1-15 tednov
Contents of the bag will be slightly cloudy, with a cream to pink colour.
Vsebina vrečke je rahlo motna in kremaste do rožnate barve.
Hyperhidrosis Pruritus Urticaria
Bolezni kože in podkožja izpuščaj hiperhidroza pruritus urtikarija
Visit 4 - Provenge infusion
4. obisk - infundiranje zdravila Provenge
Visit 6 - Provenge infusion
6. obisk - infundiranje zdravila Provenge
To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
To morajo upoštevati bolniki z zmanjšanim delovanjem ledvic ali bolniki, ki so na dieti z nadzorovanim vnosom kalija.
Atrial fibrillation Myocardial infarction Myocardial ischaemia
Bolezni srca atrijska fibrilacija miokardni infarkt miokardna ishemija
Catheter sepsis Catheter related infection Catheter site infection Sepsis
Infekcijske in parazitske bolezni pogosti bakteriemija občasni sepsa zaradi katetra s katetrom povezane okužbe okužba mesta katetra sepsa
The product also contains approximately 45 mg potassium per infusion.
Zdravilo vsebuje približno 45 mg kalija na infuzijo.
Visit 2 - Provenge infusion
2. obisk - infundiranje zdravila Provenge
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija mialgija mišični spazmi*
• Training completion form as agreed with the national competent authority
Izobraževalno gradivo za zdravstvene delavce bo vključevalo naslednje ključne postavke: • Obrazec za zaključeno usposabljanja, kot je dogovorjeno s pristojnim državnim organom
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.
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.
The dispersion is slightly cloudy, with a cream-to-pink colour.
disperzija za infundiranje Rahlo motna disperzija kremasto do rožnate barve.
Serious infections including sepsis have been observed in patients treated with Provenge.
Pri bolnikih, zdravljenih z zdravilom Provenge, so poročali o hudih okužbah, vključno s sepso.
In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the Provenge group.
V kontroliranih kliničnih preskušanjih so pri 3,5 % bolnikov iz skupine z zdravilom Provenge poročali o hudi (3. stopnje) akutni reakciji na infundiranje.
• shortness of breath, wheezing, dizziness, rash, or fever.
• zasoplost, sopenje, omotica, izpuščaj ali zvišana telesna temperatura
After the infusion
Po infundiranju
• 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.
• 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.
Summary of safety profile
Povzetek rezultatov študije
• 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.
• 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
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema zelo pogosti anemija*
The MAH shall ensure that all healthcare professionals who are expected to prescribe or use Provenge are provided with the following items:
da bodo predpisovali ali uporabljali zdravilo Provenge, da na razpolago naslednje postavke
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
(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.
The bag should be removed from the insulated polyurethane container and inspected for leaks, external damage, foreign particulate matter, or clumps/clots.
Vrečko vzemite iz izoliranega poliuretanskega vsebnika in preglejte, ali pušča, ima vidne poškodbe,
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).
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).
Gently mix and re-suspend the contents of the bag, inspecting for clumps and clots.
Vsebino vrečke nežno premešajte in ponovno suspendirajte ter preverite, ali vsebuje grudice ali strdke.
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.
pljuča ali možgane, in ki se na zdravila, ki znižujejo raven moškega hormona testosterona, več ne odziva,
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih zelo pogosti citratna toksičnost*
IgG) responses against both PAP-GM-CSF and the PAP antigens were observed in the Provenge group through the follow up period.
PAP-GM-CSF in PAP so opazili v skupini z zdravilom Provenge v času spremljanja.
To be taken into consideration by patients with reduced kidney function or on a controlled potassium diet.
To je treba upoštevati pri bolnikih z zmanjšanim delovanjem ledvic ali pri bolnikih na dieti z nadziranim vnosom kalija.
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.
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.
Before handling or administering Provenge
Navodila za ravnanje Pred ravnanjem z zdravilom ali dajanjem zdravila Provenge
Acute infusion reactions have been observed in patients treated with Provenge.
Pri bolnikih, zdravljenih z zdravilom Provenge, so poročali o akutnih reakcijah na infundiranje.
- 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
- 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):
To be taken into consideration by patients with heart conditions or those on a controlled sodium diet.
To morajo upoštevati bolniki z boleznimi srca ali bolniki, ki so na dieti z nadzorovanim vnosom natrija.
Shelf life and special precautions for storage
POSEBNA NAVODILA ZA SHRANJEVANJE
If not used immediately, in use storage times and conditions should not exceed 3 hours at room temperature (25°C).
Če se zdravilo ne uporabi takoj, se lahko shrani za največ 3 ure pri sobni temperaturi (25 °C).
To be taken into consideration by patients on a controlled sodium diet.
To je treba upoštevati pri bolnikih na dieti z nadziranim vnosom natrija.
• The Final Product Disposition Notification form is marked REJECTED.
• je na obrazcu z obvestilom o končnem razpolaganju z zdravilom zdravilo označeno kot
Acute infusion reactions such as chills, fatigue, fever, nausea, and joint ache were frequently observed in clinical studies.
V kliničnih študijah so pogosto opazili akutne reakcije na infundiranje, kot so mrzlica, utrujenost, zvišana telesna temperature, navzea in bolečine v sklepih.
• 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.
• 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
Provenge treatment checklists
Kontrolne sezname za zdravljenje z zdravilom Provenge 4.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
You may need to have further CBC tests during your treatment in line with local or country-wide practices.
Morda bodo v skladu z lokalno ali državno prakso med zdravljenjem potrebne dodatne preiskave celotne krvne slike.
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.
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.
One bag containins autologous peripheral blood mononuclear cells activated with PAP-GM-CSF, including a minimum of 50 x 106 autologous CD54+ cells.
Ena vrečka vsebuje so avtologne mononuklearne celice iz periferne krvi, aktivirane s PAP-GM-CSF), od tega najmanj 50 x 106 avtolognih CD54+ celic.
• 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.
• 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.
Vital signs should be taken at least 30 minutes prior to and 30 minutes following each infusion.
Vsaj 30 minut pred infundiranjem in še
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.
Pred lansiranjem zdravila Provenge v vsaki državi članici mora imetnik dovoljenja za promet z zdravilom
Respiratory, thoracic, and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora hipoksija sopenje dispneja bronhospazem
This medicinal product contains approximately 800 mg of sodium and 45 mg of potassium per infusion.
Pomožne snovi z znanim učinkom Ena infuzija vsebuje približno 800 mg natrija in 45 mg kalija.
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.
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.
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.
Zdravilo Provenge ni bilo testirano za povzročitelje nalezljivih bolezni, zato lahko predstavlja tveganje,
Eosinophilia
Bolezni sečil hematurija
Excipients with known effect
Z infundiranjem povezani neželeni učinki
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.
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
Cerebrovascular accident Transient ischaemic attack Tremor
Bolezni živčevja omotica parestezija* oralna parestezija* glavobol cerebrovaskularni dogodek prehodna ishemična ataka tremor hipoestezija kompresija hrbtenjače sinkopa cerebralni infarkt
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).
potrebni opioidi (enojni odmerek pethidina) na dan infundiranja zaradi reakcije na infuzijo (glejte poglavji 4.4 in 4.8).
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
Provenge v primerjavi s placebom pri bolnikih z nemetastatskim rakom prostate, pri katerih je prišlo po radikalni prostatektomiji do zvišanih ravni PSA
Exp.
celic.
Keep this leaflet.
Ne obsevajte.
Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T).
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).
Gastrointestinal disorders
Dokumentacijo za vzdrževanje katetrov za aferezo
• An infection which affects your whole body (e.g., sepsis, seen as high temperature, increased heart rate or breathing)
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)
Immunocompromised patients
Starejši bolniki
Tests
Zdravila
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).
Vsebnost kalija na infuzijo je treba upoštevati pri dajanju zdravila bolnikom z ledvično okvaro in/ali tistim na dieti z nadziranim vnosom kalija.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING INFUSION BAG
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI INFUZIJSKA VREČKA
Provenge has not been investigated in patients with hepatic impairment.
Zdravila Provenge pri bolnikih z okvarjenim delovanjem jeter niso preučili.
Cases in which Provenge cannot be infused
Provenge, ki mu je pretekel rok veljavnosti, ne infundirajte.
Pregnancy, breast-feeding and fertility Provenge is for use in men only.
Nosečnost, dojenje in plodnost
Thrombocytopenia*
pogosti trombocitopenija* eozinofilija
Pharmaceutical Form Route of Administration
Farmacevtska oblika Pot uporabe Ovojnina
It is available as tablets (375 mg).
Na voljo je v obliki tablet (375 mg).
What measures are being taken to ensure the safe use of Incivo?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Incivo?
The full EPAR for Incivo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
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.
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.
Poleg tega se lahko zdravljenje pri številnih bolnikih tudi skrajša, koristi pa so vidne pri različnih vrstah bolnikov z različnimi stopnjami okvare jeter.
The European Commission granted a marketing authorisation valid throughout the European Union
Evropska komisija je dovoljenje za promet z zdravilom Incivo, veljavno po vsej Evropski uniji, odobrila
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.
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
This is a summary of the European public assessment report (EPAR) for Incivo.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Incivo.
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.
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.
What benefit has Incivo shown during the studies?
Kakšne koristi je zdravilo Incivo izkazalo med študijami?
It blocks the action of an enzyme called NS3-4A protease in the hepatitis C virus, which is essential for its life cycle.
Zavira delovanje encima, imenovanega proteaza NS3-4A, pri virusu hepatitisa C, ki je nujen za njegov življenjski cikel.
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
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
For more information about treatment with Incivo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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.
This stops the hepatitis C virus from replicating in the infected host cells of the body.
To virusu hepatitisa C preprečuje razmnoževanje v okuženih gostiteljskih celicah telesa.
What is the risk associated with Incivo?
Kakšna tveganja so povezana z zdravilom Incivo?
The CHMP therefore concluded that the benefits of Incivo were greater than its risks, and recommended it be granted marketing authorisation.
Zato je zaključil, da so koristi zdravila Incivo večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
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.
Kadar se zdravilo Incivo dodaja peginterferonu alfa in ribavirinu (trenutnemu standardnemu zdravljenju hepatitisa C), to povečuje verjetnost uničenja virusa.
Incivo must not be used in patients who are hypersensitive (allergic) to telaprevir or any of the other ingredients.
Zdravila Incivo ne smejo uporabljati bolniki, ki so preobčutljivi za (alergični na) telaprevir ali katero koli drugo sestavino zdravila.