natgillin/translations-raw huggingface dataset:
For dogs, the corresponding “Advocate for dog” product, which contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin, must be used. 
Za pse, mora se koristiti odgovarajući proizvod „Advocate za pse“, koji sadrži 100 mg/ml imidakloprida i 25 mg/ml moksidektina.
Advocate 40 mg + 4 mg spot-on solution for small cats and ferrets Advocate 80 mg + 8 mg spot-on solution for large cats 
Advocate 40 mg + 4 mg spot-on otopina za male mačke i afričke tvorove Advocate 80 mg + 8 mg spot-on otopina za velike mačke
For large dogs weighing between 10 kg and 25 kg. 
Za velike pse od 10 do 25 kg.
For small dogs weighing 4 kg or less. 
Za male pse do 4 kg.
Excipients: Benzyl alcohol, 1 mg/ml butylhydroxytoluene (E 321; as antioxidant). 
Pomoćne tvari: benzilni alkohol, butil-hidroksitoluen 1mg/ml (E321; kao antioksidans).
> 4-8 kg Advocate for large cats > 8 kg appropriate combination of pipettes 
> 4-8 kg Advocate za velike mačke 0,8 10-20
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworm, hookworms and whipworms. 
U područjima u kojima je dirofilarioza zoonotska mjesečnim tretiranjem može se značajno smanjiti opasnost od invazije askaridima, ankilostomidima i bičastim crvima.
One treatment prevents future flea infestation for 3 weeks. 
Jednokratnim tretmanom sprječava se nova infestacija buhama tijekom 3 tjedna.
Advocate 80 mg + 8 mg spot-on solution for large cats Imidacloprid, moxidectin 
Advocate 80 mg + 8 mg spot-on otopina za velike mačke Imidakloprid, moksidektin
Advocate for small cats (≤ 4 kg) and ferrets 
Advocate za male mačke (≤ 4 kg) i afričke tvorove
Bayer Animal Health GmbH, 51368 Leverkusen, GERMANY. 
Bayer Animal Health GmbH, 51368 Leverkusen, Njemačka.
• the prevention of cutaneous dirofilariosis (L3 larvae of Dirofilaria repens), 
• prevenciju potkožne dirofilarioze (L3 ličinke Dirofilaria repens),
Skin worm 
Bičasti crv
Advocate should be administered monthly for two consecutive months. 
Advocate se treba aplicirati u mjesečnim razmacima tijekom dva uzastopna mjeseca.
Marketing authorisation holder: Bayer Animal Health GmbH 51368 Leverkusen GERMANY 
Nositelj odobrenja za stavljanje u promet: Bayer Animal Health GmbH 51368 Leverkusen
• the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis), 
• prevenciju srčane dirofilarioze (L3 i L4 ličinke Dirofilaria immitis),
• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis). 
• suzbijanje invazije želučano-crijevnim nematodima (L4 ličinke, nedozreli odrasli i odrasli stadiji Toxocara canis, Ancylostoma caninum i Uncinaria stenocephala, odrasli stadiji Toxascaris leonina i Trichuris vulpis).
PACKAGE LEAFLET: Advocate 40 mg + 10 mg spot-on solution for small dogs Advocate 100 mg + 25 mg spot-on solution for medium dogs Advocate 250 mg + 62.5 mg spot-on solution for large dogs Advocate 400 mg + 100 mg spot-on solution for extra-large dogs 
UPUTA O VMP: Advocate 40 mg + 10 mg spot-on otopina za male pse Advocate 100 mg + 25 mg spot-on otopina za srednje velike pse Advocate 250 mg + 62,5 mg spot-on otopina za velike pse Advocate 400 mg + 100 mg spot on otopina za vrlo velike pse
Advocate 40 mg + 10 mg spot-on solution for small dogs Advocate 100 mg + 25 mg spot-on solution for medium dogs Advocate 250 mg + 62.5 mg spot-on solution for large dogs Advocate 400 mg + 100 mg spot-on solution for extra-large dogs 
Advocate 40 mg + 10 mg spot-on otopina za male pse Advocate 100 mg + 25 mg spot-on otopina za srednje velike pse Advocate 250 mg + 62,5 mg spot-on otopina za velike pse Advocate 400 mg + 100 mg spot-on otopina za vrlo velike pse
Each 1 ml pipette contains: Active substances: 100 mg imidacloprid, 25 mg moxidectin. 
Svaka pipeta od 1 ml sadržava: Djelatne tvari: 100 mg imidakloprid, 25 mg moksidektin.
Advocate 40 mg + 10 mg spot-on solution for small dogs Imidacloprid, moxidectin 
Advocate 40 mg + 10 mg spot-on otopina za male pse Imidakloprid, moksidektin
Advocate 100 mg + 25 mg spot-on solution for medium dogs Imidacloprid, moxidectin 
Advocate 100 mg + 25 mg spot-on otopina za srednje velike pse Imidakloprid, moksidektin
• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis (roundworm), Ancylostoma caninum (hookworm) and Uncinaria stenocephala (hookworm), adults of Toxascaris leonina (roundworm) and Trichuris vulpis (whipworm)). 
• suzbijanje invazije želučano-crijevnim nematodima (L4 ličinke, nedozreli odrasli i odrasli stadiji Toxocara canis (oblić), Ancylostoma caninum (kukasti crv) i Uncinaria stenocephala, odrasli stadiji (kukasti crv) Toxascaris leonina (oblić) i Trichuris vulpis (bičasti crv).
Heartworm 
NUSPOJAVE
Louse 
Buha
Pack sizes 
Ličinka buhe
Roundworm and hookworm treatment (Toxocara cati and Ancylostoma tubaeforme). 
Toxocara cati (oblići) i Ancylostoma tubaeforme (kukasti crvi).
• the treatment of Eucoleus (syn. 
• suzbijanje Eucoleus (syn.
Each 4 ml pipette contains: Active substances: 400 mg imidacloprid, 100 mg moxidectin. 
Svaka pipeta od 4 ml sadržava: Djelatne tvari: 400 mg imidakloprid, 100 mg moksidektin.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton, pack size of 1, 2, 3, 4, 6, 9, 12, 21 and 42 pipettes 
Kartonsko pakiranje, veličina pakiranja 1, 2, 3, 4, 6, 9, 12, 21 i 42 pipete
For cats, the corresponding “Advocate for cat” product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used. 
Za mačke, treba koristiti odgovarajući proizvod Advocate Spot-on za mačke koji sadrži 100 mg/ml imidakloprida i 10 mg/ml moksidektina.
Treatment of the lungworm Eucoleus aerophilus (syn. 
Suzbijanje plućnog crva Eucoleus aerophilus (syn.Capillaria aerophila) (odrasli)
Advocate 400 mg + 100 mg spot-on solution for extra-large dogs Imidacloprid, moxidectin 
Advocate 400 mg + 100 mg spot-on otopina za vrlo velike pse Imidakloprid, moksidektin
Each 0.4 ml pipette contains: Active substances: 40 mg imidacloprid, 10 mg moxidectin. 
Svaka pipeta od 0,4 ml sadržava: Djelatne tvari: 40 mg imidakloprid, 10 mg moksidektin.
Advocate 40 mg + 10 mg spot-on solution for small dogs Advocate 100 mg + 25 mg spot-on solution for medium dogs Advocate 250 mg + 62.5 mg spot-on solution for large dogs Advocate 400 mg + 100 mg spot-on solution for extra-large dogs Imidacloprid, moxidectin 
Advocate 40 mg + 10 mg spot-on otopina za male pse Advocate 100 mg + 25 mg spot-on otopina za srednje velike pse Advocate 250 mg + 62,5 mg spot-on otopina za velike pse Advocate 400 mg + 100 mg spot-on otopina za velike pse Imidakloprid, moksidektin
Each 0.4 ml pipette contains: Active substances: 40 mg imidacloprid, 4 mg moxidectin 
Svaka pipeta od 0,4 ml sadržava: Djelatne tvari: 40 mg imidakloprid, 4 mg moksidektin
In non-endemic areas there should be no risk of dogs having heartworm. 
U područjima gdje se dirofilarioza ne javlja enzootski ne bi trebalo biti opasnosti od invazije pasa srčanim crvom.
Dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. 
Psi koji žive u područjima enzootskim za srčanog crva, ili oni koji su putovali u takva područja mogu biti invadirani odraslim stadijima srčanog crva.
0.4 minimum of 10 minimum of 1 
≤ 4 kg Advocate za male mačke 0,4 minimalno 10 minimalno 1
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Advocate for small dogs 
OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJ9IM PAKOVANJIMA
Φλέμινγκ 15 EL-15123 Μαρούσι - Αθήνα 
EL-15123 Μαρούσι - Αθήνα Τηλ.: +30 210 6800900-9
The product was administered to kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. 
Proizvod je primijenjen kod mačića u 5 x većoj dozi od preporučene 6 puta u intervalima od 2 tjedna, bez ozbiljnih štetnih učinaka.
Flea treatment and prevention (Ctenocephalides felis) 
Suzbijanje i sprječavanje infestacije buhama (Ctenocephalides felis)
Bayer Animal Health GmbH 51368 Leverkusen GERMANY 
Bayer Animal Health GmbH 51368 Leverkusen
For ferrets suffering from, or at risk from, mixed parasitic infections: 
Za afričke tvorove koji boluju od mješovitih parazitarnih invazija ili su u opasnosti od invazije:
EU/2/03/039/011 3 pipettes EU/2/03/039/012 6 pipettes EU/2/03/039/018 4 pipettes EU/2/03/039/029 21 pipettes EU/2/03/039/030 42 pipettes EU/2/03/039/051 1 pipette EU/2/03/039/052 2 pipettes EU/2/03/039/053 9 pipettes EU/2/03/039/054 12 pipettes 
EU/2/03/039/011 3 pipete EU/2/03/039/012 6 pipeta EU/2/03/039/018 4 pipete EU/2/03/039/029 21 pipeta EU/2/03/039/030 42 pipete EU/2/03/039/051 1 pipeta EU/2/03/039/052 2 pipete EU/2/03/039/053 9 pipeta EU/2/03/039/054 12 pipeta
Weight of cat [kg] 
Težina mačke
EU/2/03/039/009 3 pipettes EU/2/03/039/010 6 pipettes EU/2/03/039/017 4 pipettes EU/2/03/039/027 21 pipettes EU/2/03/039/028 42 pipettes EU/2/03/039/047 1 pipette EU/2/03/039/048 2 pipettes EU/2/03/039/049 9 pipettes EU/2/03/039/050 12 pipettes 
EU/2/03/039/009 3 pipete EU/2/03/039/010 6 pipeta EU/2/03/039/017 4 pipete EU/2/03/039/027 21 pipeta EU/2/03/039/028 42 pipete EU/2/03/039/047 1 pipeta EU/2/03/039/048 2 pipete EU/2/03/039/049 9 pipeta EU/2/03/039/050 12 pipeta
EU/2/03/039/007 3 pipettes EU/2/03/039/008 6 pipettes EU/2/03/039/016 4 pipettes EU/2/03/039/025 21 pipettes EU/2/03/039/026 42 pipettes EU/2/03/039/043 1 pipette EU/2/03/039/044 2 pipettes EU/2/03/039/045 9 pipettes EU/2/03/039/046 12 pipettes 
EU/2/03/039/007 3 pipete EU/2/03/039/008 6 pipeta EU/2/03/039/016 4 pipete EU/2/03/039/025 21 pipeta EU/2/03/039/026 42 pipete EU/2/03/039/043 1 pipeta EU/2/03/039/044 2 pipete EU/2/03/039/045 9 pipeta EU/2/03/039/046 12 pipeta
Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. 
Mačke koje žive u područjima gdje je enzootski proširena dirofilarioza ili jedinke koje su putovale u takva područja, mogu biti invadirane odraslim srčanim crvima.
4.2 Indications for use, specifying the target species For dogs suffering from, or at risk from, mixed parasitic infections: 
INDIKACIJE Za pse kod kojih postoji mješovita parazitarna invazija ili postoji opasnost da se ona javi:
Unit dose Imidacloprid Moxidectin 
Imidakloprid, moksidektin
EU/2/03/039/005 3 pipettes EU/2/03/039/006 6 pipettes EU/2/03/039/015 4 pipettes EU/2/03/039/023 21 pipettes EU/2/03/039/024 42 pipettes EU/2/03/039/039 1 pipette EU/2/03/039/040 2 pipettes EU/2/03/039/041 9 pipettes EU/2/03/039/042 12 pipettes 
EU/2/03/039/005 3 pipete EU/2/03/039/006 6 pipeta EU/2/03/039/015 4 pipete EU/2/03/039/023 21 pipeta EU/2/03/039/024 42 pipete EU/2/03/039/039 1 pipeta EU/2/03/039/040 2 pipete EU/2/03/039/041 9 pipeta EU/2/03/039/042 12 pipeta
EU/2/03/039/001 3 pipettes EU/2/03/039/002 6 pipettes EU/2/03/039/013 4 pipettes EU/2/03/039/019 21 pipettes EU/2/03/039/020 42 pipettes EU/2/03/039/031 1 pipette EU/2/03/039/032 2 pipettes EU/2/03/039/033 9 pipettes EU/2/03/039/034 12 pipettes 
EU/2/03/039/001 3 pipete EU/2/03/039/002 6 pipeta EU/2/03/039/013 4 pipete EU/2/03/039/019 21 pipeta EU/2/03/039/020 42 pipete EU/2/03/039/031 1 pipeta EU/2/03/039/032 2 pipete EU/2/03/039/033 9 pipeta EU/2/03/039/034 12 pipeta
EU/2/03/039/003 3 pipettes EU/2/03/039/004 6 pipettes EU/2/03/039/014 4 pipettes EU/2/03/039/021 21 pipettes EU/2/03/039/022 42 pipettes EU/2/03/039/035 1 pipette EU/2/03/039/036 2 pipettes EU/2/03/039/037 9 pipettes EU/2/03/039/038 12 pipettes 
EU/2/03/039/003 3 pipete EU/2/03/039/004 6 pipeta EU/2/03/039/014 4 pipete EU/2/03/039/021 21 pipeta EU/2/03/039/022 42 pipete EU/2/03/039/035 1 pipeta EU/2/03/039/036 2 pipete EU/2/03/039/037 9 pipeta EU/2/03/039/038 12 pipeta
Pipette size to be used Volume [ml] 
Volumen [ml]
For cats, the corresponding “Advocate for cats” product (0.4 or 0.8 ml), which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used. 
Za mačke, treba koristiti odgovarajući proizvod Advocate za mačke (0,4 ili 0,8 ml) koji sadrži 100
Treatment of Eucoleus (syn. 
Suzbijanje Eucoleus (syn.
Treatment of ear mite infestation (Otodectes cynotis) A single dose of the product should be administered. 
Suzbijanje Crenosoma vulpis Primjenjuje se jedna doza.
Seek the advice of your veterinarian. 
U takvim je slučajevima potrebno promijeniti liječenje to jest od vašeg veterinara zatražiti savjet/pomoć.
• the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme). 
• liječenje invazija želučano-crijevnim nematodima (L4 ličinke, nedozreli odrasli i odrasli stadiji
In non-endemic areas there should be no risk of ferrets having heartworm. 
U područjima gdje se dirofilarioza ne javlja enzootski ne bi trebalo biti opasnosti od invazije afričkih tvorova srčanim crvom.
Spot-on solution. 
Spot-on otopina.
Ferrets in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. 
Afrički tvorovi koji žive u područjima gdje je enzootski proširena dirofilarioza, ili oni koji su putovali u takva područja, mogu biti invadirani odraslim srčanim crvom.
Τηλ. 
Nematodi
The leukapheresis and infusion are repeated on two further occasions, each approximately 2 weeks apart. 
Leukafereza i infuzija ponavljaju se još dva puta, u razmaku od približno dva tjedna.
A risk management plan has been developed to ensure that Provenge is used as safely as possible. 
Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Provenge koristi što je sigurnije moguće.
The full EPAR for Provenge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
In a main study involving 512 patients, the average overall survival for patients treated with Provenge was 25.8 months, compared with 21.7 months for patients given placebo. 
U glavnom ispitivanju koje je uključivalo 512 bolesnika, prosječno ukupno trajanje preživljavanja bolesnika liječenih lijekom Provenge iznosilo je 25,8 mjeseci u usporedbi s 21,7 mjeseci za bolesnike koji su primali placebo.
This is a summary of the European public assessment report (EPAR) for Provenge. 
Ovo je sažetak Europskoga javnog izvješća o ocjeni (EPAR) za Provenge.
Why is Provenge approved? 
Zašto je Provenge odobren?
Other information about Provenge 
Druge informacije o lijeku Provenge
What is Provenge and what is it used for? 
Što je Provenge i za što se koristi?
What measures are being taken to ensure the safe and effective use of Provenge? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Provenge?
It is not intended to provide practical advice on how to use Provenge. 
Svrha sažetka nije davati praktične savjete o načinu korištenja Provenge.
The patient should be monitored for at least half an hour after the infusion. 
Bolesnika treba nadzirati barem pola sata nakon svake infuzije.
The European Commission granted a marketing authorisation valid throughout the European Union for Provenge on 6 September 2013. 
Europska komisija izdaje odobrenje za stavljanje u promet koje za Provenge vrijedi na prostoru Europske unije od 6. rujna 2013.
It must be given under the supervision of a doctor experienced in the treatment of prostate cancer and in an environment where resuscitation equipment is available. 
Mora se davati pod nadzorom liječnika iskusnog u liječenju karcinoma prostate i u ustanovi u kojoj je dostupna oprema za oživljavanje.
Regarding its safety, the CHMP noted that Provenge was generally well tolerated. 
Što se tiče njegove sigurnosti, CHMP je uočio da se Provenge općenito dobro podnosi.
Provenge autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (sipuleucel-T) 
Provenge autologne mononuklearne stanice periferne krvi aktivirane s PAP-GM-CSF (sipuleucel-T)
It is used when the cancer is metastatic (has spread to other parts of the body), and when medical or surgical castration (stopping the production of male hormones) has not worked or no longer works but treatment with chemotherapy (medicines that kill fast-growing cells like cancer cells) is not yet considered appropriate. 
Koristi se kad je karcinom metastatski (proširio se na druge dijelove tijela) i kada medicinska ili kirurška kastracija (prekid proizvodnje muških hormona) nije bila djelotvorna ili više ne djeluje ali liječenje kemoterapijom (lijekovima koji ubijaju brzo rastuće stanice poput stanica karcinoma) se još uvijek ne smatra odgovarajućim.
What are the risks associated with Provenge? 
Koji su rizici povezani s lijekom Provenge?
It contains immune cells that are extracted from the patient's blood. 
Sadrži stanice imunološkog sustava koje su ekstrahirane iz bolesnikove krvi.
Once prepared, the medicine is given as an infusion lasting around 1 hour. 
Nakon pripreme lijek se daje u obliku infuzije koja traje približno sat vremena.
This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to cure, diagnose or prevent a disease. 
Riječ je o vrsti lijeka koja sadrži stanice ili tkiva koja su izmijenjena kako bi se mogla koristiti za liječenje, dijagnostiku ili sprječavanje bolesti.
Around half an hour before each infusion, the patient should take paracetamol and an antihistamine to reduce infusion-related reactions with Provenge. 
Oko pola sata prije svake infuzije bolesnik treba uzeti paracetamol i antihistaminik za redukciju reakcija povezanih s infuzijom lijeka Provenge.
The company will also set up an EUbased registry of patients treated with Provenge in order to monitor overall survival and side effects reported (particularly stroke and heart attack), and will provide data from a US-based registry. 
Tvrtka će također uspostaviti EU registar bolesnika liječenih lijekom Provenge kako bi se nadziralo ukupno preživljavanje i prijavljene nuspojave (posebice moždani i srčani udar) te će osigurati podatke iz američkog registra.
In addition, the company that markets Provenge will provide educational materials for doctors and patients on how to use the medicine and the leukapheresis procedure. 
Osim toga, tvrtka koja stavlja Provenge na tržište osigurati će edukacijske materijale za liječnike i bolesnike o tome kako koristiti lijek i kako provoditi postupak leukafereze.
It will also supply cards for patients to record the scheduled leukapheresis and infusion dates. 
Također će osigurati kartice za bolesnike kako bi mogli upisivati raspored leukafereze i datume infuzije.
The main risks included acute infusion reactions, toxicities associated with the leukapheresis procedure and infections, but the CHMP considered that these were manageable and adequately addressed by risk minimisation measures for this medicine. 
Glavni rizici povezani su s akutnim infuzijskim reakcijama, toksičnosti povezanom s postupkom leukafereze i infekcijama, ali je CHMP smatrao da se te reakcije mogu liječiti i kontrolirati na odgovarajući način planom upravljanja rizicima za ovaj lijek.
Further studies will also be carried out to provide additional supportive data on the effectiveness of Provenge. 
Također će se provesti daljnja ispitivanja kako bi se dobili dodatni podaci koji potkrepljuju djelotvornost lijeka Provenge.
Provenge is available as a liquid dispersion for infusion (drip) into a vein. 
Provenge je dostupan kao tekuća disperzija za infuziju (drip) u venu.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Provenge's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Provenge nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za korištenje u Europskoj uniji.
The CHMP concluded that the improvement in overall survival seen with Provenge is important for patients. 
CHMP je zaključio da je poboljšavanje u ukupnom preživljavanju uočeno kod lijeka Provenge važno za bolesnike.
Serious side effects with Provenge include severe acute infusion reactions, severe infection (catheter sepsis and staphylococcal bacteraemia), heart attack and cerebrovascular events (related to the blood supply to the brain). 
Ozbiljne nuspojave povezane s lijekom Provenge uključuju teške akutne infuzijske reakcije, tešku infekciju (katetersku sepsu i stafilokoknu bakterijemiju), srčani udar i cerebrovaskularne događaje (povezane s opskrbom mozga krvlju).
Provenge is a type of advanced therapy medicine called a ‘somatic cell therapy product'. 
Provenge je vrsta lijeka za naprednu terapiju koji se naziva „lijek za terapiju somatskim stanicama”.
These cells are then mixed outside the patient's body with a ‘fusion protein', which is taken up by the cells. 
Te se stanice zatim miješaju izvan bolesnikova tijela s „proteinom fuzije” koji stanice apsorbiraju.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Provenge, including the appropriate precautions to be followed by healthcare professionals and patients. 
Na temelju ovog plana sigurnosne informacije uključene su u sažetak opisa svojstava lijeka i uputu o lijeku za Provenge uključujući i odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Provenge is a cancer medicine that is prepared specifically for each patient using their own immune cells (cells that form part of the body's natural defences). 
Provenge je lijek protiv karcinoma koji se priprema specifično za svakog bolesnika upotrebom stanica njegovog vlastitog imunološkog sustava (stanica koje su dio prirodnog obrambenog sustava tijela).
The fusion protein consists of prostatic acid phosphatase (PAP), a molecule found in most prostate cancer cells, attached to granulocyte-macrophage colony-stimulating factor (GM-CSF), a molecule that activates immune cells. 
Protein fuzije sastoji se od fosfataze prostatične kiseline (PAP), molekule koja se nalazi u većini stanica karcinoma prostate, pričvršćena faktor koji stimulira koloniju granulocita-makrofaga (GM-CSF), molekule koja aktivira imunološki sustav.
Provenge is used to treat adult men with cancer of the prostate (a gland of the male reproductive system) who have few or no symptoms. 
Provenge se koristi za liječenje odraslih muškaraca s karcinomom prostate (žlijezda muškog spolnog sustava) koji imaju nekoliko ili nimalo simptoma.
Three days before the infusion, a procedure called leukapheresis is performed to collect immune cells from the patient's blood, and these are then sent to a manufacturing facility to prepare the medicine. 
Tri dana prije infuzije provodi se postupak zvan leukafereza kako bi se prikupile stanice imunološkog sustava iz bolesnikove krvi i potom se iste šalju u proizvodni pogon da bi se pripremio lijek.
When the immune cells are infused back into the patient, they stimulate an immune response against PAP, resulting in the immune system attacking and killing prostate cancer cells because they contain PAP. 
Kad se stanice imunološkog sustava infundiraju natrag u bolesnika, iste stimuliraju odgovor na PAP što potiče imunološki sustav da napadne i ubije stanice karcinoma prostate jer sadrže PAP.
The most common side effects with Provenge (which may affect more than 1 in 10 people) include chills, fatigue (tiredness), pyrexia (fever), nausea (feeling sick), arthralgia (joint pain), headache and vomiting. 
Najčešće nuspojave lijeka Provenge (koje se mogu javiti u više od 1 na 10 osoba) uključuju trnce, umor (zamor), pireksiju (vrućicu), mučninu, artralgiju (bol u zglobovima), glavobolju i povraćanje.
Provenge is an immunotherapy, a medicine that stimulates the immune system to kill cancer cells. 
Provenge je imunoterapija, lijek koji stimulira imunološki sustav da ubija stanice karcinoma.