FrancophonIA/ELRC3.0 huggingface dataset:
English: Appropriate precautions should be employed when handling Provenge (see section 4.4).
Croatian: Potrebno je pridržavati se odgovarajućih mjera opreza pri rukovanju lijekom Provenge (vidjeti dio 4.4).
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).
Croatian: U slučaju da je potrebno zaustaviti infuziju lijeka Provenge, infuziju se ne smije nastaviti ako je infuzijska vrećica bila držana na sobnoj temperaturi (25°C) dulje od 3 sata (vidjeti dio 6.3).
English: Each dose of Provenge requires a standard leukapheresis procedure approximately 3 days prior to the infusion.
Croatian: Svaka doza lijeka Provenge zahtijeva provođenje standardnog postupka leukafereze oko 3 dana prije infuzije.
English: Preparing the infusion Take care to ensure aseptic handling when preparing the infusion.
Croatian: Priprema infuzije Osigurajte aseptičko rukovanje prilikom pripreme infuzije.
English: To mitigate such reactions, premedication, consisting of paracetamol and an antihistamine was administered in clinical studies prior to infusion.
Croatian: Za ublažavanje takvih reakcija, u kliničkim ispitivanjima prije infuzije primijenjivana je premedikacija koje je sadržavala paracetamol i antihistaminike.
English: Contents of the bag will be slightly cloudy, with a cream to pink colour.
Croatian: Sadržaj vrećice će biti blago mutan, kremaste do ružičaste boje.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING INFUSION BAG
Croatian: PODACI KOJI SE MORAJU NALAZITI UNUTARNJEM PAKIRANJU
English: Driving and using machines You may feel tired, faint, or dizzy or have a headache or chills after receiving your Provenge infusion.
Croatian: Moguće je da ćete se nakon primjene infuzije osjećati umorno i omamljeno ili imati vrtoglavicu, glavobolju ili zimicu.
English: Hypoxia Wheezing Dyspnoea Bronchospasm
Croatian: prsišta i sredoprsja hipoksija piskanje dispneja bronhospazam
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.
Croatian: U kontroliranim kliničkim ispitivanjima, infekcija se razvila u 27,5% ispitanika u skupini Provenge i
English: There is no relevant use of Provenge in the paediatric population in children and adolescents less than 18 years of age in the indication of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
Croatian: Nema relevantne primjene lijeka Provenge u pedijatrijskoj populaciji u djece i adolescenata u dobi do 18 godina u indikaciji asimptomatskog ili minimalno simptomatskog metastatskog (nevisceralnog)
English: The product also contains approximately 45 mg potassium per infusion.
Croatian: Pripravak također sadrži oko 45 mg kalija po infuziji.
English: If you get any side effects, talk to your doctor or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, obratite se svom liječniku ili medicinskoj sestri.
English: Sodium chloride Sodium lactate Potassium chloride Calcium chloride
Croatian: natrijev klorid natrijev laktat kalijev klorid kalcijev klorid
English: In addition, your blood will be tested for specific viruses (for example HIV-1, HIV-2, hepatitis B and hepatitis C).
Croatian: HIV-1, HIV-2, hepatitis B i hepatitis C).
English: In controlled clinical trials, myocardial infarctions were observed in 0.8% of patients in the Provenge group compared with 0.3% of patients in the control group.
Croatian: U kontroliranim kliničkim ispitivanjima, infarkt miokarda zabilježen je u 0,8% bolesnika u skupini
English: Your doctor will give you a schedule for your cell collection and infusion appointments.
Croatian: Liječnik će Vam dati raspored prikupljanja krvnih stanica i planiranih infuzija.
English: Serious infections occurred in 4.7% of subjects in the Provenge group and 4.0% of subjects in the control group.
Croatian: Ozbiljne infekcije pojavile su se u 4,7% ispitanika u skupini
English: However, as it is an autologous product, a positive test does not preclude the manufacture of the product.
Croatian: pozitivan test ujedno ne isključuje njegovu proizvodnju.
English: This medicinal product contains approximately 800 mg sodium per infusion.
Croatian: Ovaj lijek sadrži oko 800 mg natrija po infuziji.
English: Thrombocytopenia*
Croatian: često trombocitopenija*
English: Each leukapheresis was followed approximately 3 days later by infusion of Provenge or control.
Croatian: Nakon svake leukafereze slijedila je infuzija lijeka Provenge ili kontrolnog lijeka oko 3 dana nakon leukafereze.
English: A statistically significant improvement in overall survival was seen in patients treated with Provenge, with a 22.5% reduction in the risk of death compared with control (see Table 2 and Figure 1).
Croatian: Provenge, uz 22,5% smanjen rizik od smrti u usporedbi s kontrolnom skupinom (vidjeti tablicu 2. i sliku 1).
English: Dendreon UK Ltd. 41 Chalton Street London, NW1 1JD United Kingdom
Croatian: 41 Chalton Street London, NW1 1JD Ujedinjeno Kraljevstvo
English: Gently mix and re-suspend the contents of the bag, inspecting for particles, clumps or clots.
Croatian: Laganim miješanjem i resuspendiranjem sadržaja vrećice potrebno je provjeriti ima li čestica, grudica ili ugrušaka.
English: If not used immediately, in-use storage times and conditions should not exceed 3 hours at room temperature (25°C).
Croatian: Ako se ne primijeni odmah , vrijeme i uvjeti čuvanja ne smiju prijeći 3 sata na sobnoj temperaturi (25 °C).
English: • You are on a controlled sodium/potassium diet or you have reduced kidney function.
Croatian: • prehrana s ograničenim unosom natrija/kalija ili smanjena bubrežna funkcija
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.
Croatian: • Mora se osigurati da je od nositelja odobrenja za stavljanje lijeka u promet zaprimljen finalni Naputak za zbrinjavanje lijeka koji sadrži podatke o bolesniku, datum i vrijeme isteka roka valjanosti i status raspolaganja (odobren za infuziju ili odbijen).
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i vrlo često citratna toksičnost*
English: A machine is used to take blood from one arm, extract the white blood cells and return the rest of the blood to you, usually in the other arm.
Croatian: Vam se vraća ostatak krvi, obično u drugu ruku.
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.
Croatian: • U slučaju da se infuzija lijeka Provenge mora prekinuti, ista se ne smije nastaviti ako je infuzijska vrećica bila držana na sobnoj temperaturi (25 °C) više od 3 sata.
English: Gently mix and re-suspend the contents of the bag.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Lagano miješati i resuspendirati sadržaj vrećice.
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).
Croatian: U kontroliranim kliničkim ispitivanjima, u 23,8% bolesnika u skupini Provenge bila je potrebna primjena opijata (jedna doza petidina) na dan infuzije u odnosu na 2,4% bolesnika u kontrolnoj skupini (vidjeti dio 4.2 i 4.4).
English: Reactions included chills, fever, fatigue, asthenia, dyspnoea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting.
Croatian: hipoksiju, bronhospazam, omaglicu, glavobolju, hipertenziju, bol u mišićima, mučninu i povraćanje.
English: • The essential unique patient information on the infusion bag does not match that of the
Croatian: • jedinstveni podaci o bolesniku na vrećici infuzije ne odgovaraju bolesniku kojem je potrebno primijeniti lijek.
English: Store the bag in the insulated container to maintain the correct storage temperature (2°C-8°C) until infusion.
Croatian: Čuvati vrećicu u izoliranom spremniku radi održavanja ispravne temperature čuvanja (2°C-8°C) do infuzije.
English: Gently mix and resuspend the contents of the bag, inspecting for clumps and clots.
Croatian: Lagano miješajte i resuspendirajte sadržaj vrećice provjeravajući sadrži li grudice ili ugruške.
English: NAME OF THE MEDICINAL PRODUCT PROVENGE 50 x 106 CD54+ cells/250 mL dispersion for infusion.
Croatian: NAZIV LIJEKA PROVENGE 50 x 106 CD54+ stanica/250 mL disperzija za infuziju.
English: - anaemia (decrease in number of red blood cells) due tothe leukapheresis procedure
Croatian: - anemija (smanjenje broja crvenih krvnih zrnaca) zbog postupka leukafereze Česte nuspojave (mogu se pojaviti u do 1 na 10 bolesnika):
English: Catheter sepsis Catheter related infection Catheter site infection Sepsis
Croatian: Infekcije i infestacije često bakterijemija rijetko kateterska sepsa infekcija povezana s kateterom infekcija na mjestu uvođenja katetera sepsa
English: Patient leukapheresis material is tested for transmissible infectious agents in line with applicable member state requirements.
Croatian: Uzorak dobiven leukaferezomi testira se na prenosive uzročnike zaraznih bolesti u skladu s važećim propisima zemalja članica.
English: Provenge 50 x 106 CD54+ cells/250mL dispersion for infusion.
Croatian: NAZIV LIJEKA Provenge 50 x 106 CD54+ stanica/250 mL disperzija za infuziju.
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.
Croatian: U slučaju da se infuzija lijeka Provenge mora prekinuti, ne smije se nastavljati ako je infuzijska vrećica bila držana na sobnoj temperaturi (25°C) dulje od 3 sata.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip hiperhidroza svrbež urtikarija
English: Update on study outcome annually Final study report by 31 December 2019
Croatian: Završno izvješće o ispitivanju do 30. rujna
English: To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Croatian: To trebaju uzeti u obzir u bolesnici sa smanjenom bubrežnom funkcijom ili bolesnici na prehrani s kontroliranim unosom kalija.
English: Each dose of Provenge is preceded by a standard leukapheresis procedure approximately 3 days prior to the scheduled infusion date.
Croatian: Svakom doziranju lijeka Provenge prethodi standardni postupak leukafereze otprilike 3 dana prije predviđenog datuma infuzije.
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.
Croatian: Provenge se priprema od ljudske krvi pojedinog bolesnika i nije testiran na prenosive uzročnike zaraznih bolesti.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava vrlo često anemija*
English: Posology One dose of Provenge contains a minimum of 50 x 106 autologous CD54+ cells activated with
Croatian: Jedna doza lijeka Provenge sadrži najmanje 50 x 106 autolognih CD54+ stanica aktiviranih PAP-GM
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.
Croatian: Prije infuzije, mora biti potvrđeno da bolesnikov identitet odgovara jedinstvenoj informaciji o bolesniku na vrećici lijeka Provenge i na finalnom Naputku za zbrinjavanje lijeka.
English: Provenge contains sodium and potassium This medicine contains:
Croatian: Provenge sadrži natrij i kalij
English: • Once the patient is prepared for infusion and the APPROVED Final Product Disposition Notification form has been received, the Provenge bag should be removed from the insulated container and inspected for leaks, external damage, foreign particulate matter, or clumps/clots.
Croatian: ODOBRENOM raspolaganju konačnim lijekom, vrećicu s lijekom Provenge potrebno je izvaditi iz izoliranog spremnika i pregledati kako bi se uočilo eventualno propuštanje, vanjska oštećenja, prisutnost stranih čestica ili grudice/ugrušci.
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).
Croatian: U kontroliranim kliničkim ispitivanjima, u 23,8% bolesnika liječenih lijekom Provenge zbog infuzijskih reakcija bilo je potrebno primijeniti opioide (jedna doza petidina) na dan infuzije (vidjeti dio 4.2 i 4.8).
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
Croatian: Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 bolesnika): - bol - bol u zglobovima ili bol (artralgija) - trnci, utrnulost ili abnormalni osjeti (parestezije) oko usana, u ustima ili u rukama i/ili nogama tijekom postupka leukafereze - grčevi u mišićima, bol u prsima i nizak krvni tlak tijekom postupka leukafereze (uzrokovani lijekom (citrat) koji se koristi za sprječavanje zgrušavanja krvi)
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.
Croatian: • Mora biti potvrđeno da bolesnikov identitet odgovara jedinstvenoj informaciji o bolesniku na vrećici lijeka Provenge i na finalnom Naputku za zbrinjavanje lijeka.
English: Additional adverse reactions that were seen commonly ≤ 1 day following a leukapheresis procedure in controlled clinical trials included fatigue (5.5%), muscle spasm (4.0%), chills (3.0%), dizziness (2.8%), and anaemia (2.8%).
Croatian: Dodatne nuspojave koje su zabilježene često ≤ 1 dan nakon postupka leukafereze u kontroliranim kliničkim ispitivanjima uključivale su umor (5,5%), grčeve u mišićima
English: Contact a doctor immediately if you experience sudden vision loss in one eye, difficulty speaking, numbness and/or weakness affecting one side of the body as any of these may be signs of a stroke.
Croatian: utrnulost i/ili slabost koja zahvaća jednu stranu tijela jer bilo koji od njih mogu biti znakovi moždanog udara.
English: One bag containins autologous peripheral blood mononuclear cells activated with PAP-GM-CSF, including a minimum of 50 x 106 autologous CD54+ cells.
Croatian: Jedna vrećica sadrži autologne mononuklearne stanice periferne krvi aktivirane PAP-GM-CSF-om, s najmanje 50 x 106 autolognih CD54+ stanica.
English: SPECIAL STORAGE CONDITIONS Store the bag in the insulated container to maintain the correct storage temperature (2°C-8°C) until infusion.
Croatian: Vrećicu čuvati u izoliranom spremniku radi održavanja ispravne temperature čuvanja (2°C-8°C) do primjene.
English: Accordingly, healthcare professionals should employ appropriate precautions when handling the leukapheresis material or Provenge.
Croatian: Prema tome, zdravstveni djelatnici se trebaju pridržavati odgovarajućih mjera opreza prilikom rukovanja uzorkom dobivenim leukaferezom ili lijekom Provenge (vidjeti dio
English: IMPORTANT - Do not infuse Provenge if
Croatian: - Nemojte primijenjivati Provenge infuzijom ako
English: To be taken into consideration by patients with heart conditions or those on a controlled sodium diet.
Croatian: To trebaju uzeti u obzir u bolesnici sa srčanim bolestima ili bolesnici na prehrani s kontroliranim unosom natrija.
English: The first infusion of Provenge will be given approximately 3 days after the cell collection and will last approximately 1 hour (see also section 2 “Warnings and precautions”).
Croatian: Prva infuzija lijeka Provenge daje se oko 3 dana nakon prikupljanja stanica i traje oko 1 sat
English: EU/1/13/867/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/867/001
English: Patient leukapheresis material is tested for transmissible infectious agents in line with applicable local requirements.
Croatian: Bolesnikov uzorak dobiven leukaferezom testiran je na prenosive uzročnike zaraznih bolesti u skladu s važećim propisima zemalja članica.
English: Summary of Product Characteristics (SmPC) 2.
Croatian: Sažetak opisa svojstava lijeka (SPC) 2. Edukacijske materijale za zdravstvene djelatnike
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.
Croatian: Provenge nije testiran na prenosive zarazne bolesti, stoga može postojati rizik prenošenja zaraznih bolesti na zdravstvene djelatnike koji rukuju lijekom.
English: • You have not received the Final Product Disposition Notification form.
Croatian: • niste dobili finalni Naputak o zbrinjavanju lijeka od nositelja odobrenja za stavljanje lijeka u promet.
English: In the event of an acute infusion reaction, the infusion rate may be decreased, or the infusion stopped, depending on the severity of the reaction.
Croatian: U slučaju akutne infuzijske reakcije, moguće je smanjiti brzinu infuzije ili ju zaustaviti,
English: If you need more information on the testing of your blood please ask your doctor or nurse.
Croatian: Za dodatne informacije o krvnim pretragama, obratite se svom liječniku ili medicinskoj sestri.
English: • a problem at the time your blood cells are taken for the manufacturing of Provenge.
Croatian: Razlozi mogu biti svakojaki, primjerice: • problem u trenutku kada su Vaše krvne stanice uzete za pripremu lijeka Provenge.
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).
Croatian: U kontroliranim kliničkim ispitivanjima, u 23,8% bolesnika liječenih lijekom Provenge zbog reakcije na infuziju bilo je potrebno primijeniti opioide (jedna doza petidina) na dan infuzije (vidjeti dio 4.4 i
English: Infusion-related side effects
Croatian: Nuspojave povezane s infuzijom
English: Shelf life and special precautions for storage
Croatian: Rok trajanja i posebne mjere pri čuvanju lijeka
English: Visit 5 - Blood cell collection (leukapheresis)
Croatian: 5. dolazak - prikupljanje krvnih stanica (leukafereza) 6. dolazak - infuzija lijeka Provenge
English: Stroke
Croatian: Cijepljenje
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.
Croatian: (25 °C), ili ako su čestice/grudice u lijeku vidljive i nakon blagog ručnog miješanja.
English: Infections due to contaminated product also occurred in some patients.
Croatian: Infekcije kao posljedica kontaminiranosti lijeka također su zabilježene u nekih bolesnika, a manji je broj bolesnika zbog navedenog prekinuo liječenje.
English: Visit 2 - Provenge infusion
Croatian: 1. dolazak - prikupljanje krvnih stanica (leukafereza) 2. dolazak - infuzija lijeka Provenge
English: One bag contains autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (prostatic acid phosphatase-granulocyte macrophage-colony stimulating factor), including a minimum of 50 x 10
Croatian: Jedna vrećica sadrži autologne mononuklearne stanice periferne krvi aktivirane PAP-GM-CSF-om (prostatična kisela fosfataza i čimbenik poticanja rasta kolonija granulocita i makrofaga) s najmanje
English: IgG) responses against both PAP-GM-CSF and the PAP antigens were observed in the Provenge group through the follow up period.
Croatian: Stvaranje protutijela (IgM i IgG) i na PAP-GM-CSF i na PAP antigene zabilježeno je u skupini
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: Ovaj podatak potrebno je uzeti u obzir u bolesnika na prehrani s kontroliranim unosom natrija.
English: Musculoskeletal and connective tissue disorders
Croatian: Embolijski i trombotički događaji
English: Visit 4 - Provenge infusion
Croatian: 3. dolazak - prikupljanje krvnih stanica (leukafereza) 4. dolazak - infuzija lijeka Provenge
English: Eosinophilia
Croatian: • Postupak leukafereze
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.
Croatian: Bolesnici s oštećenjem funkcije bubrega i/ili hiperkalijemijom i/ili bolesnici na prehrani s kontroliranim unosom kalija
English: To be taken into consideration by patients with reduced kidney function or on a controlled potassium diet.
Croatian: Ovaj podatak potrebno je uzeti u obzir u bolesnika s oštećenom funkcijom bubrega ili u bolesnika na prehrani s kontroliranim unosom kalija.
English: EXPIRY DATE Exp.
Croatian: GM-CSF-om.
English: Infections and infestations
Croatian: • mučnina i povraćanje
English: Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T)
Croatian: Djelatna tvar su autologne mononuklearne stanice periferne krvi aktivirane PAP-GM-CSF-om
English: The study should provide a summary of baseline patient characteristics including PSA and
Croatian: Ispitivanje treba sadržavati sažetak početnih vrijednosti karakteristika bolesnika,
English: Summary of safety profile
Croatian: Sažetak rezultata ispitivanja
English: 0.331 c
Croatian: 0,586b (0,388, 0,884)
English: See leaflet for further information.
Croatian: Za dodatne informacije, vidjeti Uputu o lijeku.
English: Due dates
Croatian: PODACI O KAKVOĆI
English: The identity of the patient must be matched with the essential unique patient information on the infusion bag and the Final Product Disposition Notification form prior to infusion.
Croatian: Prije infuzije mora se potvrditi da identitet bolesnika odgovara jedinstvenim podacima o bolesniku na vrećici infuzije i na obrascu s Obavijesti o raspolaganju konačnim lijekom.
English: Tests
Croatian: Krvne pretrage
English: Package leaflet: Information for the patient
Croatian: Edukacijske materijale za bolesnike
English: Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakiranje Veličina pakiranja
English: The pregnancy section has been revised in line with the relevant guideline[7].
Croatian: Dio o trudnoći revidiran je u skladu s odgovarajućom smjernicom[7].
English: Cancer Patients 2014, Chapter 15, pp.251-269.
Croatian: Renal Disease in Cancer Patients 2014, Chapter 15, pp.251-269.
English: Etoposide is used for the treatment of various neoplastic diseases.
Croatian: Etopozid se primjenjuje za liječenje raznih neoplastičnih bolesti.
English: In section 4.5 of the SmPC the interactions that were documented in the majority of current national SmPCs have been retained in the harmonised text.
Croatian: U dijelu 4.5. SmPC-a interakcije koje su zabilježene u većini postojećih nacionalnih SmPC-a zadržane su i u usklađenom tekstu.
English: • The product information proposed by the Marketing Authorisation Holder has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Croatian: • Informacije o lijeku koje je predložio nositelj odobrenja ocijenjene su na temelju dostavljene dokumentacije i znanstvene rasprave unutar Odbora.
English: A text to consider preservation of the sperm has been included in this section.
Croatian: U ovaj dio uvršten je tekst o razmatranju mogućnosti čuvanja sperme.
English: The CHMP also noted that etoposide may decrease male fertility.
Croatian: CHMP je također napomenuo da etopozid može smanjiti plodnost kod muškaraca.
English: - Testicular cancer: first line, recurrent or refractory testicular cancer
Croatian: - rak testisa: prva linija, ponovljeni ili refraktorni rak testisa
English: - Small-cell lung cancer
Croatian: - rak pluća malih stanica
English: The revised indications in section 4.1 of the Summary of Product characteristics (SmPC) are:
Croatian: Revidirane indikacije iz dijela 4.1. sažetka opisa svojstava lijeka (SmPC) su: