FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER CARD, 100 mg dose
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU BLISTER KARTICA, doza od 60 mg
English: Pack for the 60 mg daily dose 21 x 20 mg capsules (60 mg/day dose for a 7-day supply) Each 60 mg daily dose contains three grey 20 mg capsules.
Croatian: 21 kapsula od 20 mg (dnevna doza od 60 mg za primjenu tijekom 7 dana) Svaka dnevna doza od 60 mg sadrži tri sive kapsule od 20 mg.
English: 100 mg/day dose
Croatian: 100 mg/dnevna doza
English: Uncommon (1/1,000 to
Croatian: Manje često (1/1000 do<1/100)
English: Uncommon side effects (may affect 1 in 100 people)
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba)
English: Blister cards containing either:
Croatian: Blister kartice sadrže jednu od sljedećih kombinacija:
English: The COMETRIQ 80 mg capsules contain cabozantinib (S)-malate equivalent to 80 mg of cabozantinib.
Croatian: COMETRIQ kapsule od 80 mg sadrže kabozantinib (S)-malat u količini koja odgovara 80 mg kabozantiniba.
English: 60 mg/day dose
Croatian: 60 mg/dnevna doza
English: COMETRIQ 20 mg hard capsules COMETRIQ 80 mg hard capsules
Croatian: COMETRIQ 20 mg tvrde kapsule COMETRIQ 80 mg tvrde kapsule
English: Each 100 mg daily dose contains a combination of one grey 20 mg capsule and one orange 80 mg capsule.
Croatian: Svaka dnevna doza od 100 mg sadrži jednu sivu kapsulu od 20 mg i jednu narančastu kapsulu od 80 mg.
English: България
Croatian: България, România
English: Respiratory, thoracic, and mediastinal disorders dysphonia, oropharyngeal pain non-gastrointestinal fistula (including tracheal, pneumomediastinu m, tracheooesophageal), pulmonary embolism, respiratory tract haemorrhage (including pulmonary, bronchial, tracheal), pneumonia aspiration atelectasis, pharyngeal oedema, pneumonitis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja disfonija, orofaringealna bol fistula izvan gastrointestinalnog sustava (uključujući trahealne, pneumomedijastinal ne, traheoezofagealne), plućna embolija, krvarenje iz respiratornog trakta (uključujući plućno, bronhalno, trahealno), aspiracijska pneumonija atelektaza, faringealni edem, pneumonitis
English: Each daily dose is provided in one row and contains one 80 mg capsule and one 20 mg capsule:
Croatian: Svaka dnevna doza se nalazi u jednom redu i sadrži jednu kapsulu od 80 mg i jednu kapsulu od 20 mg:
English: - have had surgery within the last month (or if surgical procedures are planned), including dental procedures - have had radiotherapy in the last 3 months - have inflammatory bowel disease (for example, Crohn's disease or ulcerative colitis or diverticulitis) - have been told that your cancer has spread to your airway or oesophagus - have a recent history of blood clot in the leg, stroke, or heart attack - are taking medicines to control your heart rhythm, have a slow heart rate, have problems with your heart or have problems with the levels of calcium, potassium or magnesium in your blood - have severe liver or kidney disease.
Croatian: Vam je rečeno da Vam se rak proširio na dišni put ili jednjak - ste nedavno imali krvni ugrušak u nozi, moždani ili srčani udar - uzimate lijekove za kontroliranje srčanog ritma, imate usporen srčani ritam, imate probleme sa srcem ili probleme s razinom kalcija, kalija ili magnezija u krvi - imate tešku bolest jetre ili bubrega.
English: 14.6 months
Croatian: 14,6 mjeseci nije dostupno
English: 60 mg Dose
Croatian: Doza od 60 mg
English: The 100 mg daily dose blister card contains seven 80 mg capsules and seven 20 mg capsules as 7 daily doses in total.
Croatian: Blister kartica s dnevnom dozom od 100 mg sadržava sedam kapsula od 80 mg i sedam kapsula od 20 mg tj. ukupno 7 dnevnih doza.
English: Eye disorders vision blurred cataract, conjunctivitis
Croatian: Poremećaji oka zamagljen vid katarakta, konjuktivitis
English: COMETRIQ 20 mg 60 mg/day dose
Croatian: COMETRIQ 80 mg 100 mg/dnevna doza
English: 100 mg Dose
Croatian: Doza od 100 mg
English: Each daily dose is provided in one row and contains one 80 mg capsule and three 20 mg capsules:
Croatian: Svaka dnevna doza se nalazi u jednom redu i sadrži jednu kapsulu od 80 mg i tri kapsule od 20 mg:
English: The COMETRIQ 20 mg capsules contain cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Croatian: COMETRIQ kapsule od 20 mg sadrže kabozantinib (S)-malat u količini koja odgovara 20 mg kabozantiniba.
English: COMETRIQ 20 mg COMETRIQ 80 mg 140 mg/day dose
Croatian: COMETRIQ 80 mg 140 mg/dnevna doza
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused product or waste material should be disposed of in accordance with local requirements.
Croatian: OD LIJEKA, AKO JE POTREBNO Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: The hard capsules are orange with “XL184 80mg” printed in black on the body of the capsule.
Croatian: Tvrde kapsule su narančaste s cmo otisnutom oznakom “XL184 80mg” na tijelu kapsule.
English: Palmar-plantar erythrodysaesthesia syndrome (PPES) has been observed with cabozantinib.
Croatian: U teškim slučajevima sindroma palmarno-plantarne eritrodizestezije mora se razmotriti prekid liječenja kabozantinibom.
English: COMETRIQ 20 mg hard capsules
Croatian: COMETRIQ 20 mg tvrde kapsule
English: • Impaired hearing
Croatian: • Oštećenje sluha
English: 7 x 20 mg capsules and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply).
Croatian: 7 kapsula od 20 mg i 7 kapsula od 80 mg (dnevna doza od 100 mg za primjenu tijekom 7 dana).
English: There is little experience with cabozantinib in non-White patients.
Croatian: Podaci o djelovanju kabozantiniba u bolesnika drugih rasnih skupina osim bijelaca su vrlo ograničeni.
English: taken as one 80 mg orange capsule and one 20 mg grey capsule, and then to 60 mg daily, taken as three 20 mg grey capsules.
Croatian: 100 mg dnevno, pri čemu se doza uzima kao jedna narančasta kapsula od 80 mg i jedna siva kapsula od 20 mg te zatim smanjiti dozu na 60 mg dnevno, pri čemu se doza uzima kao tri sive kapsule od 20 mg.
English: Hypertension has been observed with cabozantinib.
Croatian: Prilikom primjene kabozantiniba zabilježena je hipertenzija.
English: 21 x 20 mg capsules and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply).
Croatian: 21 kapsula od 20 mg i 7 kapsula od 80 mg (dnevna doza od 140 mg za primjenu tijekom 7 dana).
English: The 60 mg daily dose blister card contains twenty-one 20 mg capsules as 7 daily doses in total.
Croatian: Blister kartica s dnevnom dozom od 60 mg sadržava dvadeset i jednu kapsulu od 20 mg tj. ukupno 7 dnevnih doza.
English: COMETRIQ 20 mg hard capsules Cabozantinib
Croatian: COMETRIQ 20 mg tvrde kapsule kabozantinib
English: 84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose for a 28 day supply)
Croatian: 84 kapsule (4 blister kartice od 21 x 20 mg) (60 mg/dnevna doza)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/005 56 capsules (4 blisters cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day supply)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/890/005 56 kapsula (4 blister kartice od: 7 x 20 mg i 7 x 80 mg) (dnevna doza od 100 mg za primjenu tijekom 28 dana)
English: CEA Responsea
Croatian: Način primjene
English: 21 x 20 mg capsules (60 mg/day dose for a 7-day supply).
Croatian: 21 kapsula od 20 mg (dnevna doza od 60 mg za primjenu tijekom 7 dana).
English: EU/1/13/890/001 21 x 20 mg capsules (60 mg/day dose for a 7-day supply) EU/1/13/890/004 84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose for a 28 day supply)
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/890/001 21 kapsula od 20 mg (dnevna doza od 60 mg za primjenu tijekom 7 dana) EU/1/13/890/004 84 kapsule (4 blister kartice od 21 x 20 mg) (dnevna doza od 60 mg za primjenu tijekom 28 dana)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/890/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/890/001
English: Cabozantinib should be discontinued in patients who experience a GI perforation or a GI or non-GI fistula.
Croatian: Mora se prestati s primjenom kabozantiniba u bolesnika u kojih se pojavi gastrointestinalna perforacija ili pak gastrointestinalna ili fistula izvan gastrointestinalnog sustava.
English: Peel paper backing
Croatian: Odlijepite papirnatu pozadinu
English: 7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply) 21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply)
Croatian: 7 kapsulu od 20 mg i 7 kapsulu od 80 mg (dnevna doza od 100 mg za primjenu tijekom 7 dana) 21 kapsulu od 20 mg i 7 kapsulu od 80 mg (dnevna doza od 140 mg za primjenu tijekom 7 dana) Pakiranje za 28 dana sadržava:
English: One hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg cabozantinib.
Croatian: Jedna tvrda kapsula sadrži kabozantinib (S)-malat u količini koja odgovara 20 mg ili 80 mg kabozantiniba.
English: • Wounds that have difficulties healing
Croatian: • Rane koje slabo cijele
English: • Inflammation of the abdomen or pancreas
Croatian: • Upala trbuha ili gušterače
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER CARD OF 28 DAY PACK, 140 mg dose (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BLISTER KARTICA ZA 28 DANA PAKIRANJE, doza od 140 mg (BEZ PLAVOG OKVIRA)
English: Cabozantinib should be discontinued in patients who experience ONJ.
Croatian: Kabozantinib se mora prekinuti u bolesnika u kojih se pojavi osteonekroza čeljusti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF 28 DAY PACK, 140 mg dose (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKE KUTIJE ZA PAKIRANJE ZA 28 DANA, doza od 140 mg (UKLJUČUJUĆI PLAVI OKVIR)
English: PHARMACEUTICAL FORM AND CONTENTS 60 mg Dose 28 day pack: 84 capsules (4 blister cards of 21 x 20 mg capsules) for the 60 mg daily dose for a 28 day supply.
Croatian: Pakiranje za 28 dana: 84 kapsule (4 blister kartice od: 21 x kapsula od 20 mg) za dnevnu dozu od 60 mg za primjenu tijekom 28 dana.
English: PHARMACEUTICAL FORM AND CONTENTS 100 mg Dose 28 day pack: 56 capsules (4 blister cards of 7 x 20 mg capsules and 7 x 80 mg capsules) for the 100 mg daily dose for a 28 day supply.
Croatian: Pakiranje za 28 dana: 56 kapsula (4 blister kartice od: 7 x 20 mg i 7 x 80 mg) za dnevnu dozu od 100 mg za primjenu tijekom 28 dana.
English: PHARMACEUTICAL FORM AND CONTENTS 140 mg Dose 28 day pack: 112 capsules (4 blister cards of 21 x 20 mg capsules and 7 x 80 mg capsules) for the 140 mg daily dose for a 28 day supply.
Croatian: Pakiranje za 28 dana: 112 kapsula (4 blister kartice od: 21 x 20 mg i 7 x 80 mg) za dnevnu dozu od 140 mg za primjenu tijekom 28 dana.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/890/003
English: Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg of cabozantinib.
Croatian: Svaka tvrda kapsula sadrži kabozantinib (S)-malat u količini koja odgovara 20 mg ili 80 mg kabozantiniba.
English: Hemorrhage has been observed with cabozantinib.
Croatian: Prilikom primjene kabozantiniba zabilježeno je krvarenje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF 28 DAY PACK, 60 mg dose (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKE KUTIJE ZA PAKIRANJE ZA 28 DANA, doza od 60 mg (UKLJUČUJUĆI PLAVI OKVIR)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER CARD OF 28 DAY PACK, 100 mg dose (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BLISTER KARTICA ZA 28 DANA PAKIRANJE, doza od 100 mg (BEZ PLAVOG OKVIRA)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/006 112 capsules (4 blisters cards of 21 x 20 mg and 7 x 80 mg) (140 mg/day dose for 28 day supply)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/890/006 112 kapsula (4 blister kartice od: 21 x 20 mg i 7 x 80 mg) (dnevna doza od
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF 28 DAY PACK, 100 mg dose (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKE KUTIJE ZA PAKIRANJE ZA 28 DANA, doza od 100 mg (UKLJUČUJUĆI PLAVI OKVIR)
English: OTHER SPECIAL WARNING(S), IF NECESSARY Refer to individual blister cards for dispensing instructions.
Croatian: Za upute za uzimanje pogledajte pojedinačne blister kartice.
English: Gastric pH modifying agents
Croatian: Lijekovi koji mijenjaju pH želuca
English: Cabozantinib
Croatian: Kabozantinib
English: • Chills, tremors
Croatian: • Zimica, nevoljno drhtanje
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/890/004 84 capsules (4 blisters cards of 21 x 20 mg) (60 mg/day dose for 28 day supply) 13.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/890/004 84 kapsule (4 blister kartice od 21 x 20 mg) (dnevna doza od 60 mg za primjenu tijekom 28 dana)
English: • Swollen lymph glands
Croatian: • Otečene limfne žlijezde
English: Proteinuria has been observed with cabozantinib.
Croatian: Prilikom primjene kabozantiniba zabilježena je proteinurija.
English: EU/1/13/890/006 112 capsules (4 blister cards of 21 x 20mg and 7 x 80 mg) (140 mg/day dose for 28
Croatian: EU/1/13/890/004 84 kapsule (4 blister kartice od 21 x 20 mg) (dnevna doza od 60 mg za primjenu tijekom 28 dana)
English: Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Croatian: Svaka tvrda kapsula sadrži kabozantinib (S)-malat u količini koja odgovara 20 mg kabozantiniba.
English: General disorders and administration site conditions fatigue, mucosal inflammation, asthenia impaired wound healing, chills, face oedema cyst, facial pain, localised oedema
Croatian: Opći poremećaji i reakcije na mjestu primjene umor, upala sluznice, astenija usporeno cijeljenje rana, zimica, edem lica cista, bol u licu, lokalizirani edem
English: dabigatran etexilate, digoxin, talinolol, and tolvaptan - Medicines for diabetes, such as saxagliptin and sitagliptin - Medicines used to treat gout, such as colchicine - Medicines used to treat HIV or AIDS, such as ritonavir, maraviroc and emtricitabine - Medicines used to treat viral infections such as efavirenz - Medicines used to prevent transplant rejection (cyclosporine) and cyclosporine-based regimens in rheumatoid arthritis and psoriasis
Croatian: - Lijekovi koji se koriste za liječenje virusnih infekcija, kao što je efavirenz - Lijekovi koji se koriste za sprječavanje odbacivanja transplantata (ciklosporin) te režimi na bazi ciklosporina kod reumatoidnog artritisa i psorijaze
English: MARKETING AUTHORISATION HOLDER
Croatian: KOD UVJETNOG ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: • 60 mg (3 grey 20 mg capsules) Your doctor will decide on the right dose for you.
Croatian: • 60 mg (3 sive kapsule od 20 mg)
English: 56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for a 28 day supply) 112 capsules (4 blister cards of 21 x 20mg and 7 x 80 mg) (140 mg/day dose for a 28 day supply)
Croatian: 56 kapsula (4 blister kartice od: 7 x 20 mg i 7 x 80 mg) (dnevna doza od 100 mg za primjenu tijekom 28 dana)
English: Wound complications have been observed with cabozantinib.
Croatian: Prilikom primjene kabozantiniba zabilježene su komplikacije s ranama.
English: 84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose) 56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose) 112 capsules (4 blister cards of 21 x 20 mg and 7 x 80 mg) (140 mg/day dose)
Croatian: 112 kapsula (4 blister kartice od: 21 x 20 mg i 7 x 80 mg) (dnevna doza od 140 mg za primjenu tijekom 28 dana)
English: Events of osteonecrosis of the jaw (ONJ) have been observed with cabozantinib.
Croatian: Nadalje, "bol u ekstremitetima" je poznata nuspojava za Cabometyx (kabozantinib).
English: Caution should be used in patients receiving agents associated with ONJ, such as bisphosphonates.
Croatian: Lijekove povezane s osteonekrozom čeljusti kao što su bisfosfonati, mora se koristiti oprezno.
English: 21 x 20 mg capsules and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply) Each 140 mg daily dose contains a combination of three grey 20 mg capsules and one orange 80 mg capsule.
Croatian: jedna narančasta kapsula od 80 mg + jedna siva kapsula od 20 mg Blister kartica s dnevnom dozom od 140 mg sadržava sedam kapsula od 80 mg i 21 kapsulu od 20 mg tj. ukupno 7 dnevnih doza.
English: COMETRIQ capsules are also available in 28 day packs:
Croatian: jedna narančasta kapsula od 80 mg + tri sive kapsule od 20 mg COMETRIQ kapsule također su dostupne u pakiranjima za 28 dana:
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: PRILOG IV. Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži kabozantinib (S)-malat u količini koja odgovara 20 mg kabozantiniba.
English: BLISTER CARD OF 28 DAY PACK, 60 mg dose (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BLISTER KARTICA ZA 28 DANA PAKIRANJE, doza od 60 mg (BEZ PLAVOG OKVIRA)
English: Do not take Tadalafil Lilly if you are already taking nitrates.
Croatian: Nemojte uzimati Tadalafil Lilly ako već uzimate nitrate.
English: Take Tadalafil Lilly with water every day at approximately the same time, either with or without food.
Croatian: Uzmite Tadalafil Lilly s vodom svaki dan otprilike u isto doba, s hranom ili bez nje.
English: Tadalafil Lilly with drink and alcohol
Croatian: Tadalafil Lilly s pićem i alkoholom
English: This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”).
Croatian: To je skupina lijekova ("nitrati") koja se koristi za liječenje angine pektoris ("bolova u prsima").
English: However, it is not possible to definitively determine whether these events are related directly to these risk factors, to Tadalafil Lilly, to sexual activity, or to a combination of these or other factors.
Croatian: Međutim, nije moguće sa sigurnošću odrediti jesu li ti događaji izravno povezani s navedenim faktorima rizika, lijekom Tadalafil Lilly, seksualnom aktivnošću ili kombinacijom ovih ili drugih faktora.
English: • Always take Tadalafil Lilly exactly as your doctor has told you.
Croatian: • Uvijek uzmite Tadalafil Lilly točno onako kako Vam je rekao liječnik.
English: Children and adolescents Tadalafil Lilly is not intended for use by children and adolescents under the age of 18.
Croatian: Tadalafil Lilly nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
English: Other medicines and Tadalafil Lilly Tell your doctor if you are taking, have recently taken or might take any other medicines
Croatian: Drugi lijekovi i Tadalafil Lilly Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The patients should be informed not to take Tadalafil Lilly in such combinations.
Croatian: Bolesnike treba upozoriti da ne smiju uzimati Tadalafil Lilly u takvim kombinacijama.
English: de la Industria 30, Alcobendas, 28108 Madrid, Spain
Croatian: Avda. de la Industria 30, Alcobendas, 28108 Madrid, Španjolska
English: Start with the pill from the blister pack that corresponds with the day you start taking Tadalafil Lilly.
Croatian: Počnite s tabletom iz blistera koja odgovara danu kad počinjete uzimati Tadalafil Lilly.
English: Once a day dosing of Tadalafil Lilly may be useful to men who anticipate having sexual activity two or more times per week.
Croatian: Doziranje lijeka Tadalafil Lilly jednom na dan može biti korisno u muškaraca koji očekuju da će spolni odnos imati dva ili više puta na tjedan.
English: What Tadalafil Lilly is and what it is used for
Croatian: Što je Tadalafil Lilly i za što se koristi
English: Tadalafil Lilly may still be effective up to 36 hours after taking the tablet.
Croatian: Tadalafil Lilly može djelovati do 36 sati nakon uzimanja tablete.
English: You may take a Tadalafil Lilly tablet at least 30 minutes before sexual activity.
Croatian: Tadalafil Lilly tabletu možete uzeti najmanje 30 minuta prije seksualne aktivnosti.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c. stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring.
Croatian: takvim okolnostima nitrate treba primijeniti isključivo pod strogim nadzorom liječnika i uz odgovarajuće hemodinamičko praćenje.
English: • Drinking alcohol may affect your ability to get an erection so avoid excessive drinking with Tadalafil Lilly.
Croatian: • Konzumiranje alkohola može utjecati na sposobnost postizanja erekcije pa treba izbjegavati prekomjernu konzumaciju alkohola s lijekom Tadalafil Lilly.
English: Tadalafil Lilly does not treat prostate cancer.
Croatian: Tadalafil Lilly ne liječi rak prostate.
English: As a precautionary measure, it is preferable to avoid the use of Tadalafil Lilly during pregnancy.
Croatian: Kao mjeru opreza poželjno je izbjegavati primjenu lijeka Tadalafil Lilly u trudnoći.
English: If you have taken or are planning to take Tadalafil Lilly, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.
Croatian: Ako ste uzeli ili planirate uzeti Tadalafil Lilly, izbjegavajte prekomjernu konzumaciju alkohola (razina alkohola u krvi od 0,08% ili više) jer to može povećati rizik od omaglice pri ustajanju.
English: - priapism, a prolonged and possibly painful erection after taking Tadalafil Lilly (frequency rare).
Croatian: - prijapizam, dugotrajna i potencijalno bolna erekcija nakon uzimanja lijeka Tadalafil Lilly (rijetka učestalost).
English: If you experience sudden decrease or loss of vision, stop taking Tadalafil Lilly and contact your doctor immediately.
Croatian: Ako osjetite iznenadno smanjenje ili gubitak vida, prestanite uzimati Tadalafil Lilly i odmah se javite svom liječniku.
English: Tadalafil Lilly, must not be used in men with cardiac disease for whom sexual activity is inadvisable.
Croatian: Tadalafil Lilly se ne smije primjenjivati u muškaraca sa srčanim bolestima kojima se ne preporučuje seksualna aktivnost.
English: Some men taking Tadalafil Lilly in clinical studies have reported dizziness.
Croatian: Neki muškarci koji su uzimali Tadalafil Lilly u kliničkim ispitivanjima prijavili su omaglicu.
English: However, you have been given the dose of one 20 mg tablet as your doctor has decided that the recommended dose of 10 mg is too weak.
Croatian: Međutim, propisana Vam je doza od jedne tablete od 20 mg jer je Vaš liječnik odlučio da preporučena doza od
English: As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking Tadalafil Lilly and consult a physician immediately (see section 4.3).
Croatian: Budući da bi to moglo biti značajno za sve bolesnike izložene tadalafilu, bolesnicima treba savjetovati da u slučaju iznenadnog poremećaja vida prestanu uzimati Tadalafil Lilly i odmah se obrate liječniku (vidjeti dio 4.3).
English: Date of first authorisation: 22.
Croatian: Datum prvog odobrenja: 22. ožujka 2017.