FrancophonIA/ELRC3.0 huggingface dataset:
English: A dose of 2000 IUs of IDELVION, administered to a 80 kg patient, should be expected to result in a peak post-injection factor IX increase of 2000 IUs x 1.3 (IU/dl per IU/kg) /80 kg = 32.5 IU/dl (32.5 % of normal).
Croatian: Očekuje se da će doza lijeka IDELVION od 2000 IU, primijenjena bolesniku tjelesne težine 80 kg, dovesti do povećanja vršne vrijednosti faktora IX nakon injekcije za 2000 IU x 1,3 (IU/dl na IU/kg)/80 kg = 32,5 IU/dl (32,5 % normalne vrijednosti).
English: A peak level of 50 % of normal is required in a 80 kg patient with severe haemophilia B. The appropriate dose would be 80 kg x 50 IU/dl x 0.77 dl/kg = 3080 IUs.
Croatian: Prikladna doza bila bi 80 kg x 50 IU/dl x 0,77 dl/kg = 3080 IU.
English: Prolongation of the half-life of IDELVION and the enhanced systemic exposure are achieved by fusion with recombinant albumin.
Croatian: IDELVION (INN: albutrepenonakog alfa) je rekombinantni koagulacijski faktor IX. Produljenje poluvijeka lijeka IDELVION i povećana sistemska izloženost postižu se fuzijom s rekombinantnim albuminom.
English: The mean factor IX activity at day 7 and day 14 was 13.76% and 6.10%, respectively, after a single dose of 50 IU/kg IDELVION.
Croatian: Srednja vrijednost aktivnosti faktora IX nakon jednokratne doze lijeka IDELVION od 50 IU/kg izmjerena 7. i 14. dana iznosila je 13,76% odnosno 6,10%.
English: 1 disposable 5 ml syringe 1 venipuncture set 2 alcohol swabs 1 non-sterile plaster
Croatian: 1 štrcaljku od 5 ml za jednokratnu uporabu 1 set za venepunkciju 2 tupfera natopljena alkoholom 1 nesterilan flaster
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).
Croatian: Broj primijenjenih jedinica faktora IX izražava se u internacionalnim jedinicama (IU), koje su u skladu s važećim standardom SZO-a za lijekove koji sadrže faktor IX. Aktivnost faktora IX u plazmi izražava se ili kao postotak (u odnosu na normalnu vrijednost u ljudskoj plazmi) ili u internacionalnim jedinicama (u odnosu na međunarodni standard za faktor IX u plazmi).
English: Inhibitor development has been observed in previously treated patients in the post-marketing experience with IDELVION.
Croatian: Četrdeset prethodno liječenih bolesnika je primilo lijek IDELVION za profilaksu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 500 IU
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za 500 IU
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 2000 IU
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za 2000 IU
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial label 2.5 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica bočice s 2,5 ml otapala
English: Ей енд Ди Фарма България ЕАД Тел: +359 2 810 3949
Croatian: Новимед Фарма ЕООД Тел: +359 2 850 8617
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 1000 IU
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za 1000 IU
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Croatian: Kada se ovaj lijek primjenjuje u bolesnika s jetrenom bolešću, bolesnika nakon operacije, novorođenčadi ili bolesnika s rizikom za razvoj trombotskih pojava ili diseminirane intravaskularne koagulacije (potrošne koagulopatije), zbog mogućeg rizika od trombotskih komplikacija potrebno je uvesti klinički nadzor kako bi se uočili rani znakovi trombotske i potrošne koagulopatije, uz odgovarajuće biološko testiranje.
English: PK Parameters
Croatian: Farmakokinetički parametri
English: If you use more IDELVION than you should Please contact your doctor immediately if you inject more IDELVION than your doctor recommends.
Croatian: Ako injicirate više lijeka IDELVION nego što
English: While the product vial is upright, connect the syringe to the Mix2Vial's Luer Lock fitting by screwing clockwise.
Croatian: Držeći bočicu s lijekom uspravno, pričvrstite štrcaljku na navojni spoj ('Luer Lock') nastavka Mix2Vial navijanjem u smjeru kazaljke na satu.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 250 IU
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica s praškom od 250 IU
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial label 5 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica bočice s 5 ml otapala
English: The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation factor IX enables the protein to be produced as a single recombinant protein and assures product homogeneity by avoiding chemical conjugation.
Croatian: Albutrepenonakog alfa je pročišćen protein proizveden tehnologijom rekombinantne DNK, stvoren genskom fuzijom rekombinantnog albumina s rekombinantnim koagulacijskim faktorom IX. Genska fuzija cDNK humanog albumina i cDNK humanog koagulacijskog faktora IX omogućuje proizvodnju proteina u obliku jednog cjelovitog rekombinantnog proteina te osigurava homogenost lijeka izbjegavanjem kemijske konjugacije.
English: Comparison of Pharmacokinetic Parameters of IDELVION by Age Category (Median (min, max)) Following a Single Injection of 50 IU/kg IDELVION
Croatian: Usporedba farmakokinetičkih parametara lijeka IDELVION prema dobnim skupinama (medijan [min, max]) nakon jednokratne injekcije lijeka IDELVION u dozi od 50 IU/kg Farmakokinetički parametri
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 2000 IU
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica s praškom od 2000 IU
English: CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg Germany
Croatian: CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg Njemačka
English: IDELVION 250 IU powder and solvent for solution for injection Powder (250 IU) in a 6 ml vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Croatian: IDELVION 250 IU prašak i otapalo za otopinu za injekciju Prašak (250 IU) u bočici od 6 ml (staklo tipa I) zatvorenoj čepom (guma), pločicom (plastika) i zatvaračem (aluminij).
English: IDELVION 2000 IU powder and solvent for solution for injection 260 - 300 mOsm/kg.
Croatian: IDELVION 2000 IU prašak i otapalo za otopinu za injekciju 260 - 300 mOsm/kg.
English: IDELVION 250 IU powder and solvent for solution for injection
Croatian: IDELVION 250 IU prašak i otapalo za otopinu za injekciju
English: IDELVION 1000 IU powder and solvent for solution for injection 260 - 300 mOsm/kg.
Croatian: IDELVION 1000 IU prašak i otapalo za otopinu za injekciju 260 - 300 mOsm/kg.
English: 2.5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Croatian: 2,5 ml otapala u bočici (staklo tipa I) zatvorenoj čepom (guma), pločicom (plastika) i zatvaračem (aluminij).
English: IDELVION 2000 IU powder and solvent for solution for injection Powder (2000 IU) in a 10 ml vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Croatian: IDELVION 2000 IU prašak i otapalo za otopinu za injekciju Prašak (2000 IU) u bočici od 10 ml (staklo tipa I) zatvorenoj čepom (guma), pločicom (plastika) i zatvaračem (aluminij).
English: Ensure product and solvent vial flip caps are removed and the stoppers are treated with an antiseptic solution and allowed to dry prior to opening the Mix2Vial package.
Croatian: Prije otvaranja Mix2Vial pakiranja uklonite zatvarače s bočica s lijekom i otapalom te obrišite čepove antiseptičkom otopinom i pričekajte da se osuše.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip manje često ekcem manje često
English: 5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Croatian: 5 ml otapala u bočici (staklo tipa I) zatvorenoj čepom (guma), pločicom (plastika) i zatvaračem (aluminij).
English: IDELVION 500 IU powder and solvent for solution for injection 260 - 300 mOsm/kg.
Croatian: IDELVION 500 IU prašak i otapalo za otopinu za injekciju 260 - 300 mOsm/kg.
English: Place the solvent vial on an even, clean surface and hold the vial tight.
Croatian: 2. Bočicu s otapalom stavite na ravnu i čistu površinu i čvrsto je uhvatite.
English: CSL Behring GmbH Emil-von-Behring-Str. 76 35041 Marburg Germany
Croatian: CSL Behring GmbH Emil-von-Behring-Str. 76 35041 Marburg Njemačka
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 1000 IU
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica s praškom od 1000 IU
English: Record of use
Croatian: Zapisivanje primjene
English: 1 vial with 5 ml water for injections 1 filter transfer device 20/20
Croatian: 1 bočicu s praškom (sa ili bez RFID-a) 1 bočicu s 5 ml vode za injekcije 1 sustav za prijenos s filtrom 20/20
English: IDELVION is a haemophilia medicine that replaces a natural blood clotting (coagulation) factor IX.
Croatian: IDELVION je lijek za hemofiliju koji zamjenjuje prirodni faktor zgrušavanja (koagulacije) krvi IX. Djelatna tvar u lijeku IDELVION je albutrepenonakog alfa(rekombinantni fuzijski protein koagulacijskog faktora IX i albumina [rIX-FP]).
English: Inhibitor development was reported in an ongoing clinical study with previously untreated patients.
Croatian: Visoki titar inhibitora faktora IX razvio se u jednog prethodno neliječenog bolesnika iz kliničkog ispitivanja koje je još u tijeku.
English: 1 disposable 5 ml syringe 1 venipuncture set
Croatian: 1 štrcaljku od 5 ml za jednokratnu uporabu 1 set za venepunkciju
English: IDELVION 500 IU powder and solvent for solution for injection
Croatian: IDELVION 500 IU prašak i otapalo za otopinu za injekciju
English: Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper.
Croatian: Preokrenite bočicu s otapalom s pričvršćenim setom Mix2Vial i gurnite šiljak na kraju prozirnog nastavka ravno dolje kroz čep bočice s lijekom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 500 IU
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica s praškom od 500 IU
English: IDELVION 2000 IU powder and solvent for solution for injection
Croatian: IDELVION 2000 IU prašak i otapalo za otopinu za injekciju
English: Patients < 12 years of age
Croatian: Bolesnici u dobi
English: IDELVION 250 IU powder and solvent for solution for injection One vial contains nominally 250 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa).
Croatian: IDELVION 250 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 250 IU rekombinantnog fuzijskog proteina koagulacijskog faktora IX i albumina (rIX-FP), (INN=albutrepenonakog alfa).
English: IDELVION 1000 IU powder and solvent for solution for injection
Croatian: IDELVION 1000 IU prašak i otapalo za otopinu za injekciju
English: See the end of section 4 for how to report side effects.
Croatian: Pogledajte zadnji odlomak u dijelu 2.
English: IDELVION 1000 IU powder and solvent for solution for injection Powder (1000 IU) in a 6 ml vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Croatian: IDELVION 1000 IU prašak i otapalo za otopinu za injekciju Prašak (1000 IU) u bočici od 6 ml (staklo tipa I) zatvorenoj čepom (guma), pločicom (plastika) i zatvaračem (aluminij).
English: IDELVION 2000 IU powder and solvent for solution for injection One vial contains nominally 2000 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa).
Croatian: IDELVION 2000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 2000 IU rekombinantnog fuzijskog proteina koagulacijskog faktora IX i albumina (rIX-FP), (INN=albutrepenonakog alfa).
English: IDELVION 500 IU powder and solvent for solution for injection Powder (500 IU) in a 6 ml vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Croatian: IDELVION 500 IU prašak i otapalo za otopinu za injekciju Prašak (500 IU) u bočici od 6 ml (staklo tipa I) zatvorenoj čepom (guma), pločicom (plastika) i zatvaračem (aluminij).
English: One pack with 2000 IU containing: 1 vial with powder 1 vial with 5 ml water for injections 1 filter transfer device 20/20
Croatian: Jedno pakiranje s 250, 500 ili 1000 IU sadrži: 1 bočicu s praškom (sa ili bez RFID-a) 1 bočicu s 2,5 ml vode za injekcije 1 sustav za prijenos s filtrom 20/20
English: IDELVION 1000 IU powder and solvent for solution for injection One vial contains nominally 1000 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa).
Croatian: IDELVION 1000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 1000 IU rekombinantnog fuzijskog proteina koagulacijskog faktora IX i albumina (rIX-FP), (INN=albutrepenonakog alfa).
English: A peak level of 50 % of normal is required in a 20 kg patient with severe haemophilia B. The appropriate dose would be 20 kg x 50 IU/dl x 1 dl/kg = 1000 IUs.
Croatian: Prikladna doza bila bi 20 kg x 50 IU/dl x 1 dl/kg = 1000 IU.
English: IDELVION 500 IU powder and solvent for solution for injection One vial contains nominally 500 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa).
Croatian: IDELVION 500 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 500 IU rekombinantnog fuzijskog proteina koagulacijskog faktora IX i albumina (rIX-FP), (INN=albutrepenonakog alfa).
English: 250 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 100 IU/ml of albutrepenonacog alfa.
Croatian: 250 IU po bočici; nakon rekonstitucije s 2,5 ml vode za injekcije, otopina sadrži 100 IU/ml albutrepenonakoga alfa.
English: 500 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 200 IU/ml of albutrepenonacog alfa.
Croatian: 500 IU po bočici; nakon rekonstitucije s 2,5 ml vode za injekcije, otopina sadrži 200 IU/ml albutrepenonakoga alfa.
English: powder and solvent for solution for injection 1 vial with powder: 250 IU albutrepenonacog alfa (100 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections
Croatian: 1 bočica s praškom: 250 IU albutrepenonakoga alfa (100 IU/ml nakon rekonstitucije) 1 bočica s 2,5 ml vode za injekcije
English: powder and solvent for solution for injection 1 vial with powder: 2000 IU albutrepenonacog alfa (400 IU/ml after reconstitution) 1 vial with 5 ml water for injections
Croatian: 1 bočica s praškom: 2000 IU albutrepenonakoga alfa (400 IU/ml nakon rekonstitucije) 1 bočica s 5 ml vode za injekcije
English: IDELVION 250 IU powder for solution for injection Albutrepenonacog alfa
Croatian: IDELVION 250 IU prašak za otopinu za injekciju albutrepenonakog alfa
English: Blood and lymphatic disorders
Croatian: Stupanj krvarenja / vrsta kirurškog zahvata
English: powder and solvent for solution for injection 1 vial with powder: 500 IU albutrepenonacog alfa (200 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections
Croatian: 1 bočica s praškom: 500 IU albutrepenonakoga alfa (200 IU/ml nakon rekonstitucije) 1 bočica s 2,5 ml vode za injekcije
English: 2000 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 400 IU/ml of albutrepenonacog alfa.
Croatian: 2000 IU po bočici; nakon rekonstitucije s 5 ml vode za injekcije, otopina sadrži 400 IU/ml albutrepenonakoga alfa.
English: After reconstitution with 5 ml water for injections the solution contains 400 IU/ml of albutrepenonacog alfa.
Croatian: Nakon rekonstitucije s 5 ml vode za injekcije otopina sadrži 400 IU/ml albutrepenonakoga alfa.
English: IDELVION 2000 IU powder for solution for injection Albutrepenonacog alfa
Croatian: IDELVION 2000 IU prašak za otopinu za injekciju albutrepenonakog alfa
English: After reconstitution with 2.5 ml water for injections the solution contains 200 IU/ml of albutrepenonacog alfa.
Croatian: Nakon rekonstitucije s 2,5 ml vode za injekcije otopina sadrži 200 IU/ml albutrepenonakoga alfa.
English: IDELVION 500 IU powder for solution for injection Albutrepenonacog alfa
Croatian: IDELVION 500 IU prašak za otopinu za injekciju albutrepenonakog alfa
English: 1000 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 400 IU/ml of albutrepenonacog alfa.
Croatian: 1000 IU po bočici; nakon rekonstitucije s 2,5 ml vode za injekcije, otopina sadrži 400 IU/ml albutrepenonakoga alfa.
English: IDELVION 1000 IU powder for solution for injection Albutrepenonacog alfa
Croatian: IDELVION 1000 IU prašak za otopinu za injekciju albutrepenonakog alfa
English: After reconstitution with 2.5 ml water for injections the solution contains 100 IU/ml of albutrepenonacog alfa.
Croatian: Nakon rekonstitucije s 2,5 ml vode za injekcije otopina sadrži 100 IU/ml albutrepenonakoga alfa.
English: powder and solvent for solution for injection 1 vial with powder: 1000 IU albutrepenonacog alfa (400 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections
Croatian: 1 bočica s praškom: 1000 IU albutrepenonakoga alfa (400 IU/ml nakon rekonstitucije) 1 bočica s 2,5 ml vode za injekcije
English: NN:
Croatian: (h)
English: IDELVION 500 IU powder and solvent for solution for injection Albutrepenonacog alfa
Croatian: IDELVION 500 IU prašak i otapalo za otopinu za injekciju albutrepenonakog alfa
English: IDELVION 250 IU powder and solvent for solution for injection Albutrepenonacog alfa
Croatian: IDELVION 250 IU prašak i otapalo za otopinu za injekciju albutrepenonakog alfa
English: After reconstitution with 2.5 ml water for injections the solution contains 400 IU/ml of albutrepenonacog alfa.
Croatian: Nakon rekonstitucije s 2,5 ml vode za injekcije otopina sadrži 400 IU/ml albutrepenonakoga alfa.
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava preosjetljivost manje često
English: Type of surgical procedure
Croatian: Veći kirurški zahvati
English: IDELVION 1000 IU powder and solvent for solution for injection Albutrepenonacog alfa
Croatian: IDELVION 1000 IU prašak i otapalo za otopinu za injekciju albutrepenonakog alfa
English: IDELVION 2000 IU powder and solvent for solution for injection Albutrepenonacog alfa
Croatian: IDELVION 2000 IU prašak i otapalo za otopinu za injekciju albutrepenonakog alfa
English: 1 disposable 10 ml syringe 1 venipuncture set 2 alcohol swabs
Croatian: 1 štrcaljku od 10 ml za jednokratnu uporabu 1 set za venepunkciju
English: Attach the syringe to the threaded, locking end of the venipuncture kit.
Croatian: Pričvrstite štrcaljku na navojni, priključni dio seta za venepunkciju.
English: Cmax (IU/dl)
Croatian: Prirast po jedinici doze (IU/dl)/(IU/kg) Cmax (IU/dl)
English: • If you get any side effects talk to your doctor, pharmacist or nurse.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: This may be painful and can occur at any time.
Croatian: To može biti bolno i dogoditi se u bilo kojem trenutku.
English: Tell your doctor straight away if you have any of the following side effects…:
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koju od sljedećih nuspojava...:
English: 2 - What you need to know before you take <product name> Warnings and precautions
Croatian: 2 - Što morate znati prije nego počnete uzimati lijek <naziv lijeka> Upozorenja i mjere opreza
English: 4 - Possible side effects
Croatian: 4 - Moguće nuspojave
English: Adopted at the 28 November-1 December 2016 PRAC
Croatian: Usvojeno na sjednici PRAC-a 28. studenoga - 1. prosinca 2016.
English: Benign polyps in the stomach
Croatian: Dobroćudni polipi u želucu
English: Frequency: common
Croatian: Učestalost: često
English: During treatment, boys and adolescents may unexpectedly experience prolonged erections.
Croatian: Dječaci i adolescenti tijekom liječenja mogu doživjeti produljene erekcije.
English: The condition is mainly observed in patients with end-stage renal disease on dialysis or in patients with known risk factors such as protein C or S deficiency, hyperphosphataemia, hypercalcaemia or hypoalbuminaemia.
Croatian: To je stanje uglavnom prisutno u bolesnika s bubrežnom bolešću u završnom stadiju koji primaju dijalizu ili u bolesnika s poznatim rizičnim faktorima kao što su manjak proteina C ili S, hiperfosfatemija, hiperkalcemija ili hipoalbuminemija.
English: Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
Croatian: Bolesnici kod kojih se javljaju abnormalno duge ili česte i bolne erekcije odmah trebaju zatražiti liječničku pomoć.
English: In case calciphylaxis is diagnosed, appropriate treatment should be started and consideration should be given to stopping treatment with <product name>.
Croatian: U slučaju dijagnoze kalcifilaksije, potrebno je započeti odgovarajuće liječenje te razmotriti prestanak liječenja lijekom <naziv lijeka>.
English: Summary of product characteristics (both prescription and non-prescription) 4.8.
Croatian: Sažetak opisa svojstava lijeka (na liječnički recept i bez liječničkog recepta) 4.8.
English: Prolonged and painful erections have been reported in association with methylphenidate products, mainly in association with a change in the methylphenidate treatment regimen.
Croatian: Dugotrajne i bolne erekcije zabilježene su u vezi s lijekovima koji sadrže metilfenidat, uglavnom nakon što dođe do promjene u režimu liječenja metilfenidatom.
English: A painful skin rash.
Croatian: Bolan osip na koži.
English: On rare occasions <product name> can cause serious skin conditions, including one called calciphylaxis that can start with a painful skin rash but can lead to serious complications.
Croatian: U rijetkim slučajevima <naziv lijeka> može prouzročiti ozbiljna stanja na koži, uključujući kalcifilaksiju, koja može započeti kao bolan osip na koži, ali može dovesti do ozbiljnih komplikacija.
English: Prolonged erections, sometimes painful, or an increased number of erections Frequency: not known
Croatian: Produljene erekcije, ponekad bolne ili povećan broj erekcija Učestalost: nepoznato
English: Priapism.
Croatian: Nuspojave
English: Proton pump inhibitors (PPIs): dexlansoprazole; esomeprazole; lansoprazole; omeprazole ; pantoprazole; rabeprazole - Gastric polyps (EPITT no 18725)
Croatian: Inhibitori protonske pumpe (IPP-ovi): dekslanzoprazol; esomeprazol; lanzoprazol; omeprazol; pantoprazol; rabeprazol - Želučani polipi (EPITT br. 18725)
English: Undesirable effects Skin and subcutaneous tissue disorders Frequency ‘not known': Calciphylaxis
Croatian: Poremećaji kože i potkožnog tkiva Učestalost „nepoznato”: Kalcifilaksija
English: Methylphenidate - Priapism (EPITT no 18719)
Croatian: Metilfenidat - Prijapizam (EPITT br. 18719)
English: Summary of product characteristics (fluindione, phenindione)
Croatian: Sažetak opisa svojstava lijeka (fluindion, fenindion)
English: Package leaflet (acenocoumarol, phenprocoumon) 4 - Possible side effects
Croatian: Uputa o lijeku (acenokumarol, fenprokumon) 4 - Moguće nuspojave
English: Reproductive system and breast disorders Priapism, erection increased and prolonged erection Frequency: not known
Croatian: Poremećaji reproduktivnog sustava i dojki Prijapizam, povećana i produljena erekcija Učestalost: nepoznato
English: Bullous or exfoliative Exfoliative and bullous skin lesions, including bullous pemphigoid Frequency: not known
Croatian: Bullous or exfoliative Eksfolijativne i bulozne kožne lezije, uključujući bulozni pemfigoid Učestalost: nepoznato