FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal impairment - Fondaparinux should be used with caution in patients with moderate renal impairment (see section 4.4).
Croatian: Oštećenje bubrega - Fondaparinuks treba primjenjivati s oprezom u bolesnika s umjerenim bubrežnim oštećenjem (vidjeti dio 4.4).
English: Discard the needle shield.
Croatian: Odložite štitnik igle.
English: Syringe with a manual needle protection system Picture 2.
Croatian: Slika 2: Štrcaljka s ručnim sigurnosnim sustavom za iglu
English: It is supplied in a pre-filled, single-use syringe fitted with a safety system to help prevent needle stick injuries after use.
Croatian: Dostupna je u napunjenoj štrcaljki za jednokratnu uporabu opremljenoj sa sigurnosnim sustavom za iglu u svrhu zaštite od slučajnog uboda iglom nakon injiciranja.
English: • 5 mg fondaparinux sodium in 0.4 ml solution for injection
Croatian: • 5 mg fondaparinuksnatrija u 0,4 ml otopine za injekcije
English: Arixtra 5 mg/0.4 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Croatian: Arixtra 5 mg/0,4 ml dostupna je u pakiranjima s 2, 7, 10 ili 20 napunjenih štrcaljki.
English: The recommended dose of fondaparinux is 2.5 mg once daily, administered by subcutaneous injection.
Croatian: Preporučena doza fondaparinuksa je 2,5 mg jednom dnevno, primijenjenog supkutanom injekcijom.
English: Hepatobiliary disorders Uncommon: abnormal liver function, hepatic enzymes increased
Croatian: Manje često: povišena razina jetrenih enzima, poremećaj funkcije jetre
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Nositelj odobrenja za stavljanje gotovog lijeka u promet
English: Rare: dyspnoea, coughing
Croatian: Rijetko: dispneja, kašalj
English: There are no data regarding the use of fondaparinux 2.5 mg in superficial-vein thrombosis patients with concomitant DVT or with superficial-vein thrombosis within 3 cm of the sapheno-femoral junction (see section 4.2 and 5.1).
Croatian: Nema podataka o upotrebi fondaparinuksa od 2,5 mg u bolesnika s površinskom venskom trombozom i pratećom DVT
English: Hold the fold between the thumb and the forefinger during the entire injection (picture C).
Croatian: Cijelo vrijeme injiciranja držite kožni nabor palcem i kažiprstom. (Slika C).
English: Each pre-filled syringe contains 5 mg of fondaparinux sodium in 0.4 ml solution for injection.
Croatian: Jedna napunjena štrcaljka sadržava 5 mg fondaparinuksnatrija u 0,4 ml otopine za injekciju.
English: • The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection
Croatian: • Djelatna tvar je 1,5 mg fondaparinuksnatrija u 0,3 ml otopine za injekcije.
English: Clinical experience is limited in patients with body weight <50 kg. Fondaparinux should be used with caution at a daily dose of 5 mg in this population (see sections 4.2 and 5.2).
Croatian: U toj populaciji fondaparinuks treba koristiti uz oprez pri dnevnoj dozi od 5 mg (vidjeti dio 4.2 i 5.2).
English: Fondaparinux should be used with caution in these patients (see section 4.4).
Croatian: Fondaparinuks treba koristiti uz oprez u takvih bolesnika (vidjeti dio 4.4).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium.
Croatian: Jedna napunjena štrcaljka (0,8 ml) sadrži 10 mg fondaparinuksnatrija.
English: Rare: other bleeding (hepatic, retroperitoneal, intracranial/intracerebral), thrombocythaemia
Croatian: Rijetko: drugo krvarenje (hepatičko, retroperitonealno,
English: PCI and risk of guiding catheter thrombus
Croatian: Perkutana koronarna intervencija i rizik od nastanka tromba u provodnom kateteru
English: Peri-PCI major bleeding
Croatian: Peri-PCI veliko krvarenje
English: Twelve (0.37%) enrolled patients experienced thrombus in the arterial sheath, of these 7 were reported during angiography and 5 were reported during PCI.
Croatian: U dvanaest je bolesnika (0,37%) došlo do tromboze u arterijskoj uvodnici, od čega 7
English: Fondaparinux should be used with caution in these patients (see section 4.2).
Croatian: Fondaparinuks treba koristiti uz oprez u takvih bolesnika (vidjeti dio 4.2).
English: Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije Što Arixtra sadrži
English: • syringe with a orange plunger and an automatic safety system
Croatian: • štrcaljka s narančastim klipom i automatskim sigurnosnim sustavom za iglu
English: OTHER SPECIAL WARNING(S), IF NECESSARY Body weight below 50 kg
Croatian: • ako ste stariji od 75 godina • ako Vam je tjelesna težina manja od 50 kg.
English: Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Parenteralne otopine treba prije uporabe pregledati na prisutnost stranih čestica i promjenu boje.
English: Arixtra 10 mg/0.8 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Croatian: Arixtra 10 mg/0,8 ml dostupna je u pakiranjima s 2,7,10 ili 20 napunjenih štrcaljki.
English: For patients receiving primary PCI, the incidence of severe haemorrhage was 1.0% for fondaparinux and 0.4% for controls.
Croatian: U bolesnika podvrgnutih primarnoj perkutanoj koronarnoj intervenciji, incidencija velikog krvarenja iznosila je 1,0% u skupini liječenoj fondaparinuksom, a 0,4% u kontrolnoj skupini.
English: Treatment of unstable angina (UA) or non-ST segment elevation myocardial infarction (NSTEMI) in patients who underwent subsequent PCI with adjunctive UFH
Croatian: Liječenje nestabilne angine ili infarkta miokarda bez elevacije ST segmenta (UA/NSTEMI)
English: Prevention of Venous Thromboembolic Events (VTE) in medical patients who are at high risk for thromboembolic complications due to restricted mobility during acute illness In a randomised double-blind clinical trial, 839 patients were treated with fondaparinux 2.5 mg once daily or placebo for 6 to 14 days.
Croatian: U randomiziranom dvostruko slijepom kliničkom ispitivanju, 839 bolesnika primalo je ili fondaparinuks 2,5 mg jednom na dan ili placebo tijekom 6 - 14 dana.
English: • if you have severe kidney disease.
Croatian: • ako imate tešku bolest bubrega.
English: • drowsiness or tiredness
Croatian: • pospanost ili umor
English: Uncommon: oedema, oedema peripheral, fever, wound secretion
Croatian: Manje često: edemi, periferni edem,
English: Arixtra 10 mg/0.8 ml solution for injection, pre-filled syringe.
Croatian: Arixtra 10 mg/0,8 ml otopina za injekciju, napunjena štrcaljka
English: Prevention of Venous Thromboembolic Events (VTE) in patients undergoing hip fracture surgery treated for up to 24 days following an initial prophylaxis of 1 week In a randomised double-blind clinical trial, 737 patients were treated with fondaparinux 2.5 mg once daily for 7 +/- 1 days following hip fracture surgery.
Croatian: U randomiziranom dvostruko slijepom kliničkom ispitivanju, 737 bolesnika liječeno je fondaparinuksom 2,5 mg jednom na dan tijekom 7 +/- 1 dana nakon operacije prijeloma kuka.
English: Common: post-operative haemorrhage, anaemia Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder
Croatian: Manje često: krvarenje (epistaksa, gastrointestinalno krvarenje, hemoptiza, hematurija, hematomi) trombocitopenija, purpura,
English: • oozing from operation wound site
Croatian: • iscjedak na mjestu kirurške rane
English: • syringe with blue plunger and a manual safety system.
Croatian: • štrcaljka s plavim klipom i ručnim sigurnosnim sustavom za iglu.
English: Picture 1.
Croatian: PRILOG II.
English: Package leaflet: Information for the user Arixtra 2.5 mg/0.5 ml solution for injection fondaparinux sodium
Croatian: Uputa o lijeku: Informacije za korisnika Arixtra 2,5 mg/0,5 ml otopina za injekciju fondaparinuksnatrij
English: It is supplied in a pre-filled syringe fitted with a safety system to help prevent needle stick injuries after use.
Croatian: Dostupna je u napunjenoj štrcaljki opremljenoj sa sigurnosnim sustavom za iglu u svrhu zaštite od slučajnog uboda iglom nakon injiciranja.
English: Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
Croatian: Arixtra 7,5 mg/0,6 ml otopina za injekciju, napunjena štrcaljka.
English: • dizziness
Croatian: • svrbež
English: Package leaflet: Information for the user Arixtra 1.5 mg/0.3 ml solution for injection fondaparinux sodium
Croatian: Uputa o lijeku: Informacije za korisnika Arixtra 1,5 mg/0,3 ml otopina za injekciju fondaparinuksnatrij
English: This unlocks the sleeve.
Croatian: Na taj način se otpusti valjak.
English: Peri-PCI major or minor bleeding, or major vascular access site complications
Croatian: Primarni Peri-PCI veliko ili manje krvarenje,
English: Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe.
Croatian: Arixtra 1,5 mg/0,3 ml otopina za injekciju, napunjena štrcaljka
English: Therefore, fondaparinux is not recommended for treatment of superficial-vein thrombosis in these patients (see section 4.2).
Croatian: Stoga se primjena fondaparinuksa ne preporuča u ovoj skupini bolesnika (vidjeti dio 4.2).
English: • increase in some chemical (enzymes) produced by the liver
Croatian: • porast razine bilirubina (tvari koju proizvodi jetra) u krvi
English: • Treatment of UA/NSTEMI and STEMI - Fondaparinux should not be used in patients with creatinine clearance < 20 ml/min (see section 4.3).
Croatian: • Liječenje UA/NSTEMI i STEMI - Fondaparinuks ne treba koristiti u bolesnika s klirensom kreatinina <20 ml/min (vidjeti dio 4.3).
English: NAME OF THE MEDICINAL PRODUCT Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
Croatian: Arixtra 10 mg/0,8 ml otopina za injekciju fondaparinuks
English: • increase in some chemicals (enzymes) produced by the liver.
Croatian: • povišene razine nekih jetrenih enzima.
English: This study included acutely ill medical patients, aged ≥ 60 years, expected to require bed rest for at least four days, and hospitalized for congestive heart failure NYHA class III/IV and/or acute respiratory illness and/or acute infectious or inflammatory disease.
Croatian: dana, a koji su hospitalizirani zbog kongestivnog zatajenja srca (NYHA stupanj III/IV) i/ili akutne bolesti dišnog sustava i/ili akutne zarazne ili upalne bolesti.
English: • syringe with orange plunger and a manual safety system.
Croatian: • štrcaljka s narančastim klipom i ručnim sigurnosnim sustavom za iglu
English: The mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients with VTE receiving the fondaparinux proposed dose regimen once daily are: Cmax (mg/l) - 1.41 (23 %), Tmax (h) - 2.4 (8%) and Cmin (mg/l) -0.52 (45 %).
Croatian: Prosječne vrijednosti (CV%) farmakokinetičkih parametara fondaparinuksa u stanju dinamičke ravnoteže u bolesnika s VTE koji su primali preporučene doze fondaparinuksa jednom na dan iznose: Cmax (mg/l) - 1,41 (23 %),
English: • syringe with a violet plunger and an automatic safety system
Croatian: • štrcaljka s ljubičastim klipom i automatskim sigurnosnim sustavom za iglu
English: Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe.
Croatian: Arixtra 2,5 mg/0,5 ml otopina za injekciju, napunjena štrcaljka
English: Usual dose
Croatian: Rijetke nuspojave
English: • diarrhoea or constipation
Croatian: • mučnina ili povraćanje
English: NAME OF THE MEDICINAL PRODUCT Arixtra 1.5 mg/0.3 ml solution for injection fondaparinux sodium
Croatian: Arixtra 1,5 mg/0,3 ml otopina za injekciju fondaparinuks
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.6 ml) contains 7.5 mg fondaparinux sodium.
Croatian: Jedna napunjena štrcaljka (0,6 ml) sadrži 7,5 mg fondaparinuksnatrija.
English: Arixtra 5 mg/0.4 ml solution for injection, pre-filled syringe.
Croatian: Arixtra 5 mg/0,4 ml otopina za injekciju, napunjena štrcaljka
English: Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium.
Croatian: Jedna napunjena štrcaljka (0,5 ml) sadrži 2,5 mg fondaparinuksnatrija.
English: Instruction for self-administration is mentioned in the Package Leaflet.
Croatian: Upute za samoinjiciranje navedene su u uputi o lijeku.
English: Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium.
Croatian: Jedna napunjena štrcaljka (0,3 ml) sadrži 1,5 mg fondaparinuksnatrija.
English: NAME OF THE MEDICINAL PRODUCT Arixtra 2.5 mg/0.5 ml solution for injection fondaparinux sodium
Croatian: Arixtra 2,5 mg/0,5 ml otopina za injekciju fondaparinuks
English: What Arixtra is and what it is used for What you need to know before you use Arixtra How to use Arixtra
Croatian: Sadržaj pakiranja i druge informacije Što je Arixtra i za što se koristi
English: EU/1/02/206/024 - 2 pre-filled syringes with a manual safety system EU/1/02/206/025 - 10 pre-filled syringes with a manual safety system EU/1/02/206/026 - 20 pre-filled syringes with a manual safety system
Croatian: EU/1/02/206/024 - 2 napunjene štrcaljke sa ručnim sigurnosnim sustavom EU/1/02/206/025 - 10 napunjenih štrcaljki sa ručnim sigurnosnim sustavom EU/1/02/206/026 - 20 napunjenih štrcaljki sa ručnim sigurnosnim sustavom
English: • Prevention of VTE - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Croatian: • Prevencija VTE - Fondaparinuks se ne smije primijeniti u bolesnika s klirensom kreatinina <20 ml/min (vidjeti dio 4.3).
English: EU/1/02/206/027 - 2 pre-filled syringes with a manual safety system EU/1/02/206/028 - 10 pre-filled syringes with a manual safety system EU/1/02/206/033 - 20 pre-filled syringes with a manual safety system
Croatian: EU/1/02/206/027 - 2 napunjene štrcaljke sa ručnim sigurnosnim sustavom EU/1/02/206/028 - 10 napunjenih štrcaljki sa ručnim sigurnosnim sustavom EU/1/02/206/033 - 20 napunjenih štrcaljki sa ručnim sigurnosnim sustavom
English: If you inject too much Arixtra
Croatian: Ako primijenite više lijeka Arixtra nego što ste trebali
English: EU/1/02/206/031 - 2 pre-filled syringes with a manual safety system EU/1/02/206/032 - 10 pre-filled syringes with a manual safety system EU/1/02/206/035 - 20 pre-filled syringes with a manual safety system
Croatian: EU/1/02/206/031 - 2 napunjene štrcaljke sa ručnim sigurnosnim sustavom EU/1/02/206/032 - 10 napunjenih štrcaljki sa ručnim sigurnosnim sustavom EU/1/02/206/035 - 20 napunjenih štrcaljki sa ručnim sigurnosnim sustavom
English: NAME OF THE MEDICINAL PRODUCT Arixtra 7.5 mg/0.6 ml solution for injection fondaparinux sodium
Croatian: Arixtra 7,5 mg/0,6 ml otopina za injekciju fondaparinuks
English: EU/1/02/206/015 - 2 pre-filled syringes with an automatic safety system EU/1/02/206/016 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/017 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/020 - 20 pre-filled syringe with an automatic safety system
Croatian: EU/1/02/206/015 - 2 napunjene štrcaljke sa automatskim sigurnosnim sustavom EU/1/02/206/016 - 7 napunjenih štrcaljki sa automatskim sigurnosnim sustavom EU/1/02/206/017 - 10 napunjenih štrcaljki sa automatskim sigurnosnim sustavom EU/1/02/206/020 - 20 napunjenih štrcaljki sa automatskim sigurnosnim sustavom
English: EU/1/02/206/021 - 2 pre-filled syringes with a manual safety system EU/1/02/206/022 - 10 pre-filled syringes with a manual safety system EU/1/02/206/023 - 20 pre-filled syringes with a manual safety system
Croatian: EU/1/02/206/021 - 2 napunjene štrcaljke sa ručnim sigurnosnim sustavom EU/1/02/206/022 - 10 napunjenih štrcaljki sa ručnim sigurnosnim sustavom EU/1/02/206/023 - 20 napunjenih štrcaljki sa ručnim sigurnosnim sustavom
English: • Treatment of superficial-vein thrombosis - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Croatian: • Liječenje površinske venske tromboze - Fondaparinuks ne treba koristiti u bolesnika s klirensom kreatinina <20 ml/min (vidjeti dio 4.3).
English: EU/1/02/206/005- 2 pre-filled syringes with an automatic safety system EU/1/02/206/006 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/007 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/008 - 20 pre-filled syringes with an automatic safety system
Croatian: EU/1/02/206/005 - 2 napunjene štrcaljke sa automatskim sigurnosnim sustavom EU/1/02/206/006 - 7 napunjenih štrcaljki sa automatskim sigurnosnim sustavom EU/1/02/206/007 - 10 napunjenih štrcaljki sa automatskim sigurnosnim sustavom EU/1/02/206/008 - 20 napunjenih štrcaljki sa automatskim sigurnosnim sustavom
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.4 ml) contains 5 mg fondaparinux sodium.
Croatian: Jedna napunjena štrcaljka (0,4 ml) sadrži 5 mg fondaparinuksnatrija.
English: Haemorrhage
Croatian: Česte nuspojave
English: EU/1/02/206/012- 2 pre-filled syringes with an automatic safety system EU/1/02/206/013 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/014 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/019 - 20 pre-filled syringe with an automatic safety system
Croatian: EU/1/02/206/012 - 2 napunjene štrcaljke sa automatskim sigurnosnim sustavom EU/1/02/206/013 - 7 napunjenih štrcaljki sa automatskim sigurnosnim sustavom EU/1/02/206/014 - 10 napunjenih štrcaljki sa automatskim sigurnosnim sustavom EU/1/02/206/019 - 20 napunjenih štrcaljki sa automatskim sigurnosnim sustavom
English: NAME OF THE MEDICINAL PRODUCT Arixtra 5 mg/0.4 ml solution for injection fondaparinux sodium
Croatian: Arixtra 5 mg/0,4 ml otopina za injekciju fondaparinuks
English: Treatment of ST segment elevation myocardial infarction (STEMI) The recommended dose of fondaparinux is 2.5 mg once daily.
Croatian: Preporučena doza fondaparinuksa je 2,5 mg jedanput na dan.
English: Uncommon: headache Rare: dizziness
Croatian: Manje često: dispneja
English: EU/1/02/206/001 - 2 pre-filled syringes with an automatic safety system EU/1/02/206/002 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/003 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/004 - 20 pre-filled syringes with an automatic safety system
Croatian: EU/1/02/206/001 - 2 napunjene štrcaljke sa automatskim sigurnosnim sustavom EU/1/02/206/002 - 7 napunjenih štrcaljki sa automatskim sigurnosnim sustavom EU/1/02/206/003 - 10 napunjenih štrcaljki sa automatskim sigurnosnim sustavom EU/1/02/206/004 - 20 napunjenih štrcaljki sa automatskim sigurnosnim sustavom
English: EU/1/02/206/009- 2 pre-filled syringes with an automatic safety system EU/1/02/206//010 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/011 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/018 - 20 pre-filled syringe with an automatic safety system
Croatian: EU/1/02/206/009 - 2 napunjene štrcaljke sa automatskim sigurnosnim sustavom EU/1/02/206/010 - 7 napunjenih štrcaljki sa automatskim sigurnosnim sustavom EU/1/02/206/011 - 10 napunjenih štrcaljki sa automatskim sigurnosnim sustavom EU/1/02/206/018 - 20 napunjenih štrcaljki sa automatskim sigurnosnim sustavom
English: Fondaparinux should be used with caution in patients with a history of HIT.
Croatian: Bolesnici s trombocitopenijom izazvanom heparinom Fondaparinuks treba primjenjivati s oprezom u bolesnika s anamnezom HIT-a.
English: Arixtra 7.5 mg/0.6 ml solution for injection Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
Croatian: Uputa o lijeku: Informacije za korisnika Arixtra 5 mg/0,4 ml otopina za injekciju Arixtra 7,5 mg/0,6 ml otopina za injekciju Arixtra 10 mg/0,8 ml otopina za injekciju fondaparinuksnatrij
English: Aspen Pharma Trading Limited Teл.
Croatian: Aspen Pharma Trading Limited Tel: 00420
English: • chest pain
Croatian: • otežana probava
English: Common: bleeding (haematoma, haematuria, haemoptysis, gingival bleeding) Uncommon: anaemia
Croatian: Često: krvarenje (hematomi, hematurija, hemoptiza, krvarenje desni)
English: What Arixtra contains
Croatian: Kako Arixtra izgleda i sadržaj pakiranja
English: Fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50kg, ≤ 100 kg) or 10 mg (body weight >100 kg) SC once daily was compared to unfractionated heparin IV bolus (5,000 IU) followed by a continuous IV infusion adjusted to maintain 1.5-2.5 times aPTT control value.
Croatian: Fondaparinuks u dozi od 5 mg (tjelesna težina <50 kg), 7,5 mg (tjelesna težina ≥50 kg, ≤100 kg) ili 10 mg (tjelesna težina >100 kg)
English: Secondary
Croatian: UPOTREBE
English: Treatment of adults with acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.
Croatian: (PE), osim u hemodinamski nestabilnih bolesnika ili bolesnika kojima je potrebna tromboliza ili embolektomija pluća.
English: • syringe with a yellow plunger and an automatic safety system
Croatian: • štrcaljka s ružičastim klipom i automatskim sigurnosnim sustavom za iglu
English: SN:
Croatian: PC: SN: NN:
English: Syringe with a manual needle protection system
Croatian: Štrcaljka s ručnim sigurnosnim sustavom za iglu.
English: Parts of the syringes: 1 Needle shield 2 Plunger 3 Finger-grip 4 Security sleeve
Croatian: Otopina za injekciju, 2 napunjene štrcaljke sa ručnim sigurnosnim sustavom
English: Prophylaxis of VTE - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Croatian: • Profilaksa VTE - Fondaparinuks se ne smije primijeniti u bolesnika s klirensom kreatinina <20 ml/min (vidjeti dio 4.3).
English: All patients received standard medical treatment for UA/NSTEMI, with 34% of patients undergoing PCI and 9% undergoing CABG.
Croatian: 34% podvrgnuto perkutanoj koronarnoj intervenciji, a 9% ugradnji koronarne premosnice.
English: Aspen Pharma Trading Limited Tel.: 008001211566/+44 (0)1423 852 859 aspenmedinfo@professionalinformation.co.uk
Croatian: Aspen Pharma Trading Limited Tél/Tel: 0035 227861279 aspenmedinfo@professionalinformation.co.uk
English: Aspen Pharma Trading Limited Tlf: 80010093/+44 (0)1423 852 995 aspenmedinfo@professionalinformation.co.uk
Croatian: Aspen Pharma Trading Limited Tel: 0039 0687502429 aspenmedinfo@professionalinformation.co.uk
English: Hepatobiliary disorders Uncommon: hepatic enzymes increased, hepatic function abnormal
Croatian: Manje često: poremećaj funkcije jetre, povišene razine jetrenih enzima Poremećaji kože i potkožnog tkiva Rijetko: eritematozni osip, pruritus
English: • stomach pain
Croatian: • bolovi u trbuhu
English: Primary
Croatian: Većina
English: SC
Croatian: Na s.c.
English: Aspen Pharma Trading Limited Τηλ: 80096374/+44 (0)1423 852 990 aspenmedinfo@professionalinformation.co.uk
Croatian: Aspen Pharma Trading Limited Tel: 00356 21497982 aspenmedinfo@professionalinformation.co.uk
English: It is available as tablets (500 micrograms).
Croatian: Dostupan je u obliku tableta (500 mikrograma).
English: This summary was last updated in 03-2015.
Croatian: Ovaj je sažetak posljednji put ažuriran u 03.2015.
English: FEV1 is the most air a person can breathe out in one second.
Croatian: FEV1 je najveća količina zraka koji osoba može izdahnuti u jednoj sekundi.
English: The tablets should be swallowed with water at the same time each day.
Croatian: Tablete se gutaju s malo vode svaki dan u isto vrijeme.
English: The company is also carrying out an observational study on the long-term safety of the medicine.
Croatian: Proizvođač lijeka također provodi opservacijsko ispitivanje o dugoročnoj sigurnosti lijeka.
English: This authorisation was based on the authorisation granted to Daxas in 2010 (‘informed consent').
Croatian: Odobrenje se temeljilo na odobrenju danom lijeku Daxas 2010. godine („informirani pristanak”).
English: The full EPAR for Daliresp can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Daliresp nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The card will include an area where patients can record their weight.
Croatian: Kartica će uključivati dio gdje bolesnici mogu bilježiti svoju težinu.
English: The recommended dose of Daliresp is one tablet once a day.
Croatian: Preporučena doza lijeka Daliresp je jedna tableta jedanput na dan.