natgillin/translations-raw huggingface dataset:
• 7.5 mg fondaparinux sodium in 0.6 ml solution for injection
• 7,5 mg fondaparinuksnatrija u 0,6 ml otopine za injekcije
By binding selectively to ATIII, fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII.
Selektivnim vezanjem na AT III, fondaparinuks pojačava (oko 300 puta) prirodnu neutralizaciju faktora Xa antitrombinom III.
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a bromobutyl or chlorobutyl elastomer plunger stopper.
Staklena štrcaljka (1 ml) (staklo tipa I) s gumenim klipom (brombutil ili klorbutil guma) i pričvršćenom injekcijskom iglom (G 27 x 12,7 mm).
The needle shield of the pre-filled syringe may contain dry natural latex rubber that has the potential to cause allergic reactions in latex sensitive individuals.
Štitnik za iglu na napunjenoj štrcaljki može sadržavati suhu prirodnu lateks gumu koja može izazvati alergijsku reakciju u osoba preosjetljivih na lateks.
• after the expiry date shown on the label and carton
• ako je istekao rok valjanosti otisnut na pakiranju
The solution is a clear and colourless to slightly yellow liquid.
Otopina je bistra i bezbojna do žućkasta tekućina.
• low number of platelets (blood cells necessary for blood clotting)
• smanjenje broja krvnih pločica (krvnih stanica neophodnih za zgrušavanje krvi)
METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
NAČIN I PUT(EVI) PRIMJENE LIJEKA
This stops a clotting factor Xa (“ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from forming in the blood vessels.
Arixtra sadržava fondaparinuksnatrij, sintetički spoj koji ometa djelovanje faktora zgrušavanja Xa („deset-A“) u krvi, te time sprječava nastanak neželjenih krvnih ugrušaka (tromboze) u krvnim žilama.
• syringe with yellow plunger and a manual safety system.
• štrcaljka s žutim klipom i ručnim sigurnosnim sustavom.
In subjects undergoing PCI the incidence of adjudicated guiding catheter thrombus was 1.0% vs. 0.3% in fondaparinux vs. enoxaparin subjects, respectively.
U bolesnika podvrgnutih PCI, incidencija tromboze u provodnom kateteru je iznosila 1,0% u fondaparinuks skupini vs 0,3% u enoksaparin skupini.
Syringe with a manual needle protection system showing security sleeve being pulled over needle AFTER USE
Slika 3. Prikaz štrcaljke s ručnim sigurnosnim sustavom za iglu sa zaštitnim valjkom prevučenim preko igle NAKON
Common: bleeding (gastrointestinal, haematuria, haematoma, epistaxis, haemoptysis, utero-vaginal haemorrhage, haemarthrosis, ocular, purpura, bruise)
Poremećaji krvi i limfnog sustava Često: krvarenje (gastrointestinalno krvarenje, hematurija, hematomi, epistaksa, hemoptiza, uterovaginalno krvarenje, hemartroza, krvarenje u oku, purpura, modrice)
• the solution is clear and colourless to slightly yellow and doesn't contain particles
• da je otopina bistra i bezbojna do žućkasta te da nema stranih čestica
Picture E
Slika E
Remove the needle shield, by first twisting it (picture B1) and then pulling it in a straight line away from the body of the syringe (picture B2).
Skinite štitnik s igle tako da ga najprije zavrnete (slika B1),
· recent surgery on the brain, spine or eye
· nedavno krvarenje u mozgu (intrakranijalno krvarenje) · nedavnu operaciju na mozgu, kralježnici ili oku
The corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.3% (13/559), 4.6% (17/368), 9.7% (14/145) and 11.1% (2/18) respectively, and in patients receiving the recommended regimen of unfractionated heparin in the treatment of PE were 6.9% (36/523), 3.1% (11/352), 11.1% (18/162) and 10.7% (3/28), respectively.
U bolesnika u istim skupinama prema bubrežnoj funkciji koji su primali preporučene doze enoksaparina za liječenje DVT, incidencija krvarenja bila je 2,3% (13/559), 4,6% (17/368), 9,7% (14/145) odnosno 11,1% (2/18), dok je u bolesnika koji su primali preporučene doze UFH za liječenje PE ona iznosila
• breathlessness
• omaglica
• if you have very severe kidney disease.
• ako imate vrlo tešku bolest bubrega.
Uncommon: nausea, vomiting Rare: abdominal pain, dyspepsia, gastritis, constipation, diarrhoea
Rijetko: bol u abdomenu, dispepsija, gastritis, konstipacija, proljev
No dosage reduction is required for patients with creatinine clearance > 20 ml/min.
U bolesnika s klirensom kreatinina >20 ml/min nije potrebno smanjenje doze.
• if you have severe liver disease
• ako imate vrlo tešku bolest bubrega
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a chlorobutyl elastomer plunger stopper.
Staklena štrcaljka (1 ml) (staklo tipa I) s gumenim klipom (klorbutil guma) i pričvršćenom injekcijskom iglom (G 27 x 12,7 mm).
Severe hepatic impairment
U bolesnika s teškim oštećenjem bubrega
The main sites of surgery were colonic/rectal, gastric, hepatic, cholecystectomy or other biliary.
Kirurški zahvati bili su uglavnom na debelom crijevu/rektumu, želucu, jetri i žučovodu ili je bila izvedena kolecistektomija.
In subjects undergoing primary PCI the incidence of adjudicated guiding catheter thrombus was 1.2% vs 0% in fondaparinux vs. control subjects, respectively.
U bolesnika koji su podvrgnuti primarnoj PCI, incidencija tromboze u provodnom kateteru je u fondaparinuks skupini iznosila 1,2% vs 0% u kontrolnih ispitanika.
No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min).
U bolesnika s blagim oštećenjem bubrega (klirens kreatinina >50 ml/min) nije potrebno smanjenje doze.
• treat blood clots in blood vessels that are near the surface of the skin of the legs (superficialvein thrombosis).
• za liječenje ugrušaka u venama koje se nalaze neposredno ispod površine kože donjih udova
Fondaparinux is known to be excreted mainly by the kidney.
Poznato je da se fondaparinuks najvećim dijelom izlučuje putem bubrega.
Arixtra 7.5 mg/0.6 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Arixtra 7,5 mg/0,6 ml dostupna je u pakiranjima s 2, 7, 10 ili 20 napunjenih štrcaljki.
Respiratory, thoracic and mediastinal disorders
trombocitemija, poremećaji trombocita, poremećaj koagulacije
Each pre-filled syringe contains 7.5 mg of fondaparinux sodium in 0.6 ml solution for injection.
Jedna napunjena štrcaljka sadržava 7,5 mg fondaparinuksnatrija u 0,6 ml otopine za injekciju.
Renal impairment - Fondaparinux should be used with caution in patients with moderate renal impairment (see section 4.4).
Oštećenje bubrega - Fondaparinuks treba primjenjivati s oprezom u bolesnika s umjerenim bubrežnim oštećenjem (vidjeti dio 4.4).
Discard the needle shield.
Odložite štitnik igle.
Syringe with a manual needle protection system Picture 2.
Slika 2: Štrcaljka s ručnim sigurnosnim sustavom za iglu
It is supplied in a pre-filled, single-use syringe fitted with a safety system to help prevent needle stick injuries after use.
Dostupna je u napunjenoj štrcaljki za jednokratnu uporabu opremljenoj sa sigurnosnim sustavom za iglu u svrhu zaštite od slučajnog uboda iglom nakon injiciranja.
• 5 mg fondaparinux sodium in 0.4 ml solution for injection
• 5 mg fondaparinuksnatrija u 0,4 ml otopine za injekcije
Arixtra 5 mg/0.4 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Arixtra 5 mg/0,4 ml dostupna je u pakiranjima s 2, 7, 10 ili 20 napunjenih štrcaljki.
The recommended dose of fondaparinux is 2.5 mg once daily, administered by subcutaneous injection.
Preporučena doza fondaparinuksa je 2,5 mg jednom dnevno, primijenjenog supkutanom injekcijom.
Hepatobiliary disorders Uncommon: abnormal liver function, hepatic enzymes increased
Manje često: povišena razina jetrenih enzima, poremećaj funkcije jetre
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Nositelj odobrenja za stavljanje gotovog lijeka u promet
Rare: dyspnoea, coughing
Rijetko: dispneja, kašalj
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).
Nema podataka o upotrebi fondaparinuksa od 2,5 mg u bolesnika s površinskom venskom trombozom i pratećom DVT
Hold the fold between the thumb and the forefinger during the entire injection (picture C).
Cijelo vrijeme injiciranja držite kožni nabor palcem i kažiprstom. (Slika C).
Each pre-filled syringe contains 5 mg of fondaparinux sodium in 0.4 ml solution for injection.
Jedna napunjena štrcaljka sadržava 5 mg fondaparinuksnatrija u 0,4 ml otopine za injekciju.
• The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection
• Djelatna tvar je 1,5 mg fondaparinuksnatrija u 0,3 ml otopine za injekcije.
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).
U toj populaciji fondaparinuks treba koristiti uz oprez pri dnevnoj dozi od 5 mg (vidjeti dio 4.2 i 5.2).
Fondaparinux should be used with caution in these patients (see section 4.4).
Fondaparinuks treba koristiti uz oprez u takvih bolesnika (vidjeti dio 4.4).
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium.
Jedna napunjena štrcaljka (0,8 ml) sadrži 10 mg fondaparinuksnatrija.
Rare: other bleeding (hepatic, retroperitoneal, intracranial/intracerebral), thrombocythaemia
Rijetko: drugo krvarenje (hepatičko, retroperitonealno,
PCI and risk of guiding catheter thrombus
Perkutana koronarna intervencija i rizik od nastanka tromba u provodnom kateteru
Peri-PCI major bleeding
Peri-PCI veliko krvarenje
Twelve (0.37%) enrolled patients experienced thrombus in the arterial sheath, of these 7 were reported during angiography and 5 were reported during PCI.
U dvanaest je bolesnika (0,37%) došlo do tromboze u arterijskoj uvodnici, od čega 7
Fondaparinux should be used with caution in these patients (see section 4.2).
Fondaparinuks treba koristiti uz oprez u takvih bolesnika (vidjeti dio 4.2).
Contents of the pack and other information
Sadržaj pakiranja i druge informacije Što Arixtra sadrži
• syringe with a orange plunger and an automatic safety system
• štrcaljka s narančastim klipom i automatskim sigurnosnim sustavom za iglu
OTHER SPECIAL WARNING(S), IF NECESSARY Body weight below 50 kg
• ako ste stariji od 75 godina • ako Vam je tjelesna težina manja od 50 kg.
Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
Parenteralne otopine treba prije uporabe pregledati na prisutnost stranih čestica i promjenu boje.
Arixtra 10 mg/0.8 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Arixtra 10 mg/0,8 ml dostupna je u pakiranjima s 2,7,10 ili 20 napunjenih štrcaljki.
For patients receiving primary PCI, the incidence of severe haemorrhage was 1.0% for fondaparinux and 0.4% for controls.
U bolesnika podvrgnutih primarnoj perkutanoj koronarnoj intervenciji, incidencija velikog krvarenja iznosila je 1,0% u skupini liječenoj fondaparinuksom, a 0,4% u kontrolnoj skupini.
Treatment of unstable angina (UA) or non-ST segment elevation myocardial infarction (NSTEMI) in patients who underwent subsequent PCI with adjunctive UFH
Liječenje nestabilne angine ili infarkta miokarda bez elevacije ST segmenta (UA/NSTEMI)
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.
U randomiziranom dvostruko slijepom kliničkom ispitivanju, 839 bolesnika primalo je ili fondaparinuks 2,5 mg jednom na dan ili placebo tijekom 6 - 14 dana.
• if you have severe kidney disease.
• ako imate tešku bolest bubrega.
• drowsiness or tiredness
• pospanost ili umor
Uncommon: oedema, oedema peripheral, fever, wound secretion
Manje često: edemi, periferni edem,
Arixtra 10 mg/0.8 ml solution for injection, pre-filled syringe.
Arixtra 10 mg/0,8 ml otopina za injekciju, napunjena štrcaljka
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.
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.
Common: post-operative haemorrhage, anaemia Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder
Manje često: krvarenje (epistaksa, gastrointestinalno krvarenje, hemoptiza, hematurija, hematomi) trombocitopenija, purpura,
• oozing from operation wound site
• iscjedak na mjestu kirurške rane
• syringe with blue plunger and a manual safety system.
• štrcaljka s plavim klipom i ručnim sigurnosnim sustavom za iglu.
Picture 1.
PRILOG II.
Package leaflet: Information for the user Arixtra 2.5 mg/0.5 ml solution for injection fondaparinux sodium
Uputa o lijeku: Informacije za korisnika Arixtra 2,5 mg/0,5 ml otopina za injekciju fondaparinuksnatrij
It is supplied in a pre-filled syringe fitted with a safety system to help prevent needle stick injuries after use.
Dostupna je u napunjenoj štrcaljki opremljenoj sa sigurnosnim sustavom za iglu u svrhu zaštite od slučajnog uboda iglom nakon injiciranja.
Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
Arixtra 7,5 mg/0,6 ml otopina za injekciju, napunjena štrcaljka.
• dizziness
• svrbež
Package leaflet: Information for the user Arixtra 1.5 mg/0.3 ml solution for injection fondaparinux sodium
Uputa o lijeku: Informacije za korisnika Arixtra 1,5 mg/0,3 ml otopina za injekciju fondaparinuksnatrij
This unlocks the sleeve.
Na taj način se otpusti valjak.
Peri-PCI major or minor bleeding, or major vascular access site complications
Primarni Peri-PCI veliko ili manje krvarenje,
Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe.
Arixtra 1,5 mg/0,3 ml otopina za injekciju, napunjena štrcaljka
Therefore, fondaparinux is not recommended for treatment of superficial-vein thrombosis in these patients (see section 4.2).
Stoga se primjena fondaparinuksa ne preporuča u ovoj skupini bolesnika (vidjeti dio 4.2).
• increase in some chemical (enzymes) produced by the liver
• porast razine bilirubina (tvari koju proizvodi jetra) u krvi
• Treatment of UA/NSTEMI and STEMI - Fondaparinux should not be used in patients with creatinine clearance < 20 ml/min (see section 4.3).
• Liječenje UA/NSTEMI i STEMI - Fondaparinuks ne treba koristiti u bolesnika s klirensom kreatinina <20 ml/min (vidjeti dio 4.3).
NAME OF THE MEDICINAL PRODUCT Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
Arixtra 10 mg/0,8 ml otopina za injekciju fondaparinuks
• increase in some chemicals (enzymes) produced by the liver.
• povišene razine nekih jetrenih enzima.
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.
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.
• syringe with orange plunger and a manual safety system.
• štrcaljka s narančastim klipom i ručnim sigurnosnim sustavom za iglu
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 %).
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 %),
• syringe with a violet plunger and an automatic safety system
• štrcaljka s ljubičastim klipom i automatskim sigurnosnim sustavom za iglu
Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe.
Arixtra 2,5 mg/0,5 ml otopina za injekciju, napunjena štrcaljka
Usual dose
Rijetke nuspojave
• diarrhoea or constipation
• mučnina ili povraćanje
NAME OF THE MEDICINAL PRODUCT Arixtra 1.5 mg/0.3 ml solution for injection fondaparinux sodium
Arixtra 1,5 mg/0,3 ml otopina za injekciju fondaparinuks
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.6 ml) contains 7.5 mg fondaparinux sodium.
Jedna napunjena štrcaljka (0,6 ml) sadrži 7,5 mg fondaparinuksnatrija.
Arixtra 5 mg/0.4 ml solution for injection, pre-filled syringe.
Arixtra 5 mg/0,4 ml otopina za injekciju, napunjena štrcaljka
Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium.
Jedna napunjena štrcaljka (0,5 ml) sadrži 2,5 mg fondaparinuksnatrija.
Instruction for self-administration is mentioned in the Package Leaflet.
Upute za samoinjiciranje navedene su u uputi o lijeku.
Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium.
Jedna napunjena štrcaljka (0,3 ml) sadrži 1,5 mg fondaparinuksnatrija.
NAME OF THE MEDICINAL PRODUCT Arixtra 2.5 mg/0.5 ml solution for injection fondaparinux sodium
Arixtra 2,5 mg/0,5 ml otopina za injekciju fondaparinuks
What Arixtra is and what it is used for What you need to know before you use Arixtra How to use Arixtra
Sadržaj pakiranja i druge informacije Što je Arixtra i za što se koristi
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
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
• Prevention of VTE - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
• Prevencija VTE - Fondaparinuks se ne smije primijeniti u bolesnika s klirensom kreatinina <20 ml/min (vidjeti dio 4.3).
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
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
If you inject too much Arixtra
Ako primijenite više lijeka Arixtra nego što ste trebali
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
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
NAME OF THE MEDICINAL PRODUCT Arixtra 7.5 mg/0.6 ml solution for injection fondaparinux sodium
Arixtra 7,5 mg/0,6 ml otopina za injekciju fondaparinuks
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
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
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
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
• Treatment of superficial-vein thrombosis - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
• Liječenje površinske venske tromboze - Fondaparinuks ne treba koristiti u bolesnika s klirensom kreatinina <20 ml/min (vidjeti dio 4.3).
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
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
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.4 ml) contains 5 mg fondaparinux sodium.
Jedna napunjena štrcaljka (0,4 ml) sadrži 5 mg fondaparinuksnatrija.
Haemorrhage
Česte nuspojave
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
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
NAME OF THE MEDICINAL PRODUCT Arixtra 5 mg/0.4 ml solution for injection fondaparinux sodium
Arixtra 5 mg/0,4 ml otopina za injekciju fondaparinuks
Treatment of ST segment elevation myocardial infarction (STEMI) The recommended dose of fondaparinux is 2.5 mg once daily.
Preporučena doza fondaparinuksa je 2,5 mg jedanput na dan.
Uncommon: headache Rare: dizziness
Manje često: dispneja
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
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
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
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
Fondaparinux should be used with caution in patients with a history of HIT.
Bolesnici s trombocitopenijom izazvanom heparinom Fondaparinuks treba primjenjivati s oprezom u bolesnika s anamnezom HIT-a.
Arixtra 7.5 mg/0.6 ml solution for injection Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
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