FrancophonIA/ELRC3.0 huggingface dataset:
English: In those patients who underwent non-primary PCI 6-24 hours after the last dose of fondaparinux, the median dose of UFH was 8000 IU and the incidence of major bleeding was 2% (2/98).
Slovenian: Pri bolnikih pri katerih je bila neprimarna PCI opravljena 6-24 ur po aplikaciji zadnjega odmerka fondaparinuksa je bil povprečni odmerek nefrakcioniranega heparina 8.000 i.e., pojavnost večjih krvavitev pa 2 % (2/98).
English: The safety of fondaparinux 2.5 mg has been evaluated in 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days, in 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week, 1407 patients undergoing abdominal surgery treated up to 9 days, and in 425 medical patients who are at risk for thromboembolic complications treated up to 14 days.
Slovenian: Varnost fondaparinuksa 2,5 mg so ocenjevali pri 3.595 bolnikih po veliki ortopedski operaciji na spodnjih okončinah, ki so se zdravili do 9 dni, pri 327 bolnikih po operaciji zaradi zloma kolka, ki so po začetni enotedenski profilaksi prejemali zdravilo še 3 tedne, 1.407 bolnikih po opravljenem kirurškem posegu v trebušni votlini, ki so se zdravili do 9 dni in pri 425 internističnih bolnikih s tveganjem trombemboličnih zapletov, zdravljenih do 14 dni dolgo.
English: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom Manufacturer:
Slovenian: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, Velika Britanija Izdelovalec:
English: • If any of the side effects get serious or if you notice any side effects not listed in this leaflet,
Slovenian: • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorization Holder:
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom:
English: Hold the fold between the thumb and the forefinger during the entire injection (picture D).
Slovenian: Kožno gubo ves čas injiciranja držite s palcem in kazalcem (slika D).
English: In this study, the incidence of total VTE was 4.6% (47/1027) with fondaparinux, versus 6.1%: (62/1021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%].
Slovenian: Pri bolnikih, ki so v študiji prejemali fondaparinuks je bila pojavnost vseh VTE 4,6-odstotna (47/1027), pri bolnikih, ki so prejemali dalteparin pa 6,1-odstotna (62/1021): zmanjšano razmerje obetov (odds ratio) [95 % IZ] = -25,8 % [-49,7 %, 9,5 %].
English: In this subgroup, after an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, based on pharmacokinetic modelling (see section 4.4).
Slovenian: V tej podskupini lahko po začetnem 10-miligramskem dnevnem odmerku na podlagi farmakokinetičnega modeliranja preudarimo možnost zmanjšanja dnevnega odmerka na 7,5 mg (glejte poglavje 4.4).
English: In patients >75 years undergoing orthopaedic surgery and receiving fondaparinux 2.5 mg once daily, the estimated plasma clearance was 1.2 to 1.4 times lower than in patients <65 years.
Slovenian: Pri bolnikih, > 75 let, ki so imeli ortopedsko operacijo in so dobivali fondaparinuks v odmerku 2,5 mg enkrat na dan, je ocenjeni očistek plazme 1,2 do 1,4-krat manjši kot pri bolnikih, < 65 let.
English: Incidences in non-primary PCI in UA/NSTEMI were 1.0% vs 0.3% (fondaparinux vs. enoxaparin) and in primary PCI in STEMI were 1.2% vs 0% (fondaparinux vs. control).
Slovenian: Pri neprimarni PCI pri bolnikih z UA/NSTEMI je bila pojavnost 1,0 % v primerjavi z 0,3 % (fondaparinuks v primerjavi z enoksaparinom), pri primarni PCI pri bolnikih s STEMI pa 1,2 % v primerjavi z 0 % (fondaparinuks v primerjavi s kontrolo).
English: At the doses used for treatment, fondaparinux does not, to a clinically relevant extent, affect routine coagulation tests such as activated partial thromboplastin time (aPTT), activated clotting time (ACT) or prothrombin time (PT)/International Normalised Ratio (INR) tests in plasma nor bleeding time or fibrinolytic activity.
Slovenian: V odmerkih, ki se uporabljajo pri zdravljenju, fondaparinuks ne vpliva, v klinično pomembnem obsegu, na rutinske koagulacijske teste v plazmi, kot so merjenje aktiviranega parcialnega tromboplastinskega časa (aPTT), aktiviranega časa nastanka strdka (ACT) ali razmerja protrombinski čas (PT)/internacionalno normalizirano razmerje (INR), niti na čas krvavitve ali fibrinolitično aktivnost.
English: Body weight below 50 kg
Slovenian: Običajni odmerek manjša od 50 kg
English: At the 2.5 mg dose, fondaparinux does not affect routine coagulation tests such as activated partial thromboplastin time (aPTT), activated clotting time (ACT) or prothrombin time (PT)/International Normalised Ratio (INR) tests in plasma nor bleeding time or fibrinolytic activity.
Slovenian: V odmerku 2,5 mg fondaparinuks ne vpliva na rutinske koagulacijske teste v plazmi, kot so merjenje aktiviranega parcialnega tromboplastinskega časa (aPTT), aktiviranega časa nastanka strdka (ACT) ali razmerja protrombinski čas (PT)/internacionalno normalizirano razmerje (INR), niti na čas krvavitve ali fibrinolitično aktivnost.
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.
Slovenian: Preprečevanje venskih trombemboličnih dogodkov (VTE) pri bolnikih po operaciji zloma kolka, ki so se po začetni enotedenski profilaksi zdravili še 24 dni V naključnem dvojno slepem kliničnem preskušanju so 737 bolnikov zdravili s fondaparinuksom v odmerku 2,5 mg enkrat na dan 7 dni +/- 1 dan po operaciji zloma kolka.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: antithrombotic agents.
Slovenian: FARMAKOLOŠKE LASTNOSTI 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Antitrombotiki Oznaka ATC: B01AX05
English: Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1).
Slovenian: Preprečevanje venskih trombemboličnih dogodkov (VTE) po kirurških posegih v trebušni votlini pri bolnikih, pri katerih obstaja povečano tveganje za pojav trombemboličnih zapletov, npr. bolniki po resekciji tumorja v trebušni votlini (glejte poglavje 5.1).
English: Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.
Slovenian: Preprečevanje venskih trombemboličnih dogodkov (VTE) pri bolnikih po velikih ortopedskih kirurških posegih na spodnjih okončinah, kot so operacije zloma kolka, velike operacije kolen ali operacija zamenjave kolka.
English: Quixidar is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Slovenian: Quixidar je zdravilo, ki pomaga preprečevati nastajanje krvnih strdkov v krvnih žilah (antitrombotično zdravilo).
English: Marketing Authorization Holder: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom
Slovenian: Imetnik dovoljenja za promet z zdravilom: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, Velika Britanija
English: The pharmacokinetics of fondaparinux sodium are derived from fondaparinux plasma concentrations quantified via anti factor Xa activity.
Slovenian: Farmakokinetika natrijevega fondaparinuksa temelji na plazemskih koncentracijah fondaparinuksa, kvantitativno izmerjenih z aktivnostjo proti faktorju Xa.
English: The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/min (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih s kreatininskim očistkom med 20 in 50 ml/min je treba odmerek zmanjšati na 1,5 mg enkrat na dan (glejte poglavji 4.4 in 5.2).
English: Children Quixidar has not been tested in children and adolescents under the age of 17 years.
Slovenian: Otroci Pri otrocih in mladostnikih, mlajših od 17 let, uporabe zdravila Quixidar niso raziskovali.
English: What Quixidar contains
Slovenian: Kaj vsebuje zdravilo Quixidar
English: Patients undergoing major orthopaedic or abdominal surgery The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by subcutaneous injection.
Slovenian: Bolniki z večjimi ortopedskimi ali abdominalnimi operacijami Priporočeni odmerek fondaparinuksa je 2,5 mg enkrat na dan, daje se ga po operaciji s subkutano injekcijo.
English: In the subgroup of patients treated with fondaparinux or enoxaparin who underwent PCI, 8.8% and 8.2% of patients respectively, experience death/MI/RI within 9 days of randomisation (hazard ratio 1.08, 95% CI, 0.92;1.27).
Slovenian: Pri podskupini bolnikov, ki so se zdravili s fondaparinuksom ali enoksaparinom in pri katerih je bila izvedena PCI, so o smrtnem izidu/MI/RI v 9 dneh po randomizaciji poročali pri 8,8 % bolnikov, ki so prejemali fondaparinuks in 8,2 % bolnikov, ki so prejemali enoksaparin (razmerje tveganja 1,08, 95 % interval zaupanja, 0,92;1,27).
English: There are different syringes for the 2.5 mg and 1.5 mg doses.
Slovenian: Za odmerke 2,5 mg in 1,5 mg so na voljo različne injekcijske brizge.
English: STEP BY STEP GUIDE TO USING QUIXIDAR
Slovenian: POSTOPNA NAVODILA ZA UPORABO ZDRAVILA QUIXIDAR
English: HOW TO USE QUIXIDAR
Slovenian: Kako uporabljati zdravilo Quixidar
English: The needle protection system of the Quixidar pre-filled syringe has been designed with an automatic safety system to protect from needle stick injuries following injection.
Slovenian: Zaščitni sistem injekcijske igle na Quixidar napolnjeni injekcijski brizgi je oblikovan kot samodejni varnostni sistem za zaščito pred vbodom z iglo po injiciranju.
English: If a patient is to undergo percutaneous coronary intervention (PCI), unfractionated heparin (UFH) as per local practice should be administered during PCI, taking into account the patient's potential risk of bleeding, including the time since the last dose of fondaparinux (see section 4.4).
Slovenian: Če bo pri bolniku opravljena perkutana koronarna intervencija (PCI, “percutaneous coronary intervention”), mora bolnik med PCI prejeti nefrakcionirani heparin (UFH, “unfractionated heparin”) v skladu z lokalno prakso, pri čemer je treba upoštevati možno tveganje za pojav krvavitev, vključno s časom, ko je bolnik prejel zadnji odmerek fondaparinuksa (glejte poglavje 4.4).
English: Glaxo Wellcome Production 1, rue de l'Abbaye F-76960 Notre Dame de Bondeville France
Slovenian: Glaxo Wellcome Production 1 rue de l'Abbaye 76960 Notre Dame de Bondeville Francija
English: It is supplied in a pre-filled, single-use syringe fitted with an automatic safety system to help prevent needle stick injuries after use.
Slovenian: Na voljo je v napolnjeni injekcijski brizgi za enkratno uporabo, ki je opremljena s samodejnim varnostnim sistemom za preprečevanje vbodnih poškodb z iglo po uporabi.
English: Hepatic impairment - No dosing adjustment is necessary.
Slovenian: Jetrna okvara - Prilagajanje odmerjanja ni potrebno.
English: Manufacturer: Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.
Slovenian: Izdelovalec: Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, Francija
English: The Quixidar pre-filled syringe has been designed with an automatic needle protection system to prevent needle stick injuries following injection.
Slovenian: Quixidar napolnjena injekcijska brizga je oblikovana z avtomatičnim sistemom zaščite pred iglo, da preprečimo vbodne poškodbe z iglo po injiciranju.
English: Dosing adjustment of fondaparinux is not necessary.
Slovenian: Prilagajanje odmerka ni potrebno.
English: In those patients who underwent non-primary PCI <6 hours after the last dose of fondaparinux, the median dose of UFH was 5000 IU and the incidence of major bleeding was 4.1%
Slovenian: Pri bolnikih, pri katerih je bila opravljena neprimarna PCI < 6 ur po zadnjem odmerku fondaparinuksa, je bil povprečni odmerek nefrakcioniranega heparina 5.000 i.e., pojavnost večjih krvavitev pa 4,1 % (2/49).
English: By Day 30, the incidence of all cause mortality was significantly reduced from 3.5% on enoxaparin to 2.9% on fondaparinux (hazard ratio 0.83, 95% CI, 0.71;0.97, p = 0.02).
Slovenian: Do 30. dne se je smrtnost iz kateregakoli vzroka pomembno zmanjšala - s 3,5 % pri enoksaparinu na 2,9 % pri fondaparinuksu (razmerje tveganja 0,83, 95 % interval zaupanja, 0,71;0,97, p = 0,02).
English: Quixidar is a medicine that treats or helps to prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Slovenian: Quixidar je zdravilo, ki ga uporabljamo za zdravljenje ali preprečevanje nastanka krvnih strdkov v krvnih žilah (antitrombotično zdravilo).
English: If a patient is to undergo non-primary PCI, unfractionated heparin (UFH) as per local practice should be administered during PCI, taking into account the patient's potential risk of bleeding, including the time since the last dose of fondaparinux (see section 4.4).
Slovenian: Če bo pri bolniku opravljena neprimarna PCI, mora bolnik med PCI prejeti nefrakcionirani heparin (UHF) v skladu z lokalno prakso, pri čemer je treba upoštevati možno tveganje za pojav krvavitev, vključno s časom, ko je bolnik prejel zadnji odmerek fondaparinuksa (glejte poglavje 4.4).
English: In patients treated with primary PCI, the incidence of death/re-MI at Day 30 was not statistically different between the two groups [6.0% in fondaparinux group vs 4.8% in the control group; hazard ratio 1.26, 95% CI, 0.96, 1.66)].
Slovenian: Pri bolnikih, pri katerih je bila opravljena primarna PCI niso opazili statistično pomembne razlike pri smrtnosti/pojavnosti re-MI do 30. dne med obema skupinama [6,0 % v skupini, ki je prejemala fondaparinuks v primerjavi s 4,8 % v kontrolni skupini; razmerje tveganja 1,26, 95 % interval zaupanja, 0,96, 1,66].
English: Sodium chloride Water for injections Hydrochloric acid Sodium hydroxide
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid voda za injekcije klorovodikova kislina natrijev hidroksid
English: Picture G
Slovenian: Slika G
English: What Quixidar looks like and contents of the pack Quixidar is a clear and colourless to slightly yellow solution for injection.
Slovenian: Quixidar je bistra in brezbarvna do rahlo rumena raztopina za injiciranje.
English: There are different syringes for the 5 mg, 7.5 mg and 10 mg doses.
Slovenian: 5 mg, 7,5 mg in 10 mg so na voljo različne injekcijske brizge.
English: In the predefined stratum comparing fondaparinux to UFH (patients treated with primary PCI (58.5%), fibrin-specific lytics (13%), non-fibrin-specific lytics (2.6%) and no reperfusion (25.9%)), the effects of fondaparinux and UFH on the incidence of death/re-MI at Day 30 were not statistically different: respectively, 8.3% vs 8.7% (hazard ratio 0.94, 95% CI, 0.79, 1.11 p = 0.460).
Slovenian: Pri v naprej določeni skupini, pri kateri so fondaparinuks primerjali z UFH (bolniki, zdravljeni s primarno PCI (58,5 %), fibrinsko specifičnimi litiki (13 %), fibrinsko nespecifičnimi litiki (2,6) in brez reperfuzije (25,9)), se učinka fondaparinuksa in UFH na zmanjšanje smrtnosti/pojavnosti re-MI do 30. dne nista statistično pomembno razlikovala, in sicer sta bila 8,3 % za fondaparinuks in 8,7 % za UFH (razmerje tveganja 0,94, 95 % interval zaupanja, 0,79;1,11 p = 0,460).
English: • if you have very severe kidney disease.
Slovenian: • Če imate zelo hudo bolezen ledvic.
English: In the predefined stratum comparing fondaparinux to placebo (i.e patients treated with nonfibrin specific lytics (77.3%), no reperfusion (22%), fibrin-specific lytics (0.3%), primary PCI (0.4%)), the incidence of death/re-MI at Day 30 was significantly reduced from 14.0% on placebo to 11.3% (hazard ratio 0.80, 95% CI, 0.69, 0.93, p = 0.003).
Slovenian: Pri v naprej določenih skupinah pri katerih so fondaparinuks primerjali s placebom (to je bolniki, ki so se zdravili s fibrinsko nespecifičnimi litiki (77,3%), brez reperfuzije (22 %), fibrinsko specifičnimi litiki (0,3 %) primarno PCI (0,4 %)) se je smrtnost/pojavnost re-MI do 30. dne pomembno zmanjšala s 14,0 % pri placebu na 11,3 % (razmerje tveganja 0,80, 95 % interval zaupanja, 0,69;0,93, p = 0,003).
English: No dosage reduction is required for patients with creatinine clearance > 20 ml/min.
Slovenian: Pri bolnikih s kreatininskim očistkom > 20 ml/min odmerka ni treba prilagajati.
English: These may affect more than 1 in 100 people treated with Quixidar.
Slovenian: Pojavijo se lahko pri več kot 1 od 100 bolnikov, ki se zdravijo z zdravilom Quixidar.
English: Picture B
Slovenian: Slika B
English: When required, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of section 4.5.
Slovenian: Kadar so nujni, moramo uvesti sočasno terapijo z antagonisti vitamina K, skladno s podatki v poglavju 4.5.
English: The adverse reactions reported by the investigator as at least possibly related to fondaparinux are presented within each frequency grouping (very common ≥ 1/10; common: ≥1/100 to < 1/10; uncommon: ≥ 1/1,000 to ≤ 1/100; rare: ≥ 1/10,000 to ≤1/1,000; very rare ≤1/10,000) and system organ class by decreasing order of seriousness.
Slovenian: Neželeni učinki, o katerih so poročali raziskovalci in za katere je možna vsaj majhna povezava s fondaparinuksom, so navedeni v skupinah glede na pogostnost (zelo pogosti ≥ 1/10; pogosti ≥ 1/100 do < 1/10; občasni ≥ 1/1.000 do < 1/100; redki ≥ 1/10.000 do < 1/1.000; zelo redki ≤ 1/10.000) in organski sistem v padajočem vrstnem redu po resnosti.
English: Suomi/Finland Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
Slovenian: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
English: 1 Rigid needle guard 2 Cap
Slovenian: 1 trden ščitnik igle
English: • The other ingredients are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust the pH.
Slovenian: • Pomožne snovi so natrijev klorid, voda za injekcije in klorovodikova kislina in/ali natrijev hidroksid za uravnavanje pH.
English: The incidence of adjudicated major bleeding was 2.1% (fondaparinux) vs. 4.1% (enoxaparin) up to and including Day 9 in the Phase III UA/NSTEMI study, and the incidence of adjudicated severe hemorrhage by modified TIMI criteria was 1.1% (fondaparinux) vs. 1.4% (control [UFH/placebo]) up to and including Day 9 in the Phase III STEMI study.
Slovenian: V študiji III. faze STEMI je bila do in vključno z 9. dnem pojavnost hujših krvavitev po modificiranih kriterijih TIMI 1,1 % (fondaparinuks) v primerjavi z 1,4 % (kontrola [UFH/placebo]).
English: If you get side effects → Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Slovenian: Če katerikoli neželeni učinek postane resen ali nadležen, ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: The incidence of all cause mortality at Day 30 was also significantly reduced from 8.9% for the control group to 7.8% in the fondaparinux group (hazard ratio 0.87, 95% CI, 0.77;0.98, p = 0.02).
Slovenian: Do 30. dne se je pomembno zmanjšala tudi smrtnost iz kateregakoli vzroka - z 8,9 % v kontrolni skupini na 7,8 % v skupini, ki je prejemala fondaparinuks (razmerje tveganja 0,87, 95 % interval zaupanja, 0,77;0,98, p = 0,02).
English: Discard the needle guard.
Slovenian: Ščitnik igle zavrzite.
English: In STEMI or UA/NSTEMI patients who are to undergo coronary artery bypass graft (CABG) surgery, fondaparinux where possible, should not be given during the 24 hours before surgery and may be restarted 48 hours post-operatively.
Slovenian: Pri bolnikih s STEMI ali UA/NSTEMI, pri katerih bo izveden obvod koronarne arterije (CABG, “coronary artery bypass graft”), bolnik fondaparinuksa ne sme prejeti 24 ur pred posegom.
English: The fondaparinux clinical program was designed to demonstrate the efficacy of fondaparinux for the prevention of venous thromboembolic events (VTE), i.e. proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.
Slovenian: Preprečevanje venskih trombemboličnih dogodkov (VTE) pri bolnikih po velikih ortopedskih operacijah spodnjih okončin, ki so se zdravili do 9 dni Klinični program za fondaparinuks je bil zasnovan za dokazovanje učinkovitosti fondaparinuksa pri preprečevanju venskih trombemboličnih dogodkov (VTE), npr. proksimalne in distalne globoke venske tromboze (DVT) in pljučne embolije (PE), pri bolnikih po ortopedskih operacijah spodnjih okončin, kot je operacija zloma kolka, velike operacije kolen ali kirurška zamenjava kolka.
English: MedDRA
Slovenian: Presnova
English: • Treatment of UA/NSTEMI and STEMI - fondaparinux should not be used in patients with creatinine clearance < 20 ml/min (see section 4.3).
Slovenian: • Zdravljenje UA/NSTEMI in STEMI - Fondaparinuksa se ne sme uporabljati pri bolnikih s kreatininskim očistkom < 20 ml/min (glejte poglavje 4.3).
English: Paediatric patients - Fondaparinux has not been investigated in this population.
Slovenian: Otroci - Uporabe fondaparinuksa pri otrocih niso proučevali.
English: These may affect up to 1 in 1000 people treated with Quixidar.
Slovenian: Pojavijo se lahko pri do 1 od 1.000 bolnikov, ki se zdravijo z zdravilom Quixidar.
English: These may affect up to 1 in 100 people treated with Quixidar.
Slovenian: Pojavijo se lahko pri do 1 od 100 bolnikov, ki se zdravijo z zdravilom Quixidar.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 10 mg of fondaparinux sodium in 0.8 ml solution for injection.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka napolnjena injekcijska brizga vsebuje 10 mg natrijevega fondaparinuksa v 0,8 ml raztopine za injiciranje.
English: Uncommon: nausea, vomiting
Slovenian: Občasni: navzea, bruhanje
English: Usual dose
Slovenian: Za odmerke
English: Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.
Slovenian: Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, Francija Navodilo je bilo odobreno
English: • if you have kidney disease
Slovenian: • Če imate ledvično bolezen.
English: GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900
Slovenian: GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@gsk.com
English: If you stop the treatment before your doctor told you to, the blood clot may not be treated properly and you may also be at risk of developing a new blood clot in a vein of your leg or in the lung.
Slovenian: Zdravila Quixidar ne prenehajte uporabljati brez zdravnikovega nasveta Če prenehate uporabljati zdravilo prej, kot vam je predpisal zdravnik, ste v nevarnosti, da se vam v venah nog ali pljuč razvije krvni strdek.
English: Inject ALL of the contents of the syringe by pressing down on the plunger as far as it goes.
Slovenian: S potiskanjem bata navzdol do konca injicirajte VSO vsebino injekcijske brizge.
English: The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust the pH.
Slovenian: Pomožne snovi so natrijev klorid, voda za injekcije in klorovodikova kislina in/ali natrijev hidroksid za uravnavanje pH.
English: In patients with severe hepatic impairment, fondaparinux should be used with care (see section 4.4).
Slovenian: Pri bolnikih s hudo jetrno okvaro naj se fondaparinuks uporablja previdno (glejte poglavje 4.4).
English: • 10 mg fondaparinux sodium in 0.8 ml solution for injection
Slovenian: • 10 mg natrijevega fondaparinuksa v 0,8 ml raztopine za injiciranje.