FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you are 75 years old or older.
Slovenian: • Če ste stari 75 let ali več.
English: • if you are bleeding excessively
Slovenian: • Če prekomerno krvavite.
English: This will activate the automatic needle protection system (picture F).
Slovenian: To aktivira samodejni zaščitni sistem igle (slika F).
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Slovenian: • če se pridobijo novi podatki, ki lahko vplivajo na trenutne podatke o varnosti, načrt farmakovigilance ali dejavnosti za zmanjševanje tveganja.
English: (1) Isolated AEs have not been considered except if they were medically relevant.
Slovenian: (1) Posamezni neželeni učinki niso upoštevani, razen če so bili medicinsko pomembni.
English: Date of latest renewal: 21 March 2007
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 21. marec 2007
English: Over 4874 patients were studied in controlled Phase II and III clinical studies.
Slovenian: V kontroliranih kliničnih študijah faze II in III so proučevali več kot 4.874 bolnikov.
English: • the syringe has not been opened or damaged
Slovenian: • da injekcijska brizga še ni bila odprta ali poškodovana.
English: Quixidar is used to:
Slovenian: Quixidar se uporablja za:
English: • if you have a bacterial heart infection
Slovenian: • Če imate bakterijsko okužbo srca.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Slovenian: V skladu s smernicami CHMP o sistemih za upravljanje tveganja za zdravila za uporabo v humani medicini je treba dopolnjen načrt upravljanja tveganja predložiti sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 March 2002
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 21. marec 2002
English: Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
Slovenian: Fondaparinuks in vitro ne zavira CYP450 (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ali CYP3A4).
English: Parts of the safety syringe
Slovenian: Sestavni deli varnostne brizge
English: • after the expiry date stated on the label and carton
Slovenian: • po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli;
English: Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Undesirable effects in medical patients
Slovenian: Neželeni učinki pri internističnih bolnikih
English: Patients with body weight <50 kg are at increased risk of bleeding.
Slovenian: Bolniki s telesno maso < 50 kg imajo povečano tveganje za krvavitev.
English: Treatment should be continued until the risk of venous thrombo-embolism has diminished, usually until the patient is ambulant, at least 5 to 9 days after surgery.
Slovenian: Zdravljenje se mora nadaljevati, dokler se ne zmanjša tveganje za vensko trombembolijo, ponavadi dokler bolnik ni pomičen, najmanj 5 do 9 dni po operaciji.
English: Release the plunger and the needle will automatically withdraw from the skin and go back into the security sleeve where it will be locked permanently (picture G).
Slovenian: Popustite bat in igla se bo samodejno odstranila iz kože ter se umaknila v zaščitni tulec, kjer bo trajno zaprta (slika G).
English: • if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of
Slovenian: • Če ste alergični na (preobčutljivi za) natrijev fondaparinuks ali katerokoli sestavino zdravila
English: • Do not inject Quixidar into muscle.
Slovenian: • Ne injicirajte zdravila Quixidar v mišico.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
English: • allergic reaction
Slovenian: • alergijska reakcija;
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: • v 60 dneh, po pomembnem novem spoznanju (farmakovigilančnem ali za zmanjšanje tveganja).
English: Like all medicines, Quixidar can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Quixidar neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: • the expiry date has not passed
Slovenian: • da datum izteka roka uporabnosti še ni pretečen.
English: • treat some types of heart attack and severe angina (pain caused by narrowing of the arteries in the heart).
Slovenian: • zdravljenje nekaterih oblik srčnega infarkta in hude oblike angine pektoris (bolečine, ki je posledica zoženja arterij v srcu).
English: In addition, an updated RMP should be submitted:
Slovenian: Razen tega je dopolnjen načrt upravljanja tveganja treba predložiti:
English: Follow-up therapy with another anticoagulant medicinal product If follow-up treatment is to be initiated with heparin or LMWH, the first injection should, as a general rule, be given one day after the last fondaparinux injection.
Slovenian: Nadaljevanje zdravljenja z drugimi antikoagulanti Če moramo nadaljevanje zdravljenja začeti s heparinom ali LMWH, je splošno pravilo, da se daje prvo injekcijo zdravila en dan po zadnji injekciji fondaparinuksa.
English: Solution for injection, 2 pre-filled syringes with an automatic safety system Solution for injection, 7 pre-filled syringes with an automatic safety system Solution for injection, 10 pre-filled syringes with an automatic safety system Solution for injection, 20 pre-filled syringes with an automatic safety system
Slovenian: Raztopina za injiciranje, 2 napolnjeni injekcijski brizgi s samodejnim varnostnim sistemom Raztopina za injiciranje, 7 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom Raztopina za injiciranje, 10 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom Raztopina za injiciranje, 20 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom
English: • the solution is clear and colourless and doesn't contain particles
Slovenian: • če je raztopina bistra in brezbarvna ter ne vsebuje delcev.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISTION HOLDER
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: 6.6 Special precautions for disposal and other handling The subcutaneous injection is administered in the same way as with a classical syringe.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Subkutano injekcijo se daje na enak način kot s klasično injekcijsko brizgo.
English: • This medicine has been prescribed for you personally.
Slovenian: • Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Rare: allergic reaction
Slovenian: Redki: alergijska reakcija
English: Quixidar should not be prescribed to pregnant women unless clearly necessary.
Slovenian: Zdravilo Quixidar se ne sme predpisati nosečnicam, razen če je to nujno potrebno.
English: • Quixidar does not have to be kept in the fridge.
Slovenian: • Zdravila Quixidar ni treba shranjevati v hladilniku.
English: België/Belgique/Belgien GlaxoSmithKline s.a./n.v.
Slovenian: Belgique/België/Belgien GlaxoSmithKline s.a./n.v.
English: Quixidar does not contain any animal products.
Slovenian: Zdravilo Quixidar ne vsebuje sestavin živalskega izvora.
English: A total of 2192 patients were treated; for both groups, patients were treated for at least 5 days and up to 26 days (mean 7 days).
Slovenian: Zdravili so vsega skupaj 2.184 bolnikov; bolnike iz obeh skupin so zdravili vsaj po 5 dni in do 22 dni dolgo (povprečno po 7 dni).
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora izvesti študije in dodatne farmakovigilančne aktivnosti, ki so določene v načrtu farmakovigilance, v skladu z verzijo 1.2 načrta upravljanja tveganja (RMP) v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vse naknadne dopolnitve načrta upravljanja tveganja, ki jih odobri Odbor za zdravila za uporabo v humani medicini (CHMP).
English: In a pooled analysis of these studies, the recommended dose regimen of fondaparinux versus enoxaparin was associated with a significant decrease (54% - 95% CI, 44 %; 63%) in the rate of VTE evaluated up to day 11 after surgery, irrespective of the type of surgery performed.
Slovenian: V zbirni analizi teh preskušanj je bila priporočena shema odmerjanja fondaparinuksa v primerjavi z enoksaparinom povezana s pomembnim zmanjšanjem (54 % - 95 % IZ, 44 %; 63 %) deleža VTE proučevano do 11 dni po operaciji, neodvisno od vrste izvedene operacije.
English: Clinical trials have shown a low but increased risk of guiding catheter thrombus in patients treated with fondaparinux for anticoagulation during PCI compared to control.
Slovenian: Klinična preskušanja so pokazala majhno, vendar pa povečano tveganje za pojav trombusa vodilnega katetra pri bolnikih, ki so med PCI za antikoagulacijo prejemali le fondaparinuks v primerjavi s kontrolo.
English: · recent surgery on the brain, spine or eye
Slovenian: · nedavno operacijo na možganih, hrbtenici ali očeh.
English: What Quixidar is and what it is used for Before you use Quixidar How to use Quixidar Possible side effects
Slovenian: Kaj je zdravilo Quixidar in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Quixidar Kako uporabljati zdravilo Quixidar Možni neželeni učinki
English: Remove the needle guard, by first twisting it and then pulling it in a straight line away from the body of the syringe (picture C).
Slovenian: Odstranite ščitnik igle tako, da ga najprej zavrtite, nato pa potegnite naravnost stran od telesa injekcijske brizge (slika C).
English: WHAT QUIXIDAR IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO QUIXIDAR IN ZA KAJ GA UPORABLJAMO
English: Do not use Quixidar:
Slovenian: Ne uporabljajte zdravila Quixidar:
English: Some other medicines may affect the way that Quixidar works or be affected by Quixidar.
Slovenian: Nekatera druga zdravila lahko vplivajo na delovanje zdravila Quixidar ali pa zdravilo Quixidar vpliva na delovanje drugih zdravil.
English: You should continue Quixidar treatment for as long as your doctor has told you, since Quixidar prevents development of a serious condition.
Slovenian: Kako dolgo mora trajati zdravljenje z zdravilom Quixidar Zdravilo Quixidar morate uporabljati tako dolgo, kot vam je predpisal zdravnik, ker Quixidar preprečuje razvoj resnega zdravstvenega stanja.
English: Important information about some of the ingredients of Quixidar This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Quixidar To zdravilo vsebuje manj kot 23 mg natrija na odmerek, kar v bistvu pomeni brez natrija.
English: In patients undergoing major orthopaedic surgery, epidural or spinal haematomas that may result in long-term or permanent paralysis cannot be excluded with the concurrent use of fondaparinux and spinal/epidural anaesthesia or spinal puncture.
Slovenian: Pri bolnikih z večjimi ortopedskimi operacijami epiduralnih ali spinalnih hematomov, ki lahko povzročijo dolgotrajno ali trajno paralizo, pri sočasni uporabi fondaparinuksa in spinalne/epiduralne anestezije ali spinalne punkcije ne moremo izključiti.
English: Hold the body of the syringe firmly in one hand.
Slovenian: V eno roko trdno primite telo injekcijske brizge.
English: Treatment of 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.
Slovenian: Zdravljenje akutne globoke venske tromboze (DVT) in zdravljenje akutne pljučne embolije (PE), razen pri hemodinamsko nestabilnih bolnikih ali bolnikih, pri katerih je potrebna tromboliza ali pljučna embolektomija.
English: Treatment of ST segment elevation myocardial infarction (STEMI) OASIS 6 was a double blind, randomised study assessing the safety and efficacy of fondaparinux 2.5 mg once daily, versus usual care (placebo (47%) or UFH (53%)) in approximately 12000 patients with STEMI.
Slovenian: Zdravljenje miokardnega infarkta z dvigom segmenta ST (STEMI) OASIS 6 je bila dvojno slepa, randomizirana študija, ki je vrednotila varnost in učinkovitost fondaparinuksa v odmerku 2,5 mg enkrat na dan v primerjavi z običajnim zdravljenjem (placebo (47 %) ali UFH (53 %)) pri približno 12.000 bolnikih s STEMI.
English: Remove the cap that protects the plunger by pulling it off (picture B).
Slovenian: Odstranite pokrovček, ki ščiti bat, tako da ga potegnete (slika B).
English: The usual dose is 2.5 mg once a day, injected at about the same time each day.
Slovenian: Običajni odmerek je 2,5 mg enkrat na dan v obliki injekcije vsak dan ob istem času.
English: • increase in bilirubin (a substance produced by the liver) in the blood
Slovenian: • povečane vrednosti bilirubina (substanca, ki nastaja v jetrih) v krvi;
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: DODATEK II A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Excipient(s): Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially sodium free.
Slovenian: Pomožne snovi: Vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni brez natrija.
English: If you forget to take Quixidar
Slovenian: Če ste pozabili uporabiti zdravilo Quixidar
English: Undesirable effects in patients treated for VTE1
Slovenian: Neželeni učinki pri bolnikih, ki so se zdravili zaradi venske trombembolije (VTE)1
English: Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE and aged <65 years, 65-75 and >75 years were 3.0 %, 4.5 % and 6.5 %, respectively.
Slovenian: Incidence krvavitev pri bolnikih na priporočeni shemi zdravljenja DVT ali PE in starih < 65 let, 65-75 let oziroma > 75 let so bile 3,0 %, 4,5 % oziroma
English: Uncommon: pain, oedema, Rare: reaction at injection site
Slovenian: Občasni: bolečina, edem Redki: reakcija na mestu injiciranja
English: Prevention of Venous Thromboembolic Events (VTE) in medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease.
Slovenian: Preprečevanje venskih trombemboličnih dogodkov (VTE) pri internističnih bolnikih, za katere sodimo, da pri njih obstaja velika nevarnost VTE in ki so imobilizirani zaradi akutne bolezni, na primer srčne insuficience in/ali akutnih respiracijskih bolezni in/ali akutnih infekcij ali vnetnih bolezni.
English: · recent bleeding in the brain (intracranial bleeding)
Slovenian: · nedavno možgansko krvavitvijo (znotrajlobanjska krvavitev),
English: • Quixidar is given by injection under the skin (subcutaneously) into a skin fold of the lower abdominal area.
Slovenian: • Zdravilo Quixidar si injicirajte pod kožo (subkutano), v kožno gubo v spodnjem predelu trebuha.
English: Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1).
Slovenian: Zdravljenje nestabilne angine pektoris ali miokardnega infarkta brez dviga segmenta ST (UA/NSTEMI; “unstable angina/non-ST segment elevation myocardial infarction”) pri bolnikih, pri katerih ni indicirano urgentno (< 120 minut) invazivno zdravljenje (PCI) (glejte poglavji 4.4 in 5.1).
English: For treatment of UA/NSTEMI and STEMI, fondaparinux should be used with caution in patients who are being treated concomitantly with other agents that increase the risk of haemorrhage (such as GPIIb/IIIa inhibitors or thrombolytics).
Slovenian: Pri zdravljenju UA/NSTEMI in STEMI, je treba fondaparinuks uporabljati previdno pri bolnikih, ki se sočasno zdravijo z drugimi zdravili, ki povečajo tveganje za krvavitve (kot so zaviralci GPIIb/IIIa ali trombolitiki).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous or intravenous use Read the package leaflet before use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Subkutana ali intravenska uporaba Pred uporabo preberite priloženo navodilo.
English: Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.
Slovenian: Zdravljenje miokardnega infarkta z dvigom segmenta ST (STEMI; “ST segment elevation myocardial infarction” pri bolnikih, ki so prejeli trombolitik ali bolnikih, pri katerih v začetku ni bila izvedena druga oblika reperfuzijskega zdravljenja.
English: Quixidar is used to treat patients with a blood clot in the blood vessels of their legs (deep vein thrombosis) and/or lungs (pulmonary embolism).
Slovenian: Zdravilo Quixidar se uporablja za zdravljenje bolnikov s krvnimi strdki v žilah nog (globoka venska tromboza) in/ali pljuč (pljučna embolija).
English: If you are pregnant, think you might be, or if you are breast-feeding: → tell your doctor or pharmacist.
Slovenian: Če ste noseči, mislite, da ste noseči ali dojite, o tem obvestite svojega zdravnika ali farmacevta.
English: Insert the full length of the needle at right angles into the skin fold (picture E).
Slovenian: Celotno dolžino injekcijske igle zabodite v kožno gubo pod pravim kotom (slika E).
English: The MAH must ensure that the system of pharmacovigilance, as described in the June 2006 version presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora pred začetkom trženja zdravila vzpostaviti sistem farmakovigilance, kot je navedeno v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom iz junija 2006 in ga vzdrževati ves čas trženja zdravila.
English: • prevent the formation of blood clots during and shortly after a period of restricted mobility due to acute illness.
Slovenian: • preprečevanje nastajanja krvnih strdkov med obdobjem in po obdobju omejene gibljivosti (imobilizacije) zaradi akutne bolezni.
English: Medicines and syringes should not be disposed of via wastewater or household waste.
Slovenian: Zdravila in injekijskih brizg ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: • If you are not sure what to do, ask your doctor or pharmacist.
Slovenian: • Če ste v dvomih, kaj storiti, se posvetujte s svojim zdravnikom ali farmacevtom.
English: Undesirable effects in patients undergoing major orthopaedic surgery of lower limbs and/or abdominal surgery
Slovenian: Neželeni učinki pri bolnikih, ki so imeli večje ortopedske operacije spodnjih udov in/ali kirurški poseg v trebušni votlini
English: Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE with normal renal function, mild renal impairment, moderate renal impairment and severe renal impairment were 3.0 % (34/1132), 4.4 % (32/733), 6.6% (21/318), and 14.5 % (8/55) respectively.
Slovenian: Incidence krvavitev pri bolnikih, ki so prejemali priporočeno shemo za zdravljenje DVT ali PE in so imeli normalno ledvično funkcijo, blago ledvično okvaro, zmerno ledvično okvaro oziroma hudo ledvično okvaro, so bile 3,0 % (34/1132), 4,4 % (32/733), 6,6 % (21/318) oziroma 14,5 % (8/55).
English: In UA/NSTEMI and STEMI patients undergoing non-primary PCI, the use of fondaparinux as the sole anticoagulant during PCI is not recommended, therefore UFH should be used according to local practice (see section 4.2).
Slovenian: Pri bolnikih z UA/NSTEMI in STEMI pri katerih bo opravljena neprimarna PCI, uporabe fondaparinuksa kot edinega antigoagulanta med PCI ne priporočamo, zato je treba uporabljati nefrakcionirani heparin v skladu z lokalno prakso (glejte poglavje 4.2).
English: If you have any further questions about how to use this product, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
English: Take special care with Quixidar: Your doctor needs to know before you take Quixidar:
Slovenian: Bodite posebno pozorni pri uporabi zdravila Quixidar: Pred začetkom zdravljenja z zdravilom Quixidar morate svojemu zdravniku povedati:
English: LIST OF EXCIPIENTS Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi: natrijev klorid, vodo za injekcije, klorovodikovo kislino, natrijev hidroksid.
English: Belgique/Belgien Tél/Tel: + 32 (0)2 656 21 11
Slovenian: Luxembourg/Luxemburg Belgique/Belgien Tél/Tel: + 32 (0)2 656 21 11
English: There are limited data on the use of UFH during non-primary PCI in patients treated with fondaparinux (see section 5.1).
Slovenian: Podatki o uporabi nefrakcioniranega heparina med neprimarno PCI pri bolnikih, ki se zdravijo s fondaparinuksom, so omejeni (glejte poglavje 5.1).
English: ATC code: B01AX05
Slovenian: Farmakoterapevtska skupina: antitrombotične učinkovine Oznaka ATC: B01AX05
English: Patients with Heparin Induced Thrombocytopenia Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with Heparin Induced Thrombocytopenia (HIT) type II.
Slovenian: Bolniki s trombocitopenijo, povzročeno s heparinom Fondaparinuks se ne veže na trombocitni faktor 4 in ne reagira navzkrižno s serumi bolnikov s trombocitopenijo, povzročeno s heparinom (HIT) tipa II.
English: Take special care with Quixidar:
Slovenian: Bodite posebno pozorni pri uporabi zdravila Quixidar:
English: How to store Quixidar Further information
Slovenian: 5 Shranjevanje zdravila Quixidar Dodatne informacije
English: • prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic surgery (such as hip or knee surgery) or abdominal surgery
Slovenian: • preprečevanje tvorbe krvnih strdkov v žilah nog ali pljuč po ortopedskih operacijah (kot so operacije kolka ali kolen) ali po operacijah v trebušni votlini.
English: Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom
Slovenian: Glaxo Group Ltd Greenford Middlesex UB6 0NN Velika Britanija
English: Hepatic impairment - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment.
Slovenian: Jetrna okvara - Farmakokinetika fondaparinuksa pri jetrnih okvarah ni bila ovrednotena.
English: Breast-feeding is not recommended during treatment with Quixidar.
Slovenian: Med zdravljenjem z zdravilom Quixidar dojenje ni priporočljivo.
English: • Do not freeze
Slovenian: • Ne zamrzujte.
English: Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.
Slovenian: Fondaparinuks ne deluje navzkrižno s serumom bolnikov s heparinom inducirano trombocitopenijo.
English: • if you have a risk of uncontrolled bleeding (haemorrhage) including: · stomach ulcer · bleeding disorders · recent bleeding into the brain (intracranial bleeding) · recent surgery on the brain, spine or eye
Slovenian: • če imate tveganje za pojav nenadzorovane krvavitve, vključno z: · želodčno razjedo, · boleznijo strjevanja krvi, · nedavno možgansko krvavitvijo (znotrajlobanjska krvavitev), · nedavno operacijo na možganih, hrbtenici ali očeh.