FrancophonIA/ELRC3.0 huggingface dataset:
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; these adverse reactions should be interpreted within the surgical and medical context.
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; te neželene učinke moramo interpretirati v povezavi s kirurškim in internističnim posegom.
English: Common: bleeding (haematoma, haematuria, haemoptysis, gingival bleeding) Uncommon: anaemia
Slovenian: Pogosti: krvavitve (hematom, hematurija, hemoptiza, krvavitve dlesni) Občasni: anemija
English: Quixidar 7.5 mg/0.6 ml solution for injection Quixidar 10 mg/0.8 ml solution for injection Fondaparinux sodium
Slovenian: Quixidar 5 mg/0,4 ml raztopina za injiciranje Quixidar 7,5 mg/0,6 ml raztopina za injiciranje Quixidar 10 mg/0,8 ml raztopina za injiciranje natrijev fondaparinuks
English: Among patients initially not reperfused, the incidence of death/re-MI at Day 30 was significantly reduced from 15% for the control group to 12.1% for the fondaparinux group (hazard ratio 0.79, 95% CI, 0.65;0.97, p = 0.023).
Slovenian: Pri bolnikih, pri katerih ni bila opravljena začetna reperfuzija, je fondaparinuks pomembno zmanjšal smrtnost/pojavnost re-MI do 30. dne iz 15 % v kontrolni skupini na 12,1 % (razmerje tveganja 0,79, 95 % interval zaupanja, 0,65;0,97, p = 0,023).
English: • 7.5 mg fondaparinux sodium in 0.6 ml solution for injection
Slovenian: • 7,5 mg natrijevega fondaparinuksa v 0,6 ml raztopine za injiciranje.
English: For the prevention of VTE, 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; these adverse reactions should be interpreted within the surgical and medical context.
Slovenian: Neželeni učinki, o katerih so poročali raziskovalci pri preprečevanju VTE 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; te neželene učinke moramo interpretirati v povezavi s kirurškim in internističnim posegom.
English: No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min).
Slovenian: Pri bolnikih z blago okvaro ledvic (kreatininski očistek > 50 ml/min) odmerka ni treba prilagajati.
English: Quixidar 5 mg/0.4 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with an orange automatic safety system.
Slovenian: Quixidar 5 mg/0,4 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg z oranžnim samodejnim varnostnim sistemom.
English: Renal impairment Fondaparinux is known to be mainly excreted by the kidney.
Slovenian: Ledvična okvara Znano je, da se fondaparinuks izloča predvsem preko ledvic.
English: MARKETING AUTHORISATION NUMBERS EU/1/02/207/009-011, 018
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/207/009-011, 018
English: Your doctor needs to know before you take Quixidar:
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO QUIXIDAR
English: MARKETING AUTHORISATION NUMBERS EU/1/02/207/012-014, 019
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/207/012-014, 019
English: What Quixidar looks like and contents of the pack Quixidar is a clear and colourless solution for injection.
Slovenian: Quixidar je bistra in brezbarvna raztopina za injiciranje.
English: 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.
Slovenian: Quixidar vsebuje sintetično učinkovino, imenovano natrijev fondaparinuks, ki zavre delovanje faktorja strjevanja krvi Xa (“deset-A”) v krvi in tako prepreči razvoj neželenih krvnih strdkov (trombozo) v krvnih žilah.
English: • if you have severe kidney disease.
Slovenian: • Če imate hudo jetrno bolezen.
English: • The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection
Slovenian: • Zdravilna učinkovina je 1,5 mg natrijevega fondaparinuksa v 0,3 ml raztopine za injiciranje.
English: HOW TO STORE QUIXIDAR
Slovenian: SHRANJEVANJE ZDRAVILA QUIXIDAR
English: Quixidar is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a blue automatic safety system.
Slovenian: Quixidar je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom modre barve.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 5 mg of fondaparinux sodium in 0.4 ml solution for injection.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka napolnjena injekcijska brizga vsebuje 5 mg natrijevega fondaparinuksa v 0,4 ml raztopine za injiciranje.
English: If they do, you must not use Quixidar.
Slovenian: V teh primerih zdravila Quixidar ne smete uporabljati.
English: Renal impairment - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Slovenian: Ledvična okvara - Fondaparinuksa se ne sme uporabljati pri bolnikih, ki imajo kreatininski očistek < 20 ml/min (glejte poglavje 4.3).
English: MARKETING AUTHORISATION NUMBERS EU/1/02/207/005-008
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/207/005-008
English: Body weight 50-100 kg
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Telesna masa 50-100 kg.
English: Quixidar 10 mg/0.8 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a violet automatic safety system.
Slovenian: Quixidar 10 mg/0,8 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg z vijoličastim samodejnim varnostnim sistemom.
English: MARKETING AUTHORISATION NUMBERS EU/1/02/207/015-017, 020
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/207/015-017, 020
English: MARKETING AUTHORISATION NUMBERS EU/1/02/207/001-004
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/02/207/001-004
English: • 5 mg fondaparinux sodium in 0.4 ml solution for injection
Slovenian: • 5 mg natrijevega fondaparinuksa v 0,4 ml raztopine za injiciranje.
English: Rare: chest pain, fatigue, hot flushes, leg pain, oedema genital, flushing, syncope
Slovenian: Občasni: edem, periferni edem, povišana telesna temperatura, secerniranje iz rane Redki: bolečine v prsih, utrujenost, vročinski valovi, bolečine v nogah, genitalni edem, zardevanje, sinkopa
English: Quixidar is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a yellow automatic safety system.
Slovenian: Quixidar je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom rumene barve.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga (0,5 ml) vsebuje 2,5 mg natrijevega fondaparinuksa.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga (0,3 ml) vsebuje 1,5 mg natrijevega fondaparinuksa.
English: Quixidar 7.5 mg/0.6 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a magenta automatic safety system.
Slovenian: Quixidar 7,5 mg/0,6 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg s škrlatnim samodejnim varnostnim sistemom.
English: Contact your doctor or pharmacist for advice as soon as possible because of the increased risk of bleeding.
Slovenian: Če ste injicirali prevelik odmerek zdravila Quixidar Zaradi večje možnosti za pojav krvavitev se čim prej posvetujte s svojim zdravnikom ali farmacevtom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga (0,8 ml) vsebuje 10 mg natrijevega fondaparinuksa.
English: → Tell your doctor if you think any of these applies to you.
Slovenian: Če menite, da se karkoli od navedenega nanaša na vas, o tem obvestite svojega zdravnika.
English: NAME OF THE MEDICINAL PRODUCT Quixidar 10 mg/0.8 ml solution for injection, pre-filled syringe.
Slovenian: IME ZDRAVILA Quixidar 10 mg/0,8 ml raztopina za injiciranje, napolnjena injekcijska brizga
English: Excretion/Elimination
Slovenian: Izločanje
English: For prevention of VTE, agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Slovenian: Pri preprečevanju VTE se sočasno s fondaparinuksom ne sme uporabljati učinkovin, ki lahko povečajo tveganje za krvavitev.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Quixidar 10 mg/0.8 ml injection fondaparinux Na
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Quixidar 10 mg/0,8 ml injekcija Na fondaparinuks s.c.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use Read the package leaflet before use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Subkutana uporaba.
English: NAME OF THE MEDICINAL PRODUCT Quixidar 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
Slovenian: IME ZDRAVILA Quixidar 7,5 mg/0,6 ml raztopina za injiciranje, napolnjena injekcijska brizga
English: → Tell your doctor if any of these applies to you.
Slovenian: Če se karkoli od navedenega nanaša na vas, o tem obvestite svojega zdravnika.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.6 ml) contains 7.5 mg fondaparinux sodium.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga (0,6 ml) vsebuje 7,5 mg natrijevega fondaparinuksa.
English: Disposal of syringes
Slovenian: Žilne bolezni
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Quixidar 7.5 mg/0.6 ml injection fondaparinux Na
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Quixidar 7,5 mg/0,6 ml injekcija Na fondaparinuks s.c.
English: • feeling sick or being sick (nausea or vomiting)
Slovenian: • siljenje na bruhanje (navzea)ali bruhanje;
English: NAME OF THE MEDICINAL PRODUCT Quixidar 2.5 mg/0.5 ml solution for injection, pre-filled syringe.
Slovenian: IME ZDRAVILA Quixidar 2,5 mg/0,5 ml raztopina za injiciranje, napolnjena injekcijska brizga
English: NAME OF THE MEDICINAL PRODUCT Quixidar 1.5 mg/0.3 ml solution for injection, pre-filled syringe.
Slovenian: IME ZDRAVILA Quixidar 1,5 mg/0,3 ml raztopina za injiciranje, napolnjena injekcijska brizga
English: Prophylaxis of VTE - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Slovenian: • Preprečevanje VTE - Fondaparinuksa se ne sme uporabljati pri bolnikih, ki imajo kreatininski očistek < 20 ml/min (glejte poglavje 4.3).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Quixidar 1.5 mg/0.3 ml injection fondaparinux Na
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Quixidar 1,5 mg/0,3 ml injekcija Na fondaparinuks s.c.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 7.5 mg of fondaparinux sodium in 0.6 ml solution for injection.
Slovenian: Vsaka napolnjena injekcijska brizga vsebuje 7,5 mg natrijevega fondaparinuksa v 0,6 ml raztopine za injiciranje.
English: Contact your doctor or pharmacist before stopping.
Slovenian: Preden prenehate uporabljati zdravilo, se posvetujte s svojim zdravnikom ali farmacevtom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.3 ml) contains 1.5 mg fondaparinux sodium.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga (0,3 ml) vsebuje 1,5 mg natrijevega fondaparinuksa.
English: EU/1/02/207/015 - 2 pre-filled syringes EU/1/02/207/016 - 7 pre-filled syringes EU/1/02/207/017 - 10 pre-filled syringes EU/1/02/207/020 - 20 pre-filled syringe
Slovenian: EU/1/02/207/015 - 2 napolnjeni injekcijski brizgi EU/1/02/207/016 - 7 napolnjenih injekcijskih brizg EU/1/02/207/017 - 10 napolnjenih injekcijskih brizg EU/1/02/207/020 - 20 napolnjenih injekcijskih brizg
English: Bleeding was a commonly reported event in patients with UA/NSTEMI and STEMI.
Slovenian: Pri bolnikih z UA/NSTEMI in STEMI so pogosto poročali o krvavitvah.
English: Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.3).
Slovenian: Pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) fondaparinuksa ne smemo uporabljati (glejte poglavje 4.3).
English: NAME OF THE MEDICINAL PRODUCT Quixidar 1.5 mg/0.3 ml solution for injection Fondaparinux sodium
Slovenian: NAVODILO ZA UPORABO Quixidar 1,5 mg/0,3 ml raztopina za injiciranje natrijev fondaparinuks
English: NAME OF THE MEDICINAL PRODUCT Quixidar 10 mg/0.8 ml solution for injection Fondaparinux sodium
Slovenian: Quixidar 10 mg/0,8 ml raztopina za injiciranje natrijev fondaparinuks
English: EU/1/02/207/012- 2 pre-filled syringes EU/1/02/207/013 - 7 pre-filled syringes EU/1/02/207/014 - 10 pre-filled syringes EU/1/02/207/019 - 20 pre-filled syringe
Slovenian: EU/1/02/207/012 - 2 napolnjeni injekcijski brizgi EU/1/02/207/013 - 7 napolnjenih injekcijskih brizg EU/1/02/207/014 - 10 napolnjenih injekcijskih brizg EU/1/02/207/019 - 20 napolnjenih injekcijskih brizg
English: NAME OF THE MEDICINAL PRODUCT Quixidar 5 mg/0.4 ml solution for injection, pre-filled syringe.
Slovenian: IME ZDRAVILA Quixidar 5 mg/0,4 ml raztopina za injiciranje, napolnjena injekcijska brizga
English: Metabolism
Slovenian: Krvavitev
English: NAME OF THE MEDICINAL PRODUCT Quixidar 2.5 mg/0.5 ml solution for injection Fondaparinux sodium
Slovenian: NAVODILO ZA UPORABO Quixidar 2,5 mg/0,5 ml raztopina za injiciranje natrijev fondaparinuks
English: EU/1/02/207/005- 2 pre-filled syringes EU/1/02/207/006 - 7 pre-filled syringes EU/1/02/207/007 - 10 pre-filled syringes EU/1/02/207/008 - 20 pre-filled syringes
Slovenian: EU/1/02/207/005 - 2 napolnjeni injekcijski brizgi EU/1/02/207/006 - 7 napolnjenih injekcijskih brizg EU/1/02/207/007 - 10 napolnjenih injekcijskih brizg EU/1/02/207/008 - 20 napolnjenih injekcijskih brizg
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Quixidar 5 mg/0.4 ml injection fondaparinux Na
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Quixidar 5 mg/0,4 ml injekcija Na fondaparinuks s.c.
English: EU/1/02/207/009- 2 pre-filled syringes EU/1/02/207//010 - 7 pre-filled syringes EU/1/02/207/011 - 10 pre-filled syringes EU/1/02/207/018 - 20 pre-filled syringe
Slovenian: EU/1/02/207/009 - 2 napolnjeni injekcijski brizgi EU/1/02/207/010 - 7 napolnjenih injekcijskih brizg EU/1/02/207/011 - 10 napolnjenih injekcijskih brizg EU/1/02/207/018 - 20 napolnjenih injekcijskih brizg
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.5 ml) contains 2.5 mg fondaparinux sodium.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga (0,5 ml) vsebuje 2,5 mg natrijevega fondaparinuksa.
English: EU/1/02/207/001 - 2 pre-filled syringes EU/1/02/207/002 - 7 pre-filled syringes EU/1/02/207/003 - 10 pre-filled syringes EU/1/02/207/004 - 20 pre-filled syringes
Slovenian: EU/1/02/207/001 - 2 napolnjeni injekcijski brizgi EU/1/02/207/002 - 7 napolnjenih injekcijskih brizg EU/1/02/207/003 - 10 napolnjenih injekcijskih brizg EU/1/02/207/004 - 20 napolnjenih injekcijskih brizg
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
Slovenian: Preprečevanje venskih trombemboličnih dogodkov (VTE) pri internističnih bolnikih, pri katerih obstaja velika nevarnost trombemboličnih zapletov zaradi omejene gibljivosti (imobilizacije) med akutno fazo bolezni
English: In a double-blind clinical study, 2927 patients were randomized to receive fondaparinux 2.5mg once daily or dalteparin 5000 IU once daily, with one 2500 IU preoperative injection and a first 2500 IU post-operative injection, for 7+2 days.
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 V dvojno slepi klinični študiji je bilo 2.927 bolnikov randomiziranih tako, da so 7±2 dni prejemali bodisi fondaparinuks v odmerku 2,5 mg enkrat na dan bodisi 5.000 i.e. dalteparina enkrat na dan. Dalteparin so prejeli tudi pred operacijo (2.500 i.e.) in po operaciji (2.500 i.e.).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.4 ml) contains 5 mg fondaparinux sodium.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga (0,4 ml) vsebuje 5 mg natrijevega fondaparinuksa.
English: - hypersensitivity to the active substance or to any of the excipients - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 20 ml/min.
Slovenian: - Huda ledvična okvara, opredeljena s kreatininskim očistkom < 20 ml/min.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Quixidar 2.5 mg/0.5 ml injection fondaparinux Na
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Quixidar 2,5 mg/0,5 ml injekcija Na fondaparinuks s.c./i.v.
English: Body weight above 100 kg
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Telesna masa nad 100 kg.
English: NAME OF THE MEDICINAL PRODUCT Quixidar 5 mg/0.4 ml solution for injection Fondaparinux sodium
Slovenian: Quixidar 5 mg/0,4 ml raztopina za injiciranje natrijev fondaparinuks
English: Immune system disorders Rare: allergic reaction Metabolism and nutrition disorders
Slovenian: Bolezni kože in podkožja Redki: eritemski izpuščaj Splošne težave in spremembe na mestu aplikacije
English: NAME OF THE MEDICINAL PRODUCT Quixidar 7.5 mg/0.6 ml solution for injection Fondaparinux sodium
Slovenian: Quixidar 7,5 mg/0,6 ml raztopina za injiciranje natrijev fondaparinuks
English: The solution is a clear and colourless liquid.
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje Raztopina je bistra in brezbarvna tekočina.
English: Gastrointestinal disorders gastritis, constipation, diarrhoea
Slovenian: Bolezni jeter, žolčnika in žolčevodov
English: • The active substance is 2.5 mg fondaparinux sodium in 0.5 ml solution for injection
Slovenian: Kaj vsebuje zdravilo Quixidar • Zdravilna učinkovina je 2,5 mg natrijevega fondaparinuksa v 0,5 ml raztopine za injiciranje.
English: • breathlessness
Slovenian: • omotica;
English: The MAHs should provide within three months a detailed protocol (e.g. drug utilisation studies or survey done by record linkage) for the long term follow-up on the adherence to and effectiveness of the changes to the product information adopted by the CHMP as part of the referral procedure EMEA/H/A-31/881.
Slovenian: Imetniki dovoljenj za promet z zdravilom morajo priskrbeti podroben protokol (npr. študije uporabe zdravila ali oceno na podlagi povezovanja zapiskov) za dolgotrajno sledenje upoštevanja in učinkovitosti dopolnjenih informacij o zdravilu, ki jih je CHMP sprejel kot del napotitvenega postopka EMEA/H/A-31/881.
English: National Competent Authorities shall ensure that the following condition is fulfilled by the Marketing Authorisation Holders:
Slovenian: Pristojni nacionalni organi, katerih delo usklajuje referenčna država članica (RMS), bodo zagotovili, da imetniki dovoljenj za promet z zdravilom izpolnjujejo naslednji pogoj:
English: In particular, tell your doctor:
Slovenian: Zdravniku povejte zlasti:
English: Time was treated as a categorical variable.
Slovenian: Čas je bil obravnavan kot kategorialna spremenljivka.
English: Most of the events were mild or moderate and no serious case was reported.
Slovenian: Večina dogodkov je bila blagih ali zmernih, poročali niso o nobenem resnem primeru.
English: Patients should be monitored and treated appropriately.
Slovenian: Bolnike je treba ustrezno spremljati in zdraviti.
English: • if you drink alcohol to excess (either regularly or from time to time).
Slovenian: • če čezmerno uživate alkohol (bodisi redno bodisi občasno).
English: Ask about ways to prevent dehydration.
Slovenian: Povprašajte, kako lahko preprečite dehidracijo.
English: Elderly (≥ 65 years old)
Slovenian: Starejši (≥ 65 let)
English: • are 65 years or older
Slovenian: • če ste stari 65 let ali več.
English: Children and adolescents below 18 years should not take this medicine.
Slovenian: Otroci in mladostniki, mlajši od 18 let, ne smejo jemati tega zdravila.
English: †, 95% CI)
Slovenian: †, 95 % IZ)
English: It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Slovenian: Ni znano, ali je to zdravilo varno in učinkovito, če se uporablja pri otrocih in mladostnikih, mlajših od 18 let.
English: • fast and deep breathing
Slovenian: • hitro in globoko dihanje,
English: Signs and symptoms of low blood sugar may include:
Slovenian: Znaki in simptomi nizkega krvnega sladkorja lahko vključujejo:
English: • It is best to take your tablet with a meal.
Slovenian: • Najboljše je, da tableto vzamete s hrano.
English: * See Section 4.4.
Slovenian: *Glejte poglavje 4.4.
English: Your body can also make too much sugar.
Slovenian: V telesu lahko preveč sladkorja tudi nastaja.
English: Your doctor will tell you how to treat low blood sugar and what to do if you have any of the symptoms or signs below.
Slovenian: Zdravnik vam bo povedal, kako zdraviti nizek krvni sladkor in kaj morate narediti, če se pojavi kateri od spodaj naštetih simptomov ali znakov.
English: Subgroup analysis
Slovenian: Analiza podskupine
English: No potential acute symptoms and signs of overdose were identified.
Slovenian: Možnih akutnih simptomov in znakov prevelikega odmerjanja niso ugotovili.
English: If any of the above apply to you (or you are not sure), tell your doctor.
Slovenian: Če kaj od navedenega velja za vas (ali če niste prepričani), povejte zdravniku.
English: This may cause anaemia (low levels of red blood cells).
Slovenian: To lahko povzroči anemijo (nizko število rdečih krvnih celic).
English: Serious diabetic ketoacidosis occurred rarely.
Slovenian: Resna diabetična ketoacidoza se je pojavila redko.
English: • Your doctor will prescribe the right dose for you.
Slovenian: • Zdravnik vam bo predpisal odmerek, ki je za vas primeren.
English: This leaflet was last revised in {MM/YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM. LLLL}
English: However, if it is nearly time for your next dose, skip the missed dose and go back to your regular schedule.
Slovenian: Če pa je že skoraj čas za naslednji odmerek, preskočite izpuščeni odmerek in nadaljujte jemanje po svojem običajnem urniku.
English: Effects of age, body weight, gender and race
Slovenian: Vpliv starosti, telesne mase, spola in rase
English: This causes blood sugar to be removed in your urine.
Slovenian: To povzroči izločanje krvnega sladkorja v urinu.
English: See subsections below for additional information.
Slovenian: Za dodatne informacije glejte podpoglavja spodaj.
English: As an underlying mechanism has not been established, risk factors, apart from general risk factors, for amputation are unknown.
Slovenian: Ker osnovni mehanizem ni bil ugotovljen, dejavniki tveganja za amputacije, z izjemo splošnih dejavnikov tveganja, niso znani.
English: • if you have a severe infection or are dehydrated.
Slovenian: • če imate hudo okužbo ali ste dehidrirani.
English: General introduction
Slovenian: Splošni uvod