natgillin/translations-raw huggingface dataset:
However, in this stratum, in the subgroup of indicated population undergoing thrombolysis or no reperfusion (i.e patients not undergoing primary PCI), the incidence of death/re-MI at Day 30 was significantly reduced from 14.3% on UFH to 11.5% with fondaparinux (hazard ratio 0.79, 95% CI, 0.64, 0.98, p = 0.03).
Vendar pa se je v tej podskupini pri bolnikih, pri katerih je bila izvedena tromboliza ali reperfuzija ni bila izvedena (to je bolniki pri katerih ni bila izvedena primarna PCI) smrtnost/pojavnost re-MI do 30. dne pomembno zmanjšala s 14,3 % pri UFH na 11,5 % pri fondaparinuksu (razmerje tveganja 0,79, 95 interval zaupanja, 0,64;0,98, p = 0,03).
INFORMATION IN BRAILLE arixtra 1.5 mg
arixtra 1.5 mg
How to store Arixtra
Shranjevanje zdravila Arixtra
In this subgroup, the incidence of major bleeding on fondaparinux and enoxaparin at Day 9 was 2.2% and 5.0% respectively (hazard ratio 0.43, 95% CI, 0.33;0.57).
V tej podskupini je bila pojavnost večjih krvavitev do 9. dne pri bolnikih, ki so prejemali fondaparinuks 2,2 %, pri bolnikih, ki so prejemali enoksaparin pa 5,0 % (razmerje tveganja 0,43, 95 % interval zaupanja, 0,33;0,57).
What you need to know before you use Arixtra
Kaj morate vedeti, preden boste uporabili zdravilo Arixtra Ne uporabljajte zdravila Arixtra:
If you get any side effects, talk to your doctor or pharmacist.
Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
Sodium chloride Water for injections Hydrochloric acid Sodium hydroxide
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid voda za injekcije klorovodikova kislina natrijev hidroksid
This unlocks the sleeve.
S tem boste odblokirali tulec.
However, the use of fondaparinux should be considered with caution because of an increased risk of bleeding due to a deficiency of coagulation factors in patients with severe hepatic impairment (see section
Uporabo fondaparinuksa je treba skrbno pretehtati zaradi zvečane nevarnosti krvavitve, ki je posledica pomanjkanja koagulacijskih faktorjev pri bolnikih s hudimi okvarami jeter (glejte poglavje
The incidence of death/re-MI at Day 30 was significantly reduced from 11.1% for the control group to 9.7% for the fondaparinux group (hazard ratio 0.86, 95% CI, 0.77, 0.96, p = 0.008).
Do 30. dne se je smrtnost/pojavnost re-MI pomembno zmanjšala z 11,1 % v kontrolni skupini na 9,7 % v skupini, ki je prejemala fondaparinuks (razmerje tveganja 0,86, 95 % interval zaupanja, 0,77; 0,96, p = 0,008).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Fondaparinux should be used with caution in these patients (see section 4.2).
Fondaparinuks moramo pri teh bolnikih uporabljati previdno (glejte poglavje 4.2).
• diarrhoea or constipation
• zaspanost ali utrujenost;
The syringe needle shield contains latex.
Injekcijska brizga z zdravilom Arixtra vsebuje lateks
Syringe automatic system
Injekcijska brizga s samodejnim sistemom
Fondaparinux should be used with caution in these patients (see section 4.4).
Fondaparinuks moramo pri teh bolnikih uporabljati previdno (glejte poglavje 4.4).
There is limited experience from treatment with fondaparinux in haemodynamically unstable patients and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter.
Nikakršnih izkušenj ni na voljo z bolniki, pri katerih je potrebna tromboliza, embolektomija ali vstavitev filtra v veno kavo.
Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
Parenteralne raztopine moramo pred uporabo pregledati na prisotnost delcev in spremembo barve.
Arixtra is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Zdravilo Arixtra je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
The main sites of surgery were colonic/rectal, gastric, hepatic, cholecystectomy or other biliary.
Kirurški posegi so bili v glavnem opravljeni na kolonu, rektumu, želodcu, jetrih ali žolčnih izvodilih ali pa je bila opravljena holecistektomija.
Each pre-filled syringe contains 10 mg of fondaparinux sodium in 0.8 ml solution for injection.
Vsaka napolnjena injekcijska brizga vsebuje 10 mg natrijevega fondaparinuksata v 0,8 ml raztopine za injiciranje.
The use of fondaparinux should be considered with caution because of an increased risk of bleeding due to a deficiency of coagulation factors in patients with severe hepatic impairment (see section 4.2).
Uporabo fondaparinuksa je treba skrbno pretehtati zaradi zvečane nevarnosti krvavitve, ki je posledica pomanjkanja koagulacijskih faktorjev pri bolnikih s hudimi okvarami jeter (glejte poglavje 4.2).
- hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 20 ml/min.
- Sveža klinično pomembna krvavitev - Akutni bakterijski endokarditis - Huda ledvična okvara, opredeljena s kreatininskim očistkom < 20 ml/min.
There are different syringes for the 2.5 mg and 1.5 mg doses.
mg in 1,5 mg so na voljo različne injekcijske brizge.
• high number of platelets (blood cells necessary for blood clotting)
• zvišanje števila trombocitov (krvnih celic, potrebnih za strjevanje krvi);
• 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
· nedavno možgansko krvavitvijo (znotrajlobanjska krvavitev), · nedavno operacijo na možganih, hrbtenici ali očeh;
• oozing from operation wound site
• izcedek iz rane na mestu operacije;
Treatment of superficial-vein thrombosis
Zdravljenje povrhnje venske tromboze
Approximately 40% and 17% of patients had mild (creatinine clearance ≥50 to <80 ml/min) or moderate (creatinine clearance ≥30 to <50 ml/min) renal impairment, respectively.
Približno 40 % bolnikov je imelo blago ledvično okvaro (kreatininski očistek ≥ 50 do < 80 ml/min), približno 17 % bolnikov pa zmerno ledvično okvaro (kreatininski očistek ≥ 30 do < 50 ml/min).
No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min).
Bolnikom z blago okvaro ledvic (očistek kreatinina > 50 ml/min) odmerka ni treba zmanjšati.
• if you have severe liver disease
• če imate hudo jetrno bolezen;
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.
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.
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
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
The antithrombotic activity of fondaparinux is the result of antithrombin III (antithrombin) mediated selective inhibition of Factor Xa.
Antitrombotični učinek fondaparinuksa je rezultat selektivne inhibicije faktorja Xa preko antitrombina III (antitrombin).
Renal impairment - Fondaparinux should be used with caution in patients with moderate renal impairment (see section 4.4).
Ledvična okvara - Pri bolnikih z zmernimi okvarami ledvic je treba fondaparinuks uporabljati previdno (glejte poglavje 4.4).
INFORMATION IN BRAILLE arixtra 2.5 mg
arixtra 2.5 mg
Approximately 40% and 14% of patients had mild (creatinine clearance ≥50 to <80 ml/min) or moderate (creatinine clearance ≥30 to <50 ml/min) renal impairment, respectively.
Približno 40 % bolnikov je imelo blago ledvično okvaro (kreatininski očistek ≥ 50 do < 80 ml/min), približno 14 % bolnikov pa zmerno ledvično okvaro (kreatininski očistek ≥ 30 do < 50 ml/min).
Contact your doctor or pharmacist for advice as soon as possible because of the increased risk of bleeding.
Zaradi večje možnosti za pojav krvavitev se čim prej posvetujte s svojim zdravnikom ali s farmacevtom.
Prevention of VTE and Treatment of UA/NSTEMI and STEMI - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
• Preprečevanje VTE in zdravljenje UA/NSTEMI in STEMI - Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati.
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.
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.
The antithrombotic activity of fondaparinux is the result of antithrombin III (ATIII) mediated selective inhibition of Factor Xa.
Antitrombotični učinek fondaparinuksa je rezultat selektivne inhibicije faktorja Xa preko antitrombina III (ATIII).
Each pre-filled syringe contains 7.5 mg of fondaparinux sodium in 0.6 ml solution for injection.
Vsaka napolnjena injekcijska brizga vsebuje 7,5 mg natrijevega fondaparinuksata v 0,6 ml raztopine za injiciranje.
Medicinal product subject to medical prescription.
Predpisovanje in zdaja zdravila je le na recept.
• 7.5 mg fondaparinux sodium in 0.6 ml solution for injection
• 7,5 mg natrijevega fondaparinuksata v 0,6 ml raztopine za injiciranje.
These may affect up to 1 in every 1000 people treated with Arixtra.
Pojavijo se lahko pri do 1 od 1.000 bolnikov, ki se zdravijo z zdravilom Arixtra:
• If you get any side effects, talk to your doctor or pharmacist.
• Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
• bruising or swelling (oedema)
• nastanek modric ali oteklin (edemi);
Each pre-filled syringe contains 5 mg of fondaparinux sodium in 0.4 ml solution for injection.
Vsaka napolnjena injekcijska brizga vsebuje 5 mg natrijevega fondaparinuksata v 0,4 ml raztopine za injiciranje.
However, the use of fondaparinux should be considered with caution because of an increased risk of bleeding due to a deficiency of coagulation factors in patients with severe hepatic impairment (see section 4.2).
Vendar pa moramo uporabo fondaparinuksa skrbno obravnavati, ker obstaja pri bolnikih s hudimi jetrnimi okvarami povečano tveganje za krvavitve zaradi pomanjkanja faktorjev koagulacije (glejte poglavje 4.2).
The needle shield of the pre-filled syringe contains dry natural latex rubber that has the potential to cause allergic reactions in latex sensitive individuals.
Ščitnik igle na napolnjeni injekcijski brizgi vsebuje suho naravno gumo iz lateksa, ki lahko osebam, občutljivim na lateks, povzroči alergijsko reakcijo.
The incidence of each thromboembolic component of the primary outcome was also significantly reduced in fondaparinux patients as follows: symptomatic PE [0 (0%) vs 5 (0.3%) (p=0.031)], symptomatic DVT [3 (0.2%) vs 18 (1.2%); relative risk reduction 83.4% (p<0.001)], symptomatic superficial-vein thrombosis extension [4 (0.3%) vs 51 (3.4%); relative risk reduction 92.2% (p<0.001)], symptomatic superficial-vein thrombosis reoccurrence [5 (0.3%) vs 24 (1.6%); relative risk reduction 79.2% (p<0.001)].
Pri bolnikih, ki so prejemali fondaparinuks, se je značilno zmanjšala tudi incidenca vsake posamezne komponente primarnega opazovanega dogodka: simptomatske pljučne embolije [0 (0 %) v primerjavi s 5 (0,3 %), p = 0,031], simptomatske globoke venske tromboze [3 (0,2 %) v primerjavi z 18 (1,2 %), zmanjšanje relativnega tveganja 83,4 % (p < 0,001)],
Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
Jetrna okvara - Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati.
Peri-PCI minor bleeding
Večja krvavitev v času okrog PCI Manjša krvavitev v času okrog PCI
• Treatment of UA/NSTEMI and STEMI - Fondaparinux should not be used in patients with creatinine clearance < 20 ml/min (see section 4.3).
• Zdravljenje UA/NSTEMI in STEMI - Fondaparinuksa se ne sme uporabljati pri bolnikih s kreatininskim očistkom < 20 ml/min (glejte poglavje 4.3).
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.
Zdravilo Arixtra vsebuje sintetično učinkovino, imenovano natrijev fondaparinuksat, ki zavre delovanje faktorja strjevanja krvi Xa (“deset-A”) v krvi in tako prepreči razvoj neželenih krvnih strdkov (trombozo) v krvnih žilah.
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).
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
METHOD OF ADMINISTRATION EXPIRY DATE
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Common: post-operative haemorrhage, anaemia Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder
Občasni: krvavitve (epistaksa, krvavitve v prebavilih, hemoptiza, hematurija, hematom) trombocitopenija, purpura, trombocitemija, nepravilnosti trombocitov, motnje koagulacije
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).
Bolnikom z očistkom kreatinina od 20 do 50 ml/min je treba odmerek zmanjšati na 1,5 mg enkrat na dan (glejte poglavji 4.4 in 5.2).
Arixtra 7.5 mg/0.6 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Zdravilo Arixtra 7,5 mg/0,6 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
These may affect up to 1 in 100 people treated with Arixtra.
Pojavijo se lahko pri do 1 od 100 bolnikov, ki se zdravijo z zdravilom Arixtra:
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 4.2 and 5.2).
Bolnikom z očistkom kreatinina od 20 do 50 ml/min je treba odmerek zmanjšati na 1,5 mg enkrat na dan (glejte poglavji 4.2 in 5.2).
• The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection
• Zdravilna učinkovina je 1,5 mg natrijevega fondaparinuksata v 0,3 ml raztopine za injiciranje.
Discard the needle shield.
Ščitnik igle zavrzite.
Patients under-going urological (other than kidney) or gynaecological surgery, laparoscopic surgery or vascular surgery were not included in the study.
V študijo niso bili vključeni bolniki pri katerih je bil opravljen kirurški poseg na sečilih (vse razen ledvic), ženskih spolovilih, žilah ali laparoskopski poseg.
In subjects undergoing primary PCI the incidence of adjudicated guiding catheter thrombus was 1.2% vs 0% in fondaparinux vs. control subjects, respectively.
Pri preiskovancih z opravljeno primarno PCI je bila pogostnost tromba na vodilnem katetru 1,2 % med preiskovanci, ki so prejemali fondaparinuks, in 0 % med preiskovanci v kontrolni skupini.
The recommended dose of fondaparinux is 2.5 mg once daily administered by subcutaneous injection.
Priporočeni odmerek fondaparinuksa je 2,5 mg enkrat na dan s subkutano injekcijo.
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.
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.
By Day 9, 1.1% of patients treated with fondaparinux and 1.4% of control patients experienced a severe haemorrhage.
Hujša krvavitev se je do 9. dne pojavila pri 1,1 % bolnikov, ki so se zdravili s fondaparinuksom in 1,4 % bolnikov v kontrolni skupini.
• Prevention of VTE - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
• Preprečevanje VTE - Fondaparinuksa se ne sme uporabljati pri bolnikih, ki imajo kreatininski očistek < 20 ml/min (glejte poglavje 4.3).
Arixtra 10 mg/0.8 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Zdravilo Arixtra 10 mg/0,8 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
Arixtra syringe may contain latex
Injekcijska brizga z zdravilom Arixtra lahko vsebuje lateks
Arixtra 5 mg/0.4 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Zdravilo Arixtra 5 mg/0,4 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
Dispose of it as your doctor or pharmacist has instructed.
Injekcijsko brizgo zavrzite v skladu z navodili svojega zdravnika ali farmacevta.
Arixtra 7.5 mg/0.6 ml solution for injection Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
Navodilo za uporabo Arixtra 5 mg/0,4 ml raztopina za injiciranje Arixtra 7,5 mg/0,6 ml raztopina za injiciranje Arixtra 10 mg/0,8 ml raztopina za injiciranje natrijev fondaparinuksat
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.
V randomiziranem dvojno slepem kliničnem preskusu so zdravili 839 bolnikov s fondaparinuksom v odmerku 2,5 mg enkrat na dan ali placebom 6 do 14 dni dolgo.
• 5 mg fondaparinux sodium in 0.4 ml solution for injection
• 5 mg natrijevega fondaparinuksata v 0,4 ml raztopine za injiciranje.
Arixtra is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Arixtra je zdravilo, ki pomaga preprečevati nastajanje krvnih strdkov v krvnih žilah
• syringe with a orange plunger and an automatic safety system
• injekcijska brizga z oranžnim batom in samodejnim varnostnim sistemom.
The timing of restarting subcutaneous fondaparinux after sheath removal should be based on clinical judgment.
Klinik naj presodi o času ponovne uvedbe subkutanega zdravljenja s fondaparinuksom po odstranitvi katetra.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium.
Ena napolnjena injekcijska brizga (0,8 ml) vsebuje 10 mg natrijevega fondaparinuksata.
The recommended dose of fondaparinux is 2.5 mg once daily, administered by subcutaneous injection.
Priporočeni odmerek fondaparinuksa je 2,5 mg enkrat na dan, injiciran subkutano.
Fondaparinux should be used with caution in elderly patients (see section 4.2).
Pri starejših bolnikih moramo fondaparinuks uporabljati previdno (glejte poglavje 4.2).
EU/1/02/206/005-008 EU/1/02/206/024 EU/1/02/206/025 EU/1/02/206/026
EU/1/02/206/024 EU/1/02/206/025 EU/1/02/206/026
Arixtra 10 mg/0.8 ml solution for injection, pre-filled syringe.
Arixtra 10 mg/0,8 ml raztopina za injiciranje, napolnjena injekcijska brizga
- hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 30 ml/min.
- Sveža klinično pomembna krvavitev - Akutni bakterijski endokarditis - Huda ledvična okvara (kreatininski očistek < 30 ml/min).
Severe hepatic impairment
Huda jetrna okvara
→ Tell your doctor if you think any of these applies to you.
→ Če menite, da se karkoli od navedenega nanaša na vas, o tem obvestite svojega zdravnika.
If they do, you must not use Arixtra.
V teh primerih zdravila Arixtra ne smete uporabljati.
• syringe with orange plunger and a manual safety system.
• injekcijska brizga z oranžnim batom in ročnim varnostnim sistemom.
Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
Arixtra 7,5 mg/0,6 ml raztopina za injiciranje, napolnjena injekcijska brizga
• dizziness
• zasoplost;
In subjects undergoing PCI the incidence of adjudicated guiding catheter thrombus was 1.0% vs. 0.3% in fondaparinux vs. enoxaparin subjects, respectively.
Pri preiskovancih z opravljeno PCI je bila pogostnost tromba na vodilnem katetru 1,0 % med preiskovanci, ki so prejemali fondaparinuks, in 0,3 % med preiskovanci, ki so prejemali enoksaparin.
Uncommon: chest pain
Občasni: bolečine v prsih
NAME OF THE MEDICINAL PRODUCT Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
Arixtra 10 mg/0,8 ml raztopina za injiciranje natrijev fondaparinuksat
• syringe with a yellow plunger and an automatic safety system
• injekcijska brizga z rumenim batom in samodejnim varnostnim sistemom.
Presence of superficial-vein thrombosis greater than 3 cm from the sapheno-femoral junction should be confirmed and concomitant DVT should be excluded by compression ultrasound or objective methods prior to initiating treatment of fondaparinux.
Pred začetkom zdravljenja s fondaparinuksom je treba s kompresijskim ultrazvokom ali drugimi objektivnimi metodami potrditi, da je povrhnja venska tromboza več kot 3 cm daleč od safeno femoralnega spoja in da ni sočasne globoke venske tromboze.
Always use this medicine exactly as your doctor or pharmacist has told you.
Pri uporabi tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta.
Syringe with a manual needle protection system
Injekcijska brizga z ročnim sistemom za zaščito igle
Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (See section 4.3).
Pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) fondaparinuksa ne smemo uporabljati (glejte poglavje 4.3).
• For prevention of VTE - Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
• Za preprečevanje VTE - Sočasno s fondaparinuksom ne smemo uporabljati učinkovin, ki lahko povečajo tveganje za krvavitev.
Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe.
Arixtra 1,5 mg/0,3 ml raztopina za injiciranje, napolnjena injekcijska brizga
• Treatment of superficial-vein thrombosis - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
• Zdravljenje povrhnje venske tromboze - Fondaparinuksa se ne sme uporabljati pri bolnikih z očistkom kreatinina < 20 ml/min (glejte poglavje 4.3).
• syringe with a blue plunger and an automatic safety system
• injekcijska brizga z modrim batom in samodejnim varnostnim sistemom.
• headache
• glavobol;