qanastek/EMEA-V3 huggingface dataset:
What is the risk associated with Arixtra?
X’ inhu r- riskju assoċjat ma ’ Arixtra?
As with other antithrombotic medicines, the most common side effect of Arixtra is bleeding.
Bħall- mediċini antitrombotiċi l- oħra, l- iktar effetti sekondarji komuni ta ’ Arixtra kien il- ħruġ tad - demm.
For the full list of all side effects reported with Arixtra, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati b’ Arixtra, ara l- Fuljett ta ’ Tagħrif.
Arixtra should not be used in people who may be hypersensitive (allergic) to fondaparinux sodium or any of the other ingredients, who might be bleeding already, who have acute bacterial endocarditis (an infection of the heart) or have severe kidney problems.
Arixtra m’ għandux jintuża minn persuni allerġiċi għal fondaparinux sodium jew għal xi sustanza oħra tiegħu, li jista ’ diġà jkollhom ħruġ ta ’ demm, li għandhom endokartite batterjali akuta (acute bacterial endocarditis) (infezzjoni fil- qalb) jew li jkollhom problemi serji fil- kliewi.
Why has Arixtra been approved?
Għaliex ġie approvat Arixtra?
The European Commission granted a marketing authorisation valid throughout the European Union for Arixtra on 21 March 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal- Quixidar fil- 21 ta ’ Marzu 2002.
The marketing authorisation was renewed on 21 March 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil - 21 ta ’ Marzu 2007.
The marketing authorisation holder is Glaxo Group Ltd.
Id- detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq huwa Glaxo Group Ltd.
The full EPAR for Arixtra can be found here.
L- EPAR sħiħ dwar Arixtra jista ’ jinstab hawnhekk.
This summary was last updated in 09-2007.
Dan is- sommarju kien aġġornat l- aħħar f’ 09- 2007.
Subcutaneous or intravenous use
Użu subkutanju jew intravenuż
pre-filled syringe (glass) with an automatic safety system
siringa mimlija lesta (ħġieġ) b’ sistema awtomatika ta ’ sigurta ’
0.5 ml
siringa mimlija lesta (ħġieġ) 0. 5 ml b’ sistema awtomatika ta ’ sigurta
pre-filled syringe (glass) with an automatic safety system
siringa mimlija lesta (ħġieġ) b’ sistema awtomatika ta ’ sigurta
10 pre-filled syringes
10 siringi mimlijin lesti es
pre-filled syringe (glass) 0.6 ml with an automatic safety system
siringa mimlija lesta (ħġieġ) 0. 6 ml b’ sistema awtomatika ta ’ sigurta
pre-filled syringe (glass) 0.8 ml with an automatic safety system
siringa mimlija lesta (ħġieġ) 0. 8 ml b’ sistema awtomatika ta ’ sigurta
pre-filled syringe (glass) 0.4 ml with an automatic safety system
siringa mimlija lesta (ħġieġ) 0. 4 ml b’ sistema awtomatika ta ’ sigurta
pre-filled syringe (glass) 0.5 ml with a manual safety system
siringa mimlija lesta (ħġieġ) 0. 5 ml b’ sistema manwali ta ’ sigurta ’
pre-filled syringe (glass) with a manual safety system
siringa mimlija lesta (ħġieġ) b’ sistema manwali ta ’ sigurta ’
0.3 ml
siringa mimlija lesta (ħġieġ) 0. 3 ml b’ sistema manwali ta ’ sigurta ’
0.4 ml
siringa mimlija lesta (ħġieġ) 0. 4 ml b’ sistema manwali ta ’ sigurta ’
0.6 ml
siringa mimlija lesta (ħġieġ) 0. 6 ml b’ sistema manwali ta ’ sigurta ’
0.8 ml
siringa mimlija lesta (ħġieġ) 0. 8 ml b’ sistema manwali ta ’ sigurta ’
Arixtra 1.5 mg/ 0.3 ml solution for injection, pre-filled syringe.
Arixtra 1. 5 mg/ 0. 3 ml soluzzjoni għall- injezzjoni, siringa mimlija lesta.
Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium.
Kull siringa mimlija lesta (0. 3 ml) fiha 1. 5 mg fondaparinux sodium.
Excipient(s):
Sustanza( i):
Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially sodium free.
Kull doża fiha anqas minn 1 mmol ta ’ sodium (23 mg) u għalhekk il- prodott huwa essenzjalment mingħajr sodium.
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.
Prevenzjoni kontra eventi tromboemboliċi fil- vini (VTE) f’ pazjenti li għaddejjin minn kirurġija ortopedika maġġuri tal- partijiet t’ isfel tal- ġisem bħal fratturi fil- ġenb (hip), kirurġija maġġuri fl - irkoppa jew kirurġija għal sostituzzjoni tal- ġenb.
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).
Il- prevenzjoni ta ’ Każi Trombo- emboliċi Venużi (VTE) f’ pazjenti li jgħaddu minn kirurġija ta ’ l - addomenu li huma meqjusa f’ riskju għoli ta ’ kumplikazzjonjiet trombo- emboliċi, bħal dawk l- pazjenti li jgħaddu minn kirurġija ta ’ kanċer fl- addomenu (are sezzjoni 5. 1).
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.
Il- prevenzjoni ta ’ Każi Trombo- emboliċi Venużi (VTE) f ’ pazjenti mediċi li huma meqjusa f’ riskju għoli ta ’ VTE u li huma immobili minħabba mard akut bħal insuffiċienza kardijaka u/ jew mard respiratorju akut, u / jew mard akut infettiv jew ta ’ infjammazzjoni.
Patients undergoing major orthopaedic or abdominal surgery The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by subcutaneous injection.
Pazjenti li jgħaddu minn kirurġija maġġuri ortopedika u addomenali Id- doża rakkomandata ta ’ Arixtra hi ta ’ 2. 5 mg darba kuljum amminisrata wara l- operazzjoni permezz ta ’ injezzjoni subkutanja.
The initial dose should be given 6 hours following surgical closure provided that haemostasis has been established.
Id- doża inizzjali għandha tingħata 6 sigħat wara l- għeluq tal- kirurġija ladarba tiġi stabbilita l- emostażi.
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.
It- trattament għandu jitkompla sakemm ir- riskju ta ’ tromboemboliżmu fil- vini jonqos, solitament sakemm il- pazjent ikun ambulanti, mill- inqas 5 sa 9 t ’ ijiem wara l- operazzjoni.
2 Special populations In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in patients ≥ 75 years, and/ or with body weight < 50 kg and/ or with renal impairment with creatinine clearance ranging between 20 to 50 ml/ min.
2 Popolazzjonijiet speċjali Għall- ewwel injezzjoni b’ Arixtra hu importanti li jkun hemm aderenza stretta mal- ħin f’ pazjenti li jgħaddu minn kirurġija, li għandhom ≥ 75 sena, u/ jew b’ piż tal- ġisem < 50 kg u/ jew indeboliment renali bi clearance tal- krejatinina ta ’ bejn 20 u 50 ml/ min.
The first fondaparinux administration should be given not earlier than 6 hours following surgical closure.
L- ewwel amministrazzjoni ta ’ Arixtra għandha tingħata mhux aktar kmieni minn 6 sigħat wara t - tmiem tal- kirurġija.
The injection should not be given unless haemostasis has been established (see section 4.4).
(ara sezzjoni 4. 4)
Renal impairment - Fondaparinux should not be used in patients with creatinine clearance < 20 ml/ min (see section 4.3).
Indeboliment renali - Fondaparinux m’ għandux jingħata lil pazjenti bi clearance tal- krejatinina < 20 ml/ min (ara sezzjoni 4. 3).
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).
F’ pazjenti bi clearance tal- krejatinina ta ’ bejn 20 sa 50 ml/ min, id - doża ta ’ fondaparinux għandha titnaqqas għal 1. 5 mg darba kuljum (ara sezzjonijiet 4. 4 u 5. 2).
No dosage reduction is required for patients with mild renal impairment (creatinine clearance > 50 ml/ min).
M’ hemmx bżonn li titnaqqas id- doża f’ pazjenti b’ indeboliment renali ħafif (clearance tal- krejatinina > 50 ml/ min).
Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
Indeboliment tal- fwied - Ma hemm bżonn ta ’ l- ebda aġġustament fid- doża f’ pazjenti b’ indeboliment tal- fwied ħafif jew moderat.
In patients with severe hepatic impairment, fondaparinux should be used with care as this patient group has not been studied (see sections 4.4 and 5.2).
F’ pazjenti b’ indeboliment qawwi tal- fwied, fondaparinux għandu jintuża b’ attenzjoni għaliex dan il- grupp ta 'pazjenti ma ġiex studjat (ara sezzjonijiet 4. 4 u 5. 2).
Sites of administration should alternate between the left and the right anterolateral and left and right posterolateral abdominal wall.
Il- postijiet ta ’ amministrazzjoni għandhom jalternaw bejn il- membrana ta ’ l- addome anterolaterali tax- xellug u tal- lemin u posterolaterali tax- xellug u tal- lemin.
To avoid the loss of medicinal product when using the pre-filled syringe do not expel the air bubble from the syringe before the injection.
Biex tevita telf tal- prodott mediċinali waqt l- użu ta ’ l- injezzjoni mimlija lesta m’ għandekx tespella l- buzzieqa ta ’ l- arja minn ġos - siringa qabel l- injezzjoni.
The whole length of the needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; the skin fold should be held throughout the injection.
It- tul kollu tal- labra għandu jiġi inserit b’ mod perpendikulari f’ tinja tal- ġilda miżmuma bejn is- saba ’ l- kbir u l- werrej; it- tinja tal- ġilda għandha tinżamm matul l- injezzjoni.
For additional instructions for use and handling and disposal see section 6.6.
Għal aktar struzzjonijiet għall- użu u maniġġar u għar- rimi ara sezzjoni 6. 6.
- hypersensitivity to the active substance or to any of the excipients
- Sensittività eċċessiva għal fondaparinux jew għal xi sustanzi mhux attivi;
- active clinically significant bleeding
- Fsada attiva klinikament sinifikanti
- acute bacterial endocarditis
- Endokardite batterika akuta
Haemorrhage Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders (e. g. platelet count < 50,000/ mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups as outlined below.
Emorraġija Fondaparinux għandu jiġi amminstrat b’ kawtela f’ pazjenti li għandhom riskju akbar ta ’ emorraġija, bħal dawk li għandhom disturbi ta ’ fsadat konġeniti jew akkwiżiti (p. e. għadd taċ- ċelluli għat- tagħqid tad- demm < 50, 000/ mm3), mard ta ’ ulċera gastrointestinali attiv u emorraġija riċenti fil- kranju jew ftit taż- żmien wara kirurġija fil- moħħ, fl- ispina jew kirurġija oftalmika jew fi gruppi ta ’ pazjenti speċjali kif spjegat hawn taħt.
When required, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5.
Meta jkun hemm bżonn terapija konkomitanti ma ’ antagonist tal- vitamina K għandha tiġi amministrata skond l - informazzjoni mogħtija f’ sezzjoni 4. 5.
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution.
Mediċini oħra li jxekklu l- plejtlets (acetylsalycylic acid, dipyridamole, sulfinpyrazone, ticlopidine jew clopidrogel), u NSAIDs għandhom jiġu wżati b’ kawtela.
3 Spinal / Epidural anaesthesia 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.
3 Anesteżija spinali/ epidurali F’ pazjenti li jgħaddu minn kirurġija ortopedika maġġuri, ematomi epidurali jew spinali li jistgħu jirriżultaw f’ paraliżi permanenti jew għal żmien twil ma jistgħux jiġu esklużi bl- użu konkorrenti ta ’ Arixtra u anesteżija spinali jew epidurali jew titqib spinali.
The risk of these rare events may be higher with post- operative use of indwelling epidural catheters or the concomitant use of other medicinal products affecting haemostasis.
Ir- riskju ta ’ dawn l- avventimenti rari jista ’ jkun ogħla b’ użu post- operattiv ta ’ kateter epidurali ġewwa l- ġisem jew l- użu konkomitanti ta ’ prodotti mediċinali li jaffettwaw l- emostażi.
Elderly patients The elderly population is at increased risk of bleeding.
Pazjenti anzjani Il- popolazzjoni anzjana għandha riskju akbar ta ’ fsada.
As renal function is generally decreasing with age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 5.2).
Minħabba li l- funzjoni renali ġeneralment tonqos bl- eta`, pazjenti anzjani jista ’ jkollhom tnaqqis fl- eliminazzjoni u espożizzjoni akbar għal fondaparinux (ara sezzjoni 5. 2).
Renal impairment Fondaparinux is known to be mainly excreted by the kidney.
Indeboliment renali Fondaparinux hu magħruf li jiġi mneħħi prinċipalment mill- kliewi.
Patients with creatinine clearance < 50 ml/ min are at increased risk of bleeding and VTE and should be treated with caution (see sections 4.2, 4.3 and 5.2).
Pazjenti bi clearance tal - krejatinina ta ’ < 50 ml/ min għandhom riskju akbar ta ’ fsada u VTE w għandhom jiġu trattati b’ kawtela (ara sezzjonijiet 4. 2, 4. 3 u 5. 2).
There are limited clinical data available from patients with creatinine clearance less than 30 ml/ min.
Hemm tagħrif kliniku limitat fuq pazjenti bi clearance tal- krejatinina ta ’ anqas minn 30 ml/ min.
Severe hepatic impairment Dosing adjustment of fondaparinux is not necessary.
Indeboliment epatiku qawwi Mhux neċessarju li jsir aġġustament fid- doża ta ’ fondaparinux.
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).
Izda, l- użu ta ’ fondaparinux għandu jiġi kkunsidrat b’ kawtela minħabba riskju akbar ta ’ fsada minħabba nuqqas ta ’ fatturi koagulanti f’ pazjenti b’ indeboliment epatiku qawwi (ara sezzjoni 4. 2).
Patients with Heparin Induced Thrombocytopenia Fondaparinux should be used with caution in patients with a history of HIT.
Pazjenti bi tromboċitopenja indotta bl- Eparina Fondaparinux għandu jintuża b’ kawtela f’ pazjenti li kellhom TIE fil- passat.
Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with Heparin Induced Thrombocytopenia (HIT) type II.
Fondaparinux ma jintrabatx mal- fattur 4 tal- plejtlets u ma jirreaġixxix mas- serum minn pazjenti b ’ Tromboċitopenja Indotta bl - Eparina (TIE) tat- tip II.
However, rare spontaneous reports of HIT in patients treated with fondaparinux have been received.
Madankollu, waslu rapporti spontanji rari ta ’ TIE f’ pazjenti trattati b’ fondaparinux.
To date a causal association between treatment with fondaparinux and the occurrence of HIT has not been established.
S’ issa ma ġietx stabbilita assoċjazzjoni ta ’ kawża bejn it- trattament b’ fondaparinux u l- iżvilupp ta ’ TIE.
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4).
Ir- riskju ta ’ fsada jiżdied bl- amministrazzjoni konkomitanti ta ’ fondaparinux u aġenti li jistgħu jżidu r - riskju ta ’ emorraġija (ara sezzjoni 4. 4).
Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Sostanzi orali kontra l- koagulazzjoni tad- demm (warfarin), impedituri għat- tgħaqid tad- demm (acetylsalicylic acid), NSAIDs (piroxicam) u digoxin ma kellhomx interazzjoni mal- farmakokinetiċi ta ’ fondaparinux.
The fondaparinux dose (10 mg) in the interaction studies was higher than the dose recommended for the present indications.
Id- doża ta ’ fondaparinux (10 mg) fl- istudju ta ’ l- interazzjoni kienet ogħla mid- doża rakkomandata għall- indikazzjoni preżenti.
Fondaparinux neither influenced the INR activity of warfarin, nor the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.
Fondaparinux lanqas ma influwenza l- attivita` INR ta ’ warfarin, lanqas il- ħin ta ’ fsada taħt acetylsalicylic acid jew trattament ta ’ piroxicam, lanqas il - farmakokinetiċi ta ’ digoxin fi stat fiss.
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.
Terapija ta ’ tkomplija bi prodott mediċinali ieħor kontra l- koagulazzjoni tad- demm Jekk it- trattament ta ’ tkomplija għandu jkun mibdi bl- eparina jew LMWH, l- ewwel injezzjoni għandha, bħala regola ġenerali, tingħata ġurnata wara l- aħħar injezzjoni ta ’ fondaparinux.
If follow up treatment with a Vitamin K antagonist is required, treatment with fondaparinux should be continued until the target INR value has been reached.
Jekk hemm bżonn ta ’ trattament ta ’ tkomplija b’ antagonist tal- vitamina K, trattament b’ fondaparinux għandu jitkompla sakemm il- valur mirat ta ’ l- INR jintlaħaq.
There are no adequate data from the use of fondaparinux in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ fondaparinux waqt it- tqala.
Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk.
Fondaparinux jitneħħa fil- ħalib tal- far imma m’ hemmx tagħrif dwar l- eskrezzjoni ta ’ fondaparinux fil - ħalib tas- sider fil- bniedem.
Breast-feeding is not recommended during treatment with fondaparinux.
It- treddigħ mhux rakkomandat waqt trattament b ’ fondaparinux.
Oral absorption by the child is however unlikely.
Fit- tarbija l- assorbiment mill- ħalq huwa improbabli.
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, 1,407 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.
Is- sigurta` ta ’ fondaparinux 2. 5 mg ġiet evalwata f’ 3, 595 pazjent għaddejjin minn kirurġija ortopedika maġġuri fir- riġlejn li ġew trattati għal mhux iżjed minn 9 t ’ ijiem, f’ 327 pazjent għaddejjin minn kirurġija ta ’ ksur ta ’ l- għadma tal- ġenbejn li ġew trattati għal 3 ġimgħat wara profilassi inizjali ta ’ ġimgħa, 1, 407 pazjent għaddejjin minn kirurġija ta ’ l- addomenu li ġew trattati mhux iżjed minn 9 t’ ijiem, u f’ 425 pazjenti mediċi li huma f’ riskju ta ’ kumplikazzjonijiet ta ’ trombo- emboliżmu li ġew trattati għal 14 il- ġurnata.
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.
L- effetti mhux mixtieqa li ġew irrappurtati mill- investigatur bħala dawk li ta ’ l- inqas għandhom possibilment x’ jaqsmu ma ’ fondaparinux huma rranġati f’ kull grupp ta ’ frekwenza (komuni ħafna: ≥ 1/ 10; komuni: ≥1/ 100 sa < 1/ 10; mhux komuni: ≥ 1/ 1, 000 sa < 1/ 100; rari: ≥ 1/ 10, 000 sa < 1/ 1, 000; rari ħafna < 1/ 10, 000) u fis- sistema tal- klassifika tal- organi, bil- gravita` ta ’ l- effett mhux mixtieq dejjem jonqos; dawn l- effetti mhux mixtieqa għandhom jiġu interpretati fil- kuntest kirurġiku u mediku.
System organ class MedDRA
5 Sistema tal- klassifika tal- organi fid- database MedDRA
Undesirable effects in patients undergoing major orthopaedic surgery of lower limbs and/ or abdominal surgery
Effetti mhux mixtieqa f’ pazjenti li jgħaddu minn kirurġija ortopedika maġġuri tar- riġlejn u/ jew kirurġija ta ’ l - addomenu.
Rare: post-operative wound infection
Rari: infezzjonijiet tal- feriti wara Infezzjonijiet u l- operazzjoni Infestazzjonijiet
Common: post-operative haemorrhage, anaemia Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder
Komuni: fsada (ematoma, Disturbi tad- demm u tas - Komuni: emorraġija wara ematurja, emoptisis, fsada tal - operazzjoni, anemija sistema limfatika ħanek) Mhux komuni: telf ta ’ demm Mhux komuni: anemija (epistaxis, emoptisis gastro - intestinali, ematurja, ematoma) thromboċitopenja, purpura, thrombocitemja, plejtlet abnormali, mard tal - koagulazzjoni
Common: bleeding (haematoma, haematuria, haemoptysis, gingival bleeding) Uncommon: anaemia
Rari: reazzjonijiet allerġiċi Distubi fis- sistema immuni Disturbi fil- metaboliżmu Rari:
Immune system disorders Rare: allergic reaction
Ipokalimja u n- nutrizzjoni
Metabolism and nutrition Rare: hypokalaemia disorders
Rari: anzjeta`, ngħas, vertigo, Disturbi fis- sistema sturdament, uġigħ ta ’ ras, nervuża konfużjoni
Nervous system disorders Rare: anxiety, somnolence, vertigo, dizziness, headache, confusion
Rari: pressjoni tad- demm baxxa Disturbi vaskulari Disturbi respiratorji, toraċiċi u medjastinali
5 Vascular disorders
Rari: qtugħ ta ’ nifs, sogħla
Rare: hypotension
Mhux komuni: qtugħ ta ’ nifs
Respiratory, thoracic and Rare: dyspnoea, coughing mediastinal disorders
Disturbi gastro - intestinali
Gastrointestinal Uncommon: nausea, vomiting disorders Rare: abdominal pain, dyspepsia, gastritis, constipation, diarrhoea
Mhux komuni: dardir, rimettar Rari: uġigħ ta ’ l- addomenu, indiġestjoni, gastrite, stitikezza, dijareja
Uncommon: hepatic enzymes increased, hepatic function abnormal Rare: bilirubinaemia
Mhux komuni: żieda fl- enżimi tal - Disturbi fil- fwied u fil - fwied, funzjoni abnormali tal - marrara fwied Rari: żieda fil- bilirubin
Uncommon: oedema, oedema peripheral, fever, wound secretion Rare: chest pain, fatigue, hot flushes, leg pain, oedema genital, flushing, syncope
6 Mhux komuni: uġigħ fis- sider Mhux komuni: edema, edema Disturbi ġenerali u periferali, deni, nixxija mill- ferita kundizzjonijiet ta ’ mnejn Rari: uġigħ fis- sider, għejja, jingħata fwawar bi sħana, uġigħ fir - riġlejn, edema ġenitali, fwawar, sinkope
In other studies or in post-marketing experience, rare cases of intracranial / intracerebral and retroperitoneal bleedings have been reported.
F ’ studji oħrajn jew f’ esperjenza ta ’ wara t- tqegħid tal- prodott fis- suq, ġew irrappurtati każijiet rari ta ’ fsada fil- kranju / fil- moħħ u retroperitonejali.
Fondaparinux doses above the recommended regimen may lead to an increased risk of bleeding.
Dożi ta ’ Fondaparinux akbar mir- reġimen rakkomandat jistgħu jwasslu għal riskju akbar ta ’ fsada.
Overdose associated with bleeding complications should lead to treatment discontinuation and search for the primary cause.
Doża eċċessiva assoċjata ma ’ komplikazzjonijiet tal- fsada għandhom iwasslu għal waqfien tat - trattament u għandha ssir riċerka għall- kawża primarja.
Initiation of appropriate therapy such as surgical haemostasis, blood replacements, fresh plasma transfusion, plasmapheresis should be considered.
Għandha tiġi kkunsidrata li tinbeda terapija xierqa bħal emostażi kirurġika, sostituzzjoni tad- demm, trasfużjoni mill- ġdid ta ’ plażma, plażmafereżi.
Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa).
Fondaparinux huwa impeditur sintetiku u selettiv ta ’ Fattur X attivat (Xa).
By binding selectively to ATIII, fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII.
Billi jeħel b’ mod selettiv ma ’ ATIII, fondaparinux isaħħah (b’ madwar 300 darba) in- newtralizzazzjoni naturali ta ’ Fattur Xa b’ ATIII.
Neutralisation of Factor Xa interrupts the blood coagulation cascade and inhibits both thrombin formation and thrombus development.
In- newtralizzazzjoni ta ’ Fattur Xa tinterrompi l- kaskata tal - koagulazzjoni tad- demm u tinibixxi kemm il- formazzjoni ta ’ l- enżima li tikkawża t- tagħqid tad- demm kif ukoll żvilupp ta ’ trombożi tad- demm.
Fondaparinux does not inactivate thrombin (activated Factor II) and has no effects on platelets.
Fondaparinux ma jinattivax l- enżima li tikkawża t- tagħqid tad- demm (Fattur II attivat) u m’ ghandux effetti fuq il- plejtlets.
6 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.
Bid- doża ta ’ 2. 5 mg, fondaparinux ma jaffettwax testijiet tal- koagulazzjoni ta ’ rutina tad- demm bħal activated partial thromboplastin time (aPTT), activated clotting time (ACT) jew prothrombin time (PT) / International Normalised Ratio (INR), testijiet fil- ħin tal- plażma jew fsada jew attivita` fibronolitika.
However, rare spontaneous reports of aPTT prolongation have been received.
Madankollu, waslu rapporti spontanji rari ta ’ titwil fl’ aPTT.
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.
Fondaparinux ma jagħmilx cross reaction ma ’ sera minn pazjenti bi tromboċitopenja indotta bl - eparina.
Clinical studies
Studji klinici
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days 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.
Prevenzjoni ta ’ Eventi Tromboemboliċi fil- Vini (VTE) f’ pazjenti li għaddejjin minn kirurġija ortopedika maġġuri tal- parti t’ isfel tal- ġisem trattati sa ’ 9 t ’ ijiem Il- programm kliniku ta ’ fondaparinux kien diżinjat biex juri l- effikaċja ta ’ fondaparinux għall - prevenzjoni ta’ eventi tromboemboliċi fil- vini (VTE), jiġifieri trombożi fil- vini fondi prossimali u tat - truf u emboliżmu pulmonari (PE) f’ pazjenti għaddejjin minn kirurġija ortopedika maġġuri tal- parti t’ isfel tal- ġisem bħal frattura fil- ġenb, kirurġija maġġuri fl- irkoppa jew kirurġija għal sostituzzjoni tal - ġenb.
Over 8,000 patients (hip fracture – 1,711, hip replacement – 5,829, major knee surgery – 1,367) were studied in controlled Phase II and III clinical studies.
Fondaparinux 2. 5 mg
Fondaparinux 2.5 mg once daily started 6-8 hours postoperatively was compared with enoxaparin 40 mg once daily started 12 hours before surgery, or 30 mg twice daily started 12-24 hours after surgery.
7 darba kuljum mibdi 6- 8 sigħat wara l- operazzjoni ġie ipparagunat ma ’ enoxaparin 40 mg darba kuljum mibdi 12- il siegħa qabel il- kirurġija, jew 30 mg darbtejn kuljum mibdi 12- 24 siegħa wara l- kirurġija.
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.
F’ ġabra ta ’ analiżi ta ’ dawn l- istudji, ir- reġimen tad- doża rakkomandata ta ’ fondaparinux kontra enoxaparin ġiet assoċjata ma ’ nuqqas sinifikattiv (54% [95% CI, 44%; 63%]) fir- rata ta ’ VTE evalwata sa jum 11 wara l- kirurġija, irrispettivament mit- tip ta ’ kirurġija li tkun saret.
The majority of endpoint events were diagnosed by a prescheduled venography and consisted mainly of distal DVT, but the incidence of proximal DVT was also significantly reduced.
Il- maġġoranza ta ’ l- eventi kienu jikkonsistu fil- parti l- kbira tagħhom minn DVT periferali, iżda l- inċidenza ta ’ DVT prossimali kienet imnaqqsa b’ mod sinifikanti wkoll.
The incidence of symptomatic VTE, including PE was not significantly different between treatment groups.
L- inċidenza ta ’ VTE sintomatika, inkluż PE ma kienx differenti b’ mod sinifikanti bejn il- gruppi ta ’ trattament.
In studies versus enoxaparin 40 mg once daily started 12 hours before surgery, major bleeding was observed in 2.8% of fondaparinux patients treated with the recommended dose, compared to 2.6% with enoxaparin.
Fi studji ta ’ tqabbil kontra enoxaparin 40 mg darba kuljum mibdi 12- il siegħa qabel l- operazzjoni, fsada maġġuri kienet osservata f’ 2. 8% tal- pazjenti trattati bid- doża rakkomandata ta ’ fondaparinux, paragunati ma ’ 2. 6% b’ enoxaparin.
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.
Prevenzjoni ta ’ Eventi Tromboemboliċi fil- Vini (VTE) f’ pazjenti għaddejjin minn kirurġija għal sostituzzjoni tal- ġenb trattati sa 24 jum wara l- profilassi inizzjali ta ’ ġimgħa 1 F’ prova klinika randomized double- blind, 737 pazjent ġew trattati b’ fondaparinux 2. 5 mg darba kuljum għal 7 + / - 1 ġranet wara kirurġija għal frattura fil- ġenb.
The majority (70/ 80) of the recorded VTE events were venographically detected non-symptomatic cases of DVT.
Il- maġġoranza (70/ 80) ta ’ l- eventi VTE reġistrati kienu każijiet ta ’ DVT mingħajr sintomi li kienu skoperti b’ eżami venografiku.
Fondaparinux also provided a significant reduction in the rate of symptomatic VTE (DVT, and / or PE) [1 (0.3%) vs 9 (2.7%) patients, respectively] including two fatal PE reported in the placebo group.
Fondaparinux ipprovda wkoll tnaqqis sinifikanti fir- rata ta ’ VTE sintomatiku (DVT, u/ jew PE) [1( 0. 3% 0 vs 9 (2. 7%) pazjenti, rispettivament] inklużi żewġ PE fatali rrapurtati fil- grupp plaċebo.
Major bleedings, all at surgical site and none fatal, were observed in 8 patients (2.4%) treated with fondaparinux 2.5 mg compared to 2 (0.6%) with placebo.
Fsada maġġuri, kollha f’ siti kirurġiċi u mhux fatali, kienu osservati fi 8 pazjenti (2. 4%) trattati b’ fondaparinux 2. 5 mg ipparagunati ma ’ 2 (0. 6%) bil- plaċebo.
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 In a double-blind clinical study, 2,927 patients were randomized to receive fondaparinux 2.5mg once daily or dalteparin 5,000 IU once daily, with one 2,500 IU preoperative injection and a first 2,500 IU post-operative injection, for 7+2 days.
Il- prevenzjoni ta ’ Każi Trombo- emboliċi Venużi (VTE) f ’ pazjenti li jgħaddu minn kirurġija ta ’ l- addomenu u li huma f’ riskju għoli ta ’ kumplikazzjonijiet ta ’ trombo- emboliżmu, bħal pazjenti li jgħaddu minn kirurġija ta ’ kanċer ta ’ l- addomenu Fi studju kliniku double- blind, 2, 927 pazjent, mingħajr ma ġew magħżula, kienu mgħotija fondaparinux 2. 5 mg darba kuljum jew dalteparin 5, 000 IU darba kuljum, b ’ injezzjoni waħda qabel l - operazzjoni ta ’ 2, 500 IU u l- ewwel injezzjoni ta ’ 2, 500 IU wara l- operazzjoni, għal 7 ± 2 ġranet.
The main sites of surgery were colonic/ rectal, gastric, hepatic, cholecystectomy or other biliary.
Il - postijiet prinċipali tal- kirurġija kienu fil- kolon/ rektum, fl- istonku, fil- fwied, tneħħija tal- bużżieqa tal - marrara jew oħrajn fil- marrara.
(62/ 1,021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%].
F’ dan l- istudju, l- inċidenza ta ’ VTE totali b ’ fondaparinux kien ta ’ 4. 6% (47/ 1, 027), meta mqabbel ma ’ 6. 1% (62/ 1, 021) b ’ dalteparin: reduzzjoni ta ’ l - odds ratio [95% CI] = - 25. 8% [- 49. 7%, 9. 5%].
The difference in total VTE rates between the treatment groups, which was not statistically significant, was mainly due
Id - differenza fir - rati ta ’ VTE totali bejn il- gruppi ta ’ trattament, li ma kienx statistikament sinifikanti, kien l- biċċa l- kbira minħabba tnaqqis f ’ DVT fit- truf mhux sintomatiku.
In the large subgroup of patients undergoing cancer surgery (69% of the patient population), the VTE rate was 4.7% in the fondaparinux group, versus 7.7% in the dalteparin group.
F’ sub- grupp kbir ta ’ pazjenti b’ kirurġija għall - kanċer (69% mill- pazjenti), ir- rata ta ’ VTE kienet ta ’ 4. 7% fil- grupp ta ’ fondaparinux, meta mqabbel ma ’ 7. 7% fil - grupp ta ’ dalteparin.
Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the dalteparin group.
Fsada maġġuri kienet osservata f ’ 3. 4% tal- pazjenti fil- grupp ta ’ fondaparinux u f ’ 2. 4% fil- grupp ta ’ dalteparin.
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.
Il- prevenzjoni ta ’ Każi Trombo- emboliċi Venużi (VTE) f ’ pazjenti mediċi li huma f’ riskju għoli ta ’ kumplikazzjonijiet ta ’ trombo- emboliżmu minħabba nuqqas ta ’ mobilita` waqt mard akut Fi studju kliniku double- blind u randomised, 839 pazjent kienu trattati b’ fondaparinux 2. 5mg darba kuljum jew bil- plaċebo għal 6 sa 14 il- ġurnata.
This study included acutely ill medical patients, aged ≥ 60 years, expected to require bed rest for at least four days, and hospitalized for congestive heart failure NYHA class III/ IV and/ or acute respiratory illness and/ or acute infectious or inflammatory disease.
Fondaparinux naqqas sinifikament
Fondaparinux significantly reduced the overall rate of VTE compared to placebo [18 patients (5.6%) vs 34 patients (10.5%), respectively].
8 ir- rata sħiha ta ’ VTE meta mqabbel mal- plaċebo [18 patients (5. 6%) vs 34 pazjenti (10. 5%), rispettivament].
Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 patients (1.2%), respectively].
Fondaparinux naqqas sinifikament ukoll ir- rata ta ’ PE li kienu aġġudikati fatali [0 pazjenti (0. 0%) vs 5 pazjenti (1. 2%), rispettivament].
Major bleedings were observed in 1 patient (0.2%) of each group.
Fsada maġġuri kienet osservata f’ pazjent (0. 2%) f’ kull grupp.
Absorption After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%).
Assorbiment Wara dożaġġ subkutanju, fondaparinux huwa assorbit kompletament u malajr (biodisponibilità assoluta 100%).
Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy subjects, peak plasma concentration (mean Cmax = 0.34 mg/ l) is obtained 2 hours post-dosing.
Wara injezzjoni subkutanja waħda ta ’ fondaparinux 2. 5 mg lil suġġetti żgħar u f’ saħħithom, konċentrazzjoni massima fil- plażma (medja Cmax = 0. 34 mg/ l) huwa ottenut 2 sigħat wara d- doża.
Plasma concentrations of half the mean Cmax values are reached 25 minutes post-dosing.
Konċentrazzjonijiet fil- plażma ta ’ nofs il- medja tal- valuri Cmax jintlaħqu 25 minuta wara d - doża.
Following once daily dosing, steady state of plasma levels is obtained after 3 to 4 days with a 1.3-fold increase in Cmax and AUC.
B’ dożaġġ ta ’ darba kuljum, livelli stabbli fil- plażma huma miksuba wara 3 sa 4 t ’ ijiem b’ żieda ta ’ 1. 3- il darba fis- Cmax u AUC.
Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are:
Stimi tal- parametri farmakokinetiċi medji fissi (CV%) ta ’ fondaparinux f’ pazjenti għaddejjin minn kirurġija għal sostituzzjoni tal- ġenb u li qed jirċievu Arixtra 2. 5 mg darba kuljum huma:
In vitro, fondaparinux is highly and specifically bound to antithrombin protein with a dose-dependant plasma concentration binding (98.6% to 97.0% in the concentration range from 0.5 to 2 mg/ l).
In vitro fondaparinux huwa marbut ħafna u speċifikament mal- proteina antitrombin b’ mod dipendenti mad- doża u mal - konċentrazzjoni fil- plażma (98. 6% sa 97. 0% fil- firxa tal- konċentrazzjoni bejn 0. 5 sa 2 mg/ l).
Fondaparinux does not bind significantly to other plasma proteins, including platelet factor 4 (PF4).
Fondaparinux ma jorbotx b’ mod sinifikattiv ma ’ proteini tal- plażma oħrajn, inklużi fattur 4 tal - plejtlets (PF4).
Since fondaparinux does not bind significantly to plasma proteins other than ATIII, no interaction with other medicinal products by protein binding displacement are expected.
Peress illi fondaparinux ma jintrabatx b’ mod sinifikanti ma ’ proteini tal- plażma oħrajn minbarra ATIII, mhux mistennija l- ebda interazzjoni ma ’ prodotti mediċinali oħrajn li jikkawżaw spostament ta ’ rbit ta ’ proteini.
Metabolism Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no evidence for the formation of active metabolites.
Metaboliżmu Għalkemm mhux evalwati totalment, m’ hemm l- ebda evidenza ta ’ metaboliżmu ta ’ fondaparinux u b’ mod partikulari ma hemm l- ebda evidenza ta ’ formazzjoni ta ’ metaboli attivi.
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
Fondaparinux ma jinibixxix CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 jew CYP3A4) in vitro.
Excretion/ Elimination The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy elderly subjects.
Eskrezzjoni/ Eliminazzjoni Il- half life ta ’ l- eliminazzjoni (t1/ 2) hija madwar 17- il siegħa f’ suġġetti f’ saħħithom żgħażagħ u madwar 21 siegħa f’ suġġetti anzjani f’ saħħithom.
Fondaparinux is excreted to 64 – 77% by the kidney as unchanged compound.
64 – 77% ta ’ fondaparinux huwa mneħħi mill- kilwa bħala sustanza mhux mibdula.
8 Special populations
Popolazzjonijiet speċjali:
Paediatric patients - Fondaparinux has not been investigated in this population.
Pazjenti pedjatriċi - Fondaparinux ma ġiex investigat fuq din il- popolazzjoni.
Elderly patients - Renal function may decrease with age and thus, the elimination capacity for fondaparinux may be reduced in elderly.
Pazjenti anzjani - Il- funzjoni renali tista ’ tonqos bl- età u għalhekk, il- ħila biex jitneħħa fondaparinux tista ’ tkun imnaqqsa fl- anzjani.
In patients > 75 years undergoing orthopaedic surgery, the estimated plasma clearance was 1.2 to 1.4 times lower than in patients < 65 years.
F’ pazjenti > 75 sena li jgħaddu minn kirurġija ortopedika, il- clearance tal- plażma ġiet stmata bħala 1. 2 sa 1. 4 drabi iktar baxxa milli f’ pazjenti ta ’ < 65 sena.
Renal impairment - Compared with patients with normal renal function (creatinine clearance > 80 ml/ min), plasma clearance is 1.2 to 1.4 times lower in patients with mild renal impairment (creatinine clearance 50 to 80 ml/ min) and on average 2 times lower in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/ min).
9 Indeboliment renali - Pparagunati ma ’ pazjenti b’ funzjoni renali normali (clearance tal- krejatinina > 80 ml/ min), il- clearance tal- plażma hija minn 1. 2 sa 1. 4 drabi iktar baxxa f’ pazjenti b’ indeboliment renali ħafif (clearance tal- krejatinina minn 50 sa 80 ml/ min) u fuq medja ta ’ darbtejn iktar baxxa f’ pazjenti b’ indeboliment renali moderat (clearance tal- krejatinina minn 30 sa 50 ml/ min).
In severe renal impairment (creatinine clearance < 30 ml/ min), plasma clearance is approximately 5 times lower than in normal renal function.
F’ indeboliment renali sever (clearance tal- krejatinina < 30 ml/ min), il- clearance tal- plażma hi madwar 5 darbiet iktar baxxa milli meta jkun hemm funzjoni renali normali.
Associated terminal half-life values were 29 h in moderate and 72 h in patients with severe renal impairment.
Valuri tal- half life terminali assoċjati kienu 29 h fil- moderati u 72 h f’ pazjenti b’ indeboliment renali akut.
Gender - No gender differences were observed after adjustment for body weight.
Ġeneru - Ma ġew osservati l- ebda differenzi minħabba l- ġeneru wara li sar aġġustament tal- piż tal - ġisem.
Race - Pharmacokinetic differences due to race have not been studied prospectively.
Razza - Differenzi farmakokinetiċi minħabba razza ma ġewx studjati prospettivament.
However, studies performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile compared to Caucasian healthy subjects.
Iżda, studji magħmula fuq suġġetti f’ saħħithom Ażjatiċi (Ġappuniżi) ma wrewx profil farmakokinetiku differenti pparagunat ma ’ suġġetti f’ saħħithom Kawkasi.
Similarly, no plasma clearance differences were observed between black and Caucasian patients undergoing orthopaedic surgery.
Bl- istess mod, ma ġewx osservati differenzi fil - clearance tal- plażma bejn pazjenti suwed u Kawkasi li kienu għaddejjin minn kirurġija ortopedika.
Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg).
Piż tal- ġisem - Clearance tal- plażma b’ fondaparinux tiżdied mal- piż tal- ġisem (9% żieda għal kull 10 kg).
Hepatic impairment - Following a single, subcutaneous dose of fondaparinux in subjects with moderate hepatic impairment (Child-Pugh Category B), total (i. e., bound and unbound) Cmax and AUC were decreased by 22% and 39%, respectively, as compared to subjects with normal liver function.
Indeboliment tal- fwied - Wara doża waħda mogħtija taħt il- ġilda ta ’ fondaparinux, f’ suġġetti b’ indeboliment tal- fwied moderat (Child- Pugh Category B), Cmax totali (jiġifieri marbut u mhux marbut) u AUC tnaqqsu b’ 22% u 39%, rispettivament, meta mqabbla ma ’ suġġetti b’ funzjoni tal - fwied normali.
The lower plasma concentrations of fondaparinux were attributed to reduced binding to ATIII secondary to the lower ATIII plasma concentrations in subjects with hepatic impairment thereby resulting in increased renal clearance of fondaparinux.
Il- konċentrazzjonijiet aktar baxxi ta ’ fondaparinux fil- plażma ġew attribwiti ma ’ l- irbit mnaqqas ma ’ ATIII minħabba konċentrazzjoni fil- plażma aktar baxxa ta ’ ATIII f’ suġġetti b’ indeboliment tal- fwied u dan iwassal għal żjieda fit- tneħħija ta ’ fondaparinux mill- kliewi.
Consequently, unbound concentrations of fondaparinux are expected to be unchanged in patients with mild to moderate hepatic impairment, and therefore, no dose adjustment is necessary based on pharmacokinetics.
Minħabba f’ hekk, hu mistenni li konċentrazzjonijiet mhux marbuta ta ’ fondaparinux ma jinbidlux f’ pazjenti b’ indeboliment tal- fwied ħafif għal moderat, u għalhekk m’ hemmx bżonn ta ’ aġġustament fid- doża meta tibbaża fuq il- farmakokinetika.
The pharmacokinetics of fondaparinux has not been studied in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Il- farmakokinetika ta ’ fondaparinux ma ġietx studjata f’ pazjenti b’ indeboliment qawwi tal- fwied (ara sezzjonijiet 4. 2 u 4. 4).
Animal studies are insufficient with respect to effects on toxicity to reproduction because of limited exposure.
Studji fuq l- annimali huma insuffiċjenti rigward l- effetti tossiku fuq is- sistema riproduttiva minħabba espożizzjoni limitata.
Sodium chloride Water for injections Hydrochloric acid Sodium hydroxide
Sodium Chloride Ilma għal injezzjonijiet Hydrochloric acid Sodium hydroxide
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jablux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a bromobutyl or chlorobutyl elastomer plunger stopper.
Tubu ċilindriku tal- ħġieġ Tip1 (1 ml) mehmuż b ’ labra kalibru 27 ta ’ 12. 7 mm u magħluqa b’ tapp planġer tal- bromobutyl jew chlorobutyl elastomer.
Arixtra is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Arixtra hija disponibbli f’ daqsijiet ta ’ pakketti ta ’ 2, 7, 10 u 20 siringi mimlija lesti.
There are two types of syringes: • syringe with a yellow plunger and an automatic safety system • syringe with yellow plunger and a manual safety system.
Hemm żewġ tipi ta ’ siringi: • siringa bi planġer isfar u b’ sistema ta ’ sikurezza awtomatika. • siringa bi planġer isfar u b’ sistema manwali ta ’ sigurtà.
The subcutaneous injection is administered in the same way as with a classical syringe.
L- injezzjoni subkutanja hi amministrata fl- istess mod bħal siringa klassika.
Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
Soluzzjonijiet parenterali għandhom jiġu miflija għal frak u telf ta ’ kulur qabel jingħataw.
Instruction for self-administration is mentioned in the Package Leaflet.
Struzzjonijiet għal amministrazzjoni personali huma mniżżla fil- fuljett ta ’ tagħrif.
The needle protection system of the Arixtra pre-filled syringes have been designed with a safety system to protect from needle stick injuries following injection.
Is- sistema ta ’ protezzjoni tal- labra tas- siringi mimlija lesti Arixtra giet diżinjata b’ sistema ta ’ sikurezza biex tipproteġi minn feriti bil- labra wara l- injezzjoni.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu
Arixtra 2.5 mg/ 0.5 ml solution for injection, pre-filled syringe.
Arixtra 2. 5 mg/ 0. 5 ml soluzzjoni għall- injezzjoni, siringa mimlija lesta.
Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium.
Kull siringa mimlija lesta (0. 5 ml) fiha 2. 5 mg fondaparinux sodium.
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).
Trattament ta ’ anġina mhux stabbli jew infart mijokardijaku mingħajr elevazzjoni tas- segment ST (UA/ NSTEMI) għal dawk il- pazjenti fejn mhux indikat trattament invasif (PCI) urġenti (< 120 minuta) (ara sezzjoni 4. 4 u 5. 1).
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.
Trattament ta ’ infart mijokardijaku b’ elevazzjoni tas- segment ST (STEMI) f’ pazjenti li qed jirċievu trattament b’ trombolitiċi jew f’ dawk li inizjalment m’ għandhomx jirċievu l- ebda forma oħra ta ’ terapija ta ’ riperfużjoni.
Patients undergoing major orthopaedic or abdominal surgery The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by subcutaneous injection.
Pazjenti li jgħaddu minn kirurġija maġġuri ortopedika u addomenali Id- doża rakkomandata ta ’ fondaparinux hi ta ’ 2. 5 mg darba kuljum amminisrata wara l- operazzjoni permezz ta ’ injezzjoni subkutanja.
Experience shows that in patients undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery.
L- esperjenza turi li r - riskju ta VTE f’ pazjenti li jgħaddu minn kirurġija tal- ksur ta ’ l- għadma tal- ġenbejn, ikompli anke wara
12 Medical patients who are at high risk for thromboembolic complications based on an individual risk assessment The recommended dose of fondaparinux is 2.5 mg once daily administered by subcutaneous injection.
Id- doża rakkomandata ta ’ fondaparinux hi ta ’ 2. 5 mg darba kuljum b’ injezzjoni subkutanja.
Treatment of unstable angina/ non- ST segment elevation myocardial infarction (UA/ NSTEMI) The recommended dose of fondaparinux is 2.5 mg once daily, administered by subcutaneous injection.
Trattament ta ’ anġina mhux stabbli/ infart mijokardijaku mingħajr elevazzjoni tas- segment ST (UA/ NSTEMI) Id- doża rakkomandata ta ’ fondaparinux hi ta ’ 2. 5 mg darba kuljum b’ injezzjoni subkutanja.
Treatment should be initiated as soon as possible following diagnosis and continued for up to a maximum of 8 days or until hospital discharge if that occurs earlier.
It - trattament għandu jinbeda kemm jista jkun malajr wara d- dijanjosi u għandu jitkompla għal perjodu massimu ta ’ 8 ġranet jew sakemm il- pazjent joħroġ mill- isptar jekk dan jiġri qabel.