qanastek/EMEA-V3 huggingface dataset:
Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially
Kull doża fiha anqas minn 1 mmol ta ’ sodium (23 mg) u għalhekk il- prodott huwa
e sodium free.
riz essenzjalment mingħajr sodium.
ris For a full list of excipients, see section 6.1.
Għal lista sħiħa ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
ut Solution for injection.
Soluzzjoni għall- injezzjoni.
The solution is a clear and colourless liquid.
Is- soluzzjoni hija likwidu ċar u mingħajr kulur.
CLINICAL PARTICULARS
TAGĦRIF KLINIKU ħa 4. 1 Indikazzjonijiet terapewtiċi ’ g 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 - im
Therapeutic indications
irkoppa jew kirurġija għal sostituzzjoni tal- ġenb.
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic lo surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. no
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 l
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). ct
li jgħaddu minn kirurġija ta ’ kanċer fl- addomenu (are sezzjoni 5. 1). na
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 du
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. iċi
4.2 Posology and method of administration lP
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata ed
Patients undergoing major orthopaedic or abdominal surgery The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by subcutaneous injection. na
Pazjenti li jgħaddu minn kirurġija maġġuri ortopedika u addomenali Id- doża rakkomandata ta ’ Quixidar hi ta ’ 2. 5 mg darba kuljum amminisrata wara l- operazzjoni tm
The initial dose should be given 6 hours following surgical closure provided that haemostasis has been established. ici
Id- doża inizzjali għandha tingħata 6 sigħat wara l- għeluq tal- kirurġija ladarba tiġi stabbilita l - ot
Treatment should be continued until the risk of venous thrombo-embolism has diminished, usually ed
emostażi. od
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.
Experience shows that in patients undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery.
wara 9 t ’ ijiem wara l- kirurġija.
In these patients the use of prolonged prophylaxis with fondaparinux should be considered for up to an M
F’ dawn il- pazjenti l- użu ta ’ profilassi prolongata b’ fondaparinux għandha tiġi kkunsidrata sa ’ 24 jum addizzjonali (ara sezzjoni 5. 1).
additional 24 days (see section 5.1).
Pazjenti mediċi li huma f’ riskju għoli ta ’ kumplikazzjonijiet ta ’ trombo- emboliżmu meta jitqies ir - riskju fuq bażi individwali.
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.
A treatment duration of 6-14 days has been clinically studied in medical patients (see section 5.1).
F’ pazjenti mediċi, ġie studjat klinikament trattament ta ’ 6 – 14 il- ġurnata (ara sezzjoni 5. 1).
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’ Quixidar 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 ’ Quixidar għandha tingħata mhux aktar kmieni minn 6 sigħat wara t -
Renal impairment - Fondaparinux should not be used in patients with creatinine clearance < 20 ml/ min
(ara
d (see section 4.3).
za sezzjoni 4. 4)
e 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).
to M’ hemmx bżonn li titnaqqas id- doża f’ pazjenti b’ indeboliment renali ħafif (clearance tal- krejatinina > 50 ml/ min).
ris Hepatic impairment - No dosing adjustment is necessary.
aw Indeboliment tal- fwied - Ma hemm bżonn ta ’ l- ebda aġġustament fid- doża.
In patients with severe hepatic impairment,
F’ pazjenti b’ indeboliment qawwi tal- fwied, fondaparinux għandu jintuża b’ attenzjoni.
ho fondaparinux should be used with care (see section 4.4).
(ara sezzjoni 4. 4).
Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age
x Popolazzjonijiet pedjatriċi - Fondaparinux mhux rakkomandat għall- użu fi tfal ta ’ taħt is- 17- il sena
ut due to a lack of data on safety and efficacy.
du minħabba nuqqas ta ’ tagħrif dwar is- sikurezza u l- effikaċja.
Sites of administration should alternate between the left and the right anterolateral and left and right
Metodu ta ’ amministrazzjoni
e posterolateral abdominal wall.
Fondaparinux huwa amministrat permezz ta ’ injezzjoni subkutanja fonda waqt li l- pazjent ikun mindud.
To avoid the loss of medicinal product when using the pre-filled ng syringe do not expel the air bubble from the syringe before the injection.
Il- postijiet ta ’ amministrazzjoni għandhom jalternaw bejn il- membrana ta ’ l- addome ’ g anterolaterali tax- xellug u tal- lemin u posterolaterali tax- xellug u tal- lemin.
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. lo For additional instructions for use and handling and disposal see section 6.6. no
Biex tevita telf tal- prodott mediċinali waqt l- użu ta ’ l- injezzjoni mimlija lesta m’ għandekx tespella l- buzzieqa ta ’ l- arja minn im
4.3 Contraindications
ġos- siringa qabel l- injezzjoni.
- hypersensitivity to the active substance or to any of the excipients
Għal aktar struzzjonijiet għall- użu u maniġġar u għar- rimi ara sezzjoni 6. 6. li l
ct
4. 3 Kontra- indikazzjonijiet na
- active clinically significant bleeding
- Sensittività eċċessiva għal fondaparinux jew għal xi sustanzi mhux attivi;
- acute bacterial endocarditis
- Fsada attiva klinikament sinifikanti
du
iċi
- severe renal impairment defined by creatinine clearance < 20 ml/ min.
- Indeboliment sever renali definit bi clearance tal- krejatinina ta ’ < 20 ml/ min
4.4 Special warnings and precautions for use lP
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu tm
Fondaparinux is intended for subcutaneous use only.
Fondaparinux hu intiż għal użu subkutanju biss.
Do not administer intramuscularly.
M’ għandux jiġi amministrat b’ mod intramuskolari.
Haemorrhage na
Emorraġija ot
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 ici
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 od
ophthalmic surgery and in special patient groups as outlined below. ed
Pr
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Aġenti li jistgħu jżidu r- riskju ta ’ emorraġija m’ għandhomx jiġu amministrati flimkien ma ’ fondaparinux.
These agents include desirudin, fibrinolytic agents, GP IIb/ IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH).
Dawn l- aġenti jinkludu desirudin, aġenti fibrinolitiċi, antagonisti riċetturi GP IIb/ IIIa, eparina, eparinojdi, jew Eparina ta ’ Piż Molekulari Baxx (LMWH).
When required, concomitant M
Mediċini oħra li jxekklu l- plejtlets (acetylsalycylic acid,
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution.
3 dipyridamole, sulfinpyrazone, ticlopidine jew clopidrogel), u NSAIDs għandhom jiġu wżati b’ kawtela.
If co-administration is essential, close monitoring is necessary.
Jekk il- ko- amministrazzjoni hija essenzjali, monitoraġġ bir- reqqa huwa neċessarju.
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
Ir- riskju ta ’ dawn l- avventimenti rari
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.
t jista ’ jkun ogħla b’ użu post- operattiv ta ’ kateter epidurali ġewwa l- ġisem jew l- użu konkomitanti ta ’
Elderly patients The elderly population is at increased risk of bleeding.
riz 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).
to fondaparinux (ara sezzjoni 5. 2).
Fondaparinux should be used with caution in elderly patients (see section 4.2).
Fondaparinux għandu jiġi wżat b’ kawtela f’ pazjenti anzjani (ara sezzjoni 4. 2).
e Patients with body weight < 50 kg are at increased risk of bleeding.
aw Piż tal- gisem baxx Pazjenti li għandhom piż < 50 kg għandhom riskju ikbar ta ’ fsada.
Elimination of fondaparinux decreases with weight.
L- eliminazzjoni ta ’ fondaparinux tonqos mal- piż.
Fondaparinux should be used with caution in these patients (see section 4.2).
Fondaparinux għandu jiġi wżat b’ kawtela f’ dawn il- pazjenti (ara sezzjoni 4. 2).
ho Fondaparinux is known to be mainly excreted by the kidney.
x du 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 ħa b’ kawtela (ara sezzjonijiet 4. 2, 4. 3 u 5. 2).
There are limited clinical data available from patients with creatinine clearance less than
Hemm tagħrif kliniku limitat fuq pazjenti bi clearance tal - krejatinina ta ’ anqas minn 30 ml/ min. ’ g Indeboliment epatiku qawwi im
ra Severe hepatic impairment Dosing adjustment of fondaparinux is not necessary.
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
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). li l
Patients with Heparin Induced Thrombocytopenia ng Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with lo Heparin Induced Thrombocytopenia (HIT) type II.
Pazjenti bi tromboċitopenja indotta bl- Eparina Fondaparinux ma jintrabatx mal- fattur 4 tal- plejtlets u ma jirreaġixxix mas- serum minn pazjenti b ’ na
4.5 Interaction with other medicinal products and other forms of interaction
L- effikaċja u s- sigurta` ta ’ fondaparinux ma ġewx studjati formalment f’ pazjenti b ’ TIE tat- tip II. iċi
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may ct
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott ed
enhance the risk of haemorrhage (see section 4.4). du
Ir- riskju ta ’ fsada jiżdied bl- amministrazzjoni konkomitanti ta ’ fondaparinux u aġenti li jistgħu jżidu r- riskju ta ’ emorraġija (ara sezzjoni 4. 4). tm
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 ot
The fondaparinux dose (10 mg) in ro
ta ’ fondaparinux.
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 lP
Fondaparinux lanqas ma influwenza l- attivita` INR ta ’ od
acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.
Pr
If follow up treatment with a Vitamin K antagonist is required, treatment with fondaparinux should be ici
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.
continued until the target INR value has been reached. ed
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.
Animal studies are M
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ fondaparinux waqt it- tqala.
insufficient with respect to effects on pregnancy, embryo/ foetal development, parturition and postnatal development because of limited exposure.
Studji fuq bhejjem m’ humiex biżżejjed rigward l- effetti fuq it- tqala u fuq l - iżvilupp ta ’ l- embriju/ fetu, ħlas u żvilupp wara t- twelid.
Fondaparinux should not be prescribed to pregnant women unless clearly necessary.
Fondaparinux m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
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 -
Breast-feeding is not recommended during treatment with fondaparinux.
Fit- tarbija
Oral absorption by the child is however unlikely.
za l- assorbiment mill- ħalq huwa improbabli.
4 4.7 Effects on ability to drive and use machines
riz 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
No studies on the effect on the ability to drive and to use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
4.8 Undesirable effects
to 4. 8 Effetti mhux mixtieqa
The safety of fondaparinux 2.5 mg has been evaluated in 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days, in 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week, 1407 patients undergoing abdominal surgery
aw 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 ’
d treated up to 9 days, and in 425 medical patients who are at risk for thromboembolic complications
x ġimgħa, 1407 pazjent għaddejjin minn kirurġija ta ’ l- addomenu li ġew trattati mhux iżjed minn 9 t ’
ris 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;
du ijiem, u f’ 425 pazjenti mediċi li huma f’ riskju ta ’ kumplikazzjonijiet ta ’ trombo- emboliżmu li ġew trattati għal 14 il- ġurnata. ħa 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; ’ g rari ħafna ≤1/ 10, 000) u fis- sistema tal- klassifika tal- organi, bil- gravita` ta ’ l- effett mhux mixtieq im
ho 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.
dejjem jonqos; dawn l- effetti mhux mixtieqa għandhom jiġu interpretati fil- kuntest kirurġiku u mediku. li l
ut ra System organ class MedDRA
Sistema tal- klassifika tal- organi fid- database
Undesirable effects in patients undergoing major orthopaedic surgery of lower limbs and/ or
Effetti mhux mixtieqa f’ pazjenti li jgħaddu minn na
Undesirable effects in medical patients
Effetti mhux mixtieqa f’ pazjenti mediċi
e abdominal surgery ng Infections and
MedDRA
Rare: post-operative wound lo
ed
infestations
iċi
infection no
Rari: infezzjonijiet tal- feriti wara Infezzjonijiet u l- operazzjoni Infestazzjonijiet tm
Blood and lymphatic system disorders
Disturbi tad- demm u tas - sistema limfatika ot
Common: post-operative haemorrhage, anaemia Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, ct
Komuni: emorraġija wara operazzjoni, anemija Mhux komuni: telf ta ’ demm
Common: bleeding (haematoma, haematuria, haemoptysis, gingival bleeding) Uncommon: anaemia
Komuni: fsada (ematoma, ematurja, emoptisis, fsada tal - ħanek)
haematuria, haematoma) du
(epistaxis, emoptisis gastro - intestinali, ematurja, ematoma)
thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder ro lP
thromboċitopenja, purpura, thrombocitemja, plejtlet abnormali, mard tal - Pr
Immune system disorders Rare: allergic reaction
Distubi fis- sistema immuni
Metabolism and nutrition Rare: hypokalaemia na
Rari: reazzjonijiet allerġiċi
disorders ici
Disturbi fis- sistema nervuża
Nervous system disorders Rare: anxiety, somnolence, vertigo, dizziness, headache, ed
Rari: anzjeta`, ngħas, vertigo, sturdament, uġigħ ta ’ ras, konfużjoni
Vascular disorders
t za Rari: pressjoni tad- demm baxxa Disturbi vaskulari Disturbi respiratorji,
Rare: hypotension
Rari: qtugħ ta ’ nifs, sogħla
Respiratory, thoracic and Rare: dyspnoea, coughing mediastinal disorders
Mhux komuni: qtugħ ta ’ nifs
Uncommon: dyspnoea
riz toraċiċi u medjastinali
5 Gastrointestinal disorders
to Disturbi gastro - intestinali
Uncommon: nausea, vomiting Rare: abdominal pain, dyspepsia, gastritis, constipation, diarrhoea
Mhux komuni: dardir, rimettar Rari: uġigħ ta ’ l- addomenu,
Hepatobiliary disorders
Disturbi fil- fwied u fil -
Uncommon: hepatic enzymes increased, hepatic function abnormal Rare: bilirubinaemia
Mhux komuni: żieda fl- enżimi
e
x marrara
d
tal- fwied, funzjoni abnormali tal -
Skin and subcutaneous
du fwied
Uncommon: rash, pruritus
Rari: żieda fil- bilirubin
Uncommon: rash, pruritus
Mhux komuni: raxx, ħakk ’ g im
ris tissue disorders
Mhux komuni: raxx, ħakk
ho General disorders and administration site conditions
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata
Uncommon: oedema, oedema peripheral, fever, wound secretion
Mhux komuni: edema, edema periferali, deni, nixxija mill- ferita Rari: uġigħ fis- sider, għejja, li l
ut Rare: chest pain, fatigue, hot flushes, leg pain, oedema genital,
fwawar bi sħana, uġigħ fir - riġlejn, edema ġenitali, fwawar, na
ra flushing, syncope
sinkope iċi
e 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. ed
4.9 Overdose
4. 9 Doża eċċessiva tm
There no
Dożi ta ’ Fondaparinux akbar mir- reġimen rakkomandat jistgħu jwasslu għal riskju akbar ta ’ fsada.
is no known antidote to fondaparinux.
M’ hemmx antidotu għal fondaparinux.
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 - ot
Initiation of appropriate therapy such as surgical haemostasis, blood ct
Għandha tiġi kkunsidrata li tinbeda terapija xierqa bħal emostażi kirurġika, sostituzzjoni tad- demm, trasfużjoni mill- ġdid ta ’ plażma, od
replacements, fresh plasma transfusion, plasmapheresis should be considered. du
Pr
PHARMACOLOGICAL PROPERTIES ro
TAGĦRIF FARMAKOLOĠIKU
5.1 Pharmacodynamic properties lP
5. 1 Tagħrif farmakodinamiku
ATC code:
Kategorija farmakoterapewtika: aġent antitrombotiku Kodiċi ATC:
Pharmacodynamic effects ici
t Effetti farmakodinamiċi
Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa).
za Fondaparinux huwa impeditur sintetiku u selettiv ta ’ Fattur X attivat (Xa).
The antithrombotic activity of fondaparinux is the result of antithrombin III (ATIII) mediated selective inhibition of ed
riz ta ’ fondaparinux hija riżultat ta ’ impediment selettiv ta ’ Fattur Xa medjat b’ antithrombin III (ATIII).
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.
to 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 M
Fondaparinux ma jinattivax l- enżima li tikkawża
inactivate thrombin (activated Factor II) and has no effects on platelets.
aw t- tagħqid tad- demm (Fattur II attivat) u m’ ghandux effetti fuq il- plejtlets.
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
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.
x (PT) / International Normalised Ratio (INR), testijiet fil- ħin tal- plażma jew fsada jew attivita`
6 Clinical studies
du fibronolitika.
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 - li l
Over 8,000 patients (hip fracture – 1,711, hip replacement – 5,829, major knee surgery – 1,367) were studied in controlled
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 - na
d Phase II and III clinical studies.
ġenb.
Fondaparinux 2.5 mg once daily started 6-8 hours postoperatively was
Iktar minn 8, 000 pazjent (frattura fil- ġenb – 1, 711, sostituzzjoni tal- ġenb - 5, 829, kirurġija maġġuri fl- irkoppa – 1, 367) ġew studjati fi studji kliniċi kontrollati Fażi II u III.
e compared with enoxaparin 40 mg once daily started 12 hours before surgery, or 30 mg twice daily
Fondaparinux 2. 5 mg darba kuljum mibdi 6- 8 sigħat wara l- operazzjoni ġie ipparagunat ma ’ enoxaparin 40 mg darba kuljum iċi
ris started 12-24 hours after surgery.
mibdi 12- il siegħa qabel il- kirurġija, jew 30 mg darbtejn kuljum mibdi 12- 24 siegħa wara l- kirurġija. ed
ho 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,
Il- maġġoranza tm
ut but the incidence of proximal DVT was also significantly reduced.
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. ot
ra In studies versus enoxaparin 40 mg once daily started 12 hours before surgery, major bleeding was
Fi studji ta ’ tqabbil kontra enoxaparin 40 mg darba kuljum mibdi 12- il siegħa qabel l- operazzjoni, od
e observed in 2.8% of fondaparinux patients treated with the recommended dose, compared to 2.6% with enoxaparin.
fsada maġġuri kienet osservata f’ 2. 8% tal- pazjenti trattati bid- doża rakkomandata ta ’ fondaparinux, paragunati ma ’ 2. 6% b’ enoxaparin.
At the end of this period, 656 patients were no
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.
randomised to receive fondaparinux 2.5 mg once daily or placebo for an additional 21 +/ - 2 days.
Fit- tmiem ta ’ dan il- perijodu, 656 pazjent ġew magħżula b’ mod randomised biex jirċievu fondaparinux 2. 5 mg darba kuljum jew plaċebo għal 21+ / - 2 ġranet addizzjonali.
Fondaparinux provided a significant reduction in the overall rate of VTE compared with placebo [3 patients (1.4%) vs 77 patients (35%), respectively].
Fondaparinux ipprovda tnaqqis sinifikanti fir- rata ġenerali ta ’ VTE pparagunata ma ’ plaċebo [3 pazjenti (1. 4%) vs 77 pazjent (35%) rispettivament}.
The majority (70/ 80) of the recorded VTE events ct
Il -
were venographically detected non-symptomatic cases of DVT.
7 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%) du
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.
patients, respectively] including two fatal PE reported in the placebo group.
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.
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. ro
Il- prevenzjoni ta ’ Każi Trombo- emboliċi Venużi (VTE) f ’ pazjenti li jgħaddu minn kirurġija ta ’
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery lP
t l- addomenu u li huma f’ riskju għoli ta ’ kumplikazzjonijiet ta ’ trombo- emboliżmu, bħal pazjenti
who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery In a double-blind clinical study, 2927 patients were randomized to receive fondaparinux 2.5mg once na
za li jgħaddu minn kirurġija ta ’ kanċer ta ’ l- addomenu Fi studju kliniku double- blind, 2927 pazjent, mingħajr ma ġew magħżula, kienu mgħotija
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.
riz fondaparinux 2. 5 mg darba kuljum jew dalteparin 5000 IU darba kuljum, b ’ injezzjoni waħda qabel l - operazzjoni ta ’ 2500 IU u l- ewwel injezzjoni ta ’ 2500 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 -
Sixty-nine percent of the patients underwent surgery for cancer. ici
Disgħa u sittin fil- mija tal- pazjenti kellhom kirurġija għall- kanċer.
Patients under-going urological (other than kidney) or gynaecological surgery, laparoscopic surgery or vascular surgery were not included in the study. ed
aw vaskulari ma kienux inklużi f’ dan l- istudju.
In this study, the incidence of total VTE was 4.6% (47/ 1027) with fondaparinux, versus 6.1%:
F’ dan l- istudju, l- inċidenza ta ’ VTE totali b ’ fondaparinux kien ta ’ 4. 6% (47/ 1027), meta mqabbel ma ’ 6. 1% (62/ 1021) b ’ dalteparin: reduzzjoni ta ’ l - odds ratio [95% CI] = - 25. 8% [- 49. 7%, 9. 5%].
M
Id -
(62/ 1021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%].
x differenza fir - rati ta ’ VTE totali bejn il- gruppi ta ’ trattament, li ma kienx statistikament sinifikanti,
The difference in total VTE rates between the treatment groups, which was not statistically significant, was mainly due to a reduction of asymptomatic distal DVT.
du kien l- biċċa l- kbira minħabba tnaqqis f ’ DVT fit- truf mhux sintomatiku.
The incidence of symptomatic DVT was similar between treatment groups:
L- inċidenza ta ’ DVT sintomatiku kien simili bejn il- gruppi ta ’ trattamenti:
6 patients (0.4%) in the fondaparinux group vs 5 patients (0.3%) in the dalteparin group.
6 pazjenti (0. 4%) fil- grupp ta ’ fondaparinux meta mqabbel ma ’ 5 pazjenti (0. 3%) fil- grupp ta ’ dalteparin.
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 ħa 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. ’ g Fsada maġġuri kienet osservata f ’ 3. 4% tal- pazjenti fil- grupp ta ’ fondaparinux u f ’ 2. 4% fil- grupp ta ’ im
Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the dalteparin group.
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 li l
7 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.
Dan l- istudju inkluda pazjenti mediċi b’ mard akut, na
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 iċi
Fondaparinux significantly reduced the overall rate of VTE compared to placebo [18 patients (5.6%) vs 34 patients (10.5%), respectively].
ir- rata sħiha ta ’ VTE meta mqabbel mal- plaċebo [18 patients (5. 6%) vs 34 pazjenti (10. 5%), rispettivament].
The majority of events were asymptomatic distal DVT.
Il- maġġoranza tal- każi kienu DVT fit- truf mhux sintomatiku.
d Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5
Fondaparinux naqqas ed
e patients (1.2%), respectively].
sinifikament ukoll ir- rata ta ’ PE li kienu aġġudikati fatali [0 patients (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. tm
ris 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
ho Absorption After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%).
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,
Wara injezzjoni subkutanja waħda ta ’ fondaparinux 2. 5 mg lil suġġetti żgħar u od
ut peak plasma concentration (mean Cmax = 0.34 mg/ l) is obtained 2 hours post-dosing.
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.
Pr
ra In elderly healthy subjects, pharmacokinetics of fondaparinux are linear in the range of 2 to 8 mg by subcutaneous route.
F’ suġġetti anzjani f’ saħħithom, il- farmakokinetiċi ta ’ fondaparinux huma linejari ta ’ bejn 2 sa 8 mg mogħtija b’ mod subkutanju.
Following once daily dosing, steady state of plasma levels is obtained after 3 to 4
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.
e days with a 1.3-fold increase in Cmax and AUC. ng Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are:
Cmax (mg/ l)
Cmax (mg/ l) - 0.39 lo (31%), Tmax (h) - 2.8 (18%) and Cmin (mg/ l) -0.14 (56%).
8 – 0. 39 (31%), Tmax (h) – 2. 8 (18%) u Cmin (mg/ l) - 0. 14 (56%).
Cmax (mg/ l) - 0.50 (32%), no
F’ pazjenti bi frattura fil- ġenb, assoċjata ma ’ żieda fl- eta` tagħhom, il- konċentrazzjonijiet fissi ta ’ fondaparinux fil- plażma huma:
Cmin (mg/ l) - 0.19 (58%).
Cmax (mg/ l) – 0. 50 (32%), Cmin (mg/ l) – 0. 19 (58%).
Distribution The distribution volume of fondaparinux is limited (7-11 litres).
Distribuzzjoni Il- volum ta ’ distribuzzjoni ta ’ fondaparinux huwa limitat (7- 11 litri).
In vitro, fondaparinux is highly and ct
In vitro fondaparinux huwa marbut ħafna u speċifikament mal- proteina antitrombin b’ mod dipendenti mad- doża u mal -
Fondaparinux does not bind du
t konċentrazzjoni fil- plażma (98. 6% sa 97. 0% fil- firxa tal- konċentrazzjoni bejn 0. 5 sa 2 mg/ l).
significantly to other plasma proteins, including platelet factor 4 (PF4). ro
za 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. lP
riz 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
Metabolism Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no na
to ta ’ rbit ta ’ proteini.
evidence for the formation of active metabolites.
aw 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, ici
x Fondaparinux ma jinibixxix CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1
CYP2E1 or CYP3A4) in vitro.
du jew CYP3A4) in vitro.
Thus, fondaparinux is not expected to interact with other medicinal products in vivo by inhibition of CYP-mediated metabolism. ed
Għalhekk fondaparinux mhux mistenni li jkollu interazzjoni ma ’ prodotti mediċinali in vivo bl- inibizzjoni ta ’ metaboliżmu medjat- CYP. ħa Eskrezzjoni/ Eliminazzjoni Il- half life ta ’ l- eliminazzjoni (t1/ 2) hija madwar 17- il siegħa f’ suġġetti f’ saħħithom żgħażagħ u ’ g 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. im
Special populations
Popolazzjonijiet speċjali:
Paediatric patients - Fondaparinux has not been investigated in this population.
Pazjenti pedjatriċi - Fondaparinux ma ġiex investigat fuq din il- popolazzjoni. li l
8 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 na
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. iċi
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).
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
F’ indeboliment renali sever (clearance tal- krejatinina < 30 ml/ min), il- clearance tal- plażma hi tm
d renal function.
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
Valuri tal- half life terminali assoċjati kienu 29 h fil- moderati u 72 h f’ pazjenti b’ indeboliment renali akut. ot
ris 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. od
ho 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 Pr
Similarly, no plasma clearance differences were observed
pparagunat ma ’ suġġetti f’ saħħithom Kawkasi.
ut 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.
ra 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 - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment.
9 Indeboliment tal- fwied - Iil- farmakokinetika ta ’ fondaparinux ma ġietx evalwata f’ indeboliment tal - fwied.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety lo pharmacology, repeated dose toxicity, and genotoxicity.
Tagħrif ta ’ qabel l- użu kliniku magħmul fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti u effett tossiku fuq il- ġeni ma turi l- ebda periklu speċjali għall- bnedmin.
Animal studies are insufficient with respect to effects on toxicity to reproduction because of limited exposure. no
t Studji fuq l- annimali huma insuffiċjenti rigward l- effetti tossiku fuq is- sistema riproduttiva minħabba
6.
riz 6.
PHARMACEUTICAL PARTICULARS ct
TAGĦRIF FARMAĊEWTIKU
6.1 List of excipients du
to 6. 1 Lista ta ’ sustanzi mhux attivi
Hydrochloric acid Sodium hydroxide lP
aw Sodium Chloride Ilma għal injezzjonijiet Hydrochloric acid Sodium hydroxide
6.2 Incompatibilities na
x du 6. 2 Inkompatibilitajiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. ici
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jablux miegħu, dan il- prodott ħa mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ’ g 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali im
6.4 Special precautions for storage M
6. 4 Prekawzjonijiet speċjali għall- ħażna li l
Do not freeze.
Tiffriżahx na
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.
planġer tal- bromobutyl jew chlorobutyl elastomer. ed
Quixidar is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a yellow automatic safety system.
Quixidar huwa disponibbli f’ daqsijiet ta ’ pakketti ta ’ 2, 7, 10 u 20 siringi mimlija lesti b’ sistema ta ’ sikurezza awtomatika safra.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali. tm
6.6 Special precautions for disposal and other handling
6. 6 Struzzjonijiet għall- użu u maniġġar u għar- rimi ot
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. od
ris 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.
ho Instruction for self-administration is mentioned in the Package Leaflet.
Pr
ut The needle protection system of the Quixidar pre-filled syringe has been designed with an automatic safety system to protect from needle stick injuries following injection.
Is- sistema ta ’ protezzjoni tal- labra tas- siringi mimlija lesti Quixidar giet diżinjata b’ sistema ta ’ sikurezza awtomatika biex tipproteġi minn feriti bil- labra wara l- injezzjoni.
ra Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
e 7.
10 7.
MARKETING AUTHORISATION HOLDER Group Ltd
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
UB6 0NN United Kingdom ct
t Renju Unit
8.
za riz 8.
MARKETING AUTHORISATION NUMBERS du
NUMRI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
EU/ 1/ 02/ 207/ 005-008 ro
EU/ 1/ 02/ 206/ 005- 008
9.
to aw 9.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION lP
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
21 March 2002 Date of latest renewal:
21 ta ’ Marzu 2002 Data ta ’ l- aħħar tiġdid:
21 March 2007 na
21 ta ’ Marzu 2007
10.
x du 10.
Detailed information on this medicinal product is available on the website of the European Medicines ed
DATA TA ’ META ĠIET RIVEDUTA L- KITBA ħa Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu ’ g im li l na iċi ed tm ot od Pr
Quixidar 2.5 mg/ 0.5 ml solution for injection, pre-filled syringe.
Quixidar 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.
t Kull siringa mimlija lesta (0. 5 ml) fiha 2. 5 mg fondaparinux sodium.
respiratory disorders, and/ or acute infectious or inflammatory disease. ro
Trattament ta ’ anġina mhux stabbli jew infart mijokardijaku mingħajr elevazzjoni tas- segment ST ed
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 lP
(UA/ NSTEMI) għal dawk il- pazjenti fejn mhux indikat trattament invasif (PCI) urġenti (< 120 minuta) (ara sezzjoni 4. 4 u 5. 1). tm
Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with na
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. ot od
4.2 Posology and method of administration ici
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
Patients undergoing major orthopaedic or abdominal surgery ed
Pazjenti li jgħaddu minn kirurġija maġġuri ortopedika u addomenali Pr
M
Id- doża rakkomandata ta ’ fondaparinux 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.
12 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.
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 9 t ’ ijiem wara l- kirurġija.
In these patients the use of prolonged prophylaxis with fondaparinux should be considered for up to an additional 24 days (see section 5.1).
F’ dawn il- pazjenti l- użu ta ’ profilassi prolongata b’ fondaparinux għandha tiġi kkunsidrata sa ’ 24 jum addizzjonali (ara sezzjoni 5. 1).
11 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.
za Id- doża rakkomandata ta ’ fondaparinux hi ta ’ 2. 5 mg darba kuljum b’ injezzjoni subkutanja.