qanastek/EMEA-V3 huggingface dataset:
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 od
This medicinal product is for single use only. ici ed
Pr
Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Greenford Middlesex UB6 0NN Renju Unit
40 8.
t za 8.
EU/ 1/ 02/ 207/ 012-014, 019
riz EU/ 1/ 02/ 206/ 012- 014, 019
ris Detailed information on this medicinal product is available on the website of the European Medicines
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - ħa mediċini (EMEA) http: // www. emea. europa. eu ’ g im li l na iċi ed tm ot od Pr
Quixidar 10 mg/ 0.8 ml solution for injection, pre-filled syringe.
Quixidar 10 mg/ 0. 8 ml soluzzjoni għall- injezzjoni, siringa mimlija lesta
Each pre-filled syringe contains 10 mg of fondaparinux sodium in 0.8 ml solution for injection.
Kull siringa mimlija lesta fiha 10 mg ta ’ fondaparinux sodium f ’ 0. 8 ml ta ’ soluzzjoni għall- injezzjoni.
The recommended dose of fondaparinux is 7.5 mg (patients with body weight ≥ 50, ≤ 100kg) once ct
Id- doża rakkomandata ta ’ fondaparinux hija ta ’ 7. 5 mg (f ’ pazjenti b ’ piż ta ’ ≥ 50, ≥ 100 kg) darba kuljum li tingħata b’ injezzjoni subkutanja.
daily administered by subcutaneous injection.
Għal pazjenti b’ piż ta ’ < 50 kg, id- doża rakkomandata hija ta ’ 5 mg.
For patients with body weight < 50 kg, the du
Għal pazjenti b ’ piż ta ’ > 100 kg, id- doża rakkomandata hija ta ’ 10 mg. li l
For patients with body weight > 100 kg, the recommended dose is 10 mg.
It- trattament għandu jitkompla għal mill- inqas 5 t’ ijiem u sakemm antikoagulazzjoni adekwata na
(International Normalised Ratio 2 to 3).
b’ antikoagulant orali tkun stabbilita b’ mediċina orali (International Normalised Ratio 2 sa 3).
Concomitant oral anticoagulation treatment should be initiated as soon as possible and usually within 72 hours.
Trattament f’ istess ħin b ’ antikoagulant orali għandu jinbeda malajr kemm jista ’ jkun u s- soltu fi żmien 72 siegħa.
The average duration of administration in clinical lP
Il- tul medju tat- trattament fi studji kliniċi kien ta ’ 7 t’ ijiem u l- esperjenza klinika iċi
trials was 7 days and the clinical experience from treatment beyond 10 days is limited.
mit- trattament għal aktar minn 10 t’ ijiem hija limitata. ed
Renal impairment - Fondaparinux should be used with caution in patients with moderate renal ed
Indeboliment tal- kliewi - Għandha tittieħed attenzjoni bl- użu ta ’ fondaparinux f’ pazjenti ot
impairment (see section 4.4).
b’ indeboliment moderat tal- kliewi (ara sezzjoni 4. 4). od
There is no experience in the subgroup of patients with both high body weight (> 100 kg) and moderate M
M’ hemmx esperjenza fis- sub- grupp ta ’ pazjenti li għandhom kemm piż tal- ġisem għoli (> 100 kg) kif ukoll indeboliment renali moderat (clearance tal- krejatinina 30- 50 ml/ min).
renal impairment (creatinine clearance 30-50 ml/ min).
tad- doża għal 7. 5 mg kuljum (ara sezzjoni 4. 4).
Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (See section 4.3).
Fondaparinux m’ għandux jintuża f’ pazjenti b’ indeboliment sever tal- kliewi (clearance tal- krejatinina < 30ml/ min) (ara sezzjoni 4. 3).
42 Hepatic impairment - No dosing adjustment is necessary.
Indeboliment tal- fwied - M’ hemmx bżonn aġġustament tad- doża.
Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age due to a lack of data on safety and efficacy
46 Popolazzjonijiet pedjatriċi - Fondaparinux mhux rakkomandat għall- użu fi tfal ta ’ taħt is- 17- il sena 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
Il- postijiet ta ’ amministrazzjoni għandhom jalternaw bejn il- membrana ta ’ l- addome
d posterolateral abdominal wall.
t anterolaterali tax- xellug u tal- lemin u posterolaterali tax- xellug u tal- lemin.
e syringe do not expel the air bubble from the syringe before the injection.
za 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;
It- tul kollu tal- labra għandu jiġi inserit b’ mod perpendikulari f’ tinja tal -
ris the skin fold should be held throughout the injection.
riz ġilda miżmuma bejn is- saba ’ l- kbir u l- werrej; it- tinja tal- ġilda għandha tinżamm matul l- injezzjoni.
ho 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.
4.3 Contraindications
to 4. 3 Kontra- indikazzjonijiet
ut
aw
e 4.4
x
Special warnings and precautions for use
- Indeboliment sever tal- kliewi definit bi clearance tal- krejatinina ta ’ < 30 ml/ min.
Fondaparinux is intended for subcutaneous use only.
du 4. 4 Twissijiet speċjali u prekawzjonijiet speċjali għall- użu ħa Fondaparinux huwa intenzjonat għall- użu subkutanju biss.
Do not administer intramuscularly. lo There is limited experience from treatment with fondaparinux in haemodynamically unstable patients no
Tinjettax fil- muskoli. ’ g Hemm esperjenza limitata mit- trattament b ’ fondaparinux f’ pazjenti li m’ humiex stabbli emodinamikament u m’ hemm l- ebda esperjenza f’ pazjenti li għandhom bżonn tromboliżi, im
and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter.
embolektomija jew li jiddaħħal filter ġol- vena cava.
Haemorrhage Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, ct
Emorraġija Fondaparinux għandu jintuża b’ attenzjoni f’ pazjenti b’ riskju ogħla ta ’ emorraġija, bħal dawk b’ mard li l
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 du
ta 'fsada kemm konġenitali jew akkwistati (es. għadd ta ’ plejtlets < 50, 000 / mm3), mard gastro - intestinali ulċerattiv attiv u emorraġija riċenti fil- kranju jew ftit wara kirurgija fil- moħħ, is- sinsla jew na
ophthalmic surgery and in special patient groups as outlined below. ro
l- għajnejn u fi gruppi speċjali ta ’ pazjenti li jissemmew hawn taħt.
As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone recent surgery (< 3 days) and only once surgical haemostasis has been established. lP
kirurġija riċenti (< 3 t’ ijiem) u jintuża biss meta jiġi stabbilit emostasi kirurġiku. ed
These agents include desirudin, fibrinolytic agents, GP IIb/ IIIa receptor antagonists, na
Waqt trattament ta ’ tm
During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5.
VTE, f’ istess ħin għandha tingħata terapija b’ antagonista ta ’ vitamina K skond l- informazzjoni f ’ Sezzjoni 4. 5.
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, ici
Fil- każ li jkun essenzjali li ot
If co- administration is essential, close monitoring is necessary. ed
jingħataw flimkien, jkun hemm bżonn ta ’ osservazzjoni mill- qrib. od
Spinal / Epidural anaesthesia In patients receiving fondaparinux for treatment of VTE rather than prophylaxis, spinal/ epidural M
Pr
The corresponding incidences in patients receiving the recommended regimen of enoxaparin in the
Meta maqsumin f’ gruppi fl- istess mod, il- każi f’ pazjenti li jieħdu d- dożaġġ
43 treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively.
47 rakkomandat ta ’ enoxaparin fit- trattament ta ’ DVT kienu ta ’ 2. 5%, 3. 6% u 8. 3% rispettivament, u l - każi f’ pazjenti li jieħdu d- dożaġġ rakkomandat ta ’ UFH fit- trattament ta ’ PE kienu ta ’ 5. 5%, 6. 6% and 7. 4% rispettivament.
Low body weight Clinical experience is limited in patients with body weight < 50 kg.
Piż tal- ġisem baxx L- esperjenza klinika hija limitata f’ pazjenti b ’ piż < 50 kg.
Fondaparinux should be used with caution at a daily dose of 5 mg in this population (see sections 4.2 and 5.2).
t għandu jintuża b’ attenzjoni f ’ dan il- grupp ta ’ pazjenti (ara sezzjoni 4. 2 u 5. 2).
Renal impairment
za Indeboliment tal- kliewi
d The risk of bleeding increases with increasing renal impairment.
riz Żieda fl- indeboliment tal- kliewi iżid ir- riskju ta ’ fsada.
e excreted mainly by the kidney.
Huwa magħruf li fondaparinux jitneħħa fil - biċċa l- kbira mill- kliewi.
ris renal impairment and severe renal impairment were 3.0% (34/ 1132), 4.4% (32/ 733), 6.6% (21/ 318), and 14.5% (8/ 55) respectively.
to ta ’ DVT jew PE, kienu ta ’ 3. 0% (34/ 1132), 4. 4% (32/ 733), 6. 6% (21/ 318), u 14. 5% (8/ 55), rispettivament.
The corresponding incidences in patients receiving the recommended
Meta maqsumin f’ gruppi fl- istess mod, il- każi f’ pazjenti li jieħdu d- dożaġġ
ho regimen of enoxaparin in the treatment of DVT were 2.3% (13/ 559), 4.6% (17/ 368), 9.7% (14/ 145) and 11.1% (2/ 18) respectively, and in patients receiving the recommended regimen of unfractionated heparin in the treatment of PE were 6.9% (36/ 523), 3.1% (11/ 352), 11.1% (18/ 162) and 10.7% (3/ 28),
aw rakkomandat ta ’ enoxaparin fit- trattament ta ’ DVT kienu ta ’ 2. 3% (13/ 559), 4. 6% (17/ 368), 9. 7% (14/ 145) u 11. 1% (2/ 18), rispettivament, u l- każi f’ pazjenti li jieħdu d- dożaġġ rakkomandat ta ’ eparina mhux frazzjonata fit- trattament ta ’ PE kienu ta ’ 6. 9% (36/ 523), 3. 1% (11/ 352), 11. 1% (18/ 162) and 10. 7% (3/ 28), rispettivament.
ra Fondaparinux is contra-indicated in severe renal impairment (creatinine clearance < 30 ml/ min) and should be used with caution in patients with moderate renal impairment (creatinine clearance 30-50 ml/ min).
x du Fondaparinux huwa kontra- indikat f’ indeboliment renali sever (clearance tal - krejatinina < 30ml/ min) u jrid jintuża b’ attenzjoni f ’ pazjenti f’ indeboliment renali moderat (clearance tal - krejatinina 30- 50 ml/ min).
The duration of treatment should not exceed that evaluated during clinical trial (mean 7 days)
Fondaparinux għandu jintuża im
Fondaparinux should be used with care in these lo patients.
b’ attenzjoni f’ dawn il- pazjenti.
After an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, based on pharmacokinetic modelling (see section 4.2). no
Wara doża fil- bidu ta ’ 10 mg kuljum, tista ’ tiġi kunsidrata meta bażata fuq mudell farmakokinetiku, tnaqqis fid- doża għal 7. 5 mg kuljum, (ara sezzjoni 4. 2).
Severe hepatic impairment 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). ct du
Fondaparinux għandu jintuża b’ attenzjoni f ’ pazjenti b’ indeboliment sever tal- fwied għaliex hemm riskju ogħla ta ’ fsada minħabba nuqqas ta ’ fatturi ta ’ koagulazzjoni (ara sezzjoni 4. 2). na
Patients with Heparin Induced Thrombocytopenia Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with Heparin Induced Thrombocytopenia (HIT) type II.
Pazjenti bi tromboċitopenja indotta bl ’ Eparina Fondaparinux ma jintrabatx ma ’ l- fattur 4 tal- plejtlets u ma jirreaġixxix ma ’ serum minn pazjenti b ’ iċi
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 ’ HIT tat- tip II. ed
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may na
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott tm
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). ot
In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with ici
F ’ studji kliniċi li saru b ’ fondaparinux, antikoagulanti li jittieħdu mill- ħalq (warfarin) ma kellhom od
the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux did not influence the anticoagulation monitoring (INR) activity of warfarin. ed
Pr
not influence the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.
Fid- doża ta ’ fondaparinux (10 mg) li ntużat fl- istudji ta ’ interazzjoni, fondaparinux ma kellu ebda effett fuq il- ħin biex jieqaf id- demm (bleeding time) waqt trattament b ’ acetylsalicylic acid jew piroxicam, u lanqas fuq il- farmakokinetika ta ’ digoxin fi stat fiss.
44 4.6 Pregnancy and lactation
48 4. 6 Tqala u Treddigħ
4.7
Fit -
Effects on ability to drive and use machines
za tarbija l- assorbiment mill- ħalq huwa improbabli.
e
riz 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
ris 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.
ho 4.8 Undesirable effects
to 4. 8 Effetti mhux mixtieqa
ut Embolism and treated with fondaparinux for an average of 7 days.
aw Is- sigurta ’ ta ’ fondaparinux 2. 5 mg ġiet evalwata f’ 2, 517 pazjent li kienu fuq trattament b ’ fondaparinux għal medja ta ’ 7 t’ ijiem għal Trombo- Emboliżmu Venuż.
The most common adverse reactions were bleeding complications (see section 4.4).
L- effetti mhux mixtieqa l - iżjed komuni kienu kumplikazzjonijiet ta ’ fsada (ara sezzjoni 4. 4).
e 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. ng lo no ct du ro lP na ici ed M
x du L- effetti mhux mixtieqa li ġew irrapurtati 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; ħa rari ħafna ≤1/ 10, 000) u fis- sistema tal- klassifika tal- organi, bil- gravita` ta ’ l- effett mhux mixtieq dejjem jonqos. ’ g im li l na iċi ed tm ot od Pr
46 Pharmacodynamic effects
t Effetti farmakodinamiċi
47 Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, compared to 1.1% with unfractionated heparin.
riz fondaparinux meta mqabbel ma ’ 1. 1% fil- pazjenti fuq heparin mhux frazzjonat.
Since fondaparinux does not bind significantly to plasma proteins other than antithrombin, no na
Peress li fondaparinux ma jeħilx sinifikament ma ’ proteini fil- plażma għajr antitrombin, mhux mistenni li jkun hemm xi effett fuq mediċinali oħra għax jieħu post oħrajn biex jeħel ma ’ l - proteini.
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
52 In vitro, fondaparinux ma inibixxix CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 jew CYP3A4).
products in vivo by inhibition of CYP-mediated metabolism.
Eskrezzjoni / Eliminazzjoni Il- half- life ta ’ eliminazzjoni (t½) huwa ta ’ madwar 17- il siegħa f’ persuni żagħżagħ f’ saħħithom u
48 Special populations
riz Gruppi ta ’ nies speċjali:
6.3 Shelf life
to 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
3 years
aw 3 snin
49 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not freeze.
x du Tiffriżahx
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a chlorobutyl elastomer plunger stopper.
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih ħa Tubu ċilindriku tal- ħġieġ Tip1 (1 ml) mehmuż b ’ labra kalibru 27 ta ’ 12. 7 mm u magħluqa b’ tapp ’ g planġer tal- bromobutyl jew chlorobutyl elastomer. im
d Quixidar 10 mg/ 0.8 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a violet
Quixidar 10 mg/ 0. 8 ml jinstab f’ pakketti ta ’ 2, 7, 10, u 20 siringi mimlija lesti b ’ sistema awtomatika ta ’ sigurta ’ vjola.
ris 6.6 Special precautions for disposal and other handling
6. 5 Struzzjonijiet għall- użu u maniġġar u għar- rimi li l
ho The subcutaneous injection is administered in the same way as with a classical syringe.
L- injezzjoni subkutaneja titieħed bl- istess mod ta ’ siringa klassika. na
Parenteral solutions should be inspected visually for particulate matter and discoloration prior to
Soluzzjonijiet li jittieħdu b’ injezzjoni, għandhom jiġu spezzjonati viżwalment għal frak u telf ta ’ kulur qabel ma ’ jittieħdu. iċi
ut administration.
Tagħrif.
ra Instruction for self-administration is mentioned in the Package Leaflet.
Is- siringa mimlija lesta ta ’ Quixidar hija diżinjata b ’ sistema protettiva tal- labra awtomatika biex tm
The Quixidar pre-filled syringe has been designed with an automatic needle protection system to
tevita li wieħed jittaqqab bi żball wara l- injezzjoni.
e prevent needle stick injuries following injection. ng 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 ot
This medicinal product is for single use only. lo no
Din il- mediċina hija għall- użu ta ’ darba biss. od
EU/ 1/ 02/ 207/ 015-017, 020 na
EU/ 1/ 02/ 206/ 015- 017, 020
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
to Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu
50 d e ris ho ut e ra ng ANNEX II
55 t za riz to aw x du ħa ANNESS II ’ g
MANUFACTURING AUTHORISATION HOLDER lo RESPONSIBLE FOR BATCH RELEASE no
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL - im
CONDITIONS OF THE MARKETING AUTHORISATION ct du ro
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - li l
ici ed M
TQEGĦID FIS- SUQ na iċi ed tm ot od Pr
Glaxo Wellcome Production 1, rue de l’ Abbaye F-76960 Notre Dame de Bondeville France
Glaxo Wellcome Production 1, rue de l’ Abbaye
CONDITIONS OF THE MARKETING AUTHORISATION
t F- 76960 Notre Dame de Bondeville
d
za Franza
ris • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
ho IMPOSED ON THE MARKETING AUTHORISTION HOLDER
to • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU
Medicinal product subject to medical prescription.
aw IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
ut • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Prodott mediċinali jingħata bir- riċetta tat- tabib
ra EFFECTIVE USE OF THE MEDICINAL PRODUCT
x du • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI ħa Ma jgħoddx f’ dan il- każ. ’ g • KUNDIZZJONIJIET OĦRA im
e • OTHER CONDITIONS ng Pharmacovigilance system lo The MAH must ensure that the system of pharmacovigilance, as described in the June 2006 version presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning no
Sistema ta ’ farmakoviġilanza L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni ta ’ Ġunju 2006 preżentata fit- Taqsima 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, qiegħda li l
before and whilst the product is on the market.
f’ postha u tiffunzjona qabel ma l- prodott jitqiegħed fis- suq u waqt li l- prodott ikun fis- suq. na
Risk Management Plan ct
Pjan dwar il- Maniġġjar ta ’ Riskju L- MAH jimpenja ruħu li jwettaq l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza dettaljati iċi
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 of the Risk Management Plan (RMP) presented du
fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 1. 2 tal- Pjan dwar il- Maniġġjar ta ’ Riskju (RMP) preżentat fit- Taqsima 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u ed
in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP. ro
fl- aġġornamenti sussegwenti tal- RMP mifthema mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report lP
L- RMP aġġornat għandu jiġi ppreżentat fl- istess żmien tar- Rapport Perjodikament Aġġornat dwar tm
(PSUR).
Sigurta` (PSUR) li jmiss, skond ir- regolament tas- CHMP dwar Sistemi għal- Maniġġjar ta ’ Riskji għal - prodotti mediċinali għall- użu fil- bniedem. ot
In addition, an updated RMP should be submitted: na
Barra minn hekk, RMP aġġornat għandu jiġi ppreżentat: • Meta tasal informazzjoni ġdida li jista ’ jkollha effett fuq l- ispeċifikazzjoni tas- sigurta` od
• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being ici
kurrenti, fuq il- Pjan ta ’ Farmakoviġilanza kurrenti jew fuq l- attivitajiet għat- tnaqqis tar- riskji. • F’ żmien ta ’ 60 ġurnata wara li tkun tlaħqet xi mira importanti (ta ’ farmakoviġilanza jew ta ’ tnaqqis ta 'riskji) Pr
reached • At the request of the EMEA. ed M
• Fuq talba ta ’ l- EMEA
52 ed ris ho ut
57 t za riz to aw x du ANNESS III
LABELLING AND PACKAGE LEAFLET lo no ct du ro lP na ici ed M
TIKKETTA U FULJETT TA ’ TAGĦRIF ħa ’ g im li l na iċi ed tm ot od Pr
53 M ed ici na lP ro du ct
58 Pr od ot tm ed iċi na li l
LABELLING lo ng
59 im A.
e
KAXXA TA ’ BARRA
ra ut
t 1.
ho
za Quixidar 1. 5 mg/ 0. 3 ml soluzzjoni għal injezzjoni.
e Fondaparinux sodium
riz Fondaparinux sodium
ris 2.
to 2.
ho One pre-filled syringe (0.3 ml) contains 1.5 mg fondaparinux sodium.
aw Siringa waħda mimlija lesta (0. 3 ml) fiha 1. 5 mg fondaparinux sodium.
ra Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.
x du Fiha wkoll: sodium chloride, ilma għal injezzjonijiet, hydrochloric acid, sodium hydroxide. ħa 4.
PHARMACEUTICAL FORM AND CONTENTS ng lo Solution for injection, 2 pre-filled syringes with an automatic safety system Solution for injection, 7 pre-filled syringes with an automatic safety system Solution for injection, 10 pre-filled syringes with an automatic safety system no
Soluzzjoni għall- injezzjoni, 7 siringi mimlija lesti b’ sistema ta ’ sikurezza awtomatika. im
Solution for injection, 20 pre-filled syringes with an automatic safety system ct
Soluzzjoni għall- injezzjoni, 20 siringa mimlija lesta b’ sistema ta ’ sikurezza awtomatika. li l
METHOD AND ROUTE(S) OF ADMINISTRATION du
MOD TA ’ KIF U MNEJN JINGĦATA na
Subcutaneous use
Użu subkutanju. iċi
Read the package leaflet before use. ro
Aqra l- fuljett ta ’ tagħrif qabel l- użu. ed
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT lP
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL tm
Keep out of the reach and sight of children. na ici
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal ot
OTHER SPECIAL WARNING(S), IF NECESSARY ed M
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA od
EXPIRY DATE
DATA TA ’ META JISKADI Pr
EXP {month/ year}
JIS [xahar/ sena]
55 10.
60 10.
11.
t za 11.
d Glaxo Group Ltd
riz Glaxo Group Ltd.
ris UB6 0NN United Kingdom
to Middlesex UB6 0NN
ho 12.
aw Renju Unit
ra EU/ 1/ 02/ 207/ 006 - 7 pre-filled syringes EU/ 1/ 02/ 207/ 007 - 10 pre-filled syringes EU/ 1/ 02/ 207/ 008 - 20 pre-filled syringes
NUMRU TAL- LOTT im
BATCH NUMBER ng lo Batch {number} no
Lott [numru] li l
GENERAL CLASSIFICATION FOR SUPPLY ct
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA na
Medicinal product subject to medical prescription. du
Prodott mediċinali jingħata bir- riċetta tat- tabib. iċi
INSTRUCTIONS ON USE ro
STRUZZJONIJIET DWAR L- UŻU ed
INFORMATION IN BRAILLE lP na ici ed M
INFORMAZZJONI BIL- BRAILLE tm ot od Pr
56 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
61 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PRE-FILLED SYRINGE
SIRINGA MIMLIJA LESTA
Quixidar 1.5 mg/ 0.3 ml injection
t za Quixidar 1. 5 mg/ 0. 3 ml soluzzjoni għall- injezzjoni fondaparinux Na
e ris SC
riz SC
ho ut 3.
aw 3.
ra EXP {month/ year}
x JIS [xahar/ sena]
Batch
du ħa 4.
BATCH NUMBER {number}
NUMRU TAL- LOTT
lo
Lott [numru] ’ g im
CONTENTS BY WEIGHT, BY VOLUME
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI. li l na iċi ed tm ot od Pr
d Quixidar 2.5 mg/ 0.5 ml solution for injection
za Quixidar 2. 5 mg/ 0. 5 ml soluzzjoni għal injezzjoni.
ho One pre-filled syringe (0.5 ml) contains 2.5 mg fondaparinux sodium.
aw Siringa waħda mimlija lesta (0. 5 ml) fiha 2. 5 mg fondaparinux sodium.
Subcutaneous or intravenous use ro
Użu subkutanju jew ġol- vina. iċi
Read the package leaflet before use. lP
Aqra l- fuljett ta ’ tagħrif qabel l- użu. ed
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN na
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL tm
Keep out of the reach and sight of children. ici
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal
OTHER SPECIAL WARNING(S), IF NECESSARY ed M
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA ot od
d e 11.
t za 11.
ris Glaxo Group Ltd Greenford
Greenford
ho Middlesex UB6 0NN United Kingdom
to Middlesex UB6 0NN
ut ra 12.
aw Renju Unit
e EU/ 1/ 02/ 207/ 001 - 2 pre-filled syringes EU/ 1/ 02/ 207/ 002 - 7 pre-filled syringes EU/ 1/ 02/ 207/ 003 - 10 pre-filled syringes EU/ 1/ 02/ 207/ 004 - 20 pre-filled syringes 13.
x du EU/ 1/ 02/ 206/ 001 - 2 siringi mimlija lesti EU/ 1/ 02/ 206/ 002 - 7 siringi mimlija lesti EU/ 1/ 02/ 206/ 003 - 10 siringi mimlija lesti ħa EU/ 1/ 02/ 206/ 004 - 20 siringa mimlija lesta ’ g 13.
BATCH NUMBER
NUMRU TAL- LOTT im
Batch {number} ct
Lott [numru] li l
GENERAL CLASSIFICATION FOR SUPPLY du
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA na
Medicinal product subject to medical prescription. ro
Prodott mediċinali jingħata bir- riċetta tat- tabib. iċi
INSTRUCTIONS ON USE lP
STRUZZJONIJIET DWAR L- UŻU ed
INFORMATION IN BRAILLE na ici ed M
INFORMAZZJONI BIL- BRAILLE tm ot od Pr
59 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
64 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Quixidar 2.5 mg/ 0.5 ml injection
t za Quixidar 2. 5 mg/ 0. 5 ml soluzzjoni għall- injezzjoni fondaparinux Na
e ris SC/ IV
riz SC/ IV
e 4.
du ħa 4.
Batch {number} lo
Lott [numru] ’ g im
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT no ct du ro lP na ici ed M
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI. li l na iċi ed tm ot od Pr
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
d Quixidar 5 mg/ 0.4 ml solution for injection
za Quixidar 5 mg/ 0. 4 ml soluzzjoni għal injezzjoni.
ho One pre-filled syringe (0.4 ml) contains 5 mg fondaparinux sodium.
aw Siringa waħda mimlija lesta (0. 4 ml) fiha 5 mg fondaparinux sodium.
Keep out of the reach and sight of children. na ici
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal
OTHER SPECIAL WARNING(S), IF NECESSARY ed
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA ot
Body weight below 50 kg M
Piż tal- ġisem taħt 50 kg od
e EU/ 1/ 02/ 207/ 009- 2 pre-filled syringes EU/ 1/ 02/ 207/ /010 - 7 pre-filled syringes EU/ 1/ 02/ 207/ 011 - 10 pre-filled syringes EU/ 1/ 02/ 207/ 018 - 20 pre-filled syringe 13.
x du EU/ 1/ 02/ 206/ 009 - 2 siringi mimlija lesti EU/ 1/ 02/ 206/ 010 - 7 siringi mimlija lesti EU/ 1/ 02/ 206/ 011 - 10 siringi mimlija lesti ħa EU/ 1/ 02/ 206/ 018 - 20 siringa mimlija lesta ’ g 13.
62 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
67 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Quixidar 5 mg/ 0.4 ml injection
t za Quixidar 5 mg/ 0. 4 ml soluzzjoni għall- injezzjoni fondaparinux Na
63 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
68 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
d Quixidar 7.5 mg/ 0.6 ml solution for injection
za Quixidar 7. 5 mg/ 0. 6 ml soluzzjoni għal injezzjoni.
ho One pre-filled syringe (0.6 ml) contains 7.5 mg fondaparinux sodium.
aw Siringa waħda mimlija lesta (0. 6 ml) fiha 7. 5 mg fondaparinux sodium.
Body weight 50-100 kg M
Piż tal- ġisem 50- 100 kg od
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID
ris Glaxo Group Ltd Greenford
Greenford Middlesex
ho Middlesex UB6 0NN United Kingdom
to UB6 0NN Renju Unit
ut ra 12.
aw 12.
e EU/ 1/ 02/ 207/ 012- 2 pre-filled syringes EU/ 1/ 02/ 207/ 013 - 7 pre-filled syringes EU/ 1/ 02/ 207/ 014 - 10 pre-filled syringes EU/ 1/ 02/ 207/ 019 - 20 pre-filled syringe 13.
du EU/ 1/ 02/ 206/ 013 - 7 siringi mimlija lesti EU/ 1/ 02/ 206/ 014 - 10 siringi mimlija lesti EU/ 1/ 02/ 206/ 019 - 20 siringa mimlija lesta ħa ’ g 13.
GENERAL CLASSIFICATION FOR SUPPLY du
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
Medicinal product subject to medical prescription. ro
Prodott mediċinali jingħata bir- riċetta tat- tabib. na iċi
65 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
70 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Quixidar 7.5 mg/ 0.6 ml injection
t za Quixidar 7. 5 mg/ 0. 6 ml soluzzjoni għall- injezzjoni fondaparinux Na
BATCH NUMBER ng lo Batch {number} no
Lott [numru] ’ g im
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT ct du ro lP na ici ed M
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI. li l na iċi ed tm ot od Pr
d Quixidar 10 mg/ 0.8 ml solution for injection
za Quixidar 10 mg/ 0. 8 ml soluzzjoni għal injezzjoni.
ho One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium.
aw Siringa waħda mimlija lesta (0. 8 ml) fiha 10 mg fondaparinux sodium.
Body weight above 100 kg M
Piż tal- ġisem 'il fuq minn 100 kg od
e EU/ 1/ 02/ 207/ 015 - 2 pre-filled syringes EU/ 1/ 02/ 207/ 016 - 7 pre-filled syringes EU/ 1/ 02/ 207/ 017 - 10 pre-filled syringes EU/ 1/ 02/ 207/ 020 - 20 pre-filled syringe 13.
x du EU/ 1/ 02/ 206/ 015 - 2 siringi mimlija lesti EU/ 1/ 02/ 206/ 016 - 7 siringi mimlija lesti EU/ 1/ 02/ 206/ 017 - 10 siringi mimlija lesti ħa EU/ 1/ 02/ 206/ 020 - 20 siringa mimlija lesta ’ g 13.
68 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
73 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
d fondaparinux Na
t za Quixidar 10 mg/ 0. 8 ml soluzzjoni għall- injezzjoni fondaparinux Na
ho
aw 3.
ris
du ħa 4.
e
Lott [numru] ’ g im
d
5.
PACKAGE LEAFLET:
74 Pr od ot tm ed iċi na li l
INFORMATION FOR THE USER
75 im ’ g B.
Quixidar 1.5 mg/ 0.3 ml solution for injection fondaparinux sodium
Quixidar 1. 5mg/ 0. 3ml soluzzjoni għall- injezzjoni fondaparinux sodium
Read all of this leaflet carefully before you start using this medicine. • Keep this leaflet.
Aqra dan il- fuljett kollu qabel tibda tuża din il- mediċina
d • This medicine has been prescribed for you personally.
t • Żomm dan il- fuljett.
It may harm
Jista jkollok bżonn terġa taqrah.
e them, even if their symptoms seem to be the same as yours. •
Tista ’
ris If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
riz tagħmlilhom il- ħsara, anki jekk is- sintomi tagħhom jidhru qishom bħal tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew l- ispiżjar tiegħek.
ho In this leaflet:
to F’ dan il- fuljett:
1.
aw 1.
Before you use Quixidar
X’ inhu Quixidar u għalxiex jintuża 2.
ut 3.
Qabel ma tuża Quixidar 3.
How to use Quixidar 4.
Kif għandek tuża Quixidar 4.
ra 5.
x 5.
How to store Quixidar 6.
Kif taħżen Quixidar
e 1.
du 6.
WHAT QUIXIDAR IS AND WHAT IT IS USED FOR ng lo Quixidar is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent). no
X’ INHU QUIXIDAR U GĦALXIEX JINTUŻA ’ g Quixidar huwa mediċina li tghin biex tipprevjeni l- formazzjoni ta ’ għoqiedi tad- demm fil- vini u arterji. im
Quixidar contains a synthetic substance called fondaparinux sodium.
Quixidar fih sustanza sintetika li jisimha fondaparinux sodium.
This stops a clotting factor Xa (“ ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from forming in the blood vessels. ct
Din twaqqaf fattur tat- tagħqid tad - demm Xa ("għaxra – A “) milli jagħmel effett fid- demm, u b’ hekk tipprevjeni l- iżvilupp ta ’ għoqiedi li l
Quixidar is used to: du
Quixidar jintuża biex: na
• prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic surgery (such as hip or knee surgery) or abdominal surgery • prevent the formation of blood clots during and shortly after a period of restricted mobility due ro
• jevita l- formazzjoni ta ’ għoqiedi tad- demm fil- vini u arterji tar- riġlejn jew pulmuni wara kirurġija ortopedika, bħal kirurġija fil- ġenb jew fl- irkoppa jew wara kirurġija fl- addomenu. iċi
to acute illness. lP
• jevita l- formazzjoni ta ’ emboli waqt u ftit wara l- perjodu ta ’ mobilita` restritta minħabba mard akut. ed
BEFORE YOU USE QUIXIDAR na
QABEL MA TUŻA QUIXIDAR tm
Do not use Quixidar: • if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of ici
Tużax Quixidar: • jekk inti allerġiku (tbati minn sensittività eċċessiva) għal fondaparinux sodium jew sustanzi oħra ta ’ Quixidar ot
Quixidar • if you are bleeding excessively ed
• jekk int tinfasad b’ mod eċċessiv • jekk għandek infezzjoni batterika tal- qalb od
• if you have a bacterial heart infection • if you have very severe kidney disease. → Tell your doctor if you think any of these applies to you.
Jekk iva, m’ għandekx Pr
M
tuża Quixidar.
Take special care with Quixidar:
Oqgħod attent ħafna b’ Quixidar:
Your doctor needs to know before you take Quixidar: • if you have a risk of uncontrolled bleeding (haemorrhage) including:
Qabel tieħu Quixidar it- tabib tiegħek għandu bżonn ikun jaf: • jekk għandek riskju ta ’ ħruġ ta ’ demm (emorraġija) mhux ikkontrollat, li tinkludi:
· stomach ulcer
· ulċera fl- istonku
· bleeding disorders
· disturbi fid- demm
· recent bleeding into the brain (intracranial bleeding)
· ħruġ ta ’ demm riċenti fil- moħħ (fsada intrakraniku)
· recent surgery on the brain, spine or eye
· kirurġija riċenti fil- moħħ, kolonna vertebrali jew fl- għajnejn
71 • if you have severe liver disease • if you have kidney disease • if you are 75 years old or older • if you weigh less than 50 kg. → Tell your doctor if any of these applies to you.
• jekk tbati minn mard serju fil- fwied; • jekk tbati minn mard fil- kliewi; • jekk għandek eta` ta ’ 75 sena jew iktar; • jekk tiżen inqas minn 50 kg → Għid lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik
Children Quixidar has not been tested in children and adolescents under the age of 17 years.
t za Tfal Quixidar ma ġiex ittestjat fi tfal u addoloxxenti ta ’ taħt is- 17- il sena.
d Using other medicines
riz Meta tuża mediċini oħra:
e Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any.
Dawn
ris This includes medicines you bought without a prescription.
to jinkludu anki mediċini li tkun xtrajt mingħajr riċetta.
Some other medicines may affect the way that Quixidar works or be affected by Quixidar.
Ċerti mediċini oħrajn jistgħu jaffettwaw il- mod li jagħmel effett Quixidar jew ikunu affettwati bi Quixidar.
ho Pregnancy and breast feeding Quixidar should not be prescribed to pregnant women unless clearly necessary.
aw Tqala u Treddigħ Quixidar m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
Breast-feeding is not recommended during treatment with Quixidar.
It- treddigħ mhux rakkomandat waqt trattament b ’ Quixidar.
If you are pregnant, think you might be, or if you are
Jekk inti tqila jew taħseb li tista ’ tkun tqila, jew jekk qed tredda:
ut breast feeding: → tell your doctor or pharmacist.
x → għarraf lit- tabib jew l- ispiżjar tiegħek.
3.
du Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Quixidar Kull doża ta ’ dan il- prodott mediċinali fiha anqas minn 23 mg ta ’ sodium u għalhekk il- prodott huwa ħa essenzjalment mingħajr sodium ’ g 3.
HOW TO USE QUIXIDAR
KIF GĦANDEK TUŻA QUIXIDAR im
Always use Quixidar exactly as your doctor has told you.
Dejjem għandek tuża Quixidar skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure. no
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju. li l
The usual dose is 2.5 mg once a day, injected at about the same time each day. ct
Id- doża li ssoltu tingħata hija ta ’ 2. 5 mg darba kuljum injettata bejn wieħed u ieħor fl- istess ħin kuljum. na
If you have kidney disease, the dose may be reduced to 1.5 mg once a day. du
Jekk tbati minn mard fil- kliewi, tista ’ tnaqqas id- doża għal 1. 5 mg darba kuljum. iċi
How is Quixidar given • Quixidar is given by injection under the skin (subcutaneously) into a skin fold of the lower abdominal area.
Kif jingħata Quixidar • Quixidar jingħata permezz ta ’ injezzjoni taħt il- ġilda (b’ mod subkutanju) f’ tinja tal- ġilda tal- parti t’ isfel ta ’ l- istonku.
The syringes are pre-filled with the exact dose you need.
Is- siringi huma mimlija minn qabel bid- doża eżatta li jkollok bżonn.
There are different ro
Hemm ed
syringes for the 2.5 mg and 1.5 mg doses.
siringi differenti għad- dożi ta ’ 2. 5mg u 1. 5mg.
For step-by-step instructions please see over the page lP
Għal istruzzjonijiet li juru kollox pass- pass jekk jogħġbok ara il- paġna ta ’ wara. tm
• Do not inject Quixidar into muscle. na
• Tinjettax Quixidar ġo muskolu (b’ mod intramuskolari).
How long should Quixidar be taken for You should continue Quixidar treatment for as long as your doctor has told you, since Quixidar prevents development of a serious condition. ici
Kemm għandek iddum tieħu Quixidar Għandek tkompli t- trattament Quixidar għaż- żmien kollu li jgħidlek it- tabib peress illi Quixidar ot
If you inject too much Quixidar ed
jipprevjeni l- iżvilupp ta ’ kondizzjoni serja. od
M
Jekk tinjetta Quixidar aktar milli suppost: ikkuntatja lit- tabib jew spiżjar tiegħek għal parir kemm jista ’ jkun malajr minhabba riskju ikbar ta ’ Pr
If you forget to take Quixidar • Take the dose as soon as you remember.
Jekk tinsa tuża Quixidar: • Ħu d- doża mill- ewwel kif tiftakar.
Do not inject a double dose to make up for a forgotten dose. • If you are not sure what to do, ask your doctor or pharmacist.
Tinjettax doża doppja biex tpatti għal kull doża li tkun insejt tieħu. • Jekk m’ intix ċert x’ għandek tagħmel, staqsi lit- tabib jew spiżjar tiegħek.
Don’ t stop using Quixidar without advice If you stop the treatment before your doctor told you to, you are at risk of developing a blood clot in a vein of your leg or lung.
Jekk twaqqaf it- trattament qabel ma jgħidlek it- tabib, inti għandek riskju li tiżviluppa għoqda tad - demm f’ vina tar- riġel jew fil- pulmun.
Contact your doctor or pharmacist before stopping.
Kellem lit- tabib jew spiżjar tiegħek qabel ma twaqqaf.
72 If you have any further questions about how to use this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar kif tuża dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Quixidar can cause side effects, although not everybody gets them.
t za Bħall- kull mediċina oħra, Quixidar jista ’ jkolla effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects
riz Effetti sekondarji komuni Dawn jistgħu jaffettwaw iżjed minn wieħed kull 100 persuna trattati bi Quixidar • ħruġ ta ’ demm (per eżempju mis- sit ta ’ operazzjoni, ulċera fl- istonku diġa ’ eżistenti, fġir l -
d These may affect more than 1 in 100 people treated with Quixidar.
to imnieħer, ħanek) • anemija (tnaqqis fin- numru taċ- ċelloli ħomor tad- demm).
e • bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums) • anaemia (a reduction in the number of red blood cells).
aw Effetti sekondarji mhux komuni Dawn jistgħu jaffettwaw sa wieħed kull 100 persuna • tbenġil jew nefħa (edima)
ris Uncommon side effects
x • tħossok imqalla jew titqalla (dardir jew rimettar)
ho These may affect up to 1 in 100 people treated with Quixidar. • bruising or swelling (oedema) • feeling sick or being sick (nausea or vomiting)
du • uġigħ fis- sider • qtugħ ta ’ nifs • raxx jew ħakk fil- ġilda • tnixxija mill- ferita ta ’ l- operazzjoni • deni
ut • chest pain • breathlessness
’ g
ra • rash or itchy skin • oozing from operation wound site
ħa
e • fever • ng reduction or increase in the number of platelets (blood cells necessary for blood clotting) • increase in some chemicals (enzymes) produced by the liver. lo Rare side effects These may affect up to 1 in every 1000 people treated with Quixidar. • allergic reaction no
• nuqqas jew żieda fin- numru ta ’ plejtlets (ċelloli tad- demm neċessarji biex jagħqad id- demm) • żieda f’ xi kimiċi (enżimi) li jsiru fil- fwied. im
• internal bleeding in the brain or abdomen • anxiety or confusion • headache ct
Effetti sekondarji rari Dawn jistgħu jaffettwaw sa 1 kull 1000 persuna li l
• fainting or dizziness, low blood pressure • du
• reazzjonijiet allerġiċi • anzjeta` jew konfużjoni na
drowsiness or tiredness • flushing • coughing ro
• uġigħ ta ’ ras • ħass ħażin jew sturdament, pressjoni baxxa • tħeddil jew għajja iċi
• leg pain or stomach pain • diarrhoea or constipation lP
• fwawar • sogħla ed
• indigestion • wound infection • increase in bilirubin (a substance produced by the liver) in the blood na
• ugigħ fir- riġlejn jew fl- istonku • dijareja jew stitikezza • indiġestjoni tm
• reduction in potassium in your blood. ici
• infezzjoni fil- ferita • żieda fil- bilirubin (sustanza li ssir fil- fwied) fid- demm • tnaqqis ta ’ potassium fid- demm tiegħek. ot
If you get side effects → Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you ed
Jekk ikollok effetti mhux mixtieqa od
M
→ Għid lit- tabib jew l- ispiżjar tiegħek jekk xi wieħed mill- effetti sekondarji jiggrava jew jagħtik fastidju jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett Pr
HOW TO STORE QUIXIDAR
KIF TAĦŻEN QUIXIDAR
• Keep out of the reach and sight of children • Do not freeze • Quixidar does not need to be kept in the fridge.
• Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal • Tiffriżahx • Quixidar m’ għandux għalfejn jinżamm fil- friġġ.
Do not use Quixidar: • after the expiry date stated on the label and carton
78 Tużax Quixidar: • wara d- data ta ’ skadenza li tidher fuq it- tabella u l- kaxxa. • jekk tara xi frak fis- soluzzjoni jew telf ta ’ kulur tas- soluzzjoni; • jekk tara illi s- siringa għandha xi ħsara; • jekk ftaħt siringa u ma tużahix minnufih.
73 • if you notice any particles in the solution, or if the solution is discoloured • if you notice that the syringe is damaged • if you have opened a syringe and you do not use it straightaway.
t Rimi ta ’ siringi
Disposal of syringes Medicines and syringes should not be disposed of via wastewater or household waste.
za Mediċini u siringi m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
FURTHER INFORMATION
aw X’ fih Quixidar
ris What Quixidar contains • The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection
• Is- sustanza attiva hija 1. 5 mg ta ’ fondaparinux sodium f’ 0. 3ml ta ’ soluzzjoni għall- injezzjoni.
ho • The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/ or sodium hydroxide to adjust the pH.
x • Is- sustanzi l- oħra huma sodium chloride, ilma għal injezzjonijiet, u hydrochloric acid u jew
ut Quixidar does not contain any animal products.
du sodium hydroxide biex jaġġustaw il- pH. ħa Quixidar ma fih l- ebda prodott ta ’ l- annimali.
ra What Quixidar looks like and contents of the pack
Id- dehra ta ’ Quixidar u d- daqs tal- pakkett: ’ g Quixidar huwa soluzzjoni għal injezzjoni ċara u mingħajr kulur.
e Quixidar is a clear and colourless solution for injection.
labra wara l- użu.
It is supplied in a pre-filled, single-use syringe fitted with an automatic safety system to help prevent needle stick injuries after use.
Hija disponibbli f’ pakketti ta ’ 2, 7, 10 u 20 siringi mimlija lesti (mhux id- daqsijiet kollha tal- pakketti jistgħu jkunu għall- skop kummerċjali). li l
It is available in ng packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed). lo Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur na
Marketing Authorization Holder: no
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom
Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, Renju Unit iċi
Manufacturer: ct
Il- manifattur:
Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France. du
Glaxo Wellcome Production, 1 rue de l' Abbaye, F- 76960 Notre Dame de Bondeville, Franza. ed
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’ tm
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web ro
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu ot od Pr
74 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
79 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
d ГлаксоСмитКлайн ЕООД
t za България ГлаксоСмитКлайн ЕООД
e Teл.: + 359 2 953 10 34
riz Teл.: + 359 2 953 10 34
ut Danmark GlaxoSmithKline Pharma A/S
Danmark GlaxoSmithKline Pharma A/ S
ra Tlf: + 45 36 35 91 00 info@glaxosmithkline.dk
x Tlf: + 45 36 35 91 00
T el: + 31 (0)30 6938100 nlinfo@gsk.com
Tel: + 31 (0) 30 6938100
Norge
Norge ħa
GlaxoSmithKline AS Tlf: + 47 22 70 20 00
GlaxoSmithKline AS Tlf: + 47 22 70 20 00
GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900
Eesti GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@ gsk. com
ct
li l
du
na
Τηλ: + 30 210 68 82 100 ro
Τηλ: + 30 210 68 82 100 iċi
España GlaxoSmithKline, S.A. lP
España GlaxoSmithKline, S. A. ed
Tel: + 34 902 202 700 es-ci@gsk.com na
Tel: + 34 902 202 700 es- ci@ gsk. com tm
France Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44 ici
France Laboratoire GlaxoSmithKline Tél.: + 33 (0) 1 39 17 84 44 ot
diam@gsk.com ed
diam@ gsk. com od
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 M
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0) 1 4955000 Pr
75 Italia GlaxoSmithKline S.p.A.
80 Italia GlaxoSmithKline S. p. A.
Κύπρος GlaxoSmithKline Cyprus Ltd Τηλ: + 357 22 89 95 01
t Τηλ: + 357 22 89 95 01
Sverige GlaxoSmithKline AB Tel: + 46 (0) 8 638 93 00 info.pro dukt@gsk.com
Tel: + 46 (0) 8 638 93 00
d e Latvija GlaxoSmithKline Latvia SIA
za info. produkt@ gsk. com
ris Tel: + 371 7312687 lv-epasts@gsk.com
riz Latvija GlaxoSmithKline Latvia SIA Tel: + 371 7312687
ho Lietuva GlaxoSmithKline Lietuva UAB
customercontactuk@ gsk. com
ut Tel: + 370 5 264 90 00 info.lt@gsk.com
aw Lietuva GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info. lt@ gsk. com
no ct du ro lP na ici ed M
x du ħa ’ g im li l na iċi ed tm ot od Pr
76 Parts of the safety syringe
81 Partijiet tas- siringa ta ’ sikurezza
1 Rigid needle guard
Apparat protettiv riġidu tal- labra
2 Cap
Għatu
3 Plunger
Planġer
ed 4 Finger-grip
t za Manku għas- swaba
ris 5 Security sleeve
riz Tubu ta ’ sigurta`
ho Syringe BEFORE USE
Siringa QABEL L- UŻU
Syringe AFTER USE
Siringa WARA L- UŻU
ut STEP BY STEP GUIDE TO USING QUIXIDAR Instructions for use
aw x du ħa GWIDA PASS- PASS TA 'KIF TUŻA QUIXIDAR ’ g Istruzzjonijiet għall- użu im
Wash your hands thoroughly with soap and water and dry them with a towel.
Aħsel idejk sewwa b’ sapun u ilma u xxotta b’ xugaman.
Remove the syringe from the carton and check that: • the expiry date has not passed ct
Neħħi s- siringa mill- kaxxa u ċċekkja li: • d- data ta ’ skadenza m’ għadditx li l