qanastek/EMEA-V3 huggingface dataset:
• the solution is clear and colourless and doesn’t contain particles du
• s- soluzzjoni hija ċara w bla kulur u ma fihiex frak • s- siringa ma nfetħitx jew għandha xi ħsara na iċi
Sit or lie down in a comfortable position. ro
Agħżel post fil- parti t’ isfel ta ’ l- istonku (iż- żaqq), ta ’ l- inqas ed
Choose a place in the lower abdominal (tummy) area, at least 5 cm below your belly button (picture A). lP
Dan tm
This will help to reduce the discomfort at the injection site. na
jgħin biex inaqqas l- uġigħ fis- sit ta ’ l- injezzjoni.
If injecting in the lower abdominal area is not possible, ask your nurse or doctor for advice. ici
Jekk mhux possibli li tinjetta fl- istonku, ikkonsulta ma ’ l - infermiera jew tabib tiegħek għall- parir. ot
Picture A
Figura A od
Clean the injection area with an alcohol wipe. ed M
Naddaf iż- żona ta ’ l- injezzjoni b’ biċċa bl- alkoħol Pr
Hold the body of the syringe firmly in one hand.
Żomm iċ- ċilindru tas- siringa b’ mod sod f’ id waħda.
Discard the plunger cap.
Neħħi l- għatu li jipproteġi l- planġer billi tiġbdu (figura B) Armi l- għatu tal- planġer.
Picture B
t za Figura B
77 6.
riz 6.
Remove the needle guard, by first twisting it and then pulling it in a straight line away from the body of the syringe (picture C).
Neħħi l- apparat protettiv tal- labra, billi l- ewwel iddawwar imbagħad tiġbdu f’ linja dritta lil hinn miċ- ċilindru
Discard the needle guard.
to tas- siringa (figura C).
Do
aw Nota importanti • Tmissx il- labra u ara li ma tiġix f’ kuntatt ma ’ xi superfiċi qabel l- injezzjoni.
d not try to r emove this air bubble before making the Picture C
x • Huwa normali illi jkun hemm bużżieqa ta ’ l- arja
e injection - you may lose some of the medicine if you do.
Tippruvax tneħħi din il- bużżieqa ta ’ l- arja qabel ma tagħmel l- injezzjoni sabiex tkun żgur li ma titlef xejn mill- prodott. ħa
Hold the fold between the thumb and the forefinger during the entire injection (picture D).
Oqros bil- mod il- ġilda mnaddfa sabiex tagħmel tinja. ’ g Żomm it- tinja bejn is- saba ’ l- kbir u l- werrej matul l- injezzjoni kollha (figura D) im
ut ra Pictur e D
Figura D li l
Hold the syringe firmly by the finger grip. ng Insert the full length of the needle at right angles into the skin fold (picture E). lo Picture E no
Daħħal it- tul kollu tal- labra b’ mod perpendikulari (b’ angolu na
Inject ALL of the contents of the syringe by pressing down on the plunger as far as it goes.
Injetta il- kontenut KOLLU tas- siringa billi tagħfas il - planġer ‘ l isfel it- tul tiegħu kollu.
This will activate the automatic needle protection system (picture F). ct du
awtomatika għall- protezzjoni tal- labra (figura F). ot
Release the plunger and the needle will automatically withdraw from the skin and go back into the security sleeve where it will be locked permanently (picture G). na ici
ġilda u tidħol lura għal ġot- tubu ta ’ sigurtà fejn tinqafel b’ mod permanenti (figura G).
Do not dispose of the used syringe in the household waste.
83 Tarmix is- siringa użata fl- iskart domestiku.
M
Armiha wżata kif qallek it- tabib jew l- ispiżjar tiegħek.
78 PACKAGE LEAFLET:
t za riz to aw x du ħa ’ g im li l na iċi ed tm ot od Pr
INFORMATION FOR THE USER
84 FULJETT TA ’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
Quixidar 2.5 mg/0.5 ml solution for injection fondaparinux sodium
Quixidar 2. 5mg/ 0. 5ml soluzzjoni għall- injezzjoni fondaparinux sodium
d • If you hav e any further questions, ask your doctor or pharmacist.
Jista jkollok bżonn terġa taqrah.
e • This medicine has been prescribed for you personally.
za • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek • Din il- mediċina ġiet mogħtija lilek personalment.
It may harm them, even if their symptoms seem to be the same as yours.
Tista ’ tagħmlilhom
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 il- ħsara, anki jekk s- sintomi tagħhom jidhru l- istess 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.
1.
to F’ dan il- fuljett:
ut 2.
aw 1.
Before you use Quixidar 3.
Qabel ma tuża Quixidar 3.
How to use Quixidar
Kif għandek tuża Quixidar 4.
ra 4.
x 5.
How to stor e Quixidar
Kif taħżen Quixidar
e 6.
du 6.
Further information
Aktar tagħrif ħa 1.
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 tgħin biex tipprevjeni l- formazzjoni ta ’ għoqiedi tad- demm fil- vini u arterji (aġent antitrombotiku). im
Quixidar contains a synthetic substance called fondaparinux sodium.
Quixidar fih sustanza sintetika msemmija fondaparinux sodium.
This stops a clotting factor Xa (“ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from ct
Din twaqqaf fattur għat- tagħqid tad - demm Xa ‘ għaxra- A ’ milli jaħdem fid- demm, u għalhekk tipprevjeni l- iżvilupp ta ’ emboli mhux li l
forming in the blood vessels. du
mixtieqa (trombożi) fil- vini u arterji tad- demm.
Quixidar is used to: • 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 ro
• għall- prevenzjoni tal- formazzjoni ta ’ emboli fil- vini u arterji tad- demm tar- riġlejn jew pulmun wara kirurġija ortopedika, bħal kirurġija fil- ġenb jew fl- irkoppa jew wara kirurġija fl- addomenu iċi
• prevent the formation of blood clots during and shortly after a period of restricted mobility due to acute illness lP
• biex tevita l- formazzjoni ta ’ emboli waqt u ftit wara l- perjodu ta ’ mobilita` restritta minħabba mard akut • għat- trattament ta ’ ċerti tipi ta ’ attakk tal- qalb u anġina severa (uġigħ minħabba li jidjiequ l - ed
• treat some types of heart attack and severe angina (pain caused by narrowing of the arteries in the heart). na
arterji fil- qalb). tm
BEFORE YOU USE QUIXIDAR ici
QABEL MA TUŻA QUIXIDAR
Do not use Quixidar: ed
Tużax Quixidar: ot
• if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of Quixidar • if you are bleeding excessively M
• jekk inti allerġiku (tbati minn sensittività eċċessiva) għal fondaparinux sodium jew sustanzi oħra ta ’ Quixidar 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 tbati minn xi mard serju ħafna tal- kliewi → Għid lit- tabib tiegħek jekk taħseb li xi wieħed minn dawn japplika għalik.
If they do, you must not use Quixidar.
Jekk dan huwa l- każ, m’ għandekx tuża Quixidar.
79 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:
It- tabib tiegħek għandu jkun jaf qabel ma tieħu Quixidar: • jekk għandek riskju ta ’ ħruġ ta ’ demm (emorraġija) mhux ikkontrollat, inkluż:
· recent bleeding in the brain (intracranial bleeding)
· ħruġ ta ’ demm riċenti fil- moħħ (fsada ġol- kranju)
d • if you ar e 75 years old or older
• jekk tbati minn mard serju fil- fwied; • jekk tbati minn mard fil- kliewi; • jekk għandek eta` ta ’ 75 sena jew iktar;
e • if you weigh less than 50 kg.
t • jekk tiżen inqas minn 50 kg
ris → Tell your doctor if any of these applies to you.
za → Għid lit- tabib tiegħek jekk xi wieħed minn dawn japplika għalik.
ho Quixidar has not been tested in children and adolescents under the age of 17 years.
riz Tfal Quixidar ma ’ ġiex ippruvat f’ tfal u addoloxxenti ta ’ taħt is- 17- il sena.
Using other medicines
to Meta tuża mediċini oħra:
ut Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra.
This includes medicines you bought without a prescription.
aw Dan jinkludi mediċini li xtrajt mingħajr riċetta.
Some other medicines may affect the way
Ċerti mediċini oħra jistgħu jkollhom effett fuq kif jaħdem Quixidar jew Quixidar jista 'jkollu effett fuqhom.
ra that Quixidar works or b e affected by Quixidar.
Tqala u Treddigħ
e Pregnancy and breast feeding Quixidar should not be prescribed to pregnant women unless clearly necessary.
x Quixidar m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
Breast-feeding is not ng recommended during treatment with Quixidar.
It- treddigħ mhux rakkomandat
Important information about some of the ingredients of Quixidar no
du waqt trattament b ’ Quixidar.
This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free. ct
Jekk inti tqila jew tissuspetta li inti tqila jew jekk qed tredda ’ → għarraf lit- tabib jew lill- ispiżjar tiegħek. ħa 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 ’ g essenzjalment mingħajr sodium im
HOW TO USE QUIXIDAR du
KIF GĦANDEK TUŻA QUIXIDAR
You should check with your doctor or pharmacist if you are not sure. ro
ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
The usual dose is 2.5 mg once a day, injected at about the same time each day. lP
Id- doża li ssoltu tingħata hija ta ’ 2. 5 mg darba kuljum, injettata kuljum bejn wieħed u ieħor fl - na
If you have kidney disease, the dose may be reduced to 1.5 mg once a day. na
Jekk tbati minn mard fil- kliewi, it- tabib tiegħek jista ’ jagħtik doża iżgħar ta ’ 1. 5 mg darba kuljum.
How Quixidar is given • Quixidar is given by injection under the skin (subcutaneously) into a skin fold of the lower abdominal area.
• 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 mimlijin lesti bid- doża eżatta li għandek bżonn.
There are different ici
Hemm tm
syringes for the 2.5 mg and 1.5 mg doses.
siringi differenti għad- doża ta ’ 2. 5 mg u dik ta ’ 1. 5 mg.
For step-by-step instructions please see over the page.
Għall- istruzzjonijiet pass- pass jekk jogħġbok ara fuq wara tal- paġna.
To treat some types of heart attack, a health professional may give the first dose into a ed
Għat- trattament ta ’ ċerta tipi ta ’ attakk tal- qalb, professjonist fil- qasam tas- saħħa għandu mnejn jagħti l- ewwel doża ġol- vina (mod intravenuż). • Tinjettax Quixidar ġo muskolu. ot
M
Tul taż- żmien tat- trattament b’ Quixidar od
How long Quixidar should 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.
Pr
If you inject too much Quixidar Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of bleeding.
Jekk tinjetta aktar milli suppost ta ’ Quixidar Ikkuntatja lit- tabib jew lill- ispiżjar tiegħek biex tieħu parir mill- aktar fis possibbli, minhabba riskju ikbar ta ’ ħruġ ta 'demm.
80 If you forget to take Quixidar • Take the dose as soon as you remember.
86 Jekk tinsa tieħu Quixidar: • Ħu d- doża malli 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.
M’ għandekx tieħu doża doppja biex tpatti għal doża li tkun insejt tieħu. • Jekk m’ intix ċert x’ għandek tagħmel, staqsi lit- tabib jew lill- ispiżjar 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 embolu fid -
d If you hav e any further questions about how to use this product, ask your doctor or pharmacist.
za Jekk għandek aktar mistoqsijiet dwar kif tuża dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
e ris 4.
riz 4.
ho Like all medicines, Quixidar can cause side effects, although not everybody gets them.
to Bħall- kull mediċina oħra, Quixidar jista ’ jkollu effetti sekondarji, għalkemm mhux kulħadd ikollu dawn l- effetti.
ut These may affect more than 1 in 100 people treated with Quixidar. • bleeding (for example from an ope ration site, an existing stomach ulcer, nosebleed, gums)
aw Effetti sekondarji komuni Dawn jistgħu jaffettwaw iżjed minn wieħed kull 100 persuna li qegħdin jirċievu trattament b’ Quixidar.
ra • ana emia (a reduction in the number of red blood cells)
x • ħruġ ta ’ demm (per eżempju mis- sit ta ’ operazzjoni, ulċera fl- istonku diġa ’ eżistenti, fġir l -
e Uncommon side effects These may affect up to 1 in 100 people treated with Quixidar. ng • bruising or swelling (oedema) • feeling sick or being sick (nausea or vomiting) lo • chest pain • breathlessness • rash or itchy skin no
du imnieħer, ħanek) • anemija (tnaqqis fin- numru taċ- ċelloli ħomor tad- demm). ħa Effetti sekondarji mhux komuni Dawn jistgħu jaffettwaw sa wieħed kull 100 persuna li qegħdin jirċievu trattament b’ Quixidar. ’ g • tbenġil jew nefħa (edima) • tħossok ħażin jew tkun ma tiflaħx (dardir, rimettar) im
• oozing from operation wound site • fever • reduction or increase in the number of platelets (blood cells necessary for blood clotting) ct
• uġigħ fis- sider • qtugħ ta ’ nifs • raxx jew ħakk fil- ġilda li l
• increase in some chemicals (enzymes) produced by the liver. du
• tnixxija mill- ferita ta ’ l- operazzjoni • deni na
Rare side effects These may affect up to 1 in 1000 people treated with Quixidar. ro
• nuqqas jew żieda fin- numru ta ’ plejtlets (ċelloli tad- demm neċessarji biex jagħqad id- demm) • żieda f’ xi kimiċi (enżimi) li jsiru fil- fwied. iċi
• allergic reaction • internal bleeding in the brain or abdomen lP
Effetti sekondarji rari Dawn jistgħu jaffettwaw sa wieħed kull 1000 persuna li qegħdin jirċievu trattament b’ Quixidar. ed
• anxiety or confusion • headache • fainting or dizziness, low blood pressure na
• reazzjonijiet allerġiċi • fsada interna fil- moħħ jew fl- addomenu • anzjeta` jew konfużjoni tm
• drowsiness or tiredness • flushing • coughing ici
• uġigħ ta ’ ras • ħass ħażin jew sturdament, pressjoni tad- demm baxxa • tħeddil jew għajja ot
• leg pain or stomach pain • diarrhoea or constipation ed
• fwawar • sogħla od
• indigestion • wound infection M
• ugigħ fir- riġlejn jew uġigħ fl- istonku • dijareja jew stitikezza • indiġestjoni Pr
• increase in bilirubin (a substance produced by the liver) in the blood • reduction in potassium in your blood
• infezzjoni ġol- ferita ta ’ l- operazzjoni • żieda fil- bilirubin (sustanza li ssir fil- fwied) fid- demm • tnaqqis tal- potassju fid- demm
If you get side effects → Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
87 → Għid lit- tabib jew lill- ispiżjar tiegħek jekk xi wieħed mill- effetti sekondarji jiggrava jew isir problematiku, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett.
• Keep out of the reach and sight of children • Do not freeze • Quixidar does not need to be kept in a fridge.
• Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use Quixi dar: • after the expiry date stated on the label and carton • if you notice any particles in the solution, or if the solution is discoloured
t • Tiffriżahx.
d • if you notic e that the syringe is damaged
za • Quixidar m’ għandux bżonn jinħażen fil- friġġ
e • if you have opened a syringe and you do not use it straightaway.
riz 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
ris Disposal of syringes:
to • jekk tara illi s- siringa għandha xi ħsara • jekk ftaħt siringa ma wżajtiex minnufih
Ask your
aw Rimi tas- siringi Il- mediċini u s- siringi m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
ho pharmacist how to dispose of medicines no longer required.
x Staqsi lill- ispiżjar tiegħek dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
ut ra 6.
du ħa. 6.
e • The active substance is 2.5 mg fondaparinux sodium in 0.5 ml solution for injection
X’ fih Quixidar ’ g • Is- sustanza attiva hija 2. 5 mg ta ’ fondaparinux sodium f’ 0. 5ml ta ’ soluzzjoni għall- injezzjoni. im
• ng The other ingredients are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust the pH. lo Quixidar does not contain any animal products. no
Is- sustanzi l- oħra huma sodium chloride, ilma għal injezzjonijiet, u hydrochloric acid u jew sodium hydroxide biex jaġġustaw il- pH. li l
What Quixidar looks like and contents of the pack Quixidar is a clear and colourless solution for injection.
Quixidar huwa soluzzjoni ċara u bla kulur għal injezzjoni.
It is available in ct
Hija fornita f’ siringa mimlija lesta, għall - użu ta ’ darba u mgħammra b’ sistema ta ’ sikurezza awtomatika sabiex tipprevjeni ferimenti bil- labra iċi
packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed). du
Hija disponibbli f’ pakketti ta ’ 2, 7, 10 u 20 siringi mimlija lesti (mhux id- daqsijiet kollha tal- pakketti jistgħu jkunu għall- skop kummerċjali). ed
Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur tm
Marketing Authorization Holder: ro
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom lP
Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, Renju Unit
Manufacturer:
L- manifattur: ot
Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France. na
Glaxo Wellcome Production, 1 rue de l' Abbaye, F- 76960 Notre Dame de Bondeville, Franza. od
This leaflet was last approved in ici
Dan il- fuljett kien approvat l- aħħar f ’ Pr
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu ed M
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu
82 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
88 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
ra Tlf: + 45 36 35 91 00 info@glaxosmithklin e.dk
x Tlf: + 45 36 35 91 00
Tel: + 31 (0)30 6938100 nlinfo@gsk.com
Tel: + 31 (0) 30 6938100
Norge
’ g
ngGlaxoSmithKline AS Tlf: + 47 22 70 20 00 produkt.info@gsk.com
GlaxoSmithKline AS Tlf: + 47 22 70 20 00
83 Italia GlaxoSmithKline S.p.A.
89 Italia GlaxoSmithKline S. p. A.
Κύπρος GlaxoSmithKline Cyprus Lt d Τηλ: + 357 22 89 95 01
t Τηλ: + 357 22 89 95 01
Sv erige GlaxoSmithKline AB Tel: + 46 (0) 8 638 93 00
Tel: + 46 (0) 8 638 93 00
d info.produkt@gsk.com
za info. produkt@ gsk. com
ris GlaxoSmithKline Latvia SIA Tel: + 371 7312687
riz Latvija GlaxoSmithKline Latvia SIA Tel: + 371 7312687
ho lv-epasts@gsk.com
to lv- epasts@ gsk. com
ut GlaxoSmithKlin e Lietuva UAB Tel: + 370 5 264 90 00
aw Lietuva GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info. lt@ gsk. com
e ng lo no ct du ro lP na ici ed M
x du ħa ’ g im li l na iċi ed tm ot od Pr
84 Parts of the safety syringe
90 Il- partijiet tas- siringa ta ’ sikurezza
ut STEP BY STEP GUIDE TO USING QUIXIDAR Instructions for use
aw x du ħa GWIDA PASS- PASS BIEX 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 w ixxotthom b’ xugaman.
Remove the syringe from the carton and check that: • the expiry date has not passed ct
Neħħi s- siringa minn ġol- kaxxa w ara li: li l
• the solution is clear and colourless and doesn’t contain particles du
• d- data ta ’ skadenza m’ għadditx • s- soluzzjoni hija ċara w bla kulur u ma fihiex frak na
• the syringe has not been opened or damaged
• s- siringa ma nfetħitx jew għandha xi ħsara iċi
Sit or lie down in a comfortable position. ro
Poġġi jew imtedd f’ pożizzjoni komda. ed
Choose a place in the lower abdominal (tummy) area, at least 5 cm below your belly button (picture A). lP
Agħżel post fil- parti t’ isfel ta ’ l- istonku, ta ’ l- inqas 5 cm miż - żokra (figura A).
Alternate the left and right side of the lower abdominal area at each injection.
parti t’ isfel ta ’ l- istonku ma ’ kull injezzjoni.
This will help to reduce the discomfort at the injection site. na
Dan jgħin biex inaqqas l- iskomfort fis- sit ta ’ l- injezzjoni.
If injecting in the lower abdominal area is not possible, ask your nurse or doctor for advice. ici
infermiera jew tabib tiegħek għal parir. od
Picture A
Figura A Pr
Clean the injection area with an alcohol wipe. ed M
Naddaf iż- żona ta ’ l- injezzjoni b’ biċċa bl- alkoħol
85 6.
riz 6.
d not try to remove this air bubble before making the Picture C
x • Huwa normali illi jkun hemm bużżieqa ta ’ l- arja
e injection - you may lose some of the medicine if you do.
Tippruvax tneħħi din il- bużżieqa ta ’ l- arja qabel ma tagħmel l- injezzjoni – tista titlef ftit mill- mediċina jekk tagħmel dan. ħa
Hold th e fold between the thumb and the forefinger during the entire injection (picture D).
Oqros bil- mod il- ġilda mnaddfa sabiex tagħmel tinja. ’ g Żomm it- tinja bejn is- saba ’ l- kbir u l- werrej matul l- injezzjoni kollha (figura D) im
ut ra Picture D
Figura D li l
Hold the syringe firmly by the finger grip. ng Insert the full length of the needle at right angles into the skin fold (picture E). lo Picture E no
Daħħal it- tul kollu tal- labra b’ mod perpendikulari (b’ angolu ta ’ 90º) fit- tinja tal- ġilda (figura E). iċi
Do not dispose of the used syringe in the household waste.
92 Tarmix is- siringa wżata ma ’ l- iskart domestiku.
M
Armiha kif għallek it- tabib jew l- ispiżjar tiegħek.
86 PACKAGE LEAFLET
t za riz to aw x du ħa ’ g im li l na iċi ed tm ot od Pr
Quixidar 5 mg/0.4 ml solution for injection.
93 FULJETT TA ’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
Quixidar 7.5 mg/0.6 ml solution for injection Quixidar 10 mg/0.8 ml solution for injection Fondaparinux sodium
Quixidar 5mg/ 0. 4ml soluzzjoni għall- injezzjoni Quixidar 7. 5mg/ 0. 6ml soluzzjoni għall- injezzjoni Quixidar 10mg/ 0. 8ml soluzzjoni għall- injezzjoni Fondaparinux sodium
Rea d all of this leaflet carefully before you start using this medicine. • Keep this leaflet.
t za Aqra dan il- fuljett kollu qabel tibda tuża din il- mediċina • Żomm dan il- fuljett.
You may n eed to read it again.
Jista jkollok bżonn terġa taqrah.
d • If you have any further questions, ask your doctor or pharmacist.
riz • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek • Din il- mediċina ġiet mogħtija lilek personalment.
e • This medicine has been prescribed for you personally.
M’ għandekx tgħaddiha lil persuni oħra.
It may harm them, even if their symptoms seem to be the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk is- sintomi tagħhom jidhru qishom bħal tiegħek.
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.
to • 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:
aw F’ dan il- fuljett:
What Quixidar is and what it is used for
Qabel ma tuża Quixidar
Before you use Quixidar 3.
x 3.
How to use Quixidar
Kif għandek tuża Quixidar
ra 4.
du 4.
Possibl e side effects 5.
Kif taħżen Quixidar 6.
How to store Quixidar
Aktar tagħrif ħa ’ g 1.
Further information
X’ INHU QUIXIDAR U GĦALXIEX JINTUŻA im
WHAT QUIXIDAR IS AND WHAT IT IS USED FOR ng lo Quixidar is a medicine that treats or helps to prevent blood clots from forming in the blood vessels (an antithrombotic agent). no
Quixidar hu mediċina li tittratta jew tghin biex tipprevjeni l- formazzjoni ta ’ għoqiedi tad- demm fil - vini u arterji (aġent antitrombotiku). li l
This stops a clotting factor Xa (“ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from ct
Din twaqqaffattur tat- tagħqid tad - demm Xa ("għaxra – A") milli jagħmel effett fid- demm, u b’ hekk tipprevjeni l- iżvilupp ta ’ għoqiedi tad- demm mhux mixtieqa (trombożi) fil- vini u arterji. na
forming in the blood vessels. du
Quixidar jintuża bħala trattament f’ pazjenti li għandhom għoqda tad- demm fil- vini u arterji iċi
Quixidar is used to treat patients with a blood clot in the blood vessels of their legs (deep vein thrombosis) and/or lungs (pulmonary embolism). ro
ta ’ riġlejhom (trombożi f’ vina fonda) u/ jew fil- pulmun (emboliżmu pulmonari). ed
BEFORE YOU USE QUIXIDAR lP
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 na
Tużax Quixidar: • jekk inti allerġiku (tbati minn sensittività eċċessiva) għal fondaparinux sodium jew sustanzi oħra ta ’ Quixidar • jekk int tinfasad b’ mod eċċessiv ot
• if you have a bacterial heart infection • if you have severe kidney disease. ed
• jekk għandek minn infezzjoni batterika tal- qalb • jekk tbati minn indeboliment sever tal- kliewi od
→ Tell your doctor if you think any of these applies to you.
→ Għid lit- tabib tiegħek jekk taħseb li xi waħda minn dawn tapplika għalik.
If they do, you must not use Quixidar.
Jekk iva, m’ għandekx tuża Quixidar.
Your doctor needs to know before you take Quixidar: • if you have a risk uncontrolled bleeding (haemorrhage) including:
It- tabib tiegħek għandu jkun jaf qabel ma tieħu Quixidar: • jekk għandek riskju ta ’ ħruġ ta ’ demm (emorraġija) mhux ikkontrollat, li tinkludi:
• if you have severe liver disease • if you have kidney disease
• jekk tbati minn mard serju fil- fwied; • jekk tbati minn indeboliment tal- 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
87 • if you are 75 years old or older. → Tell your doctor if any of these applies to you.
t Tfal
Children Quixidar has not been tested in children and adolescents under the age of 17 years.
za Quixidar ma ġiex ittestjat fi tfal u addoloxxenti ta ’ taħt is- 17- il sena.
Using other medicines Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any.
Għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu xi mediċini oħra, jew ħadt dan l- aħħar.
This inclu des medicines you bought without a prescription.
Dawn jinkludu anki mediċini li tkun xtrajt mingħajr riċetta.
Som e other medicines may affect the way
Ċerti mediċini oħrajn jistgħu jaffettwaw
d that Quixidar works or be affected by Quixidar.
to il- mod li jagħmel effett Quixidar jew ikunu affettwati bi Quixidar.
ris 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.
ho breast feeding: → tell your doctor or pharmacist.
Jekk inti tqila jew taħseb li tista ’ tkun tqila, jew jekk qed tredda: → għarraf lit- tabib jew l- ispiżjar tiegħek.
ut Important information about som e of the ingredients of Quixidar This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially
x 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 essenzjalment mingħajr sodium ħa 3.
HOW TO USE QUIXIDAR ng Always use Quixidar exactly as your doctor has told you.
KIF GĦANDEK TUŻA QUIXIDAR ’ g Dejjem għandek tuża Quixidar skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure. lo Your weight Below 50 kg
Dejjem għandek taċċerta ruħek mat- tabib jew im
no
li l
Usual dose 5 mg once a day
Doża li s- soltu tingħata
Between 50 kg and 100 kg Over 100 kg
Taħt 50 kg Bejn 50 kg u 100 kg Il fuq minn 100 kg
7.5 mg once a day 10 mg once a day.
5 mg darba kuljum 7. 5 mg darba kuljum 10 mg darba kuljum.
This dose may be reduced to 7.5 mg once a day if you have moderate kidney
Din id- doża tista ’ titnaqqas
disease. du
għal 7. 5mg darba kuljum jekk għandek mard moderat tal- kliewi. iċi
You should inject at about the same time each day. ro
Għandek tieħu l- injezzjoni bejn wieħed u ieħor l- istess ħin kuljum. ed
There are different lP
Kif jingħata Quixidar • Quixidar jingħata permezz ta ’ injezzjoni taħt il- ġilda (b’ mod subkutanju) f’ tinja tal- ġilda tal- parti tm
syringes for the 5 mg, 7.5 mg and 10 mg doses.
t’ isfel ta ’ l- istonku.
For step-by-step instructions please see over the page. na
Hemm siringi differenti għad- dożi ta ’ 5mg, 7. 5mg u 10mg.
• Do not inject Quixidar into muscle.
Għal istruzzjonijiet li juru kollox pass - pass jekk jogħġbok ara l- paġna ta ’ wara. • Tinjettax Quixidar ġo muskolu (b’ mod intramuskolari). ot
How long should Quixidar be taken for ici
Kemm għandek iddum tieħu Quixidar od
You should continue Quixidar treatment for as long as your doctor has told you, since Quixidar prevents development of a serious condition. ed
Pr
If you inject too much Quixidar Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of M
Ikkuntatja it- tabib jew spiżjar tiegħek għal parir kemm jista’ jkun malajr minhabba riskju ikbar ta ’ ħruġ ta ’ demm.
bleeding.
Jekk tinsa tuża Quixidar:
If you forget to take Quixidar • Take the dose as soon as you remember.
95 • Ħu d- doża mill- ewwel kif tiftakar.
88 Don’t stop using Quixidar without advice If you stop the treatment before your doctor told you to, the blood clot may not be treated properly and you may also be at risk of developing a new blood clot in a vein of your leg or in the lung.
Jekk twaqqaf it- trattament qabel ma jgħidlek it- tabib, inti l- għoqda tad- demm tista ’ ma tkunx ittrata sew u inti jista ’ jkollok ukoll ir- riskju li tiżviluppa għoqda tad- demm ġdida f’ vina tar- riġel jew fil -
If you have any further questions about how to use this product, ask your doctor or pharmacist.
za Jekk għandek aktar mistoqsijiet dwar kif tuża dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
d Like all medicines, Quixidar can cause side effects, although not everybody gets them.
to Bħall- kull mediċina oħra, Quixidar jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
ris These may affect more than 1 in 100 people treated with Quixidar. • bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, bruising)
aw 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 - imnieħer, tbenġil).
ho Uncommon side effects These may affect up to 1 in 100 people treated with Quixidar.
x du Effetti sekondarji mhux komuni Dawn jistgħu jaffettwaw sa wieħed kull 100 persuna trattati bi Quixidar: • nefħa (edima) ħa • uġigħ ta ’ ras • uġigħ ’ g • tħossok imqalla jew titqalla (dardir jew rimettar) • numru baxx ta ’ ċelloli ħomor fid- demm (anemija) im
ra • pain • feeling sick or being sick (nausea or vomiting)
• numru baxx ta ’ plejtlets (ċelloli tad- demm neċessarji biex jagħqad id- demm) • żieda f’ xi kemikali (enżimi) li jsiru fil- fwied. li l
e • low number of red blood cells (anaemia) • low number of platelets (blood cells necessary for blood clotting) ng • increase in some chemical (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
Effetti sekondarji rari Dawn jistgħu jaffettwaw sa 1 kull 1000 persuna trattati bi Quixidar: na
• internal bleeding in the brain, liver or abdomen • rash • dizziness ct
• reazzjonijiet allerġiċi • ħruġ ta ’ demm internament fil- moħħ, fwied jew l- addomenu • raxx iċi
• pain and swelling at injection site • high number of platelets (blood cells necessary for blood clotting) du
• sturdament • uġigħ u nefħa fil- post ta ’ injezzjoni ed
• increase in the amount of non-protein nitrogen in the blood ro
• numru għoli ta ’ plejtlets (ċelloli tad- demm neċessarji biex jagħqad id- demm) • żieda fin- nitroġenu mhux minn proteini fid- demm. tm
If you get side effects → Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you lP
Jekk ikollok effetti mhux mixtieqa →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. ot
• Quixidar does not have to be kept in the fridge. ed
KIF TAĦŻEN QUIXIDAR od
Do not use Quixidar: • after the expiry date stated on the label and carton • M
Pr
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.
Tużax Quixidar: • wara d- data ta ’ skadenza li tidher fuq it- tabella u l- kaxxa • jekk tara xi frak fis- soluzzjoni jew jekk is- soluzzjoni titlef il- kulur • jekk tara illi s- siringa għandha xi ħsara; • jekk ftaħt siringa u ma tużahiex minnufih.
Medicines and syringes should not be disposed of via wastewater or household waste.
96 Rimi ta ’ siringi Mediċini u siringi m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
89 6.
. 6.
What Quixidar contains Th e active substance is: • 5 mg fondaparinux sodium in 0.4 ml solution for injection • 7.5 mg fondaparinux sodium in 0.6 ml solution for injection • 10 mg fondaparinux sodium in 0.8 ml solution for injection
riz • 5 mg ta ’ fondaparinux sodium f’ 0. 4 ml ta ’ soluzzjoni għall- injezzjoni. • 7. 5 mg ta ’ fondaparinux sodium f’ 0. 6 ml ta ’ soluzzjoni għall- injezzjoni. • 10 mg ta ’ fondaparinux sodium f’ 0. 8 ml ta ’ soluzzjoni għall- injezzjoni.
d The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/or sodium
to Is- sustanzi l- oħra huma sodium chloride, ilma għal injezzjonijiet, u hydrochloric acid u jew
e hydroxide to adjust the pH.
aw sodium hydroxide biex jaġġustaw il- pH.
ris Quixidar does not contain any animal products.
Quixidar ma fih l- ebda prodott ta ’ l- annimali.
ho What Quixidar looks like and contents of the pack Quixidar is a clear and colourless to slightly yellow sol ution for injection.
du Quixidar huwa soluzzjoni għal injezzjoni ċara, mingħajr kulur jew tagħti xi ftit fl- isfar.
It is supplied in a pre-filled syringe fitted with an automatic safety system to help prevent needle stick injuries after use.
Huwa fornit f’ siringa mimlija lesta, għall- użu ta ’ darba u mgħammra b’ sistema ta ’ sikurezza awtomatika sabiex tipprevjeni ferimenti bil- labra wara l- użu. ħa Huwa disponibbli f’ pakketti ta ’ 2, 7, 10 u 20 siringi mimlija lesti (mhux id- daqsijiet kollha tal - pakketti jistgħu jkunu għall- skop kummerċjali). ’ g im
ut It is availabl e in packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed).
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
ra Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq: li l
e Marketing Authorization Holder: ng Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom
Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, Renju Unit
Manufacturer: lo Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France. no
Glaxo Wellcome Production, 1 rue de l' Abbaye, F- 76960 Notre Dame de Bondeville, Franza. iċi
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web ct
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - ed
site: http://www.emea.europa.eu du ro lP na ici ed M
mediċini (EMEA) http: // www. emea. europa. eu tm ot od Pr
90 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
97 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
N ederland GlaxoSmithKline BV
Nederland GlaxoSmithKline BV
91 Italia GlaxoSmithKline S.p.A.
98 Italia GlaxoSmithKline S. p. A.
Sverige GlaxoSmithKline AB Tel: + 46 (0) 8 638 93 00 info.produkt@gsk.com
Tel: + 46 (0) 8 638 93 00
ut T el: + 370 5 264 90 00 info.lt@gsk.com
aw Lietuva GlaxoSmithKline Lietuva UAB Tel: + 370 5 264 90 00 info. lt@ gsk. com
92 Parts of the safety syringe
99 Partijiet tas- siringa ta ’ sikurezza
1 Rigi d needle guard
Apparat protettiv riġidu tal- labra
d 4 Finger-grip
t za Manku għas- swaba
e 5 Security sleeve
riz Tubu ta ’ sigurta`
ris Syri nge BEFORE USE
Siringa QABEL L- UŻU
Syring e AFTER USE
Siringa WARA L- UŻU
ho ut STEP BY STEP GUIDE TO USING QUIXIDAR
aw x du ħa GWIDA PASS- PASS TA ’ KIF TUŻA ARIXTRA ’ g Istruzzjonijiet għall- użu im
Wash your hands thoroughly with soap and water and dry them with a towel. lo 2.
Neħħi s- siringa minn ġol- kaxxa w ara li: • d- data ta ’ skadenza m’ għadditx li l
• the expiry date has not passed • the solution is clear and colourless to slightly yellow and doesn’t contain particles • the syringe has not been opened or damaged ct
• s- soluzzjoni hija ċara w bla kulur u ma fihiex frak • s- siringa ma nfetħitx jew għandha xi ħsara na iċi
Sit or lie down in a comfortable position. du
Poġġi jew imtedd f’ pożizzjoni komda.
Choose a place in the lower abdominal (tummy) area, at least 5 cm below your belly button (picture A).
Agħżel post fil- parti t’ isfel ta ’ l- istonku, ta ’ l- inqas 5 cm miż - ed
at each injection.
żokra (figura A).
This will help to reduce the discomfort at the injection site. lP
Dan jgħin biex tm
If injecting in the lower abdominal area is not possible, ask your nurse or doctor for advice.
Jekk mhux possibli li tinjetta fl- istonku, ikkonsulta ma ’ l - infermiera jew tabib tiegħek għal parir ot
Picture A na
Figura A od
Clean the injection area with an alcohol wipe. ici ed
Naddaf iż- żona ta ’ l- injezzjoni b’ biċċa bl- alkoħol Pr
Remove the cap that protects the plunger by pulling it off M
Neħħi l- għatu li jipproteġi l- planġer billi tiġbdu (figura B) Armi l- għatu tal- planġer.
(picture B).
t za Figura B
Picture B 6.
riz 6.
93 Discar d the needle guard.
to tas- siringa (figura C).
Important not e • Do not touch the needle or allow it to touch any surface before the injection. • It is normal to see a small air bubble in this syringe.
aw Nota importanti • Tmissx il- labra u ara li ma tiġix f’ kuntatt ma ’ xi superfiċi qabel l- injezzjoni.
Do not try to remove this air bubble before making the injection - you may lose some of the medicine if you do.
Tippruvax tneħħi din il- bużżieqa ta ’ l- arja qabel ma tagħmel l- injezzjoni – tista ’ titlef xi ftit mill- mediċina jekk tagħmel hekk. ħa
e ris 7.
7.
Hold the fold between the thumb and the forefinger
Oqros bil- mod il- ġilda mnaddfa sabiex tagħmel tinja. ’ g Żomm it- tinja bejn is- saba ’ l- kbir u l- werrej matul l- injezzjoni kollha (figura D) im
ut Picture D
Figura D li l
Hold the syringe firmly by the finger grip.
8. Żomm is- siringa soda mill- manku għas- swaba. na
e fold (picture E).
Daħħal it- tul kollu tal- labra b’ mod perpendikulari (b’ angolu ta ’ 90º) fit- tinja tal- ġilda (figura E). iċi
Picture E
Figura E ed
Inject ALL of the contents of the syringe by pressing no
Injetta il- kontenut KOLLU tas- siringa billi tagħfas il - planġer ‘ l isfel it- tul tiegħu kollu.
Picture F ro
Figura F od
Release the plunger and the needle will automatically withdraw from the skin and go back into the security sleeve lP
Eħles il- planġer u l- labra awtomatikament toħroġ mill - Pr
where it will be locked permanently (picture G). na ici
ġilda u tidħol lura għal ġot- tubu ta ’ sigurtà fejn tinqafel b’ mod permanenti (figura G).
Do not dispose of the used syringe in the household waste.
Armiha kif qallek it- tabib jew l- ispiżjar tiegħek.
M
t za riz to aw x du ħa ’ g im li l na iċi ed tm ot od Pr
94
102
ANNEX
ANNESS IV
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU MPLIMENTATI MILL- ISTATI MEMBRI KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU MPLIMENTATI MILL- ISTATI MEMBRI
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
L- Istati Membri għandhom jiżguraw li l- kundizzjonijiet u r- restrizzjonijiet kollha fir- rigward tas - sigurtà u l- użu effettiv tal- prodott mediċinali deskritti hawn taħt huma implimentati:
The Member States shall agree the details of a Patient Alert Card (PAC) with the MAH, who must provide this PAC directly to the pharmacy with each Ranexa shipment.
L- Istati Membri għandhom jaqblu fuq id- dettalji tal- Kard ta ’ Twissija tal- Pazjent (PAC) mad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, li għandu jipprovdi dan il- PAC direttament lill- ispiżerija ma ’ kull kunsinna ta ’ Ranexa.
The Pharmacist should be requested to distribute a PAC to each patient at the time Ranexa is dispensed.
L- ispiżjar għandu jkun mitlub li jqassam PAC lil kull pazjent meta jitqassam Ranexa.
The PAC must include the following key messages:
Il- PAC għandu jinkludi l- messaġġi ewlenin li ġejjin:
Health Care Professional information The PAC should include the following information for the healthcare professional information regarding Ranexa: • To refer to the Ranexa SPC prior to prescribing any medications to the patient, as there are potential drug interactions which should be taken into consideration. • Ranexa is contraindicated in patients taking: • Potent CYP3A4 inhibitors (e. g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) • Class Ia (e. g. quinidine) or Class III (e. g. dofetilide, sotalol) antiarrhythmics other than amiodarone
Informazzjoni għall- professjonisti fil- kura tas- saħħa Il- PAC għandu jinkludi l- informazzjoni li ġejja għall- professjonisti tal- kura tas- saħħa fir- rigward ta ’ Ranexa: • li ssir referenza għall- Sommarju tal- Karatteristiċi tal- Prodott ta ’ Ranexa qabel il- preskrizzjoni ta ’ kwalunkwe mediċina lill- pazjent, minħabba li hemm interazzjonijiet potenzjali tal- mediċina li għandhom jitqiesu. • Ranexa mhuwiex rakkomdanat f’ pazjenti li qegħdin jieħdu: • Inibituri CYP3A4 qawwijin (eż. itraconazole, ketoconazole, voriconazol, posaconazol, inibituri tal- protease tal- HIV, clarithromycin, telithromycin, nefazodone) • Antiarrittmiċi ta ’ Kategorija Ia (eż. quinidine) jew ta ’ Kategorija III (eż., dofetilide, sotalol) għajr amiodarone
• A dose reduction of Ranexa may be needed in combination with: • Moderate CYP3A4 inhibitors (e. g. diltiazem, erythromycin, fluconazole) • P-gp inhibitors (e. g. ciclosporin, quinidine, verapamil)
• Jista ’ jkun hemm bżonn ta ’ tnaqqis fid- doża ta ’ Ranexa f’ kombinazzjoni ma ’: • Inibituri moderati ta ’ CYP3A4 (eż., diltiazem, erythromycin, fluconazole) • Inibituri P- gp (eż., ciclosporin, quinidine, verapamil)
• Caution should be exercised when prescribing Ranexa to patients: • Taking certain other drugs mentioned in the product information • With certain other risk factors listed in the product information
• Għandha tiġi eżerċitata l- kawtela meta Ranexa jingħata lill- pazjenti: • li jkunu qegħdin jieħdu ċerti mediċini oħrajn imsemmija fl- informazzjoni dwar il- prodott • b’ ċerti fatturi ta ’ riskju oħrajn elenkati fl- informazzjoni dwar il- prodott
• Inform the patient about the potential for an interaction with other prescribed medicinal products and to contact his/ her doctor in case of dizziness, nausea or vomiting.
• Informa lill- pazjent dwar il- potenzjal għal interazzjoni ma ’ prodotti mediċinali oħrajn li jingħataw b’ riċetta u li jiġi kkuntattjat/ a it- tabib/ a tiegħu/ tagħha fil- każ ta ’ sturdament, nawsea jew rimettar.
Patient information The PAC should include the following information for the patient: • That the card should be shown to any doctor involved in their treatment • That prior to Ranexa treatment the patient should tell their doctor if they have any of the following: • Kidney problems • Liver problems • Have ever had an abnormal electrocardiogram (ECG) • Is taking medications to treat epilepsy, bacterial or fungal infections, HIV infection, depression or heart rhythm disorders • Is taking the herbal remedy St John’ s Wort • Is taking allergy medicines
Informazzjoni għall- pazjent Il- PAC għandu jinkludi l- informazzjoni li ġejja għall- pazjent: • Li l- kard għandha tintwera lil kwalunkwe tabib involut fit- trattament tagħhom • Li qabel trattament b’ Ranexa, il- pazjent għandu jgħid lit- tabib tiegħu jekk huwa għandux xi ħaġa minn dawn li ġejjin: • problemi fil- kliewi • problemi fil- fwied • qatt kellu xi elettrokardjogramma (ECG) anormali • jekk hux qiegħed jieħu mediċina biex jikkura epilepsija, infezzjonijiet batterjali jew fungali, infezzjoni ta ’ l- HIV, depressjoni jew disturbi fir- rittmu tal- qalb • jekk hux qiegħed jieħu r- rimedju erbali St John’ s Wort • jekk hux qiegħed jieħu mediċini kontra l- allerġiji
• That during treatment with Ranexa the patient should: • Not drink Grapefruit Juice • Call their doctor if they feel dizzy or sick, become sick or experience any unexpected symptoms after starting Ranexa.
• Li matul il- kura b’ Ranexa, il- pazjent għandu: • Ma jixrobx meraq tal- grapefruit • Isejjaħ lit- tabib tiegħu jekk iħossu stordut, imdardar jew jirremetti jew jesperjenza xi sintomu mhux mistenni wara li jibda Ranexa.
• To refer to the Ranexa package leaflet for more information. • To ensure to take a list of all their other medicines with them at any visit to the health care professional.
• Biex jirreferi għall- fuljett ta ’ tagħrif ta ’ Ranexa għal aktar informazzjoni.
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What is Ranexa?
X’ inhu Ranexa?
Ranexa is a medicine that contains the active substance ranolazine.
Ranexa huwa mediċina li fiha s- sustanza attiva ranolazine.
It is available as oval prolonged- release tablets (blue:
Huwa disponibbli bħala pilloli ovali li jerħu l- mediċina bil- mod (koħol:
375 mg; orange:
375 mg; oranġjo:
500 mg; green:
500 mg; ħodor:
750 mg). ‘ Prolonged release ’ means that ranolazine is released slowly from the tablet over a few hours.
Li jerħu l- mediċina bil - mod ifisser li ranolazine jintreħa bil- mod mill- pillola fuq perjodu ta 'ftit sigħat.
What is Ranexa used for?
Għal xiex jintuża Ranexa?
Ranexa is used to treat the symptoms of stable angina pectoris (chest pain caused by reduced blood flow to the heart).
Ranexa jintuża bħala trattament għas- sintomi ta ’ anġina pectoris stabbli (uġigħ fis- sider ikkawżat minn tnaqqis ta ’ fluss tad- demm lejn il- qalb).
It is used as an ‘ add-on ’ to existing treatment in patients whose disease is not adequately controlled by other medicines for angina pectoris, such as beta-blockers or calcium antagonists, or in patients who cannot take these medicines.
Jintuża bħala trattament ‘ addizzjonali ’ flimkien ma ’ trattament eżistenti f’ pazjenti li l- marda tagħhom ma hijiex ikkontrollata b’ mod xieraq minn mediċini oħrajn għal anġina pectoris, bħalma huma mblokkaturi beta jew antagonisti tal- kalċju, jew f’ pazjenti li ma jistgħux jieħdu aktar minn dawn il- mediċini.
How is Ranexa used?
Kif jintuża Ranexa?
The recommended starting dose of Ranexa is 375 mg twice a day.
Id- doża tal- bidu rakkomandata ta ’ Ranexa hija ta ’ 375 mg darbtejn kuljum.
After two to four weeks, the dose should be increased to 500 mg twice a day, and then to 750 mg twice a day, depending on the patient’ s response.
Wara ġimagħtejn sa erba ’ ġimgħat, id- doża għandha tiżdied għal 500 mg darbtejn kuljum u wara għal 750 mg darbtejn kuljum skont ir- rispons tal- pazjent.
The maximum dose is 750 mg twice a day.
Id- doża massima hija ta ’ 750 mg darbtejn kuljum.
Doses may need to be lower in patients who have certain side effects.
Jista ’ jkun hemm bżonn li d- doża tkun anqas għal pazjenti li jkollhom ċerti effetti sekondarji.