qanastek/EMEA-V3 huggingface dataset:
Solution for injection, 2 pre-filled syringes with a manual safety system Solution for injection, 10 pre-filled syringes with a manual safety system Solution for injection, 20 pre-filled syringes with a manual safety system
Soluzzjoni għall- injezzjoni, 2 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà Soluzzjoni għall- injezzjoni, 10 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà Soluzzjoni għall- injezzjoni, 20 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà
Subcutaneous use
Użu subkutanju.
Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom
Greenford Middlesex UB6 0NN Renju Unit
EU/ 1/ 02/ 206/ 005- 2 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 006 - 7 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 007 - 10 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 008 - 20 pre-filled syringes with an automatic safety system
EU/ 1/ 02/ 206/ 005 - 2 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 006 - 7 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 007 - 10 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 008 - 20 siringa mimlija lesta b’ sistema ta ’ sigurtà awtomatika
EU/ 1/ 02/ 206/ 024 - 2 pre-filled syringes with a manual safety system EU/ 1/ 02/ 206/ 025 - 10 pre-filled syringes with a manual safety system EU/ 1/ 02/ 206/ 026 - 20 pre-filled syringes with a manual safety system
EU/ 1/ 02/ 206/ 024 - 2 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà EU/ 1/ 02/ 206/ 025 - 10 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà EU/ 1/ 02/ 206/ 026 - 20 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà
Arixtra 1.5 mg/ 0.3 ml injection fondaparinux Na
Arixtra 1. 5 mg/ 0. 3 ml soluzzjoni għall- injezzjoni fondaparinux Na
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
64 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Arixtra 2.5 mg/ 0.5 ml solution for injection Fondaparinux sodium
Fondaparinux sodium
One pre-filled syringe (0.5 ml) contains 2.5 mg fondaparinux sodium.
Siringa waħda mimlija lesta (0. 5 ml) fiha 2. 5 mg fondaparinux sodium.
Subcutaneous or intravenous use
Użu subkutanju jew ġol- vina.
EU/ 1/ 02/ 206/ 001 - 2 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 002 - 7 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 003 - 10 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 004 - 20 pre-filled syringes with an automatic safety system
EU/ 1/ 02/ 206/ 001 - 2 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 002 - 7 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 003 - 10 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 004 - 20 siringa mimlija lesta b’ sistema ta ’ sigurtà awtomatika
EU/ 1/ 02/ 206/ 021 - 2 pre-filled syringes with a manual safety system EU/ 1/ 02/ 206/ 022 - 10 pre-filled syringes with a manual safety system EU/ 1/ 02/ 206/ 023 - 20 pre-filled syringes with a manual safety system
EU/ 1/ 02/ 206/ 021 - 2 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà EU/ 1/ 02/ 206/ 022 - 10 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà EU/ 1/ 02/ 206/ 023 - 20 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà
63 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
66 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Arixtra 2.5 mg/ 0.5 ml injection fondaparinux Na
Arixtra 2. 5 mg/ 0. 5 ml soluzzjoni għall- injezzjoni fondaparinux Na
64 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
67 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Arixtra 5 mg/ 0.4 ml solution for injection Fondaparinux sodium
Fondaparinux sodium
One pre-filled syringe (0.4 ml) contains 5 mg fondaparinux sodium.
Siringa waħda mimlija lesta (0. 4 ml) fiha 5 mg fondaparinux sodium.
Body weight below 50 kg
Piż tal- ġisem taħt 50 kg
EU/ 1/ 02/ 206/ 009- 2 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ /010 - 7 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 011 - 10 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 018 - 20 pre-filled syringe with an automatic safety system
EU/ 1/ 02/ 206/ 009 - 2 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 010 - 7 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 011 - 10 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 018 - 20 siringa mimlija lesta b’ sistema ta ’ sigurtà awtomatika
EU/ 1/ 02/ 206/ 027 - 2 pre-filled syringes with a manual safety system EU/ 1/ 02/ 206/ 028 - 10 pre-filled syringes with a manual safety system EU/ 1/ 02/ 206/ 033 - 20 pre-filled syringes with a manual safety system
EU/ 1/ 02/ 206/ 027 - 2 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà EU/ 1/ 02/ 206/ 028 - 10 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà EU/ 1/ 02/ 206/ 033 - 20 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà
66 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
69 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Arixtra 5 mg/ 0.4 ml injection fondaparinux Na
Arixtra 5 mg/ 0. 4 ml soluzzjoni għall- injezzjoni fondaparinux Na
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
70 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Arixtra 7.5 mg/ 0.6 ml solution for injection Fondaparinux sodium
Fondaparinux sodium
One pre-filled syringe (0.6 ml) contains 7.5 mg fondaparinux sodium.
Siringa waħda mimlija lesta (0. 6 ml) fiha 7. 5 mg fondaparinux sodium.
Body weight 50-100 kg
Piż tal- ġisem 50- 100 kg
EU/ 1/ 02/ 206/ 012- 2 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 013 - 7 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 014 - 10 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 019 - 20 pre-filled syringe with an automatic safety system
EU/ 1/ 02/ 206/ 012 - 2 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 013 - 7 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 014 - 10 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 019 - 20 siringa mimlija lesta b’ sistema ta ’ sigurtà awtomatika
EU/ 1/ 02/ 206/ 029 - 2 pre-filled syringes with a manual safety system EU/ 1/ 02/ 206/ 030 - 10 pre-filled syringes with a manual safety system EU/ 1/ 02/ 206/ 034 - 20 pre-filled syringes with a manual safety system
EU/ 1/ 02/ 206/ 029 - 2 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà EU/ 1/ 02/ 206/ 030 - 10 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà EU/ 1/ 02/ 206/ 034 - 20 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà
69 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
72 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Arixtra 7.5 mg/ 0.6 ml injection fondaparinux Na
Arixtra 7. 5 mg/ 0. 6 ml soluzzjoni għall- injezzjoni fondaparinux Na
70 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Arixtra 10 mg/ 0.8 ml solution for injection Fondaparinux sodium
Fondaparinux sodium
One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium.
Siringa waħda mimlija lesta (0. 8 ml) fiha 10 mg fondaparinux sodium.
Body weight above 100 kg
Piż tal- ġisem 'il fuq minn 100 kg
EU/ 1/ 02/ 206/ 015 - 2 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 016 - 7 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 017 - 10 pre-filled syringes with an automatic safety system EU/ 1/ 02/ 206/ 020 - 20 pre-filled syringe with an automatic safety system
EU/ 1/ 02/ 206/ 015 - 2 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 016 - 7 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 017 - 10 siringi mimlija lesti b’ sistema ta ’ sigurtà awtomatika EU/ 1/ 02/ 206/ 020 - 20 siringa mimlija lesta b’ sistema ta ’ sigurtà awtomatika
EU/ 1/ 02/ 206/ 031 - 2 pre-filled syringes with a manual safety system EU/ 1/ 02/ 206/ 032 - 10 pre-filled syringes with a manual safety system EU/ 1/ 02/ 206/ 035 - 20 pre-filled syringes with a manual safety system
EU/ 1/ 02/ 206/ 031 - 2 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà EU/ 1/ 02/ 206/ 032 - 10 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà EU/ 1/ 02/ 206/ 035 - 20 siringi mimlijin lesti b’ sistema manwali ta ’ sigurtà
Arixtra 10 mg/ 0.8 ml injection fondaparinux Na
Arixtra 10 mg/ 0. 8 ml soluzzjoni għall- injezzjoni fondaparinux Na
INFORMATION FOR THE USER
77 FULJETT TA ’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
Arixtra 1.5 mg/ 0.3 ml solution for injection fondaparinux sodium
Arixtra 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 • Żomm dan il- fuljett.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you personally.
Jista jkollok bżonn terġa taqrah. • 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. • 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.
Tista ’ 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.
What Arixtra is and what it is used for 2.
X’ inhi Arixtra u għalxiex tintuża 2.
Before you use Arixtra 3.
Qabel ma tuża Arixtra 3.
How to use Arixtra 4.
Kif għandek tuża Arixtra 4.
How to store Arixtra 6.
Kif taħżen Arixtra 6.
WHAT ARIXTRA IS AND WHAT IT IS USED FOR
X’ INHI ARIXTRA U GĦALXIEX TINTUŻA
Arixtra is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Arixtra hi mediċina li tghin biex tipprevjeni l- formazzjoni ta ’ għoqiedi tad- demm fil- vini u arterji tad - demm (aġent antitrombotiku).
Arixtra contains a synthetic substance called fondaparinux sodium.
Arixtra fiha 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.
Din twaqqaf fattur 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) milli jiffurmaw fil- vini u arterji.
Arixtra 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 • prevent the formation of blood clots during and shortly after a period of restricted mobility due to acute illness.
Arixtra tintuża biex: • tevita 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. • tevita l- formazzjoni ta ’ emboli waqt u ftit wara l- perjodu ta ’ mobilita` restritta minħabba mard akut.
BEFORE YOU USE ARIXTRA
QABEL MA TUŻA ARIXTRA
Do not use Arixtra: • if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of Arixtra • if you are bleeding excessively • 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.
Tużax Arixtra: • jekk inti allerġiku (tbati minn sensittività eċċessiva) għal fondaparinux sodium jew sustanzi oħra ta ’ Arixtra • jekk int tinfasad b’ mod eċċessiv • jekk għandek infezzjoni batterika tal- qalb • jekk tbati minn xi mard serju ħafna tal- kliewi → Għid lit- tabib tiegħek jekk taħseb li xi waħda minn dawn tapplika għalik.
If they do, you must not use Arixtra.
Jekk iva, m’ għandekx tuża Arixtra.
Take special care with Arixtra:
Oqgħod attent ħafna b’ Arixtra:
Your doctor needs to know before you take Arixtra: • if you have a risk of uncontrolled bleeding (haemorrhage) including:
Qabel tieħu Arixtra, it- tabib tiegħek għandu bżonn ikun jaf: • jekk għandek riskju ta ’ ħruġ ta ’ demm mhux ikkontrollat (emorraġija), li tinkludi:
• 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.
78 • 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 Arixtra has not been tested in children and adolescents under the age of 17 years.
Tfal Arixtra ma ġietx ittestjata fi tfal u addoloxxenti ta ’ taħt is- 17- il sena.
This includes medicines you bought without a prescription.
Dawn jinkludu anki mediċini li tkun xtrajt mingħajr riċetta.
Some other medicines may affect the way that Arixtra works or be affected by Arixtra.
Ċerti mediċini oħrajn jistgħu jaffettwaw il- mod li tagħmel effett Arixtra, jew ikunu affettwati b' Arixtra.
Pregnancy and breast feeding Arixtra should not be prescribed to pregnant women unless clearly necessary.
Tqala u Treddigħ Arixtra m’ għandiex tintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
Breast-feeding is not recommended during treatment with Arixtra.
It- treddigħ mhux rakkomandat waqt trattament b ’ Arixtra.
If you are pregnant, think you might be, or if you are 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.
Important information about some of the ingredients of Arixtra This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Arixtra Kull doża ta ’ dan il- prodott mediċinali fiha anqas minn 23 mg ta ’ sodium u għalhekk il- prodott huwa essenzjalment mingħajr sodium
HOW TO USE ARIXTRA
KIF GĦANDEK TUŻA ARIXTRA
Always use Arixtra exactly as your doctor has told you.
Dejjem għandek tuża Arixtra skond il- parir tat- tabib.
The usual dose is 2.5 mg once a day, injected at about the same time each day.
Id- doża li ssoltu tingħata hija ta ’ 2. 5 mg darba kuljum, injettata bejn wieħed u ieħor fl- istess ħin kuljum
If you have kidney disease, the dose may be reduced to 1.5 mg once a day.
Jekk tbati minn mard fil- kliewi, tista ’ titnaqqas id- doża għal 1. 5 mg darba kuljum.
How Arixtra is given • Arixtra is given by injection under the skin (subcutaneously) into a skin fold of the lower abdominal area.
Kif tingħata Arixtra • Arixtra tingħata permezz ta ’ injezzjoni taħt il- ġilda (b’ mod subkutanju) f’ tinja tal- ġilda tal- parti t’ isfel ta ’ l- istonku.
There are different syringes for the 2.5 mg and 1.5 mg doses.
Hemm siringi differenti għad- dożi ta ’ 2. 5mg u 1. 5mg.
For step-by-step instructions please see over the page • Do not inject Arixtra into muscle.
Għal istruzzjonijiet li juru kollox pass- pass jekk jogħġbok ara l- paġna ta ’ wara. • Tinjettax Arixtra ġo muskolu (b’ mod intramuskolari).
How long should Arixtra be taken for You should continue Arixtra treatment for as long as your doctor has told you, since Arixtra prevents development of a serious condition.
Kemm għandek iddum tieħu Arixtra Għandek tkompli t- trattament Arixtra għaż- żmien kollu li jgħidlek it- tabib peress illi Arixtra tipprevjeni l- iżvilupp ta ’ kondizzjoni serja.
If you inject too much Arixtra Contact your doctor or pharmacist for advice as soon as possible because of the increased risk of bleeding.
Ikkuntatja lit- tabib jew spiżjar tiegħek għal parir kemm jista ’ jkun malajr minhabba riskju ikbar ta ’ ħruġ ta ’ demm.
If you forget to take Arixtra • Take the dose as soon as you remember.
Jekk tinsa tuża Arixtra: • Ħu d- doża mill- ewwel kif tiftakar.
76 Don’ t stop using Arixtra 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.
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, Arixtra can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, Arixtra jista ’ jkolla effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects These may affect more than 1 in 100 people treated with Arixtra. • bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums) • anaemia (a reduction in the number of red blood cells).
Effetti sekondarji komuni Dawn jistgħu jaffettwaw iżjed minn wieħed kull 100 persuna trattati b’ Arixtra • ħruġ ta ’ demm (per eżempju mis- sit ta ’ operazzjoni, ulċera fl- istonku diġa ’ eżistenti, fġir l - imnieħer, ħanek) • anemija (tnaqqis fin- numru taċ- ċelloli ħomor tad- demm).
Uncommon side effects These may affect up to 1 in 100 people treated with Arixtra. • bruising or swelling (oedema) • feeling sick or being sick (nausea or vomiting) • chest pain • breathlessness • rash or itchy skin • oozing from operation wound site • fever • reduction or increase in the number of platelets (blood cells necessary for blood clotting) • increase in some chemicals (enzymes) produced by the liver.
Effetti sekondarji mhux komuni Dawn jistgħu jaffettwaw sa wieħed kull 100 persuna trattati b’ Arixtra: • tbenġil jew nefħa (edima) • tħossok imqalla jew titqalla (dardir jew rimettar) • uġigħ fis- sider • qtugħ ta ’ nifs • raxx jew ħakk fil- ġilda • tnixxija mill- ferita ta ’ l- operazzjoni • deni • nuqqas jew żieda fin- numru ta ’ plejtlets (ċelloli tad- demm neċessarji biex jagħqad id- demm), • żieda f’ xi kimiċi (enżimi) li jsiru fil- fwied.
Rare side effects These may affect up to 1 in every 1000 people treated with Arixtra. • allergic reaction • internal bleeding in the brain or abdomen • anxiety or confusion • headache • fainting or dizziness, low blood pressure • drowsiness or tiredness • flushing • coughing • leg pain or stomach pain • diarrhoea or constipation • indigestion • wound infection • increase in bilirubin (a substance produced by the liver) in the blood • reduction in potassium in your blood.
Effetti sekondarji rari Dawn jistgħu jaffettwaw sa 1 minn kull 1000 persuna trattati b’ Arixtra: • reazzjonijiet allerġiċi • ħruġ ta ’ demm internament fil- moħħ jew l- addomenu • anzjeta` jew konfużjoni • uġigħ ta ’ ras • ħass ħażin jew sturdament, pressjoni baxxa • tħeddil jew għajja • fwawar • sogħla • ugigħ fir- riġlejn jew fl- istonku • dijareja jew stitikezza • indiġestjoni • infezzjoni fil- ferita • żieda fil- bilirubin (sustanza li ssir fil- fwied) fid- demm • tnaqqis ta ’ potassium fid- demm tiegħek.
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.
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.
HOW TO STORE ARIXTRA
KIF TAĦŻEN ARIXTRA
• Keep out of the reach and sight of children • Do not freeze • Arixtra does not need to be kept in the fridge.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal
77 Do not use Arixtra: • after the expiry date stated on the label and carton • 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.
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.
Disposal of syringes:
Rimi ta ’ siringi:
Medicines and syringes should not be disposed of via wastewater or household waste.
Mediċini u siringi m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
6.
. 6.
FURTHER INFORMATION
X’ fiha Arixtra
What Arixtra 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.
• The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/ or sodium hydroxide to adjust the pH.
Is- sustanzi l- oħra huma sodium chloride, ilma għal injezzjonijiet, u hydrochloric acid u jew sodium hydroxide biex jaġġustaw il- pH.
Arixtra does not contain any animal products.
Arixtra ma fiha l- ebda prodott ta ’ l- annimali.
What Arixtra looks like and contents of the pack Arixtra is a clear and colourless solution for injection.
Arixtra hija soluzzjoni għal injezzjoni ċara u mingħajr kulur.
It is supplied in a pre-filled, single-use syringe fitted with a safety system to help prevent needle stick injuries after use.
Hija fornita f’ siringa mimlija lesta, għall - użu ta ’ darba u mgħammra b’ sistema ta ’ sikurezza awtomatika sabiex tipprevjeni ferimenti bil- labra wara l- użu.
It is available in packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed).
Hija disponibbli f’ pakketti ta ’ 2, 7, 10 u 20 siringi mimlija lesti (mhux id- daqsijiet kollha tal- pakketti jistgħu jkunu għall- skop kummerċjali).
Marketing Authorization Holder:
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
Manufacturer:
Il- manifattur:
Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.
Glaxo Wellcome Production, 1 rue de l' Abbaye, F- 76960 Notre Dame de Bondeville, Franza.
78 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
81 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
79 Italia GlaxoSmithKline S. p. A.
82 Italia GlaxoSmithKline S. p. A.
80 Types of safety syringe There are two types of safety syringes used for Arixtra, designed to protect you from needle stick injuries following injection.
83 Tipi ta ’ siringa ta ’ sikurezza Hemm żewġ tipi ta ’ siringi ta ’ sikurezza għal Arixtra ddisinjati biex jipproteġuk milli tweġġa mill - labra wara injezzjoni.
One type of syringe has an automatic needle protection system and the other type has a manual needle protection system.
Tip wieħed ta 'siringa għandha sistema awtomatika ta' protezzjoni mill- labra u t- tip l- ieħor għanda sistema manwali ta 'protezzjoni mill- labra
Parts of the syringes:
Partijiet mis- siringi:
1 Needle guard 2 Plunger 3 Finger-grip 4 Security sleeve
Apparat protettiv tal- labra Planġer Manku għas- swaba Tubu ta ’ sigurta`
Syringe with an automatic needle protection system
Stampa 1 Siringa b’ sistema awtomatika ta ’ protezzjoni mill- labra
Syringe with a manual needle protection system
Siringa b’ sistema manwali ta ’ protezzjoni mill- labra
Syringe with a manual needle protection system
Stampa 2 Siringa b’ sistema manwali ta ’ protezzjoni mill- labra
Syringe with a manual needle protection system showing security sleeve being pulled over needle AFTER USE
Stampa 3 Siringa b’ sistema manwali ta 'protezzjoni mill- labra li turi t- tubu ta ’ sigurtà jinġibed fuq il- labra WARA L- UŻU
STEP BY STEP GUIDE TO USING ARIXTRA
GWIDA PASS- PASS TA 'KIF TUŻA ARIXTRA
Instructions for use These instructions are for both types of syringes (automatic and manual needle protection system).
Istruzzjonijiet għall- użu Dawn l- istruzzjonijiet qegħdin għaż- żewġ tipi ta ’ siringi (sistema ta ’ protezzjoni mill- labra manwali u awtomatika).
Where the instruction for a syringe is different this is clearly stated.
Fejn l- istruzzjonijiet għal siringa huma differenti huwa dikjarat b’ mod ċar.
Remove the syringe from the carton and check that: • the expiry date has not passed • the solution is clear and colourless and doesn’ t contain particles • the syringe has not been opened or damaged
Neħħi s- siringa mill- kaxxa u ċċekkja li: • d- data ta ’ skadenza m’ għadditx • s- soluzzjoni hija ċara w bla kulur u ma fihiex frak • s- siringa ma nfetħitx jew għandha xi ħsara
81 3.
84 3.
Sit or lie down in a comfortable position.
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 (iż- żaqq), ta ’ l- inqas 5 cm miż- żokra (figura A).
Alternate the left and right side of the lower abdominal area at each injection.
Għandek talterna minn- naħa tax- xellug għall- lemin tan - naħa t’ isfel ta ’ l- istonku tiegħek ma ’ kull injezzjoni.
This will help to reduce the discomfort at the injection site.
Dan 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.
Jekk mhux possibli li tinjetta fl- istonku, ikkonsulta ma ’ l - infermiera jew tabib tiegħek għall- parir.
Clean the injection area with an alcohol wipe.
Naddaf iż- żona ta ’ l- injezzjoni b’ biċċa bl- alkoħol
Remove the needle guard, by first twisting it (picture B1) and then pulling it in a straight line away from the body of the syringe (picture B2).
Neħħi l- apparat protettiv tal- labra, billi l- ewwel iddawwar (figura B1) imbagħad tiġbdu f’ linja dritta lil hinn miċ- ċilindru tas- siringa (figura B2).
Discard the needle guard.
Armi l- apparat protettiv tal- labra.
Important note • 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.
Figura B1 • Huwa normali illi jkun hemm bużżieqa ta ’ l- arja żgħira fis- siringa.
Do Picture B1 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.
Gently pinch the skin that has been cleaned to make a fold.
Oqros bil- mod il- ġilda mnaddfa sabiex tagħmel tinja.
Hold the fold between the thumb and the forefinger during the entire injection (picture C).
Żomm it- tinja bejn is- saba ’ l- kbir u l- werrej matul l- injezzjoni kollha (figura C) •
Hold the syringe firmly by the finger grip.
Żomm is- siringa soda mill- manku għas- swaba.
Insert the full length of the needle at right angles into the skin fold (picture D).
Daħħal it- tul kollu tal- labra b’ mod perpendikulari (b’ angolu ta ’ 90º) fit- tinja tal- ġilda (figura D).
Inject ALL of the contents of the syringe by pressing down on the plunger as far as it goes (picture E).
Injetta il- kontenut KOLLU tas- siringa billi tagħfas il - planġer ‘ l isfel it- tul tiegħu kollu (figura E).
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 F).
Eħles il- planġer u l- labra awtomatikament toħroġ mill - ġilda u tidħol lura għal ġot- tubu ta ’ sigurtà fejn tinqafel b’ mod permanenti (figura F).
Picture F Syringe manual system
Figura F
After the injection hold the syringe in one hand by gripping the security sleeve, use the other hand to hold the finger grip and pull firmly back.
Wara l- injezzjoni żomm is- siringa b’ id waħda billi taqbad it- tubu ta ’ sigurtà, uża l- id l- oħra biex iżżomm il- manku għas- swaba u iġbed lura b’ mod sod.
This unlocks the sleeve.
B’ hekk tħoll it- tubu.
Slide the sleeve up the body of the syringe until it locks into position over the needle.
Żerżaq it- tubu fuq il- parti prinċipali tas- siringa sakemm tingħalaq f’ postha fuq il- labra.
This is shown in Picture 3 at the beginning of these instructions.
Din tidher fi Stampa 3 fil- bidu ta ’ dawn l- istruzzjonijiet.
Do not dispose of the used syringe in the household waste.
Tarmix is- siringa użata fl- iskart domestiku.
Dispose of it as your doctor or pharmacist has instructed.
Armiha kif qallek it- tabib jew l- ispiżjar tiegħek.
INFORMATION FOR THE USER
86 FULJETT TA ’ TAGĦRIF: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNHA
Arixtra 2.5 mg/ 0.5 ml solution for injection fondaparinux sodium
Arixtra 2. 5mg/ 0. 5ml soluzzjoni għall- injezzjoni fondaparinux sodium
It may harm them, even if their symptoms seem to be the same as yours. • 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.
Tista ’ tagħmlilhom 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.
Arixtra is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Arixtra hija mediċina li tgħin biex tipprevjeni l- formazzjoni ta ’ għoqiedi tad- demm fil- vini u arterji (aġent antitrombotiku).
Arixtra contains a synthetic substance called fondaparinux sodium.
Arixtra fiha 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 forming in the blood vessels.
Din twaqqaf fattur għat- tagħqid tad - demm Xa (‘ għaxra- A ’) milli jaħdem fid- demm, u għalhekk tipprevjeni l- iżvilupp ta ’ għoqiedi tad - demm mhux mixtieqa (trombożi) fil- vini u arterji tad- demm.
Arixtra 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 • prevent the formation of blood clots during and shortly after a period of restricted mobility due to acute illness • treat some types of heart attack and severe angina (pain caused by narrowing of the arteries in the heart).
Arixtra tintuża: • għall- prevenzjoni tal- formazzjoni ta ’ għoqiedi tad- demm fil- vini u arterji tar- riġlejn jew pulmun wara kirurġija ortopedika, bħal kirurġija fil- ġenb jew fl- irkoppa jew wara kirurġija fl - addomenu • 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 - arterji fil- qalb).
Do not use Arixtra: • if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of Arixtra • if you are bleeding excessively • 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.
Tużax Arixtra: • jekk inti allerġiku (tbati minn sensittività eċċessiva) għal fondaparinux sodium jew sustanzi oħra ta ’ Arixtra • jekk int tinfasad b’ mod eċċessiv • jekk għandek infezzjoni batterika tal- qalb • 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 Arixtra.
Jekk dan huwa l- każ, m’ għandekx tuża Arixtra.
84 Take special care with Arixtra:
Oqgħod attent ħafna b’ Arixtra:
Your doctor needs to know before you take Arixtra: • if you have a risk of uncontrolled bleeding (haemorrhage) including:
It- tabib tiegħek għandu jkun jaf qabel ma tieħu Arixtra: • jekk għandek riskju ta ’ ħrug ta ’ demm (emorraġija) mhux kontrollata, inkluż:
· recent bleeding into the brain (intracranial bleeding)
· ħruġ ta ’ demm fil- moħħ riċenti (ħruġ ta ’ demm ġol- kranju)
• 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 wieħed minn dawn japplika għalik.
Children Arixtra has not been tested in children and adolescents under the age of 17 years.
Tfal Arixtra ma ’ ġietx ippruvata f’ 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 jew ħadt dan l- aħħar xi mediċini oħra.
This includes medicines you bought without a prescription.
Dan jinkludi mediċini li xtrajt mingħajr riċetta.
Some other medicines may affect the way that Arixtra works or be affected by Arixtra.
Ċerti mediċini oħra jistgħu jkollhom effett fuq kif taħdem Arixtra jew Arixtra tista 'jkollha effett fuqhom.
If you are pregnant, think you might be, or if you are breast-feeding: → tell your doctor or pharmacist.
Jekk inti tqila jew tissuspetta li inti tqila jew jekk qed tredda ’ → għarraf lit- tabib jew lill- ispiżjar tiegħek.
The usual dose is 2.5 mg once a day, injected at about the same time each day.
Id- doża li ssoltu tingħata hija ta ’ 2. 5 mg darba kuljum, injettata kuljum bejn wieħed u ieħor fl - istess ħin.
If you have kidney disease, the dose may be reduced to 1.5 mg once a day.
Jekk tbati minn mard fil- kliewi, it- tabib tiegħek jista ’ jagħtik doża iżgħar ta ’ 1. 5 mg darba kuljum.
There are different syringes for the 2.5 mg and 1.5 mg doses.
Hemm siringi differenti għad- doża ta ’ 2. 5 mg u dik ta ’ 1. 5 mg.
To treat some types of heart attack, a health professional may give the first dose into a vein (intravenously). • Do not inject Arixtra into muscle.
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 Arixtra ġo muskolu..
How long should Arixtra be taken for You should continue Arixtra treatment for as long as your doctor has told you, since Arixtra prevents development of a serious condition.
Tul taż- żmien tat- trattament b’ Arixtra Għandek tkompli t- trattament Arixtra għaż- żmien kollu li jgħidlek it- tabib peress illi Arixtra tipprevjeni l- iżvilupp ta ’ kondizzjoni serja.
If you inject too much Arixtra Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of bleeding.
Jekk tinjetta aktar milli suppost ta ’ Arixtra Ikkuntatja lit- tabib jew lill- ispiżjar tiegħek biex tieħu parir mill- aktar fis possibbli, minhabba riskju ikbar ta ’ ħruġ ta ’ demm.
85 If you forget to take Arixtra • Take the dose as soon as you remember.
88 Jekk tinsa tieħu Arixtra: • Ħu d- doża malli tiftakar.
Don’ t stop using Arixtra 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 - demm f’ vina tar- riġel jew fil- pulmun.
Like all medicines, Arixtra can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra, Arixtra jista ’ jkolla effetti sekondarji, għalkemm mhux kulħadd ikollu dawn l- effetti.
Common side effects These may affect more than 1 in 100 people treated with Arixtra. • bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums) • anaemia (a reduction in the number of red blood cells)
Effetti sekondarji komuni Dawn jistgħu jaffettwaw iżjed minn wieħed kull 100 persuna li qegħdin jirċievu trattament b’ Arixtra. • ħruġ ta ’ demm (per eżempju mis- sit ta ’ operazzjoni, ulċera fl- istonku diġa ’ eżistenti, fġir l - imnieħer, ħanek) • anemija (tnaqqis fin- numru taċ- ċelloli ħomor tad- demm).
Uncommon side effects These may affect up to 1 in 100 people treated with Arixtra. • bruising or swelling (oedema) • feeling sick or being sick (nausea or vomiting) • chest pain • breathlessness • rash or itchy skin • oozing from operation wound site • fever • reduction or increase in the number of platelets (blood cells necessary for blood clotting) • increase in some chemicals (enzymes) produced by the liver.
Effetti sekondarji mhux komuni Dawn jistgħu jaffettwaw sa wieħed kull 100 persuna li qegħdin jirċievu trattament b’ Arixtra. • tbenġil jew nefħa (edima) • tħossok ħażin jew tkun ma tiflaħx (dardir, rimettar) • uġigħ fis- sider • qtugħ ta ’ nifs • raxx jew ħakk fil- ġilda • tnixxija mill- ferita ta ’ l- operazzjoni • deni • nuqqas jew żieda fin- numru ta ’ plejtlets (ċelloli tad- demm neċessarji biex jagħqad id- demm) • żieda f’ xi kimiċi (enżimi) li jsiru fil- fwied.
Rare side effects These may affect up to 1 in every 1000 people treated with Arixtra. • allergic reaction • internal bleeding in the brain or abdomen • anxiety or confusion • headache • fainting or dizziness, low blood pressure • drowsiness or tiredness • flushing • coughing • leg pain or stomach pain • diarrhoea or constipation • indigestion • wound infection • increase in bilirubin (a substance produced by the liver) in the blood • reduction in potassium in your blood
Effetti sekondarji rari Dawn jistgħu jaffettwaw sa wieħed kull 1000 persuna li qegħdin jirċievu trattament b’ Arixtra. • reazzjonijiet allerġiċi • fsada interna fil- moħħ jew fl- addomenu • anzjeta` jew konfużjoni • uġigħ ta ’ ras • ħass ħażin jew sturdament, pressjoni tad- demm baxxa • tħeddil jew għajja • fwawar • sogħla • ugigħ fir- riġlejn jew uġigħ fl- istonku • dijareja jew stitikezza • indiġestjoni • 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.
89 Jekk ikollhok xi effetti sekondarji → 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 • Arixtra does not need to be kept in the fridge.
• Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal • Tiffriżahx • Arixtra m’ għandiex bżonn tinħażen fil- friġġ.
Do not use Arixtra: • after the expiry date stated on the label and carton • 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 Arixtra: • 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 ma wżajtiex minnufih
Medicines and syringes should not be disposed of via wastewater or household waste.
Rimi tas- siringi Il- mediċini u s- siringi m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Arixtra contains • The active substance is 2.5 mg fondaparinux sodium in 0.5 ml solution for injection
Is- sustanza attiva hija 2. 5 mg ta ’ fondaparinux sodium f’ 0. 5ml ta ’ soluzzjoni għall- injezzjoni.
• The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/ or sodium hydroxide to adjust the pH.
• Is- sustanzi l- oħra huma sodium chloride, ilma għal injezzjonijiet, u hydrochloric acid u jew sodium hydroxide biex jaġġustaw il- pH.
Arixtra does not contain any animal products.
Arixtra ma fiha l- ebda prodott magħmul mill- annimali.
What Arixtra looks like and contents of the pack Arixtra is a clear and colourless solution for injection.
Arixtra hija soluzzjoni ċara u bla kulur għal injezzjoni.
It is supplied in a pre-filled, single-use syringe fitted with a safety system to help prevent needle stick injuries after use.
Hija fornita f’ siringa mimlija lesta, għall- użu ta ’ darba u mgħammra b’ sistema ta ’ sikurezza awtomatika sabiex tipprevjeni ferimenti bil- labra wara l- użu.
It is available in packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed).
Hija disponibbli f’ pakketti ta ’ 2, 7, 10 u 20 siringi mimlija lesti (mhux id- daqsijiet kollha tal - pakketti jistgħu jkunu għall- skop kummerċjali).
Manufacturer:
L- manifattur:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu
87 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
90 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
88 Italia GlaxoSmithKline S. p. A.
91 Italia GlaxoSmithKline S. p. A.
89 Types of safety syringe There are two types of safety syringes used for Arixtra, designed to protect you from needle stick injuries following injection.
92 Tipi ta ‘ siringa ta ’ sikurezza Hemm żewġ tipi ta ’ siringi ta ’ sikurezza għal Arixtra iddisinjati biex jipproteġuk milli tweġġa mill - labra wara injezzjoni.
STEP BY STEP GUIDE TO USING ARIXTRA
GWIDA PASS- PASS BIEX TUŻA ARIXTRA
Remove the syringe from the carton and check that: • the expiry date has not passed • the solution is clear and colourless and doesn’ t contain particles • the syringe has not been opened or damaged
Neħħi s- siringa minn ġol- kaxxa w ara li: • d- data ta ’ skadenza m’ għadditx • s- soluzzjoni hija ċara w bla kulur u ma fihiex frak • s- siringa ma nfetħitx jew għandha xi ħsara
90 3.
93 3.
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 - żokra (figura A).
Alternate the left and right side of the lower abdominal area at each injection.
Għandek talterna minn- naħa tax- xellug għall- lemin tal - parti t’ isfel ta ’ l- istonku ma ’ kull injezzjoni.
This will help to reduce the discomfort at the injection site.
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.
Jekk mhux possibli li tinjetta fl- istonku, ikkonsulta ma ’ l - infermiera jew tabib tiegħek għal parir.
Important note • 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.
Nota importanti • Tmissx il- labra u ara li ma tiġix f’ kuntatt ma ’ xi superfiċi qabel l- injezzjoni. • Huwa normali illi jkun hemm bużżieqa ta ’ l- arja żgħira fis- siringa.
Do Picture B1 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 Figura ta ’ l- arja qabel ma tagħmel l- injezzjoni – tista titlef B1 ftit mill- mediċina jekk tagħmel dan.
Hold the fold between the thumb and the forefinger during the entire injection (picture C).
Żomm it- tinja bejn is- saba ’ l- kbir u l- werrej matul l- injezzjoni kollha (figura C)
7.
Figura C 7.
91 8.
94 8.
Inject ALL of the contents of the syringe by pressing down on the plunger as far as it goes (picture E).
Figura E Sistema awtomatika ta 'siringa
Picture F Syringe manual system
Figura F Sistema manwali ta ’ siringa
Do not dispose of the used syringe in the household waste.
Tarmix is- siringa wżata ma ’ l- iskart domestiku.
92 PACKAGE LEAFLET
95 FULJETT TA ’ TAGĦRIF
Arixtra 7.5 mg/ 0.6 ml solution for injection Arixtra 10 mg/ 0.8 ml solution for injection Fondaparinux sodium
Arixtra 5mg/ 0. 4ml soluzzjoni għall- injezzjoni Arixtra 7. 5mg/ 0. 6ml soluzzjoni għall- injezzjoni Arixtra 10mg/ 0. 8ml soluzzjoni għall- injezzjoni Fondaparinux sodium
Arixtra is a medicine that treats or helps to prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Arixtra hi mediċina li tittratta jew tghin biex tipprevjeni l- formazzjoni ta ’ għoqiedi tad- demm fil- vini u arterji.
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.
Din twaqqaf fattur 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) milli jiffurmaw fil- vini u arterji.
Arixtra is used to treat patients with a blood clot in the blood vessels of their legs (deep vein thrombosis) and/ or lungs (pulmonary embolism).
Arixtra tintuża bħala trattament f’ pazjenti li għandhom għoqda tad- demm fil- vini u arterji ta ‘ riġlejhom (trombożi f’ vina fonda) u/ jew fil- pulmun (emboliżmu pulmonari).
Do not use Arixtra: • if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of Arixtra • if you are bleeding excessively • if you have a bacterial heart infection • if you have severe kidney disease. → Tell your doctor if you think any of these applies to you.
Tużax Arixtra: • jekk inti allerġiku (tbati minn sensittività eċċessiva) għal fondaparinux sodium jew sustanzi oħra ta ’ Arixtra • jekk int tinfasad b’ mod eċċessiv • jekk għandek infezzjoni batterika tal- qalb • Jekk għandek xi mard serju tal- kliewi → Għid lit- tabib tiegħek jekk taħseb li xi waħda minn dawn tapplika għalik.
Your doctor needs to know before you take Arixtra: • if you have a risk uncontrolled bleeding (haemorrhage) including:
Qabel tieħu Arixtra, it- tabib tiegħek għandu bżonn ikun jaf: • jekk għandek riskju ta ’ ħruġ ta ’ demm (emorraġija) mhux kontrollat, li tinkludi:
• if you have severe liver disease • if you have kidney disease
96 • jekk tbati minn mard serju fil- fwied; • jekk tbati minn mard tal- kliewi; • jekk għandek eta` ta ’ 75 sena jew iktar; Għid lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik.
Some other medicines may affect the way that Arixtra works or be affected by Arixtra.
Ċerti mediċini oħrajn jistgħu jaffettwaw il - mod li tagħmel effett Arixtra jew ikunu affettwati b’ Arixtra.
If you are pregnant, think you might be, or if you are breast feeding: → tell your doctor or pharmacist.
Jekk inti tqila jew taħseb li tista ’ tkun tqila jew qed tredda: →għarraf lit- tabib jew l- ispiżjar tiegħek.
Your weight Below 50 kg Between 50 kg and 100 kg Over 100 kg
Il- piż tiegħek Taħt 50 kg Bejn 50 kg u 100 kg Il fuq minn 100 kg
Usual dose 5 mg once a day 7.5 mg once a day 10 mg once a day.
Doża li s- soltu tingħata 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 disease.
Din id- doża tista ’ titnaqqas għal 7. 5mg darba kuljum jekk għandek mard moderat tal- kliewi.
You should inject at about the same time each day.
Għandek tieħu l- injezzjoni bejn wieħed u ieħor l- istess ħin kuljum.
They 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 syringes for the 5 mg, 7.5 mg and 10 mg doses.
Hemm siringi differenti għad- dożi ta ’ 5mg, 7. 5mg u 10mg.
For step-by-step instructions please see over the page. • Do not inject Arixtra into muscle.
Għal istruzzjonijiet li juru kollox pass - pass jekk jogħġbok ara l- paġna ta ’ wara. • Tinjettax Arixtra ġo muskolu (b’ mod intramuskolari)..
If you inject too much Arixtra Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of bleeding.
Ikkuntatja it- tabib jew spiżjar tiegħek għal parir kemm jista ’ jkun malajr minhabba riskju ikbar ta ’ ħruġ ta ’ demm.
If you forget to take Arixtra • Take the dose as soon as you remember.
Jekk tinsa tuża Arixtra: • Ħu 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.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu. • Jekk m’ intix ċert x’ għandek tagħmel, staqsi lit- tabib jew spiżjar tiegħek.