qanastek/EMEA-V3 huggingface dataset:
In MS inflammation destroys the protective sheath (called myelin) around the nerves of the CNS and stops the nerves from working properly.
F’ MS l- infjammazzjoni teqred is- saff protettiv (imsejjaħ myelin) madwar in- nervituri tas- CNS u twaqqaf lin- nervituri milli jibqgħu jaħdmu tajjeb.
The exact cause of MS is unknown.
Il- kawża eżatta ta ’ MS mhix magħrufa.
An abnormal response by the body’ s immune system is thought to play an important part in the process which damages the CNS.
Rispons anormali mis- sistema immuni tal- ġisem hija maħsuba li tifforma parti importanti mill- proċess li jagħmel ħsara lis- CNS.
Symptoms may disappear completely or partly.
Is- sintomi jistgħu jisparixxu għal kollox jew parzjalment.
Extavia has been shown to delay progression to definite multiple sclerosis.
Kif Extavia jgħin jiġġieled il- marda tiegħek Avveniment kliniku wieħed li jindika riskju għoli li tiżviluppa sklerożi multipla: intwera li Extavia idewwem il- progressjoni għal sklerożi multipla definittiva.
People with relapsing-remitting MS have occasional attacks or relapses during which symptoms become noticeably worse.
Nies b’ MS li tirkadi u tbatti jbatu minn attakki okkażjonali jew rikaduti li matulhom, is- sintomi jmorru għall- agħar b’ mod notevoli.
Extavia has been shown to cut down the number of attacks and make them less severe.
Intwera li Extavia inaqqas in - numru ta ’ attakki u jagħmilhom inqas severi.
It reduces the number of hospital stays due to the disease and prolongs the time without relapses.
Inaqqas in- numru ta ’ perjodi l- isptar minħabba l- marda u jtawwal iż- żmien mingħajr rikaduti.
32 Secondary progressive multiple sclerosis:
33 Sklerożi multipla progressiva sekondarja:
In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS.
F’ xi każijiet, nies b’ MS li tirkadi u tbatti jsibu li s - sintomi tagħhom jiżdiedu u javvanzaw għal forma oħra ta ’ MS imsejħa MS progressiva sekondarja.
With this, people find themselves becoming increasingly impaired, whether or not they have relapses.
B’ din, in- nies isibu ruħhom li qegħdin isiru dejjem iktar indeboliti, kemm jekk ikollhom rikaduti kif ukoll jekk le.
Extavia can reduce the number and severity of the attacks, and slow the progression of disability.
Extavia jista ’ inaqqas in- numru u s- severità ta ’ l- attakki, u jdewwem il- progress tad - diżabilità.
What Extavia is used for Extavia is for use in patients ► who have experienced for the first time symptoms which indicate a high risk of developing multiple sclerosis.
Għalxiex jintuża Extavia Extavia hu għall- użu f’ pazjenti ► li għall- ewwel darba kellhom sintomi li jindikaw riskju għoli għall- iżvilupp ta ’ sklerożi multipla.
Your doctor will rule out any other reasons which could explain these symptoms before you are treated. ► who suffer from relapsing-remitting multiple sclerosis, with at least two relapses within the last two years. ► who suffer from secondary progressive multiple sclerosis with active disease shown by relapses.
It- tabib tiegħek ser jelimina kull raġuni oħra li tista ’ tispjega dawk is- sintomi qabel ma tiġi kkurata/ a. ► li jbatu minn sklerożi multipla li tirkadi u tbatti, b’ mill- inqas żewġ rikaduti fl- aħħar sentejn. ► li jbatu minn sklerożi multipla progressiva sekondarja, bil- marda attiva li tintwera permezz tar- rikaduti.
BEFORE YOU USE EXTAVIA
QABEL MA TUŻA EXTAVIA
Do not use Extavia
Tużax Extavia
- if you are pregnant.
- jekk int tqila.
You should not start treatment with Extavia (see “ Pregnancy”).
M’ għandekx tibda terapija b’ Extavia (ara “ Tqala ”).
- if you are allergic (hypersensitive) to natural or recombinant interferon beta, human albumin or
- jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal interferon beta- 1 naturali jew
any of the other ingredients of Extavia.
rikombinanti, l- albumina umana jew xi sustanzi oħra ta ’ Extavia.
- if you currently suffer from severe depression and/ or suicidal thoughts (see “ Take special
- jekk attwalment tbati minn dipressjoni qawwija u/ jew ħsibijiet ta ’ suwiċidju (ara “ Oqgħod
care” and section 4, “ Possible side effects”).
attent ” u 4. “ Effetti sekondarji li jista ’ jkollu ”).
- if you have a severe liver disease (see “ Take special care”, “ Using other medicines” and
- jekk għandek marda serja tal- fwied (ara “ Oqgħod attent ”, “ Meta tuża mediċini oħra ” u 4.
section 4, “ Possible side effects”).
“ Effetti sekondarji li jista ’ jkollu ”).
Tell your doctor, if any of the above applies to you.
Għid lit- tabib tiegħek, jekk xi waħda minn dawn t’ hawn fuq tapplika għalik.
Take special care with Extavia
Oqgħod attent ħafna b’ Extavia
Your doctor also needs to know the following before you are given Extavia:
It- tabib tiegħek jeħtieġ li jkun jaf dawn l- affarijiet qabel jagħtik Extavia:
- If you have monoclonal gammopathy.
Jekk għandek gammopatija monoklonali.
This is a disorder of the immune system where an
Din hija disturb tas- sistema immuni li jkun fiha
abnormal protein is found in the blood.
proteini anormali fid- demm.
Problems with your small blood vessels (capillaries) may develop when using medicines like Extavia (systemic capillary leak syndrome).
Tista ’ tiżviluppa problemi fil- kanali ż- żgħar tad- demm (kapillari) tiegħek meta tuża mediċini bħal Extavia (sindromu ta ’ tnixxija kapillari sistemika).
This can lead to shock (collapse) and even be fatal.
Dan jista ’ jwassal għal xokk (kollass) u jista ’ jkun anke fatali,
- If you have had depression or are depressed or previously had thoughts of suicide.
Jekk kont tbati jew tbati fil- preżent minn dipressjoni jew jekk qatt għaddewlek ħsibijiet
Your
-
doctor will closely monitor you during treatment.
It- tabib tiegħek ser jimmonitorjak aktar mill- qrib matul il- kura tiegħek.
If your depression and/or suicidal thoughts are severe, you will not be prescribed Extavia (see also “Do not use Extavia”).
Jekk id - dipressjoni u/ jew il- ħsibijiet ta ’ suwiċidju tiegħek huma serji, m’ intix ser tingħata riċetta għal Extavia (ara wkoll “ Tużax Extavia ”).
- If you have ever had seizures or if you are taking medicines to treat epilepsy (anti-
- Jekk qatt kellek aċċessjonijiet jew jekk qed tieħu mediċini li jikkuraw l- epilessija (anti -
epileptics) (see also “Using other medicines” and section 4, “Possible side effects”), you doctor will monitor your treatment carefully.
epilettiċi) (ara wkoll sezzjoni “ Meta tuża mediċini oħra ” u sezzjoni 4. “ Effetti sekondarji li jista ’ jkollu ”), it- tabib tiegħek ser jimmonitorja l- kura tiegħek b’ attenzjoni.
- If you have severe kidney problems, your doctor may monitor your kidney function during
- Jekk għandek problemi serji bil- kliewi, it- tabib tiegħek jista ’ jimmonitorja l- funzjoni tal -
treatment.
kliewi matul il- kura.
Tell your doctor if any of these applies to you.
Għid lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik.
33 Your doctor also needs to know the following whilst you are using Extavia:
34 It- tabib tiegħek jeħtieġ li jkun jaf ukoll dan li ġej waqt li inti tkun qed tuża Extavia:
- If you experience symptoms such as itching all over your body, swelling of your face
- Jekk ikollok sintomi bħal ħakk fuq ġismek kollu, nefħa fil- wiċċ u/ jew fuq ilsienek jew
and/or your tongue or sudden shortness of breath.
qtugħ għall- għarrieda ta ’ nifs.
These may be symptoms of a serious allergic reaction (hypersensitivity), which may become life threatening.
Dawn jistgħu jkunu sintomi ta ’ reazzjoni allerġika serja (sensittività eċċessiva), li tista ’ ssir ta ’ theddida għal ħajtek.
- If you feel noticeably more sad or hopeless than before the treatment with Extavia, or if
- Jekk tħossok ferm aktar imdejjaq/ imdejqa jew bla ħeġġa minn qabel ma bdejt tieħu l -
you develop thoughts of suicide.
kura b’ Extavia, jew jekk tiżviluppa ħsibijiet ta ’ suwiċidju.
If you become depressed while you are on Extavia, you may need special treatment and your doctor will closely monitor you and may also consider stopping your treatment.
Jista ’ jkun ukoll li t- tabib jiddeċiedi li jwaqqaf il- kura tiegħek.
If you suffer from severe depression and/or suicidal thoughts, you will not be treated with Extavia (see also “Do not use Extavia”).
Jekk tbati minn dipressjoni qawwija u/ jew ħsibijiet ta ’ suwiċidju, inti mhux ser tiġi kkurat/ a b’ Extavia (ara wkoll “ Tużax Extavia ”).
- If you notice any unusual bruising, excessive bleeding after injury or if you seem to be
- Jekk tinnota xi tbenġil mhux normali, ħruġ ta ’ demm eċċessiv wara korriment jew jekk
catching a lot of infections.
tara li qed tieħu ħafna infezzjonijiet.
These may be symptoms of a fall in your blood cell count or in the number of platelets in your blood (cells, which help the blood to clot).
Dawn jistgħu jkunu sintomi li l- għadd taċ- ċelluli tad - demm bojod jew li n- numru ta ’ plejtlits f’ demmek (ċelluli li jgħinu lid- demm jagħqad) beda jonqos.
You may need extra monitoring by your doctor.
Jista ’ jkollok bżonn ta ’ monitoraġġ addizzjonali mit- tabib tiegħek.
- If you have loss of appetite, fatigue, feeling sick (nausea), repeated vomiting, especially if
- Jekk ikollok nuqqas fl- aptit, għeja, tħossok ma tiflaħx (dardir), rimettar ripetut, b’ mod
you notice widespread itching, yellowing of the skin or of the whites of the eyes, or easy bruising.
speċjali jekk ikollok ħakk ma ’ ġismek kollu, jekk il- ġilda tiegħek tisfar jew jekk l- abjad t’ għajnejk jisfar jew jekk titbenġel malajr.
Changes to liver function values occurred in patients treated with Extavia during clinical studies.
Seħħ tibdil fir- riżultati tal- funzjoni tal- fwied f’ pazjenti kkurati b’ Extavia waqt studji kliniċi.
As for other beta interferons, severe liver damage, including cases of liver failure, have been reported rarely in patients taking Extavia.
Bħal fil- każ ta ’ beta interferoni oħrajn, kien hemm rapporti ta ’ ħsara severa fil - fwied, li jinkludu każijiet ta ’ kollass tal- fwied f’ pazjenti li qed jieħdu Extavia.
The most serious were reported in patients taking other medicines or who were suffering from diseases that can affect the liver (e.g. alcohol abuse, severe infection).
L- aktar każijiet serji kienu rrappurtati f’ pazjenti li kienu qegħdin jieħdu mediċini oħra jew li kienu qegħdin isofru minn mard li jaffettwa l- fwied (eż. abbuż bl- alkoħol, infezzjoni qawwija).
- If you experience symptoms such as irregular heart beat, swelling such as of the ankles or
- Jekk ikollok sintomi bħal irregolarità fit- taħbit tal- qalb, nefħa bħal fl- għekiesi jew fir -
legs, or shortness of breath.
riġlejn) jew qtugħ ta ’ nifs.
This may suggest a disease of the heart muscle (cardiomyopathy) which has been reported rarely in patients using Extavia.
Dan jista ’ jissuġġerixxi marda tal- muskolu tal- qalb (kardjomijopatija) li ġiet irrappurtata f’ każijiet rari f' pazjenti li kienu qed jużaw Extavia.
- If you notice pain in your belly which is radiating to your back, and/or you feel sick or
- Jekk tinduna b’ xi uġigħ f’ żaqqek li jkun qed jinfirex għal dahrek, u / jew tħossok ma
have a fever.
tiflaħx jew ikollok id- deni.
This may suggest an inflammation of the pancreas (pancreatitis), which has been reported with Extavia use.
Dan jista ’ jissuġġerixxi li għandek infjammazzjoni tal- frixa (pankreatite), li ġiet irrappurtata bl- użu ta ’ Extavia.
This is often associated with an increase of certain blood fats (triglycerides).
Ta ’ spiss, din hija assoċjata ma żieda f’ ċerti xaħmijiet tad- demm (trigliċeridi).
Stop using Extavia and tell your doctor immediately if any of these happens to you.
Tibqax tieħu Extavia u avża lit- tabib tiegħek minnufih jekk ikollok xi wieħed minn dawn is- sintomi.
Other things to consider when using Extavia:
Affarijiet oħra li għandek tqis meta tuża Extavia:
- You will need blood tests to determine your blood cell count, blood chemistry and your liver
- Ser ikollok bżonn ta ’ testijiet tad- demm biex jitkejjel l- għadd taċ- ċelluli tad- demm tiegħek,
enzymes.
il- kimika tad- demm u l- enzimi tal- fwied tiegħek.
These will be performed before you start using Extavia, regularly after treatment with Extavia has been initiated and periodically whilst you are on it, even if you have no particular symptoms.
Dawn ser isiru qabel ma tibda tuża Extavia, regolarment wara li tkun bdiet il- kura b’ Extavia u perjodikament waqt li tkun qed tieħu din il- mediċina, anki jekk ma jkollok ebda sintomi partikolari.
These blood tests will be in addition to the tests which are normally done to monitor your MS.
Dawn it- testijiet tad- demm isiru apparti mit- testijiet li normalment isiru biex jimmonitorjaw l- MS tiegħek.
- If you have a heart disease, the flu-like symptoms which often occur at the start of
- Jekk għandek marda tal- qalb, is- sintomi simili għal dawk ta ’ l- influwenza li spiss iseħħu
treatment may prove stressful to you.
fil- bidu tal- kura jistgħu jkunu ta ’ stress għalik.
Extavia must be used with caution, and your doctor will monitor you for worsening of your heart condition, particularly at the start of treatment.
Extavia għandu jintuża b’ kawtela u t- tabib tiegħek ser jimmonitorjak biex jara jekk il- kundizzjoni ta ’ qalbek hix qed tiggrava, b’ mod partikolari fil- bidu tal- kura.
Extavia itself does not affect the heart directly.
Extavia innifsu ma jaffettwax il- qalb direttament.
- The functioning of your thyroid gland will be checked regularly or whenever thought
- Il- funzjoni tal- glandola tat- tirojde tiegħek ser tiġi eżaminata regolarment jew kull meta t -
necessary by your doctor for other reasons.
tabib tiegħek jaħseb li jkun hemm bżonn għal xi raġuni oħra.
- Extavia contains human albumin and therefore carries a potential risk for transmission of
- Extavia fih l- albumina umana u għalhekk għandu riskju potenzjali għat- trasmissjoni ta ’
viral diseases.
mard virali.
A risk of transmission of Creutzfeld-Jacob disease (CJD) cannot be ruled out.
Ir- riskju ta ’ trasmissjoni tal- marda Creutzfeld- Jacob (CJD) ma jistax jiġi eliminat.
- During treatment with Extavia your body may produce substances called neutralising
- Matul il- kura b’ Extavia, ġismek jista ’ jipproduċi sustanzi msejħa antikorpi newtralizzanti,
antibodies, which may react with Extavia (neutralising activity).
li jistgħu jagħmlu reazzjoni ma ’ Extavia (attività newtralizzanti).
It is not yet clear whether these neutralising antibodies reduce the effectiveness of the treatment.
Għadu mhux ċar jekk l - antikorpi newtralizzanti jnaqqsux l- effettività tal- kura.
Neutralising antibodies are not produced in all patients.
L- antikorpi newtralizzanti mhumiex prodotti fil- pazjenti kollha.
Currently it is not possible to predict which patients belong to this group.
Fil- preżent mhuwiex possibbli li wieħed ibassar liema pazjenti jappartjenu għal dan il- grupp.
Injection site reactions:
Reazzjonijiet fis- sit ta ’ l- injezzjoni:
During Extavia treatment you are likely to experience injection site reactions.
Matul il- kura b’ Extavia, x’ aktarx li ser ikollok reazzjonijiet fis- sit ta ’ l- injezzjoni.
Dead skin and tissue around the injection site (necrosis) are reported less frequently.
Ġilda u tessut mejjet madwar is- sit ta ’ l- injezzjoni (nekrożi) huma rrappurtati b’ mod inqas frekwenti.
Injection site reactions usually become less frequent over time.
Maż - żmien, ir- reazzjonijiet fis- sit ta ’ l- injezzjoni normalment isiru inqas frekwenti.
If this is severe a doctor may have to remove foreign matter and dead tissue (debridement) and, less often, skin grafting is required and healing may take up to 6 months.
Jekk din tkun serja, jista ’ jkun hemm bżonn li tabib ineħħi t- tessut mejjet (debridement), u f’ każijiet inqas komuni, jista ’ jkun meħtieġ li jsir trapjant ta ’ ġilda ġdida, u f’ dan il- każ, il- fejqan jista ’ jieħu sa ’ 6 xhur.
To reduce the risk of getting injection site reaction you must: − use a sterile (aseptic) injection technique, − rotate the injection sites with each injection (see Annex Self-Injection procedure).
Biex tnaqqas ir- riskju ta ’ reazzjoni fis- sit ta ’ l- injezzjoni, inti għandek: – tuża teknika ta ’ injezzjoni sterili (asettika) – tuża postijiet ta ’ injezzjoni differenti għal kull injezzjoni (ara Anness dwar il- Proċedura ta ’ Injezzjoni Personali)
Injection site reactions may occur less frequently if you use an auto-injector device.
Ir- reazzjonijiet fis- siti ta ’ injezzjoni jistgħu jseħħu inqas ta ’ spiss jekk tuża strument ta ’ injezzjoni personali.
If you experience any break in the skin, which may be associated with swelling or fluid leaking out from the injection site:
Jekk ikollok xi qsim fil- ġilda, li jista ’ jkun assoċjat ma ’ nefħa jew ma ’ tnixxija tal- fluwidu mis - sit ta ’ l- injezzjoni:
► Stop injections with Extavia and talk to your doctor.
► Waqqaf l- injezzjonijiet b’ Extavia u kellem lit- tabib tiegħek
► If you have only one sore injection site (lesion) and the tissue damage (necrosis) is not too extensive you may continue using Extavia.
► Jekk għandek post ta ’ injezzjoni wieħed biss li huwa sensibbli (leżjoni) u l- ħsara fit- tessut (nekrożi) m’ hijiex mifruxa żżejjed, tista ’ tkompli tuża Extavia.
► If you have more than one sore injection sites (multiple lesions) you must stop using Extavia until your skin has healed.
► Jekk għandek aktar minn post wieħed ta ’ injezzjoni li huwa sensibbli (leżjonijiet multipli) għandek tieqaf tuża Extavia sakemm il- ġilda tiegħek tkun fieqet.
Your doctor will regularly check the way you inject yourself, particularly if you have experienced injection site reactions.
It- tabib tiegħek sejjer jiċċekkja regolarment il- mod kif inti tinjetta lilek innifsek, b’ mod partikolari jekk inti kellek reazzjonijiet fis- sit ta ’ l- injezzjoni.
Children and adolescents There have been no formal clinical trials undertaken in children or adolescents.
Tfal u adolexxenti Ma saru l- ebda provi kliniċi formali fit- tfal jew fl- adolexxenti.
However, there is some data available in children and adolescents from 12 to 16 years.
Madankollu, hemm xi informazzjoni disponibbli fit- tfal u fl- adolexxenti minn 12 sa 16- il sena.
This data suggests that the safety profile from this age is the same as in adults for use of Extavia 8 million IU under the skin (subcutaneously) every other day.
Din l - informazzjoni tissuġġerixxi li l- profil tas- sigurtà minn din l- età hu l- istess bħala dak fl- adulti għall- użu ta ’ Extavia 8 miljun IU taħt il- ġilda kull jumejn.
Extavia should not be used in children under 12 years of age as there is no information on this use.
Extavia m’ għandux jintuża fit- tfal taħt it- 12- il sena għax m’ hemm l- ebda informazzjoni fuq dan l- użu.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew jekk dan l- aħħar ħadt xi mediċini oħra, anki dawk mingħajr riċetta.
No formal interaction studies have been carried out to find out whether Extavia affects other medicines or is affected by them.
Ma sar ebda studju formali dwar l- interazzjonijiet sabiex wieħed isir jaf jekk Extavia jaffettwax mediċini oħra jew inkella jiġix affettwat minnhom.
Using Extavia with other medicines that modify the immune system response is not recommended, except anti-inflammatory medicines called corticosteroids or the adrenocorticotropic hormone (ACTH).
36 L- użu ta ’ Extavia ma ’ mediċini oħra li jimmodifikaw ir- rispons tas- sistema immuni mhuwiex rakkomandat għajr fil- każ ta ’ mediċini anti- infjammatorji msejħa kortikosterojdi jew l- ormon adrenokortikotropiku (ACTH).
35 Extavia should be used with caution with:
Extavia għandu jintuża b’ kawtela ma ’:
their removal from the body, for example medicines used to treat epilepsy (such as phenytoin).
ċitokromju P450) għat- tneħħija tagħhom mill- ġisem, pereżempju mediċini użati fil- kura ta ’ l - epilessija (bħal phenytoin)
Using Extavia with food and drink Extavia is injected under the skin so any food or drink you consume is not thought to have any effect on Extavia.
L- użu ta ’ Extavia ma ’ l- ikel u max- xorb Extavia jingħata bħala injezzjoni taħt il- ġilda, għalhekk mhux mistenni li jiġi affettwat mill- ikel jew ix- xorb li tikkonsma.
Pregnancy Women at risk of becoming pregnant should use contraception during treatment with Extavia.
Tqala Nisa li jistgħu joħorġu tqal għandhom jużaw miżuri xierqa ta ’ kontraċezzjoni waqt il- kura b’ Extavia.
► If you are pregnant or you think you may be, tell your doctor.
► Jekk inti tqila jew taħseb li tista ’ tkun, avża lit- tabib tiegħek.
Extavia therapy should not be started if you are pregnant (see also “Do not use Extavia”).
Terapija b’ Extavia m’ għandhiex tinbeda jekk inti tqila (ara wkoll “ Tużax Extavia ”).
► If you wish to become pregnant, discuss this with your doctor first.
► Jekk qed tipprova tinqabad tqila, iddiskuti dan mat- tabib tiegħek l- ewwel.
► If you become pregnant while using Extavia, stop your treatment and contact your doctor immediately.
► Jekk tinqabad tqila waqt li tkun qed tieħu Extavia, għandek twaqqaf il- kura tiegħek u għandek tikkuntattja lit- tabib tiegħek minnufih.
Your doctor will decide together with you whether your Extavia treatment will be continued or not.
It- tabib tiegħek ser jiddeċiedi flimkien miegħek jekk il- kura ta ’ Extavia għandhiex tissokta jew le.
Breast-feeding It is not known whether interferon beta-1b passes into human breast milk.
Treddigħ Mhux magħruf jekk Interferon beta- 1b jiġix eliminat mal- ħalib tal- bniedem.
However, it is theoretically possible that a breast-fed baby could experience serious side effects to Extavia.
Madankollu, huwa teoretikament possibbli li trabi mredda ’ mis- sider jista ’ jkollhom effetti sekondarji serji għal Extavia.
► Discuss it with your doctor first to decide whether to stop breast-feeding or to stop using Extavia.
► L- ewwel iddiskuti dan mat- tabib tiegħek biex tieħu deċiżjoni fuq jekk għandekx twaqqaf it - treddigħ jew inkella għandekx twaqqaf Extavia.
Driving or using machines Extavia may cause side effects in the central-nervous system (see section 4 Possible side effects).
Sewqan jew tħaddim ta ’ magni Extavia jista ’ jikkawża effetti sekondarji fis- sistema ċentrali nervuża (ara sezzjoni 4. “ Effetti sekondarji li jista ’ jkollu ”).
If you are especially sensitive, this might influence your ability to drive or use machines.
Jekk inti sensittiv/ a żżejjed, dan jista ’ jaffettwa l- ħila tiegħek li ssuq jew tħaddem magni.
HOW TO USE EXTAVIA
KIF GĦANDEK TUŻA EXTAVIA
Treatment with Extavia should be started under the supervision of a doctor who is experienced in the treatment of multiple sclerosis.
Il- kura b’ Extavia għandha tinbeda taħt is- superviżjoni ta ’ tabib li għandu esperjenza fil- kura ta ’ l - isklerożi multipla.
Always use Extavia exactly as your doctor has instructed you.
Dejjem għandek tieħu Extavia eżatt skond il- parir tat- tabib tiegħek.
Dose The usual dose is:
Doża Id- doża normali hija:
Every other day (once every two days), 1.0 ml of the prepared Extavia solution (see Annex) injected under the skin (subcutaneously).
Ġurnata iva u ġurnata le (darba kull jumejn), 1. 0 ml tas- soluzzjoni ta ’ Extavia ippreparata (ara l - Anness) injettata taħt il- ġilda.
This equals 250 microgram (8 million IU) interferon beta-1b.
Dan huwa ekwivalenti għal 250 mikrogramma (8 miljun IU) interferon beta- 1b.
In general, treatment should be started at a low dose of 0.25 ml (62.5 micrograms).
37 B’ mod ġenerali, il- kura għandha tinbeda b’ doża baxxa ta ’ 0. 25 ml (62. 5 mikrogrammi).
Your doses will then be increased gradually to the full dose of 1.0 ml (250 micrograms).
Id- dożi tiegħek imbagħad ser jiżdiedu gradwalment saddoża sħiħa ta ’ 1. 0 ml (250 mikrogrammi).
The dose should be increased at every fourth injection in four steps (0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml).
0. 75 ml, 1. 0 ml).
Your doctor may decide together with you to change the time intervals for dose increase depending on side effects you may experience at the start of treatment.
It - tabib tiegħek jista ’ jiddeċiedi flimkien miegħek li jibdel l- intervalli ta ’ żmien għal żieda fid- doża, u dan jiddependi fuq l- effetti sekondarji li jista ’ ikollok fil- bidu tal- kura.
36 Preparing the injection Before injection, the Extavia solution has to be prepared from a vial of Extavia powder and 1.2 ml of liquid from the pre-filled solvent syringe.
Preparazzjoni ta ’ l- injezzjoni Qabel l- injezzjoni, is- soluzzjoni ta ’ Extavia għandha tiġi ppreparata minn kunjett ta ’ trab ta ’ Extavia u 1. 2 ml ta ’ likwidu minn ġos- siringa mimlija għal- lest bis- solvent.
This will either be done by your doctor or his/her assistant or by yourself after you have been carefully trained.
Dan għandu jsir jew mit - tabib jew mill- assistent/ a tiegħu jew minnek wara li tkun ġejt imħarreġ biżżejjed.
Detailed instructions for self-injection of Extavia under the skin are provided in the Annex at the back of this leaflet.
Struzzjonijiet dettaljati ta ’ kif tagħti l- injezzjoni ta ’ Extavia lilek innifsek taħt il- ġilda huma mogħtija fl- Anness fil- parti ta ’ wara ta ’ dan il- fuljett.
These instructions also tell you how to prepare the Extavia solution for injection.
Dawn l- istruzzjonijiet ifehmuk ukoll kif tħejji s - soluzzjoni għall- injezzjoni ta ’ Extavia.
The injection site must be changed regularly.
Il- post fil- ġisem mnejn tingħata l- injezzjoni għandu jinbidel b’ mod regolari.
See “Take special care with Extavia” and follow the instructions under “Rotating injection sites” in the Annex at the back of this leaflet.
Ara wkoll “ Oqgħod attent ħafna meta tuża Extavia ” u segwi l- istruzzjonijiet taħt “ Kif tibdel is- siti ta ’ l- injezzjoni ” fl - Anness fil- parti ta ’ wara ta ’ dan il- fuljett.
At present it is not known how long treatment with Extavia should last.
Attwalment għadu mhux magħruf kemm għandha ddum il- kura b’ Extavia.
If you use more Extavia than you should Giving many times the dose of Extavia recommended for the treatment of multiple sclerosis has not led to life-threatening situations.
Jekk tuża Extavia aktar milli suppost Meta ngħatat doża ħafna ikbar mid- doża ta ’ Extavia rakkomandata għall- kura ta ’ sklerożi multipla, ma kienx hemm sitwazzjonijiet fejn il- ħajja tpoġġiet fil- periklu.
► Talk to your doctor if you inject too much Extavia or injected too often.
► Kellem lit- tabib tiegħek f’ każ li tinjetta wisq Extavia jew jekk tinjettah ta ’ spiss wisq.
If you forget to use Extavia If you have forgotten to give yourself an injection at the right time do it as soon as you remember and then follow on with the next one 48 hours later.
Jekk tinsa tuża Extavia Jekk tinsa tagħti injezzjoni lilek innifsek fil- ħin li suppost, għandek tagħmel dan hekk kif tiftakar u mbagħad ħu l- injezzjoni li jkun imiss 48 siegħa wara.
Do not inject a double dose to make up for a forgotten individual dose.
M’ għandekx tinjetta doża doppja biex tpatti għal kull doża individwali li tkun insejt.
If you stop using Extavia Talk to your doctor if you stop or wish to stop treatment.
Jekk tieqaf tuża Extavia Jekk tieqaf jew tixtieq twaqqaf il- kura, għandek tiddiskuti dan mat- tabib tiegħek.
Stopping Extavia is not known to cause acute withdrawal symptoms.
Il- waqfien ta ’ Extavia mhuwiex magħruf li jikkawża sintomi akuti meta tieqaf tieħdu (withdrawal).
Like all medicines, Extavia can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Extavia jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
At the beginning of treatment side effects are common but in general they become less with further treatment.
Fil- bidu tal- kura, l- effetti sekondarji huma komuni imma ġeneralment dawn ibattu matul il- kura.
The most common side effects are:
L- aktar effetti sekondarji komuni li ġew osservati huma:
► Flu-like symptoms such as fever, chills, painful joints, malaise, sweating, headache, or muscular pain.
► Sintomi li jixbħu lil dawk ta ’ l- influwenza bħal deni, tkexkix ta ’ bard, uġigħ fil- ġogi, telqa, għaraq, uġigħ ta ’ ras jew uġigħ fil- muskoli.
These symptoms may be reduced by taking paracetamol or non-steroidal anti- inflammatory medicines such as ibuprofen.
Dawn is- sintomi jistgħu jitnaqqsu billi tieħu paracetamol jew mediċini kontra l- infjammazzjonijiet li ma fihomx sterojdi bħal ibuprofen.
► Injection site reactions.
38 ► Reazzjonijiet fis- sit ta ’ l- injezzjoni.
Symptoms can be redness, swelling, discolouration, inflammation, pain, hypersensitivity, necrosis.
Is- sintomi jistgħu jkunu ħmura, nefħa, telf fil- kulur, infjammazzjoni, uġigħ sensittività eċċessiva, nekrożi.
See “Take special care” in section 2 for more information and what to do if you experience an injection site reaction.
Ara “ Oqgħod attent ħafna b’ Extavia ” f’ sezzjoni 2 għal aktar informazzjoni u x’ għandek tagħmel jekk ikollok reazzjoni fis- sit ta ’ l - injezzjoni.
Please talk to your doctor for further information.
Jekk jogħġbok ikkonsulta t- tabib tiegħek għal aktar tagħrif.
To reduce side effects at the start of treatment, your doctor should start you on a low dose of Extavia and increase it gradually (see section 3, “How to use Extavia”).
Biex tnaqqas l- effetti sekondarji fil- bidu tal- kura, it- tabib tiegħek għandu jibdik fuq doża baxxa ta ’ Extavia u għandu jżidha gradwalment (ara sezzjoni 3. “ Kif għandek tuża Extavia ”).
Extavia may also cause serious side effects.
Extavia jista ’ jikkawża wkoll effetti sekondarji serji.
37 ► Tell your doctor immediately and stop using Extavia:
► Għid lit- tabib tiegħek minnufih u ieqaf uża Extavia:
- if you experience symptoms such as itching all over your body, swelling of your face and/or
- jekk ikollok sintomi bħal ħakk fuq ġismek kollu, nefħa f’ wiċċek u/ jew fuq ilsienek jew
your tongue or sudden shortness of breath.
qtugħ ta ’ nifs għall- għarrieda.
- if you feel noticeably more sad or hopeless than before the treatment with Extavia, or if
- jekk tħossok ferm iktar imdejjaq/ imdejqa jew bla ħeġġa minn qabel il- kura b’ Extavia, jew
you develop thoughts of suicide.
jekk tiżviluppa ħsibijiet ta ’ suwiċidju.
- if you notice any unusual bruising, excessive bleeding after injury or if you seem to be
- jekk tinnota tbenġil mhux normali, ħruġ ta ’ demm eċċessiv wara korriment jew jekk tidher
catching a lot of infections.
li tkun qed tieħu ħafna infezzjonijiet.
- if you have loss of appetite, fatigue, feeling sick (nausea), repeated vomiting, especially if
- jekk ikollok inqas aptit, għeja, tħossok ser tirremetti (dardir), rimettar ripetut, b’ mod
you notice widespread itching, yellowing of the skin, or of the whites of the eyes or easy bruising.
speċjali jekk tinnota ħakk mifrux mal- ġisem kollu, sfurija tal- ġilda jew ta ’ l- abjad ta ’ l - għajnejn jew jekk titbenġel faċilment.
- if you experience symptoms like irregular heart beat, swelling such as of the ankles or legs,
- jekk ikollok sintomi bħal taħbit tal- qalb irregolari, nefħa bħal ta ’ l- għekiesi jew tar- riġlejn,
or shortness of breath.
jew qtugħ ta ’ nifs.
- if you notice pain in your belly which is radiating to your back, and/or you feel sick or
- jekk tinnota uġigħ f’ żaqqek li jkun qed jinfirex għal dahrek, u/ jew tħossok marid/ a jew
have a fever.
ikollok id- deni.
The following side effects listing is based on reports from clinical trials with Extavia (List 1) and from side effects reported on the marketed product (List 2).
L- effetti sekondarji li ġejjin huma bbażati fuq rapporti minn provi kliniċi b’ Extavia (Lista 1) u minn effetti sekondarji rrappurtati wara li l- prodott ħareġ fis- suq (Lista 2).
Side effects which have occurred in clinical trials with Extavia very commonly (1 or more in every 10 patients) and at a higher percentage than those observed with placebo.
Effetti mhux mixtieqa li ġraw fi provi kliniċi b’ Extavia b’ mod komuni ħafna (f’ persentaġġ ta ’ ≥10% tal- każijiet) u f’ persentaġġ ogħla minn dawk osservati bil - plaċebo.
The list also includes side effects which occur in less than 1 in 10 patients but were significantly associated with the treatment:
It- tabella tinkludi wkoll effetti mhux mixtieqa li ġraw f’ inqas minn 10% tal - każijiet iżda kienu assoċjati b’ mod sinifikanti mal- kura
- reduced number of white blood cells, swollen lymph glands
- tnaqqis fl- għadd ta ’ ċelluli bojod fid- demm, glandoli limfatiċi minfuħin
- decrease of sugar in the blood
- tnaqqis fil- livell taz- zokkor fid- demm
- depression, anxiety
- dipressjoni, ansjetà
- headache, dizziness, sleeplessness, migraine, numbness or tingling feeling (paresthesia)
- uġigħ ta ’ ras, sturdamenti, problemi ta ’ nuqqas ta ’ rqad, emigranja, tnemnin jew ħass ta ’
- conjunctivitis, abnormal vision
- konġuntivite, vista mhix ċara
- ear pain
- uġigħ fil- widnejn
- irregular, rapid beating or pulsation of the heart (palpitation)
- taħbit tal- qalb irregolari jew qawwi (palpitazzjoni)
- redness and/or facial flushing due to widening of blood vessels, increased blood pressure
- ħmura u/ jew ħmura fil- wiċċ minħabba twessigħ tal- kanali tad- demm, pressjoni tad- demm
- runny nose, cough, hoarseness due to infection of the upper respiratory tract, sinusitis, cough
- imnieħer iqattar, sogħla, ħanqa minħabba infezzjoni fil- parti ta ’ fuq ta ’ l- apparat respiratorju,
increased, shortness of breath
sinusite, żieda fis- sogħla, qtugħ ta ’ nifs
- diarrhoea, constipation, nausea, vomiting, abdominal pain
- dijarea, stitikezza, tqalligħ, rimettar, uġigħ addominali
- rises in the blood levels of liver enzymes (will show up in blood tests)
- żieda fil- livelli tad- demm ta ’ l- enzimi tal- fwied (dan jintwera fit- testijiet tad- demm)
- skin disorder, rash
- problemi fil- ġilda, raxx
- muscle stiffness (hypertonia), painful muscles (myalgia), muscular debility (myasthenia), back
- ebusija tal- muskoli (ipertonija), uġigħ fil- muskoli (majalġja), indeboliment fil- muskoli
pain, pain in extremities such as fingers and toes
(mijastenija), uġigħ fid- dahar, uġigħ fl- estremitajiet bħal fis- swaba ’ kemm ta ’ l- id kif ukoll tas- saqajn
- holding urine (urine retention), protein in the urine (will show up in urine tests), urinary
- żamma ta ’ l- awrina, proteini fl- awrina (joħorġu fit- testijiet ta ’ l- awrina), tgħaddi l- awrina ta ’
- injection site reaction (including redness, swelling, discoloration, inflammation, pain, allergic
- reazzjoni fis- sit ta ’ l- injezzjoni (li tinkludi ħmura, nefħa, bdil fil- kulur, infjammazzjoni, uġigħ,
reaction (hypersensitivity), see “Take special care with Extavia”), skin breakdown and tissue destruction (necrosis) at injection site (see “Take special care with Extavia”), flu-like symptoms, fever, pain, chest pain, accumulation of fluid in arm, leg or face, lack/loss of strength, chills, sweating, malaise
reazzjoni allerġika (sensittività eċċessiva), ara “ Oqgħod attent ħafna b’ Extavia ”), problemi fil - ġilda u therrija ta ’ tessuti (nekrożi) fis- sit ta ’ l- injezzjoni (ara “ Oqgħod attent ħafna b’ Extavia ”), sintomi bħal ta ’ l- influwenza, deni, uġigħ, uġigħ fis- sider, akkumulazzjoni ta ’ fluwidu fid - dirgħajn, riġlejn jew il- wiċċ, nuqqas/ telf ta ’ saħħa, sirdat, għaraq, tħossok ser tirremetti.
Side effects reports on the marketed product (from spontaneous reporting):
Rapporti ta ’ effetti sekondarji tal- prodott wara li ħareġ fis- suq (minn rapporti spontanji);
► Very common side effects (means 1 or more in every 10 patients are likely to get these):
► Effetti sekondarji komuni ħafna tfisser 10 jew aktar minn kull 100 pazjent jista ’ jkollhom dawn:
- flu-like symptoms*,
- sintomi bħal ta ’ l- influwenza *,
- injection site reaction*,
- reazzjoni fis- sit ta ’ l- injezzjoni *,
- injection site inflammation*,
- infjammazzjoni tas- sit ta ’ l- injezzjoni *,
- injection site pain*.
- uġigħ fis- sit ta ’ l- injezzjoni *.
(* frequencies based on clinical trials)
(* frekwenzi bbażati fuq provi kliniċi)
► Common side effects (means between 1 and 10 in every 100 patients are likely to get these):
► Effetti sekondarji komuni (tfisser bejn 1 u 10 jew aktar minn kull 100 pazjent jista ’ jkollhom dawn):
- skin breakdown and tissue destruction (necrosis) at injection site*
- tqaxxir tal- ġilda u qerda tat- tessut (nekrożi) fis- sit ta ’ l- injezzjoni *
► Uncommon side effects (means between 1 and 10 in every 1,000 patients are likely to get these):
► Effetti sekondarji mhux komuni (tfisser bejn 1 u 10 jew aktar minn kull 1, 000 pazjent jista ’ jkollhom dawn):
- depression,
- dipressjoni,
- increase in blood pressure,
- żieda fil- pressjoni tad- demm,
- change in the results of liver tests (increase in the blood levels of enzymes produced by
- tibdil fir- riżultat tat- test tal- fwied (żieda fil- livelli tad- demm ta ’ l- enzimi li jipproduċi l- fwied),
- swollen and usually itching patches of skin or mucous membranes (urticaria),
- nefħa u normalment ħakk f’ postijiet fil- ġilda jew f’ membrani mukużi (urtikarja),
- painful muscles,
- uġigħ fil- muskoli,
► Rare side effects (means between 1 and 10 in every 10,000 patients are likely to get these):
► Effetti sekondarji rari (tfisser bejn 1 u 10 jew aktar minn kull 10, 000 pazjent jista ’ jkollhom dawn):
- disturbance in the functioning of the thyroid gland (too much or too little hormone is
- disturbi fil- funzjoni tal- glandola tat- tirojde (wisq jew ftit wisq ormon prodott),
- a certain type of blood fats (triglycerides) may increase, see “Take special care with Extavia”
- ċertu tip ta ’ xaħmijiet fid- demm (trigliċeridi) jistgħu jiżdiedu, ara “ Oqgħod attent ħafna
(this will show up in blood tests),
b’ Extavia ” (dawn joħorġu fit- testijiet tad- demm),
- severe loss of appetite leading to weight loss (anorexia),
- nuqqas kbir ta ’ aptit li jwassal għal telf fil- piż (anoreksja),
- mood swings,
40
- suicide attempt,
- tibdil fil- burdati,
- convulsion,
- tentattiv ta ’ suwiċidju,
- disease of the heart muscle (cardiomyopathy),
- konvulżjoni,
- faster heart beat,
- mard tal- muskolu tal- qalb (kardjomijopatija)
- irregular, rapid beating or pulsation of the heart (palpitation),
- taħbit tal- qalb aktar mgħaġġel,
- sudden shortness of breath (bronchospasm),
- taħbit jew pulsazzjoni tal- qalb (palpitazzjoni) irregolari, veloċi
- shortness of breath (dyspnoea),
- qtugħ għall- għarrieda tan- nifs (dispepsja)
- pancreatitis, see “Take special care with Extavia”,
- pankreatite, ara “ Oqgħod attent ħafna b’ Extavia ”,
- blood levels of a specific liver enzyme (gamma GT) and a reddish yellow pigment (bilirubin),
- il- livell fid- demm ta ’ enzima speċifika tal- fwied (gamma GT) u pigment safrani fl- aħmar
which is produced by your liver, may rise (this will show up in blood tests),
(bilirubin), li huwa prodott mill- fwied tiegħek, jista ’ jogħla (dan joħroġ fit- testijiet tad- demm),
- skin discoloration,
- telf fil- kulur tal- ġilda,
- malaise,
- tħossok ser tirremetti,
HOW TO STORE EXTAVIA
KIF TAĦŻEN EXTAVIA
Do not use after the expiry date which is stated on the pack.
M’ għandekx tuża wara d- data ta ’ skadenza li tidher fuq il- pakkett.
However, if you are not able to do so, it will remain usable for a period of 3 hours, if kept at 2-8°C (in a refrigerator).
Madankollu, jekk ma tkunx tista ’ tagħmel dan, tibqa stabbli għall- perijodu ta ’ 3 sigħat jekk tinżamm f’ temperatura ta ’ 2- 8°C (fi friġġ).
Do not use Extavia if you notice it contains particles or is discoloured.
M’ għandekx tuża Extavia jekk ikun fih xi frak jew ikun bidel il- kulur.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar tiegħek dwar kif għandek tarmi mediċini li m’ għandekx bżonn iżjed.
What Extavia conta ins − The active substance is interferon beta-1b.
X’ fih Extavia − Is- sustanza attiva hija interferon beta- 1b.
Each vial contains 300 microgram (9.6 million IU) interferon beta-1b per vial.
Kull kunjett fih 300 mikrogramma (9. 6 miljun IU) interferon beta- 1b.
After reconstitution, each millilitre contains 250 microgram (8 million IU) interferon beta-1b. − The other ingredients are
Wara r- rikostituzzjoni, kull millilitru jkun fih 250 mikrogramma (8 miljun IU) interferon beta- 1b. − Is- sustanzi l- oħra huma
in the powder: mannitol and human albumin. in the solvent: sodium chloride, water for injections.
fit- trab: mannitol u albumina umana fis- solvent: sodium chloride, ilma għal injezzjonijiet.
What Extavia looks like and contents of the pack Extavia is a powder and solvent for solution for injection.
Id- Dehra ta ’ Extavia u l- kontenuti tal- pakkett Extavia huwa trab u solvent għall- injezzjoni.
The powder is white to off-white.
Extavia huwa trab abjad jagħti fl- offwajt.
The Extavia powder is provided in a 3-millilitre vial.
It- trab ta ’ Extavia hu pprovdut f’ kunjett ta ’ 3 millilitri.
The solvent for Extavia is provided in a 1.2 ml pre-filled syringe and contains 1.2 ml sodium chloride 5.4 mg/ml (0.54% (w/v)) solution for injection.
Is- solvent għal Extavia hu pprovdut f’ siringa mimlija lesta ta ’ 1. 2 ml u fih 1. 2 ml ta ’ sodium chloride 5. 4 mg/ ml (0. 54% (w/ v) soluzzjoni għall- injezzjoni.
Extavia is available in pack sizes of: − 5 vials of interferon beta-1b and 5 pre-filled syringes containing solvent. − 15 vials of interferon beta-1b and 15 pre-filled syringes containing solvent. − 3-month multipack containing 45 (3x15) vials of interferon beta-1b and 45 (3x15) pre-filled syringes containing solvent.
41 Extavia hu disponibbli f’ daqsijiet tal- pakkett ta ’: − 5 kunjetti ta ’ interferon beta- 1b u 5 siringi mimlijin għal- lest li fihom is- solvent (soluzzjoni tas - sodium chloride). − 15- il kunjett ta ’ interferon beta- 1b u 15- il siringa mimlijin għal- lest li fihom is- solvent. − Pakkett b’ ħafna għal 3 xhur li fih 45 (3x15) kunjett ta ’ interferon beta- 1b u 45 (3x15) siringa mimlija għal- lest li fihom is- solvent.
40 Manufacturer Novartis Pharmaceuticals UK, Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Manifattur Novartis Pharmaceuticals UK, Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
España Novartis Farmacéutica, S.A.
42 España Novartis Farmacéutica, S. A.
42 Annex:
43 Anness:
SELF-INJECTION PROCEDURE
PROĊEDURA BIEX TAGĦTI L- INJEZZJONI LILEK INNIFSEK
The following instructions are intended to explain how to prepare Extavia for administration and how to inject Extavia yourself.
L- istruzzjonijiet li ġejjin huma maħsuba biex jispjegaw kif tipprepara Extavia għall- injezzjoni u kif għandek tipproċedi biex tinjetta lilek innifsek b’ Extavia.
Your doctor or his/her assistant will help you to learn the process of self-administration.
It- tabib tiegħek jew l- assistent/ a tiegħu/ tagħha ser jgħinuk titgħallem il- proċess ta ’ kif għandek tinjetta lilek nnifsek.
Do not attempt to inject yourself until you are sure that you understand how to prepare the injection solution and give the injection to yourself.
Tippruvax tinjetta lilek nnifsek sakemm tkun żgur li fhimt kif tipprepara s- soluzzjoni għall- injezzjoni u kif għandek tinjetta lilek nnifsek.
P ART I:
PARTI I:
STEP BY STEP INSTRUCTIONS
STRUZZJONIJIET PASS WARA PASS
The instructions include the following main steps:
L- istruzzjonijiet jinkludu dawn il- passi ewlenin li ġejjin:
A) General advice B) Getting ready to inject C) Reconstituting the solution, step by step D) Drawing up the injection E) Making the injection manually (to make an injection with an auto-injector, refer to the instructions for use provided with the auto-injector) F) Quick review of the process
A) Parir ġenerali B) Kif tipprepara għall- injezzjoni tiegħek C) Rikostituzzjoni tas- soluzzjoni, pass wara pass D) Kif tipprepara l- injezzjoni E) Kif tagħmel l- injezzjoni manwalment (biex taghmel l- injezzjoni b’ auto- injector, irreferi ghall- istruzzjonijiet ghal użu ipprovduti ma ’ l- auto- injector) F) Reviżjoni malajr tal- proċess
A) General advice
A) Parir ġenerali
• Getting off to a good start!
• Biex tibda bit- tajjeb!
You will find that within a few weeks your treatment will become a natural part of your routine.
Ser issib li wara ftit ġimgħat, il- kura tiegħek ser issir parti naturali mir- rutina tiegħek.
- Set up a permanent storage area in a convenient location out of the reach of children so that
- Sib post permanenti fejn taħżen il- mediċina li jkun konvenjenti għalik u li ma jkunx jista ’
your Extavia and other supplies are always easy to find.
jintlaħaq mit- tfal, biex Extavia u provvisti oħrajn ikunu dejjem faċli biex issibhom.
For details on storage conditions see section 5 of the leaflet, “How to store Extavia”.
Għal aktar dettalji dwar il- kundizzjoniet tal- ħażna, ara sezzjoni 5 tal- fuljett “ Kif taħżen Extavia ”.
- Try to give yourself the injection at the same time each day.
- Ipprova injetta lilek innifsek fl- istess ħin kull jum.
This makes it easier to remember
Dan jagħmilha iktar faċli biex tiftakar
and easier to plan a block of time when you will not be interrupted.
teħodha u biex talloka ħin meta inti ma jkollokx interruzzjonijiet.
Please refer to section 3 of the leaflet, “How to use Extavia”, for further details on how to use Extavia.
Jekk jogħġbok irreferi għal sezzjoni 3 tal- fuljett, “ Kif tuża Extavia ” għal aktar tagħrif dwar kif tuża Extavia.
- Prepare each dose only when you are ready for an injection.
- Ipprepara kull doża biss meta tkun lest/ a biex tieħu l- injezzjoni.
After mixing Extavia, you should
Wara li tħallat Extavia, għandek
administer the injection immediately (if Extavia is not used immediately, see section 5 of the leaflet, “How to store Extavia”).
tagħti l- injezzjoni minnufih (jekk Extavia ma jintużax immedjatament, ara sezzjoni 5 tal- fuljett, “ Kif taħżen Extavia ”).
• Important tips to keep in mind
• Suġġerimenti importanti li għandek tiftakar
- Be consistent - use Extavia as described in section 3 of the leaflet, “How to use Extavia”.
Dejjem
Always double -check your dosage.
iċċekkja mill- ġdid id- doża tiegħek.
- Keep your syringes and syringe disposal unit out of the reach of children; lock the supplies if
- Żomm is- siringi u r- reċipjent tar- rimi għas- siringi fejn ma jintlaħqux mit- tfal; aqfel dawn il -
possible.
provvisti jekk ikun possibbli.
- Never re-use syringes or needles.
- Qatt tuża mill- ġdid siringi jew labar.
- Always use a sterile (aseptic) technique as described in here.
- Dejjem uża t- teknika sterili (asettika) kif deskritt hawnhekk.
- Always place the used syringes in the proper disposal unit.
- Dejjem poġġi s- siringi użati f’ reċipjent tar- rimi xieraq biss.
43 B) Getting ready to inject
44 B) Kif tipprepara għall- injezzjoni tiegħek
• Choosing an injection site
• Kif tagħżel il- post ta ’ l- injezzjoni
Before preparing your injection, decide where you are going to inject.
Qabel tipprepara għall- injezzjoni tiegħek, iddeċiedi fejn se tinjetta l- injezzjoni.
You should inject Extavia into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 to 12 mm under the skin).
Extavia għandu jiġi injettat fis- saff tax- xaħam bejn il- ġilda u l- muskolu (jiġifieri, taħt il- ġilda, madwar 8 sa 12- il mm taħt il- ġilda).
The best places for injections are where the skin is loose and soft, and away from joints, nerves, bones, for example the abdomen, arm, thigh or buttocks.
L- aħjar postijiet għall- injezzjonijiet huma fejn il- ġilda tkun merħija u ratba, u ’ l bogħod mill - ġogi, nervituri, għadam, per eżempju ż- żaqq, fl- id, fil- koxxa jew fil- warrani.
Do not use any area where you can feel lumps, bumps, firm knots, pain or an area that is discoloured, indented, scabbed, or where the skin is broken.
Tużax żoni fejn tħoss nefħiet, daqqiet, għoqiedi, uġigħ jew żoni li għandhom telf fil - kulur, imdaħħlin ’ il ġewwa jew fejn il- ġilda hija maqsuma.
Talk to your doctor or healthcare professional about these or any other unusual conditions you may find.
Kellem lit- tabib tiegħek jew lill - professjonist tal- kura tas- saħħa dwar dan jew dwar kundizzjonijiet oħra mhux normali li tista ’ ssib.
You should rotate the injection site at every injection.
Il- post ta ’ l- injezzjoni għandu jinbidel ma ’ kull injezzjoni.
If some areas are too difficult for you to reach, you may need a family member or friend to help you with these injections.
Jekk xi partijiet jidhru li huma diffiċli ħafna biex tilħaqhom, jista ’ jkun hemm bżonn ta ’ xi membru tal- familja jew xi ħabib/ a biex jgħinuk tagħmel l- injezzjonijiet.
Follow the sequence described in the schedule at the end of the Annex (see II) Rotating injection sites) and you will come back to your first injection site area after 8 injections (16 days).
Billi ssegwi s- sekwenza deskritta fl- iskeda fi tmiem l- Anness (ara II) Rotazzjoni tas - siti ta ’ injezzjoni) u int ser terġa ’ tirritorna għall- ewwel żona tal- post ta 'l- injezzjoni wara 8 injezzjonijiet (16- il jum).