qanastek/EMEA-V3 huggingface dataset:
As for other beta interferons, severe liver damage, including cases of liver failure, have been reported rarely in patients taking Betaferon.
Bħal fil- każ ta ’ beta interferoni oħrajn, f’ pazjenti li kienu qed jieħdu Betaferon kien hemm rapporti rari ta ’ ħsara severa fil- fwied, inkluż każijiet ta ’ insuffiċjenza tal - fwied.
The most serious were reported in patients taking other drugs or who were suffering from diseases that can affect the liver (e.g. alcohol abuse, severe infection).
L- aktar każijiet serji kienu rrapportati f’ pazjenti li kienu qegħdin jieħdu mediċini oħra jew li kienu qegħdin isofru minn mard li jista ’ jaffettwa l- fwied (e. ż. abbuż bl- alkoħol, infezzjoni qawwija).
− If you experience symptoms like irregular heart beat, swelling such as of the ankles or legs, or shortness of breath.
- Jekk ikollok sintomi bħal taħbit tal- qalb mhux regolari, nefħa bħal fl- għekiesi jew fir -
This may suggest a disease of the heart muscle (cardiomyopathy) which has been reported rarely in patients using Betaferon.
Dan jista ’ jissuġġerixxi marda tal- muskolu tal- qalb (kardjomijopatija) li kienet irrapportata f’ każijiet rari f' pazjenti li kienu qed jużaw Betaferon.
− If you notice pain in your belly which is radiating to your back, and/or you feel sick or have a fever.
- Jekk tinnota uġigħ f’ żaqqek li jinfirex għal dahrek, u/ jew tħossok ma tiflaħx jew ikollok id -
This may suggest an inflammation of the pancreas (pancreatitis), which has been reported with Betaferon use.
Dan jista ’ jissuġġerixxi li għandek infjammazzjoni tal- frixa (pankreatite), li kienet irrapportata bl- użu ta ’ Betaferon.
This is often associated with an increase of certain blood fats (triglycerides).
Ta ’ spiss, din hija assoċjata ma żjieda f’ ċertu xaħmijiet fid - demm (trigliċeridi).
► Stop using Betaferon and tell your doctor immediately if any of these happens to you.
Waqqaf l- użu ta ’ Betaferon u għid lit- tabib tiegħek minnufih jekk ikollok xi wieħed minn dawn is- sintomi.
Other things to consider when using Betaferon:
Affarijiet oħra li għandek tqis meta tuża Betaferon:
− You will need blood tests to measure the number of your blood cells, blood chemistry and your liver enzymes.
- Se jkollok bżonn ta ’ testijiet tad- demm biex jiġu mkejla n- numru ta ’ ċelluli tad- demm tiegħek,
This will be done before you start using Betaferon, regularly after treatment with Betaferon has been initiated and periodically whilst you are on it, even if you have no particular symptoms.
Dan se jseħħ qabel ma tibda tuża Betaferon, regolarment wara li tkun bdiet il- kura b’ Betaferon u perjodikament waqt li tkun qed tieħu din il- mediċina, anki jekk ma jkollok l- 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 flimkien ma ’ testijiet li normalment isiru biex jissorveljaw l- MS tiegħek.
− If you have a heart disease, the flu-like symptoms, which often occur at the start of treatment, may prove stressful to you.
- Jekk għandek marda tal- qalb, is- sintomi simili għal dawk ta ’ l- influwenza, li spiss iseħħu
Betaferon must be used with caution, and your doctor will monitor you for worsening of your heart condition, particularly during the start of treatment.
Betaferon għandu jintuża b’ attenzjoni u t - tabib tiegħek se jissorveljak biex jara jekk il- kundizzjoni ta ’ qalbek hux qed tiggrava, b’ mod partikolari matul il- bidu tal- kura.
Betaferon itself does not affect the heart directly.
Betaferon innifsu ma jaffettwax il- qalb direttament.
− You will have a check of the function of your thyroid gland, regularly or whenever thought necessary by your doctor for other reasons.
- Se jkollok tittestja l- funzjoni tal- glandola tat- tirojde tiegħek, b’ mod regolari jew kull meta t -
− Betaferon contains human albumin and therefore carries a potential risk for transmission of viral diseases.
- Betaferon fih albumina umana u għalhekk għandu riskju potenzjali għal trasmissjoni ta ’
A risk of transmission of Creutzfeld-Jacob disease (CJD) cannot be ruled out.
- Matul il- kura b’ Betaferon, ġismek jista ’ jipproduċi sustanzi msejħa antikorpi
98 − During treatment with Betaferon your body may produce substances which are called neutralising antibodies, which may react with Betaferon (neutralising activity).
newtralizzanti, li jistgħu jagħmlu reazzjoni ma ’ Betaferon (attività newtralizzanti).
Symptoms include redness, swelling, change in the skin colour, inflammation, pain, and hypersensitivity.
Is- sintomi jinkludu ħmura, nefħa, bidla fil- kulur tal- ġilda, infjammazzjoni, uġigħ u sensittività eċċessiva.
To reduce the risk of getting injection site reactions you must: − use a sterile (aseptic) injection technique, − rotate the injection sites with each injection (see Annex ‘Self-injection procedure’, Part II, in the second part of this leaflet).
Biex tnaqqas ir- riskju ta ’ reazzjonijiet fil- lok ta ’ l- injezzjoni, inti għandek: – tuża teknika ta ’ injezzjoni sterili (asettika) – tuża postijiet ta ’ injezzjoni differenti għal kull injezzjoni (ara Anness ‘ Proċedura ta ’ kif tinjetta lilek innifsek ’, Parti II, fit- tieni parti ta ’ dan il- fuljett)
► Stop injections with Betaferon and talk to your doctor
► Waqqaf l- injezzjonijiet b’ Betaferon u kellem lit- tabib tiegħek.
Betaferon should be used with caution with:
103 Betaferon għandu jintuża b’ kawtela ma ’:
their removal from the body, for example medicines used to treat epilepsy (like phenytoin).
ċitokromju P450) għat- tneħħija tagħhom mill- ġisem, eżempju, mediċini wżati fil- kura ta ’ l - epilessija (bħal phenytoin)
99 Using Betaferon with food and drink:
Meta tuża Betaferon ma ’ l- ikel u max- xorb:
► If you are pregnant or you think you may be, tell your doctor.
► Jekk inti tqila jew taħseb li tista ’ tkun, għid lit- tabib tiegħek.
Betaferon treatment should not be started if you are pregnant (see also ‘Do not use Betaferon’).
Kura b’ Betaferon m’ għandhiex tinbeda jekk inti tqila (ara wkoll ‘ Tużax Betaferon ’).
► If you wish to become pregnant, discuss this with your doctor first.
► Jekk tixtieq toħroġ tqila, iddiskuti dan mat- tabib tiegħek l- ewwel.
► If you become pregnant while using Betaferon, stop your treatment and contact your doctor immediately.
► Jekk toħroġ tqila waqt li qed tuża Betaferon, għandek twaqqaf il- kura tiegħek u għandek tikkuntattja lit- tabib tiegħek minnufih.
Your doctor will decide together with you, if your Betaferon treatment will be continued or not.
It- tabib tiegħek ser jiddeċiedi flimkien miegħek, jekk il - kura ta ’ Betaferon għandhiex tissokta jew le.
Breast-feeding:
Treddigħ:
It is not known whether Interferon beta-1b passes into human breast milk.
Mhux magħruf jekk Interferon beta- 1b jiġix jgħaddix fil- ħalib tas- sider uman.
However, it is theoretically possible that a breast-fed baby could experience serious side effects to Betaferon. ► Discuss it with your doctor first to decide whether to stop breast-feeding or to stop using Betaferon.
Madankollu, huwa teoretikament possibbli li trabi mredda ’ mis- sider jista ’ jkollhom effetti sekondarji serji għal Betaferon. ► L- ewwel iddiskuti dan mat- tabib tiegħek biex tieħu deċiżjoni dwar jekk għandekx twaqqaf it- treddigħ jew għandekx twaqqaf Betaferon.
Driving or using machines:
Sewqan u tħaddim ta ’ magni
Betaferon may cause side effects in the central-nervous system (see section 4. ‘Possible side effects’).
Effetti sekondarji li jista ’ jkollu).
If you are especially sensitive, this might affect your ability to drive or use machines.
Jekk inti sensittiv/ a żżejjed, dan jista ’ jaffettwa l- ħila tiegħek li ssuq jew tħaddem magni.
Important information about some of the ingredients of Betaferon:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Betaferon
The inactive ingredients of Betaferon include small amounts of mannitol, a naturally occurring sugar and human albumin, a protein.
Is- sustanzi mhux attivi ta ’ Betaferon jinkludu ammonti żgħar ta ’ mannitol, zokkor naturali, u albumina umana, proteina.
If you know that you are allergic (hypersensitive) to any of the ingredients or if you become so, you must not use Betaferon.
Jekk taf li inti allerġiku/ a (tbati minn sensittività eċċessiva) għal xi sustanza ta ’ Betaferon, jew jekk issir hekk, m’ għandekx tuża Betaferon.
How to use Betaferon
Kif għandek tuża Betaferon
Treatment with Betaferon should be started under the supervision of a doctor who is experienced in the treatment of multiple sclerosis.
Il- kura b’ Betaferon għandha tinbeda taħt is- superviżjoni ta ’ tabib li għandu esperjenza fil- kura ta ’ l - isklerożi multipla.
Always use Betaferon exactly as your doctor has instructed you.
Dejjem għandek tuża Betaferon skond il- parir eżatt tat- tabib.
You should check with your doctor or pharmacist if you are unsure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
100 Dose:
Doża:
The usual dose is: every other day (once every two days), 1.0 ml of the prepared Betaferon solution (see Annex ‘Self-injection procedure’ in the second part of this leaflet) injected under the skin (subcutaneously).
ġurnata iva u ġurnata le (darba kull jumejn), 1. 0 ml ta ’ soluzzjoni ppreparata ta ’ Betaferon (ara Anness ‘ Proċedura ta ’ kif tinjetta lilek innifsek ’, parti II, fit- tieni parti ta ’ dan il- fuljett) injettata minn 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.
When starting treatment with Betaferon it is tolerated best by gradually increasing the dose, i.e. starting with just 0.25 ml of the medication and then increasing, after every 3rd injection to 0.5 ml, 0.75 ml and then finally to the full (1 ml) dose of Betaferon.
Meta tinbeda l- kura, Betaferon huwa ttollerat l- aħjar meta d- doża tiżdied b’ mod gradwali, i. e. tibda biss b’ 0. 25 ml tal- medikazzjoni u wara żżid, wara kull tliet injezzjonijiet għal 0. 5 ml, 0. 75 ml u fl - aħħar għad- doża sħiħa (1 ml) ta ’ Betaferon.
Your doctor may decide, together with you, to change the time interval between increases in the dose 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 bejn iż- żjidiet fid- doża, u dan jiddependi fuq l- effetti sekondarji li jista ’ jkollok fil- bidu tal- kura.
To easily increase the dosage during the first 12 injections, you may be given a special titration pack, containing four differently coloured packs with specially marked syringes and with detailed instructions on the separate introductory leaflet for titration pack.
Biex iżżid id- dożaġġ b’ mod faċli waqt l- ewwel 12- il injezzjoni għandu mnejn tingħata pakkett ta ’ titrazzjoni speċjali li fih erba ’ pakketti b’ kuluri differenti b’ siringi mmarkati b’ mod speċjali u b’ istruzzjonijiet dettaljati fuq il- fuljett ta ’ introduzzjoni separat għall- pakkett ta ’ titrazzjoni.
Preparing the injection:
Preparazzjoni ta ’ l- injezzjoni:
Before injection, the Betaferon solution has to be prepared from a vial of Betaferon powder and 1.2 ml of liquid from the pre-filled solvent syringe.
Qabel l- injezzjoni, is- soluzzjoni ta ’ Betaferon għandha tiġi ppreparata minn kunjett ta ’ trab ta ’ Betaferon 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 mit - tabib jew mill- assistent/ a tiegħu jew minnek wara li tkun ġejt imħarreġ biżżejjed.
For details how the Betaferon solution for injection is prepared see Annex ‘Self-injection procedure’, Part I.
Għad- dettalji dwar kif tiġi ppreparata s- soluzzjoni għall- injezzjoni ta ’ Betaferon ara Anness ‘ Proċedura ta ’ kif tinjetta lilek innifsek ’, Parti I.
Detailed instructions for self-injection of Betaferon under the skin are provided in Part IE of the Annex ’Self-injection procedure’.
Istruzzjonijiet dettaljati ta ’ kif tagħti l- injezzjoni ta ’ Betaferon lilek innifsek minn taħt il- ġilda huma pprovduti f’ Parti IE ta ’ l- Anness ‘ Proċedura ta ’ kif tinjetta lilek innifsek ’.
The injection site must be changed regularly.
Il- post fil- ġisem fejn tingħata l- injezzjoni għandu jinbidel b’ mod regolari.
See ‘Take special care with Betaferon’ and follow the instructions in Part II ‘Rotating injection sites’ and Part III (Betaferon Medication Record) of the Annex ’Self-injection procedure’.
Ara wkoll ‘ Oqgħod attent ħafna meta tuża Betaferon ’ u segwi l- istruzzjonijiet f’ Parti II “ Kif tibdel il- lokijiet ta ’ l - injezzjoni ” u Part III (Rekord tal- Mediċina ta ’ Betaferon) ta ’ l- Anness ‘ Proċedura ta ’ kif tinjetta lilek innifsek ’.
At present it is not known how long treatment with Betaferon should last.
Attwalment għadu mhux magħruf kemm għandha ddum il- kura b’ Betaferon.
The length of treatment will be decided by your doctor together with you.
It- tul tal- kura għandu jiġi deċiż mit- tabib tiegħek flimkien miegħek.
If you use more Betaferon than you should:
Jekk tieħu Betaferon aktar milli suppost:
Giving many times the dose of Betaferon recommended for the treatment of multiple sclerosis has not led to life-threatening situations.
Meta ngħatat doża ħafna ikbar mid- doża ta ’ Betaferon irrakkomandata għall- kura ta ’ sklerożi multipla, ma kienx hemm sitwazzjonijiet fejn il- ħajja tpoġġiet fil- periklu.
► Talk to your doctor if you injected too much Betaferon or injected it too often.
► Kellem lit- tabib tiegħek jekk injettajt wisq Betaferon jew jekk injettajt ta ’ spiss wisq.
If you forget to use Betaferon:
Jekk tinsa tuża Betaferon:
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 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 single dose.
M’ għandekx tinjetta doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you stop using Betaferon:
105 Jekk tieqaf tuża Betaferon:
Talk to your doctor if you stop or wish to stop treatment.
Jekk tieqaf jew tixtieq twaqqaf il- kura, għandek tiddiskuti dan mat- tabib tiegħek.
Stopping Betaferon is not known to lead to acute withdrawal symptoms.
Il- waqfien ta ’ Betaferon mhux magħruf li jwassal għal sintomi akuti ta ’ rtirar meta tieqaf tieħdu.
► If you have any further questions on the use of this product, ask your doctor or pharmacist.
► Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Possible side effects
Effetti sekondarji li jista ’ jkollu
Like all medicines, Betaferon can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Betaferon jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
101 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 iżdaa ġeneralment dawn ibattu matul il- kura.
The most frequently observed side effects are:
L- aktar effetti sekondarji osservati b’ mod frekwenti 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 anti- infjammatorji mhux sterojdi bħal ibuprofen.
Injection site reactions.
Reazzjonijiet fil- lok ta ’ l- injezzjoni.
Symptoms can be redness, swelling, discoloration, inflammation, pain, hypersensitivity, necrosis.
Is- sintomi jistgħu jkunu ħmura, nefħa, bidla 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 ’ f’ sezzjoni 2 għal aktar informazzjoni u x’ għandek tagħmel, jekk ikollok reazzjoni fil- lok ta ’ l- injezzjoni.
These may be reduced by the use of an auto-injector device.
Dawn jistgħu jitnaqqsu bl- użu ta ’ awto- injettatur.
Please talk to your doctor for further information.
Jekk jogħġbok kellem lit- tabib tiegħek għal aktar tagħrif.
To reduce side effects at the start of treatment, your doctor should start you on a low dose of Betaferon and increase it gradually (see section 3. ‘How to use Betaferon’).
Biex tnaqqas l- effetti sekondarji fil- bidu tal- kura, it- tabib tiegħek għandu jibdik fuq doża baxxa ta ’ Betaferon u għandu jżidha gradwalment (ara sezzjoni 3. ‘ Kif għandek tuża Betaferon ’).
Betaferon may also cause serious side effects.
Betaferon jista ’ jikkawża wkoll effetti sekondarji serji.
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.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit - tabib jew lill- ispiżjar tiegħek.
► Tell your doctor immediately and stop using Betaferon:
► Għid lit- tabib tiegħek minnufih u waqqaf l- użu ta ’ Betaferon:
− if you experience symptoms such as itching all over your body, swelling of your face and/or your tongue or sudden shortness of breath.
− jekk ikollok sintomi bħal ħakk ma ġismek kollu, nefħa fil- wiċċ u/ jew fl- ilsien jew qtugħ ta ’ nifs f’ daqqa.
− if you feel noticeably more sad or hopeless than before the treatment with Betaferon, or if you develop thoughts of suicide.
− jekk tħossok ferm aktar imdejjaq/ imdejqa jew bla ħeġġa minn qabel il- kura b’ Betaferon, jew jekk tiżviluppa ħsibijiet ta ’ suwiċidju.
− if you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections.
− jekk tinnota xi tbenġil mhux normali, ħruġ ta ’ demm eċċessiv wara korriment jew jekk jidher li tkun qed tieħu ħafna infezzjonijiet.
− if you have loss of appetite, fatigue, feeling sick (nausea), repeated vomiting, especially if you notice widespread itching, yellowing of the skin, or of the whites of the eyes or easy bruising.
− jekk ikollok nuqqas t’ aptit, għeja, tħossok ser tirremetti (dardir), rimettar ripetut, b’ mod speċjali jekk tinnota ħakk mifrux ma ’ ġismek kollu, jekk il- ġilda jew l- abjad ta ’ l - għajnejn jisfaru jew jekk titbenġel malajr.
− if you experience symptoms like irregular heart beat, swelling such as of the ankles or legs, or shortness of breath.
− jekk ikollok sintomi bħal taħbit tal- qalb mhux regolari, nefħa bħal fl- għekiesi jew fir - riġlejn, jew qtugħ ta ’ nifs.
− if you notice pain in your belly which is radiating to your back, and/or you feel sick or have a fever.
− jekk tinnota uġigħ f’ żaqqek li jinfirex għal dahrek, u/ jew tħossok ma tiflaħx jew ikollok id- deni.
The following side effects listing is based on reports from clinical trials with Betaferon (table 1) and from side effects reported on the marketed product (table 2).
106 L- effetti sekondarji li ġejjin huma bbażati fuq rapporti minn provi kliniċi b’ Betaferon (tabella 1) u minn effetti sekondarji rrapportati wara t- tqegħid fis- suq (tabella 2).
Side effects which have occurred in clinical trials with Betaferon very commonly (at least 10 per 100 of the cases) and at a higher percentage than those observed with placebo.
(Effetti mhux mixtieqa li seħħew fi provi kliniċi b’ Betaferon b’ mod komuni ħafna (ta ’ l - inqas 10 minn kull 100 każ) u f’ persentaġġ ogħla minn dawk osservati bil- plaċebo.
The table also includes side effects which occur in less than 10 per 100 but which were significantly associated with the treatment):
It- tabella tinkludi wkoll effetti sekondarji li seħħew f’ inqas minn 10 minn kull 100 iżda dawn kienu assoċjati b’ mod sinifikanti mal- kura)
- infection, abscess
- infezzjoni, axxess
- reduced number of white blood cells, swollen lymph glands
- tnaqqis fl- għadd ta ’ ċelluli bojod tad- demm, glandoli limfatiċi minfuħin
- decrease of sugar in the blood
- tnaqqis fil- livell ta ’ zokkor fid- demm
- depression, anxiety
- depressjoni, ansjetà
- headache, dizziness, sleeplessness, migraine, numbness or tingling feeling (paresthesia)
- uġigħ ta ’ ras, sturdamenti, nuqqas ta ’ rqad, emigranja, tnemnin jew tingis (parasteżija)
- conjunctivitis, abnormal vision
- konġuntivite, vista mhux normali
- ear pain
- uġigħ fil- widnejn1
102
- taħbit irregolari, mgħaġġel jew pulsazzjoni tal- qalb (palpitazzjoni)
- irregular, rapid beating or pulsation of the heart (palpitation)
- ħmura u/ jew ħmura fil- wiċċ minħabba twessigħ tal- kanali tad- demm, żjieda fil- pressjoni
- redness and/or facial flushing due to widening of blood vessels, increased blood pressure
tad- demm imnieħer iqattar, sogħla, ħanqa minħabba infezzjoni tal- apparat respiratorju ta ’ fuq, sinożite,
- runny nose, cough, hoarseness due to infection of the upper respiratory tract
-
sinusitis, cough increased, shortness of breath
żjieda fis- sogħla, qtugħ ta ’ nifs
- diarrhoea, constipation, nausea, vomiting, abdominal pain
- dijarea, stitikezza, dardir, rimettar, uġigħ addominali
- rises in the blood levels of liver enzymes (will show up in blood tests)
- żjieda fil- livelli fid- demm ta ’ l- enzimi tal- fwied (osservati fit- testijiet tad- demm)
- skin disorder, rash
- disturbi fil- ġilda, raxx
- muscle stiffness (hypertonia),painful muscles (myalgia), muscular weakness (myasthenia),
- ebusija tal- muskoli (ipertonija), uġigħ fil- muskoli (majalġja), indeboliment fil- muskoli
back pain, pain in extremities such as fingers and toes
(majastenja), uġigħ fid- dahar, uġigħ fl- estremitajiet bħal swaba ’ ta ’ l- idejn u tas- saqajn
- holding urine (urine retention),protein in the urine (will show up in urine tests), urinary
- żamma ta ’ l- awrina, proteini fl- awrina (osservati fit- testijiet ta ’ l- awrina), tgħaddi l- awrina ta ’
frequency, urinary incontinence, urinary urgency
spiss, inkontinenza, tgħaddi l- awrina b’ urġenza
- painful periods (menstruation), menstrual disorder, heavy uterine bleeding especially between
- ugigħ waqt il- menstrwazzjoni, disturbi menstrwali, tnixxija qawwija ta ’ demm mill- utru
menstrual periods, impotence
speċjalment bejn menstrwazzjoni u oħra, impotenza
- injection site reaction (including redness, swelling, discolouration, inflammation, pain, allergic
- reazzjoni fil- lok ta ’ l- injezzjoni (inkluż ħmura, nefħa, bidla fil- kulur, infjammazzjoni, uġigħ,
reactions (hypersensitivity), see ’Take special care with Betaferon’), skin breakdown and tissue destruction (necrosis) at injection site (see ‘Take special care with Betaferon’), flu -like symptoms, fever, pain, chest pain, accumulation of fluid in arm, leg or face, lack/loss of strength, chills, sweating, malaise
reazzjonijiet allerġiċi (sensittività eċċessiva), ara “ Oqgħod attent ħafna b’ Betaferon ”), problemi fil- ġilda u therrija ta ’ tessuti (nekrożi) fis- sit ta ’ l- injezzjoni (ara “ Oqgħod attent ħafna b’ Betaferon ”), sintomi jixbħu lill- influwenza, deni, uġigħ, uġigħ fis- sider, akkumulazzjoni ta ’ fluwidu fid- dirgħajn, riġlejn u l- wiċċ, nuqqas/ telf ta ’ saħħa, sirdat, għaraq, telqa
Side effects reports on the marketed product (from spontaneous reporting):
Rapporti ta ’ effetti sekondarji tal- prodott wara t- tqegħid fis- suq (minn rapporti spontanji):
► Very common side effects (more than 1 user in 10 are likely to get these):
► Effetti sekondarji komuni ħafna (aktar minn pazjent wieħed li qed jużah minn kull 10 aktarx li jkollhom dawn):
- flu-like symptoms*,
- sintomi jixbħu lill- influwenza *,
- chills*,
- sirdat *,
- fever*,
- deni *,
- injection site reaction*,
- reazzjoni fil- lok ta ’ l- injezzjoni *,
- injection site inflammation*,
- infjammazzjoni fil- lok ta ’ l- injezzjoni *,
- injection site pain*.
- uġigħ fil- lok ta ’ l- injezzjoni *.
(*frequencies based on clinical trials)
(* frekwenza bbażata fuq provi kliniċi)
► Common side effects (1 to 10 users in 100 are likely to get these):
► Effetti sekondarji komuni (pazjent wieħed sa 10 minn kull 100 li qed jużawh aktarx li jkollhom dawn):
- skin breakdown and tissue destruction (necrosis) at injection site*
- tqaxxir tal- ġilda u qerda tat- tessut (nekrożi) fil- lok ta ’ l- injezzjoni *
► Uncommon side effects (1 to 10 users in 1,000 are likely to get these):
► Effetti sekondarji mhux komuni (pazjent wieħed sa 10 minn kull 1, 000 li qed jużawh aktarx li jkollhom dawn):
- the number of white cells and red cells in the blood may fall, the number of platelets
- l- għadd ta ’ ċelluli bojod u ċelluli ħomor jista ’ jonqos, l- għadd ta ’ plejtlits (li jgħinu d- demm
(which help the blood to clot) may fall,
jaqgħad) jista ’ jonqos,
- depression
- depressjoni
- increase of blood pressure,
- żjieda fil- pressjoni tad- demm,
- nausea,
- dardir,
- vomiting,
- rimettar,
- liver test may change (rises in the blood levels of enzymes the liver produces),
- it- test tal- fwied jista ’ jinbidel (żjieda fil- livelli fid- demm ta ’ l- enzimi li jipproduċi l- fwied),
- swollen and usually itching patches of skin or mucous membranes (urticaria),
- postijiet fil- ġilda jew membrani mukużi minfuħin u ġeneralment bil- ħakk (urtikarja),
- rash,
- raxx,
- itching (pruritus),
- ħakk (prurite),
- loss of scalp hair,
- telf ta ’ xagħar mill- qorriegħa,
- p ainful muscles,
- uġigħ fil- muskoli,
- muscle stiffness.
- ebusija fil- muskoli.
► Rare side effects (1 to 10 users in 10,000 are likely to get these):
► Effetti sekondarji rari (pazjent wieħed sa 10 minn kull 10, 000 li qed jużawh aktarx li jkollhom dawn):
- swollen lymph glands,
- glandoli tal- limfa minfuħin,
- serious allergic (hypersensitivity) reactions,
- reazzjonijiet allerġiċi serji (sensittività eċċessiva),
- the thyroid gland does not work properly (too much or too little hormone is produced),
- il- glandola tat- tirojde ma taħdimx tajjeb (ħafna jew ftit wisq ormon prodott),
- a certain type of blood fats (triglycerides) may increase, see ‘Take special care with Betaferon’
- ċertu tip ta ’ xaħmijiet fid- demm (trigliċeridi) jistgħu jiżdiedu, ara ‘ Oqgħod attent ħafna
(will show up in blood tests),
b’ Betaferon ’ (dawn jiġu osservati fit- testijiet tad- demm),
- severe loss of appetite leading to weight loss (anorexia),
- nuqqas kbir t’ aptit li jwassal għal telf fil- piż (anoreksja),
- confusion,
- konfużjoni,
- anxiety,
- ansjetà
- mood swings,
- bidliet fil- burdata,
- suicide attempt,
- attentat ta ’ suwiċidju,
- convulsion,
- konvulżjoni,
- disease of the heart muscle (cardiomyopathy),
- mard tal- muskolu tal- qalb (kardjomijopatija)
- faster heart beat,
- taħbit tal- qalb aktar mgħaġġel,
- irregular, rapid beating or pulsation of the heart (palpitation),
- taħbit irregolari u mgħaġġel jew pulsazzjoni tal- qalb (palpitazzjoni),
- shortness of breath (dyspnea),
- qtugħ ta ’ nifs f’ daqqa (dispneja)
- pancreatitis, see ‘Take special care with Betaferon’,
- pankreatite, ara ‘ Oqgħod attent ħafna b’ Betaferon ’,
- a specific liver enzyme (gamma GT) and a reddish yellow pigment (bilirubin), which is
- il- livell ta ’ enzima speċifika tal- fwied (gamma GT) u pigment safrani fl- aħmar (bilirubin), li huwa
produced by your liver, may rise (this will show up in blood tests),
prodott mill- fwied tiegħek, jista ’ jogħla (dan jiġi osservat fit- testijiet tad- demm),
- skin discoloration,
- bidla fil- kulur tal- ġilda,
- menstrual disorders,
- disturbi fil- menstrwazzjoni,
- chest pain,
- uġigħ fis- sider,
- malaise,
- telqa,
- sweating,
- għaraq,
- loss of weight.
- telf fil- piż.
How to store Betaferon
Kif taħżen Betaferon
Do not use after the expiry date which is stated on the pack.
Tużax wara d- data ta ’ skadenza li tidher fuq il- pakkett.
After preparing the solution you should use it immediately.
Wara li tħejji s- soluzzjoni, għandek tużaha minnufih.
However, if you are not able to do so, it will be okay for 3 hours, if kept at 2-8 °C (in a refrigerator).
Madankollu, jekk ma tkunx tista ’ tagħmel dan, din iżżomm għal 3 sigħat jekk tinżamm f’ temperatura ta ’ 2- 8 °C (fi friġġ).
Keep out of the reach and sight of children.
Żommu fejn ma jintlaħx u ma jidhirx mit- tfal.
Do not use Betaferon if you notice it contains particles or is discoloured.
108 Tużax Betaferon jekk tinnota li fih xi frak jew ikun bidel il- kulur.
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar tiegħek dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall - protezzjoni ta ’ l- ambjent.
Further information
Aktar tagħrif
What Betaferon contains:
X’ fih Betaferon:
The active substance is Interferon beta-1b, 250 microgram per millilitre when reconstituted.
Is- sustanza attiva hija Interferon beta- 1b, 250 mikrogramma kull millilitru meta rikostitwit.
104 The other ingredients are − in the powder: mannitol and human albumin, − in the solvent (sodium chloride solution 5.4 mg/ml (0.54% (w/v)): sodium chloride, water for injections.
(soluzzjoni ta ’ sodium chloride ta ’ 5. 4mg/ ml (0. 54% (w/ v)): sodium chloride, ilma għall- injezzjonijiet.
The Betaferon powder is provided in a 3-millilitre vial, containing 300 microgram (9.6 million IU) Interferon beta-1b per vial.
It- trab ta ’ Betaferon hu pprovdut f’ kunjett ta ’ 3 millilitri, li fih 300 mikrogramma (9. 6 miljun IU) Interferon beta- 1b f’ kull kunjett.
After reconstitution each millilitre contains 250 microgram (8 million IU) Interferon beta-1b.
Wara r- rikostituzzjoni, kull millilitru jkun fih 250 mikrogramma (8 miljun IU) Interferon beta- 1b.
The solvent for Betaferon is provided in a 2.25-millilitre pre-filled syringe and contains 1.2 ml sodium chloride solution 5.4 mg/ml (0.54%).
Is- solvent għal Betaferon huwa pprovdut f’ siringa mimlija għal- lest ta ’ 2. 25 millilitru u fih 1. 2 ml ta ’ soluzzjoni ta ’ sodium chloride ta ’ 5. 4 mg/ ml (0. 54%).
What Betaferon looks like and contents of the pack:
Id- dehra ta ’ Betaferon u l- kontenuti tal- pakkett:
Betaferon is a sterile white to off-white powder for solution for injection.
Betaferon huwa trab sterili għal soluzzjoni għall- injezzjoni ta ’ lewn abjad jew abjad jagħti fil- griż.
Betaferon is available in pack sizes of:
Betaferon hu disponibbli f’ daqsijiet tal- pakkett ta ’:
− multipacks comprising 5 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or − multipacks comprising 15 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or − 3-month packs comprising 3x15 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or − 3-month packs comprising 3x14 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or − titration pack for the first 12 injections comprising 4 triple packs, each containing 3 vials with powder, 3 pre-filled syringes with solvent, 3 vial adapters with needle, 6 alcohol wipes
multipakks li fihom 5 pakketti singoli, kull wieħed fih kunjett bit- trab, siringa mimlija – għal- lest bis- solvent, adattatur tal- kunjett b’ labra, 2 imsielaħ ta ’ l- alkoħol jew multipakks li fihom 15- il pakkett singolu li kull wieħed fih kunjett bit- trab, siringa mimlija għal - – lest bis- solvent, adattatur tal- kunjett b’ labra, 2 imsielaħ ta ’ l- alkoħol jew – pakketti għal 3 xhur li fihom 3x15- il pakkett singolu li kull wieħed fih kunjett bit- trab, siringa mimlija għal- lest bis- solvent, adattatur tal- kunjett b’ labra, 2 imsielaħ ta ’ l- alkoħol jew – pakketti għal 3 xhur li fihom 3x14- il pakkett singolu li kull wieħed fih kunjett bit- trab, siringa mimlija għal- lest bis- solvent, adattatur tal- kunjett b’ labra, 2 imsielaħ ta ’ l- alkoħol jew – pakkett ta ’ titrazzjoni għall- ewwel 12- il injezzjoni li fih 4 pakketti tripli li kull wieħed fih 3 kunjetti bit- trab, 3 siringi mimlija għall- lest bis- solvent, 3 adatturi għall- kunjett b’ labra mwaħħla minn qabel, 6 imsielaħ ta ’ l- alkoħol.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali
Marketing authorisation holder and manufacturer:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
Bayer Schering Pharma AG, D-13342 Berlin, Germany
Bayer Schering Pharma AG, D- 13342 Berlin, il- Ġermanja
105 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
109 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
Your doctor has prescribed Betaferon to treat your MS.
It- tabib tiegħek ippreskrivilek Betaferon biex jikkura l- MS tiegħek.
You will best tolerate Betaferon in the beginning if you start with a low dose and gradually increase to the full standard dose (see first part of this leaflet, section 3. ‘How to use Betaferon’).
Fil- bidu se tittollera Betaferon aħjar jekk tibda b’ doża baxxa u iżżid għad- doża standàrd sħiħa b’ mod gradwali (ara l- ewwel parti ta ’ dan il- fuljett, sezzjoni 3. ‘ Kit tuża Betaferon ’).
To easily increase the dosage during the first 12 injections, you may be given a special titration pack, containing four differently coloured triple packs with special marked syringes and with detailed instructions on the separate introductory leaflet for titration pack.
Biex iżżid id- dożaġġ b’ mod faċli waqt l- ewwel 12- il injezzjoni għandu mnejn tingħata pakkett ta ’ titrazzjoni speċjali li fih erba ’ pakketti b’ kuluri differenti b’ siringi mmarkati b’ mod speċjali u b’ istruzzjonijiet dettaljati fuq il- fuljett ta ’ introduzzjoni separat għall- pakkett ta ’ titrazzjoni.
The syringes in this titration pack are marked accordingly with the appropriate doses (0.25; 0.5; 0.75 or 1.0 ml).
Is- siringi f’ dan il- pakkett ta ’ titrazzjoni huma mmarkati skond id- dożi xierqa (0. 25; 0. 5; 0. 75 jew 1. 0 ml).
The following instructions and pictures explain how to prepare Betaferon for injection and how to inject Betaferon yourself.
L- istruzzjonijiet u l- istampi li ġejjin huma maħsuba biex jispjegaw kif tipprepara Betaferon għall - injezzjoni u kif għandek tipproċedi biex tinjetta lilek innifsek b’ Betaferon.
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra dawn l - istruzzjonijiet b’ attenzjoni u segwihom pass, pass.
Your doctor or their assistant will help you to learn the process of self-administration.
It- tabib tiegħek jew l- assistent/ a tiegħu ser jgħinuk titgħallem il- proċess ta ’ kif għandek tinjetta lilek innifsek.
The instructions include the following main steps:
L- istruzzjonijiet jinkludu l- 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 F) Quick review of the process
A) Pariri ġenerali B) Preparazzjoni biex tinjetta C) Rikostituzzjoni tas- soluzzjoni, pass wara pass D) Preparazzjoni tal- injezzjoni E) Kif tagħmel l- injezzjoni F) Reviżjoni malajr tal- proċess
As you get started, you may find the following helpful:
Hekk kif tibda, tista ’ ssib is- suġġerimenti li ġejjin utli:
− Set up a permanent storage area in a convenient location out of the reach of children so your Betaferon and other supplies are always easy to find.
- Sib post permanenti fejn taħżen il- mediċina li jkun konvenjenti għalik u li ma jkunx jista ’ jintlaħaq
For details on storage conditions see section 5. ‘How to store Betaferon’ in the first part of this leaflet.
Għal aktar dettalji dwar il- kundizzjoniet tal- ħażna, ara sezzjoni 5. ‘ Kif taħżen Betaferon ’ fl- ewwel parti ta ’ dan il- fuljett.
− Try to give your injection at the same time of day.
Dan jagħmilha iktar faċli biex tiftakar teħodha
This makes it easier to remember and easier to plan a block of time when you will not be interrupted.
u biex talloka ħin meta inti ma jkollokx interruzzjonijiet.
− 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 Betaferon, you should give the injection immediately (if Betaferon is not used immediately, see section 5. ‘How to store Betaferon’ in the first part of this leaflet).
tagħti l- injezzjoni minnufih (jekk Betaferon ma jintużax immedjatament, ara sezzjoni 5. ‘ Kif taħżen Betaferon ’ fl- ewwel parti ta ’ dan il- fuljett).
− Be consistent - use Betaferon as described in section 3. ‘How to use Betaferon’ in the first part of this leaflet.
- Kun konsistenti - uża Betaferon kif deskritt f’ sezzjoni 3. ‘ Kif tuża Betaferon ’ fl- ewwel parti ta ’ dan
Always double-check your dosage. − Keep your syringes and syringe disposal unit out of the reach of children; lock the supplies away if possible. − Never re-use syringes or needles. − Always use a sterile (aseptic) technique as described in here. − Always place the used syringes in the proper disposal unit.
- Żomm is- siringi u r- reċipjent tar- rimi għas- siringi fejn ma jintlaħqux mit- tfal; jekk possibbli aqfel
107 B) Getting ready to inject
111 B) Preparazzjoni biex tinjetta
The best places for injections are where the skin is loose and soft, and away from joints, nerves, or 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 jew għadam, per eżempju ż- żaqq, l- id, il- koxxa jew il- warrani.
Important:
Importanti:
Follow the sequence described in the schedule at the end of the Annex (see Part II, ‘Rotating injection sites’) and you will come back to your first injection site area after 8 injections (16 days).
Segwi s- sekwenza deskritta fl- iskeda fi tmiem l- Anness (ara Parti II) Rotazzjoni tal- lok ta ’ l- injezzjoni) u int se terġa ’ tirritorna għall- ewwel lok ta ’ l- injezzjoni wara 8 injezzjonijiet (16 - il jum).
An example of a medication record is also included (see Annex Part III).
Hemm inkluż ukoll eżempju ta ’ rekord tal- mediċina (ara Anness Parti III).
► Checking the content of the pack
► Iċċekkja l- kontenut tal- pakkett
In the Betaferon pack you will find: − 1 Betaferon vial (with powder for solution for injection), − 1 pre-filled syringe of solvent for Betaferon (sodium chloride solution 5.4 mg/ml (0.54%)), − 1 vial adapter with a pre-attached needle, − 2 alcohol swabs to clean the skin and vial.
Fil- pakkett ta ’ Betaferon għandek issib dan li ġej: − kunjett ta ’ Betaferon (bi trab għal soluzzjoni għall- injezzjoni) − siringa mimlija għal- lest bis- solvent għal Betaferon (soluzzjoni ta ’ sodium chloride ta ’ 5. 4 mg/ ml (0. 54%). − adattatur għall- kunjett b’ labra mwaħħla bil- lest − 2 imsielaħ ta ’ l- alkoħol biex tnaddaf il- ġilda u l- kunjett
In addition you will need a disposal unit for used syringes and needles.
Barra dan se jkollok bżonn ukoll reċipjent tar- rimi għal siringi u labar użati.
If you have a Betaferon titration pack you will find 4 differently coloured and numbered triple packs, each containing: • 3 Betaferon vials (with powder for solution for injection) • 3 pre-filled syringes with solvent for the Betaferon powder (sodium chloride solution 5.4 mg/ml (0.54%)) • 3 vial adapters with a pre-attached needle • 6 alcohol wipes for skin and vial cleaning In addition you will need a disposal unit for used syringes and needles.
Jekk inti għandek pakkett ta ’ titrazzjoni ta ’ Betaferon se ssib 4 pakketti tripli ta ’ kulur u b’ numru differenti li kull wieħed fih: • 3 kunjetti ta ’ Betaferon (bi trab għal soluzzjoni għall- injezzjoni) • 3 siringi mimlija għall- lest b’ solvent għat- trab ta ’ Betaferon (soluzzjoni ta ’ sodium chloride ta ’ 5. 4 mg/ ml (0. 54%) • 3 adattaturi tal- kunjett b’ labra mwaħħla minn qabel • 6 imsielaħ ta ’ l- alkoħol biex tnaddaf il- ġilda u l- kunjett Barra dan se jkollok bżonn ukoll reċipjent tar- rimi għal siringi u labar użati.
Start with the yellow triple pack 1 containing 3 syringes with a 0.25-ml marking, for treatment days 1, 3 and 5.
Ibda ’ bil- pakkett triplu numru 1 ta ’ lewn isfar li fih 3 siringi b’ marka f’ 0. 25- ml għall- ġranet ta ’ kura 1, 3 u 5.
Use then the red triple pack 2 containing 3 syringes with a 0.5 -ml marking, for treatment days 7, 9 and 11.
Wara uża l- pakkett triplu numru 2 ta ’ lewn aħmar li fih 3 siringi b’ marka f’ 0. 5- ml għall- ġranet ta ’ kura 7, 9 u 11.
Continue with the green triple pack 3 containing 3 syringes with a 0.75-ml marking, for treatment days 13, 15 and 17.
Kompli bil- pakkett triplu numru 3 ta ’ lewn aħdar li fih 3 siringi b’ marka f’ 0. 75- ml għall- ġranet ta ’ kura 13, 15 u 17.
Use the blue triple pack 4 containing 3 syringes with a 0.25; 0.5; 0.75 and 1.0-ml marking, for treatment days 19, 21 and 23.
Uża l- pakkett triplu numru 4 ta ’ lewn blu li fih 3 siringi b’ marka f’ 0. 25; 0. 5; 0. 75 u 1. 0- ml, għall - ġranet ta ’ kura 19, 21 u 23.
108 C) Reconstituting the solution, step by step
112 Ċ) Rikostituzzjoni tas- soluzzjoni, pass wara pass
1 - Wash your hands thoroughly with soap and water before beginning this process.
1 - Aħsel idejk tajjeb bis- sapun u l- ilma qabel ma tibda dan il - proċess.
4 – Open the blister pack containing the vial adapter, but leave the vial adapter inside.
4 – Iftaħ il- pakkett tal- folja li fih l- adattatur tal- kunjett, iżda ħalli l- adapter tal- kunjett ġo fih.
Do not remove the vial adapter from the blister pack at this stage.
Għalissa, tneħħix l- adattatur tal- kunjett mill- pakkett tal - folja.
Do not touch the vial adapter.
Tmissx l- adattatur tal- kunjett.
This is to keep it sterile.
Dan sabiex iżżommu sterili.
5 – Before attaching the adapter remove and discard the alcohol wipe and rest the vial on a flat surface.
5 – Qabel twaħħal l- adattatur neħħi u armi l- imselħa ta ’ l - alkoħol u serraħ il- kunjett fuq wiċċ ċatt.
6 - Hold the blister pack on the outside and place it on top of the vial.
6 – Żomm l- pakkett tal- folja fuq barra u poġġih fuq il- kunjett.
Push it down firmly until you feel it snap into place on the vial.
Imbuttah sew l- isfel sakemm tħossu jfaqqa f’ postu fuq il- kunjett.
7 - Remove the blister pack from the vial adapter, holding the blister edges.
7 - Neħħi l- pakkett tal- folja mill- adattatur tal- kunjett, waqt li żżomm it- truf tal- folja.
Now you are ready to attach the pre-filled solvent syringe to the vial adapter.
Issa lest/ a biex twaħħal is- siringa mimlija għal- lest bis- solvent ma ’ l- adattatur tal- kunjett.
109 8 - Pick up the syringe.
8 - Aqbad is- siringa.
Be sure that the orange tip cap is firmly attached to the solvent syringe!
Kun ċert li l- għatu tat- tarf ta ’ lewn oranġjo huwa mwaħħal sew mas- siringa tas- solvent!
Remove the tip cap by twisting it off.
Neħħi l- għatu tat- tarf billi ddawru.
Throw away the tip cap.
Armi l- għatu tat- tarf.
9 - Connect the syringe to the opening on the side of the vial adapter by inserting the end of the syringe and tightening carefully with a clockwise “push and twist” motion (see arrow).
113 9 - Qabbad is- siringa mal- ftuħ li hemm fuq il- ġenb ta ’ l- adattatur tal- kunjett billi ddaħħal it- tarf tas- siringa u tissikka b’ attenzjoni billi ddawwar lejn il- lemin u timbotta (ara l- vleġġa).
This will form the syringe assembly.
Dan jifforma l- muntaġġ tas- siringa.
10 - Hold the syringe assembly at the bottom of the vial.
10 - Żomm il- muntaġġ tas- siringa fuq in- naħa t’ isfel tal- kunjett.
Slowly push the plunger of the syringe in all the way to transfer all of the solvent into the vial.
Bil- mod imbotta l- planġer tas- siringa ’ l isfel kemm tista ’ biex tittrasferixxi s- solvent kollu għal ġol- kunjett.
Release the plunger, which may go back to its original position.
Erħi l- planġer, li jista ’ jirritorna għall- pożizzjoni oriġinali tiegħu.
This applies also to the titration pack.
Dan japplika wkoll għall- pakkett ta ’ titrazzjoni.
11 - With the syringe assembly still attached, swirl the vial around gently to completely dissolve the dry Betaferon powder.
11 – Bil- muntaġġ tas- siringa mwaħħal, dawwar il- kunjett bil - mod biex iddewweb it- trab ta ’ Betaferon għal kollox.
12 - Examine the solution carefully.
12 - Eżamina s- soluzzjoni b’ attenzjoni.
If the solution is discoloured or contains particles, discard it and start again with a new single pack of supplies.
Jekk is- soluzzjoni tbiddel il - kulur jew jekk ikun fiha xi frak, armiha u ibda mill- ġdid b’ pakkett ġdid singolu ta ’ provisti.
If foam is present –- which can happen if the vial is shaken or swirled too much – let the vial sit undisturbed until the foam settles.
Jekk ikun hemm ir- ragħwa – li jista ’ jiġri jekk il- kunjett jitħarrek jew jiddawwar bis- saħħa – ħalli l- kunjett joqgħod mingħajr ma tħarrku sakemm ir- ragħwa toqgħod
110 D) Drawing up the injection
114 D) Preparazzjoni tal- injezzjoni
13 - If the plunger has moved back to its original position push it in again and hold it in place.
13 – Jekk il- planġer reġa lura fil- pożizzjoni oriġinali tiegħu, imbuttah mill- ġdid u żommu f’ postu.
To prepare your injection, turn the assembly over so that the vial is on top, cap side pointing down.
Biex tipprepara l - injezzjoni tiegħek, dawwar il- muntaġġ ta ’ taħt fuq b’ tali mod li l- kunjett ikun fuq, bin- naħa ta ’ l- għatu tipponta ’ l isfel.
Doing this allows the solution to flow down into the syringe.
Dan jippermetti li s- soluzzjoni tgħaddi ’ l isfel għal ġos- siringa.
Keep the syringe horizontal.
Żomm is- siringa f’ pożizzjoni orizzontali.
Slowly pull the plunger back to withdraw all the solution out of the vial and into the syringe.
Iġbed il- planġer lura bil- mod biex tiġbed is- soluzzjoni kollha minn ġol- kunjett għal ġos- siringa.
With the titration pack, withdraw solution only up to the mark on the syringe:
Bil- pakkett ta ’ titrazzjoni, iġbed soluzzjoni sal- marka fuq is - siringa biss:
0.25 ml for first three injections (at day 1, 3, 5 of therapy), or 0.5 ml for the injections at day 7, 9, 11 of therapy, or 0.75 ml for the injections at day 13, 15, 17 of therapy.
0. 25 ml għall- ewwel tliet injezzjonijiet (fi ġranet 1, 3, 5 tat - terapija), jew 0. 5 ml għall- injezzjonijiet fi ġranet 7, 9, 11 tat- terapija, jew 0. 75 ml għall- injezzjonijiet fi ġranet 13, 15, 17 tat- terapija.
Discard the vial with any remaining solution.
Armi l- kunjett u s- soluzzjoni li jkun fadal.
From day 19 you are injecting the full dose 1.0 ml.
Minn ġurnata 19 inti tkun qed tinjetta d- doża sħiħa ta ’ 1. 0 ml.
14 - After drawing up the solution turn the syringe assembly so that the needle is pointing up.
14 Wara li tiġbed is- soluzzjoni dawwar is- siringa b’ tali mod li l- labra tkun tipponta ’ l fuq.
This allows any air bubbles to rise to the top of the solution.
Dan iġiegħel il- bżieżaq ta ’ l- arja biex jitilgħu fin- naħa ta ’ fuq tas- soluzzjoni.
15 - Remove any air bubbles by gently tapping the syringe and pushing the plunger to the 1-ml mark, or to the volume prescribed by your doctor.
15 - Neħħi xi bżieżaq ta ’ l- arja billi ttektek fuq is- siringa bil - mod u billi timbotta l- planġer sal- marka ta ’ 1 ml, jew lejn il - volum preskritt mit- tabib tiegħek.
If you are injecting less than 1 ml with the titration pack there might not be any air bubbles, however for full dose injection some air bubbles might turn up.
Jekk qed tinjetta inqas minn 1 ml bil- pakkett ta ’ titrazzjoni jista ’ ma jkunx hemm bżieżaq ta ’ l- arja, iżda dawn jistgħu jkunu preżenti għall- injezzjoni ta ’ doża sħiħa.
Remove them by gently tapping the syringe and pushing the plunger to the respective marking on the syringe.
Neħħihom billi ttektek is- siringa bil- mod u timbotta il- planġer sal- marka rispettiva fuq is- siringa.
13) and pull the plunger back a little to withdraw the solution back into the syringe.
Jekk tidħol soluzzjoni żejda fil- kunjett flimkien ma ’ bżieżaq ta ’ l- arja, erġa ’ lura għall- pożizzjoni orizzontali (ara stampa 13) u iġbed il- planġer ftit lura biex tiġbed is- soluzzjoni minn ġol - kunjett lura għal ġos- siringa.
16 - Next, hold the blue vial adapter with the attached vial and remove it from the syringe by twisting it and then pulling it down, away from the syringe.
16 - Wara, żomm l- adattatur tal- kunjett il- blu bil- kunjett imwaħħal u neħħih minn mas- siringa billi ddawru u wara tiġbdu l- isfel minn mas- siringa.