qanastek/EMEA-V3 huggingface dataset:
- thoughts about committing suicide.
- ħsibijiet li tagħmel suwiċidju.
Changes to your mood, thoughts about suicide, feeling unusually sad, anxious or worthless, should be reported to your doctor immediately.
Tibdil fil- burdata tiegħek, ħsibijiet dwar suwiċidju, tħossok mdejjaq aktar mis- soltu, ansjuż jew li ma tiswa xejn, għandhom jiġu rrappurtati minnufih lit- tabib tiegħek.
- epilepsy or other seizure disorders not controlled by medication
- epilessija jew mard epilettiku ieħor mhux ikkontrollat bil- mediċina
- serious kidney or liver problems
- problemi serji fil- kliewi jew fwied
- heart problems, which can cause symptoms such as chest pain (angina), particularly after any
- problemifil- qalb, li jistgħu jikkawżaw sintomi bħal uġigħ fis- sider (anġina), speċjalment
activity; swollen ankles, shortness of breath (congestive heart failure); or an irregular heartbeat (arrhythmias).
wara xi sforż; għekiesi minfuħa, qtugħ ta ’ nifs (insuffiċjenza tal- qalb konġestiva); jew qalb tħabbat b’ mod irregolari (arritmija).
Talk to your doctor if you have any of these conditions, or if they worsen whilst taking Avonex.
Kellem it- tabib tiegħek jekk ikollok xi waħda minn dawn il- kundizzjonijiet, jew jekk jiggravaw waqt li qed tieħu Avonex.
Tell your doctor you are using AVONEX:
Għid lit- tabib tiegħek jekk qed tuża AVONEX:
- if you are having a blood test.
Jekk se tagħmel eżami tad- demm.
Avonex may interfere with the results.
Avonex jista ’ jinterferixxi mar- riżultati.
Sometimes you will need to remind other medical staff that you are being treated with Avonex.
Xi kultant jista ’ jkollok bżonn tfakkar lill- ħaddiema fil- qasam tas- saħħa oħrajn li qed tiġi kkurat b’ Avonex.
For example, if you are prescribed other medicines, or if you have a blood test, Avonex may affect the other medicines or the test result.
Per eżempju, jekk tiġi preskritt mediċini oħrajn, jew jekk tagħmel eżami tad- demm, Avonex jista ’ jkollu effett fuq il- mediċini l- oħra jew fuq ir- riżultat ta ’ l- eżami.
Using other medicines
Meta tuża ta ’ mediċini oħra
Avonex may affect other medicines or be affected by them.
Jekk qed tuża mediċini oħra, speċjalment dawk użati biex jikkuraw epilessija jew depressjoni, Avonex jista ’ jkollu effett fuq dawn il- mediċini jew jiġi affettwat minnhom.
This includes any other medicines including medicines obtained without a prescription.
Dan jinkludi kull mediċina oħra wkoll mediċina li tingħata mingħajr preskrizzjoni
Pregnancy and breastfeeding
Tqala u Treddigħ
If you are pregnant, do not start using Avonex.
Jekk inti tqila, tibdiex tuża Avonex.
- If you could get pregnant, you need to use contraception while you use Avonex.
- Jekk tista ’ tinqabad tqila għandek tuża kontraċezzjoni waqt li qed tuża Avonex.
- If you are planning a baby or if you become pregnant while you are using Avonex, tell your
- Jekk qed tippjana li jkollok tarbija jew tinqabad tqila waqt li qed tuża Avonex, għid lit -
doctor.
tabib tiegħek.
You and your doctor can discuss if you should carry on with treatment.
Int u t- tabib tiegħek tistgħu tiddiskutu jekk għandekx tkompli bil- kura.
- If you are already pregnant, or think that you might be, talk to a doctor as soon as you can.
- Jekk int diġa ’ tqila, jew tinkwieta li tista ’ tkun, kellem lill- tabib malajr kemm jista ’ jkun
- If you want to breastfeed talk to your doctor first.
- Jekk trid tredda ’, l- ewwel kellem lit- tabib tiegħek.
Driving and using machines
Sewqan u tħaddim ta 'magni:
If you feel dizzy, do not drive.
Jekk tħossok stordut, issuqx.
Avonex makes some people feel dizzy.
Avonex iġiegħel lil xi wħud iħossuhom storduti.
If this happens to you, or if you get any other side effects that could affect your ability, do not drive or use machines.
Jekk jiġrilek hekk, jew jekk ikollok xi effetti sekondarji oħra li jistgħu jaffettwawlek il- kapaċità tiegħek, issuqx jew tuża magni.
Important information about some of the ingredients of AVONEX
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ AVONEX
This medicine is essentially ‘ sodium-free’.
Din il- mediċina hija essenzjalment ‘ mingħajr sodju ’.
It contains less than 23 mg (1 mmol) sodium in each weekly dose.
Fiha inqas minn 23 mg (1 mmol) sodju f’ kull doża ta ’ ġimgħa.
HOW TO USE AVONEX
KIF GĦANDEK TUŻA AVONEX
The usual dose for adults and adolescents aged 12 years and over
Id- doża tas- soltu għall- adulti u adolexxenti b’ eta ta ’ 12- il sena u aktar
One injection of Avonex, once a week.
Injezzjoni waħda ta ’ Avonex, darba fil- ġimgħa.
Try to use Avonex at the same time on the same day each week.
Ipprova uża Avonex fl- istess ħin u fl- istess ġurnata kull ġimgħa.
Not for children Avonex is not to be used in children below the age of 12 years.
Mhux għat- tfal Avonex m’ għandux jintuża fit- tfal taħt l- eta´ ta´ 12- il sena.
40 Injecting yourself
40 Tinjetta lilek innifsek
You can inject Avonex yourself without the help of your doctor, if they have trained you to do this.
Tista ’ tinjetta Avonex inti stess, mingħajr l- għajnuna tat- tabib tiegħek, jekk ġejt imħarreġ tagħmel dan.
The instructions on how to inject yourself are at the end of this leaflet (see section 7, How to inject AVONEX).
L- istruzzjonijiet dwar kif tinjetta lilek innifsek jinstabu fl- aħħar ta ’ dan il- fuljett (ara sessjoni 7, Kif tinjetta AVONEX).
If you have trouble handling the syringe, ask your doctor who may be able to help.
Dan jista ’ jgħinek.
There are more details on how to inject Avonex at the end of this leaflet.
Hemm aktar dettalji dwar kif tinjetta Avonex fl- aħħar ta ’ dan il- fuljett.
Alternate needle:
Labra alternattiva:
Your pack of Avonex already includes a needle for injection.
Il- pakkett tiegħek ta ’ Avonex ġa jinkludi labra għall- injezzjoni.
It may be possible for your doctor to prescribe you a shorter and thinner needle, depending on your body type.
Jista ’ jkun possibli li t- tabib tiegħek jippreskrivilek labra iqsar u irqaq, skond it- tip tal- ġisem tiegħek.
Talk to your doctor to see if this is appropriate for you.
Kellem lit- tabib tiegħek biex tara jekk dan hux xieraq għalik.
If you have problems handling the syringe, talk to your doctor about using a syringe grip.
Jekk ikollok diffikulta biex tuża s- siringa, kellem lit- tabib tiegħek dwar l- użu tal- manku tas- siringa.
This is a specially designed holder to help you with injecting Avonex.
Dan huwa manku ddisinjat speċjalment biex jgħinek tinjetta Avonex.
How long to use AVONEX
Kemm għandek iddum tuża AVONEX
Your doctor will tell you how long you need to keep using Avonex.
It- tabib tiegħek jgħidlek kemm għandek bżonn tibqa tuża Avonex.
It is important to continue using Avonex regularly.
Huwa importanti li tkompli tuża Avonex b’ mod regolari.
Do not make changes unless your doctor tells you.
Tbiddel xejn sakemm it- tabib tiegħek ma jgħidlekx.
If you inject too much
Jekk tinjetta żżejjed
You should only have one injection of Avonex, once a week.
Għandek tieħu biss injezzjoni waħda ta ’ Avonex, darba fil- ġimgħa.
If you have used more than one injection of Avonex in a three-day period, contact your doctor or pharmacist straight away for advice.
Jekk użajt aktar minn injezzjoni waħda ta ’ Avonex f’ perjodu ta ’ tlett ijiem, kellem lit- tabib jew lill- ispiżjar tiegħek minnufiħ għall - parir.
If you miss an injection
Jekk tinsa tieħu injezzjoni
If you miss your usual weekly dose, inject a dose as soon as you can.
Jekk tinsa tieħu id- doża regolari ta´ kull ġimgħa, injetta doża minnufih meta tkun tista´.
Then leave a week before using Avonex again.
Imbagħad ħalli ġimgħa qabel ma terga´ tieħu Avonex.
Continue injecting on this new day every week.
Kompli injetta f’ din il- ġurnata ‘ ġdida ’ kull ġimgħa.
If you have a preferred day for using Avonex, talk to your doctor about managing the dose, to get back to your preferred day.
Jekk tippreferi tieħu Avonex f’ xi ġurnata partikolari, kellem lit- tabib tiegħek dwar kif tmexxi d- doża biex terġa ’ lura għall- ġurnata ppreferuta tiegħek.
Do not use two injections to make up for a missed injection.
Tużax żewġ injezzjonijiet biex tpatti għal injezzjoni li tkun insejt tieħu.
POSSIBLE SIDE EFFECTS
EFFETTI EFFETTI SEKONDARJI LI JISTA ’ JKOLLU
Like all medicines, Avonex can cause side effects, although not everyone gets them.
Bħal kull mediċina oħra, Avonex jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Although the list of possible side effects can seem worrying, it ’ s possible that you may not have any of them.
Għalkemm il- lista ta ’ effetti sekondarji li jista ’ jkollu tista ’ tidher inkwetanti, huwa possibli li int ma jkollok l- ebda wieħed minnhom.
Serious side effects: get medical help
Effetti sekondarji serji: sejjaħ għajnuna medika
41 Serious allergic reactions If you get any of these:
41 Jekk ikollok xi wieħed minn dawn:
- swelling of the face, lips or tongue
- nefħa fil- wiċċ, xoftejn jew ilsien
- difficulty breathing
- diffikultà biex tieħu n- nifs
- a rash.
- raxx.
Call a doctor immediately.
Sejjaħ tabib minnufiħ.
Do not use any more Avonex until you have spoken to a doctor.
Tużax aktar Avonex qabel ma tkun kellimt tabib.
Depression If you get any symptoms of depression:
Depressjoni Jekk ikollok xi sintomi ta ’ depressjoni:
- feeling unusually sad, anxious or worthless.
- tħossok aktar imdejjaq mis- soltu, anzjuż jew ma tiswa għal xejn.
Liver problems If you get any of these symptoms:
Problemi tal- fwied Jekk ikollok xi wieħed minn dawn is- sintomi:
- yellowing of your skin or the whites of your eyes (jaundice)
- sfura tal- ġilda jew ta ’ l- abjad ta ’ għajnejk (suffejra)
- itching all over
- ħakk ma ġismek kollu
- feeling sick, being sick (nausea and vomiting)
- tħossok imdardar, tirremetti (dardir u remettar)
- easy bruising of the skin.
- il- ġilda titbenġel malajr.
Call a doctor immediately as they may be signs of a possible liver problem.
Sejjaħ tabib minnufiħ għax dawn jistgħu jkunu sinjali ta ’ problema possibli tal- fwied.
Side effects seen in clinical trials
Effetti sekondarji li deheru fi studji kliniċi
Side effects seen in clinical trials.
Effetti sekondarji li deheru fi studji kliniċi.
These are the side effects that people reported when Avonex was being tested.
Dawn huma l- effetti sekondarji li n- nies irrappurtaw meta Avonex kien qed jiġi studjat.
The figures are based on how many people said they’ d had them.
Il- figuri huma bbażata fuq in- numri ta ’ nies li qalu li kellhom dawn l- effetti.
It gives you an idea how likely you are to get similar side effects.
Dan jagħtik ħjiel ta ’ kemm hu probbabli li int ikollok effetti sekondarji simili.
Very common side effects (at least 1 in 10 people are affected)
Effetti sekondarji komuni ħafna (Mill- inqas 1 f’ 10 persuni huma affettwati)
- flu-like symptoms – headache, muscle aches, chills or a fever: see Flu-like symptoms, below
- sintomi jixbħu lill- influwenza – uġigħ ta ’ ras, uġigħ fil- muskoli, tkexkix ta´ bard jew deni: ara
Common side effects (less than 1 in 10 people are affected)
Effetti sekondarji komuni (Inqas minn 1 f’ 10 persuni huma affettwati)
- loss of appetite
- nuqqas ta ’ aptit
- feeling weak and tired
- tħossok dgħajjef u għajjien
- difficulty sleeping
- diffikultà biex torqod
- runny nose
- imnieħer iqattar
- diarrhoea (loose stools)
- dijareja (ħmieġ maħlul)
- feeling or being sick (nausea or vomiting)
- dardir u remettar
- numbness or tingling of skin
- tirżieħ jew tmemnim tal- ġilda
- rash, bruising of the skin
- raxx, tbenġil tal- ġilda
- increased sweating, night sweats
- żieda fl- għaraq, għaraq bil- lejl
- pain in your muscles, joints, arms, legs or neck
uġigħ fil- muskoli, ġogi, idejn, saqajn jew għonq
- muscle cramps, stiffness in the joints and muscles
- bugħawwieġ fil- muskolu, egħbusija fil- ġogi u l- muskoli
- pain, bruising and redness at the injection site
- uġigħ, tbenġil u ħmura fil- lok ta ’ l- injezzjoni
- changes to blood tests.
- bidliet fir- riżultati tat- testijiet tad- demm.
Symptoms you might notice are tiredness, repeated infection,
Sintomi li tista ’ tinnota huma għejja, infezzjoni
unexplained bruising or bleeding.
repetuta, tbenġil jew fsada mingħajn spjegazzjoni.
42 Uncommon side effects (less than 1 in 100 people affected)
Effetti sekondarji mhux komuni (Inqas minn 1 f’ 100 persuni huma affettwati)
- hair loss
- jaqgħa x- xagħar
- changes to your monthly period
- tibdil fil- pirjid
- burning feeling at the site of injection.
- ħruq fil- lok ta ’ l- injezzjoni.
Rare side effects (less than 1 in 1,000 people affected)
Effetti sekondarji rari (Inqas minn 1 f’ 1000 persuni huma affettwati)
- difficulty breathing.
- Diffikultà biex tieħu n- nifs.
If any of the effects trouble you, talk to your doctor.
Jekk xi effetti jinkwetawk, kellem lit- tabib tiegħek.
These effects have been seen in people using Avonex, but we do not know how likely they are to happen.
Dawn l- effetti deheru f’ persuni li użaw Avonex, iżda mhux magħruf kemm hu possibli li dawn isseħħu.
- an underactive or overactive thyroid
- tirojde taħdem bil- mod jew tgħaġġel iżżejjed
- nervousness or anxiety, emotional instability, irrational thoughts or hallucinations (seeing or
- nervi jew ansjetà, instabilità emozzjonali, ħsibijiet irrazzjonali jew alluċinazzjonijiet (tara jew
hearing things that are not real), confusion or suicide
tisma´ affarijiet li mhux reali), konfużjoni u suwiċidju
- numbness, dizziness, seizures or fits and migraines
- tnemnim, sturdament, puplesijja u emikranja
- an awareness of your heartbeat (palpitations), a rapid or irregular heartbeat, or heart problems
- tħoss qalbek tħabbat (palpitazzjonijiet), qalb tħabbat mgħaġġla jew irregolari, jew problemi
which would have the following symptoms: a reduced ability to exercise, inability to lie flat in bed, shortness of breath or swollen ankles
fil- qalb li għandhom dawn is- sintomi: kapacità anqas biex tagħmel l- eserċizzju, ma tkunx tista´ toqgħod ċatt fis- sodda, qtugħ ta´ nifs jew għekiesi minfuħa)
- liver problems as described above
- problemi tal- fwied kif deskritti fuq
- nettle rash or blister-like rash, itching, worsening of psoriasis if you have it
- raxx qisgħu xewk jew bl- infafet, ħakk, jekk ikollok psorajażi tmur għal agħar
- swelling or bleeding at the site of injection, or chest pain after an injection
- nefħa jew fsada fil- lok ta ’ l- injezzjoni, jew uġigħ fis- sider wara injezzjoni
- gaining or losing weight
- żjieda jew tnaqqas fil- piż
- changes to test results, including changes to liver function tests.
- bidliet fir- riżultati ta ’ testijiet, inkluż bidliet fit- testijiet tal- funzjoni tal- fwied.
Effects of the injection
Effetti ta ’ l- injezzjoni
- Feeling faint:
- Iħossok ħażin:
Your first injection of Avonex may be given by your doctor.
L- ewwel injezzjoni tiegħek ta ’ Avonex tista ’ tingħata mit- tabib tiegħek.
It may make you
Tista ’
feel faint.
tqabbdek qisgħu ħass ħażin.
You may even actually faint.
Jista ’ attwalment jaqbdek ħass ħażin.
This is unlikely to happen again.
Dan mhux probabbli li jerġa ’ jseħħ.
- Just after an injection, your muscles may feel tense or very weak – as though you are having
- Eżatt wara injezzjoni l- muskoli tiegħek jistgħu jinħassu stirati jew dgħajfa ħafna – bħal
a relapse.
qisu qed terġa tirkadi.
This is rare.
Dan huwa rari.
It only happens when you inject and the effects soon pass.
Jiġri biss meta tinjetta u l- effetti jgħaddu malajr.
They may happen any time after starting on Avonex.
Dawn jistgħu jseħħu f’ kull ħin wara li tinbeda fuq Avonex.
- If you notice any irritation or skin problems after an injection, talk to your doctor.
- Jekk tinnota xi rritazzjoni jew problemi tal- ġilda wara injezzjoni, kellem lit- tabib tiegħek.
Flu-like symptoms
Sintomi li jixbħu l- influwenza
Three simple ways to help reduce the impact of flu-like symptoms:
Tliet metodi sempliċi biex jgħinu jnaqqsu l- impatt ta ’ sintomi li jixbħu l- influwenza:
Use your Avonex injection just before bedtime.
Uża l- injezzjoni tiegħek ta ’ Avonex eżatt qabel tmur torqod.
2.
Dan jista ’ jħallik torqod tul l - effetti 2.
Take paracetamol or ibuprofen half an hour before your Avonex injection and continue taking it for up to a day.
Ħu paracetamol jew ibuprofen nofs siegħa qabel l- injezzjoni ta’ Avonex u ibqa ħudhom sa ġurnata.
Speak to your doctor or pharmacist about a suitable dose.
Kellem lit- tabib jew lill- ispiżjar tiegħek dwar doża xierqa.
If you have a fever, drink plenty of water to keep you hydrated.
Jekk ikollok id- deni, ixrob ħafna ilma biex iżommok idrat.
43 Some people find that after injecting Avonex, they feel like they have flu.
Xi persuni sabu li wara li jinjettaw Avonex, iħossuhom qisu għandhom l- influwenza.
Signs are:
Sinjali huma:
- muscle aches
- uġigħ fil- muskoli
- chills or a fever.
- tkexkix ta ’ bard jew deni.
These symptoms are not really flu.
43 Dawn is- sintomi mhumiex influwenza vera.
They are more common when you first start using Avonex.
Ma tista tgħaddiha li ħadd aktar. Huma aktar komuni fil- bidu tal- kura b’ Avonex.
As you keep using your injections, the flu-like symptoms gradually decrease.
Kif tkompli tuża l - injezzjonijiet tiegħek, s- sintomi li jixbħu l- influwenza jonqsu gradwalment.
HOW TO STORE AVONEX
KIF TAĦŻEN AVONEX
Keep out of the reach and sight of children.
Żomm fejn ma jintaħaqx u ma jidhirx mit- tfal.
Do not use after the expiry date stated on the label.
Tużax Avonex wara d- data ta ’ skadenza li tidher fuq it- tikketta.
Store below 25 °C.
Aħżen f’ temperatura anqas minn 25 °C.
Once prepared in the syringe use as soon as possible.
Kif tiġi ppreparata fis- siringa uża malajr kemm jista ’ jkun.
However, the prepared syringe can be stored in the fridge (between 2 °C and 8 °C) for up to 6 hours before you inject.
Madankollu, s- siringa ppreparata tista ’ tinħażen fil- friġġ (bejn 2 °C u 8 °C) sa 6 sigħat qabel l- injezzjoni.
Bring it out half an hour before injecting.
Oħroġ mill- friġġ nofs siegħa qabel l- injezzjoni.
Do NOT use AVONEX if you notice:
M' għandekx tuża AVONEX jekk tara li:
- The seal of the cap of the BIO-SET device is broken.
- Is- siġill tat- tapp ta ’ l- apparat BIO- SET huwa miksur
- The sealed plastic tray is damaged or opened.
- It- trej tal- plastik issiġillat għandu l- ħsara jew miftuħ
- The liquid in the vial obtained after reconstitution is not colourless or slightly yellow in colour
- Il- likwidu ta ’ ġol- fjala li ġie wara r- rikostituzzjoni mhux bla kulur jew kemmxejn safrani jew
or you can see particles floating in it.
tara xi frak fil- wiċċ.
Ingredients
Sustanzi
The active ingredient is:
Is- sustanza attiva hija:
Interferon-beta 1a 30 micrograms The other ingredients are:
Interferon beta- 1a 30 mikrogramma Is- sustanzi l- oħra huma:
Human serum albumin, sodium chloride, dibasic sodium phosphate and monobasic sodium phosphate.
Albumina tas- serum uman, sodium chloride, dibasic sodium phosphate u monobasic sodium phosphate.
What is in your Avonex pack
X’ fiħ il- pakkett tiegħek ta ’ Avonex
A box of Avonex Bioset has four doses of Avonex.
Pakket ta ’ Avonex Bioset fih erba ’ dożi ta ’ Avonex.
Each dose comes in a sealed plastic tray and has a white to off-white coloured powder in a glass container (vial) and an injection syringe filled with water.
Kull doża tiġi fi trej tal- plastik issiġillat u għandha trab ta ’ kulur abjad għal abjad maħmuġ f’ kontenitur tal- ħġieġ (fjala) u siringa għall- injezzjoni mimlija bl- ilma.
These are mixed together to make up the injection you take (solution for injection).
Dawn jiġu mħallta flimkien biex jagħmlu l- injezzjoni li inti tieħu (soluzzjoni għall- injezzjoni).
A separate needle to give the injection is also included in the tray.
Labra separata biex tagħti l - injezzjoni hija wkoll inkluża fit- trej.
Marketing Authorisation Holder is:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq huwa:
Biogen Idec Limited, Innovation House, 70 Norden Road, Maidenhead, Berkshire, SL6 4AY, United Kingdom.
Biogen Idec Limited, Innovation House, 70 Norden Road, Maidenhead, Berkshire, SL6 4AY, Renju Unit.
44 Avonex is made by:
Avonex huwa magħmul minn:
Biogen Idec BV, Robijnlaan 8, NL-2132 WX Hoofddorp, The Netherlands.
Biogen Idec BV, Robijnlaan 8, NL- 2132 WX Hoofddorp, Olanda.
You can get a larger print version of this leaflet by calling the local representatives.
Tista ’ tikseb verżjoni bi kliem akbar ta ’ dan il- fuljett billi ċċempel lir- rappreżentanti lokali.
For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
44 Għal kull tagħrif dwar din il - prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Κύπρος Genesis Pharma Cyprus Ltd +3572 2 769946
45 Κύπρος Genesis Pharma Cyprus Ltd +3572 2 769946
HOW TO INJECT AVONEX
KIF TINJETTA AVONEX
You should have had training in how to inject Avonex.
Suppost kellek taħriġ dwar kif tinjetta Avonex.
These notes are a reminder.
Dawn in- noti huma tifkira.
If there’ s anything you’ re not sure about, check with your doctor or pharmacist.
Jekk hemm xi ħaġa li mhux ċert minnha, iċċekja mat- tabib jew l- ispiżjar tiegħek.
Where to inject
Fejn tinjetta
• Avonex is injected into a muscle, for example, the upper thigh muscle.
• Avonex jiġi injettat ġo muskolu, eżempju, l- parti ta ’ fuq tal- muskoli tal- koxxa.
Injection of Avonex into the buttocks is not recommended. • Use a different injection site each week.
Injezzjoni ta ’ Avonex fil- warrani mhix rakkomandata. • Uża post differenti kull ġimgħa għall- injezzjoni.
This means less risk of irritation to your skin and muscle.
Dan ifisser riskju inqas ta ’ irritazzjoni lill - ġilda jew muskoli tiegħek. • Tużax post fil- ġilda li huwa mbenġel, juġgħa jew infettat jew jekk hemm ferita miftuħa.
• Do not use any area of skin that is bruised, sore, or infected, or if there is an open wound.
Post ta ’ konnessjoni
Do not use it if it is out-of-date.
Oħroġ it- trej mill- kaxxa Iċċekkja id- data ta ’ skadenza fuq l- għatu tat- trej.
Check the blister tray contains:
Tużaħx jekk huwa skadut.
• • •
46 Neħħi għal kollox l- għatu tal- karta.
one BIO-SET (vial + base + cap) one syringe one injection needle (see picture “Contents of the plastic tray”).
Iċċekkja li t- trej tal- plastik fiħ: • BIO- SET wieħed (fjala + bażi + għatu) • siringa waħda • labra waħda għall- injezzjoni (ara l- istampa “ Kontenut fit- trej tal- plastik ”).
Wash your hands thoroughly with soap and water and dry them.
Aħsel idejk sew bis- sapun u ilma u xxutthom sew.
Prepare alcohol wipes and sticking plasters (not supplied) if you need them.
Ipprepara msielaħ ta ’ alkoħol u tejp li jeħel (mhux inkużi) jekk għandek bżonnhom.
Find a clean, hard surface to lay out the items needed for your injection.
Sib wiċċ nadif u iebes fejn tpoġġi l- oġġetti meħtieġa għall- injezzjoni tiegħek.
Lay the tray down on it.
Neħħi l - kontenut tal- pakkett u poġġihom fuq il- wiċċ fejn ħa taħdem.
Preparing the injection
Preparazzjoni ta ’ l- injezzjoni
1 Remove cap off the vial Twist, then pull cap off.
1 Neħħi l- għatu minn fuq il- fjala Dawwar, u wara iġbed u aqla ’ l- għatu.
Do not touch the connection port.
Tmissx fejn teħel is- siringa.
2 Pull the cap off the syringe Hold the base of the syringe.
Iġbed it- tapp tas- siringa 2 Żomm il- bażi tas- siringa mimlija lesta.
Pull the cap off.
Iġbed u aqla ’ t- tapp.
Do not touch the connection port.
Tmissx il- post ta ’ konnessjoni.
Do not push on the plunger.
Tinbuttax il- planġer.
3 Line up the syringe and vial Place the Bio-Set on a flat surface.
3 Allinjament tas- siringa u l- fjala Poġġi l- appart BIO- SET fuq wiċċ ċatt.
Line up the two connection ports so that they are in a straight line.
Allinja flimkien iż- żewġ postijiet ta ’ konnessjoni b’ tali mod li jiffurmaw linja dritta (allinjament dritt).
Hold the syringe by the base.
Żomm is- siringa mill- bażi.
Screw it firmly clockwise into the vial.
Issikka sew ġol- fjala billi ddawwar lejn il - lemin
4 Push the syringe down until it clicks Keep the Bio-Set on the flat surface and hold the syringe by the base.
4 Imbotta s- siringa l- isfel sakemm tikklikkja Żomm l- apparat Bio Set fuq il- wiċċ ċatt, u żomm is- siringa mill- bażi.
Keep them in a straight line.
Żommhom f’ linja dritta.
If the syringe is at an angle to the Bio-Set, it will leak.
Jekk is- siringa tkun f’ angolu ma ’ l- apparat Bio Set tista ’ tnixxi.
Push the syringe until it clicks.
Imbotta s- siringa sakemm tikklikkja.
5 Mix the water and powder Slowly inject all the water from the syringe into the vial.
5 Ħallat l- ilma mat- trab Injetta bil- mod l- ilma kollu mis- siringa għal ġol- fjala.
Don’t push the plunger quickly.
Timbuttax il- planġer malajr.
This turns the solution to foam that can’t be drawn into the syringe.
Dan iġiegħel lis- soluzzjoni tagħmel ir- rawa li ma tistax tinġibed fis- siringa.
Push the plunger right down to get air out of the syringe.
Imbotta il- planġer s’ isfel nett sabiex tneħħi l- arja mis- siringa.
47 6 Dissolve the powder fully Pick up the vial and the syringe, keeping them attached and straight.
6 Dewweb it- trab kollu Iġbor il- fjala u s- siringa, u żommhom imwaħħla u dritti.
Gently swirl the vial until all the powder has dissolved.
Dawwar bil - mod il- kontenut tal- fjala sakemm it- trab kollu jinħall.
Do not shake: this will make froth.
Tħallatx il- fjala bil- qawwi: dan iwassal għar- rawa.
7 Fill the syringe Turn the syringe and vial upside down, still in a straight line.
47 7 Imla s- siringa Aqleb is- siringa u l- fjala ta ’ taħt fuq, dejjem fl- linja dritta.
If the syringe is at an angle to the Bio-Set, it will leak.
Jekk is- siringa hija f’ angolu ma ’ l- apparat Bio Set, tista ’ tnixxi.
Slowly pull the plunger until all the liquid is in the syringe.
Iġbed bil- mod il- planġer sakemm il- likwidu kollu jkun fis- siringa.
8 Separate syringe and vial Hold the filled syringe by the base.
8 Issepara s- siringa mill- fjala Żomm is- siringa mimlija lesta mill- bażi.
Turn it anti-clockwise to remove it from the Bio-Set vial.
Dawwarha lejn ix- xellug biex tneħħijha minn mal- fjala tal- Bio Set.
Do not touch the connection port on the syringe.
Tmissx il- post ta ’ konnessjoni tas- siringa fejn teħel il- labra.
Giving the injection
Tagħti l- injezzjoni
1 Check the liquid in the syringe It should be clear and colourless.
1 Iċċekkja l- likwidu ġos- siringa Irid ikun ċar u bla kulur.
If the solution is any colour except colourless or slightly yellow, or if you can see particles floating in it, do not inject.
Jekk is- soluzzjoni tkun kulur ieħor barra bla kulur jew kemm xejn safra, jew jekk tara frak fil- wiċċ, tinjettax.
2 Fit the needle Unwrap the needle to expose the connection port.
2 Waħħal il- labra Iftaħ il- labra sabiex tikxef il- post ta ’ konnessjoni.
Keep the cover on.
Żomm l- għatu fuqha.
Push and twist the needle clockwise onto the syringe.
Inbotta u dawwar il- labra lejn il- lemin għal fuq is- siringa.
Now pull off the plastic needle cover.
Issa iġbed l- għatu tal- plastik tal- labra.
Do not twist it.
Iddawwarx.
If you twist the needle cover to remove it, you may accidentally remove the needle as well.
Jekk iddawwar l- għatu tal- labra biex tneħħih, tista ’ tneħħi wkoll il - labra bi żball.
3 Remove any air To remove air, point the syringe needle upwards.
3 Neħħi l- arja kollha Biex tneħħi l- arja, ipponta l- labra tas- siringa l- fuq.
Gently tap to bring air bubbles to the top.
Tektek bil- mod sabiex tiġbor l- bżieżaq ta ’ l- arja l- fuq.
Push the plunger carefully to remove the air.
Inbotta l- planġer b’ attenzjoni sabiex tneħħi l- arja.
Don’t let more than a small drop of liquid escape.
Tħallix iktar minn qatra żgħira tal- likwidu taħrab.
4 Clean and stretch the injection site If you need to, use an alcohol wipe to clean the skin at the injection site you’ve chosen.
4 Naddaf u stira l- post ta ’ l- injezzjoni Jekk hemm bżonn, uża mselħa ta ’ l- alkoħol biex timsaħ il- ġilda fil- post li għażilt fejn ħa tagħti l - injezzjoni.
Allow the skin to dry.
Ħalli l- ġilda tinxef.
With one hand, stretch the skin around the injection site.
B’ id waħda, stira l- ġilda madwar il- post ta ’ l- injezzjoni.
Relax your muscle.
Irrilassa l- muskolu tiegħek.
48 5 Make the injection Insert the injection needle with a quick dart-like thrust at right angles to the skin, into the muscle.
5 Tagħti l- injezzjoni Daħħal il- labra ta ’ l- injezzjoni b’ moviment ħafif qishek qed titfaħħa f’ angolu rett mal- ġilda, għal ġol- muskolu.
The needle must go all the way in.
Il- labra trid tidħol kollha l- ġewwa.
Press the plunger slowly until the syringe is empty.
Għafas il- planġer bil- mod sakemm is- siringa tkun vojta.
6 Pull the needle out Keep the skin stretched tightly or squeeze the skin around the injection site, and pull out the needle.
48 6 Iġbed il- labra l- barra Żomm il- ġilda stirata sew jew għafas il- ġilda madawar il- post ta ’ l - injezzjoni, u iġbed il- labra l- barra.
If you use alcohol wipes, hold one on the injection site.
Jekk tuża msielaħ ta ’ l- alkoħol, żomm waħda fuq il- post ta ’ l - injezzjoni.
Put a plaster over the site of injection if you need to.
Poġġi tejp li jeħel fuq il- post ta ’ l- injezzjoni jekk hemm bżonn.
Dispose of the rubbish properly
Armi l- iskart kif suppost
After you have finished each injection, put the needle, syringe and vial into a special container (such as a sharps bin), not in ordinary rubbish.
Wara li tispiċċa kull injezzjoni, poġġi l- labra, siringa u fjala ġewwa kontenitur speċjali (kontenitur ta ’ oġġetti jaqtgħu), mhux ma ’ l- iskart normali.
Waste paper and used wipes can be put in an ordinary rubbish bin.
Karti għar- rimi u msielaħ użati jistgħu jintremew f’ kontenitur normali ta ’ l- iskart.
AVONEX 30 micrograms/0.5 ml solution for Injection (Interferon beta-1a) Pre-filled syringe presentation
AVONEX 30 mikrogramma/ 0. 5 ml soluzzjoni għall- injezzjoni (Interferon beta- 1a) Preżentazzjoni siringa mimlija lesta
- If you have any further questions, ask your doctor or your pharmacist.
- Jekk ikollok aktar mistoqsijiet,, staqsi lit- tabib jew lill- spiżjar tiegħek.
Latest issue:{MM/YYYY} This leaflet is changed from time to time.
{XX/ SSSS} Dan il- fuljett jinbidel minn ħin għal ieħor.
What AVONEX is and what it is used for 2.
X’ inhu AVONEX u għalxiex jintuża 2.
1 WHAT AVONEX IS AND WHAT IT IS USED FOR
X’ INHU AVONEX U GĦALXIEX JINTUŻA
50 (Notes information)
50 (Noti ta ’ informazzjoni)
In MS, your body’s defence system reacts against it’s own myelin – the ‘insulation’ that surrounds nerve fibres.
Fi MS, is- sistema ta ’ difiża ta ’ ġismek tirreaġixxi kontra l- myelin - l - “ iżolazzjoni ” ta ’ madwar il- fibri tan- nervaturi – tiegħu stess.
Avonex seems to work by stopping your body’s defence system from attacking the myelin.
Avonex jidher li jaħdem billi jwaqqaf is- sistema ta ’ difiża tal- ġisem tiegħek milli tattakka l- myelin.
Do not use AVONEX
Tużax AVONEX:
- if you are allergic (hypersensitive) to interferon beta, or any other of the other ingredients in
- jekk int allerġiku (ipersensittiv) għal interferon beta jew għal xi wieħed mis- sustanzi l- oħra
Avonex
f’ Avonex
- if you are pregnant do not start using Avonex
- jekk inti tqila, tibdiex tuża Avonex
- thoughts about committing suicide.
- Ħsibijiet li tagħmel suwiċidju.
- heart problems, which can cause symptoms such as chest pain (angina), particularly after any
- problemi fil- qalb, li jistgħu jikkawżaw sintomi bħal uġigħ fis- sider (anġina), speċjalment wara
activity; swollen ankles, shortness of breath (congestive heart failure); or an irregular heartbeat (arrhythmias).
xi sforż; għekiesi minfuħa, qtugħ ta ’ nifs (insuffiċjenza tal- qalb konġestiva); jew qalb tħabbat b’ mod irregolari (arritmija).
- If you are having a blood test.
- jekk se tagħmeleżami tad- demm.
Avonex may interfere with the results.
Avonex jista 'jinterferixxi mar- riżultati.
If you are pregnant do not start using Avonex.
Jekk inti tqila, tibdiex tuża Avonex.
- If you want to breastfeed talk to your doctor first.
- Jekk trid tredda ’ l- ewwel kellem lit- tabib tiegħek.
This medicine is essentially ‘sodium-free’.
Din il- mediċina hija essenzjalment ‘ mingħajr sodju ’.
If you have decided to start treatment with Avonex, your doctor may recommend that you use about half the dose of Avonex initially, before increasing to the full dose.
52 Jekk tkun iddeċejt li tibda l- kura b’ Avonex, it- tabib tiegħek jista ’ jirrakkomandalek li tuża madwar nofs id- doża ta ’ Avonex inizjalment, qabel ma żżidha għad- doża sħiħa.
Your doctor may provide you with an Avostartclip that attaches onto the syringe and reduces the dose of Avonex that will be injected.
It- tabib tiegħek jista ’ jipprovdilek Avostartclip li jeħel mas- siringa u jnaqqas id- doża ta ’ Avonex li tkun injettata.
52 (Notes information)
(Noti ta ’ informazzjoni)
Starting Avonex If you are new to Avonex, your doctor may have advised that you start by taking a lower dose so that you can adjust to the effects of Avonex before increasing to the full dose.
Kif tibda b’ Avonex Jekk ser tuża Avonex għal- ewwel darba, jista ’ jkun li t- tabib tiegħek irrakkomandalek li tibda billi tieħu doża iktar baxxa biex b’ hekk tkun tista ’ taġġusta għall- effetti ta ’ Avonex qabel ma ’ żżidha għad - doża sħiħa.
You may be given an Avostartclip.
Inti tista ’ tingħata Avostartclip.
This Avostartclip will attach onto the syringe and allow about half a dose of Avonex to be administered.
Dan l- Avostartclip ser jitwaħħal mas- siringa u jippermetti li tingħata madwar nofs doża ta ’ Avonex.
For further details on use, please follow the instructions provided with the Avostartclip.
Għal dettalji addizzjonali dwar l- użu, jekk jogħġbok segwi l- istruzzjonijiet ipprovduti mal- Avostartclip.
Injecting yourself
Tinjetta lilek innifsek
Like all medicines, Avonex can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Avonex jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
53 (Notes information)
(Noti ta ’ informazzjoni)
Although the list of possible side effects can seem worrying, it’s possible that you may not have any of them.
Għalkemm il- lista ta ’ effetti sekondarji li jista ’ jkollu tista ’ tidher inkwetanti, huwa possibli li int ma jkollok l- ebda wieħed minnhom.
Serious allergic reactions If you get any of these:
Reazzjonijiet allerġiċi serji Jekk ikollok xi wieħed minn dawn:
- difficulty bre athing
- diffikultà biex tieħu n- nifs
The figures are based on how many people said they’d had them.
Il- figuri huma bbażata fuq in- numri ta ’ nies li qalu li kellhom dawn l- effetti.
- diarrhoea (loose stools)
- imnieħer iqattar
- numbness or tingling of skin
- dijareja (ħmieġ maħlul)
- pain in your muscles, joints, arms, legs or neck
- uġigħ fil- muskoli, ġogi, idejn, saqajn jew għonq
Uncommon side effects (less than 1 in 100 people affected)
Effetti sekondarji mhux komuni (Inqas minn 1 f’ 100 persuni huma affettwati)
Effects of the injection
Effetti ta ’ l- injezzjoni Iħossok ħażin:
55 (Notes information)
55 Sintomi li jixbħu l- influwenza
Some people find that after injecting Avonex, they feel like they have flu.
Xi persuni sabu li wara li jinjettaw Avonex, iħossuhom qisu għandhom l- influwenza.
These symptoms are not really flu.
Dawn is- sintomi mhumiex influwenza vera.
Do not use after the expiry date stated on the label.
Tużax wara d- data ta ’ skadenza fuq it- tikketta.
Store in the original package (sealed plastic tray) in order to protect from light.
Żommu fil- pakk oriġinali (trej tal- plastik issiġillat) sabiex tilqa ’ mid- dawl.
Store in the fridge (between 2 °C and 8 °C).
Aħżen fi- friġġ (2 °C - 8 °C).
Avonex can also be stored at room temperature (between 15 °C and 30 °C) for up to one week.
Avonex jista ’ jinħażen f’ temperatura ta ’ l- ambjent (bejn 15 °C u 30 °C) sa ġimgħa.
Do NOT use AVONEX if you notice:
M' GĦANDEKX TUŻA AVONEX jekk tara li:
- The pre-filled syringe is broken.
- Is- siringa mimlija lesta hija mkissra.
- The sealed plastic tray is damaged or opened.
- It- trej tal- plastik issiġillat għandu l- ħsara jew miftuħ.
- The solution is coloured or you can see particles floating in it.
- It- taħlita likwida hija kkulurita jew tara xi frak fil- wiċċ.
- The tamper evident cap has been broken.
- It- tapp issiġillat ġie miftuħ.
Interferon-beta 1a 30 micrograms/0.5 ml The other ingredients are:
Interferon beta- 1a 30 mikrogramma/ 0. 5 ml Is- sustanzi l- oħra huma:
Sodium acetate, trihydrate; acetic acid glacial, arginine hydrochloride, polysorbate 20 and water for injections.
Sodium acetate, trihydrate; acetic acid glacial, arginine hydrochloride, polysorbate 20 u ilma għall- injezzjoni.
What is in your Avonex pack
56 X’ fiħ il- pakkett tiegħek ta ’ Avonex
Avonex Solution for Injection comes as a ready to use injection.
Avonex Soluzzjoni għall- injezzjoni tiġi bħala injezzjoni lesta għall- użu.
In a box of Avonex there are four or twelve ready to use (pre-filled) syringes, each with 0.5 ml of a clear, colourless liquid inside.
F’ pakkett Avonex hemm erba ’ jew tnax siringi lesti għall- użu (milija lesti), kull waħda b’ 0. 5 ml ta ’ likwidu ċar u bla kulur ġewwa.
Not all pack sizes may be marketed.
Mhux kull daqs ta ’ pakkett jista ’ jkun għall- bejħ.
Each syringe is packed in a sealed plastic tray.
Kull siringa hija ppakkjata fi trej tal- plastik issiġillat.
A separate needle to give the injection is also included in the tray.
Labra separata biex tagħti l- injezzjoni hija nkluża wkoll fit- trej.
56 Marketing Authorisation Holder is:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq huwa:
Avonex is made by:
Avonex huwa magħmul minn:
Biogen Idec Denmark Manufacturing ApS, Biogen Idec Allé 1, DK-3400 Hillerød, Denmark
Biogen Idec Denmark Manufacturing ApS, Biogen Idec Allé 1, DK- 3400 Hillerød, Danimarka.
For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il - prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
France Biogen Idec France +33 (0)1 41 37 9595
57 France Biogen Idec France +33 (0) 1 41 37 9595
You should have had training in how to inject Avonex These notes are a reminder.
Dawn in- noti huma tifkira.
If there’s anything you’re not sure about, check with your doctor or pharmacist.
Jekk hemm xi ħaġa li mhux ċert minnha, iċċekja mat- tabib jew l- ispiżjar tiegħek.
This means less risk of irritation to your skin and muscle. • Do not use any area of skin that is bruised, sore, or infected, or if there is an open wound.
Dan ifisser riskju inqas ta ’ irritazzjoni lill - ġilda jew muskoli tiegħek. • Tużax post fil- ġilda li huwa mbenġel, juġgħa jew infettat jew jekk hemm ferita miftuħa.
Getting Ready
Preparazzjoni
Remove one sealed plastic tray from the refrigerator
Neħħi trej tal- palstik issiġillat mill- friġġ.
Check the expiry date on the lid of the tray.
- Iċċekkja id- data ta ’ skadenza fuq l- għatu tat- trej.
Do not use it if it is out-of-date.
Tużaħx jekk huwa skadut.
Peel back the paper lid completely.
- Neħħi għal kollox l- għatu tal- karta.
Check the blister tray contains one pre-filled syringe and one injection needle (see picture “Contents of the plastic tray”).
Iċċekkja li t- trej tal- plastik fiħ siringa waħda mimlija
Leave the syringe to warm up
Ħalli s- siringa tisħon
Leave it at room temperature for half an hour.
- Ħallijha f’ temperatura ta ’ l- ambjent għal nofs siegħa.
This makes the injection more comfortable than injecting straight from the fridge.
Dan jagħmel l- injezzjoni aktar
Do not use external heat sources such as hot water to warm the syringe.
Tużax meżżi esterni ta ’ sħana bħal misħun biex issaħħan is- siringa.
Lay the tray down on it.
Poġġi it- trej fuqu.
B.
59 B.
If the solution is cloudy, coloured or contains any floating particles, do not use the pre-filled syringe.
Jekk is- soluzzjoni tkun mdardra, kkulurita jew fiha frak fil- wiċċ, tużax is- siringa mimlija lesta.
2 Remove the syringe cap The syringe has a white tamper-evident cap.
2 Neħħi t- tapp tas- siringa Is- siringa għandha tapp abjad issiġillat.
Make sure the cap is intact and has not been opened.
Kun żgur li t- tapp huwa intatt u ma kienx miftuħ.
If it looks like it has been opened, do not use that syringe.
Jekk jidher li ġie miftuħ, tużax is- siringa.
Hold the syringe so that the white cap is facing up.
Żomm is- siringa b’ mod li t- tapp abjad iħares il- fuq.
Bend the cap at a right angle until it snaps off.
Għawweġ it- tapp f’ angolu rett sakemm jinqata ’ l’ barra.
Do not touch the connection port.
Tmissx il post ta ’ konnessjoni.
59 3 Fit the needle Open needle to expose the connection port.
3 Waħħal il- labra Iftaħ il- labra biex tikxef il- post ta ’ konnessjoni.
Keep the cover on.
Żomm l- għatu f’ postu.
Press the needle onto the syringe.
Għafas il- labra għal fuq is- siringa.
Tip:
Dawwar lejn il- lemin sakemm teħel f’ postha Parir:
Make sure the injection needle is firmly attached to the syringe.
Kun ċert li l- labra għall- injezzjoni tkun imwaħħla sew mas - siringa.
Otherwise it may leak.
Inkella tista ’ tnixxi.
If you have been prescribed a half dose of Avonex, you may need to use the Avostartclip your doctor will provide.
Jekk ingħatajt riċetta għal nofs doża ta ’ Avonex, jista ’ jkollok bżonn li tuża l- Avostartclip li t- tabib tiegħek ser jipprovdi.
Please follow the instructions provided with the Avostartclip.
Jekk jogħġbok segwi l- istruzzjonijiet ipprovduti mal- Avostartclip.
Now pull off the plastic needle cover.
Issa aqla ’ l- għatu tal- plastik minn fuq il- labra.
Do not twist it.
Iddawrux.
If you twist the needle cover to remove it, you may accidentally remove the needle as well.
Jekk iddawwar l- għatu tal- labra biex tneħħiħ, tista ’ aċċidentalment tneħħi l- labra wkoll.
1 Clean and stretch the injection site If you need to, use an alcohol wipe to clean the skin at the injection site you’ve chosen.
1 Naddaf u stira il- post ta ’ l- injezzjoni Jekk hemm bżonn, uża mselħa ta ’ l- alkoħol biex timsaħ il- ġilda fil - post li għażilt fejn ħa tagħti l- injezzjoni.
2 Make the injection Insert the injection needle with a quick dart-like thrust at right angles to the skin, into the muscle.
2 Tagħti l- injezzjoni Daħħal il- labra ta ’ l- injezzjoni b’ moviment ħafif qishek qed titfaħħa f’ angolu rett mal- ġilda, għal ġol- muskolu.
If you are using the syringe that has the Avostartclip attached, you will receive about half the dose of Avonex.
Jekk qed tuża s- siringa li jkollha l- Avostartclip imwaħħal magħha, inti ser tirċievi madwar nofs id- doża ta ’ Avonex.
The syringe will not empty.
Is- siringa mhux ser titbattal.
3 Pull the needle out Keep the skin stretched tightly or squeeze the skin around the injection site, and pull out the needle.
60 3 Iġbed il- labra l- barra Żomm il- ġilda stirata sew jew għafas il- ġilda madawar il- post ta ’ l - injezzjoni, u iġbed il- labra l- barra.
After you have finished each injection, put the needle and syringe into a special container (such as a sharps bin), not in ordinary rubbish.
Wara li tispiċċa kull injezzjoni, poġġi l- labra u siringa ġewwa kontenitur speċjali (kontenitur ta ’ oġġetti jaqtgħu), mhux ma ’ l- iskart normali.
If you have used the Avostartclip, the syringe (and the Avostartclip) must be thrown away afterwards.
Jekk tkun użajt l- Avostartclip, is- siringa (u l- Avostartclip) iridu jintrenew wara.
The unused portion of Avonex must not be re-used.
Il- porzjon mhux użat ta ’ Avonex m’ għandux jerġa ’ jintuża.
What is Axura?
X' inhu Axura?
Axura is a medicine containing the active substance memantine hydrochloride.
Axura hija mediċina li fiha s- sustanza attiva memantina idroklorur (memantine hydrochloride).
What is Axura used for?
Għal xiex jintuża Axura?
Axura is used to treat patients with moderate to severe Alzheimer’ s disease.
Axura jintuża għat- trattament ta 'pazjenti bil- marda ta' Alzheimer moderata jew gravi.
How is Axura used?
Kif jintuża Axura?
Treatment should only be started if a caregiver is available who will regularly monitor the use of Axura by the patient.
It- trattament għandu jinbeda biss jekk ikun hemm min jieħu ħsieb li jissorvelja l- użu ta 'Axura mill- pazjent.
Axura should be given once a day, with or without food, at about the same time every day.
Axura għandu jingħata darba kuljum, fuq stonku vojt jew le, f' madwar l- istess ħin kuljum.
To prevent side effects, the dose of Axura is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg.
Bil- għan li jiġu prevenuti effetti sekondarji, id- doża ta 'Axura tiżdied progressivament matul l- ewwel tliet ġimgħat tat- trattament: matul l- ewwel ġimgħa, id- doża ta' 5 mg; fit- tieni ġimgħa, titla 'għal 10 mg; u matul it- tielet ġimgħa, għal 15 mg.
The safety and effectiveness of Axura have not been established in patients with severe liver problems.
Is- sigurtà u l- effikaċja ta 'Axura ma ġewx stabbiliti f' pazjenti bi problemi gravi tal- fwied.
How does Axura work?
Kif jaħdem Axura?
The active substance in Axura, memantine hydrochloride, is an antidementia medicine.
Is- sustanza attiva f' Axura, memantina idroklorur, hija mediċina kontra d- demenza.
Axura works by blocking special types of receptor called NMDA receptors, to which the neurotransmitter glutamate normally attaches.
Axura jaħdem billi jimblokka tipi speċjali ta 'riċetturi msejħin riċetturi NMDA li magħhom normalment jeħel il- glutammat, li huwa newrotrasmettitur.
How has Axura been studied?
Kif ġie studjat Axura?
Axura has been studied in three main studies including a total of 1,125 patients with Alzheimer’ s disease, some of whom had taken other medicines for their disease in the past.
Axura ġie studjat fi tliet studji prinċipali li involvew total ta '1, 124 pazjent bil- marda ta' Alzheimer, xi wħud minnhom ħadu mediċini oħrajn għal din il- marda fil- passat.
The effects of Axura were compared with those of placebo (a dummy treatment) over 24 to 28 weeks.
L- effetti ta 'Axura tqabblu ma' dawk tal- plaċebo (trattament finta) fuq 24 sa 28 ġimgħa.
Axura was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Axura ġiet studjata wkoll fi tliet studji addizzjonali li involvew total ta '1, 186 pazjent bil- marda fi stadju ħafif jew gravi.
What benefit has Axura shown during the studies?
Liema benefiċċju wera Axura waqt l- istudji li ġew imwettqa?
Axura was more effective than placebo at controlling the symptoms of Alzheimer’ s disease.
Axura kien aktar effikaċi mill- plaċebo biex jikkontrolla s- sintomi tal- marda ta 'Alzheimer.
In the study of moderately severe to severe disease, patients taking Axura had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
Fl- istudju ta 'mard minn moderatament gravi għal gravi, pazjenti li kienu qed jieħdu Axura kellhom inqas sintomi minn dawk li kienu qed jieħdu l- plaċebo wara 28 ġimgħa, kif imkejla fuq punteġġi kemm globali kif ukoll funzjonali.
In the two studies of mild to moderate disease, patients on Axura had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
Fiż- żewġ studji ta 'mard ħafif għal moderat, il- pazjenti li kienu qed jieħdu Axura kellhom sintomi inqas gravi wara 24 ġimgħa, kif imkejla fuq l- punteġġi globali u konjittivi.
However, when these results were considered along with those of the three additional studies, it was noted that the effect of Axura was smaller in patients with mild disease.
Madankollu, meta dawn ir- riżultati ġew ikkunsidrati flimkien ma 'dawk tat- tliet studji addizzjonali, ġie nnotat li l- effett ta' Axura kien iżgħar f' pazjenti b' mard fi stadju ħafif.
What is the risk associated with Axura?
X' inhu r- riskju assoċjat ma 'Axura?
The most common side effects with Axura (seen in between 1 and 10 patients in 100) are headache, somnolence (sleepiness), hypertension (high blood pressure), constipation and dizziness.
L- aktar effetti sekondarji b' Axura (li dehru f' madwar 1 u 10 pazjenti minn kull 100) huma wġigħ ta 'ras, ħedla tan- ngħas ipertensjoni (pressjoni tad- demm għolja), stitikezza u sturdament.
For the full list of all side effects reported with Axura, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Axura, ara l- Fuljett ta' Tagħrif.
Axura should not be used in people who may be hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients.
Axura ma għandux jintuża minn persuni li jista 'jkunu ipersensittivi (allerġiċi) għal memantina idroklorur jew għal xi sustanzi oħra.
Why has Axura been approved?
Għaliex ġie approvat Axura?