qanastek/EMEA-V3 huggingface dataset:
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 tħossok ferm aktar imdejjaq/ imdejqa jew bla ħeġġa minn qabel il- kura b’ Betaferon, jew jekk tiżviluppa ħsibijiet ta ’ suwiċidju.
Do not inject a double dose to make up for a forgotten individual dose.
− jekk tinnota xi tbenġil mhux normali, ħruġ ta ’ demm eċċessiv wara korriment jew jekk jidher li tkun qed tieħu ħafna infezzjonijiet.
If you stop using Betaferon:
− jekk ikollok sintomi bħal taħbit tal- qalb mhux regolari, nefħa bħal fl- għekiesi jew fir- riġlejn, jew qtugħ ta ’ nifs.
Talk to your doctor if you stop or wish to stop treatment.
− jekk tinnota uġigħ f’ żaqqek li jinfirex għal dahrek, u/ jew tħossok ma tiflaħx jew ikollok id - deni.
Stopping Betaferon is not known to cause acute withdrawal symptoms.
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).
► If you have any further questions on the use of this product, ask your doctor or pharmacist.
It- tabella tinkludi wkoll effetti sekondarji li seħħew f’ inqas minn 10% tal- każijiet iżda kienu assoċjati b’ mod sinifikanti mal- kura)
Possible side effects
- infezzjoni, axxess
Like all medicines, Betaferon can cause side effects, although not everybody gets them.
- tnaqqis fl- għadd ta ’ ċelluli bojod tad- demm, glandoli limfatiċi minfuħin
At the beginning of treatment side effects are common but in general they become less with further treatment.
- tnaqqis fil- livell ta ’ zokkor fid- demm
83 The most common side effects are:
- depressjoni, ansjetà
► Flu-like symptoms such as fever, chills, painful joints, malaise, sweating, headache, or muscular pain.
- uġigħ ta ’ ras, sturdamenti, nuqqas ta ’ rqad, emigranja, tnemnin jew tingis (parasteżija)
These symptoms may be reduced by taking paracetamol or non-steroidal anti-inflammatory medicines such as ibuprofen.
- konġuntivite, vista mhux normali
► Injection site reactions.
- uġigħ fil- widnejn1
Symptoms can be redness, swelling, discoloration, inflammation, pain, hypersensitivity, necrosis.
- ħmura u/ jew ħmura fil- wiċċ minħabba twessigħ tal- kanali tad- demm, żjieda fil- pressjoni
See ‘Take special care’ in section 2 for more information and what to do, if you experience an injection site reaction.
tad- demm imnieħer iqattar, sogħla, ħanqa minħabba infezzjoni tal- apparat respiratorju ta ’ fuq, sinożite,
These may be reduced by the use of an auto-injector device.
żjieda fis- sogħla, qtugħ ta ’ nifs
Please talk to your doctor for further information.
- dijarea, stitikezza, dardir, rimettar, uġigħ addominali
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’).
- żjieda fil- livelli fid- demm ta ’ l- enzimi tal- fwied (osservati fit- testijiet tad- demm)
Betaferon may also cause serious side effects.
- disturbi fil- ġilda, raxx
► Tell your doctor immediately and stop using Betaferon:
- ebusija tal- muskoli (ipertonija), uġigħ fil- muskoli (majalġja), indeboliment fil- muskoli
− if you experience symptoms such as itching all over your body, swelling of your face and/or your tongue or sudden shortness of breath.
(majastenja), uġigħ fid- dahar, uġigħ fl- estremitajiet bħal swaba ’ ta ’ l- idejn u tas- saqajn
− if you feel noticeably more sad or hopeless than before the treatment with Betaferon, or if you develop thoughts of suicide.
- żamma ta ’ l- awrina, proteini fl- awrina (osservati fit- testijiet ta ’ l- awrina), tgħaddi l- awrina ta ’
− if you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections.
spiss, inkontinenza, tgħaddi l- awrina b’ urġenza
− 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.
- ugigħ waqt il- menstrwazzjoni, disturbi menstrwali, tnixxija qawwija ta ’ demm mill- utru
− if you experience symptoms like irregular heart beat, swelling such as of the ankles or legs, or shortness of breath.
speċjalment bejn menstrwazzjoni u oħra, impotenza
− if you notice pain in your belly which is radiating to your back, and/or you feel sick or have a fever.
- reazzjoni fil- lok ta ’ l- injezzjoni (inkluż ħmura, nefħa, bidla fil- kulur, infjammazzjoni, uġigħ,
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).
reazzjoni allerġika (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 which have occurred in clinical trials with Betaferon very commonly (at a percentage of ≥ 10% of the cases) and at a higher percentage than those observed with placebo.
Tabella 2: rapporti ta ’ effetti sekondarji tal- prodott wara t- tqegħid fis- suq (minn rapporti spontanji):
The table also includes side effects which occur in less than 10% but were significantly associated with the treatment)
► Effetti sekondarji komuni ħafna (aktar minn pazjent wieħed li qed jużah minn kull 10 aktarx li jkollhom dawn):
- infection, abscess
- sintomi jixbħu lill- influwenza *,
- reduced number of white blood cells, swollen lymph glands
- sirdat *,
- decrease of sugar in the blood
- deni *,
- depression, anxiety
- reazzjoni fil- lok ta ’ l- injezzjoni *,
- headache, dizziness, sleeplessness, migraine, numbness or tingling feeling (paresthesia)
- infjammazzjoni fil- lok ta ’ l- injezzjoni *,
- conjunctivitis, abnormal vision
- uġigħ fil- lok ta ’ l- injezzjoni *.
- ear pain
► Effetti sekondarji komuni (pazjent wieħed sa 10 minn kull 100 li qed jużawh aktarx li jkollhom dawn):
- irregular, rapid beating or pulsation of the heart (palpitation)
- tqaxxir tal- ġilda u qerda tat- tessut (nekrożi) fil- lok ta ’ l- injezzjoni *
- redness and/or facial flushing due to widening of blood vessels, increased blood pressure
► Effetti sekondarji mhux komuni (pazjent wieħed sa 10 minn kull 1, 000 li qed jużawh aktarx li jkollhom dawn):
- runny nose, cough, hoarseness due to infection of the upper respiratory tract, sinusitis,
- l- għadd ta ’ ċelluli bojod u ċelluli ħomor jista ’ jonqos, l- għadd ta ’ plejtlits (li jgħinu d- demm
84 cough increased, shortness of breath
jaqgħad) jista ’ jonqos,
- diarrhoea, constipation, nausea, vomiting, abdominal pain
- depressjoni,
- rises in the blood levels of liver enzymes (will show up in blood tests)
- żjieda fil- pressjoni tad- demm,
- skin disorder, rash
- rimettar,
- muscle stiffness (hypertonia), painful muscles (myalgia), muscular debility (myasthenia), back
- it- test tal- fwied jista ’ jinbidel (żjieda fil- livelli fid- demm ta ’ l- enzimi li jipproduċi l- fwied),
pain, pain in extremities such as fingers and toes
- postijiet fil- ġilda jew membrani mukużi minfuħin u ġeneralment bil- ħakk (urtikarja),
- holding urine (urine retention), protein in the urine (will show up in urine tests)
- ħakk (prurite),
urinary frequency, urinary incontinence, urinary urgency
- telf ta ’ xagħar mill- qorriegħa,
- painful periods (menstruation), menstrual disorder, heavy uterine bleeding especially between
- uġigħ fil- muskoli,
menstrual periods, impotence
- ebusija fil- muskoli.
- injection site reaction (including redness, swelling, discolouration, inflammation, pain, allergic
► Effetti sekondarji rari (pazjent wieħed sa 10 minn kull 10, 000 li qed jużawh aktarx li jkollhom dawn):
reaction (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
- glandoli tal- limfa minfuħin,
Table 2:
- reazzjonijiet allerġiċi serji (sensittività eċċessiva),
side effects reports on the marketed product (from spontaneous reporting):
- il- glandola tat- tirojde ma taħdimx tajjeb (ħafna jew ftit wisq ormon prodott),
► Very common side effects (more than 1 user in 10 are likely to get these):
b’ Betaferon ’ (dawn jiġu osservati fit- testijiet tad- demm),
- flu-like symptoms*,
- nuqqas kbir t’ aptit li jwassal għal telf fil- piż (anoreksja),
- chills*,
- konfużjoni,
- fever*,
- ansjetà
- injection site reaction*,
- bidliet fil- burdata,
- injection site inflammation*,
- attentat ta ’ suwiċidju,
- injection site pain*.
- konvulżjoni,
(*frequencies based on clinical trials)
- mard tal- muskolu tal- qalb (kardjomijopatija)
► Common side effects (1 to 10 users in 100 are likely to get these):
- taħbit tal- qalb aktar mgħaġġel,
- skin breakdown and tissue destruction (necrosis) at injection site*
- taħbit irregolari u mgħaġġel jew pulsazzjoni tal- qalb (palpitazzjoni),
(*frequencies based on clinical trials)
- qtugħ ta ’ nifs f’ daqqa (dispneja)
► Uncommon side effects (1 to 10 users in 1,000 are likely to get these):
- pankreatite, ara ‘ Oqgħod attent ħafna b’ Betaferon ’,
- the number of white cells and red cells in the blood may fall, the number of platelets
- il- livell ta ’ enzima speċifika tal- fwied (gamma GT) u pigment safrani fl- aħmar (bilirubin), li huwa
(which help the blood to clot) may fall,
prodott mill- fwied tiegħek, jista ’ jogħla (dan jiġi osservat fit- testijiet tad- demm),
- increase of blood pressure,
- bidla fil- kulur tal- ġilda,
- nausea,
- disturbi fil- menstrwazzjoni,
- vomiting,
- uġigħ fis- sider,
- rash,
- telqa,
- itching (pruritus),
- għaraq,
- loss of scalp hair,
- telf fil- piż.
- painful muscles,
Kif taħżen Betaferon
- muscle stiffness.
Tagħmlux fil- friża.
► Rare side effects (1 to 10 users in 10,000 are likely to get these):
Tużax wara d- data ta ’ skadenza li tidher fuq il- pakkett.
- swollen lymph glands,
Wara li tħejji s- soluzzjoni, għandek tużaha minnufih.
- serious allergic (hypersensitivity) reactions,
Żommu fejn ma jintlaħx u ma jidhirx mit- tfal.
- the thyroid gland does not work properly (too much or too little hormone is produced),
Tużax Betaferon jekk tinnota li fih xi frak jew ikun bidel il- kulur.
- a certain type of blood fats (triglycerides) may increase, see ‘Take special care with Betaferon’
Staqsi lill - ispiżjar tiegħek dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
(will show up in blood tests),
Aktar tagħrif
- severe loss of appetite leading to weight loss (anorexia),
X’ fih Betaferon:
85
Is- sustanza attiva hija Interferon beta- 1b, 250 mikrogramma kull millilitru meta rikostitwit.
- confusion,
Is- sustanzi l- oħra huma
- anxiety,
- fit- trab: mannitol u albumina umana,
- mood swings,
- fis- solvent:
- suicide attempt,
għall- injezzjonijiet.
- convulsion,
Wara r- rikostituzzjoni, kull millilitru jkun fih 250 mikrogramma (8 miljun IU) Interferon beta- 1b.
- disease of the heart muscle (cardiomyopathy),
Is- solvent għal Betaferon huwa pprovdut f’ siringa mimlija għal- lest ta ’ 1. 2 ml u fih 1. 2 ml ta ’ soluzzjoni ta ’ sodium chloride ta ’ 5. 4 mg/ ml (0. 54% (w/ v).
- f aster heart beat,
Id- dehra ta ’ Betaferon u l- kontenuti tal- pakkett:
- irregular, rapid beating or pulsation of the heart (palpitation),
Betaferon huwa trab sterili għal soluzzjoni għall- injezzjoni ta ’ lewn abjad jew abjad jagħti fil- griż.
- sudden shortness of breath (bronchospasm),
Betaferon hu disponibbli f’ daqsijiet tal- pakkett ta ’:
- shortness of breath (dyspnea),
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
- pancreatitis, see ‘Take special care with Betaferon’,
Bayer Schering Pharma AG, D- 13342 Berlin, il- Ġermanja
- a specific liver enzyme (gamma GT) and a reddish yellow pigment (bilirubin), which is
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
produced by your liver, may rise (this will show up in blood tests),
91 België/ Belgique/ Belgien
The following instructions are intended to explain how to prepare Betaferon for administration and how to inject Betaferon yourself.
L- istruzzjonijiet 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.
Do not attempt to inject yourself until you are sure that you understand how to prepare the injection solution and give the injection to yourself.
Tippruvax tinjetta lilek innifsek sakemm tkun żgur li fhimt kif tipprepara s- soluzzjoni għall- injezzjoni u kif għandek tinjetta lilek innifsek.
PART I:
PARTI I:
STEP BY STEP INSTRUCTIONS
ISTRUZZJONIJIET PASS WARA PASS
The instructions includes 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
Pariri ġenerali Preparazzjoni biex tinjetta Rikostituzzjoni tas- soluzzjoni, pass wara pass Preparazzjoni tal- injezzjoni Kif tagħmel l- injezzjoni Reviżjoni malajr tal- proċess
A) General advice
A) Pariri ġenerali
• Get a good start!
• Ibda bit- tajjeb!
You will find that within a few weeks your treatment will become a natural part of your routine.
Se ssib li wara ftit ġimgħat, il- kura tiegħek se ssir parti naturali mir- rutina tiegħek.
As you get started, you may find the following tips helpful:
Hekk kif tibda, tista ’ ssib dawn 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. − For details on storing conditions see section 5. ‘How to store Betaferon’ of the leaflet.) − Try to take your injection at the same time of day.
- Għal aktar dettalji dwar il- kundizzjoniet tal- ħażna, ara sezzjoni 5 tal- fuljett ‘ Kif taħżen Betaferon ’.
This makes it easier to remember and easier to plan a block of time when you will not be interrupted. − Please refer to section 3. ‘How to use Betaferon’ of the leaflet for further details on how to use Betaferon. − Prepare each dose only when you are ready for an injection.
Dan jagħmilha iktar faċli biex tiftakar teħodha
After mixing Betaferon, you should administer the injection immediately (if Betaferon is not used immediately, see section 5. ‘How to store Betaferon’).
tagħti l- injezzjoni minnufih (jekk Betaferon ma jintużax immedjatament, ara sezzjoni 5 tal- fuljett, ‘ Kif taħżen Betaferon ’).
• Important tips to keep in mind
• Suġġerimenti mportanti li għandek tiftakar
− Be consistent - use Betaferon as described in section 3. ‘How to use Betaferon’ of the leaflet.
Dejjem
Always double-check your dosage. − Keep your syringes and syringe disposal unit out of the reach of children; lock the supplies 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
B) Getting ready to inject
B) Preparazzjoni biex tinjetta
• Choosing an injection site
• Kif tagħżel lok ta ’ l- injezzjoni
Before preparing your injection, decide where you are going to inject.
Qabel tipprepara l- injezzjoni tiegħek, iddeċiedi fejn se tinjetta.
You should inject Betaferon into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 to 12 mm under the skin).
Betaferon għandu jiġi injettat fis- saff tax- xaħam bejn il- ġilda u l- muskolu (jiġifieri, taħt il- ġilda, madwar 8 sa 12- il mm taħt il- ġilda).
The best places for injections are where the skin is loose and soft, and away from joints, nerves, bones, for example the abdomen, arm, thigh or buttocks.
L- aħjar postijiet għall- injezzjonijiet huma fejn il- ġilda tkun merħija u ratba, u ’ l bogħod mill- ġogi, nervituri, għadam, per eżempju ż- żaqq, l- id, il- koxxa jew il- warrani.
89 Important:
93 Importanti:
Do not use any area where you can feel lumps, bumps, firm knots, pain or an area that is discoloured, indented, scabbed, or where the skin is broken.
Tużax żona fejn tħoss nefħa, daqqiet, għoqiedi, uġigħ jew żona li għandha bidla fil- kulur, imdaħħla ’ l ġewwa, fejn hemm xi ferita antika jew fejn il- ġilda hija maqsuma.
Talk to your doctor or healthcare professional about these or any other unusual conditions you may find.
Kellem lit- tabib tiegħek jew lill- professjonist fil- qasam tas- saħħa dwar dan jew dwar kundizzjonijiet oħra mhux normali li tista ’ ssib.
You should rotate the injection site at every injection.
Il- lok ta ’ l- injezzjoni għandu jinbidel ma ’ kull injezzjoni.
If some areas are too difficult for you to reach, you may need a family member or friend to help you with these injections.
Jekk xi partijiet jidhru li huma diffiċli ħafna biex tilħaqhom, jista ’ jkun hemm bżonn ta ’ xi membru tal- familja jew xi ħabib/ a biex jgħinuk bl - injezzjonijiet.
Follow the sequence described in the schedule at the end of the Annex (see II) ‘Rotating injection sites’) and you will come back to your first injection site area after 8 injections (16 days).
Segwi s- sekwenza deskritta fl- iskeda fi tmiem l- Anness (ara II) Rotazzjoni tal- lok ta ’ l - injezzjoni) u int se terġa ’ tirritorna għall- ewwel lok ta ’ l- injezzjoni wara 8 injezzjonijiet (16- il jum).
This will give each injection site a chance to fully recover before receiving another injection.
Dan ser jagħti ċans lil kull lok ta ’ l- injezzjoni jirkupra għal kollox qabel tirċievi injezzjoni oħra.
Please refer to the rotation schedule at the end of this Annex to learn how to choose an injection site.
Jekk jogħġbok irreferi għall- iskeda tar- rotazzjoni fl- aħħar ta ’ dan l- Anness biex titgħallem kif tagħżel lok ta ’ l- injezzjoni.
An example of a medication record is also included.
Hemm inkluż ukoll eżempju ta ’ rekord tal- mediċina.
This should give you an idea of how you can keep track of your injection sites and dates.
Dan huwa maħsub biex jagħtik ideja dwar kif tista ’ żżomm rekord tal- lokijiet ta ’ l- injezzjoni u tad- dati.
• Medication
► Medikazzjoni
You will need: • 1 Betaferon vial (with powder for solution for injection) • 1 pre-filled syringe of diluent for Betaferon (sodium chloride solution (0.54% (w/v)) • 21-gauge needle • 30-gauge needle • alcohol wipes In addition you will need a disposal unit for used syringes and needles.
Ikollok bżonn: – kunjett wieħed ta ’ Betaferon (bi trab għal soluzzjoni għall- injezzjoni) – siringa waħda mimlija għal- lest b’ dilwent għal Betaferon (soluzzjoni ta ’ sodium chloride (0. 54% (w/ v)) – labra b’ gauge 21 – labra b’ gauge 30 – imsielaħ ta ’ l- alkoħol Barra dan se jkollok bżonn reċipjent tar- rimi għal siringi u labar użati.
For skin disinfection use an appropriate disinfectant.
Uża diżinfettant xieraq għad- diżinfezzjoni tal- ġilda.
C) Reconstituting the solution, step by step
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.
2 - Open the Betaferon vial and put it on the table.
2 - Iftaħ il- kunjett ta ’ Betaferon u poġġih fuq il- mejda.
It is best to use your thumb rather than your nail as it could break.
Ikun aħjar li tuża subgħajk il- kbir minflok difrek, għax jista ’ jinkiser.
3 - Clean the top of the vial with an alcohol wipe, moving the wipe in one direction only.
3 - Naddaf in- naħa ta ’ fuq tal- kunjett b’ imselħa ta ’ l- alkoħol, billi tħarrek l- imselħa f’ direzzjoni waħda biss.
Leave the wipe on top of the vial.
Ħalli l- imselħa fuq il- kunjett.
4 – Take out the pre-filled diluent syringe from its package.
4 – Oħroġ is- siringa mimlija għal- lest bid- dilwent mill- pakkett tagħha.
Remove the tip cap from the pre-filled syringe by twisting it off.
Neħħi l- għatu tat- tarf mis - siringa mimlija għal- lest billi ddawwru u taqilgħu.
Be careful not to touch the exposed end of the syringe.
Oqgħod attent/ a li ma tmissx it- tarf espost tas - siringa.
Do not push the plunger.
Timbuttax il- planġer.
5 - Take the 21-gauge needle out of its wrapping and place it firmly onto the tip (nozzle) of the syringe.
5 – Oħroġ il- labra b’ gauge 21 mill- pakkett tagħha u poġġiha soda fit- tarf (nozzle) tas- siringa.
Remove the needle guard from the needle.
Neħħi l- għatu ta ’ protezzjoni mill- labra.
Do not touch the needle.
Tmissx il- labra.
6. - Holding the Betaferon vial on a stable surface, slowly insert the needle of the syringe (containing 1.2 ml of liquid) all the way through the stopper of the vial.
6. – Billi żżomm il- kunjett ta ’ Betaferon fuq wiċċ stabbli, bil- mod daħħal il- labra tas- siringa (li fiha 1. 2 ml ta ’ likwidu) sa ġewwa nett mit- tapp tal- kunjett.
7 - Push the plunger down slowly, directing the needle toward the side of the vial to allow the liquid to run down the inside of the vial.
7 – Imbotta l- planġer’ l isfel bil- mod, u idderieġi l- labra lejn il- ġenb tal- kunjett sabiex il- likwidu iċarċar fuq ġewwa tal- kunjett.
Injecting diluent directly onto the powder will cause excess foaming.
Jekk tinjetta d- dilwent direttament fuq it- trab, ser tifforma ħafna ragħwa.
Transfer all the diluent to the vial.
Ittrasferixxi d- dilwent kollu fil- kunjett.
Release the plunger.
Erħi l- planġer.
8 - After the diluent in the syringe has been completely injected into the Betaferon vial hold the vial between your thumb, forefinger and middle finger with the needle and syringe resting against your hand and swirl the vial gently to completely dissolve the powder of Betaferon.
8 – Wara li d- dilwent fis- siringa jkun ġie injettat kollu fil- kunjett ta ’ Betaferon, żomm il- kunjett bejn is- saba ’ l- kbir, is- saba ’ l- werrej u s- saba ’ tan- nofs bil- labra u s- siringa jserrħu ma ’ idejk u dawwar il- kunjett bil- mod biex iddewweb it- trab ta ’ Betaferon għal kollox.
Do not shake the vial.
Tħawwadx il- kunjett.
9 - Examine the solution carefully.
94 9 – Eżamina s- soluzzjoni b’ attenzjoni.
It should be clear and contain no particles.
Din għandha tkun ċara u m’ għandu jkun fiha l- ebda frak.
If the solution is discoloured or contains particles, discard it and start again with a syringe and vial out of your package.
Jekk is- soluzzjoni tbiddel il- kulur jew jekk ikun fiha xi frak, armiha u ibda mill- ġdid billi toħroġ siringa u kunjett mill- pakkett tiegħek.
90 If foam is present –- which can happen if the vial is shaken or swirled too vigorously – 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
D) Drawing up the injection
D) Preparazzjoni tal- injezzjoni
10 - In order to redraw the solution back into the syringe turn the syringe-vial-assembly, needle pointing upwards.
10 - Sabiex tiġbed is- soluzzjoni lura fis- siringa, dawwar il- muntaġġ tas- siringa u l- kunjett, bil- labra tħares ’ l fuq.
Redraw the needle a little bit back within the vial so that the needle tip rests at the lowest point of the vial.
Iġbed il- labra kemmxejn lura fil- kunjett sabiex il- ponta tal- labra tkun fl- aktar punt baxx tal- kunjett.
Keep the needle tip in the liquid, and slowly pull the plunger back all the way to withdraw the solution into the syringe.
Żomm il- ponta tal- labra fil- likwidu, u iġbed il- planġer lura bil- mod it- tul kollu sabiex tiġbed is - soluzzjoni fis- siringa.
11 - Any excessive air rises to the top of the solution.
11 – L- arja żejda titla fil- wiċċ tas- soluzzjoni.
Remove the air bubbles by gently tapping the syringe and pushing the plunger to the 1-ml mark, or to the volume prescribed by your doctor.
Neħħi l- bżieżaq ta ’ l- arja billi ttektek is- siringa bil- mod u timbotta l- planġer sal- marka ta ’ 1 ml, jew sal- volum preskritt mit- tabib tiegħek.
If too much solution goes into the vial along with the air bubbles, pull the plunger back a little to withdraw the solution back from the vial into the syringe.
Jekk flimkien ma ’ bżieżaq ta ’ l- arja ikun hemm wisq soluzzjoni fil- kunjett, iġbed il- planġer kemmxejn lura biex tiġbed is- soluzzjoni lura mill- kunjett għal ġos- siringa.
Do this until all the air is gone and there is 1 ml of reconstituted solution in the syringe.
Agħmel dan sakemm l- arja kollha tkun telqet u jkun għad fadal 1 ml ta ’ soluzzjoni rikostitwita fis- siringa.
12 - Disconnect the syringe and the needle.
12 – Skonnettja s- siringa u l- labra.
Leave the needle in the vial.
Ħalli l- labra fil- kunjett.
13 - Take the 30-gauge needle, take it out of its wrapping and place it firmly onto the tip (nozzle) of the syringe.
13 – Aqbad il- labra b’ gauge ta ’ 30, oħroġha mill- pakkett tagħha u waħħalha sewwa mat- tarf (nozzle) tas- siringa.
14 - Dispose of the vial and the remaining unused portion of the solution into the disposal unit.
14 - Armi l- kunjett u kwalunkwe porzjon mhux użat tas- soluzzjoni fir- reċipjent tar- rimi.
15 - You are now ready to inject.
15 - Issa inti lest/ a biex tinjetta.
If, for some reason, you are not able to inject Betaferon immediately, you can keep the reconstituted solution in the syringe in a refrigerator for up to 3 hours before using.
Jekk, għal xi raġuni, ma tkunx tista ’ tinjetta Betaferon minnufih, tista ’ żżomm s- soluzzjoni rikostitwita fis- siringa fi friġġ sa 3 sigħat qabel ma tużaha.
Make sure the needle cap is fixed properly while the syringe is stored in the fridge.
Kun ċert/ a li l- għatu tal- labra jkun imwaħħal sewwa waqt li s- siringa tkun maħżuna fil- friġġ.
Do not freeze the solution, and do not wait longer than 3 hours to inject it.
Tiffriżax is- soluzzjoni, u ddumx iktar minn 3 sigħat biex tinjettaha.
If more than 3 hours pass, discard the medication and prepare a new injection.
Jekk jgħaddu iktar minn 3 sigħat, armi l- mediċina u ipprepara injezzjoni ġdida.
When you use the solution, warm it up in your hands before injecting to avoid pain.
Meta tuża s - soluzzjoni, saħħanha f’ idejk qabel tinjettaha biex tevita l- uġigħ
E) Making the injection
E) Kif tagħmel l- injezzjoni
1 - Choose an area for the injection (see advice at the start and the diagrams at the end of this Annex), and make a note of it in your medication record.
1 - Agħżel żona għall- injezzjoni (ara l- parir li hemm fil- bidu u d - dijagrammi li hemm fl- aħħar ta ’ dan l- Anness), u ħu nota tagħha fir - rekord tal- mediċina tiegħek.
2 - Use an alcohol swab to clean the skin at the injection site.
95 2 - Uża mselħa bl- alkoħol biex tnaddaf il- ġilda fil- lok ta ’ l- injezzjoni.
Let the skin air-dry.
Ħalli l- ġilda tinxef.
Throw the swab away.
Armi l- imselħa.
For skin disinfection use an appropriate disinfectant.
Uża diżinfettant xieraq għad- diżinfezzjoni tal- ġilda
91 3 - Remove the cap from the needle by pulling not twisting it.
3 - Neħħi l- għatu mil- labra billi tiġbdu u mhux billi ddawru.
4 - Gently pinch the skin together around the disinfected injection site (to raise it up a little).
4 - Oqros il- ġilda bil- mod madwar il- lok ta ’ l- injezzjoni diżinfettat (biex ittellagħha ftit ’ l fuq).
5 - Holding the syringe like a pencil or a dart, push the needle straight into the skin at a 90˚ angle with a quick, firm motion.
5 – Filwaqt li żżomm is- siringa bħal ma żżomm lapes jew vleġġa, imbotta l- labra bi dritt għal ġol- ġilda f’ angolu ta ’ 90˚, b’ moviment mgħaġġel u sod.
6 - Inject the medicine using a slow, steady push on the plunger.
6 - Injetta l- mediċina billi timbotta l- planġer bil- mod u b’ mod kostanti.
(Push the plunger all the way in until the syringe is empty.)
(Imbotta l- planġer ’ l isfel kemm tista ’ sakemm is- siringa tkun vojta.)
7- Discard the syringe in the disposal unit.
7 - Armi s- siringa fir- reċipjent tar- rimi.
F) Quick review of the process
F) Reviżjoni malajr tal- proċess
Take out the contents needed (1 vial, 1 pre-filled syringe, 2 alcohol wipes, 21 gauge needle, 30 gauge needle) 2.
Oħroġ il- kontenut meħtieġ (kunjett wieħed, siringa mimlija għal- lest waħda, 2 imsielaħ ta ’ l - alkoħol, labra b’ gauge ta ’ 21, labra b’ gauge ta ’ 30) 2.
Take off the cap from the vial and clean the rubber stopper with an alcohol wipe.
Neħħi l- għatu mill- kunjett u naddaf it- tapp tal- lasktu imsielaħ ta ’ l- alkoħol.
Unwrap the 21 gauge needle and fix it to the syringe from which you removed the tip cap before.
Neħħi l- labra b’ gauge ta ’ 21 mill- pakkett tagħha u waħħalha mas- siringa minn fejn qabel tkun neħħejt l- għatu tat- tarf.
Transfer diluent from syringe to the vial by pushing the plunger in all the way 5.
Ittrasferixxi d- dilwent mis- siringa għall- kunjett billi timbotta l- planġer ġewwa t- tul kollu 5.
Turn the syringe-vial-assembly over, then withdraw plunger to redraw the dissolved drug.
Dawwar il- muntaġġ tas- siringa u l- kunjett ta ’ taħt fuq, imbagħad iġbed il- planġer biex tiġbed il - mediċina mdewba.
Disconnect syringe and needle, leave the needle in the vial and discard both.
Skonnettja s- siringa u l- labra, ħalli l- labra fil- kunjett u armi t- tnejn li huma.
Unwrap the 30 gauge needle and connect it to the syringe.
Neħħi l- labra b’ gauge ta ’ 30 mill- pakkett tagħha u waħħalha mas- siringa.
Remove needle cap just before injection - you are now ready to inject.
Neħħi l- għatu tal- labra eżatt qabel l- injezzjoni – issa lest/ a biex tinjetta.
The injection should be administered immediately after mixing (if the injection is delayed, refrigerate the solution and inject it within 3 hours).
L- injezzjoni għandha tingħata minnufih wara li tħallatha (jekk l- injezzjoni ddum ma tingħata, poġġi s- soluzzjoni fi friġġ u injettaha fi żmien 3 sigħat).
Do not freeze.
Tpoġġihiex fil- friża.
92 PART II:
PARTI II:
ROTATING INJECTION SITES
Għandek tagħżel
You need to choose a new site for each injection to allow the area time to recover and help prevent infection.
lok ġdid għal kull injezzjoni biex tagħti żmien biżżejjed biex il- post jirkupra u tevita
Advice on which areas to choose is given in the first part of this Annex.
Fl- ewwel parti ta ’ dan l- Anness hemm parir dwar liema postijiet għandek tagħżel.
It is a good idea to know where you plan to inject before you prepare your syringe.
Hija ħaġa tajba li tkun taf fejn għandek il- ħsieb li tinjetta qabel ma tipprepara s- siringa tiegħek.
The schedule shown in the diagram below will help you to vary the sites appropriately.
L- iskeda murija fid- dijagramma taħt se tgħinek sabiex tvarja l- postijiet b’ mod xieraq.
For example, give the first injection into the right side of the abdomen, choose the left side for the second injection, then move to the right thigh for the third, and so on through the diagram until all suitable areas of the body have been used.
Bħala eżempju, agħti l - ewwel injezzjoni fuq in- naħa tal- lemin taż- żaqq, għażel in- naħa tax- xellug għat- tieni injezzjoni, wara mur fuq il- koxxa tal- lemin għat- tielet, u ibqa ’ sejjer hekk mad- dijagramma sakemm jintużaw il - postijiet xierqa kollha tal- ġisem.
Keep a record of where and when you last gave yourself an injection.
Ħu nota ta ’ fejn u meta injettajt lilek nnifsek.
One way to do that is to note the injection site on the enclosed medication record card.
Mezz biex tagħmel dan huwa li żżomm nota tal- lok ta ’ l- injezzjoni fil- kartuna ta ’ rekord tal- mediċina li tinsab fil- pakkett.
By following this schedule, you will come back to your first area (e.g. the right side of the abdomen) after 8 injections (16 days).
96 Billi ssegwi din l- iskeda, għandek tiġi lura fl- ewwel lok (e. ż. in- naħa tal- lemin taż- żaqq) wara 8 injezzjonijiet (16- il jum).
This is called a Rotation Cycle.
Dan jissejjaħ Ċiklu ta ’ Rotazzjoni.
On our example schedule each area is split again into 6 injection sites (which adds up to 48 injection sites all together), left, right, upper, middle and lower part of each area.
Fuq l- iskeda bl- eżempju tagħna, kull żona hija maqsuma mill- ġdid f’ 6 lokijiet ta ’ l- injezzjoni (għal total ta ’ 48 lok ta ’ l- injezzjoni), il- parti tax - xellug u tal- lemin, ta ’ fuq, tan- nofs u t’ isfel ta ’ kull żona.
If you come back to an area after one Rotation Cycle choose the most distant injection site within this area.
Jekk terġa ’ tirritorna lejn żona minnhom wara Ċiklu ta ’ Rotazzjoni wieħed, agħżel l- iktar lok ta ’ l- injezzjoni li hu ’ l bogħod f’ din iż- żona.
If an area becomes sore, talk to your doctor or nurse about choosing other injection sites.
Jekk tħoss l- uġigħ f’ xi żona, kellem lit- tabib jew lin- ners tiegħek dwar kif tagħżel postijiet oħrajn għall- injezzjoni.
Rotation Schedule:
Skeda ta ’ Rotazzjoni:
To help you rotate the injection sites appropriately we recommend that you keep a record of the date and location of your injection.
Biex ngħinuk tagħmel rotazzjoni tal- lokijiet ta ’ l- injezzjonijiet, huwa rrakkomandat li żżomm rekord tad- data u tal- lok fejn tajt l- injezzjoni.
You can use the following rotation schedule.
Tista ’ tuża l- iskeda ta ’ rotazzjoni li ġejja.
Work through each rotation cycle in turn.
Segwi kull ċiklu ta ’ rotazzjoni, wieħed wara l- ieħor.
Each cycle will be 8 injections (16 days), given in area 1 through to area 8 in turn.
Kull ċiklu jinkludi 8 injezzjonijiet (16- il jum), mogħtija f’ żona 1 sa żona 8 f’ sekwenza.
By following this sequence, you will give each area a chance to recover before receiving another injection.
Jekk issegwi din is- sekwenza, inti se tagħti ċans lil kull żona tirkupra qabel tirċievi injezzjoni oħra.
Rotation Cycle 1:
1:
Upper left section of each area
Is- sezzjoni tax- xellug ta ’ fuq ta ’ kull żona.
Rotation Cycle 2:
2:
Lower right section of each area
Is- sezzjoni tal- lemin t’ isfel ta ’ kull żona.
Rotation Cycle 3:
3:
Middle left section of each area
Is- sezzjoni tax- xellug tan- nofs ta ’ kull żona.
Rotation Cycle 4
4:
Upper right section of each area
Is- sezzjoni tal- lemin ta ’ fuq ta ’ kull żona.
Rotation Cycle 5:
5:
Lower left section of each area
Is- sezzjoni tax- xellug t’ isfel ta ’ kull żona.
Rotation Cycle 6:
6:
Middle right section of each area
Is- sezzjoni tal- lemin tan- nofs ta ’ kull żona
PART III:
PARTI III:
BETAFERON Medication record
Rekord tal- mediċina ta ’ BETAFERON
Instructions for keeping track of your injection sites and dates Start with your first injection.
Ibda bl- ewwel injezzjoni.
Select an injection site.
Agħżel lok għall- injezzjoni.
If you have already been using Betaferon start with the area that has not been used during the last rotation cycle, i.e. the past 16 days).
Jekk diġà kont qed tuża Betaferon, ibda b’ żona li ma ntużatx fl- aħħar ċiklu ta ’ rotazzjoni, i. e. l- aħħar 16- il jum).
After your injection, fill in the used injection site and date in the table in your injection record (See the example: ‘Keeping track of your injection sites and dates’).
Kif iżżomm rekord tal- lokijiet ta ’ l- injezzjoni u tad- dati).
93 ROTATION SCHEDULE
10- 15 ċm mill - ispalla
AREA 1
ŻONA 1
AREA 2
ŻONA 2
AREA 3
ŻONA 3
AREA 4
ŻONA 4 In- naħa tax- xellug
10 – 15 cm from groin
mill- groin
AREA 5
ŻONA 5
AREA 6
ŻONA 6
AREA 78
ŻONA 7 ŻONA 8
AREA 87
ispalla
94 EXAMPLE OF A MEDICATION RECORD:
In- naħa tal- lemin taż- żaqq
95 PACKAGE LEAFLET:
In- naħa tax- xellug taż- żaqq
INFORMATION FOR THE USER
99 FULJETT TA ’ TAGĦRIF:
Betaferon 250 microgram/ml, Powder and solvent for solution for injection Interferon beta -1b
Betaferon 250 mikrogramma/ ml, Trab u solvent għal soluzzjoni għall- injezzjoni Interferon beta- 1b
Read all of this leaflet carefully before you start using this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
- Keep this leaflet.
- Żomm dan il- fuljett.
You may need to read it again.
Jista ’ jkollok bżonn terġa ’ taqrah.
- If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
- This medicine has been prescribed for you.
- Din il- mediċina ġiet mogħtija lilek.
Do not pass it on to others.
M’ għandekx tgħaddiha lil persuni oħra.
It may harm them, even
Tista ’ tagħmlilhom
if their symptoms are the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
In this leaflet:
F’ dan il- fuljett:
What Betaferon is and what it is used for 2.
X’ inhu Betaferon u għalxiex jintuża 2.
Before you use Betaferon 3.
Qabel ma tuża Betaferon 3.
How to use Betaferon 4.
Kif għandek tuża Betaferon 4.
Possible side effects 5.
Effetti sekondarji li jista ’ jkollu 5.
How to store Betaferon 6.
Kif taħżen Betaferon 6.
Further information Annex – self injection procedure
Aktar tagħrif Anness – proċedura ta ’ kif tinjetta lilek innifsek
What Betaferon is and what it is used for
X’ inhu Betaferon u għalxiex jintuża
What Betaferon is:
X’ inhu Betaferon:
Betaferon is a type of medicine known as interferon used to treat multiple sclerosis.
Betaferon huwa tip ta ’ mediċina magħrufa bħala interferon użata għal- kura ta ’ sklerożi multipla.
Interferons are proteins produced by the body that help fight against attacks on the immune system such as viral infections.
L - interferoni huma proteini prodotti mill- ġisem li jgħinu fil- ġlieda kontra attakki fuq is- sistema immuni bħal infezzjonijiet ikkawżati minn viruses.
How Betaferon works:
Kif jaħdem Betaferon:
Multiple sclerosis (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord.
L- isklerożi multipla (MS) hija kundizzjoni fit- tul li taffettwa s- sistema nervuża ċentrali (CNS), b’ mod partikolari l- funzjoni tal- moħħ u ta ’ l- ispina.
In MS inflammation destroys the protective sheath (called myelin) around the nerves of the CNS and stops the nerves from working properly.
F’ MS l- infjammazzjoni teqred il- kisja protettiva (imsejħa myelin) madwar in- nervituri tas- CNS u twaqqaf lin- nervaturi milli jibqgħu jaħdmu tajjeb.
This is called demyelination.
Dan huwa msejjaħ demyelination.
The exact cause of MS is unknown.
Il- kawża eżatta ta ’ MS mhux magħrufa.
An abnormal response by the body's immune system is thought to play an important part in the process which damages the CNS.
Rispons mhux normali mis- sistema immuni tal- ġisem huwa maħsub li jagħmel parti importanti mill- proċess li jagħmel ħsara lis- CNS.
The damage to the CNS can occur within an MS attack (relapse).
Il- ħsara lis- CNS tista ’ sseħħ f’ attakk tal- MS (rikaduta).
It can cause disability temporarily, such as difficulty walking.
Tista ’ tikkawża diżabilità temporanja bħal diffikultà fil- mixi.
Symptoms may disappear completely or partly.
Is- sintomi jistgħu jgħaddu għal kollox jew parzjalment.
Interferon beta-1b has been shown to change the response of the immune system and to help to reduce disease activity.
Interferon beta- 1b intwera li jimmodifika r- rispons tas- sistema immuni u jgħin inaqqas l- attività tal - marda.
How Betaferon helps fight your disease:
Kif Betaferon jgħin jiġġieled il- marda tiegħek:
Single clinical event indicating a high risk of developing multiple sclerosis:
Avveniment kliniku wieħed li jindika riskju għoli ta ’ żvilupp ta ’ sklerożi multipla:
Betaferon has been shown to delay progression to definite multiple sclerosis.
Intwera li Betaferon jittardja l- progressjoni għal sklerożi multipla definita.
Relapsing-remitting multiple sclerosis:
Sklerożi multipla li tirkadi u tbatti:
People with relapsing-remitting MS have occasional attacks or relapses during which symptoms become noticeably worse.
Persuni b’ MS li tirkadi u tbatti jkollhom attakki kull tant żmien jew rikaduti li matulhom is- sintomi jmorru għall- agħar b’ mod notevoli.
Betaferon has been shown to cut down the number of attacks and make them less severe.
Intwera li Betaferon inaqqas in- numru ta ’ attakki u jagħmilhom inqas severi.
It reduces the number of hospital stays due to the disease and prolongs the time without relapses.
Huwa jnaqqas in- numru ta ’ drabi li l- pazjent ikollu jiddaħħal l- isptar minħabba l- marda u jtawwal iż- żmien mingħajr rikaduti.
96 Secondary progressive multiple sclerosis:
100 Sklerożi multipla progressiva sekondarja:
In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS.
F’ xi każijiet, persuni b’ MS li tirkadi u tbatti jsibu li s - sintomi tagħhom jiżdiedu u javvanzaw għal forma oħra ta ’ MS imsejħa MS progressiva sekondarja.
With this, people find themselves becoming increasingly impaired, whether or not they have relapses.
B’ din, il- persuni jsibu ruħhom li qegħdin isiru dejjem iktar indeboliti, kemm jekk ikollhom rikaduti kif ukoll jekk le.
Betaferon can reduce the number and severity of the attacks, and slow the progression of disability.
Betaferon jista ’ jnaqqas in- numru u s- severità ta ’ l- attakki, u jittardja l- progressjoni tad - diżabilità.
What Betaferon is used for:
Għalxiex jintuża Betaferon:
Betaferon is for use in patients
Betaferon huwa għall- użu f’ pazjenti
► who have experienced symptoms for the first time which indicate a high risk of developing multiple sclerosis.
► li għall- ewwel darba kellhom sintomi li jindikaw riskju għoli ta ’ żvilupp ta ’ sklerożi multipla.
Your doctor will rule out any other reasons which could explain these symptoms before you are treated.
It- tabib tiegħek se jelimina kull raġuni oħra li tista ’ tispjega dawk is- sintomi qabel ma tiġi kkurat/ a.
► who suffer from relapsing -remitting multiple sclerosis, with at least two relapses within the last two years.
► li jbatu minn sklerożi multipla li tirkadi u tbatti, li kellhom ta ’ l- inqas żewġ rikaduti fl - aħħar sentejn.
► who suffer from secondary progressive multiple sclerosis with active disease shown by relapses.
► li jbatu minn sklerożi multipla progressiva sekondarja, bil- marda attiva li tintwera permezz tar- rikaduti.
Before you use Betaferon
Qabel ma tuża Betaferon
Do not use Betaferon:
Tużax Betaferon:
- if you are pregnant.
jekk inti tqila.
You should not start treatment with Betaferon (see ‘Pregnancy’).
M’ għandekx tibda kura b’ Betaferon (ara ‘ Tqala ’).
- if you are allergic (hypersensitive) to natural or recombinant interferon beta, human albumin or
- jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal interferon beta naturali jew
any of the other ingredients of Betaferon.
rikombinanti, għall- albumina umana jew xi sustanzi oħra ta ’ Betaferon.
- if you currently suffer from severe depression and/or suicidal thoughts (see ‘Take special
- jekk attwalment tbati minn depressjoni severa u/ jew ħsibijiet ta ’ suwiċidju (ara ‘ Oqgħod
Possible side effects).
attent ’ u 4. ‘ Effetti sekondarji li jista ’ jkollu ’).
- if you have severe liver disease (see ‘Take special care’, ‘Using other medicines’, and 4.
- jekk għandek marda severa tal- fwied (ara ‘ Oqgħod attent ’, ‘ Meta tuża mediċini oħra ’ u 4.
‘Possible side effects’).
‘ Effetti sekondarji li jista ’ jkollu ’).
► Tell your doctor if any of the above applies to you.
► Għid lit- tabib tiegħek jekk xi wieħed mill- kundizzjonijiet elenkati fuq japplika għalik.
Take special care with Betaferon:
Oqgħod attent ħafna b’ Betaferon:
Your doctor also needs to know the following before you are given Betaferon:
It- tabib tiegħek jeħtieġ li jkun jaf ukoll dan li ġej qabel tingħata Betaferon:
− If you have monoclonal gammopathy.
Jekk għandek gammopatija monoklonali.
This is a disorder of the immune system where an abnormal protein is found in the blood.
Din hija disturb tas- sistema immuni fejn ikun
Problems with your small blood vessels (capillaries) may develop when using medicines like Betaferon (systemic capillary leak syndrome).
Jistgħu jiżviluppaw problemi fil- kanali ż- żgħar tad - demm (kapillari) tiegħek meta jintużaw mediċini bħal Betaferon (sindrome sistemika ta ’ tnixxija kapillari).
This can lead to shock (collapse) and even be fatal.
Dan jista ’ jwassal għal xokk (kollass) u jista ’ anki jkun fatali.
− If you have had depression or are depressed or previously had thoughts of suicide.
It- tabib
Your doctor will closely monitor you during treatment.
tiegħek se jissorveljak mill- qrib matul il- kura tiegħek.
If your depression and/or suicidal thoughts are severe, you will not be prescribed Betaferon (see also ‘Do not use Betaferon’).
Jekk id- depressjoni u/ jew il- ħsibijiet ta ’ suwiċidju tiegħek huma severi, mhux se tingħata Betaferon (ara wkoll ‘ Tużax Betaferon ’).
− If you have ever had seizures or if you are taking medicines to treat epilepsy (anti- epileptics) (see also ‘Using other medicines’ and 4. ‘Possible side effects’), your doctor will monitor your treatment carefully.
epilettiċi) (ara wkoll ‘ Meta tuża mediċini oħra ’ u 4. ‘ Effetti sekondarji li jista ’ jkollu ’), it- tabib tiegħek se jissorvelja l- kura tiegħek b’ attenzjoni.
− If you have severe kidney problems your doctor may monitor your kidney function during treatment.
- Jekk għandek problemi severi tal- kliewi t- tabib tiegħek jista ’ jissorvelja l- funzjoni tal- kliewi
► Tell your doctor if any of these applies to you.
► Għid lit- tabib tiegħek jekk xi wieħed minn dawn japplika għalik.
97 Your doctor also needs to know the following whilst you are using Betaferon:
101 It- tabib tiegħek jeħtieġ li jkun jaf ukoll dan li ġej waqt li tkun qed tuża 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
These may be symptoms of a serious allergic reaction (hypersensitivity), which may become life threatening.
Dawn jistgħu jkunu sintomi ta ’ reazzjoni allerġika serja (sensittività eċċessiva), li tista ’ ssir ta ’ periklu għal ħajja.
− 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 ma bdejt il- kura
If you become depressed while you are on Betaferon, you may need special treatment and your doctor will closely monitor you and may also consider stopping your treatment.
Jekk issir depress/ a waqt li qed tieħu Betaferon, jista ’ jkollok bżonn ta ’ kura speċjali u t- tabib tiegħek se jissorveljak mill- qrib.
If you suffer from severe depression and/or suicidal thoughts, you will not be treated with Betaferon (see also ‘Do not use Betaferon’).
Jekk tbati minn depressjoni qawwija u/ jew ħsibijiet ta ’ suwiċidju, inti mhux ser tiġi kkurat/ a b’ Betaferon (ara wkoll ‘ Tużax Betaferon ’).
− 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
These may be symptoms of a fall in your blood cell count or in the number of platelets in your blood (cells, which help the blood to clot).
Dawn jistgħu jkunu sintomi ta ’ tnaqqis fl- għadd ta ’ ċelluli tad- demm jew fin- numru ta ’ plejtlits fid- demm tiegħek (ċelluli li jgħinu lid- demm jagħqad).
You may need extra monitoring by your doctor.
Jista ’ jkollok bżonn ta ’ sorveljanza addizzjonali mit- tabib tiegħek.
− 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.
speċjali jekk ikollok ħakk ma ’ ġismek kollu, jekk il- ġilda tiegħek tisfar, jew jekk l- abjad t’ għajnejk jisfar jew jekk titbenġel malajr.
These symptoms may suggest problems with your liver.
Dawn is- sintomi jistgħu jissuġġerixxu problemi bil- fwied tiegħek.
Changes to the liver function values occurred in patients treated with Betaferon during clinical studies.
Seħħ tibdil fir- riżultati tal- funzjoni tal- fwied f’ pazjenti kkurati b’ Betaferon waqt studji kliniċi.