qanastek/EMEA-V3 huggingface dataset:
- a hole in your gut wall,
- perforazzjoni fil- ħajt addominali,
- an abnormal tube-like connection or passage between the windpipe and the gullet, or between
- konnessjoni mhux normali qisha pajp jew passaġġ bejn il- kanal tan- nifs u l- esofagu, jew bejn
internal organs and skin or other tissues that are not normally connected, and are judged by your doctor to be severe,
organi fuq ġewwa u l- ġilda jew tessuti oħrajn li normalment mhumiex konnessi, u huma meqjusa mit- tabib tiegħek li huma severi,
- a blood clot in your arteries,
- embolu (demm mgħaqud) fl- arterji,
- a blood clot in the veins of your lungs,
- embolu (demm mgħaqud) fil- vini tal- pulmun tiegħek,
- any severe bleeding.
- fsada gravi ta ’ kull tip.
If too much Avastin is given:
Jekk tingħata Avastin aktar milli suppost:
- you may develop a severe migraine.
- tista ’ taqbdek emikranja qawwija.
If this happens you should talk to your doctor or pharmacist
Jekk jiġrilek hekk kellem lit- tabib jew lill- ispiżjar tiegħek
immediately.
immedjatament.
If a dose of Avastin is missed:
Jekk tinsa tieħu doża ta ’ Avastin:
- your doctor will decide when you should be given your next dose of Avastin.
- it- tabib tiegħek jiddeċiedi meta għandek tingħata id- doża li jmiss ta ’ Avastin.
You should
Għandek
discuss this with your doctor.
tiddiskuti dan mat- tabib tiegħek.
If you stop treatment with Avastin:
Jekk twaqqaf il- kura b’ Avastin:
Stopping your treatment with Avastin may stop the effect on tumour growth.
Li twaqqaf il- kura bAvastin jista ’ jwaqqaf l- effetti fuq l- iżvilupp tat- tumur.
Do not stop treatment with Avastin unless you have discussed this with your doctor.
Twaqqafx il- kura b’ Avastin sakemm ma ddiskutejtx dan mat- tabib tiegħek.
Like all medicines, Avastin can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Avastin jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The side effects listed below were seen when Avastin was given together with chemotherapy.
L- effetti sekondarji mniżżla isfel ġew osservati meta Avastin ingħata flimkien ma ’ kimoterapija.
This does not necessarily mean that these side effects were strictly caused by Avastin.
Dan ma jfissirx li dawn l- effetti sekondarji kienu neċessarjament ikkawżati biss minn Avastin.
Side effects described as very common were experienced in more than 1 in 10 patients.
Effetti sekondarji deskritti bħala komuni ħafna kienu osservati f’ aktar minn 1 kull 10 pazjenti.
Side effects described as common were experienced by up to 1 in 10 patients.
Effetti sekondarji deskritti bħala komuni kienu osservati f’ sa pazjent 1 minn kull 10.
You should seek help immediately if you suffer from any of the below mentioned side effects.
Għandek tfittex għajnuna minnufih jekk issofri minn xi wieħed mill- effetti sekondarji msemmija taħt.
The common (up to 1 in 10 patients) most serious side effects are:
L- effetti sekondarji komuni (sa ’ 1 kull 10 pazjenti) l- aktar gravi huma:
- perforation of the gut,
- perforazzjoni addominali,
- bleeding, including bleeding in the lungs in patients with non-small cell lung cancer,
- fsada, inkluż fsada fil- pulmun f’ pazjenti b’ kanċer taċ- ċelluli mhux żgħar tal- pulmun,
- blocking of the arteries by a blood clot,
- blukkar ta ’ l- arterji minħabba embolu,
- blocking of the veins in the lungs by a blood clot
- blukkar tal- vini fil- pulmun minħabba embolu.
The severe side effects, which may be very common (more than 1 in 10 patients), include:
Effetti sekondarji gravi, li jistgħu jkunu komuni ħafna (aktar minn 1 kull 10 pazjenti), jinkludu:
- high blood pressure,
- pressjoni tad- demm għolja,
- problems with wound healing after surgery,
- problemi bil- fejqan tal- ferita wara operazzjoni,
- feeling of numbness or tingling in hands or feet.
- sensazzjoni ta ’ tnemnim jew tingiż fl- idejn jew is- saqajn,
- decreased number of cells in the blood, including white cells that help to fight against infections,
- tnaqqis fin- numru ta ’ ċelluli fid- demm, inkluż ċelluli bojod li jgħinu biex jiġġieldu kontra
and cells that help the blood to clot,
infezzjonijiet, u ċellui li jgħinu d- demm jagħqad,
- lack of energy or tiredness.
- nuqqas ta ’ enerġija jew għejja,
- nausea and vomiting.
- tqalligħ u rimettar.
The severe side effects which may be common (up to 1 in 10 patients), include:
Effetti sekondarji gravi, li jistgħu jkunu komuni (sa ’ 1 kull 10 pazjenti), jinkludu:
- decreased number of cells in the blood, these include white cells (which may occur with a fever),
- għadd ta ’ ċelluli tad- demm imnaqqas, dawn jinkludu ċelluli bojod (li jista ’ jseħħ flimkien ma ’
and red cells,
deni), u ċelluli ħomor,
- bleeding associated with the tumour,
- fsada assoċjata mat- tumur,
- lack of energy,
- nuqqas ta ’ enerġija,
- abdominal pain,
- uġigħ addominali,
- dry mouth in combination with thirst and/ or reduced or darkened urine,
- ħalq xott flimkien ma ’ għatx u/ jew awrina mnaqqsa jew aktar skura,
- pain, including headache,
- uġigħ, inkluż uġigħ ta ’ ras,
- blood clots in the veins of the legs or difficulties in getting the blood to clot,
- emboli fil- vini tas- saqajn jew diffikultà biex id- demm jagħqad,
- localised pus collection,
- ġabra lokalizzata ta ’ materja,
- infection, and in particular infection in the blood or bladder,
- infezzjoni, speċjalment infezzjoni fid- demm jew fil- bużżieqa ta ’ l- awrina,
- reduced blood supply to the brain or stroke,
- provista mnaqqsa ta ’ demm għall- moħħ jew puplesija,
- blood clots in the arteries, which can lead to a stroke and a heart attack,
- emboli fl- arterji li jistgħu jwasslu għal puplesija u attakk ta ’ qalb,
- falling asleep or fainting
- rqad jew ħass ħażin,
- problems with the heart with breathing difficulties,
- problemi tal- qalb b’ diffikultà biex tieħu n- nifs,
- nose bleed,
- fsada mill- imnieħer,
- increase in heart rate (pulse),
- żjieda fir- rata li tħabbat il- qalb (polz),
- blockage in the gut or bowel,
- sadd addominali jew fil- musrana,
- abnormal urine test (protein in the urine),
- test ta ’ l- awrina mhux normali (proteina fl- awrina),
- shortness of breath or low levels of oxygen in the blood.
- qtuħ ta ’ nifs jew livelli baxxi ta ’ ossiġnu fid- demm.
Rarely, such side effects as seizures (fits), headache, confusion, changes in vision, or an abnormal tube-like connection between the windpipe and the passage to the stomach (gullet), may occur.
41 Rari jistgħu jseħħu effetti sekondarji bħal attakki epilettiċi (eċċessjoni), uġigħ ta ’ ras, konfużżjoni, tibdil fil- vista, jew konnezzjoni mhux normali qisha pajp bejn il- kanal tan- nifs u l- passaġġ għall - istonku (esofagu).
You should seek help as soon as possible if you suffer from any of the below mentioned side effects
Għandek tfittex għajnuna malajr kemm jista ’ jkun jekk issofri minn xi wieħed mill- effetti sekondarji msemmija taħt.
41 The very common (more than 1 in 10 patients) side effects which were not severe, include:
L- effetti sekondarji komuni ħafna (aktar minn 1 kull 10 pazjenti) mhux gravi jinkludu:
- pain,
- uġigħ,
- constipation, bleeding from the lower part of the large bowel, inflammation of the mouth,
- stitikezza, fsada fil- parti t’ isfel tal- musrana l- kbira, infjammazzjoni tal- ħalq,
- loss of appetite,
- nuqqas ta ’ aptit,
- protein in the urine,
- proteini fl- awrina,
- headache.
- uġigħ ta ’ ras.
The common (up to 1 in 10 patients) side effects which were not severe, include:
L- effetti sekondarji komuni (sa 1 kull 10 pazjenti) mhux gravi jinkludu:
- shortness of breath,
- qtuħ ta ’ nifs,
- runny nose,
- imnieħer iqattar,
- dry skin, flaking and inflammation of the skin, change in skin colour,
- ġilda xotta, qoxra u infjammazzjoni tal- ġilda, bidla fil- kulur tal- ġilda,
- change in the sense of taste,
- bidla fit- togħma,
- problems with eye (tearing),
- problemi bl- għajnejn (idemmgħu),
- voice changes, hoarseness.
- bidliet fil- vuċi, ħanqa.
Other less common side effects of any severity which have been reported are heart failure, bleeding from the lining of the mouth or vagina, and abnormal tube-like connection between internal organs and skin or other tissues that are not normally connected.
Effetti sekondarji oħra anqas komuni, ta ’ kull gravità li ġew irrapurtati huma, insuffiċjenza tal- qalb u fsada mill- mukoża tal- ħalq jew mill- vaġina, u konnezzjoni mhux normali qisha pajp bejn organi fuq ġewwa u l- ġilda jew tessuti oħrajn li normalment mhumiex konessi.
There have been very rare reports of patients developing a hole in the septum of the nose – the structure, which separates the nostrils.
Kien hemm rapporti rari ħafna ta ’ pazjenti li żviluppaw perforazzjoni fis- septum ta ’ l- imnieħer - l - istruttura li taqsam l- imnieħer.
Some side effects are more common in elderly patients.
Xi effetti sekondarji huma aktar komuni f’ pazjenti anzjani.
These side effects include blood clot in the arteries which can lead to a stroke or a heart attack.
Dawn l- effetti sekondarji jinkludu embolu fl- arterji li jista ’ jwassal għal puplessija jew attakk ta ’ qalb.
In addition, elderly patients have a higher risk of a reduction in the number of white cells in the blood, and cells that help the blood clot.
Barra minn hekk, pazjenti anzjani għanhom riskju akbar ta ’ tnaqqis fin- numru ta ’ ċelluli bojod fid- demm, u ċelluli li jgħinu d- demm jagħqad.
Other side effects reported with a higher frequency in elderly patients were diarrhoea, sickness, headache and fatigue.
Effetti sekondarji oħra rrappurtati bi frekwenza ogħla f’ pazjenti anzjani kienu dijarea, tqalligħ, uġigħ ta ’ ras u għeja.
Avastin may also cause changes in laboratory tests carried out by your doctor.
Avastin jista ’ wkoll jikkawża bidliet fir- riżultati tat- testijiet tal- laboratorju preskritti mit- tabib tiegħek.
These include; a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); decreased haemoglobin (found in red blood cells, which carry oxygen), which may be severe.
Dawn jinkludu; nuqqas fin- numru ta ’ ċelluli bojod tad- demm, speċjalment neutrofili (tip wieħed ta ’ ċelluli bojod tad- demm li jgħinu biex jipproteġu kontra nfezzjonijiet); preżenza ta ’ proteina fl- awrina; tnaqqis tal- pottassju, sodju jew fosforu (minerali) fid- demm; żjieda tal- livel taz- zokkor fid- demm; żjieda ta ’ l- alkaline phosphatase (enzima) fid- demm; tnaqqis ta ’ l- emoglobina (jinstab fiċ- ċelluli l - ħomor tad- demm, li jġorru l- ossiġnu), li jista ’ jkun sever.
HOW TO STORE AVASTIN
KIF TAĦŻEN AVASTIN
Store in a refrigerator (2°C – 8°C).
Aħżen fil- friġġ (2°C- 8°C).
Do not use after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP.
42 Tużax Avastin wara d- data ta ’ skadenza li tidher fuq il- kartuna ta ’ barra u fuq it- tikketta tal- kunjett wara l- ittri JIS.
Infusion solutions should be used immediately after dilution.
Soluzzjonijiet għall- infużjoni għandhom jintużaw immedjatament wara li jiġu dilwiti.
Discard any unused medicine.
Armi kull mediċina li ma tkunx użajt.
What Avastin contains
X’ fih Avastin:
- The active substance is bevacizumab.
- Is- sustanza attiva hi bevacizumab.
- The other ingredients are trehalose dihydrate, sodium phosphate, polysorbate 20 and water for
- Is- sustanzi l- oħra huma trehalose dihydrate, sodium phosphate, polysorbate 20 u ilma għall -
injections.
injezzjoni.
What Avastin looks like and contents of the pack Avastin is a clear, colourless to pale brown liquid in a glass vial with a rubber stopper.
Avastin huwa likwidu ċar, bla kulur għal kannella ċar, f’ kunjett tal- ħġieġ b’ tapp tal- lastiku.
Each vial contains 100 mg bevacizumab in 4 ml of solution or 400 mg bevacizumab in 16 ml of solution.
Kull kunjett fih 100 mg bevacizumab f’ 4 ml ta ’ soluzzjoni jew 400 mg bevacizumab f’ 16 ml ta ’ soluzzjoni.
Marketing Authorisation Holder:
Id- Detenturta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom.
Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, Ir- Renju Unit
Malta (See United Kingdom)
Malta (ara taħt Renju Unit)
Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
Deutschland Hoffmann- La Roche Pharma AG Tel: +49 (0) 7624 140
España Roche Farma S. A.
43 España Roche Farma S. A.
30 µg (6 million IU)
30 µg (6 miljun IU)
Powder and solvent for solution for injection
trab u solvent għal taħlita likwida għall- injezzjoni
Intramuscular use
użu intramuskolari
powder: vial (glass); solvent: pre- filled syringe (glass)
Trab: fjala (ħġieġ) Solvent: siringa mimlija (ħġieġ)
30 µg; solvent:
30 µg Solvent:
4 vials with Bioset device +4 pre-filled syringes
4 fjala b’ apparat BIO- SET + 4 siringa mimlija
30 µg/ 0.5 ml (6 million IU)
30 µg/ 0. 5 ml taħlita likwida
Solution for injection
użu intramuskolari
Intramuscular use
4 siringa
pre-filled syringe (glass)
(6 miljun IU) għall- injezzjoni
0.5 ml
(ħġieġ)
4 pre-filled syringes + 4 needles
mimlija + 4 labra
Solution for injection
użu intramuskolari siringa mimlija
Intramuscular use
12 siringa
12 pre-filled syringes + 12 needles
mimlija + 12 labra
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is Avonex?
X' inhu Avonex?
Avonex is a powder and solvent in a vial, which are made up into a solution for injection, and a solution for injection in a pre-filled syringe.
Avonex jikkonsisti minn trab u solvent f’ kunjett, li jitħalltu biex tinħoloq soluzzjoni għal injezzjoni, u soluzzjoni għal injezzjoni f' siringi mimlijin minn qabel.
Each vial and syringe contains 30 micrograms (6 million international units or ‘ MIU’) of the active substance, interferon beta-1a.
Kull kunjett u siringa fiha 30 mikrogramma (6 miljun unità internazzjonali jew 'MIU') tas- sustanza attiva, interferon beta- 1a.
What is Avonex used for?
Għal xiex jintuża Avonex?
Avonex is used to treat the following groups: • patients with relapsing multiple sclerosis (MS).
Avonex jintuża fit- trattament ta 'dawn il- gruppi: • pazjenti bl- isklerożi multipla reċidiva (relapsing) (MS).
This is the type of MS where the patient has attacks (relapses) within periods with no symptoms.
Din hija t- tip ta 'MS li tikkawża attakki rikorrenti (reċidivi) matul ċerti perjodi li fihom il- pazjent ma għandux sintomi.
Avonex slows the progression of disability and reduces the number of relapses; • patients who have experienced the signs of MS for the first time, when these are severe enough to justify treatment with injected corticosteroids (anti-inflammatory medicines).
Avonex inaqqas ir - ritmu tal- progressjoni tad- diżabilità u jbaxxi n- numru tal- attakki reċidivi; • pazjenti li għall- ewwel darba jesperjenzaw is- sintomi tal- MS jekk dawn huma tant gravi li jiġġustifikaw trattament permezz ta 'injezzjoni ta' kortikosterojdi (mediċini antinfjammatorji).
Before using Avonex, doctors need to exclude other causes for the symptoms.
Qabel ma jużaw Avonex, jeħtieġ li t- tobba jeskludu li s- sintomi ġejjin minn kawżi oħra.
Avonex is used in patients aged 12 years or over.
Avonex jintuża f' pazjenti ta 'età ta' 12- il sena jew aktar.
How is Avonex used?
Kif jintuża Avonex?
Avonex treatment should be started by a doctor who has experience in the management of MS.
It- trattament b' Avonex għandu jinbeda minn tabib b' esperjenza fil- ġestjoni tal- isklerożi multipla.
The recommended dose of Avonex is 30 micrograms, given by injection into a muscle once a week.
Id - doża rakkomandata għal Avonex hija 30 mikrogramma li tingħata permezz ta 'injezzjoni intramuskolari darba fil- ġimgħa.
To help patients adjust to treatment, the doctor may recommend that patients start with about half this dose once a week before increasing to the full dose.
Bħala għajnuna biex il- pazjenti jadattaw għat- trattament it- tabib jista ’ jirrakkomanda li pazjenti jibdew b’ madwar nofs din id- doża darba fil- ġimgħa qabel ma din tiżdied għal doża sħiħa.
This can only be done with the pre-filled syringe, when it is fitted with a special device that attaches onto the syringe and only allows about half the dose of Avonex to be injected.
Dan jista ’ jsir biss fil- każ tas- siringa mimlija minn qabel, meta tkun mqabbda ma ’ tagħmir speċjali li jitwaħħal mas- siringa u jħalli biss madwar nofs id- doża ta ’ Avonex biex tkun injettata.
The site of injection should be varied each week.
Il- punt fejn tingħata l- injezzjoni għandu jvarja kull ġimgħa.
The patients can inject Avonex themselves if they have been trained appropriately.
Il- pazjenti jistgħu jagħmlu l- injezzjoni waħedhom ladarba dawn jiġu mħarrġa b' mod xieraq.
A painkiller that prevents fever can be given before each injection and for 24 hours after injection to reduce the flu-like symptoms that may occur during the first few months of treatment.
Qabel kull injezzjoni u fl- 24 siegħa sussegwenti, il- pazjent jista 'jieħu pillola li ttaffilu l- uġigħ (painkiller) b' azzjoni antipiretika (kontra d- deni) biex inaqqas is- sintomi tal- influwenza li jistgħu jinbtu matul l- ewwel ftit xhur tat- trattament.
Avonex treatment should be stopped in patients who develop progressive (worsening) MS.
It- trattament b' Avonex għandu jitwaqqaf f' pazjenti li jiżviluppaw sklerożi multipla progressiva, jiġifieri li l- marda tmur għall- agħar.
How does Avonex work?
Kif jaħdem Avonex?
The active substance in Avonex, interferon beta-1a, belongs to the group ‘ interferons’.
Is- sustanza attiva f' Avonex, interferon beta- 1a, hija parti mill- grupp ta '' interferoni '.
The exact way that Avonex works in MS is not yet known but interferon beta seems to calm the immune system down, and prevents relapses of MS.
Il- mod eżatt ta 'kif jaħdem Avonex fil- kura tal- isklerożi multipla għadu mhux magħruf iżda interferon beta jidher li jikkalma s - sistema immunitarja u jipprevjeni l- attakki reċidivi tal- marda.
Interferon beta-1a is produced by a method known as ‘ recombinant DNA technology’: the interferon beta-1a is made by a cell that has received a gene (DNA), which makes it able to produce interferon beta-1a.
L- interferon beta- 1a huwa prodott permezz ta 'metodu magħruf bħala' teknoloġija tad- DNA rikombinanti ': l- interferon beta- 1a jinkiseb minn ċellula li fiha jkun iddaħħal ġene (DNA), li jagħmilha kapaċi li tipproduċi interferon beta- 1a.
The replacement interferon beta-1a acts in the same way as naturally produced interferon beta.
L- interferon beta- 1a sostituttiv jaġixxi bl- istess mod bħal interferon beta li jiġi prodott b' mod naturali.
How has Avonex been studied?
Kif ġie studjat Avonex?
Avonex has been studied in three main studies.
Avoenx ġie studjat fi tliet studji ewlenin.
The first study compared Avonex with placebo (a dummy treatment) in 301 patients with relapsing MS.
L- ewwel wieħed, imwettaq fuq 301 pazjent bi sklerożi multipla reċidiva, qabbel Avonex mal- plaċebo (trattament finta).
The patients had experienced at least two relapses in the previous three years or at least one relapse per year if they had had the disease for less than three years.
Il- pazejnti esperjenzaw talanqas żewġ attakki reċidivi fit- tliet snin preċedenti jew talanqas attakk reċidiv wieħed kull sena jekk ikun ilhom ibatu mill- marda għal anqas minn tliet snin.
Treatment continued for up to two years.
It- trattament kompla sa sentejn.
The main measure of effectiveness was the number of patients whose disability got worse.
Il- kejl ewlieni tal- effikaċja kien l- għadd ta 'pazjenti li d- diżabilità tagħhom marret għall- agħar.
The second study compared the effectiveness of the 60- and 30-microgram doses in 802 patients.
It- tieni studju, imwettaq fuq 802 pazjenti, qabbel l- effikaċja tad- dożi ta '60 mikrogramma u 30 mikrogramma.
The third study involved 383 patients who had experienced a single attack of demyelination and compared the effectiveness of Avonex with that of placebo in reducing the risk of a second attack.
It- tielet studju, li kien jinvolvi 383 pazjent li kellhom attakk wieħed ta ’ demjelinazzjoni u qabbel l - effikaċja ta 'Avonex ma' plaċebo fit- tnaqqis tar- riskju ta 'attakk ieħor.
The company has not carried out any formal studies of patients under 16 years of age.
Il- kumpanija ma wettqet l- ebda studju formali ta 'pazjenti taħt is- 16- il sena.
However, it presented information from published studies on the use of Avonex in children aged between 12 and 18 years.
Madankollu, hija ppreżentat informazzjoni minn studji ppublikati dwar l- użu ta 'Avonex fi tfal ta' età bejn 12 u 18- il sena.
What benefit has Avonex shown during the studies?
Liema benefiċċji wera Avonex tul l- istudji?
In the first study, 22% of the patients with relapsing MS who were treated with Avonex and 35% of the patients treated with placebo had a worsening of disability by the end of two years.
Fl- ewwel studju fi 22% tal- pazjenti bi sklerożi multipla reċidiva li kienu ttrattati b’ Avonex u fi 35% tal- pazjenti ttrattati bil- plaċebo, id- diżabilità marret għall- agħar fi żmien sentejn.
The second study showed that there is no difference between the two doses in terms of effectiveness.
It- tieni studju wera li ma kien hemm l- ebda differenza bejn iż- żewġ dożi f' termini ta 'effikaċja.
In the third study, the estimated risk of having a second attack of demyelination was lower in the patients taking Avonex than in the patients taking placebo: with Avonex, the risk was 21% in two years and 35% in three years, whereas the risk with placebo was 39% in two years and 50% in three years.
Fit- tielet studju, ir- riskju stmat ta 'attakk ieħor ta ’ demjelinazzjoni kien iktar baxx fil- pazjenti li kienu qegħdin jieħdu Avonex milli f’ dawk ittrattati bil- plaċebo: b' Avonex ir- riskju kien ta' 21% f' sentejn u ta '35% fi tliet snin, filwaqt li r- riskju għall- pazjenti ttrattati bil- plaċebo kien ta' 39% f' sentejn u ta '50% fi tliet snin.
In patients aged between 12 and 18 years, the published studies showed that the patients had a decrease in the rate of relapse.
Fil- pazjenti fl- età ta 'bejn it- 12 u t- 18- il sena, l- istudji ppubblikati wrew li l- pazjenti kellhom tnaqqis fir- rata ta' attakki reċidivi.
This may be due to Avonex treatment.
Dan jista 'jkun minħabba t- trattament b' Avonex.
What is the risk associated with Avonex?
X' inhu r- riskju assoċjat ma 'Avonex?
The most common side effects with Avonex (seen in more than 1 patient in 10) are headache, flu-like symptoms, pyrexia (fever), chills and sweating.
L- aktar effetti sekondarji komuni bl- użu ta 'Avonex (li dehru f' aktar minn pazjent 1 minn għaxra) huma wġigħ ta' ras, sintomi normalment marbuta mal- influwenza, piressija (deni), irjieħat, għaraq.
These side effects decrease with continued treatment.
Maż- żmien dawn l- effetti sekondarji jonqsu.
For the full list of all side effects reported with Avonex, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrapportati b' Avonex, ara l- Fuljett ta 'Tagħrif.
Avonex should not be used in people who have a history of hypersensitivity (allergy) to natural or recombinant interferon beta, human albumin or any of the other ingredients.
Avonex ma għandux jintuża f' persuni li għandhom anamneżi ta ’ ipersensittività (allerġija) għal interferon beta naturali jew rikombinanti, l- albumina umana jew xi wieħed mill- ingredjenti l- oħra.
The pre-filled syringes do not contain human albumin.
Is - siringi mimlijin minn qabel ma fihomx albumina umana.
Avonex treatment must not be started during pregnancy.
It- trattament b’ Avonex m' għandux jinbeda matul it- tqala.
If a woman becomes pregnant while taking the medicine, she should consult her doctor.
Jekk mara toħroġ tqila waqt li tkun qed tieħu l- mediċina, hija għandha tikkonsulta lit - tabib tagħha.
Avonex must also not be used in patients who are currently suffering from severe depression or have thoughts about suicide.
Avonex ma għandux jintuża f' pazjenti li jkunu qed ibatu minn depressjoni gravi u/ jew li jkollhom ħsibijiet ta 'suwiċidju.
Why has Avonex been approved?
Għaliex ġie approvat Avonex?
The Committee for Medicinal Products for Human Use (CHMP) decided that Avonex’ s benefits are greater than its risks for treatment of patients diagnosed with relapsing MS, or with a single demyelinating event with an active inflammatory process if it is severe enough to warrant treatment with intravenous corticosteroids.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Avonex huma ogħla mir- riskji tiegħi għat- trattament ta' pazjenti li ġew djanjostikati bl- isklerożi multipla reċidiva kif ukoll ta 'pazjenti b' attakk demjelinizzanti wieħed biss bi proċess infjammatorju attiv jekk hu gravi biżżejjed li jiġġustifika trattament b' injezzjoni ta' kortikosterojdi fil- vina.
The Committee recommended that Avonex be given marketing authorisation.
Il- Kumitat irrakkomanda li Avonex għandu jingħata awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 Other information about Avonex:
2/ 3 Avonex oriġinarjament kien awtorizzat taħt "Ċirkostanzi Eċċezzjonali", għax, għal raġunijiet xjentifiċi, kien hemm disponibbli tagħrif limitat biss fi żmien l- approvazzjoni.
The European Commission granted a marketing authorisation valid throughout the European Union for Avonex on 13 March 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Avonex fit- 13 ta 'Marzu 1997.
The marketing authorisation was renewed on 13 March 2002 and 13 March 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 13 ta 'Marzu 2002 u fit- 13 ta' Marzu 2007.
The marketing authorisation holder is Biogen Idec Limited.
Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq huwa Biogen Idec Limited.
The full EPAR for Avonex is available here.
L- EPAR sħiħ dwar Avonex jista ’ jiġi kkonsultat hawn.
AVONEX 30 micrograms powder and solvent for solution for injection
AVONEX 30 mikrogramma trab u solvent għal taħlita likwida għall- injezzjoni.
Each BIO-SET vial contains 30 micrograms (6 million IU) of interferon beta-1a.
Kull fjala ta ’ BIO- SET fiha 30 mikrogramma (6 miljun IU) ta ’ interferon beta- 1a.
Following reconstitution with the solvent (water for injections) the vial contains 1.0 ml of solution.
Wara r- rikostituzzjoni b’ solvent (ilma għall- injezzjoni) il- fjala fiha 1. 0 ml ta ’ taħlita likwida.
The concentration is 30 micrograms per ml.
Il- konċentrazzjoni hi ta ’ 30 mikrogramma kull ml.
Using the World Health Organisation (WHO) International Standard for Interferon, 30 micrograms of AVONEX contains 6 million IU of antiviral activity.
Skond l- istandard Internazzjonali ta ’ l- Organiżazzjoni Mondjali tas- Saħħa (WHO) għal Interferon, 30 mikrogramma ta ’ AVONEX fihom 6 miljun IU ta ’ attività antivirali.
The activity against other standards is not known.
L- attività meta mqabbla ma ’ standards oħrajn mhijiex magħrufa.
Powder and solvent for solution for injection.
Huwa trab u solvent għal taħlita likwida għall- injezzjoni.
The vial contains a white to off-white cake.
Il- fjala fiha trab magħqud abjad jagħti fl- offwajt.
AVONEX is indicated for the treatment of
AVONEX hu indikat għall- kura ta ’
• Patients diagnosed with relapsing multiple sclerosis (MS).
• Pazjenti dijanjostikati bi sklerosi multipla (MS) li tirkadi.
In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; AVONEX slows the progression of disability and decreases the frequency of relapses.
AVONEX inaqqas il- progressjoni tad- disabilita 'u jnaqqas il- frekwenza ta ’ l- irkadar.
• Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1).
• Pazjenti b' avveniment wieħed demyelinating bi proċess infjammatorju attiv, jekk ikun sever biżżejjed li jkun jeħtieġ il- kura b’ kortikosterojdi ġol- vina, jekk dijanjosi alternattivi kienu esklużi, u jekk kien stabbilit li huma f’ riskju għoli li jiżviluppaw sklerosi multipla definita klinikament (ara sezzjoni 5. 1).
AVONEX should be discontinued in patients who develop progressive MS.
AVONEX għandu jiġi mwaqqaf f’ dawk il- pazjenti li jiżviluppaw MS progressiva.
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Il- kura għandha timbeda taħt is- superviżjoni ta 'tabib li għandu esperjenza fil- kura ta' din il- marda.
The recommended dosage for the treatment of relapsing MS is 30 micrograms (1 ml solution), administered by intramuscular (IM) injection once a week (see section 6.6).
Id- doża rakkomandata għall- kura ta 'sklerożi multipla rikadenti hi ta' 30 mikrogramma (1 ml ta ’ taħlita likwida) li tingħata b' injezzjoni ġol- muskoli (IM) darba fil- ġimgħa (ara sezzjoni 6. 6).
No additional benefit has been shown by administering a higher dose (60 micrograms) once a week.
L- għotja ta 'doża ogħla (60 mikrogramma) darba fil- ġimgħa ma wriet l- ebda benefiċċju miżjud.
No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Ma sarux studji kliniċi jew farmakokinetiċi formali fit- tfal jew adolexxenti.
However, limited published data suggest that the safety profile in adolescents
Iżda, informazzjoni limitata ppublikata tissuġġerixxi li l- profil ta ’ sigurta ’ f’ adolexxenti minn 12 sa 16- il
2 from 12 to 16 years of age receiving AVONEX 30 micrograms IM once per week is similar to that seen in adults.
2 sena li qed jieħdu Avonex 30 mikrogramma IM darba fil- ġimgħa huwa simili għal dak li deher fl - adulti.
There is no information on the use of AVONEX in children under 12 years of age and therefore AVONEX should not be used in this population.
Ma hemm l- ebda informazzjoni dwar l- użu ta ’ Avonex fi tfal taħt 12- il sena, għalhekk Avonex m’ għandux jintuza f’ din il- popolazzjoni.
Clinical studies did not include a sufficient number of patients aged 65 and over to determine whether they respond differently than younger patients.
Studji kliniċi ma inkludewx numru suffiċjenti ta ’ pazjenti b’ eta ’ ta ’ 65 jew aktar sabiex jiġi determinat jekk dawn jirrispondu b’ mod differenti minn pazjenti iżgħar.
However, based on the mode of clearance of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Iżda, meta tibbaża fuq il- mod ta ’ kif titneħħa s- sustanza attiva, ma hemm l- ebda raġunijiet tejoriċi għal xi bżonn ta ’ aġġustamenti fid- doża fl- anzjani.
The intramuscular injection site should be varied each week (see section 5.3).
Il- post fejn tingħata l- injezzjoni ġol- muskoli għandu jinbidel kull ġimgħa (ara sezzjoni 5. 3).
Doctors may prescribe a 25 mm, 25 gauge needle to patients for whom such a needle is appropriate to administer an intramuscular injection.
It- tobba jistgħu jordnaw labra ta ’ 25 mm, gauge 25, lill- pazjenti li għalijhom labra hekk hija xierqa għall- għotja ta ’ injezzjoni intramuskolari.
Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with AVONEX administration.
Qabel kull injezzjoni u għal 24 siegħa oħra wara kull injezzjoni, l- għotja ta 'analġeżiku antipiretiku hi rakkomandata biex ittaffi sintomi li jixbħu l- influenza assoċjati ma ’ l- għotja ta ’ AVONEX.
These symptoms are usually present during the first few months of treatment.
Ġeneralment, dawn is- sintomi jidhru waqt l- ewwel ftit xhur ta ’ kura.
At the present time, it is not known for how long patients should be treated.
Għalissa għad mhux magħruf kemm il- pazjenti għandhom idumu taħt il- kura.
Patients should be clinically evaluated after two years of treatment and longer-term treatment should be decided on an individual basis by the treating physician.
Il- pazjenti għandhom jiġu evalwati klinikament wara sentejn ta 'kura u kura aktar fit- tul għandha tiġi deċiża b’ mod individwali mit- tabib li qed jikkura.
Treatment should be discontinued if the patient develops chronic progressive MS.
Il- kura għandha tiġi mwaqqfa jekk il- pazjent jiżviluppa MS kronika progressiva.
- Initiation of treatment in pregnancy (see section 4.6).
- Bidu ta ’ kura fit- tqala ’ (ara sezzjoni 4. 6).
- Patients with a history of hypersensitivity to natural or recombinant interferon -ß, human
- Pazjenti li għandhom passat ta ’ ipersensittività għal interferon- ß, naturali jew rikombinat,
albumin or to any excipients.
għall- albumina uman jew għal xi sustanzi mhux attivi.
- Patients with current severe depression and/ or suicidal ideation (see sections 4.4 and 4.8).
- Pazjenti li bħalissa għandhom depressjoni qawwija u/ jew ħsibijiet ta 'suwiċidju (ara sezzjonijiet
AVONEX should be administered with caution to patients with previous or current depressive disorders, in particular to those with antecedents of suicidal ideation (see section 4.3).
AVONEX, għandu jingħata b' kawtela lill- pazjenti li kellhom jew għandhom mard depressiv partikolarment dawk li diġa ’ kellhom ħsibijiet ta ’ suwiċidju (ara sezzjoni 4. 3).
Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in association with interferon use.
Depressjoni u ħsibijiet ta ’ suwiċidju huma magħrufa li jseħħu aktar ta ’ spiss fil- popolazzjoni bi sklerożi multipla u b’ assoċjazzjoni ma ’ l- użu ta’ interferon.
Patients should be advised to immediately report any symptoms of depression and/ or suicidal ideation to their prescribing physician.
Pazjenti għandhom jiġu avżati sabiex jirraportaw immedjatament lit- tabib li ordnalhom il- mediċina kull sintomu ta 'depressoni u/ jew ħsibijiet ta ’ suwiċidju.
Patients exhibiting depression should be monitored closely during therapy and treated appropriately.
Pazjenti li jkollhom depressjoni waqt kura għandhom jinżammu taħt osservazzjoni mill- qrib u ikkurati kif meħtieġ.
Cessation of therapy with AVONEX should be considered (see also sections 4.3 and 4.8).
Twaqqif tal- kura b’ AVONEX għandha tiġi ikkunsidrata (ara sezzjoni 4. 3 u 4. 8).
AVONEX should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti-epileptics (see sections 4.5 and 4.8).
AVONEX għandu jingħata b’ attenzjoni lill- pazjenti b’ passat ta ’ attakki epilettiċi, dawk li qed jiġu kkurati b’ anti- epilettiċi, partikolarment jekk l- epilessija li għandhom mhux ikkontrollata sew bl- anti - epilettiċi (ara sezzjonijiet 4. 5 u 4. 8).
Caution should be used and close monitoring considered when administering AVONEX to patients with severe renal and hepatic failure and to patients with severe myelosuppression.
Kawtela u superviżjoni mill- qrib għandha tiġi ikkunsidrata meta AVONEX jingħata lill- pazjenti li jsofru minn insuffiċjenza serja tal- kliewi jew tal- fwied jew minn majelosoppressjoni qawwija.
Hepatic injury including elevated serum hepatic enzyme levels, hepatitis, autoimmune hepatitis and hepatic failure has been reported with interferon beta in post-marketing (see section 4.8).
Indeboliment tal- fwied li jinkludi livelli għolja fis- serum ta ’ enżimi epatiċi, epatite awto- immunitarja u insuffiċjenza tal- fwied ġew irraportati b ’ interferon beta wara li nħareġ fis- suq (ara sezzjoni 4. 8).
In some cases, these reactions have occurred in the presence of other medicinal products that have been associated with hepatic injury.
F’ xi każijiet, dawn ir- rejazzjonijiet ġraw fil- preżenza ta ’ prodotti mediċinali oħrajn li kienu assoċjati ma ’ indeboliment tal- fwied.
The potential of additive effects from multiple medicinal products or other hepatotoxic agents (e. g. alcohol) has not been determined.
Ma kienx iddeterminat il- potenzjal ta ’ effetti miżjuda meta ’ jittieħdu diversi prodotti mediċinali jew aġenti epatotossiċi oħra (eż. alkoħol).
Patients should be monitored for signs of hepatic injury and caution exercised when interferons are used concomitantly with other medicinal products associated with hepatic injury.
Pazjenti għandhom jiġu osservati għal
3 Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during treatment with AVONEX.
3 sinjali ta ’ indeboliment tal- fwied u għandu jkun hemm kawtela meta jintuża interferon ma ’ prodotti mediċinali oħra li huma assoċjati ma ’ indeboliment tal- fwied.
Flu-like symptoms associated with AVONEX therapy may prove stressful to patients with underlying cardiac conditions.
Sintomi li jixbħu l- influenza assoċjati ma ’ kura b’ AVONEX jistgħu joħolqu tensjoni f’ pazjenti li ġa għandhom mard tal- qalb.
Laboratory abnormalities are associated with the use of interferons.
Riżultati mhux normali ta ’ eżamijiet tal- laboratorju huma assoċjati ma ’ l- użu ta ’ interferoni.
Therefore, in addition to those laboratory tests normally required for monitoring patients with MS, complete and differential white blood cell counts, platelet counts, and blood chemistry, including liver function tests, are recommended during AVONEX therapy.
Għaldaqstant, hu rakkomandat li, waqt kura b’ AVONEX, minbarra dawk l- eżamijiet li normalment isiru għas- sorveljanza ta 'pazjenti b ’ MS, għandhom jiżdiedu l- għadd totali u differenzjali taċ- ċelluli bojod fid- demm, l- għadd ta' plejtlets, u l- analiżi kimika tad- demm, kif ukoll eżamijiet tal- funzjoni epatika.
Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Pazjenti b’ mijelosoppressjoni jistgħu jinħtieġu sorveljanza aktar intensiva ta ’ l- għadd totali u differenzjali taċ- ċelluli tad- demm u l- għadd ta 'plejtlets.
Patients may develop antibodies to AVONEX.
Il- pazjenti jistgħu jiżviluppaw anti- korpi għal AVONEX.
The antibodies of some of those patients reduce the activity of interferon beta-1a in vitro (neutralising antibodies).
L- anti- korpi ta 'x' uħud minn dawn il- pazjenti jnaqqsu l- attivita' ta ’ interferon beta- 1a in vitro (anti- korpi newtralizzanti).
Neutralising antibodies are associated with a reduction in the in vivo biological effects of AVONEX and may potentially be associated with a reduction of clinical efficacy.
Anti- korpi newtralizzanti huma assoċjati ma 'tnaqqis fl- effetti bijoloġiċi ta ’ AVONEX in vivo u potenzjalment jistgħu jkunu assoċjati ma' tnaqqis ta ’ l- effikaċja klinika.
It is estimated that the plateau for the incidence of neutralising antibody formation is reached after 12 months of treatment.
Huwa meqjus li stat stabbli fil- produzzjoni ta 'anti- korpi newtralizzanti jintlaħaqa wara 12- il xahar ta' kura.
Data from patients treated up to two years with AVONEX suggests that approximately 8% develop neutralising antibodies.
Informazzjoni dwar pazjenti kkurati b’ AVONEX sa sentejn tissuġġerixxi li bejn wieħed u iehor 8% jiżżviluppaw anti- korpi newtralizzanti.
The use of various assays to detect serum antibodies to interferons limits the ability to compare antigenicity among different products.
L- użu ta 'assays differenti biex jinstabu l- anti- korpi għal interferoni fis- serum jillimita l- possibilita ’ li tqabbel l- antiġeniċita' bejn prodotti differenti.
No formal interaction studies have been performed in humans.
Ma sarux studji formali fil- bniedem dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal- prodott.
The interaction of AVONEX with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
L- interazzjoni ta ’ AVONEX ma ’ kortikosterojdi jew l’ ormon adrenokortikotropiku (ACTH) ma ġietx studjata sistematikament.
The clinical studies indicate that MS patients can receive AVONEX and corticosteroids or ACTH during relapses.
Studji kliniċi jindikaw li pajzenti bi MS jistgħu jingħataw AVONEX ma 'kortikosterojdi jew ACTH meta jirkadu.
Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Huwa rraportat li l- interferoni jnaqqsu l- attivita 'ta' enżimi epatiċi li jiddependu fuq iċ- ċitokromju P450 kemm fil- bniedem kif ukoll fl- annimali.
The effect of high-dose AVONEX administration on P450-dependent metabolism in monkeys was evaluated and no changes in liver metabolising capabilities were observed.
L- effett ta 'għotja ta' dożi għolja ta 'AVONEX fuq il- metaboliżmu li jiddependi minn P450, ġie studjat fix- xadini u l- ebda bidla ma ġiet osservata fil- kapaċitajiet metaboliċi tal- fwied.
Caution should be exercised when AVONEX is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e. g. antiepileptics and some classes of antidepressants.
Jinħtieġ kawtela meta AVONEX jingħata flimkien ma 'prodotti mediċinali oħra li għandhom indiċi terapewtiku dejjaq u li jiddependu fil- parti l- kbira fuq is- sistema epatika taċ- ċitokromju P450 sabiex jitneħħew mill- ġisem, per eżempju anti- epilettiċi u ċerti klassijiet ta' anti- depressivi.
There is limited information on the use of AVONEX in pregnancy.
Hemm informazzjoni limitata dwar l- użu ta ’ AVONEX fit- tqala.
Available data indicates that there may be an increased risk of spontaneous abortion.
Tgħarif disponibbli juri li hemm riskju akbar ta ’ abort spontanju.
Initiation of treatment is contraindicated during pregnancy (see section 4.3).
Bidu ta ’ kura hi kontra- indikata waqt it- tqala (ara sezzjoni 4. 3).
Women of child-bearing potential
Nisa li jistgħu joħorġu tqal
Women of child-bearing potential have to take appropriate contraceptive measures.
Nisa li jistħu joħorġu tqal għandhom jużaw meżżi ta ’ kontraċezzjoni xierqa.
If the patient becomes pregnant or plans to become pregnant while taking AVONEX she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3).
Jekk il- pazjenta toħroġ tqila jew qed tippjana sabiex toħroġ tqila waqt li qed tieħu AVONEX, hija għandha tiġi nformata dwar il- perikli potenżjali u twaqqif tal- kura għandha tiġi kkunsidrata (ara sezzjoni 5. 3).
In patients with a high relapse rate before treatment started, the risk of a severe relapse following discontinuation of AVONEX in the event of pregnancy should be weighed against a possible increased risk of spontaneous abortion.
F’ pazjenti b’ rata
4 Lactation
4 għolja ta ’ rkadar qabel ma nbdiet il- kura, ir- riskju ta ’ episodju qawwi ta ’ rkadar wara twaqqif ta ’ AVONEX f’ kaz ta ’ tqala għandu jitqies kontra l- possibilita ’ ta ’ riskju għola ta ’ abort spontanju.
It is not known whether AVONEX is excreted in human milk.
Mhux magħruf jekk AVONEX joħroġx fil- halib uman.
Because of the potential for serious adverse reactions in nursing infants, a decision should be made either to discontinue breast-feeding or AVONEX therapy.
Minħabba l- potenzjal ta ’ effetti serji mhux mixtieqa fit- trabi li qed jerdgħu, għandha tittieħed deċiżjoni li jew jitwaqqaf it- treddiegħ jew titwaqqaf il- kura b’ AVONEX.
No studies on the effects of AVONEX on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti ta ’ AVONEX fuq il- ħila biex issuq jew tħaddem magni.
Central nervous system-related adverse reactions may have a minor influence on the ability to drive and use machines in susceptible patients (see section 4.8).
Rejazzjonijiet mhux mixtieqa relatati mas- sistema nervuża centrali jistgħu jkollhom infuwenza żgħira fuq il- ħila ta ’ sewqan u l- użu ta ’ magni f’ pazjenti suxxettibli (ara sezzjoni 4. 8).
The highest incidence of adverse reactions associated with AVONEX therapy is related to flu-like symptoms.
L- aktar effetti mhux mixtieqa komuni li huma assoċjati ma ’ kura b ’ AVONEX huma s- sintomi li jixbħu l- influwenza.
The most commonly reported flu-like symptoms are myalgia, fever, chills, sweating, asthenia, headache and nausea.
L- aktar sintomi li jixbħu l- influwenza li ġew irraportati huma uġigħ fil- muskoli, deni, tkexkix ta ’ bard, għaraq, astenja, uġigħ ta 'ras u dardir.
Flu-like symptoms tend to be most prominent at the initiation of therapy and decrease in frequency with continued treatment.
Sintomi li jixbħu l- influwenza għandhom tendenza li jkunu l- aktar prominenti fil- bidu tal- kura u jonqsu fil- frekwenza hekk kif il- kura titkompla.
Transient neurological symptoms that may mimic MS exacerbations may occur following injections.
Sintomi newroloġiċi u li jistgħu jimitaw deterjorament ta ’ MS jistgħu jidhru għal ftit żmien wara l- injezzjonijiet.
Transient episodes of hypertonia and/ or severe muscular weakness that prevent voluntary movements may occur at any time during treatment.
Episodji qosra ta 'ipertonija u/ jew debulizza qawwija tal- muskoli li jimpedixxu movimenti volontarji jistgħu jseħħu f’ kull ħin matul il- kura.
These episodes are of limited duration, temporally related to the injections and may recur after subsequent injections.
Dawn l- episodji huma ta 'dewmien limitat, huma konnessi ma' l- għotja ta ’ l- injezzjonijiet u jistgħu jirrepetu rwieħhom wara li jerġgħu jingħataw injezzjonijiet oħra.
In some cases these symptoms are associated with flu-like symptoms.
F' ċerti każijiet dawn is- sintomi huma assoċjati ma 'sintomi li jixbħu l- influwenza.
The frequencies of adverse reactions are expressed in patient-years, according to the following categories:
Il- frekwenza ta ’ effetti mhux mixtieqa huma espressi bħala snin tal- pazjent, skond il- kategoriji li ġejjin:
Very common (≥ 1/ 10 patient-years); Common (≥ 1/ 100 to < 1/ 10 patient-years); Uncommon (≥ 1/ 1, 000 to < 1/ 100 patient-years); Rare (≥ 1/ 10, 000 to < 1/ 1,000 patient-years); Very rare (< 1/ 10,000 patient-years); Not known (cannot be estimated from the available data).
Komuni ħafna (≥1/ 10 snin tal- pazjent); Komuni (≥1/ 100 sa < 1/ 10 snin tal- pazjent); Mhux komuni (≥1/ 1, 000 sa < 1/ 100 snin tal- pazjent); Rari (≥1/ 10, 000 sa <, 1/ 1, 000 snin tal- pazjent); Rari ħafna (< 1/ 10, 000 snin tal- pazjent); Mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
Patient-time is the sum of individual units of time that the patient in the study has been exposed to AVONEX before experiencing the adverse reaction.
Iż- żmien tal- pazjent huwa l- għadd ta ’ l- unitajiet individwali ta ’ ħin li fiħ l- pazjent ġie espost għal AVONEX fl- istudju qabel ma ħass l- effett mhux mixtieq.
For example, 100 person-years could be observed in 100 patients who were on treatment for one year or in 200 patients who were on treatment for half a year.
Per eżempju, 100 sena tal- pażjent jistgħu jiġu osservati f’ 100 pazjent li kienu fuq kura għal sena jew f’ 200 pazjent li kienu fuq kura għal nofs sena.
Adverse reactions identified from studies (clinical trials and observational studies, with a period of follow-up ranging from two years to six years) and other adverse reactions identified through spontaneous reporting from the market, with unknown frequency, are provided in the table below.
Reazzjonijiet avversi identifikati mill- istudji (studji kliniċi u studji ta ’ osservazzjoni, b’ perjodu ta ’ studju wara l- kura li tvarja bejn sentejn u sitt snin) u reazzjonijiet avversi identifikati minn rapporti spontanji mis- suq, b’ frekwenza mhux magħrufa huma mniżżla fit- tabella hawn taħt.
5 Investigations
5 Investigazzjonijiet
lymphocyte count decreased, white blood cell count decreased, neutrophil count decreased, hematocrit decreased, blood potassium increased, blood urea nitrogen increased
tnaqqis fl- għadd tal- limfoċiti, tnaqqis komuni fl- għadd taċ- ċelloli bojod tad- demm, tnaqqis fl- għadd tan- newtrofili, tnaqqis fl- ematokrit, żieda fil- livell ta ’ potassju fid- demm, żieda fin- nitroġenu urea fid- demm
platelet count decreased
tnaqqis fil- plejtlets
not known
mhux magħrufa