qanastek/EMEA-V3 huggingface dataset:
weight decreased, weight increased, liver function tests abnormal
tnaqqis fil- piż, żieda fil- piż, Riżultati mhux normali ta ’ l- eżamijiet tal- funzjoni tal- fwied
cardiomyopathy, congestive heart failure (see section 4.4), palpitations, arrhythmia, tachycardia
kardjomijopatija, insuffiċjenza tal- qalb mhux magħrufa konġestiva (ara sezzjoni 4. 4) palpitazzjonijiet, arritmija, takikardja
pancytopenia, thrombocytopenia
panċitopenja, tromboċitopenja mhux magħrufa
very common
uġigħ ta ’ ras2 komuni ħafna
muscle spasticity, hypoesthesia
twebbis tal- muskoli, ipo- estesija
neurological symptoms, syncope3, hypertonia, dizziness, paraesthesia, seizures, migraine
sintomi newroloġiċi, sinkope3, ipertonija, sturdament, parasteżija, puplesija, emikranja
Respiratory, thoracic and mediastinal disorders
Disturbi respiratorju, toraċiku u medjastinali
Gastrointestinal disorders
komuni imnieħer iqattar rari qtugħ ta ’ nifs Disturbi gastro- intestinali
common
remettar, dijareja, dardir2 komuni
rash, sweating increased, contusion
Raxx, żieda fl- għaraq, tbenġil komuni
alopecia
alopeċja mhux komuni
angioneurotic oedema, pruritus, rash vesicular, urticaria, aggravation of psoriasis
edema anġjonewronika, ħakk, raxx vessikulari, urtikarja, psorajażi tiggrava
6 Musculoskeletal and connective tissue disorders
6 Disturbi muskolu skeltrali u tal- connective tissue
muscle cramp, neck pain, myalgia2, arthralgia, pain in extremity, back pain, muscle stiffness, musculoskeletal stiffness
bugħawwieġ fil- muskoli, uġigħ fl - għonq, mijalġja2, atralġja, uġigħ fl - estremitajiet, uġigħ fid- dahar, ebgħusija fil- muskoli, ebgħusija muskoloskeletali
systemic lupus erythematosus, muscle weakness, arthritis
lupus erythematosus sistematika, debbolizza fil- muskoli
hypothyroidism, hyperthyroidism
ipotajrojdiżmu, ipertajrojdiżmu mhux magħrufa
common
Anoressija komuni
injection site abscess1
axxess fil- post ta ’ l- injezzjoni1 mhux magħrufa
common
fwawar komuni
not known
vażodilatazzjoni mhux magħrufa
vasodilatation
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
General disorders and administration site conditions
sintomi li jixbħu l- influwenza, deni2, komuni ħafna tkexkix ta ‘ bard2, għaraq2
very common
komuni
injection site pain, injection site erythema,
uġigħ fil- post ta ’ l- injezzjoni, eritema fil- post ta ’ injezzjoni, tbenġil fil- post ta ’ l- injezzjoni, astenja2, uġigħ, għejja2, telqa, għaraq bil- lejl
injection site bruising, asthenia2, pain, fatigue2, malaise, night sweats
ħruq fil- post ta ’ l- injezzjoni
injection site burning uncommon injection site reaction, injection site not known
mhux magħrufa
inflammation, injection site cellulitis1, injection site necrosis, injection site bleeding, chest pain
rejazzjoni fil- post ta ’ l- injezzjoni, infjammazjoni fil- post ta ’ l- injezzjoni, ċellulite fil- post ta ’ l- injezzjoni1, nekrożi fil- post ta ’ l- injezzjoni, fsada fil- post ta ’ l- injezzjoni, uġigħ fis- sider
anaphylactic reaction, anaphylactic shock, hypersensitivity reactions (angioedema, dyspnoea, urticaria, rash, pruritic rash)
reazzjoni anafilattika, xokk mhux magħrufa anafilattiku, ipersensittività (anġoedema, qtugħ ta ’ nifs, urtikarja, raxx, raxx bil- ħakk),
7 Hepatobiliary disorders
7 Disturbi fil- fwied u fil- marrara
hepatic failure (see section 4.4), hepatitis, autoimmune hepatitis
falliment tal- fwied (ara sezzjoni 4. 4), mhux magħrufa epatite, epatite awto- immunitarja
metrorrhagia, menorrhagia
tnixxija eċċessiva ta ’ demm mill- ġuf, mhux komuni mestruwazzjoni qawwija
Psychiatric disorders
Disturbi psikjatriku
depression (see section 4.4), insomnia
Depressjoni (ara sezzjoni 4. 4), komuni problemi biex torqod
suicide, psychosis, anxiety, confusion, emotional lability
suwiċidju, psikożi, ansjetà, mhux magħrufa konfużjoni, nuqqas ta 'stabilita' emozzjonali
1 Injection site reactions including pain, inflammation and very rare cases of abscess or cellulitis that may require surgical intervention have been reported.
1 Reazzjonijiet fil- post ta ’ l- injezzjoni jinkludu uġigħ, infjammazzjoni u kienu rrappurtati każijiet rari ħafna ta ’ axxess jew ċellulite li jistgħu jinħtieġu intervent kirurġiku.
2 The frequency of occurrence is higher at the beginning of treatment.
2 Il- frekwenza ta ’ l- okkorrenza kienet għola fil- bidu tal- kura.
3 A syncope episode may occur after AVONEX injection, it is normally a single episode that usually appears at the beginning of the treatment and does not recur with subsequent injections.
3 Jista ’ jkun hemm episodju ta ’ sinkope wara injezzjoni ta ’ AVONEX, dan normalment ikun episodju wieħed li ħafna drabi jidher fil- bidu tal- kura u ma jerġax jidher fl- injezzjonijiet ta ’ wara.
However, in case of overdose, patients should be hospitalised for observation and appropriate supportive treatment given.
L- ebda każ ta ’ doża eċċessiva ma ġie rrappurtat. F‘ każ ta 'doża eċċessiva, il- pazjent għandu jidħol l- isptar għall- osservazzjoni u jingħata kura ta ’ support xierqa.
Interferons, ATC code:
Interferoni, Kodiċi ATC:
Interferons are a family of naturally occurring proteins that are produced by eukaryotic cells in response to viral infection and other biological inducers.
L- interferon huma familja ta 'proteini naturali li huma magħmula minn ċelluli ewkarjotiċi bħala rispons għall- infezzjoni virali u stimoli oħra bijoloġiċi.
Interferons are cytokines that mediate antiviral, antiproliferative and immunomodulatory activities.
L- interferoni huma ċitokini li jiffaċilitaw attivitajiet antivirali, antiproliferattivi u immunomodulatorji.
Three major forms of interferons have been distinguished: alpha, beta and gamma.
Tlett forom prinċipali ta 'interferoni ġew identifikati: alfa, beta u gamma.
Interferons alpha and beta are classified as Type I interferons and interferon gamma is a Type II interferon.
L- interferon alfa u beta huma ikklassifikati bħala interferoni tat- Tip I, u interferon gamma hu interferon tat- Tip II.
These interferons have overlapping but clearly distinguishable biological activities.
Dawn l- interferoni għandhom attivitajiet bijoloġiċi li jixxiebħu iżda jintarfgħu sew minn xulxin.
They can also differ with respect to their cellular sites of synthesis.
Jista ’ jkun hemm differenzi fil- postijiet ġoċ- ċellola fejn jiġu sintetizzati.
Interferon beta is produced by various cell types including fibroblasts and macrophages.
L- interferon beta huwa prodott minn diversi tipi ta 'ċelluli, fosthom fibroblasti u makrofaġi.
Natural interferon beta and AVONEX (interferon beta-1a) are glycosylated and have a single N-linked complex carbohydrate moiety.
Interferon beta naturali u AVONEX (interferon beta- 1a) huma glikolizzati u għandhom parti waħda minnhom magħmula minn carboidrat kumpless maqgħud permess ta 'N.
Glycosylation of other proteins is known to affect their stability, activity, biodistribution, and half-life in blood.
Hu magħruf li l- glikolizzazzjoni ta 'proteini oħra għandha effett fuq l- istabilita', attivita ', distribuzzjoni fil- ġisem, u l- half- life fid- demm tagħhom.
However, the effects of interferon beta that are dependent on glycosylation are not fully defined.
Iżda, l- effetti ta ’ interferon beta li jiddependu mill- glikolozzazzjoni għadhom ma humiex ċari għal kollox.
AVONEX exerts its biological effects by binding to specific receptors on the surface of human cells.
8 AVONEX jeżerċita l- effetti bijoloġiċi tiegħu billi jintrabat ma 'riċetturi speċifiċi li jinsabu fuq il- qoxra ta' barra taċ- ċelluli umani.
This binding initiates a complex cascade of intracellular events that leads to the expression of numerous interferon-induced gene products and markers.
Din ir- rabta tagħti bidu għal ringiela komplessa ta ’ reazzjonijiet INTRAċELLILARI li jwasslu għall- produzzjoni ta 'ħafna prodotti ġenetiċi indotti mill- interferon u indikaturi.
These include MHC Class I, Mx protein, 2’ / 5’ -oligoadenylate synthetase, β 2-microglobulin, and neopterin.
Dawn jinkludu MHC Klassi I, proteina Mx, 2 '/ 5' - oligoadenylate synthetase, β2- microglobulin u neopterin.
Some of these products have been 8 measured in the serum and cellular fractions of blood collected from patients treated with AVONEX.
Uħud minn dawn il- prodotti ġew imkejjla kemm fis- serum kif ukoll fiċ- ċelluli ta 'demm meħud minn pazjenti kkurati b’ AVONEX.
After a single intramuscular dose of AVONEX, serum levels of these products remain elevated for at least four days and up to one week.
Wara doża waħda ġol- muskolu ta ’ AVONEX, il- livelli ta 'dawn il- prodotti fis- serum jibqgħu għolja għal mill- anqas erbgħat ijiem u jistgħu jibqgħu għoljin anke sa ġimgħa.
Whether the mechanism of action of AVONEX in MS is mediated by the same pathway as the biological effects described above is not known because the pathophysiology of MS is not well established.
Minħabba li il- patofiżjoloġija ta 'MS għadha mhux daqstant ċara, mhux magħruf jekk il- mekkaniżmu ta ’ azzjoni ta ’ AVONEX fuq l’ MS hux ġej permezz ta ’ l- istess rotta ta ’ l- effetti bijoloġiċi deskritti fil- paragrafu ta' fuq.
The effects of lyophilised AVONEX in the treatment of MS were demonstrated in a placebo- controlled study of 301 patients (AVONEX n=158, placebo n=143) with relapsing MS characterised by at least 2 exacerbations in the previous 3 years or at least one exacerbation per year prior to entry when the duration of the disease was less than 3 years.
L- effetti ta ’ AVONEX lajofilizzat fil- kura ta ’ MS intwerew fi studju, ikkontrollat bil- plaċebo, fuq 301 pazjent (AVONEX n = 158, plaċebo n = 143) kollha jbatu minn MS li tirkadi kkaratterizzata minn mill- inqas 2 rikaduti fit- 3 snin ta ’ qabel, jew mill- inqas rikaduta waħda kull sena qabel ma l- pazjent daħal fl- istudju, meta t- tul tal- marda kien inqas minn 3 snin.
Patients with an EDSS of 1.0 to 3.5 at entry were included in the clinical trial.
Pazjenti b’ EDSS ta ’ 1. 0 sa 3. 5 meta daħlu fl- istudju kienu inklużi fil- prova klinika.
Due to the design of the study, patients were followed for variable lengths of time.
Minħabba id- disinn ta ’ l- istudju, il- pazjenti ġew osservati għal tulijiet varjabbli ta ’ żmien.
150 AVONEX-treated patients completed one year on study and 85 completed two years on study.
Mija u ħamsin pazjent ikkurati b’ AVONEX damu sena fl- istudju u 85 oħra damu sentejn.
In the study, the cumulative percentage of patients who developed disability progression (by Kaplan-Meier life table analysis) by the end of two years was 35% for placebo-treated patients and 22% for AVONEX-treated patients.
Fl- istudju, l- perċentwali kumulattiv ta 'pazjenti li żviluppaw deterjorazzjoni fid- diżabilita' (skond l- analiżi tal -- Kaplan- Meier life table) fl- aħħar tas- sentejn kien ta '35% f' dawk li nagħtaw plaċebo u 22% fil- pazjenti kkurati b’ AVONEX.
Disability progression was measured as an increase in the Expanded Disability Status Scale (EDSS) of 1.0 point, sustained for at least six months.
Kienet ikkunsidrata bħala deterjorazzjoni fid- diżabilita 'żieda ta' punt fl- EDSS (Expanded Disabilty Status Scale) li baqgħet għal ta ’ l- inqas sitt xhur.
It was also shown that there was a one-third reduction in annual relapse rate.
Intwera wkoll li r- rata annwali ta 'rkadar naqset b' terz.
This latter clinical effect was observed after more than one year of treatment.
Dan l- effett kliniku msemmi l- aħħar ġie osservat wara aktar minn sena ta ’ kura.
A double-blind randomised dose comparison study of 802 relapsing MS patients (AVONEX 30 micrograms n=402, AVONEX 60 micrograms n=400) has shown no statistically significant differences or trends between the 30 micrograms and the 60 micrograms doses of AVONEX in clinical and general MRI parameters.
Studju randomised u double- blind biex jikkompara d- dożi fuq 802 pazjenti b' MS li tirkadi (AVONEX 30 mikrogramma, n=402, AVONEX 60 mikrogramma, n=400) ma wera l- ebda differenza statistikament sinnifikanti, jew tendenzi bejn dożi ta ’ 30 mikrogramma u 60 mikrogramma ta ’ AVONEX, la fil- parametri kliniċi u l- anqas fil- parametri ġenerali tal- MRI.
The effects of AVONEX in the treatment of MS were also demonstrated in a randomised double-blind study performed with 383 patients (AVONEX n=193, placebo n=190) with a single demyelinating event associated with at least two compatible brain MRI lesions.
L- effetti ta ’ AVONEX fil- kura ta 'MS intwerew ukoll fi studju ieħor randomised u double- blind fuq 383 pazjenti (AVONEX n=193, plaċebo n =190) li kellhom episodju wieħed demijelanti assoċjat ma' għalmenu żewg leżjonijiet ċerebrali kompatibbli fl- MRI.
A reduction of the risk of experiencing a second event was noted in the AVONEX treatment group.
Il- grupp ikkurat b’ AVONEX wera tnaqqis fir- riskju li jkun hemm it- tieni episodju.
An effect on MRI parameters was also seen.
Kien hemm ukoll effett fuq il- parametri tal- MRI.
The estimated risk of a second event was 50% in three years and 39% in two years in the placebo group and 35% (three years) and 21% (two years) in the AVONEX group.
Ir- riskju li jkun hemm it- tieni episodju ġie stmat bħala 50% fi tlett snin u 39% f' sentejn fil- grupp fuq il- plaċebo u 35% (fi tlett snin) u 21% (f' sentejn) fil- grupp fuq AVONEX.
In a post-hoc analysis, those patients with a baseline MRI with at least one Gd-enhancing lesion and nine T2 lesions had a two-year risk of suffering a second event of 56% in the placebo group and 21% in the AVONEX treatment group.
Analiżi post- hoc uriet li dawk il- pazjenti li bdew b’ MRI linja ta ’ bażi b' għalmenu leżjoni waħda tat- tip Gd- enhancing u disa ’ leżjonijiet T2 wrew riskju li jkun hemm it- tieni episodju matul sentejn ta '56% fil- grupp fuq il- plaċebo u 21% fil- grupp ikkurati b’ AVONEX.
However, the impact of early treatment with AVONEX is unknown even in this high-risk subgroup as the study was mainly designed to assess the time to the second event rather than the long term evolution of the disease.
Iżda, l- impatt ta 'kura bikrija b’ AVONEX mhux magħruf lanqas f’ dan il- grupp b' riskju għoli minħabba li l- istudju kien imfassal prinċipalment biex jistudja it- tul ta ’ żmien sat- tieni episodju u mhux l- evoluzzjoni tal- marda fuq tul twil ta ’ żmien.
Furthermore, for the time-being there is no well established definition of a high risk patient although a more conservative approach is to accept at least nine T2 hyperintense lesions on the initial scan and at least one new T2 or one new Gd-enhancing lesion on a follow-up scan taken at least three months after the initial scan.
Barra minn hekk, għalissa għad m' hemm l- ebda definizzjoni ċerta ta 'x' jikkostitwixxi pazjent b' riskju għoli, għalkhemm mod ieħor aktar konservattiv kif tħares lejha hu li dan jiġi aċċettat meta jkun hemm għalmenu disa ’ leżonijiet hyperintense T2 fuq l- ewwel scan u għalmenu leżjoni waħda T2 ġdida jew leżjoni waħda Gd- enhancing fuq scan ieħor meħud għalmenu tlett xhur wara l- ewwel scan.
In any case, treatment should only be considered for patients classified at high risk.
Hu x' inhu il- każ, il- kura għandha tiġi kkunsidrat biss għal pazjenti ikklassifikati bħala b' riskju għoli.
The pharmacokinetic profile of AVONEX has been investigated indirectly with an assay that measures interferon antiviral activity.
Il- profil farmakokinetiku ta ’ AVONEX ġie studjat indirettament permezz ta 'assay li jkejjel l- attivita' antivirali ta ’ interferon.
This assay is limited in that it is sensitive for interferon but lacks specificity for interferon beta.
Dan l- assay għandu l- limitazzjonijiet tiegħu peress li huwa sensittiv għal interferon imma mhux speċifiku għal interferon beta.
Alternative assay techniques are not sufficiently sensitive.
Tekniki alternattivi ta ’ assay mhumiex sensittivi biżżejjed.
Following intramuscular administration of AVONEX, serum antiviral activity levels peak between 5 and 15 hours post-dose and decline with a half-life of approximately 10 hours.
9 Wara għotja ġol- muskolu ta ’ AVONEX, il- livelli ta ’ l- attivita 'antivirali fis- serum jilħqu il- quċċata minn ħames sa ħmistax- il siegħa wara li tingħata d- doża u jonqsu b' half- life ta' bejn wieħed u ieħor għaxar sigħat.
With appropriate adjustment for the rate of absorption from the injection site, the calculated bioavailability is approximately 40%.
Meta tiġi rranġata kif suppost għar- rata ta ’ assorbiment mill- post ta ’ l- injezzjoni, il- biodisponibilita 'kkalkulata hi bejn wieħed u ieħor 40%.
The calculated bioavailability is greater without such adjustments.
Il- biodisponibilita 'kkalkulata tkun akbar mingħajr dawn l- aġġustamenti.
Intramuscular bioavailability is three-fold higher than subcutaneous bioavailability.
Il- biodisponibilità intramuskolari hi tlett darbiet akbar minn dik subkutanja.
Subcutaneous administration cannot be substituted for intramuscular administration.
L- għotja taħt il- ġilda m' għandiex tintuża minflok dik ġol- muskolu.
No carcinogenicity data for interferon beta-1a are available in animals or humans.
Ma hemm l- ebda informazzjoni dwar attivita 'karċinoġenika ta ’ interferon beta- 1a la fil- bniedem u l- anqas fl- annimali.
Chronic Toxicity:
Tossiċita 'Kronika:
In a 26-week, repeated-dose toxicity study in rhesus monkeys by intramuscular route once per week, administered in combination with another immunomodulating agent, an anti CD40 ligand monoclonal antibody, no immune response toward interferon beta-1a and no signs of toxicity were demonstrated.
Fi studju ta ’ 26 gimgħa, b’ doża ġol- muskolu ripetuta darba fil- gimgħa f’ xadini rhesus, mogħtija flimkien ma ’ aġent immunomodulatorju ieħor; antikorp monoklonali b’ ligand anti CD40; ma kienx hemm rispons immunitarju għal interferon beta- 1a u ma ntwera l- ebda sinjal ta ’ tossicita ’.
Local Tolerance:
Toleranza Lokali:
Intramuscular irritation has not been evaluated in animals following repeated administration to the same injection site.
Irritazzjoni ġol- muskolu wara għotja ripetuta fl- istess post ta´ injezzjoni ma ġietx studjata fl- annimali.
Limited but relevant mutagenesis tests have been carried out.
Saru eżamijiet limitati imma relevanti.
The results have been negative.
Ir- riżultati kienu negattivi.
Impairment of Fertility:
Tnaqqis fil- Fertilita ':
Fertility and developmental studies in rhesus monkeys have been carried out with a related form of interferon beta-1a.
Studju fuq il- fertilita 'u l- iżvilupp saru fuq xadini rhesus b' forma ta' interferon li tixbaħ lil interferon beta- 1a.
At very high doses, anovulatory and abortifacient effects in test animals were observed.
B’ dożi għoljin ħafna, ġew osservati effetti anovulatorji u li jwasslu għal abort fl- annimali taħt studju.
Similar reproductive dose-related effects have also been observed with other forms of alpha and beta interferons.
Effetti bħal dawn fuq is- sistema riproduttiva, relatati mad- doża, ġew osservati wkoll b' forom oħra ta 'interferon alfa u beta.
No teratogenic effects or effects on foetal development have been observed, but the available information on the effects of interferon beta-1a in the peri- and postnatal periods is limited.
L- ebda effetti teratoġeniċi jew fuq l- iżvilupp tal- fetu ma ġew osservati, iżda l- informazzjoni disponibbli dwar l- effetti ta ’ interferon beta- 1a fil- perijodu ta 'qabel u wara t- twelid hija limitata.
No information is available on the effects of interferon beta-1a on male fertility.
Ma hemm l- ebda informazzjoni dwar l- effetti ta ’ interferon beta- 1a fuq il- fertilita 'fl- irġiel.
Human serum albumin, Dibasic sodium phosphate, Monobasic sodium phosphate, Sodium chloride.
Albumina ta 'serum uman Dibasic sodium phosphate Monobasic sodium phosphate Sodium chloride.
AVONEX should be administered as soon as possible after reconstitution.
AVONEX għandu jingħata kmieni kemm jista ’ jkun wara li jiġi rikostitwit.
However, the reconstituted solution can be stored at 2 °C-8 °C for up to six hours, prior to injection.
Iżda, it- taħlita likwida rikostitwita tista 'tinżamm f' temperatura ta' bejn 2 ºC- 8 ºC għal sa sitt sigħat qabel l- injezzjoni.
Store below 25 °C.
Aħżen f’ temperatura taħt 25 ºC.
DO NOT FREEZE the powder or the reconstituted product.
10 Tagħmilx it- trab jew il- prodott rikostitwit fil- friża.
For storage conditions of the reconstituted medicinal product see section 6.3.
Għall- kondizzjonijiet ta ’ ħażna tal- prodott mediċinali rikostitwit ara sezzjoni 6. 3.
10 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
AVONEX is available as a package of four individual doses.
AVONEX huwa disponibbli bħala pakk ta 'erba ’ dożi individwali.
Each dose is supplied in a 3 ml clear glass vial with BIO-SET device and a 13 mm bromobutyl rubber stopper.
Kull doża tiġi fi fjala tal- ħġieġ ċar li tesa ’ 3 ml u li għandha tapp tal- lastiku bromobutyl u siġill ta ’ l- aluminju.
It is provided with a 1 ml pre-filled glass syringe of solvent for reconstitution (water for injections) and one needle.
Magħha hemm ukoll siringa tal- ħġieġ mimlija lesta b '1 ml ta´ solvent għar- rikostituzzjoni (ilma għall- injezzjoni) u żewġ labar.
Use the supplied pre-filled syringe of solvent to reconstitute AVONEX for injection.
Biex tirrikostitwixxi AVONEX għall- injezzjoni, uża s- siringa mimlija lesta b’ solvent ipprovduta għandha tintuza.
Do not use any other solvent.
L’ ebda solvent ieħor m’ għandu jintuża.
Inject the content of the syringe into the vial of AVONEX by connecting the pre-filled syringe to the BIO-SET device.
Injetta l- kontenut tas- siringa ġol- fjala ta ’ AVONEX permezz tal- labra l- ħadra tar- rikostituzzjoni.
Gently swirl the contents in the vial until all materials are dissolved; DO NOT SHAKE.
Ħawwad bil- galbu il- kontenut tal- fjala sakemm il- materjal kollu ta 'ġo fiha jinħall; TĦAWWADX BIS- SAĦĦA.
Inspect the reconstituted product:
Spezzjona il- prodott rikostitwit:
If it contains particulate matter or is other than colourless to slightly yellow in colour, the vial must not be used.
Jekk fih xi frak jew hu ta´ xi kulur ieħor barra mingħajr kulur sa kemmxejn isfar, il- fjala m’ għandiex tintuza.
After reconstitution, draw all the liquid (1 ml) from the vial back into the syringe for the administration of 30 micrograms AVONEX.
Wara r- rikostituzzjoni, għall- għotja ta ’ 30 mikrogramma AVONEX, iġbed 1 ml mill- fjala (linja ta ’ gwida mmarkata fuq is- siringa mimlija lesta).
The needle for intramuscular injection is provided.
Il- labra (blu) għall- għotja ta ’ injezzjoni ġol- muskolu hi pprovduta.
The formulation does not contain a preservative.
Il- formulazzjoni ma għandiex preservattiv.
Each vial of AVONEX contains a single dose only.
Kull fjala ta ’ AVONEX fiha biss doża waħda.
Discard the unused portion of any vial.
Armi il- fdal tal- fjala li ma jiġix użat.
BIOGEN IDEC LIMITED Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom
BIOGEN IDEC LIMITED Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY Renju Unit
13 March 1997 Date of latest renewal:
13 ta ’ Marżu 1997 Data ta ’ l- aħħar tiġdid:
13 March 2007
13 ta ’ Marżu 2007
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
AVONEX 30 micrograms/ 0.5 ml solution for injection.
AVONEX 30 mikrogramma/ 0. 5 ml taħlita likwida għall- injezzjoni.
Each 0.5 ml pre-filled syringe contains 30 micrograms (6 million IU) of interferon beta-1a.
Kull siringa ta '0. 5 ml mimlija lesta fiha 30 mikrogramma (6 miljun IU) ta' interferon beta- 1a.
The concentration is 30 micrograms per 0.5 ml.
Il- konċentrazzjoni hi ta ’ 30 mikrogramma kull 0. 5 ml.
Solution for injection.
Taħlita likwida għall- injezzjoni.
Clear and colourless solution.
Taħlita likwida ċara u bla kulur.
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.
The recommended dosage for the treatment of relapsing MS is 30 micrograms (0.5 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).
At the initiation of treatment, patients may either be started on a full dose of 30 micrograms (0.5 ml solution) or on approximately half the dose once a week to help them to adjust to treatment and thereafter increased to the full dose of 30 micrograms (0.5 ml solution).
Fil- bidu tal- kura, il- pazjenti jistgħu jew jinbdew fuq doża sħiħa ta ’ 30 mikrogramma (soluzzjoni ta ’ 0. 5 ml) jew fuq madwar nofs id- doża darba f’ ġimgħa biex tgħinhom jaġġustaw għall- kura, u wara, din tista tiżdied għad- doża sħiħa ta ’ 30 mikrogramma (soluzzjoni ta ’ 0. 5 ml).
In order to obtain adequate efficacy, a dose of 30 micrograms (0.5 ml solution) once a week should be reached and maintained
Sabiex tikseb effikaċja adegwata, doża ta ’ 30 mikrogramma (soluzzjoni ta ’ 0. 5 ml) għandha tintlaħaq u tinżamm wara l -
12 after the initial titration period.
12 perjodu inizjali tat- titrazzjoni.
A manual titration device to enable delivery of approximately half the dose is available for patients initiating AVONEX treatment.
Tagħmir manwali tat- titrazzjoni li jippermetti l- forniment ta ’ madwar nofs id- doża, hu disponibbli għal pazjenti li jkunu qed jibdew il- kura b’ AVONEX.
However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving AVONEX 30 micrograms IM once per week is similar to that seen in adults.
Iżda, informazzjoni limitata ppublikata tissuġġerixxi li l- profil ta ’ sigurta ’ f’ adolexxenti minn 12 sa 16- il sena li qed jieħdu Avonex 30 mikrogramma IM darba fil- ġimgħa huwa simili għal dak li deher fl - adulti.
- Patients with a history of hypersensitivity to natural or recombinant interferon-ß or to any
- Pazjenti li għandhom passat ta ’ ipersensittività għal interferon- ß, naturali jew rikombinat jew
excipients.
għal xi sustanzi mhux attivi.
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)
13 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).
13 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).
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 sinjali ta ’ indeboliment tal- fwied u għandu jkun hemm kawtela meta jintuża interferon ma ’ prodotti mediċinali oħra li huma assoċjati ma ’ indeboliment tal- fwied.
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.
Pazjenti b' mard tal- qalb, bħal anġina, insuffiċjenza tal- qalb konġestiva, jew arritmija, għandhom jiġu issorveljati mill- qrib għal xi deterjorament tal- kundizzjoni klinika tagħhom waqt il- kura b’ AVONEX.
Recent clinical studies with patients treated up to three years with AVONEX suggest that approximately 5% to 8% develop neutralising antibodies.
Informazzjoni dwar pazjenti kkurati b’ AVONEX sa sentejn tissuġġerixxi li bejn wieħed u iehor 5% - 8% jiżżviluppaw anti- korpi newtralizzanti.
Women of child-bearing potential
14 Nisa li jistgħu joħorġu tqal
If the patient becomes pregnant or plans to become pregnant while taking AVONEX she should be informed of the 14 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 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.
No studies of 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)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjet à ta ’ tagħhom.
15 Investigations
15 Investigazzjonijiet
common
imnieħer iqattar komuni
rhinorrhoea
qtugħ ta ’ nifs rari
16 Musculoskeletal and connective tissue disorders
16 Disturbi muskolu skeltrali u tal- connective tissue
17 Hepatobiliary disorders
17 Disturbi fil- fwied u fil- marrara
Interferons are cytokines that mediate antiviral, antiproliferative, and immunomodulatory activities.
L- interferoni huma ċitokini li jiffaċilitaw attivitajiet antivirali, antiproliferattivi u immunomodulatorji.
Three major forms of interferons have been distinguished: alpha, beta, and gamma.
Tlett forom prinċipali ta 'interferoni ġew identifikati: alfa, beta u gamma.
Interferons alpha and beta are classified as Type I interferons, and interferon gamma is a Type II interferon.
L- interferon alfa u beta huma ikklassifikati bħala interferoni tat- Tip I, u interferon gamma hu interferon tat- Tip II.
AVONEX exerts its biological effects by binding to specific receptors on the surface of human cells.
18 AVONEX jeżerċita l- effetti bijoloġiċi tiegħu billi jintrabat ma 'riċetturi speċifiċi li jinsabu fuq il- qoxra ta' barra taċ- ċelluli umani.
Some of these products have been 18 measured in the serum and cellular fractions of blood collected from patients treated with AVONEX.
Uħud minn dawn il- prodotti ġew imkejjla kemm fis- serum kif ukoll fiċ- ċelluli ta 'demm meħud minn pazjenti kkurati b’ AVONEX.
The effects of lyophilised AVONEX in the treatment of MS were demonstrated in a placebo-controlled study of 301 patients (AVONEX n=158, placebo n=143) with relapsing MS characterised by at least 2 exacerbations in the previous 3 years or at least one exacerbation per year prior to entry when the duration of the disease was less than 3 years.
L- effetti ta ’ AVONEX lajofilizzat fil- kura ta ’ l- isklerożi multipla intwerew fi studju, ikkontrollat bil- plaċebo, fuq 301 pazjent (AVONEX n = 158, plaċebo n = 143) kollha jbatu minn MS li tirkadi kkaratterizzata minn mill- inqas 2 rikaduti fit- 3 snin ta ’ qabel, jew mill- inqas rikaduta waħda kull sena qabel ma l- pazjent daħal fl- istudju, meta t- tul tal- marda kien inqas minn 3 snin.
However, the impact of early treatment with AVONEX is unknown even in this high-risk subgroup as the study was mainly designed to assess the time to the second event rather than the long-term evolution of the disease.
Iżda, l- impatt ta 'kura bikrija b’ AVONEX mhux magħruf lanqas f’ dan il- grupp b' riskju għoli minħabba li l- istudju kien imfassal prinċipalment biex jistudja it- tul ta ’ żmien sat- tieni episodju u mhux l- evoluzzjoni tal- marda fuq tul twil ta ’ żmien.
Following intramuscular administration of AVONEX, serum antiviral activity levels peak between 5 and 15 hours post-dose and decline with a half-life of approximately 10 hours.
19 Wara għotja ġol- muskolu ta ’ AVONEX, il- livelli ta ’ l- attivita 'antivirali fis- serum jilħqu il- quċċata minn ħames sa ħmistax- il siegħa wara li tingħata d- doża u jonqsu b' half- life ta' bejn wieħed u ieħor għaxar sigħat.
In a 26-week repeated dose toxicity study in rhesus monkeys by intramuscular route once per week, administered in combination with another immunomodulating agent, an anti CD40 ligand monoclonal antibody, no immune response toward interferon beta-1a and no signs of toxicity were demonstrated.
Fi studju ta ’ 26 gimgħa, b’ doża ġol- muskolu ripetuta darba fil- gimgħa f’ xadini rhesus, mogħtija flimkien ma ’ aġent immunomodulatorju ieħor; antikorp monoklonali b’ ligand anti CD40; ma kienx hemm rispons immunitarju għal interferon beta- 1a u ma ntwera l- ebda sinjal ta ’ tossicita ’.
No teratogenic effects or effects on foetal development have been observed, but the available information on the effects of Interferon beta-1a in the peri- and postnatal periods is limited.
L- ebda effetti teratoġeniċi jew fuq l- iżvilupp tal- fetu ma ġew osservati, iżda l- informazzjoni disponibbli dwar l- effetti ta ’ interferon beta- 1a fil- perijodu ta 'qabel u wara t- twelid hija limitata.
Sodium acetate trihydrate, Acetic acid, glacial, Arginine hydrochloride, Polysorbate 20, Water for injections.
Sodium acetate trihydrate, Acetic acid, glacial, Arginine hydrochloride, Polysorbate 20, Ilma għall- injezzjoni.
Store in a refrigerator (2 oC -8 oC).
Aħżen fi friġġ (2 oC – 8 oC).
DO NOT FREEZE.
Tagħmlux fil- friża.
AVONEX can be stored at room temperature (between 15 oC and 30 oC) for up to one week.
20 Avonex jista ’ jinħażen f’ temperatura ta ’ l- ambjent (bejn 15 oC u 30 oC) sa ġimgħa.
Store in the original package (sealed plastic tray) in order to protect from light (see section 6.5).
Aħżen fil- pakk oriġinali (trej tal- plastik issiġillat) sabiex tilqa’ mid- dawl (ara sezzjoni 6. 5).
1 ml pre-filled syringe made of glass (Type I) with a tamper evident cap and plunger stopper (bromobutyl) containing 0.5 ml of solution.
Siringa mimlija lesta ta '1 ml magħmula minn ħġieġ (Tip I), bit- tapp tat- tarf issiġillat u b’ tapp planġer (- bromobutyl) li fiha 0. 5 ml ta ’ taħlita likwida.
Pack size: box of four or twelve pre-filled syringes of 0.5 ml.
Kaxxa b' erba ’ jew tnax siringi mimlijin lesti b’ 0. 5 ml.
Each syringe is packed in a sealed plastic tray, which also contains one injection needle for intramuscular use.
Kull siringa hi ppakkjata ġo trej tal- plastik issiġillat flimkien ma 'labra għal injezzjoni ġol- muskolu.
AVONEX is provided as ready to use solution for injection in a pre-filled syringe.
AVONEX huwa pprovdut bħala taħlita likwida għall- injezzjoni lesta għall- użu ġo siringa mimlija lesta.
Once removed from the refrigerator, AVONEX in a pre-filled syringe should be allowed to warm to room temperature (15 °C -30 °C) for about 30 minutes.
Meta titneħħa mill- friġġ, is- siringa mimlija lesta b’ AVONEX għandha titħalla għal xi 30 minuta sakemm tilħaq it- temperatura ta ’ l- ambjent (15 oC – 30 oC).
Do not use external heat sources such as hot water to warm AVONEX 30 micrograms solution for injection.
Tużax xi mezz estern ta 'sħana bħal ilma sħun, biex issaħħan it- taħlita likwida għall- injezzjoni ta ’ AVONEX 30 mikrogramma.
If the solution for injection contains particulate matter or if it is any colour other than clear colourless, the pre-filled syringe must not be used.
Jekk it- taħlita likwida għall- injezzjoni fiha xi frak jew hi ta´ xi kulur ieħor barra mingħajr kulur u ċar, is- siringa mimlija lesta m’ għandiex tintuza.
The injection needle for intramuscular injection is provided.
Il- labra għall- għotja ta ’ injezzjoni ġol- muskolu hi pprovduta.
Each pre-filled syringe of AVONEX contains a single dose only.
Kull siringa mimlija lesta ta ’ AVONEX fiha biss doża waħda.
Discard the unused portion of any pre-filled syringe.
Armi il- fdal mhux użat ta´ kull siringa mimlija lesta.
22 ANNEX II
22 ANNESS II
Biogen Idec Inc., 14 Cambridge Center, Cambridge, Massachusetts 02142, USA.
Biogen Inc., 14 Cambridge Centre, Cambridge, Massachusetts 02142, L- Istati Uniti.
Biogen Idec Inc., 5000 Davis Drive, POB 14627, Research Triangle Park, North Carolina, 27709, USA.
Biogen Inc., 5000 Davis Drive, POB 14627, Research Triangle Park, North Carolina, 27709, L- Istati Uniti.
Biogen Idec B. V., Robijnlaan 8, 2132 WX Hoofddorp, The Netherlands.
Biogen Idec B. V., Robijnlaan 8, 2132 WX Hoofddorp, L- Olanda.
Biogen Idec Denmark Manufacturing ApS, Biogen Idec Allé 1, DK-3400 Hillerød, Denmark.
Biogen Idec Denmark Manufacturing ApS, Biogen Idec Allé 1, DK- 3400 Hillerød, Danimarka.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli għal- ħruġ tal- lott konċernat.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Sid ta 'din l- awtorizzazzjoni għall- kummerċ għandu jagħti tagħrif lill- Kummissjoni Ewropeja dwar il- pjanijiet kummerċjali tal- prodott mediċinali awtorizzat b' din id- deċiżjoni.
BIO-SET PRESENTATION
PREŻENTAZZJONI BIO- SET
Each vial contains 30 micrograms (6 million IU) of interferon beta-1a.
Kull fjala fiha 30 mikrogramma (6 miljun IU) ta ’ interferon beta- 1a.
Human serum albumin, sodium chloride, di- and monobasic sodium phosphate.
Albumina ta 'serum uman, sodium chloride, di - u monobasic sodium phosphate.
See the package leaflet for further information.
Aqra l- fuljett ta ’ tagħrif għall- aktar informazzjoni.
Powder and solvent for solution for injection.
Trab u solvent għall- soluzzjoni għal injezzjoni.
Packs of four doses presented as: vial with BIO-SET device containing medicinal product, pre-filled syringe of water for injections, one injection needle for intramuscular use.
Pakkijiet ta 'erba ’ dożi ppreżentati bħala: fjala b’ apparat BIO- SET li fih prodott mediċinali, siringa mimlija lesta b' ilma għall- injezzjoni u labra għall- użu intramuskolari.
For intramuscular use after reconstitution with solvent.
Għall- użu intramuskolari wara rikostituzzjoni b' solvent.
Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom
Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY Renju Unit
28 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
28 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
AVONEX 30 micrograms powder and solvent for solution for injection
AVONEX 30 mikrogramma trab u solvent għal taħlita likwida għall- injezzjoni
Medicinal product (3 ml vial)
Prodott mediċinali (fjala ta ’ 3 ml)
AVONEX 30 micrograms powder for injection
AVONEX 30 mikrogramma trab għall- injezzjoni
See package leaflet.
Ara l- fuljett tal- pakk.
30 micrograms interferon beta-1a
30 mikrogramma interferon beta- 1a
Solvent for reconstitution:
Solvent għar- rikostituzzjoni:
(1 ml pre-filled syringe)
(siringa mimlija lesta ta ’ 1 ml)
AVONEX 30 micrograms/ 0.5 ml solution for injection
AVONEX 30 mikrogramma/ 0. 5 ml taħlita likwida għall- injezzjoni.
STATEMENT OF ACTIVE SUBSTANCE (S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA
Each pre-filled syringe of 0.5 ml contains 30 micrograms (6 million IU) of interferon beta-1a.
Kull siringa mimlija lesta ta '0. 5 ml fiha 30 mikrogramma (6 miljun IU) ta' interferon beta- 1a.
Sodium acetate trihydrate, acetic acid glacial, arginine hydrochloride, polysorbate 20, water for injections.
Sodium acetate trihydrate, acetic acid, glacial: arginine hydrochloride, polysorbate 20, ilma għall- injezzjoni.
Box of four pre-filled syringes of 0.5 ml of solution.
Kaxxa ta 'erbgħa siringi mimlija lesti b’ 0. 5 ml ta' taħlita likwida.
Box of twelve pre-filled syringes of 0.5 ml of solution.
Kaxxa ta 'tnax- il siringa mimlija lesti b’ 0. 5 ml ta' taħlita likwida.
Each syringe is packed in a sealed plastic tray which also contains one injection needle for intramuscular use.
Kull siringa hi ppakkjata ġo trej tal- plastik issiġillat flimkien ma 'labra għal injezzjoni intramuskolari.
METHOD AND ROUTE (S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA
Intramuscular use.
Għall- użu intramuskolari.
Avonex can be stored at room temperature (between 15 oC-30 oC) for up to one week.
Avonex jista ’ jinħażen f’ temperatura ta ’ l- ambjent (bejn 15 OC u 30 OC) sa ġimgħa.
Store in the original package (sealed plastic tray) in order to protect from light.
Aħżen fil- pakkett oriġinali (trej tal- plastik issiġillat) sabiex tilqa ’ mid- dawl.
EU/ 1/ 97/ 033/ 003 4 pack EU/ 1/ 97/ 033/ 004 12 pack
EU/ 1/ 97/ 033/ 003 pakkett ta ’ 4 EU/ 1/ 97/ 033/ 004 pakkett ta ’ 12
NAME OF THE MEDICINAL PRODUCT AND ROUTE (S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA
AVONEX 30 micrograms/ 0.5 ml solution for injection
AVONEX 30 mikrogramma/ 0. 5 ml taħlita likwida għall- injezzjoni
See package leaflet.
Ara il- fuljett ta ’ tagħrif.
AVONEX 30 micrograms powder and solvent for solution for injection (Interferon beta-1a) BIO-SET Presentation
AVONEX 30 mikrogramma trab u soluzzjoni għall- infużjoni (Interferon beta- 1a) Preżentazzjoni BIO- SET
Even if you have used Avonex before, some of the information may have changed.
Anke jekk ġa ħadt Avonex qabel, xi informazzjoni jista jkun li nbidlet.
- If you have any further questions, ask your doctor or your pharmacist
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
It may harm them, even
M’ għandekx tgħaddihaTAGĦTIHIEX lil persuni oħra.
- If any of the side effects gets serious, or if you notice any side effects not listed in this
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
leaflet, please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
(Notes information)
(Noti ta ’ informazzjoni)
Latest issue:
L- aħħar ħarga:
{MM/ YYYY} This leaflet is changed from time to time.
{XX/ SSSS} Dan il- fuljett jinbidel minn ħin għal ieħor.
Please check every time you get your prescription refilled to see if the leaflet has been updated.
Jekk jogħġbok iċċekja kull darba li timla l- preskrizzjoni tiegħek biex tara jekk il- fuljett ġiex rivedut.
What AVONEX is and what it is used for 2.
X' inhu AVONEX u għalxiex jintuża 2.
Before you use AVONEX 3.
Qabel ma tuża AVONEX 3.
How to use AVONEX 4.
Kif għandek tuża AVONEX 4.
How to store AVONEX 6.
Kif taħżen AVONEX 6.
How to inject AVONEX
Kif tinjetta AVONEX
WHAT AVONEX IS AND WHAT IT IS USED FOR
X’ INHU AVONEX U GĦALXIEX JINTUŻA
What AVONEX is
X’ inhu AVONEX
The active ingredient in Avonex is a protein called interferon beta-1a.
Is- sustanza attiva f’ Avonex hija proteina li tissejjaħ interferon beta- 1a.
Interferons are natural substances made in your body to help protect you from infections and diseases.
Interferons huma sustanzi naturali magħmula fil- ġisem tiegħek biex jgħinu jipproteġuk minn infezzjonijiet u mard.
The protein in Avonex is made up of exactly the same ingredients as interferon beta that is found in the human body.
Il- proteina f’ Avonex hija magħmula eżatt mill- istess ingredjenti bħal interferon beta li jinstab fil- ġisem uman.
What AVONEX is used for
Għalxiex jintuża AVONEX
Avonex is used to treat Multiple Sclerosis (MS).
Avonex jintuża għall- kura ta ’ Sklerożi Multipla (MS).
Treatment with Avonex can help to prevent you from getting worse, although it will not cure MS.
Kura b’ Avonex tista ’ tgħin biex tipprevjeni li inti tiggrava, għalkemm ma tikkurax MS.
Everyone has their own set of MS symptoms.
Kulħadd għandu għadd ta ’ sintomi ta ’ MS partikolari għalih.
These can include:
Dawn jinkludu:
- feeling off-balance or light headed, walking problems, stiffness and muscle spasms, tiredness,
- tħossok mhux f’ sikktek jew stordut, diffikultà biex timxi, għebusija u spasmu fil- muskolu,
numbness in the face, arms or legs
għejja, telf ta ’ sensazzjoni f’ wiċċek, idejk jew saqajk
- acute or chronic pain, bladder and bowel problems, sexual problems and problems seeing things
- uġigħ akut jew kroniku, problemi tal- bużżieqa ta ’ l- awrina u tal- imsaren, problemi sesswali u
- difficulty in thinking and concentrating, depression.
- diffikultà biex taħseb u tikkonċentra, depressjoni.
MS also tends to flare up from time to time: this is called a relapse.
MS għandha tendenza li tiggrava minn ħin għal ieħor: dan jissejjaħ irkadar.
38 (Notes information)
38 (Noti ta ’ informazzjoni)
Avonex works best when you use it at the same time, once a week, on a regular basis.
Avonex jaħdem l- aħjar meta tużaħ fl- istess ħin, darba fil- ġimgħa, fuq bażi regolari.
Do not stop your Avonex treatment without speaking to your neurologist.
T’ waqqafx il- kura tiegħek b’ Avonex mingħajr ma tkellem lin- newroloġista tiegħek.
Avonex can help to reduce the number of relapses that you have and slow down the disabling effects of MS.
Avonex jista ’ jgħin biex inaqqas in- numru ta ’ episodji ta ’ rkadar li inti jkollok u irażżan l - iżvilupp ta ’ effetti disabillitanti ta ’ MS.
Your doctor will advise you for how long you can use Avonex or when to stop.
It- tabib tiegħek javżak kemm tista ’ ddum tuża Avonex jew meta tieqaf.
How AVONEX works
Kif jaħdem AVONEX
Multiple sclerosis is linked to nerve (brain or spinal cord) damage.
Sklerożi multipla hija marbuta ma ’ ħsara fin- nervaturi (moħħ jew sinsla tad- dahar).
In MS, your body’ s defence system reacts against it’ s own myelin – the ‘ insulation ’ that surrounds nerve fibres.
Fi MS, is- sistema ta ’ difiża ta ’ ġismek tirreaġixxi kontra l- myelin - l - “ iżolazzjoni ” ta ’ madwar il- fibri tan- nervaturi – tiegħu stess.
When myelin is damaged, the messages between the brain and other parts of the body are disrupted.
Meta l- myelin ikollu l- ħsara il- messaġġi bejn il- moħħ u partijiet oħra tal- ġisem jiġu mtellfa.
This is what causes the symptoms of MS.
Dan hu li jikkawża s- sintomi ta ’ MS.
Avonex seems to work by stopping your body’ s defence system from attacking the myelin.
Avonex jidher li jaħdem billi jwaqqaf is- sistema ta ’ difiża tal- ġisem tiegħek milli tattakka l- myelin.
BEFORE YOU USE AVONEX
QABEL MA TUŻA AVONEX
Do not use AVONEX
Tużax AVONEX
- if you are allergic (hypersensitive) to interferon beta, human serum albumin or any of the
- jekk int allerġiku (ipersensittiv) għal interferon beta, albumina tas- serum uman jew għal xi
other ingredients in Avonex
wieħed mis- sustanzi l- oħra f’ Avonex
- if you are pregnant, do not start using Avonex
- jekk inti tqila, tibdiex tuża Avonex
- if you have severe depression or think about committing suicide.
jekk għandek depressjoni serja jew għandek ħsibijiet ta´ suwiċidju.
Talk to a doctor straight away if any of these apply to you.
Kellem lill- tabib minnufih jekk xi wieħed minn dawn japplikaw għalik.
Avonex and allergic reactions.
Avonex u reazzjonijiet allerġiċi.
Because Avonex is based on a protein, there is a small chance of an allergic reaction.
Minħabba li Avonex għandu bażi ta ’ proteina, hemm riskju żgħir ta ’ reazzjoni allerġika.
More about depression.
Aktar dwar depressjoni.
If you have severe depression or thoughts about suicide, you must not use Avonex.
Jekk għandek depressjoni serja jew ħsibijiet ta´ suwiċidju, m’ għandekx tuża Avonex.
If you have depression, your doctor may still prescribe Avonex for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your moods.
Jekk għandek depressjoni it- tabib tiegħek xorta jista ’ jippreskrivilek Avonex, iżda huma mportanti li tgħarraf lit- tabib tiegħek li kellek depressjoni jew problemi simili li għadhom effett fuq il- burdata tiegħek.
Take special care with AVONEX
Oqgħod attent ħafna b’ AVONEX
Talk to your doctor first:
Kellem lit- tabib tiegħek l- ewwel:
If you have or have had in the past:
Jekk għandek jew fil- passat kellek:
- depression or problems affecting your moods
- depressjoni jew problemi li għadhom effett fuq il- burdata tiegħek