qanastek/EMEA-V3 huggingface dataset:
Each tablet contains 125 mg, 250 mg or 500 mg deferasirox: • EXJADE 125 mg tablets are stamped on each tablet with “J 125”. • EXJADE 250 mg tabletsare stamped on each tablet with “J 250”. • EXJADE 500 mg tablets are stamped on each tablet with “J 500”.
Kull pillola fiha 125 mg, 250 mg jew 500 mg deferasirox: • Il- pilloli EXJADE 125 mg huma ttimbrati fuq kull pillola b “ J 125 ”. • Il- pilloli EXJADE 250 mg huma ttimbrati fuq kull pillola b “ J 250 ”. • Il- pilloli EXJADE 500 mg huma ttimbrati fuq kull pillola b “ J 500 ”.
Each blister pack contains 28, 84 or 252 dispersible tablets.
Kull folja f’ pakkett fiha 28, 84 jew 252 pillola li jinxterdu.
Not all pack sizes or strengths may be available in your country.
Xi daqsijiet mill- pakketti jew qawwiet jista ’ jkun li ma jkunux disponibbli f’ pajjiżek
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
What is Extavia?
X' inhu Extavia?
Extavia is a powder and solvent that are made up into a solution for injection.
Extavia huwa trab u solvent li jitħalltu flimkien sabiex jiffurmaw soluzzjoni għall- injezzjoni.
It contains 250 micrograms (8 million international units - MIU) per millilitre of the active substance interferon beta-1b.
Fih 250 mikrogramma (8 miljun unità internazzjonali - MIU) għal kull millilitru tas- sustanza attiva interferon beta- 1b.
This medicine is the same as Betaferon, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Betaferon, li hija diġà awtorizzata fl- Unjoni Ewropea (UE).
The company that makes Betaferon has agreed that its scientific data can be used for Extavia.
Il - kumpanija li tipproduċi Betaferon qablet li l- informazzjoni xjentifika tagħha tista 'tintuża għal Extavia.
What is Extavia used for?
Għal xiex jintuża Extavia?
Extavia is used to treat adult patients who have multiple sclerosis (MS).
Extavia jintuża għat- trattament ta 'pazjenti adulti bi sklerożi multipla (MS).
MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
L- isklerożi multipla hija marda tas- sistema nervuża, fejn l- infjammazzjoni teqred il- kisja protettiva madwar n- nervituri.
This is called ‘ demyelination’.
Din tissejjaħ 'demjelinizzazzjoni'.
It is used in patients: • who have experienced the signs of MS (‘ demyelination event ’) for the first time, and these are severe enough to justify treatment with injected corticosteroids (anti-inflammatory medicines).
Tintuża fi: • pazjenti li għall- ewwel darba esperjenzaw is- sintomi ta 'l- MS (' każ demjelinizzanti ') u dawn huma tant gravi li jiġġustifikaw trattament permezz ta' injezzjoni ta 'kortikosterojdi (mediċini antinfjammatorji).
It is used when the patient is considered to be at high risk of developing MS.
Jintuża meta l- pazjent jitqies li għandu riskju għoli li jiżviluppa l- MS.
Before using it, doctors need to exclude other causes for the symptoms. • who have MS of the type known as ‘ relapsing-remitting ’, when the patient has attacks (relapses) within periods with no symptoms (remissions), and with at least two relapses within the last two years. • who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
Qabel ma jużaw din il- mediċina, jeħtieġ li t- tobba jeskludu li s- sintomi ġejjin minn kawżi oħra. • pazjenti bl- isklerożi multipla tat- tip magħruf bħala "reċidiv- remittenti", karatterizzat minn attakki (reċidivi) alternati ma 'perjodi mingħajr sintomi (remissjonijiet) f' pazjenti b' talanqas żewġ attakki reċidivi fi żmien l- aħħar sentejn. • pazjenti bl- isklerożi multipla sekondarja progressiva (it- tip ta' MS li jiġi wara l- sklerożi multipla reċidiva- remittenti), b' marda f' fażi attiva.
How is Extavia used?
Kif jintuża Extavia?
Extavia treatment should be started by a doctor who has experience in the treatment of MS.
It- trattament b' Extavia għandu jinbeda minn tabib b' esperjenza fit- trattament ta 'l- isklerożi multipla.
The treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 19 days to reach the recommended dose of 250 micrograms (8 MIU) given every other day.
It - trattament għandu jibda bi 62. 5 mikrogrammi (kwart tad- doża) kull jumejn u tiżdied progressivament il- kwantità fi 19- il ġurnata sakemm tintlaħaq id- doża rakkomandata ta '250 mikrogramma (8 MIU) mogħtija kull jumejn.
Extavia is given by an injection under the skin.
Extavia jingħata b' injezzjoni taħt il- ġilda.
The patients can inject Extavia themselves, provided that they have been trained.
Il- pazjenti jistgħu jinjettaw Extavia huma stess dejjem jekk ikunu ġew mħarrġa kif.
Extavia treatment should be stopped in patients who fail to respond.
It- trattament b' Extavia għandu jieqaf jekk il- pazjent ma jirrispondix għat- terapija.
How does Extavia work?
Kif jaħdem Extavia?
The active substance in Extavia, interferon beta-1b, belongs to the group ‘ interferons’.
Is- sustanza attiva f' Extavia, interferon beta- 1b, hija parti mill- grupp ta '' interferoni '.
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
L - 'interferoni' huma sustanzi naturali prodotti mill- ġisem biex jgħinuh jiġġieled kontra attakki bħal infezzjonijiet ikkawżati mill- vajrusis.
The exact way that Extavia works in MS is not yet known but beta-interferon seems to calm down the immune system (the body ’ s natural defences) and prevents the relapses of MS.
Il- mod eżatt ta 'kif jaħdem Extavia fl- MS għadu mhux magħruf imma jidher li beta- interferon jikkalma s- sistema immunitarja (id- difiżi naturali tal- ġisem) u jipprevjeni l- attakki reċidivi ta' l- MS.
Interferon beta-1b is produced by a method known as ‘ recombinant DNA technology’.
L- interferon beta- 1b huwa prodott permezz ta 'metodu magħruf bħala' teknoloġija tad- DNA rikombinanti '.
The interferon beta-1b is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
L- interferon beta- 1b jinkiseb minn batterju li jkun irċieva ġene (DNA), li jagħmlu kapaċi li jipproduċi l- interferon.
The replacement interferon beta-1b acts in the same way as naturally produced interferon beta.
L- interferon beta- 1b sostituttiv jaġixxi bl- istess mod bħal interferon beta li jiġi prodott b' mod naturali.
How has Extavia been studied?
Kif ġie studjat Extavia?
Extavia was studied over a two year period in 338 patients with relapsing remitting MS and able to walk unaided, where its effectiveness was compared with placebo (a dummy treatment).
Extavia ġie studjat fuq perjodu ta 'sentejn fuq 338 pazjent bl- isklerożi multipla reċidiva- remittenti li jistgħu jimxu mingħajr assistenza, u l- effikaċja tiegħu tqabblet ma' dik ta 'plaċebo (trattament finta).
The main measure of effectiveness was the reduction in the number of relapses.
Il - kejl ewlieni ta 'l- effikaċja kienet it- tnaqqis tan- numru ta' attakki reċidivi.
Extavia has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with placebo.
Extavia ġie wkoll studjat f' 1, 657 pazjent f' żewġ studji mwettqa fuq persuni bl- isklerożi multipla sekondarja progressiva li jistgħu jimxu; li fihom il- mediċina tqabblet ma 'plaċebo.
The main measure of effectiveness was the delay to progression of disability.
Il- kejl ewlieni ta 'l - effikaċja kien id- dewmien għall- progressjoni tad- diżabilità.
The study of Extavia in patients with a single demyelinating event involved 487 patients, who received either Extavia or placebo for two years.
L- istudju ta 'Extavia f' pazjenti b' każ demjelinizzanti wieħed biss involva 487 pazjent, li ġew trattati b' Extavia jew plaċebo għal sentejn.
The study measured the time it took for a patient to develop clinically defined MS.
L- istudju kejjel iż- żmien li ħa pazjent biex jiżviluppa MS klinikament definita.
What benefit has Extavia shown during the studies?
X' benefiċċji wera Extavia f' dawn l- istudji?
In patients with relapsing remitting MS, Extavia was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27 relapses.
F' pazjenti b' MS reċidiva- remittenti, Extavia kien aktar effikaċi mill- plaċebo fit- tnaqqis tan- numru ta 'attakki reċidivi fis- sena: il- pazjenti trattati bil- mediċina kellhom medja ta' 0. 84 attakki reċidivi fis- sena, filwat li dawk trattati bil- plaċebo kellhom 1. 27.
One of the two studies in patients with secondary progressive MS showed a significant delay in the time to disability progression (31% risk reduction due to Extavia) and in the time to becoming wheelchair bound (39%).
Wieħed miż- żewġ studji mwettqa fil- pazjenti bl- isklerożi multipla sekondarja progressiva wera dewmien sinifikanti fil- progressjoni tad- diżabilità (tnaqqis tar- riskju ta '31% bis- saħħa ta' Extavia) u żieda fiż- żmien preċedenti għal meta l- pazjent ikun imġiegħel juża siġġu tar- roti (39%).
In the second trial, no delay in the time to disability progression was seen.
Fit- tieni studju ma ġie osservat l- ebda dewmien fil- progressjoni tad- diżabilità.
In both trials, Extavia showed a reduction in the number (30%) of clinical relapses.
Fiż- żewġ studji, Extavia wera tnaqqis (30%) tan- numru ta 'attakki reċidivi kliniċi.
In the study of patients with a single demyelinating event, Extavia was shown to reduce the risk of developing clinically defined MS:
Fl- istudju mwettaq fuq pazjenti b' każ demjelinizzanti wieħed biss, Extavia wera li jnaqqas ir- riskju ta 'sklerożi multipla klinikament definita:
28% of the patients who received Extavia developed MS, against 45% of those who received placebo.
28% tal- pazjenti trattati b' Extavia żviluppaw sklerożi multipla, meta mqabbel ma '45% tal- pazjenti trattati bil- plaċebo.
What is the risk associated with Extavia?
X' inhu r- riskju assoċjat ma 'Extavia?
Very common side effects with Extavia (seen more than 1 patients in 10) are flu-like symptoms, fever, chills and injection site reactions (inflammation and pain at the site of injection).
Effetti sekondarji komuni ħafna b' Extavia (li dehru f' iktar minn pazjent wieħed minn kull 10) huma sintomi normalment marbuta ma 'l- influwenza, deni, tkexkix ta' bard u reazzjonijiet fil- punt fejn tingħata l- injezzjoni (infjammazzjoni u wġigħ fil- punt ta 'l- injezzjoni).
For the full list of all side effects reported with Extavia, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrappurtati b' Extavia, ara l- Fuljett ta' Tagħrif.
Extavia 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.
Extavia ma għandux jintuża f' persuni li jkunu diġà esperjenzaw ipersensittività (allerġija) għal interferon beta naturali jew rikombinanti, l- albumina umana jew xi wieħed mill- ingredjenti l- oħra.
Extavia treatment should not be started during pregnancy.
It - trattament b' Extavia ma 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.
Extavia should not be used in patients who are currently suffering from severe depression and/ or have thoughts of suicide.
Extavia ma għandux jintuża f' pazjenti li jkunu qed ibatu minn depressjoni gravi u/ jew li jkollhom ħsibijiet ta 'suwiċidju.
Extavia should not be used in patients who have decompensated liver disease (when the liver does not function normally).
Extavia ma għandux jintuża f' pazjenti b' insuffiċjenza epatika (meta l- fwied ma jaħdimx bħan- normal).
Why has Extavia been approved?
Għaliex ġie approvat Extavia?
The Committee for Medicinal Products for Human Use (CHMP) decided that Extavia’ s benefits are greater than its risks for the treatment of patients with a single demyelinating event, if it is severe enough to justify treatment with intravenous corticosteroids, patients with relapsing-remitting MS and patients with secondary progressive MS with active disease.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Extavia huma akbar mir- riskji għat- trattament ta' pazjenti b' każ demjelinizzanti wieħed biss, jekk it - tali każ huwa hekk gravi li jiġġustifika trattament bil- kortikosterojdi fil- vina, pazjenti li jbatu minn sklerożi multipla tat- tip reċidiv- remittenti u pazjenti bi sklerożi multipla sekondarja progressiva b' marda f' fażi attiva.
They recommended that Extavia be given marketing authorisation.
Il- Kumitat irrakkomanda li Extravia jingħata l- awtorizzazzjoni għat- tqegħid fis - suq.
Other information about Extavia:
2/ 3 Tagħrif ieħor dwar Extavia:
The European Commission granted a marketing authorisation valid throughout the European Union, for Extavia to Novartis Europharm Limited on 20 May 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Extavia lil Novartis Europharm Limited fi 20 ta 'Mejju 2008.
The full EPAR for Extavia can be found here.
L- EPAR sħiħ għal Extavia jista 'jiġi kkonsultat hawn.
Route of Administration
Mnejn Jingħata
Package size
Daqs tal- Pakkett
Powder and solvent for solution for injection
Trab u solvent għal soluzzjoni għall - injezzjoni
Subcutaneous use
Użu għal taħt il - ġilda
powder: vial (glass); solvent: pre-filled syringe (glass)
Siringa mimlija għal- lest (ħġieġ)
powder:
Trab:
5 vials + 5 pre-filled syringes
5 kunjetti + 5 siringi mimlijin għal- lest
15 vials + 15 pre-filled syringes
15- il kunjett + 15- il siringa mimlija għal- lest
EU/ 1/ 08/ 454/ 005
EU/ 1/ 08454/ 005
3 x 15 vials + 3 x 15 pre- filled syringes
3 x 15- il kunjett + 3 x 15- il siringa mimlija għal- lest
Extavia 250 microgram/ ml powder and solvent for solution for injection.
Extavia 250 mikrogramma/ ml, trab u solvent għas- soluzzjoni għall- injezzjoni.
Extavia contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial.
Extavia fiħ 300 mikrogramma (9. 6 miljun IU) ta ’ interferon beta- 1b rikombinanti f’ kull fjala.
Recombinant interferon beta-1b* 250 microgram (8.0 million IU) per ml when reconstituted.
Interferon beta- 1b * rikombinat 250 mikrogramma (8. 0 miljun IU) f’ kull ml wara li jkun rikostitwit.
* produced by genetic engineering from strain of Escherichia coli.
* magħmul permezz ta ’ l- inġenjerija ġenetika minn razza ta ’ Escherichia coli.
White to off-white powder.
Trab ta ’ lewn bajdani jew abjad jagħti fil- griż.
Extavia is indicated for the treatment of • 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). • Patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years. • Patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Extavia jintuża għall- kura ta ’ • Pazjenti b’ każ wieħed ta ’ demajlinazzjoni bi proċess ta ’ infjammazzjoni attiva, jekk tkun serja biżżejjed li tinħtieġ trattament b’ kortikostrerojdi intravenużi, jekk dijanjosi alternattiva ġiet eskluża, u jekk jiġi stabbilit li jinsabu f’ riskju għoli li jiżviluppaw sklerożi multipla klinikament definittiva (ara sezzjoni 5. 1). • Pazjenti bi sklerożi multipla li tirkadi u tbatti b’ żewġ episodji ta ’ rkadar jew iktar fl- aħħar sentejn. • Pazjenti bi sklerożi multipla progressiva sekondarja bil- marda attiva, evidenzjata mill- irkadar.
The treatment with Extavia should be initiated under the supervision of a physician experienced in the treatment of the disease.
Il- kura b’ Extavia għandha tinbeda taħt is- superviżjoni ta ’ tabib li għandu esperjenza fil- kura ta ’ din it - tip ta ’ mard.
Adults The recommended dose of Extavia is 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution (see section 6.6), to be injected subcutaneously every other day.
Adulti Id- doża rakkomandata ta ’ Extavia hi ta ’ 250 mikrogrammi (8. 0 miljun IU), li tinsab f’ 1 ml tas - soluzzjoni rikostitwita (ara sezzjoni 6. 6), li trid tiġi injettata taħt il- ġilda ġurnata iva u oħra le.
Children and adolescents No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Tfal u adolexxenti Ma saru l- ebda provi kliniċi formali jew studji farmakokinetiċi fit- tfal jew fl- adolexxenti.
However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Extavia 8.0 million IU subcutaneously every other day is similar to that seen in adults.
Madankollu, informazzjoni limitata li kienet ippubblikata tissuġġerixxi li l- profil tas- sigurtà fl- adolexxenti minn 12 sa 16- il sena li kienu qed jużaw Extavia 8. 0 miljun IU taħt il- ġilda kull jumejn hu simili għal dak li ntwera fl- adulti.
There is no information on the use of Extavia in children under 12 years of age and therefore Extavia should not be used in this population.
M’ hemm l- ebda informazzjoni fuq l- użu ta ’ Extavia fi tfal taħt it- 12- il sena u għalhekk Extavia m’ għandux jintużaw f’ din il- popolazzjoni.
Generally, dose titration is recommended at the start of treatment.
Ġeneralment tittrazzjoni tad- doża hija rakkomandata fil- bidu tat- trattament
2 Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A).
2 Il- pazjenti għandhom jinbdew b’ doża ta ’ 62. 5 mikrogramm (0. 25 ml) li tingħata taħt il- ġilda ġurnata iva u ġurnata le, u li tiżdied bil- mod għal doża ta ’ 250 mikrogramm (1. 0 ml) ġurnata iva, ġurnata le (ara Tabella A).
The titration period may be adjusted, if any significant adverse reaction occurs.
Il- perijodu ta ’ titrazzjoni jista ’ jiġi aġġustat, jekk ikun hemm reazzjoni avversa sinifikanti.
In order to obtain adequate efficacy, a dose of 250 microgram (1.0 ml) every other day should be reached.
Sabiex tintlaħaq effikaċja adegwata, għandha tintlaħaq doża ta ’ 250 mikrogramm (1. 0 ml) li tingħata ġurnata iva, ġurnata le.
Schedule for dose titration*
Skeda għal tittrazzjoni tad- doża *
Treatment day
Jum ta ’ trattament
62.5 microgram
62. 5 mikrogramm
187.5 microgram 250 microgram
187. 5 mikrogramm 250 mikrogramm
0.75 ml 1.0 ml
0. 75 ml 1. 0 ml
* The titration period may be adjusted if any significant adverse reaction occurs.
* Il- perijodu ta ’ tittrazzjoni jista ’ jiġi aġġustat jekk isseħħ reazzjoni avversa sinifikanti.
The optimal dose has not been fully clarified.
L- aħjar doża għada mhix ċara.
At the present time, it is not known for how long the patient should be treated.
Attwalment, għadu mhux magħruf kemm pazjent għandu jdum jieħu din il- kura.
There are follow-up data under controlled clinical conditions for patients with relapsing-remitting multiple sclerosis for up to 5 years and for patients with secondary progressive multiple sclerosis for up to 3 years.
Hemm tagħrif tal - follow- up taħt kundizzjonijiet kliniċi kontrollati għal pazjenti li għandhom sklerożi multipla li tirkadi u tbatti sa 5 snin u għal pazjenti li għandhom sklerożi multipla progressiva sekondarja sa 3 snin.
The available data for the additional three years are consistent with sustained treatment efficacy of Extavia over the whole time period.
L - effikaċja tal- kura għal aktar minn sentejn f’ kazijiet ta ’ sklerożi multipla li tirkadi u tbatti ġiet murija għat- terapija għall- ewwel sentejn, it- tagħrif disponibbli għat- tliet snin ta ’ wara hija konsistenti bl - effikaċja tat- trattament sostnut ta ’ Extavia fuq il- perijodu kollu.
In patients with a single clinical event suggestive of multiple sclerosis, efficacy has been demonstrated over a period of three years.
F’ pazjenti b’ każ kliniku waħdieni li jimputa l- isklerożi multipla, l- effikaċja ġiet murija fuq perijodu ta ’ tlett snin.
Treatment is not recommended in patients with relapsing-remitting multiple sclerosis who have experienced less than 2 relapses in the previous 2 years or in patients with secondary-progressive multiple sclerosis who have had no active disease in the previous 2 years.
Din il- kura mhux rakkomandata f’ pazjenti bi sklerożi multipla li tirkadi u tbatti li kellhom inqas minn 2 episodji ta ’ rkadar fl- aħħar sentejn jew f’ pazjenti bi sklerożi multipla progressiva sekondarja li ma kellhomx il- marda attiva fl- aħħar sentejn.
If the patient fails to respond, for example a steady progression in Expanded Disability Status Scale (EDSS) for 6 months occurs or treatment with at least 3 courses of adrenocorticotropic hormone (ACTH) or corticosteroids during a one-year period is required despite Extavia therapy, treatment with Extavia should be stopped.
Jekk il- pazjent ma jirrispondix għall- kura, per eżempju jekk ikun hemm progress regolari fl- Iskala Mwessa ’ ta ’ l- Istat ta ’ Diżabilità (EDSS) għal 6 xhur jew ikun hemm il- htieġa ta ’ kura b’ ta ’ l- anqas 3 korsijiet ta ’ ormon adrenokortikotropiku (ACTH) jew kortikosterojdi tul perijodu ta ’ sena minnkejja l- użu ta ’ Extavia, il- kura b’ Extavia għandha titwaqqaf.
− Initiation of treatment in pregnancy (see section 4.6). − Patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin or to any of the excipients. − Patients with current severe depression and/ or suicidal ideation (see sections 4.4 and 4.8). − Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).
− Bidu ta ’ trattament fit- tqala (ara sezzjoni 4. 6). − Pazjenti bi storja ta ’ sensittività eċċessiva għal interferon- beta naturali jew rikombinanti, l - albumina umana jew xi wieħed mis- sustanzi mhux attivi. − Pazjenti li bħalissa għandhom dipressjoni qawwija u/ jew ħsibijiet ta ’ suwiċidju (ara sezzjonijiet 4. 4 u 4. 8). − Pazjenti b’ mard tal- fwied dekompensat (ara sezzjonijiet 4. 4, 4. 5 u 4. 8).
Immune system disorders The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
Mard tas- sistema immuni L- għotja ta ’ ċitokini lill- pazjenti li ġà għandhom gammopatija monoklonali ġiet assoċjata ma ’ l - iżvilupp tas- sindromu ta ’ tnixxija tal- kapillari sistemiċi, b’ sintomi bħal dawk ta ’ xokk u konsegwenzi fatali.
Gastrointestinal disorders In rare cases, pancreatitis was observed with Extavia use, often associated with hypertriglyceridaemia.
Mard gastro- intestinali F’ każijiet rari, pankreatite ġiet osservata bl- użu ta ’ Extavia, li ta ’ spiss kienet assoċjata ma ’ livell għoli ta ’ trigliċeridi fid- demm.
3 Nervous system disorders Extavia 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).
3 Mard tas- sistema nervuża Extavia għandu jingħata b’ attenzjoni lil pazjenti b’ disturbi dipressivi passati jew attwali, b’ mod partikolari dawk bi 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.
Id- dipressjoni u l- ħsibijiet ta ’ suwiċidju huma magħrufa li jseħħu fi frekwenza akbar fil- popolazzjoni ta ’ sklerosi multipla u bl- użu assoċjat ta ’ interferon.
Patients treated with Extavia should be advised to immediately report any symptoms of depression and/ or suicidal ideation to their prescribing physician.
Pazjenti trattati b’ Extavia għandhom jingħataw parir sabiex jirraportaw sintomi bħal dawn ta ’ dipressjoni u/ jew ta ’ ħsibijiet ta ’ suwiċidju lit- tabib li jiktbilhom ir- riċetta.
Patients exhibiting depression should be monitored closely during therapy with Extavia and treated appropriately.
Pazjenti li juru mard dipressiv għandhom jiġu monitorati mill- qrib waqt it- terapija b’ Extavia u trattati skond dan.
Cessation of therapy with Extavia should be considered (see also sections 4.3 and 4.8).
Il- waqfien ta ’ terapija b’ Extavia għandu jiġi kkonsidrat (ara wkoll sezzjonijiet 4. 3 u 4. 8).
Extavia 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).
Extavia għandu jingħata b’ kawtela lil pazjenti li għandhom storja ta ’ puplesija, lil dawk li qed jirċievu trattament b’ anti- epilettiċi, b’ mod partikolari jekk l- epilessija tagħhom mhix adegwatament ikkontrollata b’ anti- epilettiċi (ara sezzjonijiet 4. 5 u 4. 8).
This product contains human albumin and hence carries a potential risk for transmission of viral diseases.
Dan il- prodott fih l- albumina umana u minħabba f’ hekk hemm ir- riskju potenzjali għat- trasmissjoni ta ’ mard virali.
A risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded.
Ir- riskju għat- trasmissjoni tal- marda ta ’ Creutzfeld- Jacob (CJD) ma tistax tiġi eskluża.
Laboratory tests Thyroid function tests are recommended regularly in patients with a history of thyroid dysfunction or as clinically indicated.
Testijiet tal- laboratorju Huwa rakkomandat li jsiru eżamijiet tal- funzjoni tat- tirojde regolari f’ pazjenti b’ passat ta ’ funzjoni ħażina tat- tirojde jew hekk kif indikat kilinkament.
In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e. g. aspartate aminotransferase serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase serum glutamate pyruvate transaminase (SGPT) and gamma glutamyltransferase), are recommended prior to initiation and at regular intervals following introduction of Extavia therapy, and then periodically thereafter in the absence of clinical symptoms.
Barra minn dawk it- testijiet tal- laboratorju li ġeneralment huma meħtieġa biex jimmonitorjaw pazjenti bl- isklerożi multipla, huwa rakkomandat li jsiru testijiet biex jiġi determinat l- għadd sħiħ ta ’ ċelloli tad- demm u għall- għadd ta ’ ċelloli bojod differenti, l- għadd ta ’ plejtlets u l- kimiċi tad- demm li jinkludu t- testijiet għall- funzjoni tal- fwied (eż. aspartate aminotransferase glutamic- oxaloacetic transaminase fis- serum (SGOT), alanine aminotransferase glutamate pyruvate transaminase fis- serum (SGPT) u gamma glutamyltransferase), qabel ma jinbeda u b’ mod regolari wara l- introduzzjoni ta ’ terapija b’ Extavia, u mbagħad kull tant żmien wara dan fin- nuqqas ta ’ sintomi kliniċi.
Patients with anaemia, thrombocytopenia or leukopenia (alone or in any combination) may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
Pazjenti li għandhom anemija, tromboċitopenija jew lewkopenija (waħedha jew f’ kombinazzjoni) jistgħu jeħtieġu monitoraġġ aktar intensiv ta ’ l- għadd taċ- ċelloli tad- demm sħiħ, b’ għadd divrenzjali u tal- plejtlets.
Patients who develop neutropenia should be monitored closely for the development of fever or infection.
Pazjenti li jiżviluppaw newtropenija għandhom jiġu sorveljati mill- qrib minħabba xi deni jew infezzjonijiet li jistgħu jiżviluppaw.
There have been reports of thrombocytopenia, with profound decreases in platelet count.
Kien hemm rapporti ta ’ tromboċitopenija bi tnaqqis sostanzjali fl- għadd ta ’ plejtlets.
Hepatobiliary disorders Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Extavia during clinical trials.
Mard tal- fwied u tal- marrara Waqt provi kiniċi f’ pazjenti trattati b’ Extavia, kien hemm irrappurtat komuni ħafna żieda fit - transaminases fis- serum bla sintomi li fil- biċċa l- kbira tal- każijiet kienet ħafifa u għaddiena.
As for other beta interferons, severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients taking Extavia.
Kien hemm rapporti ta ’ każijiet rari ta ’ ħsara qawwija fil- fwied, kif ukoll każijiet ta ’ insuffiċjenza tal- fwied f’ pazjenti li qed jieħdu Extavia, bħal b’ beta interferoni oħrajn.
The most serious events often occurred in patients exposed to other medicinal products or substances known to be associated with hepatotoxicity or in the presence of co-morbid medical conditions (e. g. metastasising malignant disease, severe infection and sepsis, alcohol abuse).
L- aktar każijiet serji, ħafna drabi seħħew f’ pazjenti li ġew esposti għal prodotti mediċinali oħrajn jew sustanzi magħrufa li huma assoċjati ma ’ epatotossicità jew fil- preżenża ta ’ żewġ kundizzjonijiet mediċi indipendenti minn xulxin (eż. mard malinn b’ metastasi, infezzjoni qawwija u sepsis, abbuż ta ’ l- alkoħol).
Patients should be monitored for signs of hepatic injury.
Pażjenti għandhom jiġu sorveljati għas- sinjali ta ’ ħsara fil- fwied.
Withdrawal of Extavia should be considered if the levels significantly increase or if they are associated with clinical symptoms such as jaundices.
Żieda fil- livelli ta ’ diversi transaminases fis- serum għandha tkun sorveljata u investigata bir- reqqa. Kemm il- darba l- livelli jogħlew b’ mod sinifikanti jew jekk ikunu assoċjati ma ’ sintomi kliniċi bħas- suffejra, għandu jiġi kkunsidrat li titwaqqaf il- kura b’ Extavia.
In the absence of clinical evidence for liver damage, and after normalisation of liver enzymes, a reintroduction of therapy could be considered with appropriate follow-up of hepatic functions.
Jekk ma jkunx hemm evidenza klinika ta ’ ħsara fil- fwied u wara li l- livelli ta ’ enżimi tal- fwied jerġgħu għan- normal tista ’ tiġi kkunsidrata jekk għandhiex terġa ’ tinbeda l- kura b’ sorveljanza xierqa tal- funzjonijiet tal- fwied.
Renal and urinary disorders Caution should be used and close monitoring considered when administering interferon beta to patients with severe renal failure.
Mard tal- kliewi u tas- sistema urinarja Għandu jkun hemm kawtela u monitoraġġ mill- qrib għandu jiġi kkonsidrat meta interderon beta jingħata lil pazjenti li għandhom indeboliment renali serju.
Cardiac disorders Extavia should also be used with caution in patients who suffer from pre-existing cardiac disorders.
4 Mard tal- qalb Extavia għandu jintuża b’ kawtela f’ pazjenti li jbatu minn disturbi kardijaċi pre- eżistenti.
Patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia, should be monitored for worsening of their cardiac condition, particularly during initiation of treatment with Extavia.
Pazjenti li għandhom mard tal- qalb sinifikanti eżistenti diġà, bħal insuffiċjenza tal- qalb konġestiva, mard ta ’ l - arterja tal- qalb jew arritmija, għandhom jiġu sorveljati għal tiħżin tal- kundizzjoni kardijaka tagħhom, b’ mod partikolari mal- bidu tat- trattament b’ Extavia.
4 While Extavia does not have any known direct-acting cardiac toxicity, symptoms of the flu-like syndrome associated with beta interferons may prove stressful to patients with pre-existing significant cardiac disease.
Peress li Extavia mhux magħruf li għandu xi tossiċità kardijaka li taġixxi direttament, sintomi bħas - sindromu bħal ta ’ l- influwenza li hu assoċjat ma ’ beta interferons jista ’ jkun ta ’ stress b’ mard tal- qalb sinifikanti li jeżisti diġà.
During the post-marketing period very rare reports have been received of worsening of cardiac status in patients with pre-existing significant cardiac disease temporarily associated with the initiation of Extavia therapy.
Waqt il- perijodu ta ’ wara t- tqegħid fis- suq waslu rapporti li kienu rari ħafna ta ’ tiħżin fl- istat kardijaku f’ pazjenti b’ mard tal- qalb sinifikanti li diġà eżista li temporanjament ġie assoċjat mat- terapija ta ’ Extavia.
Rare cases of cardiomyopathy have been reported.
Kien hemm xi każijiet rari rapportati ta ’ kardjomijopatija.
If this occurs and a relationship to Extavia is suspected, treatment should be discontinued.
F’ każ li jiġri dan u jkun hemm suspett li dan ikun assoċjat ma ’ Extavia, il- kura għandha titwaqqaf.
General disorders and administration site conditions Serious hypersensitivity reactions (rare but severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur.
Mard ġenerali u kondizzjonijiet ta 'mnejn jingħata Reazzjonijiet serji ta ’ sensittività eċċessiva (reazzjonijiet rari iżda serji u akuti bħal bronkospasżmu, anafilassi u urtikarja) jistgħu jiġru.
If reactions are severe, Extavia should be discontinued and appropriate medical intervention instituted.
Jekk ir- reazzjonijiet ikunu serji ħafna, Extavia għandu jitwaqqaf u jittieħdu passi ta ’ intervent mediku xierqa.
Injection site necrosis has been reported in patients using Extavia (see section 4.8).
Nekrożi fil- lok ta ’ l- injezzjoni ġiet rapportata f’ pazjenti li jużaw Extavia (ara sezzjoni 4. 8).
It can be extensive and may involve muscle fascia as well as fat and therefore can result in scar formation.
Nekrożi tista ’ tkun mifruxa u tista ’ tinvolvi l- faxxa tal- muskoli kif ukoll ix- xaħam.
Occasionally debridement and, less often, skin grafting are required and healing may take up to 6 months.
Il- fejqan jista ’ jieħu sa 6 xhur.
If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with his/ her physician before continuing injections with Extavia.
Jekk il- pazjent ikollu diversi feriti, Extavia għandu jitwaqqaf sakemm dawn ifiequ.
If the patient has multiple lesions Extavia should be discontinued until healing has occurred.
Pazjenti b’ ferita waħda jistgħu jkomplu l- kura b’ Extavia jekk in- nekrożi ma tkunx estensiva żżejjed.
Patients with single lesions may continue on Extavia provided the necrosis is not too extensive, as some patients have experienced healing of injection site necrosis whilst on Extavia.
Dan minħabba li xi pazjenti kellhom fejqan minn nekrożi tal- lok ta ’ l- injezzjoni waqt il- kura b’ Extavia.
To minimise the risk of injection site necrosis patients should be advised to: − use an aseptic injection technique, − rotate the injection sites with each dose.
Biex jitnaqqas ir- riskju ta ’ nekrożi fil- lok ta ’ l- injezzjoni, pazjenti għandhom jingħataw parir sabiex: − tintuża teknika ta ’ injezzjoni asettika − jinbidel il- lok ta ’ injezzjoni għal kull doża
The incidence of injection site reactions may be reduced by the use of an auto-injector.
L- inċidenza ta ’ reazzjonijiet fis- sit ta ’ l- injezzjoni tista ’ titnaqqas jekk jintuża awto- injettatur.
In the pivotal study of patients with a single clinical event suggestive of multiple sclerosis an auto-injector was used in the majority of patients.
Fi studju ewlieni ta ’ pazjenti b’ każ kliniku wieħed li hu suġġestiv għal sklerożi multipla intuża awto- injettur fil - maġġoranza tal- pazjenti.
Injection site reactions as well as injection site necroses were observed less frequently in this study than in the other pivotal studies.
Reazzjonijiet tas- sit ta ’ l- injezzjoni kif ukoll nekrosi tas- sit ta ’ l- injezzjoni kienu osservati anqas frekwentament f’ dan l- istudju milli fl- istudji ewlenin l- oħra.
The procedure for self-administration by the patient should be reviewed periodically, especially if injection site reactions have occurred.
Il- proċedura użata biex pazjent jinjetta lilu nnifsu għanda terġa ’ tiġi verifikata kull tant żmien speċjalment jekk kien hemm xi reazzjonijiet fil- lok ta ’ l- injezzjoni.
Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity.
Immunoġeniċità Bħal fil- każ tal- proteini terapewtiċi kollha, hemm potenzjal għal immunoġeniċità.
Serum samples in controlled clinical trials were collected every 3 months for monitoring of development of antibodies to Extavia.
Kampjuni tas- sirum fi provi kliniċi kkontrollati kienu miġbura kull 3 xhur għal monitoraġġ u żvilupp ta ’ antikorpi għal Extavia.
In the different controlled clinical trials, between 23% and 41% of the patients developed serum interferon beta-1b neutralising activity confirmed by at least two consecutive positive titres; of these patients, between 43% and 55% converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the respective study.
Fil- provi kliniċi kontrollati b’ mod differenti, bejn 23% u 41% tal- pazjenti żviluppaw attività newtralizzanti għal interferon beta 1- b fis- sirum li ġiet ikkonfermata b’ żewġ titres konsekuttivi pożittivi; fost dawn il- pazjenti, bejn 43% u 55% ikkonvertaw għal stat ta ’ antikorp stabbli negattiv (skond żewġ titres konsekuttivi negattivi) matul il- perijodu ta ’ osservazzjoni sussegwenti ta ’ l- istudju rispettiv.
The development of neutralising activity is associated with a reduction in clinical efficacy only with regard to relapse activity.
L- iżvilupp ta ’ attività li tinnewtralizza hija assoċjata biss ma ’ tnaqqis ta ’ l- effikaċja klinika li għandha x’ taqsam ma ’ l- attivita ta ’ rkadar.
Some analyses suggest that this effect might be larger in patients with higher titre levels of neutralising activity.
Xi analiżi ssuġġerew li dan l- effett jista ’ jkun akbar f’ pazjenti li għandhom titri ogħla ta ’ attività li tinnewtralizza.
In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at least once in 32% (88) of the patients treated immediately with Extavia; of these, 47% (41) returned to negative status over a 3-year period.
5 Fl- istudju ta ’ pazjenti li kellhom każ kliniku wieħed li kien suġġestiv għal sklerożi multipla, l- attività newtralizzanti li ġiet imkejla kull 6 xhur kienet osservata mill- anqas darba f’ 32% (88) tal- pazjenti kkurati mill- ewwel b’ Extavia; minn dawn 47% (41) marru lura għal stat negattiv fuq perijodu ta ’ 3 snin.
Within this period, the development of neutralising activity was not associated with a reduction in clinical efficacy (with regard to time to clinically definite multiple sclerosis (CDMS), and time to confirmed EDSS progression).
F’ dan il- perijodu, l- iżvilupp ta ’ attività newtralizzanti ma kinetx assoċjata ma ’ tnaqqis fl - effikaċja klinika (fir- rigward ta ’ l- isklerożi multipla klinika definittiva (CDMS), u ż- żmien biex jiġi konfermat l- avvanz ta ’ l- EDSS).
5 New adverse events have not been associated with the development of neutralising activity.
Każijiet avversi ġodda ma ġewx assoċjati ma ’ l- iżvilupp ta ’ attività li tinnewtralizza.
It has been demonstrated in vitro that Extavia cross-reacts with natural interferon beta.
Ġie muri li minn provi li saru in vitro wrew li Extavia jagħmel reazzjoni ma ’ l- interferon beta naturali.
However, this has not been investigated in vivo and its clinical significance is uncertain.
Madankollu dan ma ġiex studjat in vivo u l- importanza klinika ta ’ dan għadha mhix aċċertata.
There are sparse and inconclusive data on patients who have developed neutralising activity and have completed Extavia therapy.
It- tagħrif li hemm dwar pazjenti li żviluppaw attività li tinnewtralizza u li spiċċaw il- kura b’ Extavia huwa skars u mhux konklussiv.
The decision to continue or discontinue treatment should be based on clinical disease activity rather than on neutralising activity status.
Id- deċiżjoni biex jissokta jew jitwaqqaf it- trattament għandha tkun ibbażata fuq l- attività tal- mard kliniku aktar milli l- istat ta ’ l- attività li tinnewtralizza.
The effect of alternate-day administration of 250 microgram (8.0 million IU) of Extavia on drug metabolism in multiple sclerosis patients is unknown.
L- effett ta ’ għotja ta ’ 250 mikrogramma (8. 0 miljun IU) ta ’ Extavia ġurnata iva u oħra le fuq il - metaboliżmu ta ’ prodotti mediċinali f’ pazjenti bi sklerożi multipla mhux magħruf.
Corticosteroid or ACTH treatment of relapses for periods of up to 28 days has been well tolerated in patients receiving Extavia.
Tul ta ’ kura sa ’ 28 ġurnata bi sterojdi jew b’ ACTH f’ każijiet ta ’ rkadar kienu tollerati sew f’ pazjenti li qed jirċievu Extavia.
Due to the lack of clinical experience in multiple sclerosis patients, the use of Extavia together with immunomodulators other than corticosteroids or ACTH is not recommended.
Minħabba nuqqas ta ’ esperjenza klinika f’ pazjenti bi sklerożi multipla, l- użu ta ’ Extavia ma ’ immunomodulaturi ħlief sterojdi jew ACTH, mhux rakkomandat.
Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
L- interferoni kienu rrapportati li jnaqqsu l- attività ta ’ enżimi li jiddependu fuq ċitokromi tat- tip P- 450 tal- fwied fil- bnedmin u l- annimali.
Caution should be exercised when Extavia 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. anti-epileptics.
Għandha tintuża kawtela meta Extavia jingħata flimkien ma ’ prodotti mediċinali oħra li għandhom indiċi terapewtiċi dojoq u li huma dipendenti ħafna fuq is - sistema ta ’ ċitokroma tat- tip P450 tal- fwied għat- tneħħija mil- ġisem per eżempju mediċini għall- kura ta ’ l- epilessija.
Additional caution should be exercised with any co-medication which has an effect on the haematopoetic system.
Għandu jkun hemm aktar kawtela meta Extavia jingħata flimkien ma ’ mediċini li għandhom effett fuq is- sistema tad- demm.
No interaction studies with anti-epileptics have been carried out.
Ma sarux studji dwar interazzjoni bejn Extavia u mediċini għall- kura ta ’ l- epilessija.
Pregnancy There is limited information on the use of Extavia in pregnancy.
Tqala Hemm informazzjoni limitata dwar l- użu ta ’ Extavia fit- tqala.
Available data indicates that there may be an increased risk of spontaneous abortion.
Id- dejta disponibbli tindika li hemm riskju ogħla ta ’ korrimenti spontanji.
Initiation of treatment is contraindicated during pregnancy (see section 4.3).
Il- bidu tat- trattament mhux indikat waqt it- tqala (ara sezzjoni 4. 3).
Women of child-bearing potential Women of child-bearing potential should take appropriate contraceptive measures.
Nisa li jistgħu jinqabdu tqal Nisa li jistgħu jinqabdu tqal għandom jużaw metodu kontraċettiv xieraq.
If the patient becomes pregnant or plans to become pregnant while taking Extavia, she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3).
Jekk il- pazjenta tinqabad tqila jew qed tippjana li tinqabad tqila waqt il- kura b’ Extavia, għandha tiġi nfurmata dwar il- possibiltà ta ’ ħsara u għandu jiġi rakkomandat li titwaqqaf il- kura (ara sezzjoni 5. 3).
In patients with a high relapse rate before treatment started, the risk of a severe relapse following discontinuation of Extavia in the event of pregnancy should be weighed against a possible increased risk of spontaneous abortion.
F’ pazjenti li għandhom rata għolja ta ’ rkadar qabel ma beda t- trattament, ir- riskju ta ’ rkadar serju wara l- waqfien ta ’ Extavia fil - każ ta ’ tqala għandu jiġi mwieżen kontra l- possibilità ta ’ riskju ogħla ta ’ korriment spontaneju
Lactation It is not known whether interferon beta-1b is excreted in human milk.
6 Treddigħ Mhux magħruf jekk l- interferon beta- 1b jiġix eliminat fil- ħalib tas- sider tal- bniedem.
Because of the potential for serious adverse reactions in nursing infants a decision should be made whether to discontinue breast- feeding or Extavia therapy.
Minħabba l - possibiltà ta ’ reazzjonijiet avversi għal Extavia fit- trabi li qed jerdgħu, għandha tittieħed deċiżjoni li jew jitwaqqaf it- treddiegħ jew titwaqqaf il- kura b’ Extavia.
Central nervous system-related adverse events associated with the use of Extavia might influence the ability to drive and use machines in susceptible patients.
Effetti avversi fuq is- sistema nervuża ċentrali tal- ġisem assoċjati ma ’ l- użu ta ’ Extavia jistgħu jeffettwaw il- ħila biex issuq jew tħaddem magni f’ pazjenti suxxettibli.
6 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
a) At the beginning of treatment adverse reactions are common but in general they subside with further treatment.
a) Fil- bidu tal- kura, effetti avversi huma komuni iżda normalment dawn ibattu wara ftit żmien bil - kura.
The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia), which is mainly due to the pharmacological effects of the medicinal product, and injection site reactions.
L- aktar effetti avversi komuni huma numru ta ’ sintomi jixbħu l- influwenza (deni, sirdat, artralġja, tħossok ma tiflaħx, joħroġlok l- għaraq, uġigħ ta ’ ras, jew uġigħ fil- muskoli), li huma dovuti prinċipalment għal effetti farmakoloġiċi tal- prodott mediċinali u reazzjonijiet fil- lok ta ’ l - injezzjoni.
Injection site reactions occurred frequently after administration of Extavia.
Reazzjonijiet tas- sit ta ’ l- injezzjoni seħħew b’ mod frekwenti wara l- għoti ta ’ Extavia.
Redness, swelling, discoloration, inflammation, pain, hypersensitivity, necrosis and non-specific reactions were significantly associated with 250 microgram (8 million IU) Extavia treatment.
Ħmura, tinfiħ, skolorazzjoni, infjammazzjoni, uġigħ, sensittività eċċessiva, nekrosi u reazzjonijiet mhux speċifiċi kienu sinifikament assoċjati ma ’ 250 mikrogramm (8 miljun IU) trattament ta ’ Extavia.
Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Extavia (see section 4.2).
Ġeneralment, tittrazzjoni tad- doża hija rakkomandata fil- bidu tat- trattament sabiex tkun tista ’ tiżdied it- tollerabilità ta ’ Extavia (ara sezzjoni 4. 2).
Flu-like symptoms may also be reduced by administration of non- steroidal anti-inflammatory medicinal products.
Sintomi bħal ta ’ l- influwenza jistgħu wkoll jitnaqqsu bl- għoti ta ’ prodotti mediċinali mhux sterojdi u anti- infjammatorji.
The incidence of injection site reactions may be reduced by the use of an auto-injector.
L- inċidenza ta ’ reazzjonijiet fil- lok ta ’ l- injezzjoni jistgħu jitnaqqsu bl- użu ta ’ awto- injettatur.
b) The following adverse event listing is based on reports from clinical trials (Table 1, adverse events and laboratory abnormalities) and from the post-marketing surveillance (Table 2, reporting rates based on spontaneous adverse drug reaction reports classified as very common ≥ 1/ 10, common ≥ 1/ 100 to < 1/ 10, uncommon ≥ 1/ 1,000 to < 1/ 100, rare ≥ 1/ 10,000 to < 1/ 1,000, very rare < 1/ 10,000) of Extavia use.
Dawn huma klassifikati bħala komuni ħafna (≥1/ 10), komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥1/ 1, 000 sa < 1/ 100), rari (≥1/ 10, 000 sa < 1/ 1, 000) u rari ħafna (< 1/ 10, 000) bl- użu ta ’ Extavia.
Experience with Extavia in patients with multiple sclerosis (MS) is limited, consequently those adverse events which occur very rarely may not yet have been observed.
L - esperjenza b’ Extavia f’ pazjenti li jbatu minn sklerożi multipla (MS) hija limitata, għalhekk effetti avversi rari ħafna jista ’ jkun li għadhom ma ġewx osservati:
Adverse events and laboratory abnormalities with incidence rates ≥ 10% and the respective percentages under placebo; significantly associated side effects < 10%
Effetti avversi li ġraw ≥10% u l- perċentwali rispettivi għall- plaċebo; effetti oħra assoċjati b’ mod sinnifikattiv < 10%
System Organ
Sistema tal- Klassifika
Class Single Event Secondary Secondary suggestive of Progressive Progressive
Okkorenza
Relapsing- Remitting
Sklerożi
Adverse Event and
Sklerożi Multipla
Multiple Multiple Multiple Sclerosis Sclerosis Sclerosis
Sklerożi Multipla li
Multiple Sclerosis
tal- Organi
Laboratory Abnormalities
Waħdanija li
(BENEFIT)
Multipla
(European
Progressiva
(North
Progressiva
Study)
Sekondarja
American Study)
Sekondarja (Studju
Extavia
Laboratorju
Extavia
(BENEFIT) Extavia
Extavia
Ewropew) Extavia Extavia
Infections and infestations
250 250
250 microgram (Placebo) n=292 (n=176)
250 mikrogramm
250 microgram (Placebo) n=360 (n=358)
250 mikrogramm
250 microgram (Placebo) n=317 (n=308)
mikrogramm mikrogramm
Infection Abscess
Infezzjonijiet u infestazzjonijiet Infezzjoni Axxess