qanastek/EMEA-V3 huggingface dataset:
Blood and lymphatic system disorders Lymphocyte count decreased (< 1500/ mm³) × Λ °
Mard tad- demm u tas- sistema limfatika L- għadd ta ’ limfoċiti mnaqqas (< 1500/ mm³) × Λ °
Absolute neutrophil count decreased (< 1500/ mm³) × Λ *°
Għadd Assolut ta ’ Newtrofili. < 1500/ mm³ * °
White blood cell count decreased (< 3000/ mm³) × Λ *°
Ċelloli Bojod tad- Demm < 3000/ mm³ * °
Lymphadenopathy
Limfadenopatija Mard marbut mal- metabolismu u
1% (1%)
1% (1%) nutrizzjoni
Metabolism and nutrition disorders Blood glucose decreased (< 55 mg/ dl) ×
Glukożju fid- demm mnaqqas < 55 mg/ dl Mard psikjatriku
Psychiatric disorders
Dipressjoni Ansjetà Mard tas- sistema nervuża
Headache Λ Dizziness Insomnia Migraine Paraesthesia Eye disorders
Uġigħ ta ’ ras Λ Sturdament Problemi ta ’ rqad Migranja Parestesija Mard tal- għajnejn
Conjunctivitis Λ
Konġunktivite Λ
Abnormal vision
Vista anormali
Ear and labyrinth disorders Ear pain Cardiac disorders
Mard fil- widnejn u sistema labrintika Uġigħ fil- widna Mard tal- qalb
Palpitation * Vascular disorders
Palpitazzjoni * Mard vaskulari
Vasodilatation Hypertension °
Vażodilatazzjoni Pressjoni għolja °
Respiratory, thoracic and mediastinal disorders Upper respiratory infection
Mard respiratorju, toraċiku u medjastinali Infezzjoni fil- parti respiratorja ta ’ fuq
Sinusitis Cough increased Dyspnoea * Gastrointestinal disorders
8 Sklerożi Multipla li Sklerożi Multipla Sklerożi Sistema tal- Klassifika
4% (6%) 2% (2%) 0% (0%)
0% (0%)
6% (6%) 5% (10%) 3% (2%)
3% (2%)
16% (18%) 11% (15%) 8% (6%)
8% (6%)
36% (26%) 31% (23%) 8% (2%)
8% (2%)
Diarrhoea
Dijarrea
Constipation Nausea Vomiting Λ Abdominal pain ° Hepatobiliary disorders
Stitikezza Dardir RimettarΛ Uġigħ addominali Mard tal- fwied u tal- marrara
Alanine aminotransferase increased (SGPT > 5 times baseline) × Λ * °
Alanine aminotransferase miżjud (SGPT > 5 darbiet il- linja bażi ta ’ referenza) ×Λ * °
Aspartate aminotransferase increased (SGOT > 5 times baseline) × Λ * °
Aspartate aminotransferase miżjud (SGOT > 5 darbiet il- linja bażi ta ’ referenza) × Λ * °
Skin and subcutaneous tissue
Mard tal- ġilda u tessuti taħta Problemi fil- ġilda Λ
Rash °
Raxx °
Musculoskeletal and connective tissue disorders Hypertonia° Myalgia * ° Myasthenia
Mard muskolu- skeltrali, tal- connective tissue Ipertonja° Uġigħ fil- muskoli * ° Mijastenja
Back pain
Uġigħ fid- dahar Uġigħ fl- estremitajiet Mard tal- kliewi u tas- sistema
10% (7%)
10% (7%) 6% (3%) urinarja
Pain in extremity Renal and urinary disorders
Diffikultà biex tgħaddi l - awrina
Urinary protein positive (> 1+)×
Pożittiv għal proteina × awrinarja (> 1+)
3% (5%)
5% (3%)
Urinary incontinence Urinary urgency
Awrina frekwenti Inkontinenza awrinarja Awrina b’ urġenza
1% (1%) 1% (1%)
1% (1%) 1% (1%) 1% (1%)
8% (15%) 8% (7%)
6% (5%) 8% (15%) 8% (7%)
20% (19%) 21% (17%)
12% (11%) 20% (19%) 21% (17%)
2% (1%) 4% (2%)
3% (5%) 2% (1%) 4% (2%)
Reproductive system and breast disorders Dysmenorrhoea
Mard tas- sistema riproduttiva u tas- sider Dismenorreja
Menstrual disorder *
Problemi ta ’ menstrwazzjoni *
Metrorrhagia Impotence
Dmijja bejn pirjid u ieħor Impotenza
General disorders and administration site conditions Injection site reaction (various kinds) Λ * ° §
(Studju fl’ Amerka Sekondarja ta ’ Sklerożi Effett Avvers u ta ’ Fuq) (Studju Multipla Abnormalitajiet fil - Ewropew) (BENEFIT) Laboratorju Extavia Extavia Extavia Extavia 250 mikrogramm 250 mikrogramm 250 250 (Plaċebo) (Plaċebo) mikrogramm mikrogramm n=124 (n=123) n=317 (n=308) (Plaċebo) (Plaċebo) n=360 (n=358) n=292 9n=176 _ Mard ġenerali u kundizzjonijiet ta 'mnejn jittieħed Reazzjonijiet mnejn tingħata l- injezzjoni (diversi tipi) Λ * ° §
Injection site necrosis & Λ
Nekrożi mnejn tingħata l - injezzjoni * °
Flu-like symptoms Fever Λ * ° Pain Chest pain ° Peripheral oedema Asthenia * Λ
Sintomu kumpless bħall- influwenza * °
Chills * ° Sweating * Malaise * ×
Deni * ° Uġigħ Uġigħ fis- sider ° Edema periferika Astenja * Sirdat Λ * ° Għaraq * Telqa *
Laboratory abnormality Λ Significantly associated with Extavia treatment for patients with first event suggestive of MS, p < 0.05 * Significantly associated with Extavia treatment for RRMS, p < 0.05 ° Significantly associated with Extavia treatment for SPMS, p < 0.05 § Injection site reaction (various kinds) comprises all adverse events occurring at the injection site, i. e. the following terms: injection site haemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site necrosis, injection site pain, injection site reaction, injection site oedema, and injection site atrophy & “ Flu-like symptom complex” denotes flu syndrome and/ or a combination of at least two adverse events from fever, chills, myalgia, malaise, sweating.
Abnormalità tal- laboratorju Λ Assoċjat b’ mod sinifikanti mat- trattament b’ Extavia għal pazjenti bl- ewwel okkorenza suġġestiva ta ’ sklerożi multipla, p < 0. 05 * Assoċjati b’ mod sinifikanti mal- kura b’ Extavia għal RRMS, p < 0. 05 ° Assoċjati b’ mod sinifikanti mal- kura b’ Extavia għal SPMS, p < 0. 05 § Reazzjoni fil- lok ta ’ injezzjoni (diversi tipi) li tikkonsisti minn każijiet avversi li jseħħu fil- lok ta l - injezzjoni, i. e. it- termini li ġejjin: emorraġija fil- lok ta ’ l- injezzjoni, sensittività eċċessiva fil- lok ta ’ l - injezzjoni, massa fil- lok ta ’ l- injezzjoni, nekrosi fil- lok ta ’ l- injezzjoni, uġigħ fil- lok ta’ l - injezzjoni, reazzjoni fil- lok ta ’ l- injezzjoni, edema fil- lok ta ’ l- injezzjoni, u atropija fil- lok ta ’ l- injezzjoni & “ Kumpless tas- sintomi bħal ta ’ l- influwenza ” jindika s- sindromu ta ’ l- influwenza u/ jew kombinazzjoni ta ’ lanqas żewġ reazzjonijiet avversi minn deni, sirdat, mijalġja, telqa u ħruġ ta ’ għaraq.
9 The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
L- aktar terminu xieraq tal- MedRA jiġi użat biex jiddeskrivi ċertu reazzjoni u s- sinonimi tiegħu u kundizzjonijiet relatati.
Table 2
10 Tabella 2
Reporting rates (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) based on spontaneous adverse drug reaction reports
Rati ta ’ episodji ta’ effetti avversi li ġew rapurtati spontanjament, 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)
System Organ Class
Sistema tal -
Very common Common Uncommon Rare ≥ 1/ 10 ≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000
Komuni ħafna Komuni Mhux komuni Rari ≥1/ 10 ≥1/ 100 sa < 1/ 10 ≥1/ 1, 000 sa < 1/ 100 ≥1/ 10, 000 sa
lymphatic system disorders Immune system disorders Endocrine disorders
Klassifika tal - Organi Mard tad- demm u tas- sistema limfatika Mard marbut mal- metabolismu u nutrizzjoni Mard fis- sistema endokrinarja Mard marbut mal- metabolismu u nutrizzjoni
Thrombocytopenia, Leukopenia
Anemija, Tromboċitopenija, Lewkopenija
Anaphylactic reactions Hyperthyroidism, Hypothyroidism, Thyroid disorder
< 1/ 1, 000 Limfadenopatija Reazzjonijiet anafilattiċi Ipertajrojdiżmu, Ipotajrojdiżmu, Disturb tat- tajrojd Żieda tat - trigliċeridi fid - demm, Anoreksja
Metabolism and nutrition disorders
Mard psikjatriku
Blood triglycerides increased, Anorexia
Dipressjoni (ara
Psychiatric disorders
Konfużjoni,
Depression (see also section 4.4)
wkoll sezzjoni 4. 4) Ansjetà, Labilità emozzjonali, Attentat ta ’ suwiċidju (ara wkoll sezzjoni 4. 4) Aċċessjoni Mard tas- sistema nervuża Cardjomajopatija, Mard tal- qalb Takikardja, Palpitazzjoni Pressjoni baxxa Mard vaskulari ħafna Bronkospasmu, Mard Dispnea respiratorju, toraċiku u medjastinali Mard gastro - intestinali
Nervous system disorders
Remettar, Tqallih
Convulsion
Pankreatite
Cardiac disorders
Mard tal- fwied u
Cardiomyopathy, Tachycardia, Palpitation
Żieda fil- livell ta ’
Vascular disorders
Bilirubin fid- demm
Hypertension
tal- marrara
Bronchospasm, Dyspnoea
alanine amino -
Gastrointestinal disorders
ogħla, Livell ogħla
Vomiting, Nausea
Mard tal- ġilda u
Pancreatitis
transferase, Żieda fl- aspartate amino - transferase Urtikarja, Raxx,
Hepatobiliary disorders
ta ’ Gamma - glutamyl - transferase, Epatite Tibdil fil- kulur tal -
Alanine amino- transferase increased, Aspartate amino- transferase increased
tessuti taħta Mard muskolu - skeltrali, tal - connective tissue Mard tas- sistema riproduttiva u tas- sider
Blood bilirubin increased, Gamma-glutamyl- transferase increased, Hepatitis
Prurite, Alopeċja Mijalġja, Ipertonja
Skin and subcutaneous tissue disorders
ġilda Disturb menstruwali
Urticaria, Rash, Pruritus, Alopecia
11 Sistema tal -
Skin discolouration
Komuni ħafna
Musculoskeletal, connective tissue and bone disorders
Komuni
Myalgia, Hypertonia
Mhux komuni
10 System Organ Class
Klassifika tal -
Common ≥ 1/ 100 to < 1/ 10
≥1/ 100 sa < 1/ 10
Uncommon ≥ 1/ 1,000 to < 1/ 100
≥1/ 1, 000 sa < 1/ 100
Rare ≥ 1/ 10,000 to < 1/ 1,000
< 1/ 1, 000
Reproductive system and breast disorders
Sintomi bħal ta ’ l - Nekrosi fil- lok ta ’
Menstrual disorder
Uġigħ fis- sider,
General disorders and administration site conditions
kundizzjonijiet
Flu-like symptoms*, Chills*, Fever *, Injection site reaction*, Injection site inflammation*, Injection site pain
influwenza *, l- injezzjoni *
Injection site necrosis*
tiflaħx, Ħruġ ta ’
Chest pain, Malaise, Sweating
jittieħed IStħarriġ
Investigations
Reazzjoni fil- lok ta ’ l- injezzjoni *, Infjammazzjoni fil - lok ta ’ l- injezzjoni *, Uġigħ fil- lok ta ’ l - injezzjoni
Weight decrease
għaraq Tnaqqis fil- piż
* frequencies based on clinical trials
* frekwenzi msejsa fuq provi kliniċi
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
L- aktar terminu xieraq tal- MedRA jiġi użat biex jiddeskrivi ċertu reazzjoni u s- sinonimi tiegħu u kundizzjonijiet relatati.
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- serjetata ’ tagħhom.
Interferon beta-1b has been given without serious adverse events compromising vital functions to adult cancer patients at individual doses as high as 5,500 microgram (176 million IU) intravenously three times a week.
L- interferon beta- 1b ingħata mingħajr effetti avversi serji li jikkompromettu l- organi vitali, lill - pazjenti adulti bil- kanċer f’ dożi individwali għolja sa 5, 500 mikrogramma (176 miljun IU) mogħtija ġol- vina, tliet darbiet fil- ġimgħa.
Interferons, ATC Code:
Interferoni, Kodiċi ATC:
Interferons belong to the family of cytokines, which are naturally occurring proteins.
L- interferoni huma membri tal- familja taċ- ċitokini, li huma proteini naturali.
Interferons have molecular weights ranging from 15,000 to 21,000 Daltons.
L- interferoni għandhom piż molekulari li jvarja minn 15, 000 sa 21, 000 Daltons.
Three major classes of interferons have been identified: alpha, beta, and gamma.
Tliet klassijiet prinċipali ta ’ interferoni ġew identifikati: alfa, beta, u gamma.
Interferon alpha, interferon beta, and interferon gamma have overlapping yet distinct biological activities.
Interferon alfa, interferon beta u interferon gamma għandhom karatteristiċi bioloġiċi komuni iżda distinti.
The activities of interferon beta-1b are species-restricted and therefore, the most pertinent pharmacological information on interferon beta-1b is derived from studies of human cells in culture or in human in vivo studies.
L- attivitatjiet ta ’ interferon beta- 1b huma limitati għal l - ispeċi, u għalhekk, l- aktar informazzjoni farmakoloġika rilevanti dwar l- interferon beta- 1b ġej minn studji f’ kolturi ta ’ ċelloli tal- bniedem jew minn studji in vivo fil- bniedem.
Interferon beta-1b has been shown to possess both antiviral and immunoregulatory activities.
L- interferon beta- 1b għandu kemm azzjoni kontra il- virus kif ukoll azzjonijiet immuno- regulatorji.
The mechanisms by which interferon beta-1b exerts its actions in multiple sclerosis are not clearly understood.
Il - mekkaniżmi li bihom l- interferon beta- 1b jeffettwa l- isklerożi multipla għadhom mhumiex mifhuma sew.
However, it is known that the biological response-modifying properties of interferon beta-1b are mediated through its interactions with specific cell receptors found on the surface of human cells.
Madankollu, hu magħruf li l- karatteristiċi bioloġiċi ta ’ interferon beta- 1b, li jimmodifika r - rispons, iseħħu permezz ta ’ l- interazzjoni tiegħu ma ’ riċevituri speċifiċi li jinsabu fuq is- superfiċje taċ - ċelloli tal- bniedem.
The binding of interferon beta-1b to these receptors induces the expression of a number of gene products that are believed to be the mediators of the biological actions of interferon beta-1b.
L- irbit ta ’ l- interferon beta- 1b ma ’ dawn ir- riċevituri jwassal għall- ħelisen ta ’ numru ta ’ prodotti ġenetiċi li huma meqjusa bħala medjaturi ta ’ l- azzjonijiet bioloġiċi ta ’ interferon beta- 1b.
A number of these products have been measured in the serum and cellular fractions of blood collected from patients treated with interferon beta-1b.
Numru minn dawn il- prodotti ġew imkejla fis- serum u fi frazzjonijiet ċellulari tad- demm, miġbura minn pazjenti kkurati b’ interferon beta- 1b.
Interferon beta-1b both decreases the binding affinity and enhances the internalisation and degradation of the interferon-gamma receptor.
Interferon beta- 1b inaqqas l- affinità ta ’ rabta u jżid l- internament u d- degradazzjoni tar- riċevitur gamma ta ’ l- interferon.
Interferon beta-1b also enhances the suppressor activity of peripheral blood mononuclear cells.
L- interferon beta- 1b iżid ukoll it - trażżin taċ- ċelloli mononuklejari periferali fid- demm.
No separate investigations were performed regarding the influence of Extavia on the cardiovascular system, respiratory system and the function of endocrine organs.
Ma sarux studji separati dwar l- effett ta ’ Extavia fuq is- sistema kardjuvaskulari, is- sistema respiratorja u fuq il- funzjoni ta ’ l- organi endokrinali.
11 Clinical trials Relapsing-remitting multiple sclerosis (RR-MS) One controlled clinical trial with Extavia in patients with relapsing-remitting multiple sclerosis and able to walk unaided (baseline EDSS 0 to 5.5) was performed.
12 Provi kliniċi Sklerożi multipla li tirkadi- tbatti (RR- MS) Sar studju kliniku kontrollat b’ Extavia f’ pazjenti b’ sklerożi multipla li tirkadi u tbatti, u li setgħu jimxu mingħajr għajnuna (linja ta ’ bażi EDSS 0 sa 5. 5).
Patients receiving Extavia showed a reduction in frequency (30%) and severity of clinical relapses, as well as the number of hospitalisations due to disease.
Pazjenti li ħadu Extavia kellhom tnaqqis fil - frekwenza (30%) u fis- severità ta ’ l- irkadar kliniku, kif ukoll fuq in- numru ta ’ drabi li kellhom jittieħdu l- isptar minħabba l- marda.
Furthermore, there was a prolongation of the relapse-free interval.
Minnbarra dan, ittawwal l- intervall mingħajr episodji ta ’ rikaduti.
There is no evidence of an effect of Extavia on the duration of relapses or on symptoms in between relapses, and no significant effect was seen on the progression of the disease in relapsing-remitting multiple sclerosis.
Ma kienx hemm evidenza ta ’ l- effett ta ’ Extavia fuq it- tul ta ’ kemm idumu r- rikaduti jew fuq is - sintomi li nħassu bejn r- rikaduti, u ma deherx li kien hemm effett sinnifikattiv fuq il- progress tal - marda ta ’ sklerożi multipla li tirkadi u tbatti.
Secondary progressive multiple sclerosis (SP-MS) Two controlled clinical trials with Extavia involving a total of 1,657 patients with secondary progressive multiple sclerosis (baseline EDSS 3 to 6.5, i. e. patients were able to walk) were performed.
Sklerożi multipla progressiva sekondarja (SP- MS) Saru żewġ studji kliniċi kkontrollati b’ Extavia li fihom kien hemm total ta ’ 1, 657 pazjent bi sklerożi multipla progressiva sekondarja (linja ta ’ bażi EDSS 3 sa 6. 5, tfisser pazjenti li setgħu jimxu).
Patients with mild disease and those unable to walk were not studied.
Pazjenti b’ marda ħafifa u dawk li ma setgħux jimxu, ma ġewx studjati.
The two studies showed inconsistent results for the primary endpoint time to confirmed progression, representing delay of disability progression:
Iż- żewġ studji wrew riżultati mhux konsistenti għall- ħin li għadda sabiex tkun konfermata l- progress tal- marda, li tirrapreżenta tardjar fil - firxa ta ’ diżabilità.
One of the two studies demonstrated a statistically significant delay in the time to disability progression (Hazard Ratio = 0.69, 95% confidence interval (0.55, 0.86), p=0.0010, corresponding to a 31% risk reduction due to Extavia) and in the time to becoming wheelchair-bound (Hazard Ratio = 0.61, 95% confidence interval (0.44, 0.85), p=0.0036, corresponding to a 39% risk reduction due to Extavia) in patients who received Extavia.
Wieħed minn dawn iż- żewġ studji wera tardjar statistikament sinifikanti fiż- żmien li d- diżabilità tieħu biex tinfirex (Proporzjon ta ’ Riskju = 0. 69, 95% livell ta ’ kunfidenza (0. 55, 0. 86), p=0. 0010, ekwivalenti għal- 31% fit- tnaqqis tar- riskju minħabba Extavia) u fiż- żmien li wieħed jieħu biex ikollu bżonn siġġu tar- roti (Proporzjon ta ’ Riskju = 0. 61, 95% livell ta ’ kunfidenza (0. 44, 0. 85), p=0. 0036, ekwivalenti għal- 39% fit- tnaqqis tar- riskju minħabba Extavia) f’ pazjenti li rċevew Extavia.
This effect continued over the observation period of up to 33 months.
Dan l - effett kompla fil- perijodu ta ’ osservazzjoni sa ’ 33 xahar.
The treatment effect occurred in patients at all levels of disability investigated and independent of relapse activity.
L- effett tal- kura issokta fuq il- pazjenti kollha f’ kull livell ta ’ diżabilità investigata u indipendenti minn jekk irkadewx.
In the second trial of Extavia in secondary progressive multiple sclerosis, no delay in the time to disability progression was observed.
Fit- tieni studju ta ’ l- użu ta ’ Extavia fi sklerożi multipla progressiva sekondarja ma ġiex osservat tardjar fiż- żmien tal- firxa tad- diżabilità.
There is evidence that the patients included in this study had overall less active disease than in the other study in secondary progressive multiple sclerosis.
Hemm evidenza li l- pazjenti ta ’ dan l- istudju kellhom marda anqas attiva meta mqabbla ma ’ studju ieħor fuq l- isklerożi multipla progressiva sekondarja.
In retrospective meta-analyses including the data of both studies, an overall treatment effect was found which was statistically significant (p=0.0076; 8 million IU Extavia versus all placebo patients).
F’ meta- analiżi retrospettiva li tinkludi informazzjoni miż- żewġ studji, instab effett globali tal- kura li kien statistikament sinifikanti (p=0. 0076; 8 MIU Extavia kontra l- pazjenti kollha tal- plaċebo).
Retrospective analyses in subgroups showed that a treatment effect on disability progression is most likely in patients with active disease before treatment commences (Hazard Ratio 0.72, 95% confidence interval (0.59, 0.88), p=0.0011, corresponding to a 28% risk reduction due to Extavia in patients with relapses or pronounced EDSS progression, 8 million IU Extavia versus all placebo patients).
Analiżi retrospettivi fi gruppi żgħar wriet li l- effett tal- kura fuq il- firxa tad- diżabilità hi l- aktar probabbli f’ pazjenti bil- marda attiva qabel ma bdiet il- kura (Proporzjon ta ’ Riskju 0. 72, 95% livell ta ’ kunfidenza (0. 59, 0. 88), p=0. 0011, li jikkorispondu għal tnaqqis ta ’ 28% tar- riskju minħabba Extavia f’ pazjenti rikaduti jew b’ firxa ta ’ EDSS qawwija, 8 MIU Extavia kontra il- pazjenti kollha tal- plaċebo).
From these retrospective subgroup analyses there was evidence to suggest that relapses as well as pronounced EDSS progression (EDSS > 1 point or > 0.5 point for EDSS > =6 in the previous two years) can help to identify patients with active disease.
Minn din l- analiżi retrospettiva fi gruppi żgħar, hemm evidenza li tagħti x’ tifhem li r- rikaduti kif ukoll EDSS qawwija (EDSS > 1 punt jew > 0. 5 punt għal EDSS > =6 fis- sentejn ta ’ qabel) jistgħu jgħinu biex jidentifikaw dawk il- pazjenti li għandhom marda attiva.
In both trials secondary progressive multiple sclerosis patients receiving Extavia showed a reduction in frequency (30%) of clinical relapses.
Fiż- żewġ studji kliniċi l- pazjenti bi sklerożi multipla progressiva sekondarja li ħadu Extavia, kellhom tnaqqis fil- frekwenza (30%) ta ’ episodji ta ’ irkadar kliniku.
There is no evidence of Extavia having an effect on the duration of relapses.
M’ hemmx evidenza li Extavia għandu xi effett fuq it- tul ta ’ żmien ta ’ l- irkadar.
Single clinical event suggestive of multiple sclerosis One controlled clinical trial with Extavia was performed in patients with a single clinical event and Magnetic Resonance Imaging (MRI) features suggestive of multiple sclerosis (at least two clinically silent lesions on the T2-weighted MRI).
Okkorenza klinika waħdanija indikattiva ta ’ sklerożi multipla Prova klinika waħda kkontrollata b’ Extavia saret fuq pazjenti b’ każ kliniku waħdieni u karatteristiċi ta ’ l- MRI li jimputaw sklerożi multipla (ta ’ lanqas żewġ feriti klinikament siekta fuq l- Immaġini b’ Reżonanza Manjetika (MRI) ppiżat b’ T2).
Patients with monofocal or multifocal onset of the disease were included (i. e. patients with clinical evidence for a single or at least two lesions, respectively, of the central nervous system).
Pazjenti bil- marda monofokali jew b’ bidu monofokali ġew inklużi (i. e. pazjenti b’ xhieda klinika ta ’ ferita waħda jew ta ’ lanqas tnejn, rispettivament tas - sistema nervuża ċentrali).
Any disease other than multiple sclerosis that could better explain signs and symptoms of the patient had to be excluded.
Kull marda oħra li mhix sklerożi multipla li tista ’ tispjega aħjar is- sinjali u s- sintomi tal- pazjent kellha tiġi eskluża.
This study consisted of two phases, a placebo- controlled phase followed by a pre-planned follow-up phase.
Dan l- istudju kien jikkonsisti f’ żewġ fażijiet, fażi kontrollata bi plaċebo segwita b’ fażi ta ’ follow- up ippjanata minn qabel.
The placebo-controlled phase lasted for 2 years or until the patient developed clinically definite multiple scleroiss (CDMS), whichever came first.
Il- fażi kontrollata bil- plaċebo damet għal sentejn jew sakemm il- pazjent żviluppa sklerożi multipla definita klinikament (CDMS), skond liema ġiet l- ewwel.
After the placebo-controlled phase, patients entered a pre-planned follow-up phase with Extavia to evaluate the effects of immediate versus delayed start of Extavia treatment, comparing patients initially randomised to Extavia (“ immediate treatment group”) or to placebo (“ delayed treatment group”).
Wara l- fażi kontrollata bil- plaċebo, il- pazjenti daħlu fil- fażi follow- up li kienet ippjanata minn qabel b’ Extavia sabiex jiġu evalwati l- effetti immedjati kontra dawk li damu biex jibdew bil - kura b’ Extavia, billi tqabblu pazjenti li kienu randomised għal Extavia (“ grupp kkurat
Patients and investigators remained blinded to the initial treatment allocation.
13 immedjatament ”) jew mal- plaċebo (“ grupp li damu biex jibdew il- kura ”).
12 In the placebo-controlled phase, Extavia delayed the progression from the first clinical event to clinically definite multiple sclerosis (CDMS) in a statistically significant and clinically meaningful manner, corresponding to a risk reduction of 47% (Hazard Ratio = 0.53, 95% confidence interval (0.39, 0.73), p < 0.0001).
0. 73), p < 0. 0001).
Within the study period of two years, CDMS occurred in 45% of the placebo group compared to 28% of the Extavia group (Kaplan-Meier estimates).
Fi ħdan il- perijodu ta ’ studju ta ’ sentejn CDMS seħħ f’ 45% tal - grupp ta ’ plaċebo, meta mqabbel mat- 28% tal- grupp ta ’ Extavia (stimi ta ’ Kaplan- Meier).
Extavia prolonged the time to CDMS by 363 days, from 255 days in the placebo group to 618 days in the Extavia group (based on the 25th percentiles).
Extavia dewwem iż- żmien għal CDMS bi 363 jum, minn 255 jum fil- grupp ta ’ plaċebo għal 618- il jum fil - grupp ta ’ Extavia (msejjes fuq il- 25 perċentili).
This treatment effect was still evident after the additional year of follow-up at which stage the risk reduction was 41% (Hazard Ratio = 0.59, 95% confidence interval (0.42, 0.83), p=0.0011).
Dan l- effett tal- kura kien għadu evidenti wara s- sena żejda ta ’ follow- up li fih it- tnaqqis fir- riskju kien 41% (Proporzjon tal- Periklu = 0. 59, 95% confidence interval (0. 42, 0. 83), p=0. 0011).
Within the study period of three years, CDMS occurred in 51% of the delayed treatment group compared to 37% of the immediate treatment group (Kaplan-Meier estimates).
Tul it- tlett snin tal- perijodu ta ’ l- istudju, CDMS seħħet f’ 51% tal - grupp li dam biex jingħata l- kura imqabbel ma ’ 37% tal- grupp li ngħata l- kura immedjatament (stimi Kaplan- Meier).
The persistence of the treatment effect was observed although the majority of patients from the placebo-group was treated with Extavia in the third year of the study.
L- effett tal- kura baqa jippersisti għalkemm il- maġġoranza tal- pazjenti mill- grupp tal - plaċebo kienu ikkurati b’ Extavia fit- tielet sena ta ’ l- istudju.
The robustness of the treatment effect was also shown by the delay of progression to multiple sclerosis according to the McDonald criteria.
Ir- robustezza ta ’ l- effett tat- trattament ġiet murija wkoll bid- dewmien fil- firxa ta ’ sklerożi multipla skond il- kriterji ta ’ McDonald.
In two years, the risk in the placebo group was 85% and 69% in the Extavia group (Hazard Ratio = 0.57, 95% confidence interval (0.46, 0.71), p < 0.00001).
F’ sentejn, ir- riskju tal- grupp tal- plaċebo kien ta ’ 85% u 69% fil- grupp ta ’ Extavia (Proporzjon ta ’ Periklu = 0. 57, 95% intervall ta ’ kunfidenza (0. 46, 0. 71), p < 0. 0001).
After 3 years, a pre-planned interim analysis showed EDSS progression (confirmed increase in EDSS of greater than or equal to 1.0 compared to baseline) occurred in 24% of the patients in the delayed treatment group compared to 16% in the immediate treatment group [Hazard Ratio = 0.6, 95% confidence interval (0.39, 0.92), p=0.022].
Wara 3 snin, analiżi li kienet ippjanata minn qabel fl- intervall uriet li l- avvanz ta ’ l- EDSS (żieda konfermata fl- EDSS ta ’ aktar jew ugwali għall- 1. 0 meta mqabbla mal- linja bażi) seħħ f’ 24% tal - pazjenti fil- grupp li dam biex jibda l- kura meta mqabbel ma ’ 16% fil- grupp li ngħata l- kura immedjatament [Proporzjon tal- Periklu = 0. 6, 95% confidence interval (0. 39, 0. 92), p=0. 022].
There is no evidence for benefit in terms of confirmed disability progression in the majority of patients receiving “ immediate” treatment.
M’ hemmx evidenza ta ’ benefiċċju f’ dak li jirrigwarda l- avvanz ta ’ diżabilità konfermata fil - maġġoranza tal- pazjenti li kienu qed jirċievu kura “ immedjata ”.
Follow-up of patients is continuing in order to provide additional data.
Follow- up tal- pazjenti għadu għaddej sabiex tinkiseb aktar dejta.
No benefit, attributable to Extavia, in quality of life (as measured by FAMS – Functional Assessment of MS:
Ma deherx benefiċċju, li seta jiġi attribwit għal Extavia, fil- kwalità tal- ħajja (hekk kif imkejla bil- FAMS – Stima Funzjonali tal- MS.
Treatment Outcomes Index) was seen.
Indiċi tar- Riżultati tal- Kura).
Subgroup analyses according to baseline factors demonstrated evidence of efficacy in all subgroups evaluated.
L- analiżi tas- sottogrupp skond il- fatturi tal- linja bażi ta ’ referenza wera xhieda ta ’ effikaċja fis - sottogruppi kollha evalwati.
Significant effects were also obtained in patients with less disseminated and less active disease at the time of the first event, the risk in two years for progression to CDMS in patients with monofocal onset was 47% for placebo and 24% for Extavia, without gadolinium (Gd-) enhancement 41% and 20%, with less than 9 T2 lesions 39% and 18%.
Effetti sinifikanti kienu wkoll miksuba f’ pazjenti li għandhom il- marda anqas mifruxa u anqas attiva fiż- żmien ta ’ l- ewwel okkorenza, ir- riskju għal sentejn ta ’ firxa għal CDMS f’ pazjenti b’ bidu monofokali kien 47% għal plaċebo u 24% għal Extavia mingħajr gadolinium (Gd -) enhancement 41% u 20%, b’ inqas minn 9 leżjonijiet T2 39% u 18%.
Further subgroup analyses indicated a high risk for progression to CDMS within 2 years in monofocal patients with at least 9 T2-lesions (55% risk for placebo, 26% for Extavia) or Gd-enhancement (63% versus 33%).
Aktar analiżi tas - sottogrupp indika riskju għoli ta ’ firxa għal CDMS fi żmien sentejn f’ pazjenti monofokali b’ ta ’ lanqas 9 leżjonijiet T2 (55% riskju għal plaċebo, 26% għal Extavia) jew Gd- enhancement (63% kontra 33%).
In multifocal patients, the risk for CDMS was independent from MRI findings at baseline, indicating a high risk for CDMS because of the dissemination of the disease based on clinical findings.
F’ pazjenti multifokali r- riskju għal CDMS kien indipendenti mir- riżultati ta ’ MRI fil- livelli bażi ta ’ referenza, li jindika riskju għoli għal CDMS minħabba l- firxa tal- marda skond ir- riżultati kliniċi.
However, the long-term impact of early treatment with Extavia is unknown even in these high risk subgroups as this study was mainly designed to assess the time to CDMS rather than the long term evolution of the disease.
Madankollu, l- impatt fuq perijodu ta ’ żmien twil ta ’ trattament bikri b’ Extavia mhux magħruf f’ dawn il- gruppi ta ’ riskju għoli billi dan l- istudju hu mfassal biex jassessja ż- żmien ta ’ CDMS aktar milli l - iżvilupp tal- marda.
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 1 month after the initial scan.
Barraminhekk, għall- perijodu attwali għad m’ hemmx definizzjoni stabbilita ta ’ x’ inhu pazjent ta ’ riskju għoli, għalkemm b’ mod konservattiv wieħed għandu jaċċetta ta ’ lanqas disa ’ leżjonijiet T2 ipertensivi fuq l- iskansjoni inizjali u ta ’ lanqas T2 ġdida jew leżjoni Gd- enhanced ġdida fuq skansjoni sussegwenti li għandha tittieħed ta ’ lanqas xahar wara l- iskansjoni inizjali.
In any case, treatment should only be considered for patients classified as high risk.
Fi kwalunkwe każ, it- trattament għandu jiġi kkonsidrat għal pazjenti klassifikati f’ riskju għoli.
Therapy with Extavia was well accepted in the study of patients with a single clinical event as indicated by a high rate of trial completion (92.8% in the Extavia group).
It- terapija b’ Extavia kienet aċċettata sew fl- istudju b’ pazjenti b’ okkorenza klinika waħdanija kif indikat b’ rata għolja tat- tlestija (92. 8% tal- grupp ta ’ Extavia).
To increase tolerability of Extavia in the study of patients with a first clinical event, a dose titration was applied and non- steroidal anti-inflammatory medicinal products were administered at start of therapy.
Sabiex tiżdied it- tollerabilità ta ’ Extavia fl- istudju ta ’ pazjenti fl- ewwel okkorenza klinika, ġiet applikata tittrazzjoni tad- doża u prodotti mediċinali mhux sterojdi ta ’ kontra l- infjammazzjoni ġew mogħtija fil- bidu tat- trattament.
Moreover, an autoinjector was used by the majority of patients throughout the study.
Barraminhekk, intuża awto- injettur fil- maġġoranza ta ’ pazjenti matul l- istudju kollu.
RR-MS, SP-MS and single clinical event suggestive of MS Extavia was effective in all multiple sclerosis studies to reduce disease activity (acute inflammation in the central nervous system and permanent tissue alterations) as measured by magnetic resonance imaging (MRI).
RR- MS, SP- MS u każ kliniku wieħed li jissuġġerixxi MS Extavia kien effettiv biex inaqqas l- attività tal- marda f’ kull studju li sar fuq sklerożi multipla (infjammazzjoni akuta tas- sistema nervuża ċentrali u tibdil permanenti fit- tessuti) kif imkejjel bl - immaġini ta ’ reżonanza manjetika (MRI).
The relation of multiple sclerosis disease activity as measured by MRI and clinical outcome is currently not fully understood.
Għadha mhiex mifhuma sew ir- relazzjoni ta ’ l- attività tal - marda ta ’ l- isklerożi multipla kif imkejla bl- MRI, ma ’ kif tidħer klinikament.
13 5.2 Pharmacokinetic properties
14 5. 2 Tagħrif farmakokinetiku
Extavia serum levels were followed in patients and volunteers by means of a not completely specific bioassay.
Il- livelli ta ’ Extavia fis- serum ġew studjati f’ pazjenti u voluntieri permezz ta ’ bioassay mhux kompletament speċifiku.
Maximum serum levels of about 40 IU/ ml were found 1-8 hours after subcutaneous injection of 500 microgram (16.0 million IU) interferon beta-1b.
L- ogħla livelli fis- serum ta ’ xi 40 IU/ ml instabu minn 1sa 8 sigħat wara injezzjoni taħt il- ġilda ta ’ 500 mikrogramm (16. 0 miljun IU) interferon beta- 1b.
From various studies mean clearance rates and half-lives of disposition phases from serum were estimated to be at most 30 ml·min-1·kg-1 and 5 hours, respectively.
Studji varji wrew li r - rata medja tal- clearance u l- half lives tal- fażijiet ta ’ dispożizzjoni fis- serum, kienu stmati li ma kienux aktar minn 30 ml· min- 1· kg- 1 u 5- sigħat, rispettivament.
Extavia injections given every other day do not lead to serum level increases, and the pharmacokinetics does not seem to change during therapy.
Injezzjoni ta ’ Extavia mogħtija ġurnata iva u oħra le ma twassalx għall- żidiet fil- livelli fis- serum, u l - farmakokinetika ma tidhirx li titbiddel waqt il- kura.
The absolute bioavailability of subcutaneously administered interferon beta-1b was approximately 50%.
Il- bijodisponibilità assoluta ta ’ interferon beta- 1b wara injezzjoni taħt il- ġilda kien bejn wieħed u ieħor ta ’ 50%.
5.3 Preclinical safety data
5. 3 Tagħrif qabel l- użu kliniku dwar is- sigurtà tal- mediċina
No acute toxicity studies have been carried out.
Ma sarux studji dwar it- tossiċità akuta.
As rodents do not react to human interferon beta, repeated dose studies were carried out with rhesus monkeys.
Peress li l- firien ma jagħmlux reazzjoni għal interferon beta ’ uman, saru studji ripetuti b’ dozi fuq xadini rhesus.
Transitory hyperthermia was observed, as well as a significant rise in lymphocytes and a significant decrease in thrombocytes and segmented neutrophils.
Ġiet osservata żieda transitorja fit- tempertura tal - ġisem, kif ukoll żieda sostanzjali fil- limfoċiti u nuqqas sinifikanti fit- tromboċiti u newtrofili segmentati.
No long-term studies have been conducted.
Ma sarux studji fuq tul ta ’ żmien.
Reproduction studies with rhesus monkeys revealed maternal toxicity and an increased rate of abortion, resulting in prenatal mortality.
Studji dwar ir- riproduzzjoni fuq ix- xadini rhesus urew tossiċità fl - omm u fil- fetu, li wasslet għall- mewt qabel it- twelid.
No malformations have been observed in the surviving animals.
Ma dehrux malformazzjonijiet fuq l- annimali li għexu.
No investigations on fertility have been conducted.
Ma sarux studji fuq il- fertilità.
No influence on the monkey oestrous cycle has been observed.
Ma kienx hemm effett fuq iċ- ċiklu tal- bajd tax- xadini.
Experience with other interferons suggest a potential for impairment of male and female fertility.
Esperjenza b’ interferoni oħrajn tagħti x’ tifhem li jista ’ jkun hemm il- possibiltà ta ’ indeboliment fil- fertilità maskili u femminili.
In one single genotoxicity study (Ames test), no mutagenic effect has been observed.
Fl- uniku studju ġenotossiku (test ta ’ Ames), l- ebda effett mutaġeniku ma deher.
Carcinogenicity studies have not been performed.
Studji karċinoġeniċi ma sarux.
An in vitro cell transformation test gave no indication of tumorigenic potential.
Test in vitro tat- trasformazzjoni taċ- ċelloli ma wriex potenzjal tumoriġeniku.
Powder Human albumin Mannitol (E421)
Trab Human albumin Mannitol (E421)
Solvent Sodium chloride Water for injections
Solvent Sodium chloride Ilma għall- injezzjonijiet
This medicinal product must not be mixed with other medicinal products except for the supplied solvent mentioned in section 6.6.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ sezzjoni 6. 6.
After reconstitution immediate use is recommended.
Wara li jiġi rikostitwit huwa rakkomandat l- użu immedjat.
However, in-use stability has been demonstrated for 3 hours at 2-8 °C.
Madankollu, intweriet stabbilità fl- użu ta ’ tlett sigħat f’ temperatura ta ’ 2- 8°C.
14 6.4 Special precautions for storage
15 6. 4 Prekawzjonijiet speċjali għall- ħażna
For storage conditions of the reconstituted product, see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikonstitwit, ara sezzjoni 6. 3.
Powder 3 ml vial (clear type I glass) with a butyl rubber stopper (type I) and aluminium overseal.
Trab Kunjett ta ’ 3 ml (ħġieġ ċar tat- tip I) b’ tapp tal - butyl rubber (tip I) u b’ siġill fuq kollox ta ’ l- aluminju.
Solvent 1.2 ml pre-filled syringe (type I glass) with 1.2 ml solvent.
Solvent Siringa mimlija minn qabel ta ’ 1. 2ml (ħġieġ tip I) b’ 1. 2ml ta ’ solvent.
Pack sizes
Daqsijiet tal- pakkett:
- Unit pack containing 5 vials with powder and 5 pre-filled syringes with solvent
- Pakkett wieħed li fih 5 kunjetti bit- trab u 5 siringi mimlija għal- lest bis- solvent, jew
- Unit pack containing 15 vials with powder and 15 pre-filled syringes with solvent
- Pakkett wieħed li fih 15- il kunjett bit- trab u 15- il siringa mimlija għal- lest bis- solvent
- 3-month multipack containing 45 (3x15) vials with powder and 45 (3x15) pre-filled syringes
- Pakkett b’ ħafna għal 3 xhur li fih 45 (3x15) kunjett bit- trab u 45 (3x15) siringa mimlija għal- lest
with solvent
bis- solvent
Reconstitution To reconstitute lyophilised interferon beta-1b for injection, the pre-filled syringe with solvent should be used with a needle or a vial adapter to inject the 1.2 ml of the solvent (sodium chloride 5.4 mg/ ml (0.54%) solution for injection) into the Extavia vial.
Rikostituzzjoni Sabiex tirrikostitwixxi interferon beta- 1b lijofiliżżat għall- injezzjoni, s- siringa bis- solvent għandha tintuża ma ’ labra jew adapter tal- kunjett biex tinjetta l- 1. 2 ml tas- solvent (sodium chloride, 5. 4mg/ ml (0. 54%) soluzzjoni għall- injezzjoni) fil- kunjett ta ’ Extavia.
The powder should dissolve completely without shaking.
It- trab għandu jinħall kompletament mingħajr ma ’ tħawwad.
After reconstitution, 1.0 ml of the solution should be drawn from the vial into the syringe for the administration of 250 micrograms Extavia.
Wara r- rikostituzzjoni, iġbed 1. 0ml tas- soluzzjoni għandhom jinġibdu mill - kunjett għal ġos- siringa għall- għoti ta ’ 250 mikrogramma ta ’ Extavia.
Inspection prior to use The reconstituted product should be inspected visually before use.
Spezzjoni qabel l- użu Il- prodott rikostitwit għandu jiġi mifli qabel l- użu.
The reconstituted product is colourless to light yellow and slightly opalescent to opalescent.
Il- prodott rikostitwit huwa bejn mingħajr kulur sa jkanġi fl- isfar ċar u daqsxejn opalexxenti għal opalexxenti.
The product should be discarded before use if it contains particulate matter or is discoloured.
Il- prodott għandu jintrema qabel l- użu jekk ikun fih xi frak jew jekk jibdel il- kulur.
Disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Rimi Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
17 A.
17 ANNESS II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Boehringer Ingelheim Austria Dr. -Boehringer-Gasse 5-11 A-1121 Vienna Austria
Boehringer Ingelheim Austria Dr. - Boehringer- Gasse 5- 11 A- 1121 Vjenna L- Awstrija
5650 Hollis Street Emeryville, CA 94608 USA
5650 Hollis Street Emeryville, CA 94608 L- Istati Uniti
The PSUR cycle of Extavia is aligned with the cross-referred product, Betaferon, until otherwise specified.
Iċ- ċiklu ta ’ PSUR ta ’ Extavia jaqbel ma ’ dak tal- prodott cross- referred, Betaferon, sakemm ma jiġix speċifikat mod ieħor.
Pharmacovigilance system:
Is- sistema ta ’ farmakoviġilanza:
The Marketing Authorisation Holder ensures that the system of pharmacovigilance, as described in version 3 dated 01 December 2008 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Id- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq jiżgura li s - sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 3 bid- data tal- 01 ta ’ Diċembru 2008 ippreżentata f’ Module 1. 8. 1 tal- Awtorizzazzjoni għat- tqegħid fis- Suq, qiegħda fis- seħħ u tiffunzjona qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan:
Pjan għall- Immaniġġar tar- Riskju:
The Marketing Authorisation Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq jintrabat li jagħmel l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali kif iddettaljat fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 1. 0 tal- Pjan għall- Immaniġġar tar- Riskju (RMP) ippreżentat f’ Module 1. 8. 2. tal- Awtorizzazzjoni għat- tqegħid fis- Suq u kwalunkwe aġġornamenti sussegwenti tal- RMP bi qbil mas- CHMP.
19 ANNEX III
19 Skont il- Linji Gwida tas- CHMP dwar is- Sistemi tal- Immaniġġar tar- Riskju għall- prodotti mediċinali għall- użu uman, kwalunkwe RMP aġġornat għandu jiġi sottomess fl- istess ħin mar- Rapport Perjodiku Aġġornat ta ’ Sigurtà (PSUR).
LABELLING AND PACKAGE LEAFLET
Flimkien ma dan, għandu jiġi sottomess RMP aġġornat • Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà, il - Pjan ta ’ Farmakoviġilanza jew l- attivitajiet tat- tnaqqis tar- riskju kurrenti • Fi żmien 60 ġurnata minn meta jintlaħaq pass importanti (ta ’ farmakoviġilanza jew tnaqqis tar - riskju) • Meta dan jiġi mitlub mill- EMEA
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
CARTON FOR UNIT PACK
KARTUNA TAL- PAKKETT B’ WIEĦED
Extavia 250 microgram/ ml powder and solvent for solution for injection Interferon beta-1b
Extavia 250 mikrogramm/ ml, Trab u solvent għas- soluzzjoni għall- injezzjoni Interferon beta- 1b
1 ml contains 250 microgram (8 million IU) interferon beta-1b when reconstituted.
1 ml fih 250 mikrogramma (8 miljun IU) interferon beta- 1b meta jiġi rikostitwit.
1 vial contains 300 microgram (9.6 million IU) interferon beta-1b.
Kunjett 1 fih 300 mikrogramma (9. 6 miljun IU) interferon beta- 1b.
Human albumin, mannitol.
Human albumin, mannitol.
Sodium chloride, water for injections.
Sodium chloride, ilma għall- injezzjonijiet.
15 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
5 kunjetti ta ’ trab u 5 siringi mimlija lesti b’ 1. 2 ml solvent 15 il- kunjett ta ’ trab u 15 il- siringa mimlija lesti b’ 1. 2 ml solvent
For subcutaneous use after reconstitution with 1.2 ml of solvent.
Użu għall- injezzjoni taħt il- ġilda wara r- rikostituzzjoni b’ 1. 2 ml ta ’ solvent.
Read the package leaflet before use.
Użu ta ’ darba Aqra l- fuljett ta ’ tagħrif qabel l- użu.
In-use stability demonstrated for 3 hours at 2-8°C.
Intweriet stabbilità fl- użu ta ’ tliet sigħat f’ temperatura ta ’ 2- 8°C.
5 vials with powder and 5 pre-filled syringes with solvent 15 vials with powder and 15 pre-filled syringes with solvent
5 kunjetti bi trab u 5 siringi mimlijin għal- lest b’ solvent 15 il- kunjett bi trab u 15 il- siringa mimlijin għal- lest b’ solvent
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
KARTUNA TA ’ BARRA TAL- PAKKETT B’ ĦAFNA (INKLUŻ IL- KAXXA ĊELESTI)
45 vials with powder and 45 pre-filled syringes with 1.2 ml solvent.
45 kunjett bit- trab u 45 siringa mimlija għal- lest b’ 1. 2 ml ta ’ solvent.
3-month multipack comprising 3 cartons, each containing 15 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
Pakkett b’ ħafna għal 3 xhur li jinkludi fih 3 pakketti tal- kartun, li kull wieħed fih 15 il- kunjett bit- trab u 15 il- siringa mimlija għal- lest b’ 1. 2 ml ta ’ solvent.
3-month multipack comprising 45 vials with powder and 45 pre-filled syringes with solvent
Pakkett b’ ħafna għal 3 xhur li jinkludi fih 45 kunjett bit- trab u 45 siringa mimlija għal- lest bis- solvent
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
26 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
KARTUNA INTERMEDJA TAL- PAKKETT B’ ĦAFNA (MINGĦAJR IL- KAXXA ĊELESTI
15 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
15- il kunjett bit- trab u 15- il siringa mimlija għal- lest b’ 1. 2 ml ta ’ solvent.
Component of a 3-month multipack comprising 3 cartons, each containing 15 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
Parti minn pakkett b’ ħafna għal 3 xhur li jinkludi fih 3 pakketti tal- kartun, li kull wieħed fih 15 il - kunjett bit- trab u 15- il siringa mimlija għal- lest b’ 1. 2 ml ta ’ solvent.
BLISTER OF PRE-FILLED SYRINGE
FOLJA TAS- SIRINGA MIMLIJA LESTA
Solvent for reconstitution of Extavia 1.2 ml sodium chloride solution 5.4 mg/ ml
Solvent għar- rikostituzzjoni ta ’ Extavia 1. 2 ml ta ’ soluzzjoni ta ’ sodium chloride 5. 4 mg/ ml
28 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
29 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
LABEL OF PRE-FILLED SYRINGE
TIKKETTA TAS- SIRINGA MIMLIJA LESTA
Solvent for reconstitution of Extavia 1.2 ml sodium chloride solution 5.4 mg/ ml
Solvent għar- rikostituzzjoni ta ’ Extavia 1. 2 ml soluzzjoni ta ’ sodium chloride 5. 4 mg/ ml
0.25 / 0.5 / 0.75 / 1.0 / 1.2
0. 25 / 0. 5 / 0. 75 / 1. 0 / 1. 2
29 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Extavia 250 microgram/ ml powder for solution for injection Interferon beta-1b Subcutaneous use
Extavia 250 mikrogramm/ ml, Trab li jinħall f' likwidu għall- injezzjoni Interferon beta- 1b Użu għal taħt il- ġilda
After reconstitution immediate use recommended.
Wara r- rikostituzzjoni, l- użu immedjat huwa rakkomandat.
In-use stability demonstrated for 3 hours at 2-8°C.
Stabbilità fl- użu ntweriet għal sa tliet sigħat f’ temperatura ta ’ 2- 8°C.
250 mcg (8 million IU) per ml after reconstitution.
250 mcg (8 miljun IU) kull ml wara r- rikostituzzjoni
31 PACKAGE LEAFLET:
31 B.
Extavia 250 microgram/ ml powder and solvent for solution for injection Interferon beta-1b Read all of this leaflet carefully before you start using this medicine.
Extavia 250 mikrogramma/ ml, trab u solvent għas- soluzzjoni għall- injezzjoni Interferon beta- 1b
You may need to read it again.
Jista ’ jkollok bżonn terġa ’ taqraħ.
- This medicine has been prescribed for you.
- Din il- mediċina ġiet mogħtija għalik.
if their symptoms are the same as yours.
tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħall- tiegħek.
What Extavia is and what it is used for 2.
X’ inhu Extavia u għalxiex jintuża 2.
Before you use Extavia 3.
Qabel ma tuża Extavia 3.
How to use Extavia 4.
Kif għandek tuża Extavia 4.
How to store Extavia 6.
Kif taħżen Extavia 6.
Further information Annex – self-injection procedure
Aktar tagħrif Anness – proċedura ta ’ injezzjoni personali
WHAT EXTAVIA IS AND WHAT IT IS USED FOR
X’ INHU EXTAVIA U GĦALXIEX JINTUŻA
What Extavia is Extavia is a type of medicine known as interferon used to treat multiple sclerosis.
X’ inhu Extavia Extavia huwa tip ta ’ mediċina magħrufa bħala interferon użata għat- trattament ta ’ l- isklerożi multipla.
Interferons are proteins produced by the body that help it fight against attacks on the immune system such as viral infections.
L- interferoni huma proteini prodotti mill- ġisem li jgħinu fil- ġlieda kontra l- attakki fuq is- sistema immuni bħal infezzjonijiet virali.
How Extavia works Multiple sclerosis (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord.
Kif jaħdem Extavia L- isklerożi multipla (MS) hija kundizzjoni fit- tul li taffettwa s- sistema nervuża ċentrali (CNS), b’ mod partikolari l- funzjoni tal- moħħ u ta ’ l- ispina.