FrancophonIA/ELRC3.0 huggingface dataset:
English: Redness, swelling, discolouration, inflammation, pain, hypersensitivity, necrosis and non-specific reactions were significantly associated with 250 microgram (8.0 million IU) Extavia treatment.
Maltese: Ħmura, tinfiħ, skolorazzjoni, infjammazzjoni, uġigħ, sensittività eċċessiva, nekrosi u reazzjonijiet mhux speċifiċi kienu sinifikament assoċjati ma' 250 mikrogramm (8.0 miljun IU) trattament ta' Extavia.
English: EU/1/08/454/008-014
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/454/008-014
English: The risk for progression to CDMS within two years 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%.
Maltese: Ir-riskju ta' firxa għal CDMS fi żmien sentejn 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%.
English: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon beta products.
Maltese: Kienu rrappurtati każijiet ta' sindrome nefrotiku b'elementi nefropatiċi differenti inkluż kollass talglomerulosklerożi segmentali fokali (FSGS), tibdil minimu tal-marda (MCD), glomerulonefriti membranoproliferattiva (MGPN) u glomerulopatija membranoża (MGN) matul it-trattament bi prodotti interferon beta.
English: The following adverse event listings are based on reports from clinical trials (Table 1, adverse events and laboratory abnormalities) and from post-marketing surveillance (Table 2, frequencies - where known - based on pooled clinical trials (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.
Maltese: Il-listi ta' effetti oħra li ġejjin huma bażati fuq rapporti miġbura minn provi kliniċi (Tabella 1, effetti avversi u anormalitajiet tal-laboratorju) u minn sorveljanza ta' wara it-tqegħid għall-kummerċ (Tabella 2, frekwenzi - fejn magħrufin - ibbażati fuq ġabra ta' provi kliniċi (komuni ħafna 1/10, komuni 1/100 sa <1/10, mhux komuni 1/1000 sa <1/100, rari 1/10,000 sa <1/1000, rari ħafna <1/10,000)) tal-użu ta' Extavia.
English: In-use stability demonstrated for 3 hours at 2°C - 8°C.
Maltese: Intweriet stabbilità fl-użu ta' tliet sigħat f'temperatura ta' 2°C - 8°C.
English: Extavia 250 microgram (Placebo) n=124 (n=123)
Maltese: Extavia 250 mikrogramm (Plaċebo) n=124 (n=123)
English: Hepatic injury (including hepatitis), Hepatic failure*
Maltese: Ħsara fil-fwied (inkluż epatite), Indeboliment epatiku*
English: Extavia may cause serious side effects.
Maltese: Extavia jista' jikkawża effetti sekondarji serji.
English: 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).
Maltese: Extavia dewwem iż-żmien għal CDMS bi 363 jum, minn 255 jum fil-grupp ta' plaċebo għal 618-il jum filgrupp ta' Extavia (msejjes fuq il-25 perċentili).
English: 2.25 ml graduated (with dose marks of: 0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml) pre-filled syringe (type I glass) with 1.2 ml solvent.
Maltese: Siringa mimlija bil-mod il-mod (b'marki tad-doża ta': 0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml) minn qabel ta' 2.25ml (ħġieġ tip I) b'1.2ml ta' solvent.
English: Interferon beta-1b has been given to adult cancer patients at individual doses as high as 5,500 microgram (176 million IU) intravenously three times a week without serious adverse events compromising vital functions.
Maltese: L-interferon beta-1b ingħata lill-pazjenti adulti bil-kanċer f'dożi individwali għolja sa 5,500 mikrogramma (176 miljun IU) mogħtija ġol-vina, tliet darbiet fil-ġimgħa mingħajr effetti avversi serji li jikkompromettu l-organi vitali.
English: Relapsing-remitting multiple sclerosis (RR-MS)
Maltese: Sklerożi multipla li tirkadi-tbatti (RR-MS)
English: In two years, the risk was 85% in the placebo group and 69% in the Extavia group (Hazard Ratio = 0.57, 95% confidence interval (0.46, 0.71), p<0.00001).
Maltese: F'sentejn, ir-riskju kien ta' 85% fil-grupp tal-plaċebo u 69% fil-grupp ta' Extavia (Proporzjon ta' Periklu = 0.57, 95% intervall ta' kunfidenza (0.46, 0.71), p<0.0001).
English: • 1 pre-filled syringe of solvent for Extavia (sodium chloride solution)
Maltese: • 1 siringa mimlija għal-lest għal Extavia (soluzzjoni ta' sodium chloride)
English: Adverse Event and Laboratory Abnormalities
Maltese: Effett Avvers u Abnormalitajiet filLaboratorju
English: Extavia 250 microgram (Placebo) n=317 (n=308)
Maltese: Extavia 250 mikrogramm (Plaċebo) n=317 (n=308)
English: 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.
Maltese: 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.
English: - If you have monoclonal gammopathy.
Maltese: Jekk għandek gammopatija monoklonali.
English: Solvent for reconstitution of Extavia 1.2 ml sodium chloride solution 5.4 mg/ml
Maltese: Solvent għar-rikostituzzjoni ta' Extavia 1.2 ml ta' soluzzjoni ta' sodium chloride 5.4 mg/ml
English: Solvent - clear/colourless solution.
Maltese: Solvent - soluzzjoni ċara/bla kulur.
English: Metabolism and nutrition disorders Blood glucose decreased (<55 mg/dl)
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Glukożju fid-demm mnaqqas < 55 mg/dl
English: In both trials there was a reduction (30%) in frequency of clinical relapses in patients with secondary progressive multiple sclerosis patients receiving Extavia.
Maltese: Fiż-żewġ studji kliniċi kien hemm tnaqqis (30%) fil-frekwenza ta' rkaduti kliniċi f'pazjenti bi sklerożi multipla progressiva sekondarja li ħadu Extavia.
English: Further subgroup analyses indicated a high risk for progression to CDMS within 2 years in monofocal patients with at least 9 T2lesions (55% risk for placebo, 26% for Extavia) or Gd-enhancement (63% versus 33%).
Maltese: Aktar analiżi tassottogrupp 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%).
English: Contents of the pack and other information Annex - self-injection procedure
Maltese: Kontenut tal-pakkett u informazzjoni oħra Anness - proċedura ta' injezzjoni personali
English: 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).
Maltese: Fil-fażi kontrollata bil-plaċebo, Extavia dewwem il-firxa mill-ewwel okkorenza klinika għal sklerożi multipla klinikament definita (CDMS) b'mod statistikament sinifikattiv u ta' tifsira klinika, li jikkorrispondi għal tnaqqis fir-riskju ta' 47% (Proporzjon ta' Periklu = 0.53, 0.95% intervall ta' kunfidenza (0.39. 0.73), p<0.0001).
English: • Patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Maltese: • Pazjenti bi sklerożi multipla progressiva sekondarja bil-marda attiva, evidenzjata mill-irkadar.
English: 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.
Maltese: Fil-provi kliniċi kontrollati b'mod differenti, bejn 23% u 41% tal-pazjenti żviluppaw attività newtralizzanti għal interferon beta 1-b fis-serum li ġiet ikkonfermata b'żewġ titres konsekuttivi pożittivi.
English: Aspartate aminotransferase increased (SGOT >5 times baseline)
Maltese: Aspartate aminotransferase miżjud (SGOT >5 darbiet il-linja bażi ta' referenza)   * °
English: Experience with exposure during the second and third trimesters is very limited.
Maltese: L-esperjenza waqt lespożizzjoni matul it-tieni u t-tielet trimestri hi limitata ħafna.
English: 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).
Maltese: Fi ħdan il-perijodu ta' studju ta' sentejn CDMS seħħ f'45% talgrupp ta' plaċebo, meta mqabbel mat-28% tal-grupp ta' Extavia (stimi ta' Kaplan-Meier).
English: Malaise *
Maltese: Dispnea *
English: 3 ml vial (clear type I glass) with a butyl rubber stopper (type I) and aluminium overseal containing 300 microgram (9.6 million IU) of (recombinant interferon beta-1b) powder.
Maltese: Kunjett ta' 3 ml (ħġieġ ċar tat-tip I) b'tapp tal- butyl rubber (tip I) u b'siġill fuq kollox ta' l-aluminju li fih 300 mikrogramma (9.6 miljun IU) ta' trab (interferon beta-1b rikombinant).
English: No separate investigations were performed regarding the influence of Extavia on the cardiovascular system, respiratory system and the function of endocrine organs.
Maltese: Ma sarux studji separati dwar l-effett ta' Extavia fuq is-sistema kardjuvaskulari, is-sistema respiratorja u fuq il-funzjoni tal-organi endokrinali.
English: • Alcohol swabs
Maltese: • Garżi bl-alkoħol
English: - 3-month multipack containing 42 (3x14) vials with powder and 42 (3x14) pre-filled syringes with solvent - 3-month multipack containing 45 (3x15) vials with powder and 45 (3x15) pre-filled syringes with solvent - 3-month multipack containing 42 (3x14) vials with powder and 45 (3x15) pre-filled syringes with solvent
Maltese: - Pakkett b'ħafna għal 3 xhur li fih 42 (3x14) kunjett bit-trab u 42 (3x14) siringa mimlija għal-lest bis-solvent - Pakkett b'ħafna għal 3 xhur li fih 45 (3x15) kunjett bit-trab u 45 (3x15) siringa mimlija għal-lest bis-solvent - Pakkett b'ħafna għal 3 xhur li fih 42 (3x14) kunjett bit-trab u 45 (3x15) siringa mimlija għal-lest bis-solvent
English: Single clinical event indicating a high risk of developing multiple sclerosis: Extavia has been shown to delay progression to definite multiple sclerosis.
Maltese: Avveniment kliniku wieħed li jindika riskju għoli li tiżviluppa sklerożi multipla: intwera li Extavia idewwem il-progressjoni għal sklerożi multipla definittiva.
English: EU/1/08/454/009 3-month multipack comprising 45 vials with powder and 45 pre-filled syringes with solvent EU/1/08/454/012 3-month multipack comprising 42 vials with powder and 42 pre-filled syringes with solvent EU/1/08/454/014 3-month multipack comprising 42 vials with powder and 45 pre-filled syringes with solvent
Maltese: EU/1/08/454/009 Pakkett b'ħafna għal 3 xhur li jinkludi fih 45 kunjett bit-trab u 45 siringa mimlija għal-lest bis-solvent EU/1/08/454/012 Pakkett b'ħafna għal 3 xhur li jinkludi fih 42 kunjett bit-trab u 42 siringa mimlija għal-lest bis-solvent EU/1/08/454/014 Pakkett b'ħafna għal 3 xhur li jinkludi fih 42 kunjett bit-trab u 45 siringa mimlija għal-lest bis-solvent
English: Suicide attempt (see also section 4.4), Emotional lability
Maltese: Attentat ta' suwiċidju (ara wkoll sezzjoni 4.4), Instabbiltà emozzjonali
English: 250 microgram (8.0 million IU) per ml after reconstitution.
Maltese: 250 mikrogramma (8.0 miljun IU) kull ml wara r-rikostituzzjoni.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull ml, jiġifieri essenzjalment “ħieles mis-sodium”.
English: Extavia 250 microgram (Placebo) n=360 (n=358)
Maltese: Extavia mikrogramm (Plaċebo) n=360 (n=358)
English: An in vitro cell transformation test gave no indication of tumorigenic potential.
Maltese: Test in vitro tat-trasformazzjoni taċ-ċelloli ma wriex potenzjal tumoriġeniku.
English: Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).
Maltese: Pazjenti b'mard tal-fwied dekompensat (ara sezzjonijiet 4.4, 4.5 u 4.8).
English: Bronchospasm* Pulmonary arterial hypertension**
Maltese: Ipertensjoni arterjali talpulmun**
English: ► Rare (may affect up to 1 in 1,000 people):
Maltese: ► Rari (jista' jaffettwa sa persuna 1 minn 1,000):
English: Interferon beta-1b both decreases the binding affinity and enhances the internalisation and degradation of the interferon-gamma receptor.
Maltese: Interferon beta-1b inaqqas l-affinità ta' rabta u jżid l-internament u d-degradazzjoni tar-riċevitur gamma ta' l-interferon.
English: Experience with other interferons suggest a potential for impairment of male and female fertility.
Maltese: Esperjenza b'interferoni oħrajn tagħti x'tifhem li jista' jkun hemm il-possibiltà ta' indeboliment fil-fertilità maskili u femminili.
English: Secondary Progressive Multiple Sclerosis (North American Study)
Maltese: Sklerożi Multipla Progressiva Sekondarja (Studju fl'Amerka ta' Fuq)
English: Therefore, the tip cap may contain natural rubber latex.
Maltese: Għaldaqstant, it-tapp jista' jkollu lastiku naturali latex.
English: - infection, abscess - reduced number of white blood cells, swollen lymph glands (lymphadenopathy) - decrease in the amount of sugar in the blood (hypoglycaemia) - depression, anxiety - headache, dizziness, sleeplessness, migraine, numbness or tingling feeling (paraesthesia) - eye inflammation (conjunctivitis), abnormal vision - ear pain - irregular, rapid beating or pulsation of the heart (palpitation) - redness and/or facial flushing due to widening of blood vessels(vasodilation), increased blood pressure (hypertension) - runny nose, cough, hoarseness due to infection of the upper respiratory tract, sinusitis, cough increased, shortness of breath (dyspnoea) - diarrhoea, constipation, nausea, vomiting, abdominal pain - rises in the blood levels of liver enzymes (will show up in blood tests) - skin disorder, rash - muscle stiffness (hypertonia), painful muscles (myalgia), muscular debility (myasthenia), back pain, pain in extremities such as fingers and toes - holding urine (urinary retention), protein in the urine (will show up in urine tests), urinary frequency, inability to hold back urination (urinary incontinence), urinary urgency
Maltese: - ebusija tal-muskoli (ipertonija), uġigħ fil-muskoli (mijalġija), indeboliment fil-muskoli (mijastenija), uġigħ fid-dahar, uġigħ fl-estremitajiet bħal fis-swaba' kemm ta' l-id kif ukoll tassaqajn - żamma ta' l-awrina, proteini fl-awrina (joħorġu fit-testijiet ta' l-awrina), tgħaddi l-awrina ta' spiss, nuqqas ta' kapaċità li żżomm l-awrina (inkontinenza), tgħaddi l-awrina b'urġenza - ugigħ waqt il-menstrwazzjoni (dismenorrea), disturbi menstrwali, tnixxija qawwija ta' demm mill-utru (metrorraġija) speċjalment bejn menstrwazzjoni u oħra, impotenza - reazzjoni fis-sit ta' l-injezzjoni (li tinkludi ħmura, nefħa, bdil fil-kulur, infjammazzjoni, uġigħ, reazzjoni allerġika, ara sezzjoni 2 “Twissijiet u prekawzjonijiet”), problemi fil-ġilda u therrija u ħsara tat-tessuti (nekrożi) fis-sit ta' l-injezzjoni (ara sezzjoni 2 “Twissijiet u prekawzjonijiet”) - sintomi bħal ta' l-influwenza, deni, uġigħ, uġigħ fis-sider, akkumulazzjoni ta' fluwidu fiddirgħajn, riġlejn jew il-wiċċ (edima periferali), nuqqas/telf ta' saħħa (astenija), sirdat, għaraq, ma tħossokx tajjeb b'mod ġenerali.
English: Table 2 Adverse drug reactions (ADRs) identified during post-marketing surveillance (frequencies - where known - calculated based on pooled clinical trial data N = 1,093)
Maltese: Tabella 2 Reazzjonijiet Avversi tal-Mediċina (ADRs) identifikati matul il-perjodu ta' sorveljanza wara t-tqegħid tal-prodott fis-suq (frekwenzi - meta magħrufaikkalkulati skont tagħrif miksub minn ġabra ta' provi kliniċi N = 1,093)
English: - Extavia contains human albumin and therefore carries a potential risk for transmission of viral diseases.
Maltese: - Extavia fih l-albumina umana u għalhekk għandu riskju potenzjali għat-trasmissjoni ta' mard virali.
English: Other things to consider when using Extavia:
Maltese: Affarijiet oħra li għandek tqis meta tuża Extavia:
English: 1 vial contains 300 microgram (9.6 million IU) interferon beta-1b.
Maltese: Kull kunjett fih 300 mikrogramma (9.6 miljun IU) interferon beta-1b.
English: Between 43% and 55% of these patients converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the trial concerned.
Maltese: Bejn 43% u 55% fost dawn il-pazjenti kkonvertaw għal stat ta' antikorp stabbli negattiv (skond żewġ titres konsekuttivi negattivi) matul il-perijodu ta' osservazzjoni sussegwenti tal-prova kkonċernata.
English: Reproductive system and breast disorders
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Dismenorrea
English: In MS, inflammation destroys the protective sheath (called myelin) around the nerves of the CNS and stops the nerves from working properly.
Maltese: F'MS, l-infjammazzjoni teqred is-saff protettiv (imsejjaħ myelin) madwar in-nervituri tas-CNS u twaqqaf lin-nervituri milli jibqgħu jaħdmu tajjeb.
English: Sodium chloride Water for injection
Maltese: Sodium chloride, ilma għall-injezzjoni.
English: Hepatobiliary disorders Alanine aminotransferase increased (SGPT >5 times baseline)
Maltese: Disturbi fil-fwied u fil-marrara Alanine aminotransferase miżjud (SGPT >5 darbiet il-linja bażi ta' referenza)
English: Interferon beta-1b also enhances the suppressor activity of peripheral blood mononuclear cells.
Maltese: L-interferon beta-1b iżid ukoll it- trażżin taċ-ċelloli mononuklejari periferali fid-demm.
English: The effect of alternate-day administration of 250 microgram (8.0 million IU) Extavia on drug metabolism in multiple sclerosis patients is unknown.
Maltese: L-effett ta' għotja ta' 250 mikrogramma (8.0 miljun IU) Extavia ġurnata iva u oħra le fuq ilmetaboliżmu ta' prodotti mediċinali f'pazjenti bi sklerożi multipla mhux magħruf.
English: Extavia 250 microgram/ml powder and solvent for solution for injection.
Maltese: Extavia 250 mikrogramma/ml, trab u solvent għas-soluzzjoni għall-injezzjoni.
English: Secondary progressive multiple sclerosis (SP-MS) Two controlled clinical trials were performed 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).
Maltese: 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).
English: Extavia 250 microgram (Placebo) n=292 (n=176)
Maltese: Extavia mikrogramm (Plaċebo) n=292 9n=176_
English: Extavia 250 microgram/ml powder and solvent for solution for injection interferon beta-1b
Maltese: Extavia 250 mikrogramm/ml, trab u solvent għas-soluzzjoni għall-injezzjoni interferon beta-1b
English: AREA 4
Maltese: Dublin 4
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskelettriċi u tattessuti konnettivi
English: In retrospective meta-analyses including the data of both studies, a statistically significant overall treatment effect was found (p=0.0076; 8.0 million IU Extavia versus all placebo patients).
Maltese: F'meta-analiżi retrospettiva li tinkludi informazzjoni miż-żewġ studji, instab effett globali tal-kura statistikament sinifikanti (p=0.0076; 8.0
English: The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated by means of the currently available data, but the data suggest no increased risk so far.
Maltese: Ir-riskju ta' korrimenti spontanji f'nisa tqal esposti għal interferon beta ma jistax jitkejjel kif jixraq permezz tad-data disponibbli bħalissa, imma d-data ma tissuġġerix li hemm żieda fir-riskju s'issa.
English: Cases of thrombotic microangiopathy, manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta products.
Maltese: Kienu rrappurtati każijiet ta' mikroanġjopatija trombotika, li dehret bħala purpura tromboċitopenika trombotika (TTP) jew sindrome emolitika uraemika (HUS), li jinkludu każijiet fatali, bil-prodotti interferon beta.
English: It has been demonstrated in vitro that Extavia cross-reacts with natural interferon beta.
Maltese: Ġie muri li minn provi li saru in vitro wrew li Extavia jagħmel reazzjoni ma' l-interferon beta naturali.
English: Cessation of therapy with Extavia should be considered (see also sections 4.3 and 4.8).
Maltese: Il-waqfien ta' terapija b'Extavia għandu jiġi kkonsidrat (ara wkoll sezzjonijiet 4.3 u 4.8).
English: Extavia can reduce the number and severity of the attacks, and slow the progression of disability.
Maltese: Extavia jista' inaqqas in-numru u s-severità ta' l-attakki, u jdewwem il-progress taddiżabilità.
English: If reactions are severe, Extavia should be discontinued and appropriate medical intervention instituted.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: The solvent for Extavia is provided in a 2.25 ml pre-filled syringe and contains 1.2 ml sodium chloride 5.4 mg/ml (0.54% w/v) solution for injection.
Maltese: Is-solvent għal Extavia hu pprovdut f'siringa mimlija lesta ta' 2.25 ml u fih 1.2 ml ta' sodium chloride 5.4 mg/ml (0.54% w/v) soluzzjoni għall-injezzjoni.
English: However, limited published data suggest that the safety profile in adolescents from 12 to 17 years of age receiving Extavia 8.0 million IU subcutaneously every other day is similar to that seen in adults.
Maltese: Madankollu, informazzjoni limitata li kienet ippubblikata tissuġġerixxi li l-profil tas-sigurtà fl-adolexxenti minn 12 sa 17-il sena li kienu qed jużaw Extavia 8.0 miljun IU taħt il-ġilda kull jumejn hu simili għal dak li ntwera fl-adulti.
English: Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Extavia (see section 4.2).
Maltese: Ġeneralment, tittrazzjoni tad-doża hija rakkomandata fil-bidu tat-trattament sabiex tkun tista' tiżdied it-tollerabilità ta' Extavia (ara sezzjoni 4.2).
English: 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).
Maltese: 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).
English: B) Getting ready to inject
Maltese: Preparazzjoni ta' l-injezzjoni
English: Hypersensitivity to natural or recombinant interferon beta, human albumin or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal interferon-beta naturali jew rikombinanti, l-albumina umana jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Extavia serum levels were followed in patients and volunteers by means of a bioassay that was not completely specific.
Maltese: Il-livelli ta' Extavia fis-serum ġew studjati f'pazjenti u voluntieri permezz ta' bioassay li ma kenitx kompletament speċifika.
English: ► Uncommon (may affect up to 1 in 100 people):
Maltese: ► Mhux komuni (jista' jaffettwa sa persuna 1 minn 100):
English: 17 - Leave the needle cap on. You are now ready to manually inject yourself or to use the ExtaviPro 30G auto-injector for the administration of Extavia.
Maltese: Issa inti lest/a biex tinjetta ssoluzzjoni b'idejk jew biex tuża l-auto-injector ExtaviPro 30G għall-amministrazzjoni ta' Extavia.