FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe liver problems can be associated with additional signs, e.g. difficulty concentrating, sleepiness and confusion.
Maltese: Problemi severi fil-fwied jistgħu jkunu assoċjati ma' sinjali addizzjonali, eż. diffikultà filkonċentrazzjoni, ħedla u konfużjoni.
English: Each syringe contains 44 micrograms, corresponding to 12 million International Units (IU) of interferon beta-1a.
Maltese: Kull pinna mimlija għal-lest fiha 44 mikrogramma li jikkorrispondu għal 12 miljun Unità Internazzjonali (IU) ta' interferon beta-1a.
English: Limited safety data suggest that the safety profile in children and adolescents (2 to 17 years old) receiving Rebif 22 micrograms or 44 micrograms three times weekly is similar to that seen in adults.
Maltese: Informazzjoni limitata dwar is-sigurtà tissuġġerixxi li l-profil tas-sigurtà fit-tfal u fl-adoloxxenti (sentejn sa 17-il sena) li kienu qed jirċievu Rebif 22 mikrogramma jew 44 mikrogramma tliet darbiet kull ġimgħa hu simili għal dak li ġie osservat fl-adulti.
English: INFORMATION IN BRAILLE rebif 44
Maltese: rebif 44
English: The proportion of patients with disability progression, as defined by at least one point increase in EDSS confirmed three months later, was reduced from 39% (placebo) to 30% (Rebif 22 micrograms).
Maltese: Il-proporzjon ta' pazjenti bi progressjoni ta' diżabilità, hekk kif definiti b'mill-anqas punt aktar żieda fl-EDSS konfermat tliet xhur wara, naqas minn 39% (placebo) sa 30% (Rebif 22 mikrogramma).
English: Tell your doctor as they may be signs of a possible kidney problem.
Maltese: Għid lit-tabib tiegħek għax dawn jistgħu jkunu sinjali ta' problema possibbli fil-kliewi.
English: Each cartridge contains 132 micrograms corresponding to 36 million International Units (IU) of interferon beta-1a.
Maltese: Kull skartoċċ fih 132 mikrogrammi li jikkorrispondu għal 36 miljun Unità Internazzjonali (IU) ta' interferon beta-1a.
English: Titration dose for Rebif 44 micrograms three times per week (tiw)
Maltese: Titrazzjoni tad-doża għal Rebif 44 mikrogramma tlett darbiet kull ġimgħa (tiw)
English: Each pre-filled syringe (0.5 mL) contains 44 micrograms (12 MIU*) of interferon beta-1a**.
Maltese: Kull siringa mimlija għal-lest (0.5 mL) fiha 44 mikrogrammi (12 MIU*) ta' interferon beta-1a**.
English: Cartridges (type 1 glass) with a plunger stopper (rubber) and crimp cap (aluminium and halobutyl rubber) containing 1.5 mL solution for injection.
Maltese: Skrataċ (ħġieġ ta' tip I), b'tapp bi planġer (lastku) u b'għatu li jissiġilla (aluminju u lastku halobutyl) li fihom soluzzjoni għall-injezzjoni ta' 1.5 mL.
English: EU/1/98/063/004 1 pre-filled syringe EU/1/98/063/005 3 pre-filled syringes EU/1/98/063/006 12 pre-filled syringes EU/1/98/063/021 36 pre-filled syringes
Maltese: EU/1/98/063/004 siringa waħda mimlija għal-lesta EU/1/98/063/005 3 siringi mimlija għal-lest EU/1/98/063/006 12-il siringa mimlija għal-lesti EU/1/98/063/021 36 siringa mimlija għal-lest
English: Rebif 22 micrograms solution for injection interferon beta-1a
Maltese: Rebif 22 mikrogrammi soluzzjoni għall-injezzjoni Interferon beta-1a
English: corresponding to 6 million International Units (IU) of interferon beta-1a.
Maltese: 6-il miljun Unità Internazzjonali (IU) ta' interferon beta-1a.
English: Asymptomatic transaminase increase
Maltese: Żieda asintomatika fit-transaminases
English: At licensed posology, Rebif 22 micrograms has been demonstrated to decrease the incidence (approximately 30% over 2 years) and severity of clinical relapses in patients with at least 2 exacerbations in the previous 2 years and with an EDSS of 0-5.0 at entry.
Maltese: F'posoloġija liċenzjata, Rebif 22 mikrogramma instab li jnaqqas l-inċidenza (bejn wieħed u ieħor bi 30% fi żmien sentejn) u s-severità ta' attakki ripetuti f'pazjenti bi tnejn jew iżjed exaserbazzjonijiet fis-sentejn ta' qabel u bi EDSS ta' 0-5.0 meta beda l-kura.
English: For storage of the device with the cartridge, see section 6.4.
Maltese: Għall-ħżin tal-apparat bl-iskartoċċ, ara sezzjoni 6.4.
English: During week one and two: 0.1 mL, which corresponds to the dose of 8.8 micrograms
Maltese: Matul l-ewwel u t-tieni ġimgħa: 0.1 mL, li jikkorrispondi għal doża ta' 8.8 mikrogrammi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 6 X 8.8 MICROGRAMS SYRINGES + 6 X 22 MICROGRAMS SYRINGES
Maltese: SIRINGI X 8.8 MIKROGRAMMI + 6 SIRINGI X 22 MIKROGRAMMI
English: 6 pre-filled syringes of Rebif 8.8 micrograms and 6 pre-filled syringes of Rebif 22 micrograms.
Maltese: 6 siringi mimlija għal-lest ta' Rebif 8.8 mikrogrammi u 6 siringi mimlija għal-lest ta' Rebif 22 mikrogrammi.
English: EU/1/98/063/001 1 pre-filled syringe EU/1/98/063/002 3 pre-filled syringes EU/1/98/063/003 12 pre-filled syringes EU/1/98/063/020 36 pre-filled syringes
Maltese: EU/1/98/063/001 siringa waħda mimlija għal-lest EU/1/98/063/002 3 siringi mimlija għal-lest EU/1/98/063/003 12-il siringa mimlija għal-lest EU/1/98/063/020 36 siringa mimlija għal-lest.
English: Pack size of 4 or 12 cartridges.
Maltese: Daqs tal-pakkett ta' 4 jew 12 il-skartoċċ.
English: Each pre-filled cartridge contains 66 micrograms (18 MIU*) of interferon beta-1a** in 1.5 mL solution, corresponding to 44 micrograms/mL.
Maltese: Kull skartoċċ mimli għal-lest fih 66 mikrogrammi (18-il MIU*) ta' interferon beta-1a** f'soluzzjoni ta' 1.5 mL, li jikkorrispondu għal 44 mikrogrammi/mL.
English: Dose The usual dose is 44 micrograms (12 million IU) given three times per week.
Maltese: Id-doża normali hi 44 mikrogrammi (12 miljun IU) mogħtija tlett darbiet fil-ġimgħa.
English: Rebif contains 0.5 mg benzyl alcohol per dose of 0.1 mL and 1.25 mg benzyl alcohol per dose of 0.25 mL.
Maltese: Dan il-prodott mediċinali fih 0.5 mg ta' benzyl alkohol f'kull doża ta' 0.1 mL u 1.25 mg ta' benzyl alkohol f'kull doża ta' 0.25 mL.
English: NAME OF THE MEDICINAL PRODUCT Rebif 44 micrograms/0.5 mL solution for injection in cartridge
Maltese: Rebif 44 mikrogrammi/0.5 mL soluzzjoni għall-injezzjoni fi skartoċċ
English: (UPPER FLAP)
Maltese: (KARTA TA' FUQ)
English: Rebif 8.8 micrograms/0.1 mL solution for injection in cartridge Rebif 22 micrograms/0.25 mL solution for injection in cartridge interferon beta-1a Initiation pack
Maltese: Rebif 8.8 mikrogrammi/0.1 mL soluzzjoni għall-injezzjoni fi skartoċċ Rebif 22 mikrogrammi/0.25 mL soluzzjoni għall-injezzjoni fi skartoċċ Interferon beta-1a Pakkett inizjali
English: Rebif is indicated for the treatment of
Maltese: Rebif jista' jintuża waqt it-treddigħ.
English: Rebif is available in packs of 1, 3, 12 and 36 pre-filled syringes.
Maltese: Rebif huwa disbonibbli f'pakketti ta' 1, 3, 12 u 36 siringa mimlija għal-lest.
English: Rebif 44 micrograms/0.5 mL solution for injection in cartridge interferon beta-1a
Maltese: Rebif 44 mikrogrammi/0.5 mL soluzzjoni għall-injezzjoni fi skartoċċ Interferon beta-1a
English: One 2-year controlled clinical trial with Rebif was performed in patients with a single clinical event suggestive of demyelination due to multiple sclerosis.
Maltese: Prova klinika kkontrollata waħda b'Rebif li damet sentejn twettqet f'pazjenti li kellhom avveniment kliniku wieħed li jissuġġerixxi demyelination minħabba sklerożi multipla.
English: • Visually check that there is no liquid left.
Maltese: • Ikkontrolla viżwalment li ma jkun għad baqa' ebda likwidu.
English: No information is available on the effects of the interferon beta-1a on male fertility.
Maltese: L-ebda informazzjoni ma tinstab fuq l-effetti ta' interferon beta-1a fuq il-fertilità maskili.
English: Relapsing multiple sclerosis
Maltese: Sklerożi multipla li tirkadi
English: The administration of interferons has been associated with anorexia, dizziness, anxiety, arrhythmias, vasodilation and palpitation, menorrhagia and metrorrhagia.
Maltese: It-teħid ta' interferons ġie assoċjat ma' anoressja, sturdament, anzjetà, arythmias, twessigħ ta' l-arterji u taħbit qawwi tal-qalb, menorraġja u metrorraġja.
English: The proportion of patients with disability progression, as defined by at least one point increase in EDSS confirmed three months later, was reduced from 39% (placebo) to 27% (Rebif 44 micrograms).
Maltese: Il-proporzjon ta' pazjenti bi progressjoni ta' diżabilità, hekk kif definiti b'mill-anqas punt aktar żieda fl-EDSS konfermat tliet xhur wara, naqas minn 39% (plaċebo) sa 27% (Rebif 44 mikrogramma).
English: Limited information available on the transfer of interferon beta-1a into breast milk, together with the chemical/physiological characteristics of interferon beta, suggests that levels of interferon beta-1a excreted in human milk are negligible.
Maltese: Informazzjoni limitata disponibbli dwar it-trasferiment ta' interferon beta-1a fil-ħalib tas-sider talbniedem, flimkien mal-karatteristiċi kimiċi/fiżjoloġiċi ta' interferon beta, tissuġġerixxi li l-livelli ta' interferon beta-1a li jiġu eliminati fil-ħalib tas-sider tal-bniedem huma negliġibbli.
English: If a patient responds poorly to therapy with Rebif, and has neutralising antibodies, the treating physician should reassess the benefit/risk ratio of continued Rebif therapy.
Maltese: Jekk pazjent jkollu rispons fqir għat-terapija b'Rebif, u għandu antikorpi newtralizzanti, it-tabib li jikkurah għandu jerġa' jeżamina mill-ġdid ir-rata benefiċċju/riskju tat-tkomplija tat-terapija b'Rebif.
English: Rebif contains 2.5 mg benzyl alcohol per dose.
Maltese: Rebif fih 2.5 mg ta' benzyl alkoħol f'kull doża.
English: Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity (see section 5.1).
Maltese: L-effikaċja ma dehritx fuq pazjenti bi sklerożi multipla sekondarja progressiva mingħajr każi ta' ripetizzjoni (ara sezzjoni 5.1).
English: If a second clinical demyelinating event occurred confirming definite multiple sclerosis, patients switched to the recommended posology of Rebif 44 micrograms three times per week in an open label manner, while maintaining blinding as to initial randomisation.
Maltese: Jekk ikun seħħ it-tieni avveniment kliniku demyelinating li jikkonferma sklerożi multipla definita, il-pazjenti nqelbu għall-pożoloġija rakkomandata ta' Rebif 44 mikrogramma tlett darbiet kull ġimgħa b'mod open label, filwaqt li żammew il-blinding għall-għażla każwali inizjali.
English: Each pre-filled syringe (0.5 mL) contains 22 micrograms (6 MIU*) of interferon beta-1a**.
Maltese: Kull siringa mimlija għal-lest (0.5 mL) fiha 22 mikrogrammi (6 MIU*) ta' interferon beta-1a**.
English: 12 pre-filled pens.
Maltese: Tagħmlux fil-friża.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each cartridge contains 66 micrograms (18 MIU) of interferon beta-1a in 1.5 mL solution.
Maltese: Kull skartoċċ fih 66 mikrogrammi (18 MIU) ta' interferon beta-1a f'soluzzjoni ta' 1.5 mL.
English: * Million International Units, measured by cytopathic effect (CPE) bioassay against the in-house interferon beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531).
Maltese: * Miljun Unità Internazzjonali, meqjus permezz ta' test tal-effett kitopatiku (EKP) mqabbel ma' listandard interferon beta-1a li jsir fil-fabbrika li jinstab wara li jitqabbel ma' l-istandard kurrenti internazzjonali
English: Each 8.8 micrograms pre-filled pen contains 8.8 micrograms of interferon beta-1a (2.4million IU).
Maltese: - Kull 8.8 mikrogrami pinna mimlija għal-lest fiha 8.8 mikrogrammi ta' interferon-beta-1a (2,4 milljuni IU).
English: Excipient with known effect: 2.5 mg benzyl alcohol For the full list of excipients, see section 6.1.
Maltese: 2.5 mg benzyl alkohol Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: The results of this study suggest that the safety profile in children (2 to 11 years old) and in adolescents (12 to 17 years old) receiving Rebif 22 micrograms or 44 micrograms subcutaneous three times per week is similar to that seen in adults.
Maltese: Ir-riżultati ta' dan l-istudju jissuġġerixxu li l-profil tas-sigurtà fit-tfal (sentejn sa 11-il sena) u fl-adoloxxenti (12 sa 17-il sena) li kienu qed jirċievu Rebif 22 mikrogramma jew 44 mikrogramma taħt il-ġilda tliet darbiet kull ġimgħa hu simili għal dak li ġie osservat fl-adulti.
English: This medicinal product contains 2.5 mg benzyl alcohol per dose of 0.5 mL.
Maltese: Dan il-prodott mediċinali fih 2.5 mg ta' benzyl alkohol f'kull doża ta' 0.5 mL.
English: Caution should be used, and close monitoring considered when administering interferon beta-1a to patients with severe renal and hepatic failure and to patients with severe myelosuppression.
Maltese: Il-maġġoranza ta' l-effetti mhux mixtieqa osservati b'interferon beta-1a huma ġeneralment ħfief u riversibbli, u jaqblu sew mar-riduzzjonijiet tad-dożi.
English: Severe renal or hepatic failure and severe myelosuppression
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: If you experience symptoms suggesting a liver disorder, such as loss of appetite accompanied by other symptoms such as nausea, vomiting, jaundice, please contact your doctor immediately (see above “Tell your doctor immediately...”).
Maltese: Jekk tesperjenza sintomi li jindikaw problemi fil-fwied akkompanjati minn sintomi oħra bħall nawsja, rimettar, suffejra, jekk jogħġbok ikkuntattja lit-tabib tiegħek immedjatament (ara “Għid lit-tabib tiegħek immedjatament...”).
English: An increased risk of abortions has been reported in animal studies of other alpha and beta interferons.
Maltese: Ġie rrappurtat riskju miżjud ta' korrimenti fi studji fuq l-annimali dwar interferons alfa u beta oħrajn.
English: • Check the expiry date on the RebiDose label or on the outer box (as indicated as “EXP”).
Maltese: • Ara d-data ta' skadenza fuq it-tikketta jew il-kaxxa ta' barra ta' RebiDose (indikata bħala “JIS”).
English: Tissue destruction (necrosis), abscess and mass at injection site are uncommon (may affect up to 1 in 100 people).
Maltese: Distruzzjoni tat-tessut (nekrożi), axxess u ċappa fis-sit ta ‘l-injezzjoni huma mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100).
English: Rebif contains 1.0 mg benzyl alcohol per dose of 0.2 mL and 2.5 mg benzyl alcohol per dose of 0.5 mL.
Maltese: Dan il-prodott mediċinali fih 1.0 mg ta' benzyl alkohol f'kull doża ta' 0.2 mL u 2.5 mg ta' benzyl alkohol f'kull doża ta' 0.5 mL.
English: • Fatigue, fever, chills
Maltese: • Dijareja, nawsja, rimettar
English: If tests are normal at baseline, routine testing is not needed but should be performed if clinical findings of thyroid dysfunction appear (see section 4.8).
Maltese: Jekk it-testijiet huma normali fil-bidu, testijiet ta' rutina mhumiex bżonnjużi iżda għandhom isiru jekk tidher disfunzjoni klinika tat-tirojde (ara sezzjoni 4.8).
English: Single clinical event suggestive of multiple sclerosis
Maltese: Avveniment kliniku wieħed li jissuġġerixxi sklerożi multipla
English: Excipient with known effect: 1.0 mg benzyl alcohol For the full list of excipients, see section 6.1.
Maltese: 1.0 mg benzyl alkohol Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: The patients enrolled into the trial had at least two clinically silent lesions on the T2-weighted MRI scan, with a size of at least 3 mm, at least one of which is ovoid or periventricular or infratentorial.
Maltese: Il-pazjenti rreġistrati filprova kellhom mill-inqas żewġ leżjonijiet klinikament silenzjużi fuq T2-weighted MRI scan, b'daqs ta' mill-inqas 3 mm, li mill-inqas waħda minnhom tkun ovojde jew periventrikulari jew infratentorjali.
English: Experience with exposure during the second and third trimester is very limited.
Maltese: Esperjenza b'esponiment matul it-tieni u t-tielet trimestru hija limitata ħafna.
English: A study on embryo/foetal toxicity in monkeys showed no evidence of reproductive disturbances.
Maltese: Studju ta' tossiċità fuq l-embriju/il-fetu fix-xadini ma weriex evidenza ta' probemi ta' riproduttività.
English: The patient may store Rebif at or below 25°C for a single period up to 14 days.
Maltese: Il-pazjent jista' jaħżen Rebif f'temperatura ta' 25°C jew inqas għal perjodu wieħed ta' mhux iktar minn 14-il jum.
English: Clinical data suggest that after 24 to 48 months of treatment with Rebif 22 micrograms, approximately 24% of patients develop persistent serum antibodies to interferon beta-1a.
Maltese: Informazzjoni klinika tissuġġerixxi li wara 24 sa 28 xhar ta' kura b'Rebif 22 mikrogramma, madwar 24% tal-pazjenti jiżviluppaw antikorpi persistenti fis serum għal interferon beta-1a.
English: KM Estimate
Maltese: KM
English: Each Rebif 22 micrograms pre-filled syringe (0.5 mL) contains 22 micrograms (6 Million IU) of interferon beta-1a.
Maltese: Kull siringa mimlija għal-lest (0.5 mL) fiha 22 mikrogrammi (6 MIU) ta' interferon beta-1a.
English: In particular you should tell your doctor if you are using antiepileptics or antidepressants.
Maltese: anti-epilettiċi u xi tipi ta' antidipressivi.
English: Each 22 micrograms pre-filled pen contains 22 micrograms of interferon beta-1a (6 million IU).
Maltese: - Kull 22 mikrogrammi pinna mimlija għal-lest fiha 22 mikrogrammi ta' interferon-beta-1a (6 milljuni IU).
English: Relapsing-remitting multiple sclerosis
Maltese: Forom oħra ta' sklerosi multipla
English: 6 pre-filled syringes of Rebif 8.8 micrograms (LOWER FLAP)
Maltese: (KARTA TA' FUQ) 6 siringi mimlija għal-lest ta' Rebif 8.8 mikrogrammi
English: If, immediately following Rebif administration you experience a sudden difficulty breathing, which may appear in association with swelling of face, lips, tongue or throat, nettle rash, itching all over the body, and a feeling of weakness or faintness, contact your doctor immediately or seek urgent medical attention.
Maltese: Jekk immedjatament wara li tingħata Rebif tħoss qtuh ta' nifs f'daqqa, li timmanifesta ruħha b'tinfiħ tal-wiċċ, xuftejn, ilsien jew griżmejn, urtikarja, ħakk f'kull parti tal-ġisem, u sensazzjoni ta' dgħjufija/debulizza jew ħass ħażin, ikkuntatja lit-tabib tiegħek minnufih jew fittex attenzjoni medika immedjatament.
English: Rebif 8.8 mcg/0.1 mL Rebif 22 mcg/0.25 mL Solution for injection interferon beta-1a SC use
Maltese: Rebif 8.8 mikrogrammi/0.1 mL soluzzjoni għall-injezzjoni fi skartoċċ Rebif 22 mikrogrammi/0.25 mL soluzzjoni għall-injezzjoni fi skartoċċ Interferon beta-1a
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each cartridge contains 132 micrograms (36 MIU) of interferon beta-1a in 1.5 mL solution.
Maltese: Kull skartoċċ fih 132 mikrogrammi (36 MIU) ta' interferon beta-1a f'soluzzjoni ta' 1.5 mL.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each pre-filled syringe (0.5 mL) contains 44 micrograms (12 MIU) of interferon beta-1a.
Maltese: Kull siringa mimlija għal-lest (0.5 mL) fiha 44 mikrogrammi (12 MIU) ta' interferon beta-1a.
English: Hepatic dysfunction
Maltese: Disturbi fis-sistema endokrinarja
English: SN
Maltese: UŻU
English: Solution for injection in pre-filled syringe.
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni.
English: One-month initiation pack contains six Rebif 8.8 micrograms pre-filled syringes and six Rebif 22 micrograms pre-filled syringes.
Maltese: Pakkett inizjali għal xahar fih 6 Rebif 8.8 mikrogrammi pinen mimlijin għal-lest u 6 Rebif 22 mikrogrammi pinen mimlijin għal-lest.
English: NAME OF THE MEDICINAL PRODUCT Rebif 22 micrograms/0.5 mL solution for injection in cartridge
Maltese: Rebif 22 mikrogrammi/0.5 mL soluzzjoni għall-injezzjoni fi skartoċċ
English: Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film.
Maltese: Riżultati tal-laboratorju li jissuġġerixxu TMA jinkludu tnaqqis fl-għadd tal-plejtlits, żieda fil-livell ta' serum lactate dehydrogenase (LDH) minhabba l-emolisi u xistoċiti (frammentazzjoni ta' eritroċiti) fuq film taddemm.
English: Rebif 22 micrograms/0.5 mL solution for injection in cartridge interferon beta-1a
Maltese: Rebif 22 mikrogrammi/0.5 mL soluzzjoni għall-injezzjoni fi skartoċċ Interferon beta-1a
English: Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Maltese: Huwa rrakkomandat monitoraġġ perjodiku ta' sinjali jew sintomi bikrin, eż. edema, proteinurija u indeboliment fil-funzjoni tal-kliewi, speċjalment f'pazjenti f'riskju ogħla ta' mard tal-kliewi.
English: • Hives
Maltese: • Sturdament
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/011 1 pre-filled pen EU/1/98/063/012 3 pre-filled pens EU/1/98/063/013 12 pre-filled pens
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/98/063/011 1 pinna mimlija għal-lest EU/1/98/063/012 3 pinen mimlijin għal-lest EU/1/98/063/013 12-il pinna mimlija għal-lest
English: Therefore, in addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, liver enzyme monitoring and complete and differential blood cell counts and platelet counts are recommended at regular intervals (1, 3 and 6 months) following introduction of Rebif therapy and then periodically thereafter in the absence of clinical symptoms.
Maltese: Għaldaqstant, flimkien ma' testijiet tal-laboratorju ġeneralment mitluba sabiex tinstab l-isklerożi multipla fuq il-pazjenti, u flimkien ma' testijiet ta' enżimi tal-fwied, l-għadd komplut u differenzjat ta' ċelluli tad-demm u lgħadd ta' platelets huma wkoll rakkomandati ta'spis (1,3 u 6 xur) wara l-introduzzjoni tal-kura ta' Rebif u imbagħad perjodikament jekk ma hemmx sintomi kliniċi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 3, 12 AND 36 SYRINGES
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA TA' 1, 3, 12 U 36 SIRINGA
English: NAME OF THE MEDICINAL PRODUCT Rebif 8.8 micrograms/0.1 mL solution for injection in cartridge Rebif 22 micrograms/0.25 mL solution for injection in cartridge
Maltese: Rebif 8.8 mikrogrammi/0.1 mL soluzzjoni għall-injezzjoni fi skartoċċ Rebif 22 mikrogrammi/0.25 mL soluzzjoni għall-injezzjoni fi skartoċċ
English: Dose
Maltese: Stima
English: Each syringe contains 22 micrograms, corresponding to 6 million International Units (IU) of interferon beta-1a.
Maltese: Kull pinna mimlija għal-lest fiha 22 mikrogrammi li jikkorrispondu għal 6-il miljun Unità Internazzjonali (IU) ta' interferon beta-1a.
English: B. Transparent window C. Plunger
Maltese: • B'tajjara jew garża
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 44 mcg solution for injection interferon beta-1a
Maltese: U MNEJN GĦANDU JINGĦATA Rebif 44 mcg soluzzjoni għall-injezzjoni Interferon beta-1a
English: If a bit of alcohol is left on the skin, you may get a stinging sensation.
Maltese: Jekk ikun baqa' xi ftit alkoħol fuq il-ġilda, tista' tħoss sensazzjoni ta' tingiż.
English: Each Rebif 22 micrograms pre-filled pen contains 22 micrograms (6 Million IU) of interferon beta-1a in 0.5 mL solution.
Maltese: Kull Rebif 22 mikrogrammi pinna mimlija għal-lest fiha 22 mikrogrammi (6 MIU) ta' interferon beta-1a f'soluzzjoni ta' 0.5 mL.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/014 1 pre-filled pen EU/1/98/063/015 3 pre-filled pens EU/1/98/063/016 12 pre-filled pens
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/98/063/014 1 pinna mimlija għal-lest EU/1/98/063/015 3 pinen mimlijin għal-lest EU/1/98/063/016 12-il pinna mimlija għal-lest
English: Patients with multiple sclerosis The usual dose is 44 micrograms (12 million IU) given three times per week.
Maltese: Pazjenti bi sklerożi multipla Id-doża normali hi 44 mikrogrammi (12 miljun IU) mogħtija tlett darbiet fil-ġimgħa.
English: This medicinal product contains 2.5 mg benzyl alcohol per dose.
Maltese: Dan il-prodott mediċinali fih 2.5 mg ta' benzyl alkohol f'kull doża.
English: • use an aseptic injection technique,
Maltese: • jużaw teknika ta' injezzjoni asettika
English: Rebif 44 micrograms solution for injection in pre-filled syringe interferon beta-1a
Maltese: U MNEJN GĦANDU JINGĦATA Rebif 44 mikrogrammi soluzzjoni għall-injezzjoni Interferon beta-1a
English: 6 pre-filled pens of 8.8 micrograms and 6 pre-filled pens of 22 micrograms.
Maltese: 6 pinen mimlijin għal-lest ta' 8.8 mikrogrammi u 6 pinen mimlijin għal-lest ta' 22 mikrogramma.