FrancophonIA/ELRC3.0 huggingface dataset:
English: c. Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern).
Maltese: It-titjib tad-dehra endoskopika tal-mukuża ġie definit bħala sottopunteġġ tal-endoskopija Mayo ta' 0 (marda normali jew mhux attiva) jew 1 (eritema, xejra vaskulari mnaqqsa).
English: In a human radiolabeled study, more than 65% of the total circulating radioactivity was accounted for by unchanged active substance, with the remaining 35% attributed to 8 metabolites, each accounting for less than 8% of total radioactivity.
Maltese: Fi studju radjutikkettat tal-bniedem, aktar minn 65% tar-radjuattività li tiċċirkola totali kienet irrappreżentata mis-sustanza attiva mhux mibdula, bil-35% li jifdal attribwiti għal 8 metaboliti, b'kull wieħed jirrappreżenta anqas minn 8% tar-radjuattività totali.
English: Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5).
Maltese: mhijiex xierqa (ara sezzjonijiet 4.4 u 4.5).
English: Table 7: Phase 3 Clinical Trials of Tofacitinib 5 and 10 mg Twice Daily Doses in Patients with RA
Maltese: Provi Kliniċi tal-Fażi 3 ta' Dożi ta' Tofacitinib 5 u 10 Darbtejn Kuljum f'Pazjenti b'RA
English: Least Squares Mean Change From Baseline in HAQ-DI Conventional Synthetic DMARD Inadequate Respondersa (TNFi-Naïve)
Maltese: Inti tista' tgħin billi tirrapporta kwalunkwe effett sekondarju li jista' jkollok.
English: • chest tightness
Maltese: • mejt jew sturdament severi
English: Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal hepatic function is 10 mg twice daily (see section 5.2).
Maltese: Id-doża għandha titnaqqas għal 5 mg darbtejn kuljum meta d-doża indikata fil-preżenza ta' funzjoni tal-kliewi normali tkun 10 mg darbtejn kuljum (ara sezzjoni 5.2).
English: There is a higher rate of shingles in Japanese and Korean patients.
Maltese: Hemm rata ogħla ta' ħruq ta' Sant'Antnin f'pazjenti Ġappuniżi u Koreani.
English: Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in both scales compared to placebo in ORAL Sync, ORAL Standard and ORAL Scan.
Maltese: Il-pazjenti li jirċievu tofacitinib ta' 5 jew 10 mg darbtejn kuljum urew titjib ferm akbar mil-linja bażi fiż-żewġ skali meta mqabbla mal-plaċebo f'ORAL Sync, ORAL Standard u ORAL Scan.
English: • The centralised website shall contain: o The educational material in digital format o The patient alert card in digital format
Maltese: • Is-sit elettroniku ċentralizzat għandu jkun fih: o Il-materjal edukattiv f'format diġitali o Il-kard ta' twissija tal-pazjent f'format diġitali
English: ACR20 Month 3 Month 6
Maltese: Xahar 3 Xahar 6
English: Month 3 ORAL Sync: DMARD Inadequate Responders Tofacitinib 5 mg twice daily
Maltese: ORAL Sync: Persuni li Ma Rrispondewx b'Mod Adegwat għal DMARD
English: Time to onset was rapid (as early as week 2 in studies ORAL Solo, ORAL Sync, and ORAL Step) and the magnitude of response continued to improve with duration of treatment.
Maltese: ORAL Solo, ORAL Sync, ORAL Standard, u ORAL Step) u f'xahar 6 (studji ORAL Sync u ORAL Standard).
English: Drug-drug interactions
Maltese: L-attività farmakoloġika ta'
English: Lymphocytes
Maltese: Tofacitinib
English: Tofacitinib 10 mg Twice Daily + MTX
Maltese: Tofacitinib 10 mg darbtejn kuljum + MTX
English: Tofacitinib 10 mg twice daily + MTX
Maltese: Tofacitinib 10 mg Darbtejn Kuljum + MTX
English: In the maintenance study (OCTAVE Sustain), tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily demonstrated greater maintenance of improvement compared to placebo in the total and all 4 domain scores of the IBDQ at week 24 and week 52.
Maltese: Fl-istudju ta' manteniment (OCTAVE Sostenn), tofacitinib 5 mg darbtejn kuljum jew tofacitinib 10 mg darbtejn kuljum wera manteniment ikbar ta' titjib meta
English: There was a higher incidence of adverse events for the combination of tofacitinib with MTX versus tofacitinib as monotherapy in RA clinical studies.
Maltese: (AST) elevat, b'mod partikulari meta jinbeda f'kombinazzjoni ma' prodotti mediċinali potenzjalment epatotossiċi bħal MTX.
English: NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg tablets tofacitinib
Maltese: XELJANZ 5 mg pilloli miksija b'rita tofacitinib
English: The treatment effect was similar in patients independent of rheumatoid factor status, age, gender, race, or disease status.
Maltese: L-effett tal-kura kien simili f'pazjenti indipendenti mill-istatus tal-fattur rewmatiku, l-età, is-sess, ir razza, jew l-istatus tal-marda.
English: A controlled study was conducted in patients with RA on background MTX immunised with a live attenuated virus vaccine (Zostavax®) 2 to 3 weeks before initiating a 12-week treatment with tofacitinib 5 mg twice daily or placebo.
Maltese: Twettaq studju kkontrollat f'pazjenti b'RA fuq MTX fl-isfond imlaqqma b'vaċċin tal-virus attenwat ħaj (Zostavax®) ġimagħtejn sa 3 ġimgħat qabel ma bdew kura ta' 12-il ġimgħa b'tofacitinib 5 mg darbtejn kuljum jew il-plaċebo.
English: Tofacitinib 5 mg film-coated tablets
Maltese: Tofacitinib 5 mg darbtejn kuljum
English: Proportion of Patients Meeting Primary and Key Secondary Efficacy Endpoints at Week 8 by TNF Inhibitor Therapy Subgroups (OCTAVE Induction Study 1 and OCTAVE Induction Study 2, Central Endoscopy Read) OCTAVE Induction Study 1
Maltese: Proporzjon ta' Pazjenti Li Ssodisfaw il-Punti tat-tmiem tal-Effikaċja Primarja u Sekondarja Ewlenin f'Ġimgħa 8 minn Sottogruppi ta' Terapija b'Inibitur ta' TNF (OCTAVE Studju ta' Induzzjoni 1 u OCTAVE Studju ta' Induzzjoni 2, Qari tal
English: In ORAL Scan and ORAL Start, inhibition of progression of structural joint damage was assessed radiographically and expressed as mean change from baseline in mTSS and its components, the erosion score and joint space narrowing (JSN) score, at months 6 and 12.
Maltese: Rispons radjugrafiku F'ORAL Scan u ORAL Start, l-inibizzjoni tal-progress ta' ħsara strutturali tal-ġogi kienet ivvalutata b'mod radjugrafiku u espressa bħala bidla medja mil-linja bażi f'mTSS u l-komponenti tiegħu, il punteġġ tal-erożjoni u l-punteġġ tat-tidjiq tal-ispazju bejn il-ġogi (JSN), f'xhur 6 u 12.
English: Tofacitinib 10 mg twice daily is contraindicated in patients who are at high risk for pulmonary embolism (see also section 4.3).
Maltese: Tofacitinib m'għandux jintuża f'pazjenti b'indeboliment tal-fwied sever (ara sezzjoni 4.3).
English: • The recommended dose is 10 mg twice a day for 8 weeks, followed by 5 mg twice a day.
Maltese: • Id-doża rrakkomandata hija ta' 10 mg darbtejn kuljum għal 8 ġimgħat, segwita minn 5 mg darbtejn kuljum.
English: Inhibitors of CYP2C19 alone or P-glycoprotein are unlikely to significantly alter the PK of tofacitinib.
Maltese: L-inibituri ta' CYP2C19 waħedhom jew P-glikoproteina mhumiex mistennija li jbiddlu lPK ta' tofacitinib b'mod sinifikanti.
English: Hibernomas (malignancy of brown adipose tissue) were observed in female rats at exposures greater than or equal to 83 or 41 times the clinical exposure level at 5 mg or 10 mg twice daily.
Maltese: L-ibernomi (tumur malinn tat-tessut xaħmi kannella) kienu osservati fil-firien nisa f'esponimenti akbar minn jew daqs 83 jew 41 darba tal-livell tal-esponiment kliniku b'5 mg jew 10 mg darbtejn kuljum.
English: Changes in total serum IgG, IgM, and IgA levels over 6-month tofacitinib dosing in patients with RA were small, not dose-dependent and similar to those seen on placebo, indicating a lack of systemic humoral suppression.
Maltese: kienu żgħar, mhux dipendenti fuq id-doża u simili għal dawk li dehru fil-plaċebo, li jindikaw nuqqas ta' suppressjoni umorali sistemika.
English: NAME OF THE MEDICINAL PRODUCT XELJANZ 10 mg tablets tofacitinib
Maltese: XELJANZ 10 mg pilloli miksija b'rita tofacitinib
English: For patients who do not achieve adequate therapeutic benefit by week 8, the induction dose of 10 mg twice daily can be extended for an additional 8 weeks (16 weeks total), followed by 5 mg twice daily for maintenance.
Maltese: Għal pazjenti li ma jiksbux benefiċċju terapewtiku adegwat sa ġimgħa 8, id-doża ta' induzzjoni ta' 10 mg darbtejn kuljum tista' tiġi estiża għal 8 ġimgħat addizzjonali (total ta' 16-il ġimgħa), segwita minn 5 mg darbtejn kuljum għall-manteniment.
English: XELJANZ is used to treat a condition called psoriatic arthritis.
Maltese: XELJANZ jintuża biex jikkura kondizzjoni msejħa artrite psorjatika.
English: e
Maltese: L
English: EU/1/02/240/001 10 mg 30 vials EU/1/02/240/002 15 mg 30 vials EU/1/02/240/004 20 mg 1 vial EU/1/02/240/003 20 mg 30 vials EU/1/02/240/009 25 mg 1 vial EU/1/02/240/010 25 mg 30 vials EU/1/02/240/011 30 mg 1 vial EU/1/02/240/012 30 mg 30 vials
Maltese: EU/1/02/240/001 10 mg 30 kunjett EU/1/02/240/002 15 mg 30 kunjett EU/1/02/240/004 20 mg 1 kunjett EU/1/02/240/003 20 mg 30 kunjett EU/1/02/240/009 25 mg 1 kunjett EU/1/02/240/010 25 mg 30 kunjett EU/1/02/240/011 30 mg 1 kunjett EU/1/02/240/012 30 mg 30 kunjett
English: (angioedema)
Maltese: (Anġjoedema).
English: Date of first authorization: 13 November 2002 Date of latest renewal: 20 September 2007
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta' Novembru 2002 Data tal-aħħar tiġdid: 20 ta' Settembru 2007
English: LT Levels and Clinical Signs/Symptoms
Maltese: Livelli ta' LT u Sinjali/Sintomi Kliniċi
English: Note: This may take up to 5 minutes.
Maltese: Nota: Din tista' tieħu sa 5 minuti.
English: The apparent volume of distribution of pegvisomant is relatively small (7-12 L).
Maltese: Il-volum apparenti ta' distribuzzjoni ta' pegvisomant huwa relattivament żgħir (7 - 12 L).
English: • An alcohol swab.
Maltese: • Swab tal-alkoħol.
English: • Muscle pain, arthritis.
Maltese: • Uġigħ fil-muskoli, artrite.
English: Pfizer Health AB Mariefredsvagen 37 645 41 Strängnäs Sweden
Maltese: Pfizer Health AB Mariefredsvagen 37 645 41 Strvagen L-Iżvezja
English: Do not use SOMAVERT:
Maltese: Tużax SOMAVERT:
English: - The other ingredients are glycine, mannitol (E421), disodium phosphate anhydrous and sodium dihydrogen phosphate monohydrate.
Maltese: - Is-sustanzi l-oħra huma glycine, mannitol (E421), disodium phosphate anhydrous u sodium dihydrogen phosphate monohydrate.
English: Solvent for SOMAVERT SC
Maltese: Solvent għal SOMAVERT SC
English: Disodium phosphate anhydrous Sodium dihydrogen phosphate monohydrate
Maltese: Disodium phosphate anyhydrous Sodium dihydrogen phosphate monohydrate
English: Incompatibilities
Maltese: .2 Inkompatibbilitajiet
English: Dose-dependent, statistically significant reductions in mean IGF-I (p<0.0001), free IGF-I (p<0.05), IGFBP-3 (p<0.05) and ALS (p<0.05) were observed at all post-baseline visits in the pegvisomant treatment groups.
Maltese: Ġie nnotat tnaqqis statistiku sinifikanti dipendenti fuq id-doża fl-IGF-I medju (p<0.0001), IGHF-I liberu (p<0.05), IGFBP-3 (p<0.05) u ALS (p<0.05), f'kull viżita sussegwenti għal dik inizjali, fil-gruppi kkurati b'pegvisomant.
English: The metabolism of pegvisomant has not been studied.
Maltese: Il-metaboliżmu ta' pegvisomant ma huwiex studjat.
English: • Feeling abnormal, impaired healing.
Maltese: • Sensazzjoni ta' anormalità, fejqan imfixkel.
English: Pegvisomant is not recommended during pregnancy (see section 4.6).
Maltese: Pegvisomant ma huwiex rakkomandabbli waqt it-tqala (ara sezzjoni 4.6).
English: Uncommon (≥1/1,000 to <
Maltese: Mhux komuni: ≥1/1,000 sa <1/100
English: 1 ml water for injections
Maltese: 1 ml ilma għal injezzjonijiet
English: The data from 145 patients in two long-term studies who received daily doses of 10, 15, or 20 mg, demonstrate pegvisomant mean serum concentrations (± SD) of approximately 8800 ± 6300, 13200 ± 8000 and 15600 ± 10300 ng/ml, respectively.
Maltese: Minn informazzjoni miksuba wara żewġ studji fittul, minn 145 pazjent li rċevew kuljum dożi ta' 10, 15 jew 20 mg, jintwerew konċentrazzjonijiet medji ta' pegvisomant fis-serum (±SD) ta' madwar 8800 ± 6300, 13200 ± 8000 u 15600 ± 10300 ng/ml, rispettivament.
English: Serum IGF-1 monitoring
Maltese: Monitoraġġ ta' IGF-1 fis-serum
English: Common to <1/10)
Maltese: Komuni ħafna: 1/10
English: Pack sizes of 1 and/or 30.
Maltese: Il-pakketti fihom 1 u/jew 30.
English: For the different dose regimens the following strengths are available: SOMAVERT 10 mg, SOMAVERT 15 mg, SOMAVERT 20 mg, SOMAVERT 25 mg and SOMAVERT 30 mg.
Maltese: SOMAVERT 10 mg, SOMAVERT 15 mg, SOMAVERT 20 mg, SOMAVERT 25 mg u SOMAVERT 30 mg.
English: Occurrence of injection site hypertrophy has been observed, including lipohypertrophy.
Maltese: Ġrajjiet ta' ipertrofija fis-siti ta' l-injezzjoni ġew osservati, inkluża lipoipertrofija.
English: What SOMAVERT contains - The active substance is pegvisomant.
Maltese: - Is-sustanza attiva hi pegvisomant.
English: Hepatobiliary disorders abnormal liver function tests (e.g. transaminase elevation) (see section 4.4)
Maltese: Disturbi fil-fwied u filmarrara testijiet abnormali tal-funzjoni talfwied (eż. żieda fit-transaminase) (ara sezzjoni 4.4)
English: The serum IGF-1 was normalised at the end of the study (week 12) in 9.7%, 38.5%, 75% and 82% of subjects treated with placebo, 10 mg/day, 15 mg/day or 20 mg/day pegvisomant respectively.
Maltese: L-IGF-I fis-serum ġie għan-normal fi tmiem l-istudju (it-12-il ġimgħa) fi 9.7%, 38.5%, 75% u 82% tal-pazjenti ttrattati bil-plaċebo, 20 mg kuljum, 15 mg kuljum jew 20 mg kuljum pegvisomant rispettivament.
English: The development of isolated low-titre anti-growth hormone antibodies was observed in 16.9% of patients treated with pegvisomant.
Maltese: L-iżvilupp ta' antikorpi low-titre ta' kontra l-ormoni tat-tkabbir ġie nnutat f'16.9% tal-pazjenti kkurati b'pegvisomant.
English: • Sweating, itching, rash, tendency to bruise.
Maltese: • Għaraq, ħakk, raxx, tendenza ta' tbenġil.
English: For pegvisomant no data on fertility are available.
Maltese: Għal pegvisomant, m'hemmx dejta disponibbli dwar il-fertilità.
English: *produced in Escherichia coli cells by recombinant DNA technology.
Maltese: *prodott f'ċelluli ta' Escherichia coli b'teknologija rikombinanti tad-DNA.
English: Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: The mean IGF-I concentration in this cohort fell from 917 ng/ml to 299 ng/ml on pegvisomant, with 92% achieving a normal (age-adjusted) IGF-I concentration.
Maltese: Il-konċentrazzjoni medja ta' IGF-I f'din il-ġemgħa niżlet minn 917 ng/ml għal 299 ng/ml fuq pegvisomant, bi 92% jirnexxilhom jiksbu konċentrazzjoni ta' IGF-I (aġġustata skond l-età) normali.
English: • Eyestrain, inner ear problems.
Maltese: • Sforz ta' l-għajnejn, problemi fil-widna interna.
English: • Severe breathlessness (laryngospasm)
Maltese: • Qtugħ ta' nifs sever (spażmi tal-larinġi)
English: Musculoskeletal and connective tissue disorders arthralgia myalgia, arthritis
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi artralġja uġigħ fil-muskoli, artrite
English: • Abnormal dreams.
Maltese: • Ħolm abnormali.
English: Pharmacotherapeutic group: Other anterior pituitary lobe hormones and analogues, ATC code: H01AX01.
Maltese: Ormoni oħra tal-lobu pitwitarju anterjuri u analogi, Kodiċi ATC:
English: • Discontinue SOMAVERT immediately.
Maltese: • Waqqaf SOMAVERT immedjatament.
English: What SOMAVERT looks like and contents of the pack SOMAVERT is presented as a powder and a solvent for injection (either 10 mg, 15 mg, 20 mg, 25 mg or 30 mg pegvisomant in a vial and 1 ml of solvent in a pre-filled syringe).
Maltese: SOMAVERT huwa ppreżentat bħala trab u solvent għal injezzjoni (10 mg, 15 mg, 20 mg, 25 mg jew 30 mg pegvisomant ġo kunjett u 1 ml ta' solvent f'siringa mimlija għal-lest).
English: How can I prevent the medicine from foaming?
Maltese: Kif nista' nwaqqaf milli jkun hemm ir-ragħwa fil-mediċina?
English: Abbreviations: ALT = alanine aminotransferase; AST = aspartate transaminase; LT = liver test; ULN = upper limit of normal.
Maltese: LT = test talfwied; ULN = limitu ta' fuq tan-normal
English: Disodium phosphate anhydrous Sodium dihydrogen phosphate monohydrate Water for Injections
Maltese: Disodium phosphate anyhydrous Sodium dihydrogen phosphate monohydrate Ilma għall-Injezzjonijiet
English: The safety and efficacy of SOMAVERT in children aged 0 to 17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' SOMAVERT fit-tfal minn età ta' 0 sa 17-il sena ma ġewx determinati s'issa.
English: 10 mg or 15 mg or 20 mg or 25 mg or 30 mg of pegvisomant in powder in a vial (type I flint glass) with a stopper (chlorobutyl rubber) and 1 ml solvent (water for injections) in a pre-filled syringe (type I borosilicate glass) with a plunger stopper (bromobutyl rubber) and a tip cap (bromobutyl rubber).
Maltese: 10 mg jew 15 mg jew 20 mg jew 25 mg jew 30 mg ta' pegvisomant bħala trab f'kunjett (ħġieġ ta' tip I) b'tapp (tal-gomma tal-chlorobutyl) u 1ml solvent (ilma għall-injezzjonijiet) f'siringa mimlija għallest (ħġieġ ta' tip I tal-borosilicate) bi planġer b'tapp (tal-gomma tal-bromobutyl) u tapp tal-ponta (talgomma tal-bromobutyl)..
English: Store the powder vial(s) in a refrigerator (2C - 8C).
Maltese: Aħżen il-kunjett(i) bit-trab fi friġġ (2C - 8C).
English: This is normal.
Maltese: Dan huma normali.
English: A loading dose of 80 mg pegvisomant should be administered subcutaneously under medical supervision.
Maltese: Loading dose ta' 80 mg pegvisomant għandha tiġi mogħtija taħt il-ġilda taħt sorveljanza medika.
English: • Protein in the urine, increased urine, kidney problems.
Maltese: • Proteina fl-awrina, żieda fl-awrina, problemi fil-kliewi.
English: Somavert comes in a vial as a white block of powder.
Maltese: Somavert jiġi f'kunjett bħala blokka bajda ta' trab.
English: Approximately linear pharmacokinetics is observed at steady state in the population pharmacokinetic studies.
Maltese: Bejn wieħed u ieħor il-farmakokinetika lineari hija nnutata b'mod stabbli fl-istudji ta' gruppi farmakokinetiċi.
English: Other medicines and SOMAVERT
Maltese: Mediċini oħra u SOMAVERT
English: The list below contains adverse reactions seen in clinical trials with SOMAVERT.
Maltese: Il-lista ta' hawn taħt turi reazzjonijiet avversi li rriżultaw waqt provi kliniċi b'SOMAVERT.
English: Assessment of baseline levels of liver enzymes prior to initiation of SOMAVERT Prior to the start of SOMAVERT, patients should have an assessment of baseline levels of liver tests (LTs) [serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP)].
Maltese: Qabel il-bidu ta' SOMAVERT, il-pazjenti għandha ssirilhom valutazzjoni tal-livelli fil-linja bażi ta' testijiet tal-fwied (LTs) [alanine aminotransferase (ALT) fis-serum, aspartate aminotransferase (AST), bilirubina totali (TBIL) fis-serum, u alkaline phosphatase (ALP)].
English: Metabolism and nutrition disorders hypercholesterol aemia, hyperglycaemia, hypoglycaemia, weight increased hypertriglyceridemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni iperkolesterolemija , ipergliċemija, ipogliċemija, żieda fil-piż ipertrigliċeridemija
English: Swirl vial
Maltese: 1 kunjett ta' trab
English: SOMAVERT 10 mg and 15 mg Pack size of 30 vials, pre-filled syringes and safety needles.
Maltese: SOMAVERT 10 mg u 15 mg Pakkett ta' 30 kunjett, siringi mimlijin għal-lest u labar tas-sigurtà.
English: Gastrointestinal disorders diarrhoea vomiting, constipation, nausea, abdominal distension, dyspepsia, flatulence haemorrhoids, salivary hypersecretion, dry mouth, tooth disorder
Maltese: Disturbi gastrointestinali dijarea rimettar, stitikezza, nawsja, distensjoni taż-żaqq, dispepsja, gass flistonku murliti, żieda flammont ta' saliva, ħalq xott, disturb dentali
English: • May continue therapy with SOMAVERT.
Maltese: • Kunjett ta' trab Somavert.
English: Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: (Cyprus Branch)
Maltese: PFIZER ΕΛΛΑΣ Α.Ε. (Cyprus Branch)
English: • Lack of interest, feeling confused, increased sex drive, panic attack, loss of memory, problems sleeping.
Maltese: • Telf tal-interess, sensazzjoni ta' konfużjoni, żieda fl-impuls sesswali, attakk ta' paniku, telf tal memorja, problemi biex torqod.
English: SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection pegvisomant
Maltese: SOMAVERT 10 mg trab u solvent għal soluzzjoni għal injezzjoni SOMAVERT 15 mg trab u solvent għal soluzzjoni għal injezzjoni SOMAVERT 20 mg trab u solvent għal soluzzjoni għal injezzjoni SOMAVERT 25 mg trab u solvent għal soluzzjoni għal injezzjoni SOMAVERT 30 mg trab u solvent għal soluzzjoni għal injezzjoni pegvisomant
English: SOMAVERT 20 mg, 25 mg and 30 mg Pack sizes of 1 and 30 vial(s), pre-filled syringe(s) and safety needle(s) Not all pack sizes may be marketed.
Maltese: SOMAVERT 20 mg, 25 mg u 30 mg Pakkett ta' 1 u 30 kunjett(i), siringa(i) mimlija/mimlijin għal-lest u labar/labra tas-sigurtà..
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: The use of this medicine in combination with other medicinal products for the treatment of acromegaly has not been extensively investigated.
Maltese: L-użu ta' din il-mediċina flimkien ma' prodotti mediċinali oħra għat-trattament tal-akromegalija ma ġiex investigat b'mod estensiv.
English: Skin and subcutaneous tissue disorders hyperhidrosis, contusion, pruritusb, rashb face oedema, dry skin, increased tendency to bruise, night sweats, erythema b, urticaria b angioedemab
Maltese: raxx edema fil-wiċċ, ġilda xotta, , żieda fittendenza għal tbenġil, perspirazzjoni matul illejl, eritema b, urtikarja anġjoedema
English: Store the carton(s) of powder vials in the refrigerator at 2°C to 8°C and away from direct sunlight.
Maltese: Aħżen il-kartuna(i) tal-kunjetti bit-trab fil-friġġ minn 2°C sa 8°C u 'l bogħod mid-dawl tax-xemx dirett.
English: Immune system disorders hypersensitivity reactionsb anaphylactic reactionb, anaphylactoid reactionb
Maltese: Disturbi fis-sistema immuni reazzjonijiet ta' sensittività eċċessiva reazzjoni anafilattika b,
English: Acromegalic patients (n=112) have been treated in a 12-week, randomised, double-blind, multicentre study comparing placebo and pegvisomant.
Maltese: Pazjenti akromegaliċi (n=112) ġew trattati għal 12-il ġimgħa fi studju tat-tip double blind, multiċentri, magħmul b'għażla każwali, fejn il-plaċebo ġie pparagunat ma' pegvisomant.
English: - SOMAVERT 20 mg: One vial of powder contains 20 mg pegvisomant.
Maltese: - SOMAVERT 20 mg: Kunjett wieħed bit-trab fih 20 mg ta' pegvisomant.
English: • Rapid swelling of skin and underlying tissue and inner lining (mucosa) of organs
Maltese: • Nefħa rapida tal-ġilda u tat-tessut ta' taħt il-ġilda u tar-rita ta' ġewwa (mukoża) tal-organi
English: The most commonly reported adverse reactions occurring in  10% of patients with acromegaly treated with pegvisomant during the clinical trials were headache 25%, arthralgia 16% and diarrhoea
Maltese: L-iktar reazzjonijiet avversi li ġew irrappurtati l-aktar fi provi kliniċi u li rriżultaw f'≥10% tal-pazjenti b'akromegalija kkurati b'pegvisomant, kienu uġigħ ta' ras 25%, artralġja 16%, u dijarea 13%.
English: Systemic hypersensitivity reactions including anaphylactic/anaphylactoid reactions, laryngospasm, angioedema, generalized skin reactions (rash, erythema, pruritus, urticaria).have been reported in post marketing use.
Maltese: Reazzjonijiet sistemiċi ta' sensittività eċċessiva li jinkludu reazzjonijiet anafillatiċi/anaphylactoid, laringospażmu, anġoedema, reazzjonijiet ġenerali fil-ġilda (raxx, eritema, ħakk, urtikarja) kienu rrapurtati waqt l-użu ta' wara t-tqegħid fis-suq.