FrancophonIA/ELRC3.0 huggingface dataset:
English: • in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products
Maltese: • flimkien ma' prodotti mediċinali oħra għat-trattament tal-dijabete f'pazjenti mhux ikkontrollati biżżejjed b'metformin u dawn il-prodotti mediċinali
English: As Synjardy contains empagliflozin it may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Maltese: Synjardy fih empagliflozin u jista' jżid l-effett dijuretiku ta' thiazide u dijuretiċi loop u jista' jżid ir-riskju ta' deidratazzjoni u pressjoni baxxa (ara sezzjoni 4.4).
English: Foot care
Maltese: Mhux komuni
English: EU/1/15/1003/019 10 film-coated tablets EU/1/15/1003/020 14 film-coated tablets EU/1/15/1003/021 30 film-coated tablets EU/1/15/1003/022 56 film-coated tablets EU/1/15/1003/023 60 film-coated tablets EU/1/15/1003/039 90 film-coated tablets EU/1/15/1003/024 100 film-coated tablets
Maltese: EU/1/15/1003/019 10 pilloli miksija b'rita EU/1/15/1003/020 14 pilloli miksija b'rita EU/1/15/1003/021 30 pilloli miksija b'rita EU/1/15/1003/022 56 pilloli miksija b'rita EU/1/15/1003/023 60 pilloli miksija b'rita EU/1/15/1003/039 90 pilloli miksija b'rita EU/1/15/1003/024 100 pilloli miksija b'rita
English: Eli Lilly Italia S.p.A. Tel: +39 055 42571
Maltese: Tel: +39 055 42571
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/1,000 mg
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA TIKKETTA TA' BARRA FUQ IL-PAKKETTI MULTIPLI - INKLUŻA L-KAXXA BLU5 mg/1,000 mg
English: Empagliflozin is a substrate of the human uptake transporters OAT3, OATP1B1, and OATP1B3, but not OAT1 and OCT2.
Maltese: Empagliflozin huwa sottostrat tat-trasportaturi tat-teħid uman OAT3, OATP1B1, u OATPiB3, imma mhux OAT1 u OCT2. Empagliflozin huwa sottostrat ta' P-glycoprotein (P-gp) u proteina ta' reżistenza għall-kanċer tas-sider (BCRP - breast cancer resistance protein).
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Maltese: Wara doża orali, il-frazzjoni li ma tiġix assorbita rkuprata mill-feċi kienet ta' 20-30%.
English: In patients ≥75 years of age volume depletion events have been reported in a single patient treated with empagliflozin 25 mg as add-on to metformin therapy.
Maltese: F'pazjenti li għandhom ≥ 75 sena, l-avvenimenti ta' żvojtar ta' volum kienu rrapportati f'pazjent wieħed ikkurat b'empagliflozin 25 mg bħala terapija aġġuntiva ma' metformin.
English: Table 5: Efficacy results of a 24 week placebo-controlled study in patients inadequately controlled with metformin and linagliptin 5 mg Add-on to metformin and linagliptin 5 mg Placebo
Maltese: Ir-riżultati tal-effikaċja ta' studju kkontrollat bi plaċebo ta' 24 ġimgħa f'pazjenti kkontrollati b'mod mhux adegwat b'metformin u linagliptin 5 mg Terapija aġġuntiva għal metformin u linagliptin 5 mg Plaċebo
English: HbA1c (%) at week 78 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Maltese: HbA1c (%) f'Ġimgħa 78 Linja bażi (medja) Bidla mil-linja bażi Differenza mill-plaċebo (97.5% CI)
English: Each Synjardy 5 mg/850 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Maltese: U KWANTITATTIVA Synjardy 5 mg/850 mg pilloli miksijin b'rita Kull pillola fiha 5 mg empagliflozin u 850 mg metformin hydrochloride.
English: EU/1/15/1003/028 10 film-coated tablets EU/1/15/1003/029 14 film-coated tablets EU/1/15/1003/030 30 film-coated tablets EU/1/15/1003/031 56 film-coated tablets EU/1/15/1003/032 60 film-coated tablets EU/1/15/1003/040 90 film-coated tablets EU/1/15/1003/033 100 film-coated tablets
Maltese: EU/1/15/1003/028 10 pilloli miksija b'rita EU/1/15/1003/029 14 pilloli miksija b'rita EU/1/15/1003/030 30 pilloli miksija b'rita EU/1/15/1003/031 56 pilloli miksija b'rita EU/1/15/1003/032 60 pilloli miksija b'rita EU/1/15/1003/040 90 pilloli miksija b'rita EU/1/15/1003/033 100 pilloli miksija b'rita
English: Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Maltese: Linja bażi (medja) Bidla mil-linja bażi Differenza mill-plaċebo (97.5% CI)
English: EU/1/15/1003/010 10 film-coated tablets EU/1/15/1003/011 14 film-coated tablets EU/1/15/1003/012 30 film-coated tablets EU/1/15/1003/013 56 film-coated tablets EU/1/15/1003/014 60 film-coated tablets EU/1/15/1003/038 90 film-coated tablets EU/1/15/1003/015 100 film-coated tablets
Maltese: EU/1/15/1003/010 10 pilloli miksija b'rita EU/1/15/1003/011 14 pilloli miksija b'rita EU/1/15/1003/012 30 pilloli miksija b'rita EU/1/15/1003/013 56 pilloli miksija b'rita EU/1/15/1003/014 60 pilloli miksija b'rita EU/1/15/1003/038 90 pilloli miksija b'rita EU/1/15/1003/015 100 pilloli miksija b'rita
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/034 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/035 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/036 200 (2 x 100 x 1) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1003/034 120 (2 x 60 x 1) pilloli miksija b'rita EU/1/15/1003/035 180
English: What you need to know before you take Synjardy 3.
Maltese: X'għandek tkun taf qabel ma tieħu Synjardy 3.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/025 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/026 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/027 200 (2 x 100 x 1) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1003/025 120 (2 x 60 x 1) pilloli miksija b'rita EU/1/15/1003/026 180
English: HbA1c (%) at week 18 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Maltese: HbA1c (%) f'Ġimgħa 18 Linja bażi (medja) Bidla mil-linja bażi Differenza mill-plaċebo (97.5% CI)
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDL cholesterol and triglyceride levels.
Maltese: Dan intwera f'dożi terapewtiċi fi studji kliniċi kkontrollati li damu għal żmien medju jew twil: metformin inaqqas il-kolesterol totali, il-kolesterol LDL u l-livelli ta' trigliċeridi.
English: • if you are allergic to empagliflozin, metformin or any of the other ingredients of this medicine (listed in section 6);
Maltese: • jekk inti allerġiku għal empagliflozin, metformin jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6);
English: Synjardy is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:
Maltese: Synjardy huwa indikat għat-trattament ta' adulti bid-dijabete mellitus ta' tip 2 mad-dieta u l-eżerċizzju
English: HbA1c (%) at week 52 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Maltese: HbA1c (%) f'Ġimgħa 52 Linja bażi (medja) Bidla mil-linja bażi Differenza mill-plaċebo (97.5% CI)
English: Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (95% CI)
Maltese: Linja bażi (medja) Bidla mil-linja bażi Differenza minn plaċebo (95% CI)
English: Each Synjardy 5 mg/1,000 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Maltese: Kull Synjardy 5 mg/1,000 mg pillola miksija b'rita fiha 5 mg empagliflozin u 1,000 mg metformin hydrochloride.
English: Synjardy 12.5 mg/1,000 mg film-coated tablets
Maltese: Synjardy 12.5 mg/1,000 mg pilloli miksijin b'rita
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/016 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/017 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/018 200 (2 x 100 x 1) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1003/016 120 (2 x 60 x 1) pilloli miksija b'rita EU/1/15/1003/017 180
English: No patient had a major hypoglycaemic event in the combination with metformin and a sulphonylurea and as add-on to linagliptin and metformin.
Maltese: L-ebda pazjent ma kellu avveniment ipoglikemiku maġġuri fil-kombinazzjoni ma' metformin u sulphonylurea u bħala terapija aġġuntiva għal linagliptin u metformin.
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Maltese: Metformin Studju randomised prospettiv (UKPDS) stabbilixxa l-benefiċċju fit-tul ta' kontroll intensiv tal-glukosju fid-demm fid-dijabete ta' tip 2.
English: In a prespecified subgroup of patients with baseline HbA1c greater or equal than 8.5% the reduction from baseline in HbA1c was -1.3% with empagliflozin 10 mg or 25 mg at 24 weeks (p<0.0001) compared to placebo.
Maltese: F'subgrupp speċifikat minn qabel ta' pazjenti b'HbA1c tal-linja bażi jew ugwali għal 8.5%, it-tnaqqis mil-linja bażi f'HbA1c kien -1.3% b'empagliflozin 10 mg jew 25 mg wara 24 ġimgħa (p<0.0001) meta mqabbel ma' plaċebo.
English: • a general feeling of not being well with severe tiredness
Maltese: • sensazzjoni ġenerali li ma tiflaħx flimkien ma' għeja severa
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Maltese: Synjardy 5 mg/850 mg pilloli miksijin b'rita empagliflozin/metformin hydrochloride
English: In a 2 year carcinogenicity study, empagliflozin did not increase the incidence of tumours in female rats up to the highest dose of 700 mg/kg/day, which corresponds to approximately 72-times the maximal clinical AUC exposure to empagliflozin.
Maltese: Fi studju li dam sejjer sentejn dwar il-karċinoġeniċità, empagliflozin ma żiedx l-inċidenza ta' tumuri f'firien nisa sal-ogħla doża ta' 700 mg/kg/jum, li tikkorrispondi għal madwar 72 darba l-espożizzjoni AUC klinika massima ta' empagliflozin.
English: Diuretics
Maltese: Disurja
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Maltese: Synjardy 12.5 mg/850 mg pilloli miksijin b'rita empagliflozin/metformin hydrochloride
English: In the EMPA-REG OUTCOME study, empagliflozin reduced the risk of heart failure requiring hospitalization compared with placebo (empagliflozin 2.7 %; placebo 4.1 %; HR 0.65, 95 % CI 0.50,
Maltese: Fl-istudju EMPA-REG OUTCOME, empagliflozin naqqas ir-riskju ta' insuffiċjenza tal-qalb li teħtieġ dħul l-isptar meta mqabbel ma' plaċebo (empagliflozin 2.7%; plaċebo 4.1%;
English: A greater proportion of patients with a baseline HbA1c ≥7.0% and treated with empagliflozin plus linagliptin achieved a target HbA1c of <7% compared to linagliptin 5 mg. Clinically meaningful reductions in HbA1c were maintained for 52 weeks.
Maltese: Proporzjon akbar ta' pazjenti bl-HbA1c fil-linja bażi ≥ 7.0% u kkurati b'empagliflozin flimkien ma' linagliptin kisbu HbA1c fil-mira ta' < 7% mqabbel ma' linagliptin 5 mg.
English: Blood creatinine increased/ Glomerular filtration rate decreased Haematocrit increased
Maltese: Żieda fil-krejatinina fid-demm/Tnaqqis fir-rata ta' filtrazzjoni glomerulari
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Synjardy.
Maltese: Id-dikjarazzjonijiet li ġejjin jirriflettu t-tagħrif farmakokinetiku tas-sustanzi attivi ta' Synjardy.
English: Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Subgroup analysis for patients on additional background of metformin (FAS, LOCF) Mean adjusted for baseline value Not evaluated for statistical significance as a part of the sequential confirmatory testing procedure LOCF, values after antihypertensive rescue censored * p-value <0.0001 ** p-value <0.01
Maltese: Mhux evalwat għal sinifikat ta' statistika bħala riżultat ta' proċedura ta' ttestjar konfermatorju sekwenzjali LOCF, valuri wara salvataġġ minn pressjoni għolja ċċensurati * valur p < 0.0001 ** valur p < 0.01
English: After the first 12 weeks glycaemic control was optimized independent of investigative treatment.
Maltese: Wara l-ewwel 12-il ġimgħa il-kontroll gliċemiku tjieb indipendentement mit-trattament investigat.
English: Body Weight (kg) Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Maltese: Piż tal-Ġisem (kg) Linja bażi (medja) Bidla mil-linja bażi Differenza mill-plaċebo (97.5% CI)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Maltese: Kull pillola fiha 12.5 mg empagliflozin u 850 mg metformin hydrochloride.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 5 mg/850 mg
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA PAKKETTI MULTIPLI - KARTUNA INTERMEDJA MINGĦAJR KAXXA BLU5 mg/850 mg
English: No additional adverse reactions were identified in clinical trials with empagliflozin as add-on to metformin compared to the side effects of the single components.
Maltese: L-ebda reazzjoni avversa ma ġiet identifikata fil-provi kliniċi b'empagliflozin bħala terapija aġġuntiva ma' metformin imqabbla mal-effetti sekondarji tal-komponenti uniċi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/007 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/008 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/009 200 (2 x 100 x 1) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1003/007 120 (2 x 60 x 1) pilloli miksija b'rita EU/1/15/1003/008 180
English: Subgroup analysis of full analysis set (FAS) for patients on additional background of metforminCompleters using last observation carried forward (LOCF) prior to glycaemic rescue therapy mean adjusted for baseline value * p-value <0.0001 ** p-value ≤0.025
Maltese: Sett ta' analiżi sħiħa (FAS - Full analysis set) fejn intużat l-aħħar osservazzjoni li ġiet miġjuba 'l quddiem (LOCF - Last observation carried forward) qabel l-għoti ta' terapija għal salvataġġ gliċemiku.
English: The pharmacokinetics of 5 mg empagliflozin twice daily and 10 mg empagliflozin once daily were compared in healthy subjects.
Maltese: Il-farmakokinetika ta' empagliflozin 5 mg darbtejn kuljum u empagliflozin 10 mg darba kuljum tqabblet f'individwi b'saħħithom.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Maltese: Synjardy 5 mg/1,000 mg pilloli miksijin b'rita empagliflozin/metformin hydrochloride
English: • if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see ‘Risk of lactic acidosis' below) or ketoacidosis.
Maltese: • jekk għandek dijabete mhux ikkontrollata, b'pereżempju, ipergliċemija severa (glucose għoli fid-demm), dardir, rimettar, dijarea, telf mgħaġġel fil-piż, aċidożi lattika (ara "Riskju ta' aċidożi lattika" hawn taħt) jew ketoaċidożi.
English: Based on the mode of action of SGLT2 inhibitors, osmotic diuresis accompanying therapeutic glucosuria may lead to a modest decrease in blood pressure (see section 5.1).
Maltese: Abbażi tal-mod ta' azzjoni tal-impedituri ta' SGLT2, dijuresi osmotika li takkompanja glukosurja terapewtika tista' twassal għal tnaqqis modest fil-pressjoni tad-demm (ara sezzjoni 5.1).
English: If no adequate strength of Synjardy is available, individual monocomponents should be used instead of the fixed dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Synjardy, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: Administration of empagliflozin 25 mg after intake of a high-fat and high calorie meal resulted in slightly lower exposure; AUC decreased by approximately 16% and Cmax by approximately 37% compared to fasted condition.
Maltese: L-għoti ta' empagliflozin 25 mg wara teħid ta' ikla b'ħafna xaħam u ħafna kaloriji rriżulta f'esponiment ftit aktar baxx; l-AUC naqas b'madwar 16% u Cmax b'madwar 37% meta mqabbel mal-kondizzjoni tas-sawm.
English: Synjardy 5 mg/1,000 mg film-coated tablets
Maltese: Synjardy 5 mg/1,000 mg pilloli miksijin b'rita
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Maltese: Synjardy 12.5 mg/1,000 mg pilloli miksijin b'rita empagliflozin/metformin hydrochloride
English: No metabolites have been identified in humans.
Maltese: L-ebda metaboliti ma kienu identifikati fil-bnedmin.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Maltese: Empagliflozin ma wera l-ebda effetti avversi fuq il-fertilità jew l-iżvilupp embrijoniku bikri, f'esponimenti suffiċjentement eċċessivi mill-esponiment fil-bniedem wara dożi terapewtiċi.
English: Table 6: Efficacy results at 104 week in an active controlled study comparing empagliflozin to glimepiride as add on to metformin
Maltese: Tabella 6: Riżultati ta' effikaċja wara 104 ġimgħat fi studju kontrollat b'mod attiv li qabbel empagliflozin ma' glimepiride bħala terapija addizzjonali għal metformin Empagliflozin 25 mg
English: Yellowish white, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm).
Maltese: Pillola ovali, ta' lewn abjad fl-isfar, mżaqqa fuq żewġ naħat, miksija b'rita, imnaqqxa b'“S5” u l-logo ta' Boehringer Ingelheim fuq naħa waħda u “850” fuq in-naħa l-oħra (tul tal-pillola:
English: Necrotising fasciitis of the perineum (Fournier's gangrene) Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier's gangrene), have been reported in female and male patients taking SGLT2 inhibitors.
Maltese: Każijiet wara t-tqegħid fis-suq ta' fasciitis nekrotika tal-perineum, (magħrufa wkoll bħala kankrena ta' Fournier), ġew irrappurtati f'pazjenti nisa u rġiel li kienu qed jieħdu inibituri SGLT2.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Maltese: Kull pillola fiha 12.5 mg empagliflozin u 1,000 mg metformin hydrochloride.
English: The safety and efficacy of Synjardy in children and adolescents aged 0 to 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Synjardy fit-tfal u adolexxenti li għandhom minn 0 sa 18-il sena ma ġewx determinati s'issa.
English: In the EMPA-REG OUTCOME study, 10.1% of the patients were reported with cardiac failure at baseline.
Maltese: 1% tal-pazjenti ġew irrapportati b'falliment kardijaku fil-linja bażi.
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with metformin (see sections 4.2 and 4.8).
Maltese: Għalhekk, doża iktar baxxa ta' insulina jew ta' sekretagog tal-insulina, għandha mnejn tkun meħtieġa biex jitnaqqas ir-riskju ta' ipogliċemija meta tintuża ma' metformin (ara sezzjonijiet 4.2 u 4.8).
English: In the population pharmacokinetic analysis, AUC was estimated to be 13.5% higher in Asians with a body mass index of 25 kg/m2 compared to non-Asians with a body mass index of 25 kg/m
Maltese: Fl-analiżi farmakokinetika tal-popolazzjoni, l-AUC kienet stmata li kienet 13.5% ogħla f'persuni mill-Ażja b'indiċi tal-piż tal-ġisem ta' 25 kg/m2, meta mqabbla ma' individwi mhux Ażjatiċi b'indiċi tal-piż tal-ġisem ta' 25 kg/m
English: Pinkish white, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm).
Maltese: Pillola ovali, ta' lewn abjad fir-roża, mżaqqa fuq żewġ naħat, miksija b'rita, imnaqqxa b'“S12” u l-logo ta' Boehringer Ingelheim fuq naħa waħda u “850” fuq in-naħa l-oħra (tul tal-pillola:
English: 90 (3 x 30) tablets (multipack)
Maltese: 90 (3 x 30) pillola (pakkett multiplu)
English: Further information on Somavert can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Somavert.
Maltese: ema.europa.eu/medicines/human/EPAR/Somavert.
English: IGF-I levels were normal at the end of the study (week 12) in 38.5%, 75% and 82% of patients treated with 10, 15 or 20 mg/day Somavert, respectively, compared with 9.7% of the patients treated with placebo.
Maltese: IGF-I kienu normali fl-aħħar tal-istudju (il-ġimgħa 12) fi 38.5 %, 75 % u 82 % tal-pazjenti kkurati b'10, 15 jew 20 mg/kuljum ta' Somavert rispettivament, meta mqabbla ma' 9.7 % tal-pazjenti kkurati bi plaċebo.
English: Somavert contains the active substance pegvisomant.
Maltese: Somavert fih is-sustanza attiva pegvisomant.
English: The maximum dose is 30 mg per day.
Maltese: Id-doża massima hija ta' 30 mg kuljum.
English: Other information about Somavert
Maltese: Informazzjoni oħra dwar Somavert
English: Somavert received a marketing authorisation valid throughout the EU on 13 November 2002.
Maltese: Somavert ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-13 ta' Novembru 2002.
English: Somavert (pegvisomant) EMA/790890/2018
Maltese: EMA/717525/2018
English: What are the risks associated with Somavert?
Maltese: X'inhuma r-riskji assoċjati ma' Somavert?
English: Somavert has been studied in 112 patients with acromegaly in a 12-week study.
Maltese: Somavert ġie studjat f'112-il pazjent b'akromegalija fi studju ta' 12-il ġimgħa.
English: Afterwards, they received 10, 15 or 20 mg Somavert per day or placebo.
Maltese: Wara, huma jirċievu 10, 15 jew 20 mg Somavert kuljum jew plaċebo.
English: Somavert is used in patients who did not respond well to surgery and/or radiation therapy, and to treatment with somatostatin analogues (another type of medicine used in acromegaly).
Maltese: Somavert jintuża f'pazjenti li ma rrispondewx tajjeb għall-kirurġija u/jew għat-terapija bir-radjazzjoni, u għall-kura bl-analogi somatostatin (tip ieħor ta' mediċina użat f'akromegalija).
English: Patients received a starting dose of 80 mg Somavert or placebo (a dummy treatment).
Maltese: Il-pazjenti jirċievu doża tal-bidu ta' 80 mg Somavert jew plaċebo (kura finta).
English: Somavert is a medicine used to treat adults with acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults and is caused by the pituitary gland producing excess growth hormone.
Maltese: Somavert huwa mediċina li tintuża għall-kura ta' adulti li jbatu minn akromegalija, disturb ormonali rari li s-soltu jimirdu bih adulti ta' mezza età, li huwa kkawżat minħabba li l-glandola pitwitarja tipproduċi l-ormon tat-tkabbir b'mod eċċessiv.
English: IGF-I is regulated by human growth hormone and causes growth in the body.
Maltese: IGF-I huwa regolat mill-ormon tat-tkabbir uman u jġiegħel lillġisem jikber.
English: As for all medicines, data on the use of Somavert are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Somavert hija ssorveljata kontinwament.
English: Following this, Somavert is given as an injection of 10 mg once a day.
Maltese: Wara dan, Somavert jingħata bħala injezzjoni ta' 10mg darba kuljum.
English: The active substance in Somavert, pegvisomant, is very similar to human growth hormone, but it has been designed so that it blocks the receptors to which growth hormone normally attaches itself.
Maltese: Is-sustanza attiva f'Somavert, ilpegvisomant, hija simili ħafna għall-ormon tat-tkabbir uman, iżda tfasslet biex timblokka r-riċetturi li normalment jeħel magħhom l-ormon tat-tkabbir.
English: The most common side effects of Somavert (seen in more than 1 in 10 people) were headache, diarrhoea and joint pain.
Maltese: L-effetti sekondarji l-aktar komuni ta' Somavert (li dehru f'aktar minn 1 minn kull 10 persuni) kienu luġigħ ta' ras, dijarea u wġigħ fil-ġogi.
English: For the full list of side effects and restrictions with Somavert, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Somavert, ara l-fuljett ta' tagħrif.
English: Somavert is available as powder and solvent that are mixed together to make up a solution for injection under the skin.
Maltese: Somavert huwa disponibbli bħala trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għal injezzjoni taħt il-ġilda.
English: The effectiveness was measured by comparing the levels of insulin-like growth factor-I (IGF-I) before and at the end of the study.
Maltese: L-effikaċja ġiet imkejla billi tqabblu l-livelli tal-fattur-I (IGF-I)I tat-tkabbir li jixbah lill-insulina qabel u fl-aħħar tal-istudju.