FrancophonIA/ELRC3.0 huggingface dataset:
English: In the second study, Viracept, in combination with zidovudine and lamivudine (other antiviral medicines) was compared with the combination of zidovudine and lamivudine in 297 treatment-naïve patients (who had not taken any antiviral medicines to treat HIV infection before).
Maltese: Fit-tieni studju, it-taħlita ta' Viracept mażżidovudina u mal-lamivudina (mediċini antivirali oħra) tqabblet mat-taħlita taż-żidovudina u llamivudina f'297 pazjent (li qatt ma kienu ħadu mediċini kontra l-infezzjoni tal-HIV).
English: Doctors should consider using alternatives to medicines that speed up the breakdown of Viracept, such as phenobarbital and carbamazepine (used to treat epilepsy), in patients taking Viracept.
Maltese: F'pazjenti li jieħdu Viracept, it-tobba għandhom jikkunsidraw l-użu ta' alternattivi għall-mediċini li jħaffu t-tkissir ta' Viracept, bħall-fenobarbital u l-karbamażepina (użati fit-trattament tal-epilessija).
English: The CHMP decided that Viracept's benefits are greater than its risks in antiviral combination treatment of HIV-1 infected adults, adolescents and children of three years of age and older.
Maltese: Is-CHMP iddeċieda li Viracept iġib iktar benefiċċji milli riskji meta jintuża flimkien ma' sustanzi antiretrovirali oħra fit-trattament ta' adulti, adolexxenti u tfal li għalqu t-tliet snin.
English: CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Maltese: Iċ-ċelloli T CD4 huma ċelloli tad-demm bojod li huma importanti filġlieda kontra l-infezzjonijiet, imma li jinqatlu mill-HIV.
English: It blocks an enzyme called protease that is involved in the reproduction of HIV.
Maltese: Timblokka enzima li tissejjaħ proteażi li għandha sehem fir-riproduzzjoni tal-HIV.
English: For the full list of all side effects seen with Viracept, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Viracept, ara l-fuljett ta' tagħrif.
English: How has Viracept been studied?
Maltese: Kif ġie studjat Viracept?
English: The main measures of effectiveness were the change in the levels of HIV in the blood (viral load) and the change in the number of CD4 T-cells in the blood (CD4 cell count).
Maltese: Il-kejl ewlieni taleffikaċja kien il-bidla fil-livelli tal-HIV fid-demm (tagħbija virali) u l-bidla fl-għadd taċ-ċelloli-T CD4 fiddemm (għadd taċ-ċelloli CD4).
English: Three studies have compared the effectiveness of dosing Viracept twice and three times a day, in combination with stavudine and lamivudine in 635 patients.
Maltese: Tliet studji qabblu l-effikaċja tad-dożi ta' Viracept meħud darbtejn u tliet darbiet kuljum, flimkien malistavudina u l-lamivudina f'635 pazjent.
English: • medicines that are broken down in the same way as Viracept and are harmful at high levels in the blood.
Maltese: • mediċini li jitkissru bl-istess mod ta' Viracept u li jagħmlu l-ħsara meta l-livelli tagħhom fid-demm ikunu għolja.
English: Why has Viracept been approved?
Maltese: Għaliex ġie approvat Viracept?
English: What is the risk associated with Viracept?
Maltese: X'inhu r-riskju assoċjat ma' Viracept?
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Maltese: Meta l-enzima tiġi mblukkata, il-virus ma jirriproduċix ruħu bħas-soltu, u dan inaqqas il-firxa tal-infezzjoni.
English: After 24 weeks, Viracept brought about greater reductions in viral load and increases in CD4 cell counts than the comparator medicines.
Maltese: Wara 24 ġimgħa, apparagun mal-mediċini li tqabbel magħhom, Viracept wassal għal żieda fit-tnaqqis tat-tagħbijiet virali u żidiet fl-għadd taċ-ċelloli CD4. Ma kienx hemm differenzi bejn iż-żewġ dożi ta' Viracept.
English: Viracept does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Viracept ma jfejjaqx l-infezzjoni tal-HIV jew l-AIDS, iżda jista' jtawwal iż-żmien sa ma tibda ssir il-ħsara fis-sistema immunitarja u sa ma jibdew jiżviluppaw infezzjonijiet u mardiet marbuta mal-AIDS.
English: Doctors should only prescribe Viracept to patients who have already taken medicines in the same class as Viracept (protease inhibitors) once they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine.
Maltese: It-tobba għandhom jippreskrivu Viracept biss lil pazjenti li jkunu ħadu mediċini mill-istess klassi ta' Viracept (inibituri tal-proteażi) wara li jkunu analizzaw x'mediċini kien ħa l-pazjent u l-probabilità li lvirus jirrispondi għall-mediċina.
English: Other information about Viracept
Maltese: Kif jintuża Viracept?
English: D-35039 Marburg
Maltese: D-35039 Marburg ilĠermanja
English: Aristo Pharma GmbH Wallenroder Strasse 8-10 D-13435 Berlin Germany
Maltese: Aristo Pharma GmbH Wallenroder Strasse 8-10
English: D-35039 Marburg Germany
Maltese: D-35039 Marburg Il-Ġermanja
English: Diotop 75 mg / 20 mg modified release hard capsules
Maltese: Diotop 75 mg / 20 mg kapsuli ibsin b'rilaxx modifikat
English: (Invented) Name Strength Pharmaceutica l form
Maltese: Isem (Ivvintat) Qawwa Għamla farmaċewtika
English: Atorvastatin Cmax was decreased by 38%.
Maltese: Is-Cmax ta' atorvastatin tnaqqas bi 38%.
English: Cardiac electrophysiology (QTc)
Maltese: Elettrofiżjoloġija kardijaka (QTc)
English: Gender, race and ethnicity
Maltese: Età, sess u razza
English: SUSTAIN 1 - Monotherapy
Maltese: SUSTAIN 1 - Monoterapija
English: 1.5 ml (4 doses)
Maltese: 1.5 ml (4 dożi)
English: • The active substance is semaglutide.
Maltese: • Is-sustanza attiva hi semaglutide.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż
English: In 8 phase 3a trials 4,792 patients were exposed to semaglutide.
Maltese: Fi 8 provi ta' fażi 3a, 4,792 pazjenti ġew esposti għal semaglutide.
English: Primary endpoint - MACE Components of MACE
Maltese: Għan primarju - MACE Komponenti ta' MACE
English: Metabolism/Biotransformation
Maltese: Metaboliżmu/Bijotrasformazzjoni
English: Combination with premix insulin ± 1-2 OADs
Maltese: Kombinazzjoni ma' insulina mħallta ± 1-2 OADs
English: Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1.
Maltese: Semaglutide hu analogu ta' GLP-1 b'omoloġija fis-sekwenza għal GLP-1 uman ta' 94%.
English: The total numbers of cardiovascular deaths, non-fatal myocardial infarctions and non-fatal strokes were 90, 111, and 71, respectively, including 44 (2.7%), 47 (2.9%), and 27 (1.6%), respectively, with semaglutide (figure 4).
Maltese: In-numri totali ta' mwiet kardjovaskulari, infarti mijokardijaċi li ma jkunux fatali u attakki ta' puplesija li ma jkunux fatali kienu 90, 111, u 71, rispettivament, inklużi 44 (2.7%), 47 (2.9%) u 27 (1.6%), rispettivament, b'semaglutide (figura 4).
English: The enzyme neutral endopeptidase (NEP) is expected to be involved in the metabolism of semaglutide.
Maltese: L-enzima newtrali endopeptidase (NEP) hi mistennija li tkun involuta fil-metaboliżmu ta' semaglutide.
English: EU/1/17/1251/002 EU/1/17/1251/003 EU/1/17/1251/004 EU/1/17/1251/005 EU/1/17/1251/006
Maltese: EU/1/17/1251/002 EU/1/17/1251/003 EU/1/17/1251/004
English: See step 2 ‘Check the flow'.
Maltese: Ara pass 2 ‘Iċċekkja l-fluss'.
English: The total number of primary component MACE endpoints was 254, including 108 (6.6%) with semaglutide and 146 (8.9%) with placebo.
Maltese: In-numru totali ta' għanijiet primarji b'komponent MACE kien ta' 254, inklużi 108 (6.6%) b'semaglutide u 146 (8.9%) bi plaċebo.
English: Gastro-oesophageal reflux disease Eructation Flatulence
Maltese: gastro-esophageal reflux disease)
English: Ozempic contains the active substance semaglutide.
Maltese: Ozempic fih is-sustanza attiva semaglutide.
English: *human glucagon-like peptide-1 (GLP-1) analogue produced in Saccharomyces cerevisiae cells by recombinant DNA technology.
Maltese: *analogu ta' glucagon-like peptide-1 (GLP-1) uman magħmul minn teknoloġija tad-DNA rikombinanti f'ċelluli ta' Saccharomyces cerevisiae.
English: Patients (%) achieving HbA1c <7% FPG (mmol/L)
Maltese: Pazjenti (%) li kisbu HbA1c <7% FPG (mmol/L)
English: Ozempic Placebo
Maltese: Ozempic Plaċebo
English: Difference from sitagliptin [95% CI] -2.3 [-3.1, -1.6]a
Maltese: Differenza minn sitagliptin [95% CI] -2.3 [-3.1, -1.6]a
English: The most frequent adverse events leading to discontinuation were gastrointestinal.
Maltese: L-avvenimenti avversi l-aktar frekwenti li wasslu għat-twaqqif kienu gastrointestinali.
English: • increase of pancreatic enzymes (such as lipase and amylase).
Maltese: • gass • żieda fl-enzimi pankreatiċi (bħal lipase u amylase).
English: There were 61% males, the mean age was 65 years and mean BMI was 33 kg/m2.
Maltese: Kien hemm 61% li kienu rġiel, l-età medja kienet ta' 65 sena u BMI medju kien ta' 33 kg/m2.
English: Semaglutide improves beta-cell function.
Maltese: Semaglutide itejjeb il-funzjoni taċ-ċelluli beta.
English: Semaglutide is not a substitute for insulin.
Maltese: Semaglutide mhuwiex sostitut għall-insulina.
English: • diarrhoea - this usually goes away over time
Maltese: • dijarea - din normalment tmur maż-żmien
English: Therapeutic experience in patients ≥75 years of age is limited (see section 5.2).
Maltese: L-esperjenza terapewtika f'pazjenti ta' ≥75 sena hi limitata (ara sezzjoni 5.2).
English: The risk reduction in the primary composite outcome was mainly driven by decreases in the rate of non-fatal stroke (39%) and non-fatal myocardial infarction (26%) (figure 3).
Maltese: It-tnaqqis tar-riskju firriżultat tal-kompost primarju kien xprunat l-aktar minn tnaqqis fir-rata ta' attakki ta' puplesiji li ma jkunux fatali (39%) u minn tnaqqis f'infarti mijokardijaċi li ma jkunux fatali (26%) (figura 3).
English: Beta-cell function and insulin secretion
Maltese: Funzjoni taċ-ċelluli beta u sekrezzjoni tal-insulina
English: Difference from dulaglutide [95% CI]
Maltese: Id-differenza minn dulaglutide [95% CI]
English: The mean duration of diabetes was 13.9 years.
Maltese: It-tul ta' żmien tad-dijabete kien medja ta' 13.9 snin.
English: Frequencies are defined as: 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) and very rare: (<1/10,000).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna: (≥1/10); komuni: (≥1/100 sa <1/10); mhux komuni: (≥1/1,000 sa <1/100); rari:
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Disodium phosphate dihydrate Propylene glycol
Maltese: Disodium phosphate dihydrate Propylene glycol
English: The trial population was distributed by age as: 1,598 patients (48.5%) ≥65 years, 321 (9.7%) ≥75 years, and 20 (0.6%) ≥85 years.
Maltese: Il-popolazzjoni tal-prova kienet mqassma skont l-età kif ġej: 1,598 pazjent (48.5%) ≥65 sena, 321 (9.7%) ≥75 sena, u 20 (0.6%) ≥85 sena.
English: Difference from insulin glargine [95% CI] -4.6 [-5.3, -4.0]
Maltese: Differenza minn insulin glargine [95% CI] -4.6
English: Prior to excretion, semaglutide is extensively metabolised through proteolytic cleavage of the peptide backbone and sequential beta-oxidation of the fatty acid sidechain.
Maltese: Qabel l-ippurgar, semaglutide jiġi metabolizzat b'mod estensiv permezz ta' cleavage tal-peptide backbone u ossidazzjoni beta sekwenzali tal-fatty acid sidechain.
English: Furthermore, semaglutide is stabilised against degradation by the DPP-4 enzyme.
Maltese: Barra minn hekk, semaglutide jiġi stabbilizzat kontra d-degradazzjoni mill-enzima DPP-4.
English: Semaglutide compared to placebo lowered the energy intake of 3 consecutive ad libitum meals by 18-35%.
Maltese: Semaglutide meta mqabbel mal-plaċebo baxxa t-teħid tal-enerġija ta' 3 ikliet konsekuttivi ad libitum bi 18-35%.
English: LIST OF EXCIPIENTS disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injections
Maltese: TA' EĊĊIPJENTI disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (għal aġġustament tal-pH), ilma għall-injezzjonijiet
English: Combination with sulfonylurea monotherapy
Maltese: Kombinazzjoni ma' monoterapija b'sulfonylurea
English: INFORMATION IN BRAILLE Ozempic 0.25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Ozempic 0.25 mg
English: The hazard ratio [95% CI] for time to nephropathy (new onset of persistent macroalbuminuria, persistent doubling of serum creatinine, need for continuous renal replacement therapy and death due to renal disease) was 0.64 [0.46; 0.88] driven by new onset of persistent macroalbuminuria.
Maltese: Il-proporzjon ta' periklu [95% CI] għaż-żmien sa nefropatija (bidu ġdid ta' makroalbuminurija persistenti, l-irduppjar persistenti talkreatinina fis-serum, il-ħtieġa għal terapija ta' sostituzzjoni renali kontinwa u mewt minħabba mard renali) kien ta' 0.64 [0.46; 0.88], xprunat mill-bidu ġdid ta' makroalbuminurija persistenti.
English: Nausea occurred in 17.0% and 19.9% of patients when treated with semaglutide 0.5 mg and 1 mg, respectively, diarrhoea in 12.2% and 13.3% and vomiting in 6.4% and 8.4%.
Maltese: In-nawseja seħħet fi 17.0% u 19.9% tal-pazjenti meta ġew ikkurati b'semaglutide 0.5 mg u 1 mg, rispettivament, dijarea fi 12.2% u 13.3%, u r-rimettar f'6.4% u 8.4%.
English: a a p <0.0001 (2-sided) for superiority
Maltese: 7]a p <0.0001 (2-sided) għas-superjorità
English: Pharmacotherapeutic group: Drugs used in diabetes, Glucagon-like peptide-1 (GLP-1) analogues, ATC code: A10BJ06
Maltese: Mediċini użati fid-dijabete, analogi ta' peptide-1 (GLP-1) li jxbħu lil glucagon, Kodiċi ATC:
English: Significant reductions in mean systolic blood pressure were observed when Ozempic 0.5 mg (3.5-5.1 mmHg) and 1 mg (5.4-7.3 mmHg) were used in combination with oral antidiabetic medicinal products or basal insulin.
Maltese: Tnaqqis sinifikanti fil-medja tal-pressjoni sistolika tad-demm ġie osservat meta Ozempic 0.5 mg (3.55.1 mmHg) u 1 mg (5.4-7.3 mmHg) intużaw f'kombinazzjoni ma' prodotti mediċinali antidijabetiċi orali jew insulina bażali.
English: Semaglutide 0.25 mg is not a maintenance dose.
Maltese: Semaglutide 0.25 mg mhijiex doża ta' manteniment.
English: NovoFine Plus needles are included in the pack.
Maltese: Il-labar NovoFine Plus huma inklużi fil-pakkett.
English: Table 7 SUSTAIN 5: Results at week 30
Maltese: Tabella 7 SUSTAIN 5:
English: Gastrointestinal disorders were the most frequent adverse events, and occurred in similar proportion of patients receiving Ozempic 0.5 mg (129 patients [43%]), Ozempic 1 mg (133 [44%]), and dulaglutide 1.5 mg (143 [48%]); fewer patients had gastrointestinal disorders with dulaglutide 0.75 mg (100
Maltese: Disturbi gastrointestinali kienu l-avvenimenti avversi l-aktar frekwenti, u seħħew f'proporzjoni simili ta' pazjenti li rċevew Ozempic 0.5 mg (129 pazjent [43%]), Ozempic 1 mg (133 [44%]), u dulaglutide 1.5 mg (143 [48%]); inqas pazjenti kellhom disturbi gastrointestinali b'dulaglutide 0.75 mg (100
English: Gender, race (White, Black or African-American, Asian) and ethnicity (Hispanic or Latino, nonHispanic or -Latino) had no effect on the pharmacokinetics of semaglutide.
Maltese: Is-sess, ir-razza (Abjad, Iswed jew Afro-Amerikan, Asjatiku) u l-etniċità (Ispaniku jew Latin, mhuxIspaniku jew -Latin) ma kellhom l-ebda effett fuq il-farmakokinetika ta' semaglutide.
English: Semaglutide compared to placebo lowered fasting triglyceride and very low density lipoproteins (VLDL) cholesterol concentrations by 12% and 21%, respectively.
Maltese: Semaglutide meta mqabbel mal-plaċebo, baxxa l-konċentrazzjonijiet tal-kolesterol tat-triglycerides u llipoproteins ta' densità baxxa ħafna (VLDL, very low density lipoproteins) fl-istat sajjem bi 12% u 21% rispettivament.
English: INFORMATION IN BRAILLE Ozempic 1 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Ozempic 1 mg
English: In SUSTAIN 6 (see subsection Cardiovascular disease) 123 patients were on sulfonylurea monotherapy at baseline.
Maltese: F'SUSTAIN 6 (ara s-subsezzjoni Mard kardjovaskulari), 123 pazjent kienu fuq sulfonylurea waħdu fil-linja bażi.
English: GLP--1 is a physiological hormone that has multiple actions in glucose and appetite regulation, and in the cardiovascular system.
Maltese: GLP-1 huwa ormon fiżjoloġiku li għandu azzjonijiet multipli fir-regolazzjoni tal-glucose u l-aptit, u fis-sistema kardjovaskolari.
English: Intent-to-Treat (ITT) Population(N)
Maltese: Kura -Intent-to-Treat (ITT)
English: Severe hypoglycaemia was primarily observed when semaglutide was used with a sulfonylurea (1.2% of subjects, 0.03 events/patient year) or insulin (1.5% of subjects, 0.02 events/patient year).
Maltese: Ipogliċemija severa ġiet osservata l-aktar meta semaglutide intuża ma' xi sulfonylurea (1.2% tal-individwi, 0.03 avvenimenti/pazjent fis-sena) jew insulina (1.5% tal-individwi, 0.02 avvenimenti/pazjent fissena).
English: Semaglutide is not anticipated to decrease the effect of oral contraceptives as semaglutide did not change the overall exposure of ethinylestradiol and levonorgestrel to a clinically relevant degree when an oral contraceptive combination medicinal product (0.03 mg ethinylestradiol/0.15 mg levonorgestrel) was co-administered with semaglutide.
Maltese: Semaglutide mhuwiex antiċipat li jnaqqas l-effett tal-kontraċettivi orali għax semaglutide ma bidilx lespożizzjoni globali ta' ethinylestradiol u levonorgestrel sa grad klinikament rilevanti meta prodott mediċinali ta' kombinazzjoni b'kontraċettiv orali (0.03 mg ethinylestradiol/0.15 mg levonorgestrel) ingħata flimkien ma' semaglutide.
English: • injection site reactions - such as bruising, pain, irritation, itching and rash.
Maltese: • reazzjonijiet fis-sit tal-injezzjoni - bħal tbenġil, uġigħ, irritazzjoni, ħakk u raxx.
English: The events led to treatment discontinuation in 3.9% and 5% of patients.
Maltese: L-avvenimenti wasslu għat-twaqqif talkura fi 3.9% u 5% tal-pazjenti.
English: At week 40, the increase in pulse rate for Ozempic (0.5 mg and 1 mg) and dulaglutide (0.75 mg and 1.5 mg) was 2.4, 4.0, and 1.6, 2.1, beats/min, respectively.
Maltese: Fl-40 'Ġimgħa, iż-żieda fir-rata tal-polz għal Ozempic (0.5 mg u 1 mg) u dulaglutide (0.75 mg u 1.5 mg) kien ta' 2.4, 4.0, u 1.6, 2.1, taħbit/min, rispettivament.
English: Glucagon secretion
Maltese: Sekrezzjoni tal-glucagon
English: In patients with type 2 diabetes, treatment with semaglutide 1 mg resulted in reductions in glucose in terms of absolute change from baseline (mmol/L) and relative reduction compared to placebo (%) for fasting glucose (1.6 mmol/L; 22% reduction), 2 hour postprandial glucose (4.1 mmol/L; 37% reduction), mean 24 hour glucose concentration (1.7 mmol/L; 22% reduction) and postprandial glucose excursions over 3 meals (0.6-1.1 mmol/L) compared with placebo.
Maltese: F'pazjenti b'dijabete ta' tip 2, il-kura b'semaglutide 1 mg irriżultat fi tnaqqis tal-glucose f'termini ta' bidla assoluta millinja bażi (mmol/L) u tnaqqis relattiv meta mqabbel mal-plaċebo (%) għall-glucose fl-istat sajjem (1.6 mmol/L; tnaqqis ta' 22%), glucose sagħtejn wara ikla (4.1 mmol/L; tnaqqis ta' 37%), medja ta' konċentrazzjoni ta' glucose f'24 siegħa (1.7 mmol/L; tnaqqis ta' 22%) u differenzi fil-glucose wara 3 ikliet (0.6-1.1 mmol/L) meta mqabbel mal-plaċebo.
English: Ozempic is used:
Maltese: Tużax Ozempic:
English: Semaglutide doses of 0.5 mg and 1 mg provide adequate systemic exposure over a body weight range of 40-198 kg.
Maltese: Dożi ta' 0.5 mg u 1 mg ta' semaglutide jipprovdu espożizzjoni sistemika adegwata fuq medda ta' piż tal-ġisem ta' 40-198 kg.
English: There were 2,358 patients with normal or mild renal impairment, 832 with moderate and 107 with severe or end stage renal impairment.
Maltese: Kien hemm 2,358 pazjent b'indeboliment renali normali jew ħafif, 832 b'indeboliment renali moderat u 107 b'indeboliment renali sever jew b'indeboliment renali tal-aħħar stadju.
English: SUSTAIN 4 - Ozempic vs. insulin glargine both in combination with 1-2 oral antidiabetic drugs (metformin or metformin and sulfonylurea)
Maltese: SUSTAIN 4 - Ozempic vs. insulin glargine it-tnejn f'kombinazzjoni ma' 1-2 mediċini antidijabetiċi orali (metformin jew metformin ma' sulfonylurea)
English: SUSTAIN 2 - Ozempic vs. sitagliptin both in combination with 1-2 oral antidiabetic drugs (metformin and/or thiazolidinediones)
Maltese: SUSTAIN 2 - Ozempic vs. sitagliptin it-tnejn f'kombinazzjoni ma' 1-2 mediċini antidijabetiċi orali: metformin u/jew thiazolidinediones
English: Few episodes (0.1% of subjects, 0.001 events/patient year) were observed with semaglutide in combination with oral antidiabetics other than sulfonylureas.
Maltese: Ftit episodji (0.1% tal-individwi, 0.001 avvenimenti/pazjent fis-sena) ġew osservati meta semaglutide ingħata flimkien ma' antidijabetiċi orali li ma kinux sulfonylureas.
English: • The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, water for injections, sodium hydroxide/hydrochloric acid (for pH adjustment).
Maltese: • Is-sustanzi mhux attivi l-oħra huma: disodium phosphate dihydrate, propylene glycol, phenol, ilma għall-injezzjonijiet, sodium hydroxide/hydrochloric acid (għal aġġustament tal-pH).
English: For further information on administration, see section 6.6.
Maltese: Għal aktar istruzzjonijiet dwar l-għoti, ara sezzjoni 6.6.
English: INFORMATION IN BRAILLE Ozempic 0.5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Ozempic 0.5 mg
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 February 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 08 Frar 2018
English: Patients with event (%)
Maltese: Pazjenti b'avveniment (%)
English: In patients with diabetic retinopathy treated with insulin and semaglutide, an increased risk of developing diabetic retinopathy complications has been observed (see section 4.8).
Maltese: F'pazjenti b'retinopatija dijabetika kkurati bl-insulina u semaglutide, ġiet osservata żieda fir-riskju li jiżviluppaw kumplikazzjonijiet ta' retinopatija dijabetika (ara sezzjoni 4.8).
English: In the phase 3a trials, mean increases of 1 to 6 beats per minute (bpm) from a baseline of 72 to 76 bpm were observed in subjects treated with Ozempic.
Maltese: Fil-provi ta' fażi 3a, , ġew osservati żidiet ta' medja ta' 1 sa 6 taħbitiet kull minuta (bpm-beats per minute ) minn linja bażi ta' 72 sa 76 bpm f'suġġetti ttrattati b'Ozempic.
English: Semaglutide did not prolong QTc intervals at supra-therapeutic dose levels (up to 1.5 mg at steady state).
Maltese: Semaglutide ma tawwalx l-intervalli tal-QTc fil-livelli ta' doża supraterapewtika (sa 1.5 mg fl-istat stabbli).
English: The incidence of discontinuation of treatment due to adverse events was 6.1% and 8.7% for patients treated with semaglutide 0.5 mg and 1 mg, respectively, versus 1.5% for placebo.
Maltese: L-inċidenza ta' twaqqif tal-kura minħabba avvenimenti avversi kienet ta' 6.1% u 8.7% għal pazjenti kkurati b'semaglutide 0.5 mg u 1 mg, rispettivament, kontra 1.5% għal plaċebo.
English: Table 1 lists adverse reactions identified in all phase 3a trials in patients with type 2 diabetes mellitus (further described in section 5.1).
Maltese: Tabella 1 telenka reazzjonijiet avversi identifikati fil-provi kollha ta' fażi 3a f'pazjenti b'dijabete mellitus ta' tip 2 (deskritti f'aktar dettall f'sezzjoni 5.1).
English: Gastric emptying
Maltese: Tbattil gastriku
English: HbA1c at baseline was 8.8%, 8.9% and 8.9% for Ozempic 0.5 mg, Ozempic 1 mg, and placebo, respectively.
Maltese: HbA1c fil-linja bażi kienet 8.8%, 8.9% u 8.9% għal Ozempic 0.5 mg, Ozempic 1 mg, u plaċebo, rispettivament.
English: Ozempic 0.5 mg vs dulaglutide 0.75 mg c Ozempic 1 mg vs dulaglutide 1.5 mg
Maltese: Ozempic 0.5 mg vs dulaglutide 0.75 mg c
English: Figure 1 Mean change in HbA1c (%) and body weight (kg) from baseline to week 56
Maltese: Figura 1 Bidla medja fl-HbA1c (%) u piż tal-ġisem (kg) mil-linja bażi sa ġimgħa 56
English: • severe allergic reactions (anaphylactic reactions).
Maltese: • reazzjonijiet allerġiċi severi (reazzjonijiet anafilattiċi).
English: Baseline (mean)
Maltese: Linja Bażi (medja)
English: • less appetite
Maltese: • inqas aptit
English: Favours placebo
Maltese: Jiffavorixxi plaċebo
English: Diabetic retinopathy
Maltese: Retinopatija dijabetika