FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse drug reactions are based on evaluation of data from pre-marketing phase 2-3 studies and updated based on pooled data from 18 placebo-controlled pre- and post-marketing studies, including approximately 5,000 patients treated with varenicline.
Maltese: Ir-reazzjonijiet avversi talmediċina huma bbażati fuq evalwazzjoni tad-dejta minn studji ta' fażi 2-3 ta' qabel it-tqegħid fis-suq u aġġornati skont id-dejta miġbura minn 18-il studju ta' qabel u ta' wara t-tqegħid fis-suq ikkontrollati bi plaċebo, inklużi madwar 5,000 pazjent ikkurati b'varenicline.
English: CHAMPIX is not recommended in paediatric patients because its efficacy in this population was not demonstrated (see sections 4.2 and 5.1).
Maltese: CHAMPIX mhuwiex rakkomandat f'pazjenti pedjatriċi għax ma ntwerietx l-effikaċja tiegħu f'din ilpopolazzjoni (ara sezzjonijiet 4.2 u 5.1).
English: Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling
Maltese: Pakkett tal-kartun issiġillat bis-sħana li fih pakkett folji ta' 11 x 0.5 mg u 14 x 1 mg varenicline pilloli miksijin b'rita u pakkett folji ta' 28 jew 2 pakketti folji ta' 14 x 1 mg varenicline pilloli miksijin b'ritatikketta ta' ġewwa u ta' barra
English: CA* wk 13-24 70.6% 49.8% 20.8% CA* wk 13-52 44.0% 37.1% 6.9%
Maltese: CA* ġimgħa 9-12 45.0%
English: Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg varenicline film-coated tablets and 1 blister pack of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling
Maltese: Pakkett tal-kartun issiġillat bis-sħana li fih pakkett folji ta' 11 x 0.5 mg varenicline pilloli miksijin b'rita u pakkett folji ta' 14 x 1 mg varenicline pilloli miksijin b'rita - tikketta ta' ġewwa u ta' barra
English: Conjunctivitis, eye pain
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Through end of study MACE, n (%)
Maltese: Sal-aħħar tal-istudju MACE, n (%)
English: Subjects were randomised to CHAMPIX 1 mg twice daily (n=353) or placebo (n=350) for 12 weeks and then were followed for 40 weeks post-treatment.
Maltese: Suġġetti magħżula bl-addoċċ ingħataw CHAMPIX 1 mg darbtejn kuljum (n=353) jew plaċebo (n=350) għal 12-il ġimgħa, li mbagħad kienu osservati għal 40 ġimgħa wara t-trattament.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Maltese: Folji tal-PCTFE/PVC b'rinforz ta' folja ta' l-aluminju f'pakkett li fih 28 x 1 mg pillola miksija b'rita f'pakkett sekondarju tal-kartun issiġillat bis-sħana.
English: PVC blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in one secondary heat sealed card pack and PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 x 1 mg film-coated tablets.
Maltese: Folji tal-PVC b'rinforz ta' folja tal-aluminju li fihom folja waħda trasparenti ta' 11 x 0.5 mg u 14 x 1 mg pillola miksija b'rita u folja 1 trasparenti ta' 28 jew 2 folji trasparenti ta' 14 x 1 mg pillola miksija b'rita f'pakkett sekondarju wieħed tal-kartun issiġillat bis-sħana u folji tal-PVC b'rinforz ta' folja tal-aluminju li fihom żewġ pakketti sekondarji tal-kartun issiġillati bis-sħana li kull wieħed fih 56 x 1 mg pillola miksija b'rita.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton.
Maltese: Folji tal-PCTFE/PVC b'rinforz ta' folja ta' l-aluminju f'pakkett li fih 56 x 1 mg pillola miksija b'rita f'kaxxa.
English: The efficacy of CHAMPIX in smoking cessation was demonstrated in 3 clinical trials involving chronic cigarette smokers ( 10 cigarettes per day).
Maltese: L-effikaċja ta' CHAMPIX fil-waqfien mit-tipjip ġiet murija fi 3 provi kliniċi li kienu jinvolvu fumaturi kroniċi tas-sigarretti (10 sigarretti kuljum).
English: In addition, the table shows the subset of the composite NPS AE endpoint of severe intensity:
Maltese: Barraminhekk, it-tabella turi l-punt tat-tmiemtal-AE NPS kompost ta' intensità severa:
English: CHAMPIX can also reduce the enjoyment of cigarettes if you do smoke when on treatment.
Maltese: CHAMPIX jista' jnaqqas ukoll il-pjaċir tas-sigarretti jekk inti tpejjep waqt il-kura.
English: Patients taking CHAMPIX should be instructed to notify their doctor of new or worsening cardiovascular symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke (see section 5.1).
Maltese: Il-pazjenti għandhom iffittxu għajnuna medika immedjatament jekk ikollhom sinjali jew sintomi ta' infart mijokardijaku jew puplesija (ara sezzjoni 5.1).
English: For patients with moderate renal impairment who experience adverse reactions that are not tolerable, dosing may be reduced to 1 mg once daily.
Maltese: Għall-pazjenti b'indeboliment moderat tal-kliewi li jesperjenzaw reazzjonijiet avversi li ma jkunux tollerabbli, id-doża tista' titnaqqas għal 1 mg darba kuljum.
English: Rash, pruritus Erythema, acne, hyperhidrosis, night sweats
Maltese: Raxx, ħakk Eritema, akne, iperidrosi, tagħriq bil-lejl
English: INTERMEDIATE CARTON
Maltese: TIKKETTAR
English: In the offspring of pregnant rats treated with varenicline there were decreases in fertility and increases in the auditory startle response (see section 4.6).
Maltese: Fil-frieħ ta' firien tqal ikkurati b'varenicline kien hemm tnaqqis fil-fertilita' u żidiet fir-rispons ta' ħasda għall-ħoss (ara sezzjoni 4.6).
English: Eye disorders Uncommon Rare
Maltese: Imġiba anormali
English: Haematochezia, gastritis, change of bowel habit, eructation, aphthous stomatitis, gingival pain Haematemesis, abnormal faeces, tongue coated Skin and subcutaneous tissue disorders Common Uncommon
Maltese: Tensjoni akbar fil-muskoli, diffikultà fid-diskors, diffikultà fil-koordinazzjoni, tnaqqis fis-sens tat-togħma, bdil fil-ħin tal-irqad
English: Reproductive system and breast disorders Uncommon
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni
English: If you have problems with your kidneys, you should speak to your doctor before taking CHAMPIX.
Maltese: Għal aktar dettalji ara hawn taħt fis-sezzjoni ‘Mediċini oħra u CHAMPIX' .
English: Furthermore since metabolism of varenicline represents less than 10% of its clearance, active substances known to affect the cytochrome P450 system are unlikely to alter the pharmacokinetics of varenicline (see section 5.2) and therefore a dose adjustment of CHAMPIX would not be required.
Maltese: Barra minn hekk, billi l-metaboliżmu ta' varenicline jirrappreżenta anqas minn 10% ta' l-eliminazzjoni tiegħu, sustanzi attivi magħrufa li jaffettwaw is-sistema taċ-ċitokromu P450 mhumiex probabbli li jbiddlu l-farmakokinetiċi ta' varenicline (ara sezzjoni 5.2) u għalhekk m'għandux ikun meħtieġ aġġustament fid-doża ta' CHAMPIX.
English: Contains No Blue Box
Maltese: Ma fih l-Ebda Kaxxa Blu
English: Pharmacokinetics in special patient populations
Maltese: Farmakokinetiċi f'popolazzjonijiet speċjali ta' pazjenti
English: All studies were retrospective cohort studies and included patients with and without a psychiatric history.
Maltese: L-istudji kollha kienu studji ta' koorti retrospettivi u inkludew pazjenti bi storja psikjatrika jew mingħajrha.
English: There have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients taking CHAMPIX.
Maltese: Kien hemm rapporti ta' dipressjoni, ideat u atteġjamenti ta' suwiċidju f'pazjenti li jkunu qed jieħdu CHAMPIX.
English: To quit gradually, please refer to package leaflet for dosing instructions.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għal skop kummerċjali.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton.
Maltese: Folji tal-PCTFE/PVC b'rinforz ta' folja ta' l-aluminju f'pakkett li fih 28 x 1 mg pillola miksija b'rita f'kaxxa.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets, heat sealed card
Maltese: Pakkett folji ta' 11 x 0.5 mg u 14 x 1 mg varenicline pilloli miksija b'rita, kartuna issiġillata bis-sħana
English: History of psychiatric disorders
Maltese: Disturbi psikjatriċi
English: PVC blisters with aluminium foil backing in a pack containing 56 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Maltese: Folji tal- PVC b'rinforz ta' folja ta' l-aluminju f'pakkett li fih 56 x 0.5 mg pillola miksija b'rita f'pakkett sekondarju tal-kartun issiġillat bis-sħana.
English: Pooled data from these 18 trials showed a similar incidence rate of individual categories of psychiatric events in patients treated with varenicline compared to patients treated with placebo.
Maltese: Id-dejta miġbura minn dawn it-18-il prova wriet rata ta' inċidenza simili ta' kategoriji individwali ta' avvenimenti psikjatriċi f'pazjenti kkurati b'varenicline meta mqabbla ma' pazjenti kkurati bi plaċebo.
English: In addition, independent observational studies have not supported an increased risk of serious neuropsychiatric events in patients treated with varenicline compared to patients prescribed nicotine replacement therapy (NRT) or bupropion.
Maltese: Barra minn hekk, l-istudji ta' osservazzjoni indipendenti ma appoġġjawx żieda fir-riskju ta' avvenimenti newropsikjatriċi serji f'pazjenti kkurati b'varenicline meta mqabbla ma' pazjenti li ġew ordnati kura b'terapija ta' sostituzzjoni tan-nikotina (NRT) jew bupropion.
English: NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg film-coated tablets CHAMPIX 1 mg film-coated tablets
Maltese: CHAMPIX 0.5 mg pilloli miksijin b'rita CHAMPIX 1 mg pilloli miksijin b'rita
English: Study in subjects with a history of major depressive disorder The efficacy of varenicline was confirmed in a randomised placebo-controlled trial of 525 subjects with a history of major depression in the past two years or under current stable treatment.
Maltese: L-effikaċja ta' varenicline kienet ikkonfermata fi studju randomizzat, double-blind, ikkontrollat bilplaċebo li sar f'525 suġġett bi storja ta' dipressjoni maġġuri fl-aħħar sentejn jew li bħalissa qegħdin fuq trattament stabbli.
English: 56 film-coated tablets
Maltese: 56 pillola miksijin b'rita
English: Blood pressure increased, hot flush Respiratory, thoracic and mediastinal disorders Common
Maltese: Pressjoni tad-demm aktar għolja, fawra Disturbi respiratorji, toraċiċi u medjastinali Komuni
English: Heat sealed card pack containing 2 blister packs of 28 or 4 blister packs of 14 x 1 mg varenicline film-coated tablets- inner and outer labelling
Maltese: Pakkett tal-kartun issiġillat bis-sħana li fih 2 pakketti folji ta' 28 jew 4 pakketti folji ta' 14 x 1 mg varenicline pilloli miksija b'rita - tikketta ta' ġewwa u ta' barra.
English: Patients treated with CHAMPIX had a superior rate of CO-confirmed abstinence during weeks 9 through 12 and from weeks 9 through 52 compared to subjects treated with placebo.
Maltese: Pazjenti kkurati b'CHAMPIX kellhom rata superjuri ta' astinenza kkonfermata ta' CO matul ġimgħat 9 sa 12 u minn ġimgħat 9 sa 52 meta mqabbla ma' individwi kkurati bi plaċebo.
English: Continuous abstinence rate between weeks 9-12 was 35.9% in the varenicline treatment group versus 15.6% in the placebo group (OR 3.35 (95% CI 2.16-5.21)) and between weeks 9-52 was 20.3% versus 10.4% respectively (OR 2.36 (95% CI 1.40-3.98)).
Maltese: Ir-rata ta' astinenza kontinwa bejn id-9 u t-12 il-ġimgħa kienet ta' 35.9% filgrupp li qed jingħata trattament b'varenicline meta mqabbla ma' 15.
English: The full EPAR and risk management plan summary for Odomzo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Of those with locally advanced basal cell carcinoma, around 56% (37 of 66 patients) on the 200-mg dose and 45% (58 of 128 patients) started on the 800-mg dose responded to treatment.
Maltese: Minn dawk b'karċinoma taċ-ċelloli bażali avvanzata lokalment, madwar 56% (37 minn 66 pazjent) fuq id-doża ta' 200 mg u 45% (58 minn 128 pazjent) li nbdew fuq id-doża ta' 800 mg irrispondew għallkura.
English: Odomzo contains the active substance sonidegib.
Maltese: Odomzo fih is-sustanza attiva sonidegib.
English: This is a summary of the European public assessment report (EPAR) for Odomzo.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Odomzo.
English: The most common side effects with Odomzo (which may affect more than 1 in 10 people) are muscle spasms, hair loss, taste disturbance, tiredness, nausea, vomiting, muscle and bone pain, belly ache, headache, diarrhoea, weight loss, loss of appetite, and itching.
Maltese: L-effetti sekondarji l-aktar komuni b'Odomzo (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma spażmi tal-muskoli, telf tax-xagħar, disturb fit-tomgħa, nawżja, rimettar, uġigħ fil-muskoli u flgħadam, uġigħ ta' żaqq, uġigħ ta' ras, telf fil-piż tal-ġisem, nuqqas ta' aptit, u ħakk.
English: Sonidegib, the active substance in Odomzo, attaches to a protein that controls the Hedgehog signalling pathway.
Maltese: Sonidegib, is-sustanza attiva f'Odomzo, jeħel ma' proteina li tikkontrolla l-passaġġ ta' sinjalazzjoni ta' Hedgehog.
English: Other information about Odomzo
Maltese: Informazzjoni oħra dwar Odomzo
English: Patients were started on two different doses of Odomzo: 200 or 800 mg once a day.
Maltese: Il-pazjenti nbdew fuq żewġ dożi differenti ta' Odomzo: 200 jew 800 mg darba kuljum.
English: Why is Odomzo approved?
Maltese: Għaliex ġie approvat Odomzo?
English: It also considered that the side effects were manageable.
Maltese: Ikksunsidra wkoll li l-effetti sekondarji kienu maniġġabbli.
English: What are the risks associated with Odomzo?
Maltese: X'inhuma r-riskji assoċjati ma' Odomzo?
English: Odomzo is a cancer medicine used to treat adults with basal cell carcinoma (a type of skin cancer) which is locally advanced (has started to spread nearby) and which cannot be treated either by surgery or by radiotherapy (treatment with radiation).
Maltese: Odomzo huwa mediċina kontra l-kanċer li tintuża fil-kura ta' adulti b'karċinoma (tip ta' kanċer talġilda) taċ-ċelloli bażali avvanzata lokalment (beda jinfirex fil-qrib) u li ma tistax titfejjaq permezz ta' operazzjoni jew radjuterapija (kura bir-radjazzjoni).
English: Response rates were less than 20% in patients with metastatic cancer started on either 200 or 800 mg Odomzo and the company withdrew its application for use in metastatic basal cell carcinoma.
Maltese: Ir-rati ta' rispons kienu inqas minn 20% f'pazjenti b'kanċer metastatiku li nbdew fuq 200 jew 800 mg ta' Odomzo u l-kumpanija rtirat l-applikazzjoni tagħha għall-użu f'karċinoma metastatika taċċelloli bażali.
English: Odomzo was studied in one main study involving 230 patients with basal cell carcinoma which was either locally advanced or metastatic (spread to other parts of the body).
Maltese: Odomzo ġie studjat fi studju wieħed ewlieni li involva 230 pazjent b'karċinoma taċ-ċelloli bażali li kienet jew avvanzata lokalment jew metastatika (mifruxa ma' partijiet oħrajn tal-ġisem).
English: Odomzo is available as capsules (200 mg) and the recommended dose is one capsule taken once a day at least two hours after the last meal and an hour before the next.
Maltese: Odomzo jiġi bħala kapsuli (200 mg) u d-doża rakkomandata hija ta' kapsula waħda darba kuljum talanqas sagħtejn wara l-aħħar ikla u siegħa qabel dik li jmiss.
English: It will also supply educational material to doctors and to patients, including a reminder card about the risks of the medicine and, in particular, the possibility of serious harm to the unborn baby if Odomzo is taken during pregnancy.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Odomzo jintuża bl-aktar mod sigur possibbli.
English: This pathway normally controls a number of cell activities including cell growth and how cells develop correctly to make up different body organs in unborn babies.
Maltese: Dan il-passaġġ normalment jikkontrolla numru ta' attivitajiet taċ-ċelloli inkluż tkabbir taċ-ċelloli u kif iċ-ċelloli jiżviluppaw b'mod korrett biex jagħmlu l-organi tal-ġisem differenti fi trabi fil-ġuf.
English: By attaching to this protein, sonidegib blocks the Hedgehog signalling pathway and thereby reduces the growth and spread of cancer cells.
Maltese: Billi jeħel ma' din il-proteina, sonidegib jimblokka l-passaġġ ta' sinjalazzjoni ta' Hedgehog u b'hekk inaqqas it-tkabbir u l-firxa ta' ċelloli tal-kanċer.
English: For the full list of all side effects reported with Odomzo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Odomzo, ara l-fuljett ta' tagħrif.
English: Women who could potentially become pregnant must not take Odomzo unless they comply with the Odomzo pregnancy prevention programme.
Maltese: Nisa li jistgħu joħorġu tqal m'għandhomx jieħdu Odomzo sakemm ma jikkonformawx mal-programm ta' prevenzjoni tat-tqala ta' Odomzo.
English: Some cancers, including basal cell carcinoma, result from overactivity of a specific set of cell processes called the Hedgehog signalling pathway.
Maltese: Xi kanċers, inkluż karċinoma taċ-ċelloli bażali, jirriżultaw minn attività żejda ta' sett speċifiku ta' proċessi taċ-ċelloli msejjaħ il-passaġġ ta' sinjalazzjoni ta' Hedgehog.
English: The main measure of effectiveness was the response to treatment, based on a reduction in tumour size and improvement in other signs of cancer; treatment was considered sufficiently effective if the response rate was at least 30%.
Maltese: Il-kejl ewlieni tal-effikaċja kien ir-rispons għall-kura, abbażi ta' tnaqqis fid-daqs tat-tumur u titjib f'sinjali oħrajn tal-kanċer; ilkura ġiet ikkunsidrata effikaċi b'mod suffiċjenti jekk ir-rata ta' rispons kienet tal-anqas 30%.
English: Cats and dogs
Maltese: Qtates u klieb
English: 1 bottle + 1 oral syringe + 1 press-in bottle adapter
Maltese: 1 flixkun + 1 siringa orali + 1 adapter li jingħafas tal-flixkun
English: Powder for oral suspension
Maltese: Użu orali
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (EU) Isem (ivvintat)Qawwa Għamla farmaċewtika
English: 1 vial + 1 vial + 2 vial adapters + 1 syringe + 1 infusion set + 2 alcohol swabs +1 sterile swab + 1 plaster
Maltese: 1 kunjett + 1 kunjett + 2 adapters talkunjett + 1 siringa + 1 sett tal-infużjoni + 2 tajjariet blalkoħol +1 pad sterili + 1 stikk
English: Powder: 2100 U Solvent: 20 ml
Maltese: U Solvent: 20 ml
English: 2100 U Powder for solution for injection
Maltese: 2100 U Trab għal soluzzjoni għal injezzjoni
English: Intravenous use Powder: vial (glass)
Maltese: Trab: kunjett (tal-ħġieġ) Solvent: kunjett (talħġieġ)
English: Solvent: vial (glass)
Maltese: Isem (ivvintat)
English: 2100 U Powder and solvent for solution for injection
Maltese: U Trab u solvent għal soluzzjoni għal injezzjoni
English: Icandra with alcohol
Maltese: Icandra ma' alkoħol
English: Icandra is not a substitute for insulin.
Maltese: Icandra mhux sostitut għall-insulina.
English: Icandra should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
Maltese: Icandra m'għandux jintuża f'pazjenti b'indeboliment tal-fwied, inklużi pazjenti li jkollhom alanine aminotransferase (ALT) jew aspartate aminotransferase (AST) qabel il-kura > 3 darbiet il-limitu ta' fuq tan-normal (ULN) (ara sezzjonijiet 4.3, 4.4 u 4.8).
English: The rate and extent of absorption of metformin from Icandra 50 mg/1000 mg were decreased when given with food as reflected by the decrease in Cmax by 26%, AUC by 7% and delayed Tmax (2.0 to 4.0 h).
Maltese: Ir-rata u l-grad ta' assorbiment ta' metformin milIcandra 50 mg/1000 mg kienu mnaqqsa meta mogħtija ma' l-ikel bi tnaqqis fis-Cmax b'26%, AUC b'7% u Tmax ittardjat (2.0 sa 4.0 h).
English: Adults with normal renal function (GFR ≥ 90 ml/min) The dose of antihyperglycaemic therapy with Icandra should be individualised on the basis of the patient's current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin.
Maltese: Adulti b'funzjoni renali normali (GFR ≥ 90 mL/min) Id-doża ta' terapija anti-ipergliċemika b'Icandra għandha tiġi individwalizzata abbażi tal-programm ta' kura attwali tal-pazjent, l-effettività u t-tollerabilità waqt li ma taqbiżx id-doża massima rakkomandata ta' kuljum ta' 100 mg vildagliptin.
English: Icandra combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class.
Maltese: Icandra jikkombina żewġ aġenti kontra l-ipergliċemija b'mekkaniżmu ta' azzjoni kumplimentari sabiex jitjieb il-kontroll ta' pazjenti bid-dijabete tat-tip 2: vildagliptin, membru tal-klassi li jtejjeb lislet, u metformin hydrochloride, membru tal-klassi biguanide.
English: The active substances of Icandra, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”.
Maltese: Is-sustanzi attivi ta' Icandra, vildagliptin u metformin, jagħmlu parti minn grupp ta' mediċini li jissejħu “antidijabetiċi orali”.
English: Other medicines and Icandra
Maltese: Mediċini oħra u Icandra
English: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Icandra should have their renal function monitored regularly (see sections 4.4 and 5.2).
Maltese: Peress illi metformin jiġi eliminat mill-kilwa, u pazjenti anzjani għandhom it-tendenza li jkollhom funzjoni renali mnaqsa, pazjenti anzjani li jkunu qed jieħdu Icandra għandu jkollhom il-funzjoni renali immonitorata b'mod regolari (ara sezzjonijiet 4.4 u 5.2).
English: Bioequivalence has been demonstrated between Icandra at three dose strengths (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) versus free combination of vildagliptin and metformin hydrochloride tablets at the corresponding doses.
Maltese: Intweriet bioekwivalenza mejn Icandra fi tlett qawwiet ta' dożi (50 mg/500 mg, 50 mg/850 mg u 50 mg/1000 mg), kontra kombinazzjoni ħielsa ta' pilloli ta' vildagliptin u metformin hydrochloride bid-dożi li jikkorrispondu għalihom.
English: Metformin is contraindicated in patients with GFR < 30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Maltese: Metformin huwa kontraindikat f'pazjenti b'GFR < 30 mL/min u għandu jitwaqqaf temporanjament filpreżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali (ara sezzjoni 4.3).
English: However, bioequivalence of Icandra with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
Maltese: Madankollu, il-bioekwivalenza ta'Icandra meta ngħata flimkien ma' vildagliptin u metformin ġiet murija (ara sezzjoni 5.2).
English: Icandra 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Maltese: Icandra 50 mg/850 mg pilloli miksija b'rita vildagliptin/metformin hydrochloride
English: What Icandra contains - The active substances are vildagliptin and metformin hydrochloride.
Maltese: X'fih Icandra - Is-sustanzi attivi huma vildagliptin u metformin hydrochloride.
English: There have been no therapeutic clinical trials conducted with Icandra.
Maltese: Ma sarux provi kliniċi terapewtiċi b'Icandra.
English: Children and adolescents The use of Icandra in children and adolescents up to 18 years of age is not recommended.
Maltese: Tfal u adolexxenti L-użu ta' Icandra fi tfal u adolexxenti ta' età ta' sa 18-il sena mhux rakkomandat.
English: Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Maltese: Icandra 50 mg/1000 mg pilloli miksija b'rita vildagliptin/metformin hydrochloride