FrancophonIA/ELRC3.0 huggingface dataset:
English: Codeine is an opioid that is authorised as a painkiller in adults and children.
Maltese: Il-kodeina hija opjojde awtorizzata bħala analġesiku fl-adulti u fit-tfal.
English: The product information for codeine should also include general information for healthcare professionals, patients and carers on the risk of morphine side effects with codeine, and how to recognise their symptoms.
Maltese: L-informazzjoni dwar il-prodott għall-kodeina għandha wkoll tinkludi informazzjoni ġenerali għall-professjonisti tal-kura tas-saħħa, għall-pazjenti u dawk li jieħdu ħsiebhom dwar ir-riskju ta' effetti sekondarji tal-morfina bil-kodeina, u kif jagħrfu s-sintomi tagħhom.
English: Nevertheless, it is considered that codeine still has a place in the treatment of acute pain in the paediatric population and given the concerns about its risks, it should only be used in line with the updated indication, contraindications, warnings and other changes to the product information described above.
Maltese: Madankollu, huwa meqjus li lkodeina għad għandha post fil-kura tal-uġigħ akut fil-popolazzjoni pedjatrika u minħabba t-tħassib dwar ir-riskji tagħha, għandha tintuża biss skont l-indikazzjoni, kontraindikazzjonijiet, twissijiet u tibdil ieħor lill-informazzjoni dwar il-prodott aġġornati deskritti hawn fuq.
English: • The available efficacy data on codeine for pain relief in children suggest that the analgesic effect of codeine on pain is not superior to that of other analgesics, such as non-steroidal anti-inflammatory drugs and non-opioid analgesics.
Maltese: • Id-dejta disponibbli dwar l-effikaċja tal-kodeina għas-serħan mill-uġigħ fit-tfal tissuġġerixxi li leffett analġesiku tal-kodeina fuq l-uġigħ mhuwiex superjuri għal dak b'analġesiċi oħra, bħal mediċini anti-infjammatorji mhux sterojdi u analġesiċi mhux opjojdi.
English: ATCvet code: QM01AH92.
Maltese: QM01AH92.
English: Località Marino del Tronto 63100 Ascoli Piceno (AP) ITALY
Maltese: Località Marino del Tronto 63100 Ascoli Piceno (AP)
English: Date of last renewal: 12/08/2013.
Maltese: Data tal-aħħar tiġdid: 12/08/2013.
English: It is a diarylsubstituted pyrazole.
Maltese: Hija diarylsubstituted pyrazole.
English: EU/2/08/084/001 (6 mg) EU/2/08/084/002 (20 mg) EU/2/08/084/003 (30 mg) EU/2/08/084/004 (75 mg) EU/2/08/084/005 (95 mg)
Maltese: EU/2/08/084/001 (6 mg) EU/2/08/084/002 (20 mg) EU/2/08/084/003 (30 mg) EU/2/08/084/004
English: Mavacoxib is 4-[5-(4-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-benzenesulfonamide.
Maltese: Mavacoxib hija 4-[5-(4-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-benzenesulfonamide.
English: Bodyweight (kg)
Maltese: Piż (kg)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/084/001-005
Maltese: EU/2/08/084/001-005
English: At 25 mg/kg there was evidence of gastrointestinal ulceration.
Maltese: B'doża ta' 25mg/kg kien hemm sinjali ta' ulċerazzjoni gastrointestinali.
English: There are two isoforms of COX, COX-1, and COX-2.
Maltese: Hemm żewġ isoforms ta' COX, COX-1 u COX-2.
English: Manufacturer responsible for batch release: Pfizer Italia s.r.l.
Maltese: Manifattur responsabbli għall-ħrug tal-lott: Pfizer Italia s.r.l.
English: Oral use.
Maltese: Doża orali.
English: Silicified microcrystalline cellulose Artificial powdered beef flavour Croscarmellose sodium Sodium laurylsulfate Magnesium stearate
Maltese: Croscarmellose sodium Sodium laurylsulfate Magnesium stearate
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/09/2008
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 09/09/2008.
English: Mavacoxib exhibits an extended plasma half life (up to > 80 days, see section 5.2) due to its low rate of elimination.
Maltese: Mavacoxib jesibixxi plasma half life imtawla (sa aktar minn 80 ġurnata, ara sezzjoni 5.2) minħabba li għandu rata baxxa ta' eliminazzjoni.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għal użu orali.
English: Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1
Maltese: ZoetisBelgium SA Rue Laid Burniat 1
English: THIS IS NOT A DAILY NSAID.
Maltese: NSAID TA' KULJUM.
English: Mavacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class.
Maltese: Mavacoxib hija mediċina anti-infjammatorja li mhix sterojd (NSAID) tal-klassi coxib.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal)
English: Based on the results of canine whole blood assays, plasma concentrations producing 20% COX-1 inhibition and 80% COX-2 inhibition were 2.46 µg/mL and 1.28 µg/mL, respectively, so that the IC20COX-1:IC80COX-2 potency ratio is approximately 2:1, whilst the IC80COX-1:IC80COX-2 potency ratio is approximately 40:1.
Maltese: Abbażi ta' studji fuq demm sħiħ tal-klieb, il-konċentrazzjoni fil-plażma li jwasslu għal inibizzjoni ta' 20% tal-COX-1 u 80% tal-COX-2 kienu ta' 2.46 μg/ml u 1.28 μg/ml rispettivament biex il-potency ratio IC20COX-1:IC80COX-2 hija bejn wieħed u ieħor 2:1, filwaqt li l-potency ratio IC80COX1:IC80COX-2 hija bejn wieħed u ieħor 40:1.
English: In laboratory studies with young adult dogs, mean elimination half-life values ranged from 13.8 to 19.3 days.
Maltese: Il-half-life medja ta' eliminazzjoni fi studji tal-laboratorju fuq klieb adulti żgħar kienet ta' bejn 13.8 u 19.3 ġranet.
English: Mavacoxib is approximately 98% bound to plasma proteins.
Maltese: Madwar 98% ta' mavacoxib tabbina mal-proteini tal-plażma.
English: Chewable tablets
Maltese: Żewġ pilloli
English: -Blister foil base: PVC film /aluminium foil/ nylon -Blister backing: vinyl heat seal coating /aluminium foil/polyester film/printable paper Not all pack sizes may be marketed.
Maltese: - Bażi tal-folja: film tal-PVC, /folja tal-aluminjum/najlon - Warrani tal-folja: kisja ta' vinyl issiġillata bis-sħana, folja tal-aluminjum, qoxra irqiqa ta' polyester, karta li tista' tistampa fuqha.
English: The products of COX-2 metabolism are also involved in ovulation, implantation and closure of the ductus arteriosus.
Maltese: Il-prodotti mill-metaboliżmu ta' COX-2 huma involuti ukoll fl-ovulazzjoni, impjantazzjoni u l-għeluq tad-ductus arteriosus.
English: Do not use concomitantly with glucocorticoids or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), see section 4.8.
Maltese: Tużax fl-istess ħin ma' glukokortikosterojdi jew Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) oħra, ara sezzjoni 4.8.
English: In overdose safety studies, repeated doses of 5 mg/kg and 10 mg/kg were not associated with adverse clinical events, abnormal clinical chemistry or significant histological abnormalities.
Maltese: Fi studji tas-sigurtà waqt dożi eċċessivi, dożi ta' 5mg/kg u 10mg/kg mogħtija ripetutament, ma kinux assoċjati ma' sinjali kliniċi mhux mixtieqa, kimika klinika mhux normali jew abnormalitajiet ħistoloġiċi sinifikanti.
English: The principal mode of action is inhibition of cyclooxygenase (COX).
Maltese: Il-mod prinċipali ta' azzjoni hija li timblokka is-cyclooxygenase (COX).
English: Population pharmacokinetic data derived from studies in dogs with a predominantly older population with heavier dogs as compared to the experimental studies (mean 9 years of age) showed that the mean elimination half-life was 39 days with a small sub-population (<5%) having an elimination half-life of more than 80 days and correspondingly an increased exposure was recorded in these individuals.
Maltese: Data farmakokinetika miġbura minn studji fuq popolazzjoni bi predominazzjoni ta' popolazzjoni ta' klieb aktar xjuħ u kabbarin ikkumparat ma' studji esperimentali (medja ta' 9 snin) urew half-life ta' eliminazzjoni medja ta' 39 ġurnata u fi grupp żgħir tal-popolazzjoni (<5%) b'half-life ta' eliminazzjoni ta' aktar minn 80 ġurnata, u b'mod korrispondenti, f'dawn l-individwi, kienet irrekordjata rata akbar ta' espozizzjoni.
English: Each blister contains two tablets of 6 mg, 20 mg, 30 mg, 75 mg or 95 mg mavacoxib, respectively.
Maltese: Kull folja fiha żewġ pilloli ta' 6 mg, 20 mg, 30 mg, 75 mg jew 95 mg mavacoxib rispettivament.
English: Use the dose prescribed by the veterinarian.
Maltese: Uża d-doża preskritta mill-veterinarju.
English: These IC concentrations may be compared with mean trough concentrations of mavacoxib in plasma in clinical subjects of 0.52 and 1.11 µg/mL, respectively, after the first and fifth doses.
Maltese: Dawn il-konċentrazzjonijiet IC jistgħu jiġu mqabbla malmedja ta' konċentrazzjonijiet baxxi fil-plażma ta' pazjenti kliniċi ta' 0.52 u 1.11 μg/ml mavacoxib rispettivament, wara l-ewwel u l-ħames doża.
English: Mavacoxib is well absorbed after oral administration; bioavailability was 87% in fed dogs and 46 % in fasted conditions and the recommended dose is based on administration with food.
Maltese: Mavacoxib tiġi assorbita sew wara li tingħata mill-ħalq; il-bioavilibilita kienet ta' 87% fi klieb li kienu mitmugħa u 46% f'kundizzjonijiet ta' sawm u d-doża rakkomandata hija bbażata fuq amministrazzjoni mal-ikel.
English: Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, Coxibs.
Maltese: Prodotti kontra l-infjammazzjoni u r-rewmatiżmu, mhux sterojdi, coxibs.
English: Trocoxil 6 mg chewable tablets for dogs Trocoxil 20 mg chewable tablets for dogs Trocoxil 30 mg chewable tablets for dogs Trocoxil 75 mg chewable tablets for dogs Trocoxil 95 mg chewable tablets for dogs
Maltese: Trocoxil 6 mg pilloli li jintmagħdu għal klieb Trocoxil 20 mg pilloli li jintmagħdu għal klieb Trocoxil 30 mg pilloli li jintmagħdu għal klieb Trocoxil 75 mg pilloli li jintmagħdu għal klieb Trocoxil 95 mg pilloli li jintmagħdu għal klieb
English: COX is a key enzyme in pathways of arachidonic acid metabolism.
Maltese: COX huwa l-enżim ewlieni fil-proċess ta' metaboliżmu ta' aċidu arakidoniku.
English: A maximum treatment administration of 6.5 months continuous therapy is recommended so as to manage plasma levels of mavacoxib in animals which exhibit reduced elimination
Maltese: Huwa rakkomandat trattament kontinwu sa massimu ta' 6.5 xhur sabiex timmaniġja il-livell ta' mavacoxib fil-plasma t'annimali li juru rata mnaqqsa ta' eliminazzjoni.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/
English: 1 tablet contains 30 mg of mavacoxib.
Maltese: Mavacoxib 6 mg Mavacoxib 20 mg Mavacoxib 30 mg.
English: Apathy, degradation of renal biochemistry parameters and impaired renal function have been reported in uncommon cases.
Maltese: Nuqqas ta' ħeġġa, tħarbit fil-parametri bijokimiċi u mpediment fil-funzjoni renali ġew rappurtatib'mod anqas komuni.
English: Sucrose
Maltese: Zokkor
English: If you have a known hypersensitivity to NSAIDs you should avoid contact with the veterinary medicinal product.
Maltese: Jekk taf li inti sensittiv għal NSAIDs għandek tevita li tmiss mal-prodott mediċinali veterinarju.
English: At 15 mg/kg there was evidence of vomiting, and softened/mucoid faeces and an increase in clinical chemistry parameters reflecting renal function.
Maltese: B'doża ta' 15mg/kg kien hemm sinjali ta' remettar, u ppurgar artab/sliħ u żieda fil-parametri kliniċi kimiċi li jirriflettu l-funzjoni renali.
English: 1 tablet contains 75 mg of mavacoxib.
Maltese: Mavacoxib 75 mg Mavacoxib 95 mg
English: COX-1 is a widely distributed constitutive enzyme, primarily involved in maintaining organ and tissue function, whilst COX-2 is inducible at sites of tissue damage but in some organs it is also constitutive.
Maltese: COX-1 huwa enżim essenzjali mifrux ħafna, li x-xogħol prinċipali tiegħu huwa li jmantni l-funzjoni tal-organi u t-tessuti, filwaqt li COX-2 jifforma f'postijiet fejn it-tessuti jġarrbu ħsara imma f'xi organi huwa wkoll kostitwent.
English: Mavacoxib acts by preferential inhibition of COX-2-mediated prostaglandin synthesis.
Maltese: Mavacoxib jaħdem billi b'mod preferenzjali jimblokka is-sinteżi ta' prostaglandins li jiffurmaw permezz tal-COX-2.
English: Blister packs containing two tablets of the same strength per pack, each tablet containing 6 mg, 20 mg, 30 mg, 75 mg or 95 mg of mavacoxib.
Maltese: Folji li fihom żewġ pilloli tal-istess saħħa f'kull pakkett, kull pillola fiha 6mg, 20mg, 30mg, 75mg jew 95mg mavacoxib.
English: In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
Maltese: F'każ ta' amministrazzjoni aċċidentali lilek innifsek, fittex parir mediku immedjatament u qis li turilfuljett ta' informazzjoni li jkun fih il-pakkett jew it-tikketta lit-tabib.
English: Do not use concomitantly with glucocorticoids or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Maltese: Tużax fl-istess ħin ma' glukokortikosterojdi jew Non-Steroidal Anti-Inflammatory Drugs(NSAIDs) oħra,
English: Trocoxil 6 mg chewable tablets for dogs Trocoxil 20 mg chewable tablets for dogs Trocoxil 30 mg chewable tablets for dogs Trocoxil 75 mg chewable tablets for dogs Trocoxil 95 mg chewable tablets for dogs Mavacoxib
Maltese: Pillola waħda fiha 6 mg mavacoxib Pillola waħda fiha 20 mg mavacoxib Pillola waħda fiha 30 mg mavacoxib Pillola waħda fiha 75 mg mavacoxib Pillola waħda fiha 95 mg mavacoxib
English: 95 mg For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Ingestion of Trocoxil may be harmful for children, and prolonged pharmacological effects leading to e.g. gastrointestinal disorders may be observed.
Maltese: It-teħid ta' Trocoxil jista' jkun ta' ħsara fit-tfal , u jistgħu jidhru effetti farmakoloġiċi fit-tul li jwasslu għal eż. taqlib gastrointestinali.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Maltese: Saqsi lill-kirurgu veterinarju tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: Read the package leaflet before use.
Maltese: Mhux id-daqsijiet kollha tal-pakketti jistgħu qegħdin fis-suq.
English: In rare cases these adverse reactions may be fatal.
Maltese: F'każijiet rari dawn leffetti mhux mixtieqa jistgħu ikunu fatali.
English: Carton boxes containing one blister.
Maltese: Mhux applikabbli.
English: Both COX-1 and COX-2 are present constitutively in the kidney and are assumed to possess protective roles in adverse physiological circumstances.
Maltese: Kemm COX-1 u COX2 huma parti mill-kliewi u huwa mifhum li għandhom rwol ta' protezzjoni f'ċirkustanzi fisjoloġiċi mhux mixtieqa.
English: Veterinarians should be aware that clinical signs of adverse reactions may continue when supportive therapy (such as gastro protectants) is discontinued.
Maltese: Il-veterinarji għandhom ikunu jafu li sinjali kliniċi ta' reazzjonijiet mhux mixtieqa jistgħu ikomplu wara li titwaqqaf il-kura ta' appoġġ (bħal għoti ta' kura protettiva għall-istonku).
English: Do not use where there is evidence of a haemorrhagic disorder.
Maltese: Tużax meta jkun hemm sinjali ta' diżordnijiet emorraġiċi.
English: Its activity culminates in the synthesis of local hormones and inflammatory mediators, termed eicosanoids, which include several prostaglandins.
Maltese: L-attività tiegħu tilħaq il-qofol fis-sintesi ta' ormoni lokali u medjaturi tal-infjammazzjoni, imsejħa eikosanojdi, li jinkludu ħafna prostaglandins.
English: Trocoxil should not be used in dehydrated dogs.
Maltese: Trocoxil m'għandux jintuża fi klieb disidratati.
English: Gastrointestinal ulceration was reported in rare cases.
Maltese: Ġew rappurtati b'mod rari każijiet ta' ulċerazzjoni gastro-intestinali.
English: Care should be taken to ensure that the tablet is ingested.
Maltese: Tużax f'każi ta' insuffiċjenza kardijaka
English: In common with other NSAIDs, Trocoxil should not be administered simultaneously with other NSAIDs or glucocorticosteroids.
Maltese: Għandha tiġi evitata l-amministrazzjoni fl-istess ħin ta' prodotti mediċinali li jistgħu jkunu nefrotossiċi.
English: Adverse reactions of the digestive tract such as vomiting and diarrhoea were commonly reported, loss of appetite, haemorrhagic diarrhoea and melaena have been reported in uncommon cases.
Maltese: It-trattament għandu jiġi ripetut 14-il jum wara, imbagħad il perjodu bejn doża u oħra huwa TA' XAHAR.
English: Do not use in case of known hypersensitivity to sulphonamides.
Maltese: Tużax f'każ ta' sensittività magħrufa għas-sulfonamidi.
English: Trocoxil belongs to a group of medicines called Non-steroidal Anti-inflammatory drugs (NSAIDs) which are used to treat pain and inflammation.
Maltese: Trocoxil tagħmel parti mill-grupp ta' mediċini li jissejħu Non-steroidal Anti-inflammatory drugs (NSAIDs) li jintużaw għal kura ta'uġiegħ u infjammazzjoni.
English: Before prescribing Trocoxil and during treatment with Trocoxil, your veterinarian will check your dog for kidney and liver problems as well as for diseases of the intestines.
Maltese: Qabel ma jikteb Trocoxil u waqt il-kura bi Trocoxil, il-veterinarju tiegħek jinvista l-kelb tiegħek għal problemital-kliewi u tal-fwied kif ukoll għal mard fl-imsaren.
English: PHARMACEUTICAL FORM Chewable tablets
Maltese: GĦAMLA FARMAĊEWTIKA Pilloli li jintmagħdu
English: POLPHARMA Biuro Handlowe Sp. z o.o.
Maltese: POLPHARMA Biuro Handlowe Sp. z o.o. Tel.
English: Date of first authorisation: 21 March 2007 Date of latest renewal: 20 January 2012
Maltese: Data tal-aħħar tiġdid: 20 ta' Jannar 2012
English: - an allergic reaction to Xelevia (see section 4).
Maltese: - reazzjoni allerġika għal Xelevia (ara sezzjoni 4).
English: Suomi/Finland Orion Oyj
Maltese: Orion Oyj
English: Neopharmed Gentili S.p.A. Tel: +39 02891321 regulatory@neogen.it
Maltese: Tel: +39 02891321 regulatory@neogen.it
English: Ferrer Internacional, S.A. Tel: +34 93 600 37 00 medicaldep@ferrergrupo.com
Maltese: Tel: +34 93 600 37 00 medicaldep@ferrergrupo.com
English: Xelevia is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Maltese: Xelevia huwa membru ta' klassi ta' sustanzi anti-ipergliċemiċi orali li jissejħu inibituri ta' dipeptidyl peptidase 4 (DPP-4).
English: Deutschland BERLIN-CHEMIE AG Tel: +49 (0) 30 67070
Maltese: Tel: +49 (0) 30 67070
English: Over the course of the study, the overall estimated mean (SD) difference in HbA1c between thesitagliptin and placebo groups was 0.29 % (0.01), 95 % CI (-0.32, -0.27); p < 0.001.
Maltese: Matul l-istudju, il-medja totali stmata (SD) tad-differenza f'HbA1c bejn il-gruppi ta' sitagliptin u lplaċebo kienet 0.29 % (0.01), CI ta' 95 % (-0.32, -0.27); p < 0.001.
English: The effect of potent CYP3A4 inhibitors in the setting of renal impairment has not been assessed in a clinical study.
Maltese: Leffett ta' inibituri qawwija ta' CYP3A4 fil-każ ta' indeboliment renali ma ġiex valutat fi studju kliniku.
English: Sitagliptin prevents the hydrolysis of incretin hormones by DPP-4, thereby increasing plasma concentrations of the active forms of GLP-1 and GIP.
Maltese: Sitagliptin tipprevjeni l-idroliżi tal-ormoni incretin mill-DPP-4, u dan għalhekk iwassal għal żieda fil konċentrazzjonijiet ta' forom attivi ta' GLP-1 u GIP fil-plażma.
English: Other medicines and Xelevia
Maltese: Mediċini oħra u Xelevia
English: Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of Xelevia as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Maltese: Ipogliċemija meta jintuża flimkien ma' prodotti mediċinali anti-iperglimiċi oħrajn Fi provi kliniċi ta' Xelevia bħala terapija waħedha u f'terapija flimkien ma' prodotti mediċinali li mhumiex magħrufin li jikkawżaw ipogliċemija (i.e. metformin u/jew agonist ta' PPARγ), ir-rati ta' ipogliċemija li ġew irrappurti b'sitagliptin kienu simili għar-rati f'pazjenti li kienu qed jieħdu plaċebo.
English: EU/1/07/382/013 EU/1/07/382/014 EU/1/07/382/015 EU/1/07/382/016 EU/1/07/382/017 EU/1/07/382/018 EU/1/07/382/023 EU/1/07/382/024
Maltese: EU/1/07/382/016 EU/1/07/382/017 EU/1/07/382/018 EU/1/07/382/023 EU/1/07/382/024
English: Rates of Composite Cardiovascular Outcomes and Key Secondary Outcomes sitagliptin 100 mg
Maltese: Tabella 3. Rati tar-Riżultati Komposti Kardjovaskulari u Riżultati Sekondarji l-Aktar Importanti
English: Xelevia 25 mg film-coated tablets Sitagliptin
Maltese: Xelevia 25 mg pilloli miksija b'rita Sitagliptin
English: Xelevia 100 mg film-coated tablets Sitagliptin
Maltese: Xelevia 100 mg pilloli miksija b'rita Sitagliptin
English: A 24-week active (metformin)-controlled study was designed to evaluate the efficacy and safety of sitagliptin 100 mg once daily (N=528) compared to metformin (N=522) in patients with inadequate glycaemic control on diet and exercise and who were not on anti-hyperglycaemic therapy (off therapy for at least 4 months).
Maltese: sitagliptin 100 mg darba kuljum (N=528) meta mqabbel ma' metaformin (N=522) f'pazjenti b'kontroll gliċemiku mhux adegwat fuq dieta u eżerċizzju u li ma kinux fuq terapija kontra lipergliċemija (ma ħadux it-terapija għal mill-inqas 4 xhur).
English: For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of Xelevia is 25 mg once daily.
Maltese: Għal pazjenti b'indeboliment qawwi tal-kliewi (GFR ≥ 15 sa <30 ml/min) jew b'mard tal-kliewi talaħħar stadju (ESRD - End Stage Renal Disease) (GFR < 15 mL/min), inklużi dawk li jeħtieġu dijalisi tad-demm jew dijalisi mill-peritonew, id-doża ta' Xelevia hija 25 mg darba kuljum.
English: Xelevia 50 mg tablets Sitagliptin
Maltese: Pilloli Xelevia 50 mg
English: Xelevia 25 mg tablets Sitagliptin
Maltese: Pilloli Xelevia 25 mg
English: EU/1/07/382/001 EU/1/07/382/002 EU/1/07/382/003 EU/1/07/382/004 EU/1/07/382/005 EU/1/07/382/006 EU/1/07/382/019 EU/1/07/382/020
Maltese: EU/1/07/382/005 EU/1/07/382/006 EU/1/07/382/019 EU/1/07/382/020
English: EU/1/07/382/013 14 film-coated tablets EU/1/07/382/014 28 film-coated tablets EU/1/07/382/023 30 film-coated tablets EU/1/07/382/015 56 film-coated tablets EU/1/07/382/016 84 film-coated tablets EU/1/07/382/024 90 film-coated tablets EU/1/07/382/017 98 film-coated tablets EU/1/07/382/018 50 x 1 film-coated tablets
Maltese: EU/1/07/382/013 14-il pillola miksija b'rita EU/1/07/382/014 28 pillola miksija b'rita EU/1/07/382/023 30 pillola miksija b'rita EU/1/07/382/015 56 pillola miksija b'rita EU/1/07/382/016 84 pillola miksija b'rita EU/1/07/382/024 90 pillola miksija b'rita EU/1/07/382/017 98 pillola miksija b'rita EU/1/07/382/018 50 x 1 pillola miksija b'rita
English: Xelevia contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Maltese: Xelevia fih is-sustanza attiva sitagliptin li hija membru tal-klassi ta' mediċini msejħa inibituri DPP-4 (inibituri dipeptidyl peptidase-4) li tbaxxi l-livell taz-zokkor fid-demm f'pazjenti adulti li għandhom id-dijabete mellitus tat-tip 2.
English: How to store Xelevia
Maltese: Jekk tinsa tieħu Xelevia