FrancophonIA/ELRC3.0 huggingface dataset:
English: Sandoz B.V. Veluwezoom 22 1327 AH ALMERE The Netherlands
Maltese: Sandoz B.V. Veluwezoom 22 1327 AH ALMERE L-Olanda
English: Teva UK Limited Brampton Road, Hampden Park
Maltese: Ir-Renju Unit Teva UK Limited Brampton Road, Hampden Park
English: PSC 170 00 Holesovice Czech Republic
Maltese: PSC 170 00 Holesovice Ir-Repubblika Ċeka
English: Belgium Takeda Belgium Gentsesteenweg 615
Maltese: Il-Belġju Takeda Belgium Gentsesteenweg 615
English: Apotex Europe B.V. Darwinweg 20 2333 CR LEIDEN The Netherlands
Maltese: Apotex Europe B.V. Darwinweg 20 2333 CR LEIDEN L-Olanda
English: 17 Bonifraterska Str. 00-203 Warsaw Poland
Maltese: Sp. z o.o. 17 Bonifraterska Str. 00-203 Warsaw Il-Polonja
English: Austria sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Maltese: L-Awstrija sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
English: Denmark Sanofi-aventis Denmark A/S
Maltese: Id-Danimarka Sanofi-aventis Denmark A/S
English: D-22311 HAMBURG Deutschland
Maltese: D-22311 HAMBURG
English: Germany Mylan dura GmbH Wittichstr.
Maltese: Il-Ġermanja Mylan dura GmbH Wittichstr.
English: Germany Hexal Aktiengesellschaft Industriestr.
Maltese: Il-Ġermanja Hexal Aktiengesellschaft Industriestr. 25
English: Belgium Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Maltese: Il-Belġju Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
English: Luxembourg Eurogenerics SA Esplanade Heysel b22
Maltese: Eurogenerics SA Esplanade Heysel b22 1020
English: Belgium Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Maltese: Il-Belġju Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
English: Germany 1 A Pharma GmbH Keltenring 1 + 3
Maltese: Il-Ġermanja 1 A Pharma GmbH Keltenring 1 + 3
English: Finland Sanofi Oy Huopalahdentie 24 PL 22
Maltese: Il-Finlandja Sanofi Oy Huopalahdentie 24
English: Luxembourg Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
Maltese: Industriestrasse 25 83067 Holzkirchen Il-Ġermanja
English: Sanofi-Aventis Bulgaria EOOD
Maltese: Il-Bulgarija Sanofi-Aventis Bulgaria EOOD
English: Finland Orion Pharma Orionintie 1
Maltese: Il-Finlandja Orion Pharma Orionintie 1
English: Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM The Netherlands
Maltese: Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM
English: Germany Stadapharm GmbH Stadastr 2-18
Maltese: Il-Ġermanja Stadapharm GmbH Stadastr 2-18
English: Germany Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1
Maltese: Il-Ġermanja Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
English: Finland Sandoz A/S C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Maltese: Il-Finlandja Sandoz A/S C. F. Tietgens Boulevard 40 5220
English: Germany Sanofi-Aventis Deutschland GmbH
Maltese: Il-Ġermanja Sanofi-Aventis Deutschland GmbH
English: Orion Corporation Orionintie 1 A FI-02200 Espoo Finland
Maltese: Orion Corporation Orionintie 1 A FI-02200
English: Sanofi Malta Ltd St. Julian's Rd., San Gwann SGN 2805 Malta
Maltese: Julian's Rd., San Gwann SGN 2805
English: Largo Umberto Boccioni, 1 21040 Origgio (Varese) Italy
Maltese: Largo Umberto Boccioni, 1 21040
English: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom
Maltese: Wrexham Industrial Estate Wrexham, LL13 9UF
English: Winthrop Pharmaceuticals UK Limited
Maltese: Ir-Renju Unit Winthrop Pharmaceuticals UK Limited
English: Pharmachemie B.V. Swensweg 5 2031 GA HAARLEM The Netherlands
Maltese: Pharmachemie B.V. Swensweg 5 2031 GA HAARLEM
English: 400, poeder voor injectievloeistof 400 mg
Maltese: Depakine i.v. 400, poeder voor injectievloeistof 400 mg
English: Generics UK Limited Station Close, Potter's Bar Hertfordshire EN6 1TL
Maltese: Ir-Renju Unit Generics UK Limited Station Close, Potter's Bar Hertfordshire
English: Sanofi-Aventis SpA Viale Luigi Bodio, 37/B 20158 Milano Italy
Maltese: Sanofi-Aventis SpA Viale Luigi Bodio, 37/B 20158 Milano L-Italja
English: Germany Neuraxpharm Arzneimittel GmbH
Maltese: Il-Ġermanja Neuraxpharm Arzneimittel GmbH
English: Rua Tierno GalvanAmoreiras - Torre 3 - 12º Lisboa
Maltese: - Torre 3 - 12º Lisboa
English: Zentiva Italia Srl Viale Bodio 37/B 20158 Milano Italy
Maltese: Italia Srl Viale Bodio 37/B 20158 Milano L-Italja
English: 65926 Frankurt am main Germany
Maltese: 65926 Frankurt am main Il-Ġermanja
English: Capsule, soft
Maltese: Kapsula, iebsa
English: Sanofi-Aventis zrt.
Maltese: L-Ungerija Sanofi-Aventis zrt.
English: Romania Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Maltese: Ir-Rumanija Sanofi-Aventis France 1-13 Boulevard Romain Rolland
English: Germany Winthrop Arzneimittel GmbH
Maltese: Il-Ġermanja Winthrop Arzneimittel GmbH
English: SI-1000 Ljubljana Slovenia
Maltese: 1000 Ljubljana
English: 64295 Darmstadt Germany valprodura 150mg
Maltese: 64295 Darmstadt Il-Ġermanja valprodura 150mg
English: ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.
Maltese: Ir-Rumanija S.C. ARENA GROUP S.A. Str.
English: Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Maltese: Il-Ġermanja ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
English: 64295 Darmstadt Germany valprodura 600 mg
Maltese: 64295 Darmstadt Il-Ġermanja valprodura 600 mg
English: 64295 Darmstadt Germany valprodura 300 mg
Maltese: 64295 Darmstadt Il-Ġermanja valprodura 300 mg
English: One Onslow Street Guildford, Surrey GU1 4YS
Maltese: Guildford, Surrey
English: Convulex 300 mg/ml - Lösung zum Einnehmen
Maltese: Convulex 300 mg/mlLösung zum Einnehmen
English: Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5
Maltese: Il-Ġermanja TAD Pharma GmbH Heinz-Lohmann-Str.
English: Germany G.L.
Maltese: L-Irlanda Ltd.
English: Germany AbZ-Pharma GmbH Graf-Arco-Str. 3
Maltese: Il-Ġermanja AbZ-Pharma GmbH Graf-Arco-Str.
English: Luxembourg Ratiopharm GmbH Graf-Arco-Strasse 3
Maltese: Il-Ġermanja Ratiopharm GmbH Graf-Arco-Strasse 3
English: Depakine Chronosphere 1000 666,60 mg 290.27 mg
Maltese: Depakine Chronosphere 1000 666,60 mg 290.
English: Aventis Pharma Limited One Onslow Street Guildford, Surrey GU1 4SY
Maltese: Pharma Limited One Onslow Street
English: 2a
Maltese: Benzstr. 2a
English: 2015 Strovolos Nicosia Cyprus valproate sodium
Maltese: Strovolos Nicosia Ċipru valproate sodium
English: Belgium Eurogenerics N.V. Heizel Esplanade b22
Maltese: Heizel Esplanade b22
English: Germany Ratiopharm GmbH Graf-Arco-Strasse 3
Maltese: Ir-Renju Unit Ratiopharm GmbH Graf-Arco-Strasse 3
English: Germany betapharm Arzneimittel GmbH
Maltese: Il-Ġermanja betapharm Arzneimittel GmbH
English: Lithuania Orion Corporation Orionintie 1 A
Maltese: Il-Litwanja Orion Corporation Orionintie 1 A
English: Capsule, hard
Maltese: Kapsula, ratba
English: H-1045 Budapest Hungary
Maltese: H-1045
English: Denmark Orion Corporation Orionintie 1 A
Maltese: Id-Danimarka Orion Corporation Orionintie 1 A
English: DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Coated granules in sachet
Maltese: DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Granijiet miksijin ġo qartas
English: 500 mg/sachet
Maltese: 500 mg/sachet Pillola gastroreżistenti
English: Belgium
Maltese: Brussels
English: Lithuania G.L.
Maltese: Milano L-Italja
English: Ireland Sanofi-aventis Ireland Ltd. T/A SANOFI
Maltese: Sanofi-aventis Ireland Ltd.
English: 2015 Strovolos Nicosia Cyprus
Maltese: Strovolos Nicosia Ċipru
English: VALPROATE DE SODIUM DAKOTA PHARM 200 mg, comprimé gastro-résistant
Maltese: DAKOTA PHARM 200 mg, comprimé gastro-résistant
English: Greece
Maltese: Deutschland
English: DEPAKINE CHRONO (SPHERE) 750 mg/sachet
Maltese: DEPAKINE CHRONO (SPHERE) 750 mg/sachet Granijiet miksijin ġo qartas
English: Germany TEVA GmbH Graf-Arco-Str. 3
Maltese: Il-Ġermanja TEVA GmbH Graf-Arco-Str.
English: 1000 Ľubľana Slovenia
Maltese: Ľubľana Is-Slovenja
English: VALPROATE DE SODIUM DAKOTA PHARM 500 mg, comprimé gastro-résistant
Maltese: DAKOTA PHARM 500 mg, comprimé gastro-résistant
English: DEPAKINE CHRONO (SPHERE) 250 mg/sachet
Maltese: DEPAKINE CHRONO (SPHERE) 250 mg/sachet Granijiet miksijin ġo qartas
English: Lithuania Sandoz d.d.
Maltese: Il-Litwanja Sandoz d.d. Verovškova 57
English: Lyophilisate and solvent for suspension for injection
Maltese: Lajofiliżejt u solvent għal suspensjoni għall-injezzjoni
English: Sweden Orion Corporation Orionintie 1 A
Maltese: Il-Ġermanja Orion Corporation Orionintie 1 A
English: DEPAKINE CHRONO (SPHERE) 100 mg/sachet
Maltese: DEPAKINE CHRONO (SPHERE) 100 mg/sachet Granijiet miksijin ġo qartas
English: 103, Alexander Stamboliiski Blvd 1303 Sofia
Maltese: 1303 Sofia
English: DEPAKINE CHRONO (SPHERE) 500 mg/sachet
Maltese: DEPAKINE CHRONO (SPHERE) 500 mg/sachet Granijiet miksijin ġo qartas
English: Finland Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Maltese: Il-Finlandja Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Depakine Chronosphere 500 333.30 mg 145,14 mg
Maltese: 333.30 mg 145,14 mg
English: România
Maltese: Roma
English: Romania Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Maltese: Ir-Rumanija Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: NATRIUMVALPROAATTI LONG DESITIN
Maltese: LONG DESITIN
English: Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
Maltese: Generica KG Südwestpark 50
English: Depakine Crono 300 mg comprimidos recubiertos
Maltese: Depakine Crono 300 mg comprimidos de liberación prolongada
English: Depakine Crono 500 mg comprimidos recubiertos
Maltese: Depakine Crono 500 mg comprimidos de liberación prolongada
English: Denmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Maltese: Id-Danimarka Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: VALPROATE DE SODIUM ZENTIVA 200 mg, comprimé gastro-résistant
Maltese: ZENTIVA 200 mg, comprimé gastro-résistant
English: Germany Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Maltese: Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Hungary
Maltese: Vilnius
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl
English: Epilim 500 Gastro resistant tablets
Maltese: Gastro resistant tablets
English: Sanofi-Aventis d.o.o.
Maltese: Sanofi-Aventis S.P.A.
English: Epilim 200 Gastro Resistant Tablets
Maltese: Gastro Resistant Tablets
English: Epilim 500 Gastro-Resistant Tablets
Maltese: Gastro-Resistant Tablets
English: France
Maltese: PARIS
English: VALPROATE DE SODIUM ZENTIVA 500 mg, comprimé gastro-résistant
Maltese: ZENTIVA 500 mg, comprimé gastro-résistant
English: Whereas
Maltese: IV.
English: The CHMP, having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(3) of Directive 2001/83/EC, is of the opinion that the marketing authorisations for combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norgestimate should be varied.
Maltese: Is-CHMP, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata l-10 ta' Ottubru 2013 skont lArtikolu 107k(3) tad-Direttiva 2001/83/KE, huwa tal-opinjoni li l-awtorizzazzjonijiet għat-tqegħid fissuq għal kontraċettivi ormonali kkombinati li fihom chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norgestimate għandhom jiġu varjati.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation measures.
Maltese: Il-PRAC, bħala konsegwenza, ikkonkluda li l-bilanċ tal-benefiċċju-riskju tal-prodotti mediċinali identifikati fl-Anness I fl-indikazzjoni ta' kontraċezzjoni jibqa' favorevoli, soġġett għall-kundizzjonijiet, restrizzjonijiet, twissijiet, tibdil ieħor lill-informazzjoni dwar il-prodott u miżuri addizzjonali għallminimizzazzjoni tar-riskju miftiehma.
English: For some products (i.e. chlormadinone, dienogest, nomegestrol) there are currently insufficient data to establish the risk compares with the lower risk products.
Maltese: Għal xi prodotti (jiġifieri chlormadinone, dienogest, nomegestrol) attwalment ma hemmx biżżejjed dejta biex ir-riskju jiġi stabbilit meta mqabbel mal-prodotti b'riskju aktar baxx.
English: In particular, these medicinal products should be contraindicated in patients with multiple risk factors (overweight, smoking, hypertension, increasing age etc.), in patients after major surgery with prolonged immobilisation and patients with history or hereditary predisposition of venous thrombosis.
Maltese: B'mod partikolari, dawn il-prodotti mediċinali għandhom ikunu kontraindikati f'pazjenti b'bosta fatturi ta' riskju (piż żejjed, tipjip, pressjoni għolja, età akbar, eċċ), f'pazjenti wara kirurġija maġġuri b'immobilizzazzjoni fit-tul u pazjenti bi storja jew bi predispożizzjoni ereditarja ta' trombożi filvini.
English: However, the PRAC recommended routine risk minimisation measures, including a strengthening of the wording of the product information to reflect the current knowledge of risks (incidence rate) as well as symptoms for VTE and ATE and clarifying the situations for which these products are contraindicated.
Maltese: Madankollu, il-PRAC irrakkomanda miżuri ta' rutina għall-minimizzazzjoni tar-riskji, fosthom tisħiħ tat-test tal-informazzjoni dwar il-prodott biex jirrifletti l-għarfien attwali tar-riskji (rata ta' inċidenza) kif ukoll is-sintomi għal VTE u ATE u jiġu kkjarifikati s-sitwazzjonijiet li għalihom dawn il-prodotti huma kontraindikati.
English: Strength Pharmaceutical Form Route of Administration Packaging Package size EU/1/10/654/001 Leflunomide ratiopharm 10 mg Film-coated tablet
Maltese: Qawwa Għamla farmaċewtika
English: MSD Polska Sp. z o.o.
Maltese: Polska MSD Polska Sp. z o.o.
English: - an allergic reaction to Januvia (see section 4).
Maltese: - reazzjoni allerġika għal Januvia (ara sezzjoni 4).
English: Initial therapy (twice daily) Sitagliptin 50 mg + metformin 1,000 mg (N=178)
Maltese: Sitagliptin 50 mg + metformin 1,000 mg (N=178)
English: Pharmacotherapeutic group: Drugs used in diabetes, Dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH01.
Maltese: Mediċini użati fid-dijabete, inibituri ta' dipeptidyl peptidase 4 (DPP-4), Kodiċi ATC:
English: In vitro data showed that sitagliptin is not an inhibitor of CYP isozymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
Maltese: Tagħrif in vitro wera li sitagliptin mhux inibitur tal-isoenzimi CYP, CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 jew 2B6, u mhux stimulatur ta' CYP3A4 u CYP1A2.
English: Date of first authorisation: 21 March 2007 Date of latest renewal: 23 February 2012
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 ta' Marzu 2007
English: Januvia is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Maltese: Januvia huwa membru ta' klassi ta' sustanzi antiipergliċemiċi orali li jissejħu inibituri ta' dipeptidyl peptidase 4 (DPP-4).
English: Other medicines and Januvia
Maltese: Mediċini oħra u Januvia
English: The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyzes the incretin hormones to produce inactive products.
Maltese: L-attività ta' GLP-1 u GIP hija limitata mill-enzima DPP-4, li malajr tidrolizza l ormoni incretin biex b'hekk tipproduċi prodotti inattivi.
English: Improvement of surrogate markers of beta cell function, including HOMA-β (Homeostasis Model Assessment-β), proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test were observed.
Maltese: It-titjib f'markaturi sostitutivi tal-funzjoni taċ-ċelluli beta, inkluż HOMA-β (Mudell Omeostatiku ta' Assessjar-β (Homeostasis Model Assessment)), il-proporzjon bejn proinsulina u insulina, u l-kejl tar-rispons taċ-ċelluli beta minn kampjuni meħuda frekwentament fit-test tattolleranza għall-ikel ġew osservati.
English: Co-administration of a single 100 mg oral dose of sitagliptin and a single 600 mg oral dose of ciclosporin increased the AUC and Cmax of sitagliptin by approximately 29 % and 68 %, respectively.
Maltese: L-amministrazzjoni flimkien ta' doża orali waħda ta' 100 mg ta' sitagliptin u doża orali waħda ta' 600 mg ta' ciclosporine kattar l-AUC u Cmax ta' sitagliptin b'madwar 29 % u 68 %, rispettivament.
English: The reduction in HbA1c from mean baseline values of 7.2 % was -0.43 % for sitagliptin and -0.57 % for metformin (Per Protocol Analysis).
Maltese: It-tnaqqis f'HbA1c mill-valuri tal-linja bażi medji ta' 7.2 % kien ta' -0.43 % għal sitagliptin u -0.57 % għal metformin (Skont l-Analiżi tal-Protokoll).
English: The effect of potent CYP3A4 inhibitors in the setting of renal impairment has not been assessed in a clinical study.
Maltese: L-effett ta' inibituri qawwija ta' CYP3A4 fil-każ ta' indeboliment renali ma ġiex valutat fi studju kliniku.
English: The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis.
Maltese: Incretins huma parti mis-sistema endoġena li hija involuta fir-regolazzjoni fiżjoloġika talomeostażi tal-glucose.
English: These included hypoglycaemia (frequency very common with the combination of sulphonylurea and metformin), influenza (common with insulin (with or without metformin)), nausea and vomiting (common with metformin), flatulence (common with metformin or pioglitazone), constipation (common with the combination of sulphonylurea and metformin), peripheral oedema (common with pioglitazone or the combination of pioglitazone and metformin), somnolence and diarrhoea (uncommon with metformin), and dry mouth (uncommon with insulin (with or without metformin)).
Maltese: Dawn kienu jinkludu ipogliċemija (frekwenza komuni ħafna b'sulphonylurea flimkien ma' metformin), influwenza (komuni bl-insulina (flimkien ma' metformin jew mingħajru)), nawsja u rimettar (komuni b'metformin), gass (komuni b'metformin jew pioglitazone), stitikezza (komuni b'sulphonylurea flimkien ma' metformin), edima periferali (komuni b'pioglitazone jew b'pioglitazone flimkien ma' metformin), ħedla ta' ngħas u dijarea (mhux komuni b'metformin), u ħalq xott (mhux komuni bl insulina (flimkien ma' metformin jew mingħajru)).
English: Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11 %, and the plasma Cmax on average by 18 %.
Maltese: 0.25 mg digoxin flimkien ma' 100 mg ta' sitagliptin kuljum għal 10 ijiem, l-AUC ta' digoxin filplażma żdiedet b'medja ta' 11 %, u s-Cmax fil-plażma b'medja ta' 18 %.
English: In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin was CYP3A4, with contribution from CYP2C8.
Maltese: Studji in vitro indikaw li l-enzima prinċipali responsabbli għall-metaboliżmu limitat ta' sitagliptin hija CYP3A4, b'kontribuzzjoni minn CYP2C8.
English: Uncommon: dizziness, constipation, itching
Maltese: Mhux komuni: sturdament, stitikezza, ħakk
English: Adverse reactions are listed below (Table 1) by system organ class and frequency.
Maltese: Reazzjonijiet avversi huma elenkati hawn taħt (Tabella 1) skont is-sistema tal-klassifika tal-organi u lfrekwenza.
English: EU/1/07/383/013 EU/1/07/383/014 EU/1/07/383/015 EU/1/07/383/016 EU/1/07/383/017 EU/1/07/383/018 EU/1/07/383/023 EU/1/07/383/024
Maltese: EU/1/07/383/015 EU/1/07/383/016 EU/1/07/383/017 EU/1/07/383/018 EU/1/07/383/023 EU/1/07/383/024
English: Compared to normal healthy control subjects, plasma AUC of sitagliptin was increased by approximately 1.2-fold and 1.6-fold in patients with mild renal impairment (GFR ≥ 60 to < 90 mL/min) and patients with moderate renal impairment (GFR ≥ 45 to < 60 mL/min), respectively.
Maltese: Meta mqabbla ma' individwi normali f'saħħithom bħala kontroll, l-AUC ta' sitagliptin fil-plażma żdiedet b'madwar 1.2 drabi u 1.6 drabi f'pazjenti b'indeboliment ħafif tal-kliewi (GFR ≥ 60 sa < 90 mL/min) u pazjenti b'indeboliment moderat tal-kliewi (GFR ≥ 45 sa < 60 mL/min), rispettivament.
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 filkonċentrazzjonijiet ta' forom attivi ta' GLP-1 u GIP fil-plażma.
English: Initial therapy (twice daily) Sitagliptin 50 mg + metformin 500 mg (N=183)
Maltese: metformin 500 mg (N=183)
English: Placebo-corrected mean change in HbA1c (%) (95 % CI)
Maltese: Bidla medja kkoreġuta bi plaċebo f'HbA1c (%)†
English: In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
Maltese: Studji in vitro indikaw li l-enżima li hi primarjament responsabbli għall-metaboliżmu limitat ta' sitagliptin kienet CYP3A4, b'kontribuzzjoni minn CYP2C8.
English: In patients with type 2 diabetes with hyperglycaemia, these changes in insulin and glucagon levels lead to lower haemoglobin A1c (HbA1c) and lower fasting and postprandial glucose concentrations.
Maltese: bl-ipergliċemija, dawn il-bidliet fil-livelli tal-insulina u glucagon inaqqsu l-emoglobina A1c (HbA1c) u jnaqqsu l-livelli ta' konċentrazzjonijiet ta' glucose meta sajjem u wara l-ikel.
English: Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of Januvia 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: Fi provi kliniċi ta' Januvia 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: The incidence of hypoglycaemia was not significantly different between the treatment groups (sitagliptin, 6.3 %; glipizide, 10.8 %).
Maltese: ipogliċemija ma kinitx differenti b'mod sinifikanti bejn il-gruppi ta' kura (sitagliptin, 6.3 %; glipizide,
English: Sitagliptin is modestly dialysable.
Maltese: Sitagliptin huwa kemxejn dijaliżabbli.
English: Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with sitagliptin (not reaching the 5 % level, but occurring with an incidence of > 0.5 % higher with sitagliptin than that in the control group) included osteoarthritis and pain in extremity.
Maltese: Esperjenzi avversi addizjonali rrappurtati mingħajr ma tqies jekk il-kawża tagħhom kinitx il-mediċina, li seħħew b'mod aktar frekwenti f'pazjenti kkurati b'sitagliptin (li ma laħqux il-livell ta' 5 %, iżda li seħħew b'inċidenza ta' > 0.5 % ogħla b'sitagliptin minn dik fil-grupp ta' kontroll) kienu jinkludu osteoartrite u uġigħ fid-dirgħajn u fir-riġlejn.
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: Tfassal studju attiv ta' 24 ġimgħa b'kontroll (ta' metaformin) biex jevalwa l-effikaċja u s-sigurtà ta' 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 l-ipergliċemija (ma ħadux it-terapija għal mill-inqas 4 xhur).
English: In addition, the effects of renal impairment on sitagliptin pharmacokinetics in patients with type 2 diabetes and mild, moderate, or severe renal impairment (including ESRD) were assessed using population pharmacokinetic analyses.
Maltese: indeboliment tal-kliewi fuq il-farmakokinetika ta' sitagliptin f'pazjenti b'dijabete tat-tip 2 u indeboliment tal-kliewi, ħafif, moderat jew qawwi (inkluż ESRD) ġew ivvalutati bl-użu ta' analiżi farmakokinetika tal-popolazzjoni.