FrancophonIA/ELRC3.0 huggingface dataset:
English: Dengue disease is a mosquito-borne tropical disease caused by the dengue virus leading to mild, flulike symptoms in most people.
Maltese: Il-marda dengue hija marda tropikali li tinġarr min-nemus li tiġi kkawżata mill-virus dengue li fil-biċċa l-kbira tan-nies, twassal għal sintomi ħfief li jixbhu l-influwenza.
English: Three studies were carried out in Asia and Latin America involving over 35,000 children aged 2 to 16 years.
Maltese: Saru tliet studji fl-Asja u fl-Amerika Latina li kienu jinvolvu aktar minn 35 000 tifel u tifla ta' bejn issentejn u s-16-il sena.
English: Dengvaxia is only for use in people from 9 to 45 years of age who have been infected with dengue virus before and who live in areas where this infection is endemic.
Maltese: Dengvaxia jintuża biss f'nies minn 9 snin sa 45 sena li ġew infettat bil-virus dengue qabel u li jgħixu f'żoni fejn din l-infezzjoni hija endemika.
English: For the full list of side effects and restrictions with Dengvaxia, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Dengvaxia, ara l-fuljett ta' tagħrif.
English: However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage.
Maltese: Madankollu, numru żgħir ta' pazjenti jiżviluppaw marda serja, bi ħsara tal-organi u fsada potenzjalment fatali.
English: However, people who have not had dengue infection in the past may have a higher risk of severe dengue disease if they become infected with the virus after vaccination with Dengvaxia.
Maltese: Madankollu, nies li ma kellhomx l-infezzjoni b'dengue fil-passat jista' jkollhom riskju ogħla tal-marda dengue serja jekk jiġu infettati bil-virus wara t-tilqima b'Dengvaxia.
English: The company that markets Dengvaxia will provide educational material for healthcare professionals with information on the use of Dengvaxia including the need to test for previous dengue infection and how to detect early dengue disease.
Maltese: Il-kumpanija li tqiegħed Dengvaxia fis-suq ser tipprovdi materjal edukattiv għall-professjonisti filqasam tal-kura tas-saħħa b'informazzjoni dwar l-użu ta' Dengvaxia inkluż il-ħtieġa li jsiru testijiet għal infezzjoni b'dengue preċedenti u kif tiġi identifikata marda dengue bikrija.
English: As for all medicines, data on the use of Dengvaxia are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Dengvaxia hija ssorveljata kontinwament.
English: Dengvaxia must not be given to people with weakened immune systems, including people whose immune system has been weakened by HIV infection or medicines such as cancer medicines or high doses of corticosteroids.
Maltese: Dengvaxia m'għandux jingħata lil nies b'sistemi immunitarji dgħajfin, inklużi nies li s-sistema immunitarja tagħhom iddgħajfet b'infezzjoni tal-HIV jew b'mediċini bħall-mediċini kontra l-kanċer jew b'dożi għoljin ta' kortikosterojdi.
English: Dengvaxia must only be given to people who have had a positive test result showing a previous infection with dengue virus.
Maltese: Dengvaxia għandu jingħata biss lil nies li kellhom riżultat ta' test pożittiv li juri infezzjoni preċedenti bil-virus dengue.
English: In the future, when the person comes into contact with dengue virus, these antibodies together with other components of the immune system will be able to kill the virus and help protect against the disease.
Maltese: Fil-futur, meta l-persuna tiġi f'kuntatt mal-virus dengue, dawn l-antikorpi flimkien ma' komponenti oħra tas-sistema immunitarja jkunu kapaċi joqtlu l-virus u jgħinu biex jipproteġu kontra l-marda.
English: When a person is given the vaccine, the immune system recognises the dengue proteins in the weakened viruses as
Maltese: Meta persuna tingħata ttilqima, is-sistema immunitarja tagħraf il-proteini ta' dengue fil-virusis imdgħajfin bħala ‘barranin' u tagħmel antikorpi kontrihom.
English: How does Dengvaxia work?
Maltese: Kif jintuża Dengvaxia?
English: What measures are being taken to ensure the safe and effective use of Dengvaxia?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Dengvaxia?
English: Available data are not sufficient to confirm how well the vaccine works in individuals previously infected by dengue virus and younger than 9 years.
Maltese: Id-data disponibbli mhijiex biżżejjed biex tikkonferma kemm jaħdem tajjeb il-vaċċin f'individwi preċedentement infettati bil-virus dengue u li jkollhom inqas minn 9 snin.
English: Dengvaxia (dengue tetravalent vaccine [live, attenuated])
Maltese: Aktar informazzjoni dwar Dengvaxia tinstab fis-sit elettroniku tal-Aġenzija:
English: The risk of severe disease is higher in people who have been infected a second time.
Maltese: Ir-riskju ta' marda serja huwa ogħla f'nies li ġew infettat għat-tieni darba.
English: Dengvaxia's side effects are usually mild or moderate and do not last longer than three days.
Maltese: L-effetti sekondarji b'Dengvaxia normalment ikunu ħfief jew moderati u ma jdumux iktar minn tlett ijiem.
English: The European Medicines Agency therefore decided that Dengvaxia's benefits are greater than its risks and it can be authorised for use in the EU in areas where dengue disease is endemic.
Maltese: Għaldaqstant, l-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Dengvaxia huma akbar mirriskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE f'żoni fejn il-marda dengue tkun endemika.
English: An overview of Dengvaxia and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Dengvaxia u għalfejn huwa awtorizzat fl-UE
English: 50 ml (10 mg/ml) 1 vial
Maltese: Daqs tal-pakkett kunjett (ħġieġ) 50 ml (10 mg/ml) 1 kunjett kunjett (ħġieġ) 10 ml (10 mg/ml) 2 kunjetti
English: Strength Pharmaceutical Form
Maltese: Qawwa Għamla farmaċewtika
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA (EU) Isem (ivvintat)
English: • There is insufficient data on Epoetin alfa HEXAL to know the size of any increased immunogenicity risk with sc use
Maltese: • Hemm informazzjoni insuffiċjenti fuq Epoetin alfa HEXAL biex ikun magħruf il-kobor ta' xi żieda fir-riskju ta' immunoġeniċità bl-użu minn taħt il-ġilda
English: • That with other epoetin products, the risk of immunogenicity in Chronic Kidney Disease (CKD) is increased with the subcutaneous (sc) route.
Maltese: • Li ma' prodotti oħrajn ta' epoetin, ir-riskju ta' immunoġeniċità f'Mard Kroniku tal-Kliewi (CKD) jiżdied meta jingħata minn taħt il-ġilda (sc).
English: • Educational leaflet • Summary of product characteristics (SPC) and Package Leaflet and Labelling
Maltese: • Fuljett edukattiv • Sommarju tal-Karatteristiċi tal-Prodott (SPC) u Fuljett ta' Tagħrif u Tikketta
English: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA)
Maltese: • Li l-użu tal-prodotti li fihom epoetin alfa jista' jikkawża immunoġeniċità li f'każijiet rari tista' twassal għal Aplasija taċ-Ċelluli l-Ħomor Pura (PRCA)
English: • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Maltese: • It-telf ta' effikaċja jew sintomi oħrajn ta' l-iżvilupp ta' immunoġeniċità għandhom ikunu investigati
English: Copovidone Magnesium stearate Maize starch
Maltese: Magnesium stearate Maize starch
English: (95% CI)
Maltese: (CI ta' 95%)
English: (corticosteroids).
Maltese: (kortikosterojdi).
English: Date of latest renewal: 22 March 2017
Maltese: Data tal-aħħar tiġdid: 22 ta' Marzu, 2017
English: Oral contraceptives:
Maltese: Kontraċettivi orali:
English: • Severe renal failure (GFR <30 ml/min).
Maltese: • Insuffiċjenza renali severa (GFR < 30 ml/min).
English: HbA1c (%) Number of patients n = 65 n = 135
Maltese: HbA1c (%) Numru ta' pazjenti n = 65 n = 135
English: Table 1:
Maltese: Tabella 1:
English: Urticaria rare
Maltese: Urtikarja rari
English: • Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib,
Maltese: • Inibituri ta' OCT2 (bħal cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib,
English: (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Maltese: (ara s-sezzjonijiet 4.4, 4.5 u 5.1 għal data disponibbli dwar kombinazzjonijiet differenti).
English: Immune system disorders Hypersensitivity (e.g. bronchial hyperreactivity)
Maltese: Disturbi fis-sistema immuni Sensittività eċċessiva (eż. iperreattività tal-bronki)
English: D-55216 Ingelheim am Rhein, Germany.
Maltese: D-55216 Ingelheim am Rhein, Il-Ġermanja.
English: Difference from placebo (adjusted mean) (95% CI)
Maltese: Differenza mill-plaċebo (medja aġġustata) (95% CI)
English: INFORMATION IN BRAILLE Jentadueto
Maltese: INFORMAZZJONI BIL-BRAILLE Jentadueto
English: In vitro assessment of interactions
Maltese: Evalwazzjoni in vitro tal-interazzjonijiet
English: The mean volume of distribution (Vd) ranged between 63-276 l.
Maltese: Il-medja tal-volum ta' distribuzzjoni (Vd) varjat bejn 63-276 l.
English: - The other ingredients are: - Tablet core: arginine, copovidone, magnesium stearate, maize starch, silica, colloidal anhydrous.
Maltese: Qalba tal-pillola: arginine, copovidone, magnesium stearate, maize starch, silica, colloidal anhydrous.
English: Number of patients n = 61 n = 134
Maltese: Numru ta' pazjenti n = 61 n = 134
English: - Film coating: hypromellose, titanium dioxide (E171), talc, propylene glycol.
Maltese: Kisja tar-rita: hypromellose, titanium dioxide (E171), talc, propylene glycol.
English: Jentadueto with alcohol
Maltese: Jentadueto mal-alkoħol
English: Linagliptin binds selectively to DPP-4 and exhibits a > 10,000 fold selectivity versus DPP-8 or DPP-9 activity in vitro.
Maltese: Linagliptin jeħel b'mod selettiv ma' DPP-4 u juri selettività ta' > 10,000 darba kontra attività ta' DPP-8 jew DPP-9 in vitro.
English: • Hepatic impairment, acute alcohol intoxication, alcoholism (see section 4.5).
Maltese: • Indeboliment tal-fwied, intossikazzjoni akuta tal-alkoħol, alkoħoliżmu (ara sezzjoni 4.5).
English: The study included 3494 patients treated with linagliptin (5 mg) and 3485 patients treated with placebo.
Maltese: L-istudju inkluda 3494 pazjent ittrattati b'linagliptin (5 mg) u 3485 pazjent ittrattati bil-plaċebo.
English: Metformin hydrochloride may act via 3 mechanisms:
Maltese: Metformin hydrochloride jista' jaġixxi permezz ta' 3 mekkaniżmi:
English: Linagliptin is an inhibitor of the enzyme DPP-4 (Dipeptidyl peptidase 4) an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide-1, glucosedependent insulinotropic polypeptide).
Maltese: Linagliptin hu impeditur tal-enzima DPP-4 (Dipeptidyl peptidase 4) enzima li hi involuta fl-inattivazzjoni tal-ormoni ta' incretin GLP-1 u GIP (peptide-1 jixbah lil glucagon, polypeptide insulinotropiku dipendenti fuq il-glucose).
English: The incidence of hypoglycaemia was similar across treatment groups (placebo 1.4%, linagliptin 5 mg 0%, metformin 2.1%, and linagliptin 2.5 mg plus metformin twice daily 1.4%).
Maltese: L-inċidenza ta' ipogliċemija kienet simili fil-gruppi ta' kura (plaċebo 1.4%, linagliptin 5 mg 0%, metformin 2.1%, u linagliptin 2.5 mg flimkien ma' metformin darbtejn kuljum 1.4%).
English: Difference from placebo (adjusted mean) (95% CI) Patients (n, %) achieving HbA1c
Maltese: Differenza mill-plaċebo (medja aġġustata) (95% CI) Pazjenti (n, %) li kisbu HbA1c
English: They have "D2/1000" debossed on one side and the Boehringer Ingelheim logo debossed on the other.
Maltese: Għandhom “D2/1000” imnaqqxa fuq naħa waħda u l-logo ta' Boehringer Ingelheim imnaqqax fuq in-naħa l-oħra.
English: In clinical studies, as described below, linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-glycoprotein, and organic cationic transporter (OCT).
Maltese: L-effetti ta' linagliptin fuq prodotti mediċinali oħrajn Fl-istudji kliniċi, kif deskritt hawn taħt, linagliptin ma kellu l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' metformin, glyburide, simvastatin, warfarin, digoxin jew kontraċettivi orali, u pprovda evidenza in vivo ta' propensità baxxa biex jikkawża interazzjonijiet tal-mediċina ma' substrati ta' CYP3A4, CYP2C9, CYP2C8, P-glikoproteina, u t-trasportatur katajoniku organiku (OCT).
English: The mean HbA1c at baseline was 7.15%.
Maltese: HbA1c medja fil-linja bażi kienet ta' 7.15%.
English: They have "D2/850" debossed on one side and the Boehringer Ingelheim logo debossed on the other.
Maltese: Għandhom “D2/850” imnaqqxa fuq naħa waħda u l-logo ta' Boehringer Ingelheim imnaqqax fuq in-naħa l-oħra.
English: Yellow iron oxide (E172) Red iron oxide (E172)
Maltese: Yellow iron oxide (E172)
English: Metformin hydrochloride stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Maltese: Metformin hydrochloride jistimula s-sintesi ta' glycogen intraċellulari billi jaġixxi fuq glycogen synthase.
English: Tablet core Arginine
Maltese: Qalba tal-pillola Arginine
English: C] linagliptin oral 10 mg dose, approximately 5% of the radioactivity was excreted in urine.
Maltese: C] linagliptin orali ta' 10 mg, madwar 5% tar-radjuattività ġiet eliminata fl-awrina.
English: Placebo Linagliptin 5 mg Once
Maltese: Plaċebo Linagliptin 5 mg
English: Risk of lactic acidosis.
Maltese: Riskju ta' aċidożi lattika.
English: INFORMATION IN BRAILLE Jentadueto 2.5 mg/850 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Jentadueto 2.5 mg/850 mg
English: Secondary renal composite (renal death, ESRD, 40% sustained decrease in eGFR)
Maltese: Kompost sekondarju tal-kliewi (mewt talkliewi, ESRD, tnaqqis sostnut ta' 40% fl-eGFR) Mortalità minn kull kawża
English: INFORMATION IN BRAILLE Jentadueto 2.5 mg/1,000 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Jentadueto 2.5 mg/1,000 mg
English: Body Mass Index (BMI)
Maltese: Indiċi tal-Piż tal-Ġisem (BMI)
English: Component of a multipack, cannot be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament.
English: The absolute bioavailability of linagliptin is approximately 30%.
Maltese: Il-bijodisponibilità assoluta ta' linagliptin hi ta' madwar 30%.
English: In controlled clinical trials, maximum metformin hydrochloride plasma levels (Cmax) did not exceed 5 microgram/ml, even at maximum doses.
Maltese: Fi provi kliniċi kkontrollati, il-livelli massimi ta' metformin hydrochloride fil-plażma (Cmax) ma qabżux 5 mikrogrammi/ml, anki fid-dożi massimi.
English: The adverse reactions are listed by system organ class and absolute frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi u l-frekwenza assoluta.
English: Lipase increased*
Maltese: Żieda ta' lipase *
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 July 2012
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Lulju, 2012
English: common
Maltese: komuni
English: Other side effects of Jentadueto include:
Maltese: Effetti sekondarji oħra ta' Jentadueto jinkludu:
English: • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
Maltese: • Kull tip ta' aċidożi metabolika akuta (bħal aċidożi lattika, ketoaċidożi dijabetika)
English: - The active substances are linagliptin and metformin hydrochloride.
Maltese: - Is-sustanzi attivi huma linagliptin u metformin hydrochloride.
English: Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucureşti Tel: +40 21 302 2800
Maltese: KG Viena - Sucursala Bucureşti Tel: +40 21 302 2800
English: - Metformin belongs to a class of medicines called biguanides.
Maltese: - Metformin jappartjeni għal klassi ta' mediċini msejħa biguanides.
English: • a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patientyears (p=0.021),
Maltese: • tnaqqis sinifikanti tar-riskju assolut ta' mortalità totali: metformin (13.5 avvenimenti/1,000 sena ta' pazjenti) versus id-dieta waħidha (20.6 avvenimenti/1,000 sena ta' pazjenti), p=0.011, u versus il-gruppi kombinati ta' sulphonylurea u insulina mogħtija waħidhom 18.9 avvenimenti/1,000 sena ta' pazjenti (p=0.021),
English: had eGFR < 30 mL/min/1.73 m2.
Maltese: ≥30 sa <45 mL/min/1.73 m 2 u 15% kellhom eGFR ta' < 30 mL/min/1.73 m 2.
English: Both incretin hormones are involved in the physiological regulation of glucose homeostasis.
Maltese: Iż-żewġ ormoni ta' incretin huma involuti fir-regolazzjoni fiżjoloġika tal-omeostażi tal-glucose.
English: Linagliptin 5 mg once daily and 2.5 mg twice daily provided comparable (CI: -0.07; 0.19) significant HbA1c reductions of -0.80% (from baseline 7.98%), and -0.74% (from baseline 7.96%) compared to placebo.
Maltese: Linagliptin 5 mg darba kuljum u 2.5 mg darbtejn kuljum ipprovda tnaqqis komparabbli sinifikanti (CI: -0.07; 0.19) f'HbA1c ta' -0.80% (mil-linja bażi 7.98%), u -0.74% (mil-linja bażi 7.96%) meta mqabbel mal-plaċebo.
English: The study population included 1211 (17.4%) patients ≥ 75 years of age and 4348 (62.3%) patients with renal impairment.
Maltese: Il-popolazzjoni tal-istudju kienet tinkludi 1211-il pazjent (17.4%) b'età ta' ≥ 75 sena u 4348 (62.3%) pazjent b'indeboliment renali.
English: OUTER CARTON AND LABEL - HDPE BOTTLE (17 AND 18 APPLICABLE ONLY FOR CARTON)
Maltese: TAL-HDPE (17 U 18 JAPPLIKAW BISS GĦALL-KARTUNA)
English: Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Maltese: NSAIDs, inklużi inibituri selettivi ta' cyclo-oxygenase (COX) II, inibituri ta' ACE, antagonisti tar-riċetturi ta' angiotensin II u dijuretiċi, speċjalment dijuretiċi loop.
English: Metformin is contraindicated
Maltese: Metformin huwa kontraindikat
English: • Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efficacy and renal elimination of metformin.
Maltese: • Inibituri kemm ta' OCT1 kif ukoll ta' OCT2 (bħal crizotinib, olaparib) jistgħu jibdlu l-effikaċja u l-eliminazzjoni renali ta' metformin.
English: Pancreatitis rare #
Maltese: Pankreatite rari
English: Race had no obvious effect on the plasma concentrations of linagliptin based on a composite analysis of available pharmacokinetic data, including patients of Caucasian, Hispanic, African, and Asian origin.
Maltese: Ir-razza ma kellha l-ebda effett ovvju fuq il-konċentrazzjonijiet ta' linagliptin fil-plażma abbażi tal-analiżi komposta ta' dejta farmakokinetika disponibbli, li tinkludi pazjenti ta' oriġini Kawkasi, Ispanika, Afrikana, u Asjatika.
English: In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Maltese: F'pazjenti b'riskju akbar ta' aktar progressjoni ta' indeboliment renali u flanzjani, il-funzjoni renali għandha tkun evalwata b'mod aktar frekwenti, eż. kull 3-6 xhur.
English: It contains two different active substances linagliptin and metformin.
Maltese: Fiha żewġ sustanzi attivi differenti: linagliptin u metformin.
English: Hepatic impairment
Maltese: Epatite rari ħafna
English: The intra-subject and inter-subject coefficients of variation for linagliptin AUC were small (12.6% and 28.5%, respectively).
Maltese: Il-koeffiċjenti ta' varjazzjoni fl-individwi nfishom u bejn l-individwi għall-AUC ta' linagliptin kienu żgħar (12.6% u 28.5%, rispettivament).
English: Jentadueto combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Maltese: Jentadueto jgħaqqad żewġ prodotti mediċinali antiipergliċemiċi ma' mekkaniżmi kumplimentari ta' azzjoni biex itejjeb il-kontroll taz-zokkor fid-demm f'pazjenti b'dijabete ta' tip 2: linagliptin, inibitur ta' dipeptidyl peptidase 4 (DPP-4), u metformin hydrochloride, membru tal-klassi biguanide.
English: FPG (mg/dL)
Maltese: GFR mL/min
English: Jentadueto 2.5 mg/850 mg film-coated tablets also contains iron oxide red (E172) and iron oxide yellow (E172).
Maltese: Jentadueto 2.5 mg/850 mg pilloli miksija b'rita fihom ukoll iron oxide red (E172) u iron oxide yellow (E172).
English: Number of patients Primary CV composite (Cardiovascular death, non-fatal MI, non-fatal stroke)
Maltese: Numru ta' pazjenti Kompost CV primarju (Mewt kardjovaskulari, MI mhux fatali, puplesija mhux fatali)
English: - Pack sizes of 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 and 120 x 1 film-coated tablets and multipacks containing 120 (2 packs of 60 x 1), 180 (2 packs of 90 x 1) and 200 (2 packs of 100 x 1) film-coated tablets in aluminium lidding foil and PVC/polychlorotrifluoro ethylene/PVC based forming foil perforated unit dose blisters.
Maltese: - Daqsijiet tal-pakkett ta' 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 u 120 x 1 pillola miksija b'rita u pakketti multipli li fihom 120 (2 pakketti ta' 60 x 1), 180 (2 pakketti ta' 90 x 1) u 200 (2 pakketti ta' 100 x 1) pillola miksija b'rita f'folji perforati tad-doża waħda li jikkonsistu minn lidding foil tal-aluminju u forming foil magħmul minn PVC/polychlorotrifluoro ethylene/PVC.
English: Adults with normal renal function (GFR ≥90 ml/min) The dose of antihyperglycaemic therapy with Jentadueto should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability, while not exceeding the maximum recommended daily dose of 5 mg linagliptin plus 2,000 mg of metformin hydrochloride.
Maltese: Adulti b'funzjoni renali normali (GFR≥ 90 mL/min) Id-doża ta' terapija antiipergliċemika b'Jentadueto għandha tiġi individwalizzata fuq il-bażi tal-programm tal-kura attwali, l-effettività, u t-tollerabilità tal-pazjent filwaqt li ma taqbiżx id-doża massima rrakkomandata ta' kuljum ta' 5 mg ta' linagliptin flimkien ma' 2,000 mg ta' metformin hydrochloride.
English: • Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin.
Maltese: • Indutturi ta' OCT1 (bħal rifampicin) jista' jżid l-assorbiment gastrointestinali u l-effikaċja ta'
English: In analyses for albuminuria progression (change from normoalbuminuria to micro- or macroalbuminuria, or from microalbuminuria to macroalbuminuria) the estimated hazard ratio was 0.86 (95% CI 0.78, 0.95) for linagliptin versus placebo.
Maltese: Fl-analiżi għall-progressjoni tal-albuminurja (bidla minn albuminurja normali għal mikro- jew makroalbuminurja, jew minn mikroalbuminurja għal makroalbuminurja) il-proporzjon ta' periklu stmat kien ta' 0.86 (CI ta' 95% 0.78, 0.95) għal linagliptin kontra l-plaċebo.
English: Twice Daily Metformin HCl 500 mg
Maltese: Darbtejn Kuljum1 + Metformin HCl 500 mg
English: PHARMACEUTICAL FORM AND CONTENTS 60 x 1 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 60 x 1 pillola miksija b'rita.
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Maltese: Wara doża orali, il-half-life terminali apparenti tal-eliminazzjoni hi ta' madwar 6.5 sigħat.
English: • Diabetic pre-coma.
Maltese: • Prekoma dijabetika.
English: Clinically meaningful interactions would not be expected with other sulphonylureas (e.g., glipizide, tolbutamide, and glimepiride) which, like glibenclamide, are primarily eliminated by CYP2C9.
Maltese: Interazzjonijiet klinikament sinifikanti mhux se jkunu mistennija ma' sulphonylureas oħrajn (eż., glipizide, tolbutamide, u glimepiride) li, bħal glibenclamide, jiġu eliminati prinċipalment minn CYP2C9.
English: - alcohol-containing medicines.
Maltese: -mediċini li fihom l-alkoħol.
English: - carbamazepine, phenobarbital or phenytoin.
Maltese: trimethoprime, vandetanib, isavuconazole, crizotinib, olaparib). - carbamazepine, phenobarbital jew phenytoin.