FrancophonIA/ELRC3.0 huggingface dataset:
English: Erectile dysfunction General disorders and administration site conditions Uncommon: Rare:
Maltese: Disfunzjoni erettili Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Mhux komuni: Rari:
English: Chloride deficit is generally mild and usually does not require treatment.
Maltese: In-nuqqas ta' chloride ġeneralment ikun ħafif u normalment ma jkollux bżonn ta' kura.
English: Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola fiha 80 mg ta' telmisartan u 12.5 mg ta' hydrochlorothiazide.
English: Rare side effects (may affect up to 1 in 1,000 people):
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000 persuna):
English: Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma) Blood and lymphatic system disorders Rare:
Maltese: Kanċer tal-ġilda mhux melanoma (Karċinoma ta' ċellola bażali u Karċinoma ta' ċellola skwamuża) Disturbi tad-demm u tas-sistema limfatika Rari:
English: Renal impairment (including acute renal failure) General disorders and administration site conditions Uncommon:
Maltese: Indeboliment renali (li jinkludi insuffiċjenza renali akuta) Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Mhux komuni:
English: No statistically significant difference in the incidence of the primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for congestive heart failure) was found [15.7 % in the telmisartan and 17.0 % in the placebo groups with a hazard ratio of 0.92 (95 % CI 0.81 - 1.05, p = 0.22)].
Maltese: Ma nstabet l-ebda differenza statistikament sinifikanti fl-inċidenza tar-riżultat aħħari kompost primarju (mewt kardjovaskulari, infart mijokardijaku mhux fatali, puplesija mhux fatali, jew dħul fl-isptar minħabba insuffiċjenza konġestiva tal-qalb) [15.7% fil-grupp ta' telmisartan u 17.0% fil-grupp ta' plaċebo bi proporzjon ta' periklu ta' 0.
English: Non-steroidal anti-inflammatory medicinal products NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics and the antihypertensive effects of angiotensin II receptor antagonists.
Maltese: acetylsalicylic acid f'korsijiet ta' dożaġġ kontra l-infjammazzjoni, inibituri ta' COX-2 u NSAIDs mhux selettivi) jistgħu jnaqqsu l-effetti dijuretiċi, natriuretiċi u kontra l-pressjoni għolja ta' thiazide, u l-effetti kontra l-pressjoni għolja ta' l-antagonisti tar-riċettur ta' angiotensin II.
English: In patients with impaired renal function the rate of hydrochlorothiazide elimination is reduced.
Maltese: F'pazjenti b'indeboliment fil-funzjoni renali, ir-rata tat-tneħħija ta' hydrochlorothiazide titnaqqas.
English: Blood uric acid increased
Maltese: Żieda tal-uric acid fid-demm
English: Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia (see section 4.5).
Maltese: Intwera li t-thiazides jistgħu jżidu t-tneħħija urinarja tal-magnesium, li jista' jirriżulta f'ipomanjesemija (ara sezzjoni 4.5).
English: Studies with hydrochlorothiazide have shown equivocal evidence for a genotoxic or carcinogenic effect in some experimental models.
Maltese: Studji b'hydrochlorothiazide wrew evidenza ekwivoka għal effett ġenotossiku jew karċinoġeniku f'xi mudelli sperimentali.
English: The overall incidence and pattern of adverse reactions reported with Kinzalkomb 80 mg/25 mg was comparable with Kinzalkomb 80 mg/12.5 mg. A dose-relationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients.
Maltese: L-inċidenza totali u l-andament ta' l-reazzjonijiet avversi rrappurtati b'Kinzalkomb 80 mg/25 mg kienu komparabbli ma' dawk b'Kinzalkomb 80 mg/12.5 mg.
English: Hydrochlorothiazide: Following oral administration of Kinzalkomb peak concentrations of hydrochlorothiazide are reached in approximately 1.0 - 3.0 hours after dosing.
Maltese: Wara l-għoti ta' Kinzalkomb mill-ħalq, il-konċentrazzjonijiet massimi ta' hydrochlorothiazide jintlaħqu wara madwar 1.0 - 3.0 sigħat wara d-dożaġġ.
English: ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporin or other medicinal products such as heparin sodium)
Maltese: Prodotti mediċinali li jistgħu jżidu l-livelli tal-potassium jew jikkaġunaw iperkalemija (eż. inibituri ta' ACE, dijuretiċi potassium-sparing, supplimenti tal-potassium, sostituti tal-melħ li fihom il-potassium, cyclosporin jew prodotti mediċinali oħrajn, bħal heparin sodium)
English: How to store Kinzalkomb
Maltese: Mediċini oħra u Kinzalkomb
English: Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their myelosuppressive effects.
Maltese: Thiazides jistgħu jnaqqsu t-tneħħija renali ta' prodotti mediċinali ċitotossiċi u jsaħħu l-effetti majelosuppressivi tagħhom.
English: Risk factors for developing acute angleclosure glaucoma may include a history of sulfonamide or penicillin allergy.
Maltese: Fatturi ta' riskju li tiżviluppa glawkoma ta' angolu magħluq jistgħu jinkludu storja medika ta' allerġija għal sulfonamide jew penicillin.
English: In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Maltese: Fi studju wieħed, l-għoti flimkien ta' telmisartan u ramipril wassal għal żieda ta' sa 2.5 darbiet fl-AUC0-24 u Cmax ta' ramipril u ramiprilat.
English: Gastrointestinal disorders Rare:
Maltese: Disturbi fl-għajnejn Rari:
English: Pancreatitis, stomach discomfort
Maltese: Pankreatite, skonfort fl-istonku
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Maltese: F'pazjenti fejn it-ton vaskulari u l-funzjoni renali jiddependu b'mod predominanti fuq l-attività tassistema renin-angiotensin-aldosterone (eż. pazjenti b'insuffiċjenza konġestiva severa tal-qalb jew li għandhom mard prinċipali renali, li jinkludi stenosi ta' l-arterja renali), il-kura bi prodotti mediċinali oħrajn li jaffettwaw din is-sistema kienet assoċjata ma' pressjoni baxxa ħafna akuta, iperażotemija, oligurja, jew, b'mod rari, ma' insuffiċjenza renali akuta (ara sezzjoni 4.8).
English: Presumably through blockade of the reninangiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss associated with these diuretics.
Maltese: Hu maħsub li permezz ta' imblokk tas-sistema renin-angiotensin-aldosterone, l-għoti ta' telmisartan fl-istess waqt għandu tendenza li jreġġa' lura t-telf tal-potassium assoċjat ma' dawn id-dijuretiċi.
English: • Kinzalkomb 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Kinzalmono 80 mg
Maltese: • Kinzalkomb 80 mg/12.5 mg jista' jingħata darba kuljum lil pazjenti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata sew bi Kinzalmono 80 mg
English: Adverse reactions reported in all clinical trials and occurring more frequently (p 0.05) with telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ class.
Maltese: Reazzjonijiet avversi rrappurtati fil-provi kliniċi kollha u li seħħew b'mod iktar frekwenti (p 0.05) meta ngħata telmisartan flimkien ma' hydrochlorothiazide milli meta ngħata l-plaċebo, qed jintwerew hawn taħt skond il-klassi tas-sistema ta' l-organi.
English: Chest pain Influenza-like illness, pain
Maltese: Uġigħ fis-sider Mard bħal dak ta' l-influwenza, uġigħ
English: Medicinal products that may increase potassium levels or induce hyperkalaemia (e.g.
Maltese: Prodotti mediċinali mhux sterojdi kontra l-infjammazzjoni NSAIDs (i.e.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Maltese: Żidiet riversibbli fil-konċentrazzjonijiet ta' lithium fis-serum u t-tossiċità kienu rrappurtati bl-għoti flimkien ta' lithium ma' inibituri ta' l-enzimi li jibdlu l-angiotensin.
English: Anticholinergic agents (e.g. atropine, biperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Maltese: Mediċini anti-kolinerġiċi (eż. atropine u biperiden) jistgħu jżidu l-bijodisponibilità ta' dijuretiċi tat-tip thiazide billi jnaqqsu moviment spontanju gastrointestinali u r-rata tat-tbattil ta' l-istonku.
English: Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of Kinzalkomb, hyperkalaemia might occur.
Maltese: Għal kuntrarju, minħabba l-antaġoniżmu tar-riċetturi ta' angiotensin II (AT1) mill-komponent ta' telmisartan ta' Kinzalkomb, tista' sseħħ l-iperkalemija.
English: Decreased blood potassium levels, anxiety, fainting (syncope), sensation of tingling, pins and needles (paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to get or keep an erection), chest pain, increased blood uric acid levels.
Maltese: Tnaqqis fil-livelli tal-potassium fid-demm, ansjetà, ħass ħażin (sinkope), sensazzjoni ta' tnemnim, sensazzjoni bħal qisu xi ħadd qed iniggżek bil-labar (parestesija), tħoss kollox idur bik (vertigo), taħbit tal-qalb mgħaġġel (takikardija), disturbi fir-ritmu tat-taħbit tal-qalb, pressjoni tad-demm baxxa, ilpressjoni tad-demm taqa' f'daqqa meta tkun bilwieqfa, qtugħ ta' nifs (dispneja), dijarea, ħalq xott, gass, uġigħ fid-dahar, spażmi fil-muskoli, uġigħ fil-muskoli, disfunzjoni erettili (ma tkunx kapaċi jkollok jew iżżomm erezzjoni), uġigħ fis-sider, żieda fil-livelli tal-uric acid fid-demm.
English: Plasma concentrations of telmisartan are generally 2 - 3 times higher in females than in males.
Maltese: Il-konċentrazzjonijiet ta' telmisartan fil-plażma huma ġeneralment 2-3 darbiet ogħla fin-nisa milli flirġiel.
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with Kinzalkomb (see section 4.5).
Maltese: Dijuretiċi potassiumsparing, supplimenti tal-potassium jew sostituti tal-potassium li fihom il-melħ, għandhom jingħataw bl-attenzjoni flimkien ma' Kinzalkomb (ara sezzjoni 4.5).
English: • Kinzalkomb 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Kinzalmono 40 mg
Maltese: • Kinzalkomb 40 mg/12.5 mg jista' jingħata darba kuljum lil pazjenti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata sew bi Kinzalmono 40 mg
English: Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: • if you are allergic to hydrochlorothiazide or to any other sulfonamide-derived medicines.
Maltese: • jekk inti allerġiku għal hydrochlorothiazide jew għal xi mediċini oħrajn derivati minn sulfonamide.
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 40 mg/12.5 mg tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Kinzalkomb 40 mg/12.5 mg pilloli
English: The risk of hypokalaemia is greater in patients with cirrhosis of liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or Adrenocorticotropic hormone (ACTH) (see section 4.5).
Maltese: Ir-riskju ta' ipokalemija hu akbar f'pazjenti biċ-ċirrożi tal-fwied, f'pazjenti li jkollhom dijuresi attiva, f'pazjenti li mhumiex jirċievu biżżejjed elettroliti mill-ħalq, u f'pazjenti li qed jirċievu terapija fl-istess bil-kortikosterojdi jew bl-ormon Adrenokortikotropiku (ACTH) (ara sezzjoni 4.5).
English: Medicinal products affected by serum potassium disturbances
Maltese: Prodotti mediċinali affettwati minn disturbi fil-livell tal-potassium fis-serum
English: Total plasma clearance of telmisartan after oral administration is >1500 ml/min.
Maltese: It-tneħħija totali ta' telmisartan mill-plażma wara l-għoti mill-ħalq hi ta' 1500 ml/min.
English: Anti-cholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia) such as atropine and biperiden.
Maltese: - Supplimenti tal-calcium u/jew supplimenti ta' vitamina D. - Mediċini antikolinerġiċi (mediċini użati biex jikkuraw varjetà ta' disturbi bħal bugħawwieġ gastrointestinali, spażmu tal-bużżieqa tal-awrina, ażżma, dardir waqt il-moviment/ivvjaġġar, spażmi muskolari, il-marda tal-Parkinson u bħala għajnuna meta tingħata l-anestesija) bħal atropine u biperiden.
English: Light-headedness
Maltese: Il-Ġermanja
English: Experience with Kinzalkomb is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Maltese: L-esperjenza b'Kinzalkomb hi modesta f'dawk il-pazjenti b'indeboliment renali minn ħafif sa moderat, u għalhekk, monitoraġġ pejodiku tal-livelli tal-potassium, tal-krejatinina u ta' l-uric acid serum hu rakkomandat.
English: Toxicological findings also well known from preclinical studies with angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists were: a reduction of red cell parameters (erythrocytes, haemoglobin, haematocrit), changes of renal haemodynamics (increased blood urea nitrogen and creatinine), increased plasma renin activity, hypertrophy/hyperplasia of the juxtaglomerular cells and gastric mucosal injury.
Maltese: Is-sejbiet tossikoloġiċi magħrufa sew minn studji li kienu saru qabel l-użu kliniku b'inibituri ta' lenzimi li jibdlu l-angiotensin u b' antagonisti tar-riċetturi ta' angiotensin II kienu: tnaqqis fil-parametri taċ-ċelluli l-ħomor (eritroċiti, emoglobina, ematokrit), bidliet ta' l-emodinamika renali (żieda finnitroġenu ta' l-urea fid-demm u krejatinina), żieda fl-attività tar-renin fil-plażma, ipertrofija/iperplasija taċ-ċelluli juxtaglomerulari, u ħsara mukożali gastrika.
English: Eye disorders Not known:
Maltese: Investigazzjonijiet Mhux magħrufa:
English: Date of latest renewal: 22 March 2016
Maltese: Data tal-aħħar tiġdid: 22 ta' Marzu 2016
English: • Carbamazepine, phenobarbital or phenytoin.
Maltese: • Carbamazepine, phenobarbital jew phenytoin.
English: In vitro assessment of interactions
Maltese: Evalwazzjoni in vitro ta' interazzjonijiet
English: Film coating: Hypromellose, titanium dioxide (E171), talc, macrogol (6000), iron oxide red (E172)
Maltese: Hypromellose, titanium dioxide (E171), talc, macrogol (6000), iron oxide red (E172)
English: INFORMATION IN BRAILLE Trajenta 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Trajenta 5 mg
English: Tablet core: Mannitol, pregelatinised starch (maize), maize starch, copovidone, magnesium stearate
Maltese: Qalba tal-pillola: Mannitol, pregelatinised starch (lamtu), maize starch, copovidone, magnesium stearate
English: In vivo assessment of interactions
Maltese: Evalwazzjoni in vivo ta' interazzjonijiet
English: Film coating Hypromellose Titanium dioxide (E171) Talc
Maltese: Kisja tar-rita Hypromellose Titanium dioxide (E171) Talc
English: Macrogol (6000) Iron oxide red (E172)
Maltese: Iron oxide red (E172)
English: Rash*
Maltese: Raxx*
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: Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase 4, EC 3.4.14.5) an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide1, glucose-dependent insulinotropic polypeptide).
Maltese: Linagliptin hu impeditur tal-enzima DPP-4 (dipeptidyl peptidase 4, EC 3.4.14.5) 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: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 August 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 24 t'Awwissu, 2011
English: Incidence Rate per 1000 PY*
Maltese: Rata ta' Inċidenza kull 1000
English: The observed incidence of hypoglycaemia in patients treated with linagliptin was similar to placebo (22.2% linagliptin; 21.2% placebo).
Maltese: ipogliċemija f'pazjenti ttrattati b'linagliptin kienet simili għal plaċebo (22.2% linagliptin; 21.2% plaċebo).
English: What Trajenta contains - The active substance is linagliptin
Maltese: X'fih Trajenta - Is-sustanza attiva hi linagliptin
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: • Trajenta is available in perforated aluminium/aluminium unit dose blisters.
Maltese: • Trajenta hu disponibbli f'folji perforati tal-aluminju/aluminju ta' doża waħda.
English: The pack sizes are 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 tablets.
Maltese: Id-daqsijiet talpakkett huma 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.
English: Gastrointestinal disorders Pancreatitis rare #
Maltese: Disturbi gastro-intestinali Pankreatite rari
English: Trajenta may be used together with other anti-diabetic medicines e.g. metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin, or insulin.
Maltese: Trajenta jista' jintuża flimkien ma' mediċini oħrajn kontra d-dijabete eż. metformin, sulphonylureas (eż. glimepiride, glipizide), empagliflozin, jew insulina.
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 medicinal product 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-prodott mediċinali ma' substrati ta' CYP3A4, CYP2C9, CYP2C8, P-glikoproteina, u t-trasportatur katajonikukatajoniku organiku (OCT).
English: EU/1/11/707/001 10 x 1 tablets EU/1/11/707/002 14 x 1 tablets EU/1/11/707/003 28 x 1 tablets EU/1/11/707/004 30 x 1 tablets EU/1/11/707/005 56 x 1 tablets EU/1/11/707/006 60 x 1 tablets EU/1/11/707/007 84 x 1 tablets EU/1/11/707/008 90 x 1 tablets EU/1/11/707/009 98 x 1 tablets EU/1/11/707/010 100 x 1 tablets EU/1/11/707/011 120 x 1 tablets
Maltese: EU/1/11/707/001 10 x 1 pilloli EU/1/11/707/002 14 x 1-il pillola EU/1/11/707/003 28 x 1 pillola EU/1/11/707/004 30 x 1 pillola EU/1/11/707/005 56 x 1 pillola EU/1/11/707/006 60 x 1 pillola EU/1/11/707/007 84 x 1 pillola EU/1/11/707/008 90 x 1 pillola EU/1/11/707/009 98 x 1 pillola EU/1/11/707/010 100 x 1 pillola EU/1/11/707/011 120 x 1 pillola
English: Table 3 Major adverse cardiovascular events (MACE) and mortality by treatment group in the
Maltese: Tabella 3 Avvenimenti avversi kardjovaskulari maġġuri (MACE - major adverse cardiovascular events) u mortalità skont il-grupp ta' trattament fl-istudju CAROLINA
English: had eGFR < 30 mL/min/1.73 m 2.
Maltese: ≥30 sa <45 mL/min/1.73 m 2 u 15% kellhom eGFR ta' < 30 mL/min/1.73 m 2.
English: CrCl = (140 - age) x weight/72 x serum creatinine [x 0.85 for females], where age is in years, weight in kg, and serum creatinine is in mg/dl.
Maltese: CrCl = (140 - età) x piż/72 x krejatininakrejatinina fis-serum [x 0.85 għan-nisa], fejn l-età hi fi snin, il-piż f'kg, u l-krejatininakrejatinina fis-serum hi f'mg/dl.
English: Table 2 Cardiovascular and renal outcomes by treatment group in the CARMELINA study
Maltese: Tabella 2 Riżultati kardjovaskulari u renali skont il-grupp ta' trattament fl-istudju CARMELINA
English: Linagliptin as add-on to metformin therapy
Maltese: Linagliptin bħala żieda mat-terapija b'metformin
English: System organ class Adverse reaction
Maltese: Klassifika tas-sistemi u tal-organi Reazzjoni avversa
English: Lipase increased**
Maltese: Żieda ta' lipase**
English: The reductions in glycosylated haemoglobin A1c (HbA1c) were similar across different subgroups including gender, age, renal impairment and body mass index (BMI).
Maltese: It-tnaqqis fl-emoglobina glycosylated A1c (HbA1c) kien simili fis-sottogruppi differenti li kienu jinkludu s-sess, l-età, indeboliment tal-kliewi u indiċi tal-piż tal-ġisem (BMI).
English: Warfarin: multiple daily doses of 5 mg linagliptin did not alter the pharmacokinetics of S(-) or R(+) warfarin, a CYP2C9 substrate, administered in a single dose.
Maltese: Warfarin: dożi multipli ta' kuljum ta' 5 mg ta' linagliptin ma bidlux il-farmakokinetika ta' S(-) jew R(+) warfarin, substrat ta' CYP2C9, li jingħata f'doża waħda.
English: EU/1/11/707/006 (60 x 1 tablets) EU/1/11/707/007 (84 x 1 tablets) EU/1/11/707/008 (90 x 1 tablets) EU/1/11/707/009 (98 x 1 tablets) EU/1/11/707/010 (100 x 1 tablets) EU/1/11/707/011 (120 x 1 tablets)
Maltese: EU/1/11/707/001 (10 x 1 pilloli) EU/1/11/707/002 (14 x 1 pillola) EU/1/11/707/003 (28 x 1 pillola) EU/1/11/707/004 (30 x 1 pillola) EU/1/11/707/005 (56 x 1 pillola) EU/1/11/707/006 (60 x 1 pillola) EU/1/11/707/007 (84 x 1 pillola) EU/1/11/707/008 (90 x 1 pillola) EU/1/11/707/009 (98 x 1 pillola) EU/1/11/707/010 (100 x 1 pillola) EU/1/11/707/011 (120 x 1 pillola)
English: Simvastatin: multiple daily doses of linagliptin had a minimal effect on the steady-state pharmacokinetics of simvastatin, a sensitive CYP3A4 substrate, in healthy volunteers.
Maltese: Simvastatin: dożi multipli ta' kuljum ta' linagliptin kellhom effett minimu fuq l-istat fiss tal-farmakokinetika ta' simvastatin, substrat sensittiv ta' CYP3A4, f'voluntiera b'saħħithom.
English: • Rare: blistering of skin (bullous pemphigoid).
Maltese: • Rari: infafet fil-ġilda (pemfigojd bulluża).
English: Rifampicin: multiple co-administration of 5 mg linagliptin with rifampicin, a potent inductor of P-glycoprotein and CYP3A4, resulted in a 39.6% and 43.8% decreased linagliptin steady-state AUC and Cmax, respectively, and about 30% decreased DPP-4 inhibition at trough.
Maltese: Rifampicin: l-għoti multiplu ripetutament ta' 5 mg ta' linagliptin ma' rifampicin, induttur potenti ta' P-glycoprotein u CYP3A4, irriżulta fi tnaqqis ta' 39.6% u 43.8% fl-AUC u fis-Cmax fl-istat fiss ta' linagliptin rispettivament, u tnaqqis ta' madwar 30% fl-inibizzjoni minima ta' DPP-4.
English: Perforated alu/alu unit dose blisters in cartons containing 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.
Maltese: Folji perforati ta' doża waħda tal-alu/alu f'kaxxi tal-kartun li jkun fihom 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 pilloli miksija b'rita.