FrancophonIA/ELRC3.0 huggingface dataset:
English: Libertek is not used on its own but as an ‘add-on' to treatment with bronchodilators (medicines that widen the airways in the lungs).
Maltese: Libertek ma jintużax waħdu imma bħala ‘żieda' mal-kura bi bronkodilataturi (mediċini li jwessgħu lpassaġġi tan-nifs fil-pulmuni).
English: A risk management plan has been developed to ensure that Libertek is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Libertek jintuża bl-aktar mod sigur possibbli.
English: The main measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in the number of moderate or severe flare-ups of their COPD over a year of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien it-titjib filvolumi espiratorji furzati (FEV1) u t-tnaqqis fin-numru ta' feġġiet moderati jew severi tas-COPD tagħhom matul sena ta' kura.
English: In addition, the company that makes Libertek will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used.
Maltese: Barra minn dan, il-kumpanija li tipproduċi Libertek ser tiżgura li professjonisti tal-kura tas-saħħa, li jippreskrivu l-mediċina fl-Istati Membri kollha tal-Unjoni Ewropea (UE) jiġu pprovduti b'materjali edukattivi li jkun fihom informazzjoni dwar l-effetti sekondarji tal-mediċina u kif għandha tintuża.
English: What is the risk associated with Libertek?
Maltese: X'inhu r-riskju assoċjat ma' Libertek?
English: This authorisation was based on the authorisation granted to Daxas in 2010 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija għal Libertek fl-2010 (‘kunsens infurmat').
English: Why has Libertek been approved?
Maltese: Għaliex ġie approvat Libertek?
English: For the full list of all side effects reported with Libertek, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Libertek, ara l-fuljett ta' tagħrif.
English: Libertek must not be used in patients who have moderate or severe problems with their liver.
Maltese: Libertek m'għandux jingħata lil pazjenti li għandhom problemi moderati jew severi fil-fwied.
English: FEV1 is the most air a person can breathe out in one second.
Maltese: FEV1 huwa l-akbar volum ta' arja li persuna tista' toħroġ man-nifs f'sekonda waħda.
English: See section 2, Do not take Janumet.
Maltese: Ara sezzjoni 2, Tiħux Janumet.
English: Date of first authorisation: 16 July 2008 Date of latest renewal: 13 March 2013
Maltese: Data tal-aħħar tiġdid: 13 ta' Marzu 2013
English: Janumet with alcohol
Maltese: Janumet ma' alkoħol
English: See section 4.4.
Maltese: - treddigħ. 4.4
English: 2031 BN Haarlem The Netherlands
Maltese: Waarderweg 39 2031 BN Haarlem
English: Janumet combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Maltese: Janumet jikkumbina żewġ prodotti mediċinali kontra l-ipergliċemija b'mekkaniżmi ta' azzjoni kumplimentari biex jitjieb il-kontroll gliċemiku f'pazjenti b'dijabete tip 2: sitagliptin phosphate, li hu impeditur dipeptidyl peptidase 4 (DPP-4), u metformin hydrochloride, li hu membru tal-klassi biguanide.
English: By inhibiting the DPP-4 enzyme, sitagliptin increases the levels of two known active incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
Maltese: Sitagliptin iżid il-livelli ta' żewġ ormoni incretin attivi magħrufin, glucagon-like peptide-1 (GLP-1) u glucose-dependent insulinotropic polypeptide
English: HbA1c (%) at week 24.
Maltese:  HbA1c (%) f'ġimgħa 24.
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 fil plażma żdiedet b'medja ta' 11 %, u s-Cmax tal-plażma b'medja ta' 18 %.
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient--years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 - 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 patient-years (p=0.021) - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Maltese: - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe kumplikazzjoni relatata mad-dijabete filgrupp ta' metformin (29.8 episodju/1,000 pazjenti-snin) kontra dieta waħidha (43.3 episodju/1,000 pazjenti-snin), p=0.0023, u kontra l-gruppi ta' monoterapija ta' kumbinazzjoni ta' sulphonylurea u insulina (40.1 episodju/1,000 pazjenti-snin), p=0.0034 - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe mortalità relatata mad-dijabete: metformin 7.5 episodji/1,000 pazjenti-snin, dieta waħidha 12.7-il episodju/1,000 pazjenti-snin, p=0.017 - tnaqqis sinifikanti fir-riskju assolut ta' mortalità totali: metformin 13.5-il episodju/1,000 pazjenti-snin kontra dieta waħidha 20.6 episodju/1,000 pazjenti-snin, (p=0.011), u kontra l-gruppi ta' monoterapija ta' kumbinazzjoni ta' sulphonylurea u insulina 18.9-il episodju/1,000 pazjenti-snin (p=0.021) - tnaqqis sinifikanti fir-riskju assolut ta' infart majokardjali: metformin 11-il episodju/1,000 pazjenti-snin, dieta waħidha 18-il episodju /1,000 pazjenti-snin, (p=0.01).
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: Għoti flimkien ta' doża orali waħda ta' 100 mg ta' sitagliptin u doża orali waħda ta' 600 mg ta' ciclosporin żiedet l-AUC u s-Cmax ta' sitagliptin b'madwar 29 % u 68 %, rispettivament.
English: EU/1/08/455/001 14 film-coated tablets EU/1/08/455/002 28 film-coated tablets EU/1/08/455/003 56 film-coated tablets EU/1/08/455/019 60 film-coated tablets EU/1/08/455/004 112 film-coated tablets EU/1/08/455/005 168 film-coated tablets EU/1/08/455/020 180 film-coated tablets EU/1/08/455/006 196 film-coated tablets EU/1/08/455/007 50 x 1 film-coated tablets EU/1/08/455/015 196 (2 x 98) film-coated tablets EU/1/08/455/017 168 (2 x 84) film-coated tablets
Maltese: EU/1/08/455/001 14-il pillola miksija b'rita EU/1/08/455/002 28 pillola miksija b'rita EU/1/08/455/003 56 pillola miksija b'rita EU/1/08/455/019 60 pillola miksija b'rita EU/1/08/455/004 112-il pillola miksija b'rita EU/1/08/455/005 168 pillola miksija b'rita EU/1/08/455/020 180 pillola miksija b'rita EU/1/08/455/006 196 pillola miksija b'rita EU/1/08/455/007 50 x 1 pillola miksija b'rita EU/1/08/455/015 196 (2 pakketti ta' 98) pillola miksija b'rita EU/1/08/455/017 168 (2 pakketti ta' 84) pillola miksija b'rita
English: Sitagliptin 100 mg once daily added to ongoing glimepiride + metformin therapy (N=115)
Maltese: Sitagliptin 100 mg darba kuljum miżjud ma' terapija bi glimepiride + metformin li diġà tkun qegħda tittieħed (N=115)
English: Frequency not known exfoliative skin conditions including Stevens-Johnson syndrome
Maltese: Frekwenza mhix magħrufa kondizzjonijiet ta' taqxir tal-ġilda inkluż issindrome ta' Stevens-Johnson*,†
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-enzima primarja responsabbli għall-metaboliżmu limitat ta' sitagliptin hija CYP3A4, b'kontribuzzjoni minn CYP2C8.
English: Janumet contains two different medicines called sitagliptin and metformin.
Maltese: Janumet fih żewġ mediċini differenti msejħin sitagliptin u metformin.
English: Capsule-shaped, red film-coated tablet with “577” debossed on one side.
Maltese: Pillola ħamra miksija b'rita, forma ta' kapsula, b'“577” imnaqqxa fuq naħa waħda.
English: Merck Sharp & Dohme Ltd. Shotton Lane, Cramlington Northumberland NE23 3JU United Kingdom
Maltese: Shotton Lane, Cramlington
English: Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels.
Maltese: L-evalwazzjoni għandha tinkludi elettroliti u ketoni fis-serum, zokkor fid-demm, u, jekk indikati, livelli ta' pH, lactate, pyruvate, u metformin fiddemm.
English: EU/1/08/455/008 14 film-coated tablets EU/1/08/455/009 28 film-coated tablets EU/1/08/455/010 56 film-coated tablets EU/1/08/455/021 60 film-coated tablets EU/1/08/455/011 112 film-coated tablets EU/1/08/455/012 168 film-coated tablets EU/1/08/455/022 180 film-coated tablets EU/1/08/455/013 196 film-coated tablets EU/1/08/455/014 50 x 1 film-coated tablets EU/1/08/455/016 196 (2 x 98) film-coated tablets EU/1/08/455/018 168 (2 x 84) film-coated tablets
Maltese: EU/1/08/455/008 14-il pillola miksija b'rita EU/1/08/455/009 28 pillola miksija b'rita EU/1/08/455/010 56 pillola miksija b'rita EU/1/08/455/021 60 pillola miksija b'rita EU/1/08/455/011 112-il pillola miksija b'rita EU/1/08/455/012 168 pillola miksija b'rita EU/1/08/455/022 180 pillola miksija b'rita EU/1/08/455/013 196 pillola miksija b'rita EU/1/08/455/014 50
English: In a 52-week study, comparing the efficacy and safety of the addition of sitagliptin 100 mg once daily or glipizide (a sulphonylurea ) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c (-0.7 % mean change from baselines at week 52, with baseline HbA1c of approximately 7.5 % in both groups).
Maltese: Fi studju ta' 52 ġimgħa, li qabbel l-effikaċja u s-sigurtà taż-żieda ta' sitagliptin 100 mg darba kuljum jew glipizide (sulphonylurea) f'pazjenti b'kontroll gliċemiku inadegwat fuq monoterapija b'metformin, sitagliptin kien simili għal glipizide fit-tnaqqis ta' HbA1c (-0.7 % bidla medja mil-linji bażi f'ġimgħa 52, b' HbA1c fil-linja bażi ta' madwar 7.5 % fiż-żewġ gruppi).
English: For the different doses on metformin, Janumet is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
Maltese: Għal dożi differenti ta' metformin, Janumet jinsab bħala 50 mg sitagliptin u 850 mg metformin hydrochloride jew 1,000 mg metformin hydrochloride.
English: Janumet is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.
Maltese: Janumet huwa indikat bħala terapija tripla kombinata ma' agonist ta' peroxisome proliferator-activated receptor gamma (PPARγ) (jiġifieri, thiazolidinedione) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament b'metformin u agonist ta' PPARγ bid-doża massima ttollerata tagħhom.
English: Least squares means adjusted for prior antihyperglycaemic therapy status and baseline value.
Maltese: Least squares tfisser aġġustat għal status ta' qabel kontra l-ipergliċemija u l-valur fil-linja bażi.
English: If no adequate strength of Janumet is available, individual monocomponents should be used instead of the fixed-dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Janumet, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: Janumet is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Maltese: Janumet huwa indikat f'kumbinazzjoni ma' sulphonylurea (jiġifieri, terapija ta' kumbinazzjoni tripla) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u sulphonylurea.
English: Janumet 50 mg/1,000 mg tablets sitagliptin/metformin HCl
Maltese: Pilloli Janumet 50 mg/1,000 mg sitagliptin/metformin hydrochloride
English: Janumet 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride
Maltese: Pilloli Janumet 50 mg/850 mg sitagliptin/metformin hydrochloride
English: p< 0.001 compared to placebo or placebo + combination treatment.
Maltese: ‡ p< 0.001 imqabbel ma' plaċebo jew plaċebo + kura ta' kumbinazzjoni.
English: A bioequivalence study in healthy subjects demonstrated that the Janumet (sitagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Maltese: Studju ta' bijoekwivalenza f'suġġetti b'saħħithom wera li pilloli ta' kumbinazzjoni Janumet (sitagliptin/metformin hydrochloride) huma bijoekwivalenti għal għoti konkomitanti ta' sitagliptin phosphate u metformin hydrochloride bħala pilloli individwali.
English: The dose of antihyperglycaemic therapy with Janumet should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Maltese: Id-doża ta' terapija kontra l-ipergliċemija b'Janumet għandha tkun individwalizzata fuq il-bażi tal-kors kurrenti, l-effettività, u t-tolerabbilità tal-pazjent waqt li ma tinqabiżx id-doża massima ta' kuljum irrakkomandata ta' 100 mg sitagliptin.
English: Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride.
Maltese: Kull pillola miksija b'rita (pillola) fiha sitagliptin phosphate monohydrate ekwivalenti għal 50 mg ta' sitagliptin u 1,000 mg ta' metformin hydrochloride.
English: There have been no therapeutic clinical trials conducted with Janumet tablets however bioequivalence of Janumet with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Maltese: Ma saru l-ebda provi terapewtiċi kliniċi b'pilloli Janumet, madankollu ntweriet il-bijoekwivalenza ta' Janumet ma' sitagliptin u metformin mgħotijin flimkien (ara sezzjoni 5.2).
English: For composite endpoints, the p-values correspond to a test of non-inferiority seeking to show that the hazard ratio is less than 1.3.
Maltese: Għall-iskopijiet finali komposti, il-valuri p jaqblu ma' test ta' nuqqas ta' inferjorità li jfittex li juri li l-proporzjon ta' periklu huwa inqas minn 1.3.
English: EU/1/08/455/016 EU/1/08/455/018
Maltese: EU/1/08/455/017 EU/1/08/455/019 EU/1/08/455/020
English: Do not pass it on to others.
Maltese: L-inċidenza ta' każijiet ta'
English: Frequency not known bullous pemphigoid
Maltese: Frekwenza mhix magħrufa pemfigojd bl-infafet*
English: - if you have severely reduced kidney function - if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Maltese: - jekk għandek dijabete mhux ikkontrollata, b'pereżempju ipergliċemija severa (glucose għoli fiddemm), dardir, rimettar, dijarea, telf mgħaġġel fil-piż, aċidożi lattika (ara "Riskju ta' aċidożi lattika" hawn taħt) jew ketoaċidożi.
English: Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy (N=152)
Maltese: metformin li diġà tkun qegħda tittieħed (N=115)
English: Janumet 50 mg/850 mg film-coated tablets
Maltese: Janumet 50 mg/850 mg pilloli miksijin b'rita
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDLc and triglyceride levels.
Maltese: Dan intwera f'dożi terapewtiċi fi studji kliniċi kkontrollati, ta' żmien medju jew żmien twil: metformin inaqqas il-kolesterol totali, LDLc u l-livelli ta' trigliċeridi.
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 - 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 patient-years (p=0.021) - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Maltese: - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe kumplikazzjoni relatata mad-dijabete filgrupp ta' metformin (29.8 episodju/1,000 pazjenti-snin) kontra dieta waħidha (43.3 episodju/1,000 pazjenti-snin), p=0.0023, u kontra l-gruppi ta' monoterapija ta' kumbinazzjoni ta' sulphonylurea u insulina (40.1 episodju/1,000 pazjenti-snin), p=0.0034
English: Frequency not known arthropathy
Maltese: Frekwenza mhix magħrufa artropatija*
English: Avoid excessive alcohol intake while taking Janumet since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Maltese: Evita konsum eċċessiv ta' alkoħol waqt li tkun qed tieħu Janumet peress li dan jista' jżid ir-riskju ta'
English: Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Janumet
English: Janumet 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride
Maltese: Janumet 50 mg/1,000 mg pilloli miksijin b'rita sitagliptin/metformin hydrochloride
English: When Janumet is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Maltese: sulphonylurea, tista' tkun meħtieġa doża aktar baxxa ta' sulphonylurea biex tnaqqas ir-riskju ta' ipogliċemija (ara sezzjoni 4.4).
English: Pharmacokinetic drug interaction studies with Janumet have not been performed; however, such studies have been conducted with the individual active substances, sitagliptin and metformin.
Maltese: Ma sarux studji farmakokinetiċi ta' interazzjoni ta' mediċini b'Janumet; madankollu, studji bħal dawn saru individwalment bis-sustanzi attivi, sitagliptin u metformin.
English: In addition, osteoarthritis and pain in extremity were reported with frequency uncommon (> 0.5 % higher among sitagliptin users than that in the control group).
Maltese: Barra dan, osteoartrite u uġigħ fl-idejn u fis-saqajn kienu rrappurtati bi frekwenza mhix komuni (> 0.5 % ogħla fost dawk li jużaw sitagliptin minn dawk fil-grupp ta' kontroll).
English: Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal impairment or end-stage renal disease (ESRD).
Maltese: Ilmetaboliżmu jista' jkollu rwol aktar sinifikanti fl-eliminazzjoni ta' sitagliptin fl-isfond ta' indeboliment tal-kliewi sever jew mard tal-kliewi tal-aħħar fażi (ESRD).
English: Janumet must be discontinued at the time of surgery under general, spinal or epidural anaesthesia.
Maltese: Janumet għandu jitwaqqaf fil-ħin ta' kirurġija taħt anestesija ġenerali, fis-sinsla tad-dahar jew epidurali.
English: Frequency not known acute renal failure
Maltese: Frekwenza mhix magħrufa insuffiċjenza akuta tal-kliewi*
English: Janumet is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued during conditions with the potential to alter renal function (see section 4.3).
Maltese: Janumet huwa kontraindikat f'pazjenti b'GFR <30 mL/min u għandu jitwaqqaf temporanjament filpreżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali (ara sezzjoni 4.3).
English: The incidence of adjudication-confirmed pancreatitis events was 0.3 % in sitagliptin-treated patients and 0.2 % in placebo-treated patients.
Maltese: pankreatite kkonfermati permezz ta' aġġudikazzjoni kienet 0.3 % f'pazjenti ttrattati b'sitagliptin u 0.2 % f'pazjenti ttrattati bi plaċebo.
English: Janumet 50 mg/850 mg tablets sitagliptin/metformin HCl
Maltese: Pilloli miksijin b'rita Janumet 50 mg/850 mg sitagliptin/metformin hydrochloride
English: Janumet should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Maltese: Janumet għandu jingħata darbtejn kuljum mal-ikel sabiex jitnaqqsu r-reazzjonijiet gastrointestinali avversi assoċjati ma' metformin.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after 'EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-folja u l-kartuna wara ‘JIS'.
English: The NOEL in these studies was observed at exposures to sitagliptin of approximately 6 times the human exposure and to metformin of approximately 2.5 times the human exposure.
Maltese: f'dawn l-istudji ġie osservat f'espożizzjonijiet għal sitagliptin ta' madwar 6 darbiet l-espożizzjoni umana u għal metformin ta' madwar 2.5 drabi l-espożizzjoni umana.
English: The active substance is telaprevir.
Maltese: Is-sustanza attiva hi telaprevir.
English: 3 and/or albumin < 3.3 g/dl.
Maltese: 3 u/jew albumina < 3.3 g/dl.
English: Via C. Janssen IT-04100 Borgo San Michele Latina, Italy
Maltese: Janssen IT-04100 Borgo San Michele Latina, L-Italja
English: Refer to section 4.4, Laboratory tests.
Maltese: Ara sezzjoni 4.4, Testijiet tal-laboratorju.
English: Study 110
Maltese: Studju 110
English: Medicine (name of the active substance)
Maltese: Mediċina (isem tas-sustanza attiva)
English: PDE-5 INHIBITORS sildenafil tadalafil vardenafil
Maltese: IMPEDITURI PDE-5 sildenafil tadalafil vardenafil
English: hypromellose acetate succinate, calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, silica colloidal anhydrous, sodium lauryl sulphate, croscarmellose sodium, sodium polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide yellow (E172)
Maltese: hypromellose acetate succinate, calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, silica colloidal anhydrous, sodium lauryl sulphate, croscarmellose sodium, sodium polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide isfar (E172)
English: Patients receiving cyclosporine A N = 24 % (n/N)
Maltese: Patients li rċevew cyclosporine A N = 24 % (n/N)
English: Date of first authorisation: 19 September 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 19 Settembru 2011
English: • Pictures of rash according to different grades
Maltese: • Ritratti tar-raxx skont gradi differenti
English: Table 9 shows response rates.
Maltese: Tabella 9 turi r-rati ta' rispons.
English: Moderate rash: Diffuse rash ≤ 50% of body surface area
Maltese: Raxx moderat: raxx diffuż ≤ 50% tal-erja
English: Telaprevir inhibits organic anion transporter polypeptides (OATPs) OATP1B1 and OATP2B1.
Maltese: Telaprevir jimpedixxi l-polipeptidi trasportaturi anajoniċi organiċi (OATPs - organic anion transporter polypeptides) OATP1B1 u OATP2B1.
English: The total daily dose is 6 tablets (2,250 mg).
Maltese: Id-doża totali tal-kuljum hija ta' 6 pilloli (2,250 mg).