FrancophonIA/ELRC3.0 huggingface dataset:
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku aripiprazole
English: • schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Maltese: • skiżofrenja, marda mentali b'għadd ta' sintomi, inkluż diżorganizzazzjoni fil-ħsibijiet u l-kliem, alluċinazzjonijiet (smigħ jew viżjoni ta' oġġetti li mhumiex hemm), suspetti u delużjonijiet (twemmin falz).
English: In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Maltese: F'pazjenti li għandhom bejn 15 u 17-il sena, iddoża inizjali hija ta' 2 mg kuljum (permezz ta' prodott li fih aripiprazole f'għamla likwida), li gradwalment tiżdied għad-doża rakkomandata ta' 10 mg darba kuljum.
English: Because Aripiprazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Aripiprazole Accord huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Why is Aripiprazole Accord approved?
Maltese: Għaliex ġie approvat Aripiprazole Accord?
English: To prevent manic episodes in adults, the same dose should be continued.
Maltese: Sabiex jiġu evitati episodji manijaċi f'adulti, l-istess doża għandha titkompla.
English: A risk management plan has been developed to ensure that Aripiprazole Accord is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Aripiprazole Accord jintuża bl-aktar mod sigur possibbli.
English: Aripiprazole Accord is used in patients aged 15 years or over;
Maltese: Aripiprazole Accord jintuża f'pazjenti ta' 15-il sena jew iktar;
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Accord has been shown to have comparable quality and to be bioequivalent to Abilify.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Aripiprazole Accord wera li għandu kwalità komparabbli u huwa bijoekwivlenti għal Abilify.
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Maltese: Aripiprazole huwa maħsub li jaġixxi primarjament bħala ‘agonista parzjali' għar-riċetturi għannewrotrażmettituri dopamina u 5-hydroxytryptamine (magħruf ukoll bħala serotonina).
English: For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg once a day, either on its own or in combination with other medicines.
Maltese: Għall-kura ta' episodji manijaċi f'disturb bipolari, id-doża inizjali rakkomandata hija ta' 15 mg darba kuljum, jew waħedha jew f'kombinazzjoni ma' mediċini oħrajn.
English: For further information, see the Summary of Product Characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni, ara s-Sommarju tal-Karatteristiċi tal-Prodott (parti wkoll mill-EPAR).
English: How is Aripiprazole Accord used?
Maltese: Kif jintuża Aripiprazole Accord?
English: Aripiprazole Accord is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Maltese: Aripiprazole Accord jintuża wkoll sa 12-il ġimgħa għall-kura ta' episodji manijaċi minn moderati sa severi f'pazjenti ta' 13-il sena jew iktar.
English: How does Aripiprazole Accord work?
Maltese: Kif ġie studjat Aripiprazole Accord?
English: The Committee recommended that Aripiprazole Accord be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Aripiprazole Accord ikun approvat għall-użu fl-UE.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Maltese: Dan ifixkel is-sinjali trażmessi bejn iċ-ċelloli tal-moħħ permezz ta' ‘newrotrażmettituri', sustanzi kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: In addition, the company that markets Aripiprazole Accord will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Aripiprazole Accord fis-suq sejra tipprovdi materjali edukattivi biex jingħataw lill-pazjenti jew lil dawk li jieħdu ħsiebhom u lit-tobba biex jiġi spjegat l-użu sigur tal-mediċina f'pazjenti li għandhom bejn 13 u 17-il sena.
English: Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Abilify, ilbenefiċċju huwa akbar mir-riskju identifikat.
English: Psoriasis
Maltese: Psorjażi
English: Further information on Remicade can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Remicade.
Maltese: ema.europa.eu/medicines/human/EPAR/Remicade.
English: Other information about Remicade
Maltese: Informazzjoni oħra dwar Remicade
English: Ulcerative colitis, ankylosing spondylitis and psoriatic arthritis For ulcerative colitis (728 adults), ankylosing spondylitis (70 adults) and psoriatic arthritis (104 adults), Remicade has been compared with placebo.
Maltese: Għall-kolite ulċerattiva, (728 adult), l-ispondilite ankilosanti (70 adult) u l-artrite psorjatika (104 adulti), Remicade tqabbel mal-plaċebo.
English: Remicade contains the active substance infliximab.
Maltese: Remicade fih is-sustanza attiva infliksimab.
English: Remicade is an anti-inflammatory medicine.
Maltese: Remicade huwa mediċina antiinfjammatorja.
English: Remicade received a marketing authorisation valid throughout the EU on 13 August 1999.
Maltese: Remicade ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-13 ta' Awwissu 1999.
English: The most common side effects with Remicade (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper respiratory tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Remicade (li dehru f'aktar minn pazjent wieħed minn kull 10) huma infezzjonijiet virali (bħall-influwenza jew selħiet tax-xofftejn), uġigħ ta' ras, infezzjoni fin-naħa ta' fuq tal-apparat respiratorju (irjiħat), sinusite (infjammazzjoni tas-sinus), nawżja (tħossok ma tiflaħx), uġigħ addominali (uġigħ ta' stonku), reazzjonijiet relatati mal-infużjoni u wġigħ.
English: Remicade is used with methotrexate (a medicine that acts on the immune system);
Maltese: Remicade jintuża ma' methotrexate (mediċina li taħdem fuq is-sistema immunitarja);
English: The dose is 5 mg per kilogram for the other diseases.
Maltese: Għall-mard l-ieħor, id-doża hija 5 mg għal kull kilogramm.
English: What are the risks associated with Remicade?
Maltese: X'inhuma r-riskji assoċjati ma' Remicade?
English: Remicade has been studied in a total of 1,432 patients with rheumatoid arthritis in two studies.
Maltese: Remicade ġie studjat f'total ta' 1 432 pazjent li jbatu bl-artrite rewmatojde f'żewġ studji.
English: • rheumatoid arthritis (an immune system disease causing inflammation of the joints).
Maltese: • artrite rewmatojde (marda tas-sistema immunitarja li tikkawża infjammazzjoni tal-ġogi).
English: A sixth study in 508 adult patients looked at the number of patients whose symptoms improved and who did not need additional treatment with corticosteroids (other medicines used in Crohn's disease).
Maltese: Is-sitt studju f'508 pazjenti adulti ħares lejn in-numru ta' pazjenti li s-sintomi tagħhom tjiebu u li ma kinux jeħtieġu kura addizzjonali bil-kortikosterojdi (mediċini oħra użati kontra l-marda ta' Crohn).
English: Remicade alone and in combination with azathioprine was more effective than azathioprine alone.
Maltese: Remicade waħdu u b'kombinazzjoni ma' azathioprine kien iktar effettiv minn azathioprine waħdu.
English: Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Maltese: L-infliksimab tfasslet biex teħel ma' messaġġier kimiku fil-ġisem magħruf bħala l-fattur alfa ta' nekrożi tumorali (TNF-alpha).
English: • Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulae, abnormal passageways between the gut and other organs);
Maltese: • il-marda ta' Crohn (marda li tikkawża infjammazzjoni tal-passaġġ diġestiv), meta l-marda tkun moderata sa severa jew fistulanti (bil-formazzjoni ta' fistuli, passaġġi anormali bejn l-imsaren u organi oħrajn);
English: In a study with 60 children aged between 6 and 17 years with ulcerative colitis 73% of patients responded to treatment with Remicade at week eight (44 out of 60).
Maltese: Fi studju b'60 tifel u tifla ta' bejn is-6 snin u s-17-il sena b'kolite ulċerattiva 73 % tal-pazjenti rrispondew għall-kura b'Remicade fil-ġimgħa tmienja (44 minn 60).
English: In Crohn's disease in adults, Remicade was compared with placebo (a dummy treatment) in 1,090 adults in four studies.
Maltese: Fil-marda ta' Crohn fl-adulti, Remicade tqabbel mal-plaċebo (kura finta) f'1 090 adult f'erba' studji.
English: The active substance in Remicade, infliximab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Maltese: Is-sustanza attiva f'Remicade, l-infliksimab, hija antikorp monoklonali, tip ta' proteina li tfasslet sabiex tagħraf u teħel ma' struttura fil-mira speċifika (imsejħa antiġen) fil-ġisem.
English: How is Remicade used?
Maltese: Kif jaħdem Remicade?
English: Remicade is also used in patients aged between 6 and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Maltese: Remicade jintuża wkoll f'pazjenti ta' bejn 6 snin u 17-il sena bil-marda ta' Crohn severa u attiva jew kolite ulċerattiva attiva severa, meta ma jkunux irrispondew għal jew ma jkunux jistgħu jieħdu mediċini jew kuri oħrajn.
English: Patients who receive Remicade must be given a special reminder card.
Maltese: Il-pazjenti li jirċievu Remicade għandhom jingħataw karta ta' tfakkira speċjali.
English: The patients were treated for 6 months with Remicade, another medicine azathioprine, or the combination of Remicade and azathioprine.
Maltese: Ilpazjenti ġew ikkurati għal 6 xhur b'Remicade, b'mediċina oħra azathioprine, jew b'kombinazzjoni ta' Remicade u azathioprine.
English: Crohn's disease
Maltese: Il-marda ta' Crohn
English: In a study in 627 adults with psoriasis, Remicade led to a greater improvement in symptoms than placebo.
Maltese: Fi studju f'627 adult bi psorjażi, Remicade wassal għal iktar titjib fis-sintomi milli l-plaċebo.
English: Remicade is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary.
Maltese: Remicade ġeneralment jingħata bħala 3 mg għal kull kilogramm tal-piż tal-ġisem fl-artrite rewmatodje, għalkemm id-doża tista' tiżdied jekk ikun meħtieġ.
English: As for all medicines, data on the use of Remicade are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Remicade hija ssorveljata kontinwament.
English: What measures are being taken to ensure the safe and effective use of Remicade?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Remicade?
English: How often the treatment is repeated depends on which disease is being treated, and on the patient's response to the medicine.
Maltese: Il-frekwenza tar-repetizzjoni tal-kura tiddependi mill-marda li tkun qiegħda tiġi kkurata, u mir-rispons tal-pazjent għall-mediċina.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
Maltese: • artrite psorjatika (marda li tikkawża rqajja' ħomor, bil-qxur fuq il-ġilda u infjammazzjoni fil-ġogi).
English: Some side effects, including infections, may be more common in children than in adults.
Maltese: Xi effetti sekondarji, inklużi l-infezzjonijiet, jistgħu jkunu aktar komuni fit-tfal milli fl-adulti.
English: The effects of adding Remicade to existing treatment have also been studied in 103 children and adolescents with Crohn's disease who were aged between 6 and 17 years.
Maltese: L-effetti taż-żieda ta' Remicade għal kura eżistenti ġew studjati wkoll f'103 tifel u tifla u adoloxxenti li jbatu mill-marda ta' Crohn li l-età tagħhom kienet bejn is-6 snin u s-17-il sena.
English: Remicade must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Remicade.
Maltese: Remicade m'għandux jintuża f'pazjenti li, fil-passat, esperjenzaw sensittività eċċessiva (allerġija) għallinfliksimab, jew li għandhom sensittività eċċessiva (allerġiċi) għall-proteini tal-ġrieden jew għal kwalunkwe sustanza oħra ta' Remicade.
English: (Invented) name Strength
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa
English: Rash g, Urticaria rare
Maltese: Raxx g, Urtikarja rari
English: „Кораб планина“ № 8 офис 1
Maltese: ТП„Мундифарма медикъл ООД“ ул. „Кораб планина“ № 8 офис 1
English: P value for superiority (2-sided) = 0.0158.
Maltese: Valur p għas-superjorità (2-sided) = 0.0158.
English: Mundipharma Pharmaceuticals Ltd Οθέλλου 13, Βιομηχανική Περιοχή Ιδαλίου CY-2540 Λευκωσία
Maltese: Mundipharma Pharmaceuticals Ltd Οθέλλου 13, Βιομηχανική Περιοχή Ιδαλίου CY-2540
English: Mundipharma Polska Sp. z o.o.
Maltese: Mundipharma Polska Sp. z o.o. ul.
English: The mean Vd ranged between 63-276 litres.
Maltese: Il-medja ta' Vd kienet fuq firxa bejn 63-276 litru.
English: A-1070 Wien
Maltese: A-1070
English: Mundipharma Farmacêutica Lda Lagoas Park - Edifício 8
Maltese: Lagoas Park - Edifício 8
English: • Severe renal failure (eGFR < 30 mL/min) (see sections 4.2 and 4.4);
Maltese: • Insuffiċjenza renali severa (eGFR <30 mL/min) (ara sezzjonijiet 4.2 u 4.4);
English: Adults with normal renal function (estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m
Maltese: Adulti b'funzjoni renali normali (rata stmata ta' filtrazzjoni mill-glomeruli [eGFR] ≥ 90 mL/min/1.73 m
English: Balanitis or balanoposthitis b, l
Maltese: Balanite jew balanopostite b,l
English: Placebo (N = 93)
Maltese: Plaċebo (N = 93)
English: Vulvovaginal candidiasis b, k common
Maltese: Kandidjasi vulvovaġinali b,k komuni
English: In in vitro studies, canagliflozin neither inhibited cytochrome P450 CYP1A2, CYP2A6, CYP2C19, CYP2D6, or CYP2E1, CYP2B6, CYP2C8, CYP2C9, nor induced CYP1A2, CYP2C19, CYP2B6,
Maltese: Fi studji in vitro, canagliflozin la inibixxa CYP1A2,CYP2A6, CYP2C19, CYP2D6, jew CYP2E1, CYP2B6, CYP2C8, CYP2C9, u lanqas induċa CYP1A2, CYP2C19, CYP2B6, CYP3A4 taċ-ċitokroma P450 f'konċentrazzjonijiet ogħla minn dawk terapewtiċi.
English: Dehydration rare
Maltese: Deidratazzjoni rari
English: p = 0.013 compared to placebo.
Maltese: p = 0.013 meta mqabbel ma' plaċebo.
English: Bahía de Pollensa, 11
Maltese: Mundipharma Pharmaceuticals, S.L. Bahía de Pollensa, 11
English: Vokanamet contains sodium
Maltese: Vokanamet fih sodium
English: The mean age was 63 years and 64% were male.
Maltese: L-età medja kienet ta' 63 sena u 64% kienu rġiel.
English: No clinically relevant effect on CYP3A4 was observed in vivo (see section 4.5).
Maltese: Ma kien osservat l-ebda effett kliniku rilevanti fuq CYP3A4 in vivo (ara sezzjoni 4.5).
English: Pharmacodynamic effects of canagliflozin
Maltese: Effetti farmakodinamiċi ta' canagliflozin
English: Mundipharma Pharmaceuticals, S.L.
Maltese: Mundipharma Farmacêutica, Lda.
English: Related to volume depletion; see section 4.4 and description of adverse reaction (AR) below.
Maltese: Marbuta ma' tnaqqis fil-volum; ara sezzjoni 4.4 u deskrizzjoni tar-reazzjoni avversa (AR, adverse reaction) taħt.
English: Incidence rate (per 100 subject-years) 0.34 HR (95% CI) vs. placebo Minor amputation, n (%) Major amputation, n (%)
Maltese: HR (95% CI) vs. plaċebo Amputazzjoni żgħira, n (%) Amputazzjoni kbira, n (%)
English: Mundipharma Pharmaceuticals Srl Via G. Serbelloni 4
Maltese: Mundipharma Pharmaceuticals Srl Via G.
English: Date of first authorisation: 23 April 2014 Date of latest renewal: 18 December 2018
Maltese: Data tal-aħħar tiġdid: 18 ta' Diċembru 2018
English: Medicinal product/laboratory test interference
Maltese: Interferenza bejn il-prodott mediċinali/test tal-laboratorju
English: (listed in section 6)
Maltese: (ara sezzjoni 4.8).
English: Placebo + metformin (N = 183)
Maltese: Plaċebo + metformin (N = 183)
English: Note: Incidence is based on the number of patients with at least one amputation, and not the total number of amputation events.
Maltese: Nota: L-Inċidenza hija bbażata fuq in-numru ta' pazjenti b'mill-inqas amputazzjoni waħda, u mhux in-numru totali ta' avvenimenti ta' amputazzjoni.
English: Renal endpoints
Maltese: Skopijiet Finali Renali
English: Liver function test abnormal, Hepatitis
Maltese: Riżultat mhux normali tat-test tal-funzjoni talfwied, Epatite
English: Canagliflozin 100 mg titrated to 300 mg p < 0.01 compared to placebo
Maltese: Canagliflozin 100 mg titrat għal 300 mg p < 0.01 meta mqabbel ma' plaċebo
English: The study included 8 subjects with normal renal function (CrCl ≥ 80 mL/min), 8 subjects with mild renal impairment (CrCl 50 mL/min to < 80 mL/min), 8 subjects with moderate renal impairment (CrCl 30 mL/min to < 50 mL/min), and 8 subjects with severe renal impairment (CrCl < 30 mL/min) as well as 8 subjects with ESRD on haemodialysis.
Maltese: L-istudju inkluda 8 individwi b'funzjoni normali tal-kliewi (CrCl ≥ 80 mL/min), 8 individwi b'indeboliment ħafif tal-kliewi (CrCl 50 mL/min sa < 80 mL/min), 8 individwi b'indeboliment moderat tal-kliewi (CrCl 30 mL/min sa < 50 mL/min), u 8 individwi b'indeboliment qawwi tal-kliewi (CrCl < 30 mL/min) kif ukoll 8 individwi b'ESRD fuq id-dijaliżi tad-demm.
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma ddefiniti skont ilkonvenzjoni li ġejja: komuni ħafna ( 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Further symptoms are reduced body temperature and heartbeat.
Maltese: Sintomi oħra huma tnaqqis fit-temperatura tal-ġisem u fit-taħbit tal-qalb.
English: ul.
Maltese: oC.
English: Luxembourg/Luxemburg Mundipharma Comm VA Blarenberglaan 3C B-2800 Mechelen Belgique/Belgien Tél/Tel: +32 15 45 11 80
Maltese: Luxembourg/Luxemburg Mundipharma Comm VA Blarenberglaan 3C B-2800 Mechelen Belgique/Belgien
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 patient-years (p = 0.021)
Maltese: • tnaqqis sinifikanti fir-riskju assolut ta' mortalità totali: metformin 13.5 każ/1,000 sena ta' pazjent kontra dieta waħedha 20.6 każ/1,000 sena ta' pazjent, (p = 0.011), u kontra il-gruppi kkombinati ta' monoterapija b'sulphonylurea u insulina 18.9 każ/1,000 sena ta' pazjent (p = 0.021)
English: Necrotising fasciitis of the perineum (Fournier's gangrene)
Maltese: Fasciitis nekrotika tal-perineum (kankrena ta' Fournier)
English: A total of 10,134 patients were treated (4,327 in CANVAS and 5,807 in CANVAS-R; total of 4,344 randomly assigned to placebo and 5,790 to canagliflozin) and exposed for a mean of 149 weeks (exposed for a mean of 223 weeks in CANVAS and 94 weeks in CANVAS-R).
Maltese: Total ta' 10,134 pazjent ġew ittrattati (4,327 f'CANVAS u 5,807 f'CANVAS-R; total ta' 4,344 assenjati b'mod arbitrarju għal plaċebo u 5,790 għal canagliflozin) u esposti għal medja ta' 149 ġimgħa (esposti għal medja ta' 223 ġimgħa f'CANVAS u 94 ġimgħa f'CANVAS-R).
English: In addition, canagliflozin reduced progression of albuminuria 25.8% versus placebo 29.2% (HR: 0.73; 95% CI: 0.67, 0.79) in patients with baseline normo- or micro-albuminuria.
Maltese: Barra minnhekk, canagliflozin naqqas il-progressjoni ta' albuminurja 25.8% kontra plaċebo 29.2% (HR: 0.73; 95% CI: 0.67, 0.79) f'pazjenti b'normoalbuminurja jew mikroalbuminurja fil-linja bażi.
English: UAB "JOHNSON & JOHNSON" Konstitucijos pr. 21C LT-08130 Vilnius Lithuania
Maltese: LT-08130 Vilnius Lithuania
English: Mundipharma A/S Frydenlundsvej 30 DK-2950 Vedbæk Tlf: +45 45 17 48 00
Maltese: Mundipharma A/S Frydenlundsvej 30 DK-2950
English: Dyslipidemia m, Haematocrit increased b, n uncommon
Maltese: Dislipidemija m, Żieda fl-ematokrit b,n mhux komuni
English: There were 2,011 patients with eGFR 30 to < 60 mL/min/1.73 m 2.
Maltese: Kien hemm 2,011-il pazjent b'eGFR minn 30 sa < 60 mL/min/1.73 m 2.
English: Mean percent increases from baseline for canagliflozin 100 mg and 300 mg versus placebo, respectively, were total cholesterol 3.4% and 5.2% versus 0.9%; HDL-cholesterol 9.4% and 10.3% versus 4.0%; LDL-cholesterol 5.7% and 9.3% versus 1.3%; non-HDL-cholesterol 2.2% and 4.4% versus 0.7%; triglycerides 2.4% and 0.0% versus 7.6%.
Maltese: 3% kontra 4.0%; kolesterol LDL 5.7% u 9.3% kontra 1.3%; kolesterol mhux HDL 2.2% u 4.4% kontra 0.7%; trigliċeridi 2.4% u 0.0% kontra 7.6%.
English: EU/1/14/918/001 (50 mg/850 mg - 20 film-coated tablets) EU/1/14/918/002 (50 mg/850 mg - 60 film-coated tablets) EU/1/14/918/003 (50 mg/850 mg - 180 film-coated tablets) EU/1/14/918/004 (50 mg/1000 mg - 20 film-coated tablets) EU/1/14/918/005 (50 mg/1000 mg - 60 film-coated tablets) EU/1/14/918/006 (50 mg/1000 mg - 180 film-coated tablets) EU/1/14/918/007 (150 mg/850 mg - 20 film-coated tablets) EU/1/14/918/008 (150 mg/850 mg - 60 film-coated tablets) EU/1/14/918/009 (150 mg/850 mg - 180 film-coated tablets) EU/1/14/918/010 (150 mg/1000 mg - 20 film-coated tablets) EU/1/14/918/011 (150 mg/1000 mg - 60 film-coated tablets) EU/1/14/918/012 (150 mg/1000 mg - 180 film-coated tablets)
Maltese: EU/1/14/918/001 (50 mg/850 mg - 20 pillola miksija b'rita) EU/1/14/918/002 (50 mg/850 mg - 60 pillola miksija b'rita) EU/1/14/918/003 (50 mg/850 mg - 180 pillola miksija b'rita) EU/1/14/918/004 (50 mg/1000 mg - 20 pillola miksija b'rita) EU/1/14/918/005 (50 mg/1000 mg - 60 pillola miksija b'rita) EU/1/14/918/006 (50 mg/1000 mg - 180 pillola miksija b'rita) EU/1/14/918/007 (150 mg/850 mg - 20 pillola miksija b'rita) EU/1/14/918/008 (150 mg/850 mg - 60 pillola miksija b'rita) EU/1/14/918/009 (150 mg/850 mg - 180 pillola miksija b'rita) EU/1/14/918/010 (150 mg/1000 mg - 20 pillola miksija b'rita) EU/1/14/918/011 (150 mg/1000 mg - 60 pillola miksija b'rita) EU/1/14/918/012 (150 mg/1000 mg - 180 pillola miksija b'rita)
English: Sitagliptin 100 mg + metformin and sulphonylurea (N = 378)
Maltese: Sitagliptin 100 mg + metformin u sulphonylurea (N = 378)
English: Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and medicinal product-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (area under the curve, AUC) and peak concentration (Cmax) were observed.
Maltese: Wara għoti ta' canagliflozin ma' rifampicin (induttur ta' diversi trasportaturi attivi u enzimi li jimmetabolizzaw il-prodott mediċinali), kien osservat tnaqqis ta' 51% u 28% fl-esponiment sistemiku (żona taħt il-kurva, AUC - area under the curve) għal canagliflozin u fl-ogħla konċentrazzjoni (Cmax) ta' canagliflozin.