FrancophonIA/ELRC3.0 huggingface dataset:
English: The study showed that Rituzena and MabThera had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Rituzena and 73% (43 of 59 patients) with MabThera.
Maltese: L-istudju wera li Rituzena u MabThera kellhom effetti kumparabbli fuq is-sintomi tal-artrite: wara 24 ġimgħa, il-proporzjon ta' pazjenti li kellhom titjib ta' 20 % fil-punteġġ tas-sintomi (imsejjaħ ACR20) kien ta' 74 % (114 minn 155 pazjent) b'Rituzena u ta' 73% (43 minn 59 pazjent) b'MabThera.
English: Rituzena is a ‘biosimilar medicine'.
Maltese: Rituzena huwa 'mediċina bijosimili'.
English: In this study improvement was seen in 96% of cases (67 of 70 patients) with Rituzena and 90% (63 of 70 patients) with Rituxan.
Maltese: F'dan l-istudju deher titjib f'96 % tal-każijiet (67 minn 70 pazjent) b'Rituzena u 90 % (63 minn 70 pazjent) b'Rituxan.
English: This is a summary of the European public assessment report (EPAR) for Rituzena.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rituzena.
English: Other serious side effects include hepatitis B reactivation (return of previous active liver infection with hepatitis B virus) and a rare and severe brain infection known as progressive multifocal leukoencephalopathy (PML).
Maltese: Effetti sekondarji serji oħra jinkludu riattivazzjoni tal-epatite B (ritorn ta' infezzjoni attiva preċedenti fil-fwied bil-virus tal-epatite B) u infezzjoni fil-moħħ severa u rari magħrufa bħala lewkoenċefalopatija multifokali progressiva (PML).
English: The reference medicine for Rituzena is MabThera.
Maltese: Ilmediċina ta' referenza għal Rituzena hija MabThera.
English: Further evidence came from supportive studies, including one involving 121 patients with advanced follicular lymphoma, where adding Rituzena to chemotherapy medicines was at least as effective as adding Rituxan, the US version of MabThera.
Maltese: Evidenza ulterjuri minn studji ta' sostenn, inkluż wieħed li involva 121 pazjent b'linfoma follikulari avvanzata, fejn iż-żieda ta' Rituzena mal-mediċini tal-kimoterapija kienet tal-inqas effettiva daqs iżżieda ta' Rituxan, il-verżjoni tal-Istati Uniti ta' MabThera.
English: Why is Rituzena approved?
Maltese: Għaliex ġie approvat Rituzena?
English: • granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis
Maltese: • granulomatożi b'polianġite (GPA jew granulomatożi ta' Wegener) u polianġite mikroskopika (MPA), li huma kondizzjonijiet infjammatorji tal-vażi tad-demm.
English: The European Commission granted a marketing aithorisation valid throughout the European Union for Tuxella on 13 July 2017.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Tuxella fit-13 ta' Lulju 2017.
English: Rituzena contains the active
Maltese: Rituzena fih is-sustanza attiva rituximab.
English: The active substance in Rituzena, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B cells (types of white blood cells).
Maltese: Is-sustanza attiva f'Rituzena, ir-rituximab, hija antikorp monoklonali (tip ta' proteina) imfassla biex tagħraf u teħel ma' proteina msejħa CD20 preżenti fuq il-wiċċ taċ-ċelloli B (tipi ta' ċelloli bojod taddemm).
English: Laboratory studies comparing Rituzena with MabThera have shown that the active substance in Rituzena is highly similar to that in MabThera in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Rituzena ma' MabThera wrew li s-sustanza attiva f'Rituzena hija simili ħafna għal dik f'MabThera f'termini ta' struttura, purità u attività bijoloġika.
English: What are the risks associated with Rituzena?
Maltese: X'inhuma r-riskji assoċjati ma' Rituzena?
English: The name of the product was changed to Rituzena on 4 August 2017.
Maltese: L-isem tal-prodott inbidel għal Rituzena fl-4 ta' Awwissu 2017.
English: The company that markets Rituzena will provide doctors and patients using the medicine for noncancer conditions with educational material including information on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Maltese: Il-kumpanija li tqiegħed Rituzena fis-suq se tipprovdi lit-tobba u lill-pazjenti li jużaw il-mediċina għal kondizzjonijiet mhux tal-kanċer b'materjal edukattiv inkluża informazzjoni dwar il-ħtieġa li l-mediċina tingħata fejn ikun hemm disponibbli faċilitajiet għar-risuxxitazzjoni u dwar ir-riskju ta' infezzjoni, inkluż PML.
English: It is available as a concentrate for making a solution that must be given by infusion (drip) into a vein.
Maltese: Jiġi bħala konċentrat sabiex issir soluzzjoni li għandha tingħata permezz ta' infużjoni (dripp) ġo vina.
English: This means that Rituzena is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Rituzena huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala l-'mediċina ta' referenza') li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: The most common serious side effects are infusion reactions, infections and, in cancer patients, heart-related problems.
Maltese: L-effetti sekondarji l-aktar komuni huma reazzjonijiet ta' infużjoni, infezzjonijiet u, f'pazjenti bil-kanċer problemi relatati mal-qalb.
English: When rituximab attaches to CD20, it causes the death of B cells, which helps in lymphoma and CLL, where B cells have become cancerous.
Maltese: Meta r-rituximab teħel ma' CD20, din tikkawża l-mewt taċ-ċelloli B, li jgħin fil-linfoma u fisCLL, fejn iċ-ċelloli B ikunu saru kanċerużi.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Rituzena has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Rituzena għandu struttura, purità u attività bijoloġika simili ħafna għal MabThera u jiġi distribwit bl-istess mod fil-ġisem.
English: Rituzena is a medicine used in adults to treat the following blood cancers and inflammatory conditions: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's
Maltese: Skont il-kondizzjoni li jintuża biex jikkura, Rituzena jista' jingħata waħdu, jew flimkien malkimoterapija (mediċini oħra kontra l-kanċer) jew ma' mediċini li jintużaw għal disturbi infjammatorji (kortikosterojdi).
English: Because Rituzena is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Rituzena.
Maltese: Peress li Rituzena huwa mediċina bijosimili, l-istudji dwar l-effikaċja u s-sigurtà ta' rituximab li saru b'MabThera ma għandhomx bżonn jiġu ripetuti kollha għal Rituzena.
English: In addition, a study comparing Rituzena to MabThera in patients with rheumatoid arthritis (which can support its use in other inflammatory disorders such as GPA and MPA) showed that both medicines are similarly effective, and a supportive study in follicular lymphoma showed effectiveness in cancer.
Maltese: Barra minn hekk, studju li jqabbel Rituzena ma' MabThera f'pazjenti b'artrite rewmatojde (li jista' jappoġġja l-użu tiegħu f'disturbi infjammatorji oħra bħal GPA u MPA) wera li ż-żewġ mediċini huma effettivi b'mod simili, u studju ta' sostenn f'linfoma follikulari wera effekiċja filkanċer.
English: For the full list of side effects reported with Rituzena, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Rituzena, ara l-fuljett ta' tagħrif.
English: The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in most cancer patients and in more than 1 in 10 GPA or MPA patients at the time of the first infusion.
Maltese: L-effetti sekondarji l-aktar komuni b'rituximab huma reazzjonijiet relatati mal-infużjoni (bħal deni, dehxiet u rogħda) li jseħħu fil-maġġoranza tal-pazjenti bil-kanċer u f'aktar minn 1 minn kull 10 pazjenti b'GPA jew MPA meta ssir l-ewwel infużjoni.
English: In addition, Rituzena has been compared with MabThera given into a vein in a main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease).
Maltese: 372 pazjent b'artrite rewmatojde attiva (marda infjammatorja).
English: How is Rituzena used?
Maltese: Kif jintuża Rituzena?
English: Before each infusion, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine to reduce fever).
Maltese: Qabel kull infużjoni, il-pazjent għandu jingħata antistamina (għall-prevenzjoni ta' reazzjonijiet allerġiċi) u antipiretiku (mediċina kontra d-deni).
English: 14 tablets 28 tablets 30 tablets 50 tablets 90 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 50 pillola 90 pillola 98 pillola
English: Extrapancreatic activity
Maltese: Attività extrapankrejatika
English: It may harm them,
Maltese: oestrogens u progestagens,
English: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland Delpharm Novara S.r.l., Via Crosa, 86, 28065 Cerano (NO), Italy Takeda GmbH, Production Site Oranienburg, Lehnitzstrasse 70 - 98, 16515 Oranienburg, Germany
Maltese: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, L-Irlanda Delpharm Novara S.r.l., Via Crosa, 86, 28065 Cerano (NO), L-Italja Takeda GmbH, Production Site Oranienburg, Lehnitzstrasse 70 - 98, 16515
English: There was no relevant accumulation.
Maltese: Ma kienx hemm akkumulazzjoni rilevanti.
English: very rare very rare
Maltese: rari ħafna rari ħafna
English: Deutschland Takeda GmbH Tel: 0800 825 3325 medinfo@takeda.de
Maltese: Takeda GmbH Tel: 0800 825 3325 medinfo@takeda.de
English: Takeda GmbH Production Site Oranienburg Lehnitzstrasse 70 - 98 16515 Oranienburg, Germany
Maltese: Takeda GmbH Production Site Oranienburg Lehnitzstrasse 70 - 98
English: 5 Gastro-intestinal complaints are very rare and seldom lead to discontinuation of therapy.
Maltese: 5Problemi gastro-intestinali huma rari ħafna u rarament iwasslu għall-waqfien tat-terapija.
English: Nederland Takeda Nederland bv Tel: +31 23 56 68 777
Maltese: Takeda Nederland bv Tel: +31 23 56 68 777
English: Date of latest renewal: 09 September 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 08 ta' Jannar 2007 Data tal-aħħar tiġdid: 09 ta' Settembru 2016
English: Risk related to glimepiride
Maltese: Riskju relatat ma'glimepiride
English: Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o.
Maltese: Takeda Pharmaceuticals Slovakia s.r.o.
English: Via Crosa 86, 28065 Cerano (NO) Italy
Maltese: Delpharm Novara S.r.l. Via Crosa 86, 28065 Cerano (NO) L-Italja
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Maltese: studju kellha età medja ta' 62 sena; it-tul medju ta' dijabete kien 9.5 sena.
English: Polycystic ovarian syndrome
Maltese: Sindromu poliċistiku fl-ovarji
English: United Kingdom Takeda UK Ltd Tel: +44 (0)1628 537 900
Maltese: Takeda UK Ltd Tel: +44 (0)1628 537 900
English: phenylbutazone, azapropazone and oxyfenbutazone insulin and oral antidiabetic products metformin salicylates and p-amino-salicylic acid anabolic steroids and male sex hormones chloramphenicol clarithromycin coumarin anticoagulants disopyramide fenfluramine fibrates angiotensin-converting enzyme (ACE) inhibitors fluoxetine allopurinol sympatholytics cyclo-, tro- and iphosphamides sulphinpyrazone certain long-acting sulphonamides tetracyclines
Maltese: phenylbutazone, azapropazon u oxyfenbutazone insulina u prodotti anti-dijabetiċi orali metformin salicylates u p-amino-salicylic acid sterojdi anaboliċi u ormoni sesswali ta' l-irġiel chloramphenicol clarithromycin coumarin anticoagulants disopyramide fenfluramine fibrates inibituri tal-enzima li tikkonverti angiotensin (ACE, angiotensin-converting enzyme) fluoxetine allopurinol sympatholytics cyclo-, tro- u iphosphamides sulphinpyrazone ċertu sulphonamides li jaħdmu fit-tul tetracyclines inibituri MAO anti-bijotiċi quinolone probenecid miconazole pentoxyfylline (doża għolja mogħtija b'mod parenterali)
English: common common
Maltese: komuni komuni
English: Denmark
Maltese: Danmark
English: very rare very rare allergic vasculitis2
Maltese: rari ħafna rari ħafna vaskulite allerġika 2
English: Danmark Takeda Pharma A/S Tlf: +45 46 77 11 11
Maltese: Takeda Pharma A/S Tlf: +45 46 77 11 11
English: 6.5 Nature and contents of container Aluminium/aluminium blisters; packs of 14, 28, 30, 50, 90 or 98 tablets.
Maltese: Aluminju/folji tal-aluminju; pakketti ta' 14, 28, 30, 50, 90 jew 98 pillola.
English: Further treatment should be symptomatic.
Maltese: Aktar kura għandha tkun sintomatika.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: barcode 2D li jkollu l­identifikatur uniku inkluż.
English: Glimepiride is transferred to the placenta.
Maltese: Glimepiride jiġi trasferit għal ġol-plaċenta.
English: - weight gain - dizziness - gas - respiratory infection - numbness
Maltese: - sturdament - gass - infezzjoni respiratorja - tnemnim
English: After oral administration of glimepiride, the terminal half-lives of those metabolites were 3 to 6 and 5 to 6 hours respectively.
Maltese: glimepiride, il-half-lives terminali ta' dawk il-metaboliti kienu 3 sa 6 u 5 sa 6 sigħat rispettivament.
English: very rare very rare hypersensitivity and allergic reactions3
Maltese: rari ħafna rari ħafna sensittività eċċessiva u reazzjonijiet allerġiċi 3
English: Ελλάδα
Maltese: Tiħux
English: In the 3.5 year PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
Maltese: Fl-istudju PROactive ta' 3.5 snin, 44/870 (5.1%; 1.0 ksur għal kull 100 sena ta' pazjent) tal-pazjenti nisa kkurati b'pioglitazone kellhom esperjenza ta' fratturi meta mqabbel ma' 23/905 (2.5%; 0.5 ksur għal kull 100 sena ta' pazjent) tal-pazjenti nisa kkurati bi prodott paragun.
English: Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 10,212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, p=0.029).
Maltese: kontroll (7 każijiet minn 10,212 pazjent, 0.07%) HR = 2.64 (95% CI 1.11-6.31, p = 0.029).
English: - The other ingredients are cellulose microcrystalline, croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate (see section 2 ‘Tandemact contains lactose monohydrate'), magnesium stearate and polysorbate 80.
Maltese: - Is-sustanzi mhux attivi l-oħra huma cellulose microcrystalline, croscarmellose sodium, hydroxypropylcellulose, lattosju monohydrate (ara sezzjoni 2 ‘Tandemact fih lattosju monohydrate'), magnesium stearate u polysorbate 80.
English: Immune system disorders allergic shock2
Maltese: Disturbi fis-sistema immuni xokk allerġiku 2
English: Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Maltese: Tibdiliet simili dehru fi provi komparattivi kkontrollati b'pioglitazone f'pazjenti kkurati b'metformin (tnaqqis relattiv fl-emoglobina ta' 3-4% u fl-ematokrita ta' 3.6-4.1%) u fi kwantità inqas b'sulphonylurea u insulina (tnaqqis relattiv fl-emoglobina ta' 1-2% u fl-ematokrita ta' 1-3.2%).
English: Frequencies are defined as: 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-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10), komuni (≥ 1/100 to < 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: Tandemact contains lactose monohydrate
Maltese: Tandemact fih lattosju monohydrate
English: TAKEDA ΕΛΛΑΣ Α.Ε Τηλ: +30 210 6387800 gr.info@takeda.com
Maltese: Τηλ: +30 210 6387800 gr.info@takeda.com
English: There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9, and 3A4 in man.
Maltese: Ma hemm l-ebda induzzjoni tal-isożimi prinċipali ta' P450 induċibbli 1A, 2C8/9, u 3A4 fil-bniedem.
English: The effect of glimepiride is dose-dependent and reproducible.
Maltese: L-effett ta' glimepiride huwa dipendenti mid-doża u riprodottiv.
English: Two metabolites - most probably resulting from hepatic metabolism (major enzyme is CYP2C9) - were identified both in urine and faeces: the hydroxy derivative and the carboxy derivative.
Maltese: Żewġ metaboliti - wisq probabbli rriżultaw minn metaboliżmu epatika (l-enżima prinċipali hija CYP2C9) - kienu identifikati kemm fl-awrina kif ukoll fil-feċi: id-derivat ta' hydroxyl u d-derivat ta' carboxy.
English: Proportional increases of the plasma concentration were observed for doses from 2-60 mg.
Maltese: Żieda proporzjonali fil-konċentrazzjoni fil-plażma kienet osservata f'dozi minn 2-60 mg.
English: EU/1/06/366/018 EU/1/06/366/019 EU/1/06/366/020 EU/1/06/366/021 EU/1/06/366/022
Maltese: EU/1/06/366/018 EU/1/06/366/019 EU/1/06/366/020
English: Lactose monohydrate
Maltese: Fih lattosju monohydrate.
English: The tablets are supplied in aluminium/aluminium blister packs containing either 14, 28, 30, 50, 90 or 98 tablets.
Maltese: Il-pilloli huma disponibbli f'alluminju u f'pakketti tal-folja ta' l-alluminju li fihom 14, 28, 30, 50, 90 jew 98 pillola.
English: 7 A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
Maltese: 7Twettqet analiżi ta' tagħrif miġbur ta' rapporti ta' avvennimenti avversi ta' fratturi fl-għadam minn provi kliniċi randomised, ikkontrollati b'paragun, u double blind b'aktar minn 8,100 pazjent fil-gruppi kkurati b'pioglitazone u 7,400 pazjent fil-gruppi kkurrati bi prodott paragun li damu sa 3.5 snin.
English: Insulin release
Maltese: Reħa ta' insulina
English: In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.
Maltese: Fi provi kliniċi ta' sena, pioglitazone b'mod konsistenti wassal għal tnaqqis statistikament sinifikanti fil-proporzjon ta' albumin/krejatinina meta mqabbel mal-linja bażika.
English: In healthy persons, the minimum effective oral dose is approximately 0.6 mg.
Maltese: F'persuni b'saħħithom, id-doża orali minima effettiva hija ta' madwar 0.6 mg.
English: Tandemact combines two antihyperglycaemic active substances with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: pioglitazone, a member of the thiazolidinedione class and glimepiride, a member of the sulphonylurea class.
Maltese: Tandemact jikkombina żewġ sustanzi attivi anti-ipergliċemiċi b'mekkaniżmi ta' azzjoni li jikkumplimentaw lil xulxin biex itejbu l-kontroll gliċemiku f'pazjenti b'dijabete mellitus tat-tip 2: pioglitazone, membru tal-klassi thiazolidinedione u glimepiride, membru tal-klassi sulphonylurea.
English: During therapy with pioglitazone there was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction), consistent with haemodilution.
Maltese: Kien hemm tnaqqis żgħir fil-medja ta' l-emoglobina (tnaqqis relattiv ta' 4%) u l-ematokrita (tnaqqis relattiv ta' 4.1%) konsistenti ma' emodiluzzjoni, waqt terapija b'pioglitazone.
English: Clinical trials have been conducted with co-administered pioglitazone and glimepiride (see section 5.1).
Maltese: Saru provi kliniċi meta' pioglitazone u glimepiride ingħataw flimkien (ara sezzjoni 5.1).
English: Some patients experienced the following side effects whilst taking pioglitazone and sulphonylureas, including glimepiride:
Maltese: Xi pazjenti esperjenzaw l-effetti sekondarji li ġejjin waqt li kienu qed jieħdu pioglitazone u sulphonylureas, inkluż glimepiride:
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, acetylsalicylic acid, statins, fibrates).
Maltese: Kważi l-individwi kollha (95%) kienu qed jirċievu prodotti mediċinali kardjovaskulari (imblokkaturi tar-riċetturi beta, inibituri ACE, antagonisti ta' angiotensin II, imblokkaturi tal-kanali tal-kalċju,
English: Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5).
Maltese: L-għotja ta' pioglitazone flimkien ma' gemfibrozil (inibitur taċ-ċitokromju P450 2C8) jew ma' rifampicin (induttur taċ-ċitokromju P450 2C8) hija rrappurtata li żżid jew tnaqqas, rispettivament, il-konċentrazzjoni ta' pioglitazone fil-plażma (ara sezzjoni 4.5).
English: After a single dose of radiolabelled glimepiride, 58% of the radioactivity was recovered in the urine, and 35% in the faeces.
Maltese: Wara doża waħda ta' glimepiride radjulabiljat, 58% tar-radjuattività kienet irkuprata fl-awrina, u 35%
English: Summary of the safety profile
Maltese: Sommarju tal-profil tas-sigurta'
English: Tandemact 30 mg/2 mg tablets Tandemact 30 mg/4 mg tablets Tandemact 45 mg/4 mg tablets pioglitazone/glimepiride
Maltese: Pilloli Tandemact 30 mg/2 mg Pilloli Tandemact 30 mg/4 mg Pilloli Tandemact 45 mg/4 mg
English: Glimepiride has a very low distribution volume (approximately 8.8 litres) which is roughly equal to the albumin distribution space, high protein binding (> 99%), and a low clearance (approximately 48 mL/min).
Maltese: Distribuzzjoni Glimepiride għandu volum ta' distribuzzjoni żgħir ħafna (madwar 8.8 litri) li huwa bejn wieħed u ieħor ugwali għal l-ispazju ta' distribuzzjoni ta' l-albumina, twaħħil għoli mal-proteini (> 99%), u tneħħijja baxxa (madwar 48 mL/min).
English: Under the influence of sympatholytic active substances such as betablockers, clonidine, guanethidine and reserpine, the signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent.
Maltese: Taħt l-influwenza ta' sustanzi attivi simpatolitiċi bħal imblukkaturi beta, clonidine, guanethidine u reserpine, is-sinjali ta' kontra-regolazzjoni adrinerġika għall-ipogliċemija jistgħu jkunu mnaqqsa jew assenti.
English: Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, granulocytopenia, agranulocytosis, haemolytic anaemia and pancytopenia may occur rarely (≥ 1/10,000 to < 1/1,000) (see section 4.4).
Maltese: Din hija reazzjoni serja li tista sseħħ mhux komuni (≥ 1/1,000 sa < 1/100) (ara sezzjoni 4.4). Tromboċitopenija, leukopenija, eritroċitopenija, agranuloċitopenija, agranuloċitosi, anemija emolitika u panċito-penija moderata għal severa jistgħu jseħħu rari (≥ 1/10,000 sa < 1/1,000) (ara sezzjoni 4.4).
English: 1 Moderate to severe thrombocytopenia, leucopenia, erythrocytopenia, granulocytopenia, agranulocytosis, haemolytic anaemia and pancyto-penia may occur.
Maltese: 1Tromboċitopenija, leukopenija, eritroċitopenija, agranuloċitopenija, agranuloċitosi, anemija emolitika u panċito-penija moderata għal severa jistgħu jseħħu.
English: Each tablet contains approximately 177 mg lactose monohydrate (see section 4.4).
Maltese: Kull pillola fiha madwar 177 mg lattosju monohydrate (ara sezzjoni 4.4).
English: Wed. Thu.
Maltese: Jekk tieqaf tieħu Tandemact
English: Each tablet contains approximately 125 mg lactose monohydrate (see section 4.4).
Maltese: Kull pillola fiha madwar 125 mg lattosju monohydrate (ara sezzjoni 4.4).