FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Xiliarx.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Xiliarx.
English: Xiliarx is a medicine that contains the active substance vildagliptin.
Maltese: Xiliarx huwa mediċina li fiha s-sustanza attiva vildagliptin.
English: In adults, the recommended dose of Xiliarx is:
Maltese: Fl-adulti, id-doża rakkomandata ta' Xiliarx hija:
English: Four studies compared the effects of Xiliarx, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).
Maltese: Erba' studji qabblu l-effetti ta' Xiliarx, meħud f'dożi ta' 50 jew 100 mg kuljum għal 24 ġimgħa, ma' dawk tal-plaċebo, meta użat bħala trattament aġġuntiv mat-trattament eżistenti bil-metformina (544 pazjent), bil-pijoglitażonu (tijażolidinedjonu, 463 pazjent), bil-glimepiride (sulfonilurea, 515-il pazjent) jew bl-insulina (296 pazjent).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xiliarx on 19 November 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Xiliarx valida fl-Unjoni Ewropea kollha fid-19 ta' Novembru 2008.
English: The CHMP noted that Xiliarx was effective as an add-on to metformin, a thiazolidinedione, or a sulphonylurea (dual therapy), a sulphonylurea and metformin (triple therapy) or insulin with or without metformin, and concluded that the benefits of the add-on treatment outweigh the risks.
Maltese: Is-CHMP innota li Xiliarx kien effikaċi bħala trattament aġġuntiv mat-trattament bil-metformina, bittijażolidinedjonu jew bis-sulfonilurea (terapija doppja), bis-sulfonilurea u bil-metformina (terapija tripla) jew bl-insulina bil-metformina jew mingħajrha, u kkonkluda li l-benefiċċji tat-trattament aġġuntiv huma akbar mir-riskji.
English: Five of these studies looked at the effects of Xiliarx taken alone in a total of 3,644 patients, comparing it with placebo (a dummy treatment), metformin, rosiglitazone (a thiazolidinedione) or gliclazide (a sulphonylurea).
Maltese: Ħamsa minn dawn l-istudji analizzaw l-effetti ta' Xiliarx meħud waħdu f'total ta' 3,644 pazjent, u qabbluh ma' plaċebo (trattament finta), mal-metformina, mar-rosiglitażonu (tijażolidinedjonu) jew mal-glikażide (sulfonilurea).
English: In combination with glimepiride, both 50 mg and 100 mg daily doses caused a reduction of around 0.6 percentage points.
Maltese: Flimkien mal-glimepiride, iżżewġ dożi ta' kuljum ta' 50 mg u 100 mg ikkawżaw tnaqqis ta' madwar 0.6 punti perċentwali.
English: • one tablet in the morning (50 mg per day) when taken with a sulphonylurea.
Maltese: • pillola waħda filgħodu (50 mg kuljum) meta jittieħed mas-sulfonilurea.
English: What is Xiliarx?
Maltese: X'inhu Xiliarx?
English: Why has Xiliarx been approved?
Maltese: Għaliex ġie approvat Xiliarx?
English: In combination with metformin and glimepiride, 50 mg Galvus taken twice a day reduced HbA1c levels by 1 percentage point, compared with a reduction of 0.3 percentage points in patients taking placebo.
Maltese: Flimkien mal-metformina u l-glimepiride, 50 mg Xiliarx meħud darbtejn kuljum naqqsu l-livelli ta' HbA1c b'punt perċentwali wieħed, meta mqabbel ma' tnaqqis ta' 0.3 punti perċentwali f'pazjenti li kienu qed jieħdu l-plaċebo.
English: With metformin and with pioglitazone, the 100 mg daily dose was more effective than the 50 mg daily dose, with a reduction in HbA1c levels of between 0.8 and 1.0 percentage points.
Maltese: Id-doża ta' kuljum ta' 100 mg meħuda mal-metformina u mal-pijoglitażonu kienet aktar effikaċi mid-doża ta' kuljum ta' 50 mg, tant li rreġistrat tnaqqis bejn 0.8 u 1.0 punti perċentwali fil-livelli tal-HbA1c.
English: Xiliarx is used to treat type 2 diabetes mellitus.
Maltese: Xiliarx jintuża fil-kura tad-dijabete mellitu tat-tip 2.
English: What is the risk associated with Xiliarx?
Maltese: X'inhu r-riskju assoċjat ma' Xiliarx?
English: Patients taking Galvus in addition to insulin, with or without metformin, had a reduction in HbA1c levels of 0.77 percentage points, compared with 0.05 percentage points in patients taking placebo in addition to insulin.
Maltese: Il-pazjenti li kienu qed jieħdu Xiliarx flimkien malinsulina, bil-metformina jew mingħajrha, kellhom tnaqqis ta' 0.77 punti perċentwali fil-livelli ta' HbA1c, meta mqabbla ma' 0.05 punti perċentwali f'pazjenti li kienu qed jieħdu l-plaċebo flimkien mal-insulina.
English: The most common side effect with Xiliarx (seen in between 1 and 10 patients in 100) is dizziness.
Maltese: L-effett sekondarju l-aktar komuni bi Xiliarx (li deher f'bejn pazjent wieħed u 10 fost 100) huwa sturdament.
English: In the study comparing Xiliarx with metformin, significantly better results were seen with metformin: a reduction in HbA1c of 1.5 percentage points after 52 weeks compared with a reduction of around 1 percentage point in patients treated with Xiliarx.
Maltese: Fl-istudju li qabbel lil Xiliarx mal-metaformina, il-kura bil-metaformina tat riżultati aħjar b'mod sinifikanti: tnaqqis fil-HbA1c ta' 1.5 punti perċentwali wara 52 ġimgħa meta mqabbel ma' tnaqqis ta' madwar perċentwal 1 f'pazjenti kkurati b'Xiliarx.
English: • together with a sulphonylurea and metformin (triple therapy) in patients whose diabetes is not sufficiently controlled by these medicines plus diet and exercise;
Maltese: • flimkien mas-sulfonilurea u l-metformina (terapija tripla) f'pazjenti li d-dijabete tagħhom ma tkunx ikkontrollata biżżejjed b'dawn il-mediċina flimkien mad-dieta u l-eżerċizzju;
English: Because vildagliptin has been associated with liver problems, patients should have tests to check their liver function before treatment with Xiliarx and at regular intervals during treatment.
Maltese: Peress li l-vildagliptin kienet assoċjata ma' problemi fil-fwied, il-pazjenti għandhom jagħmlu testijiet tal-fwied qabel it-trattament bi Xiliarx u f'intervalli regolari matul it-trattament.
English: • one tablet in the morning and another in the evening (100 mg per day), when used alone, with metformin, with a thiazolidinedione, with metformin plus a sulphonylurea, or with insulin (with or without metformin);
Maltese: • pillola waħda filgħodu u oħra filgħaxija (100 mg kuljum), meta jintuża waħdu, mal-metformina, mat-tijażolidinedjonu, mal-metformina flimkien mas-sulfonilurea, jew mal-insulina (bil-metformina jew mingħajrha).
English: Xiliarx used on its own was effective at reducing levels of HbA1c, but was less effective than the comparator medicines.
Maltese: Xiliarx użat waħdu kien iżjed effikaċi fit-tnaqqis tal-livelli tal-HbA1c, iżda inqas effikaċi mill-mediċini li tqabbel magħhom.
English: When used as an add-on to existing treatment for type 2 diabetes, Xiliarx was more effective than placebo in reducing HbA1c levels.
Maltese: Meta użat bħala terapija aġġuntiva mat-trattament eżistenti għad-dijabete tat-tip 2, irriżulta li Xiliarx kien aktar effikaċi mill-plaċebo fit-tnaqqis tal-livelli tal-HbA1c.
English: Xiliarx has been studied in eleven main studies involving a total of over 5,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Maltese: Xiliarx ġie studjat fi ħdax-il studju prinċipali li kienu jinvolvu total ta' aktar minn 5,000 pazjent li jbatu mid-dijabete tat-tip 2 u b'kontroll insuffiċjenti tal-livelli tal-glukożju fid-demm.
English: For the full list of all side effects reported with Xiliarx, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati bi Xiliarx, ara l-fuljett ta' tagħrif.
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Maltese: Din taħdem billi timblokka t-tkissir tal-ormoni ‘inkretini' fil-ġisem.
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Maltese: Dawn l-ormoni jiġu rilaxxati wara likel u jistimulaw il-produzzjoni tal-insulina mill-frixa.
English: Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Maltese: Il-vildagliptin tnaqqas ukoll lammont ta' glukożju prodott mill-fwied, billi żżid il-livelli tal-insulina u tnaqqas il-livelli tal-ormon glukagon.
English: How has Xiliarx been studied?
Maltese: Kif ġie studjat Xiliarx?
English: A further study compared Galvus with placebo as an add-on treatment in 449 patients who were already taking a stable dose of long-acting insulin.
Maltese: Studju ieħor qabbel Xiliarx mal-plaċebo bħala trattament aġġuntiv f'449 pazjent li kienu diġà qed jirċievu doża stabbli tal-insulina li taħdem fit-tul.
English: • together with metformin, a thiazolidinedione or a sulphonylurea (dual therapy) when the patient's diabetes is insufficiently controlled by this other medicine taken alone, but it is only used in combination with a sulphonylurea in patients who cannot take metformin;
Maltese: • flimkien mal-metformina, it-tijażolidinedjonu jew is-sulfonilurea (terapija doppja) meta d-dijabete tal-pazjent ma tkunx ikkontrollata biżżejjed b'din il-mediċina l-oħra meħuda waħedha, iżda tintuża biss flimkien mas-sulfonilurea f'pazjenti li ma jkunux jistgħu jieħdu l-metformina;
English: How does Xiliarx work?
Maltese: Għal xiex jintuża Xiliarx?
English: By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Maltese: Billi żżid il-livelli ta' ormoni inkretini fid-demm, ilvildagliptin tistimula l-frixa tipproduċi aktar insulina meta l-livelli tal-glukożju fid-demm ikunu għoljin.
English: • together with insulin (with or without metformin) in patients whose diabetes is not sufficiently controlled by diet and exercise plus a stable dose of insulin.
Maltese: • flimkien mal-insulina (bil-metformina jew mingħajrha) f'pazjenti li d-dijabete tagħhom ma tkunx ikkontrollata biżżejjed bid-dieta u bl-eżerċizzju flimkien ma' doża stabbli ta' insulina.
English: • The contraindication of Simponi in patients with history of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure being worsened by Simponi,
Maltese: • Il-kontra-indikazzjoni ta' Simponi f'pazjenti li fil-passat kellhom insuffiċjenza talqalb moderata għal-severa (NYHA III/IV), u r-riskju potenzjali ta' insuffiċjenza talqalb konġestiva li tista' taggrava b'Simponi,
English: • The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Simponi,
Maltese: • Ir-riskju ta' infezzjonijiet serji, inklużi infezzjonijiet opportunistiċi tal-batteri, vajrus jew fungi f'pazjenti ikkurati b'Simponi,
English: • Physician information
Maltese: ANNESS
English: • Patient Alert Card
Maltese: • Kartuna ta' l-Avviż tal-Pazjent
English: • The need to evaluate patients for both active and inactive tuberculosis prior to starting the treatment, including use of appropriate screening tests,
Maltese: • Il-bżonn li l-pazjenti jiġu evalwati għal tuberkulożi attiva kif ukoll inattiva qabel tibda l-kura, inkluż l-uzu ta' testijiet ta' screening xierqa,
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Simponi are provided with a physician information pack containing the following:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ser jaċċerta li, qabel ma joħroġ għal-ewwel darba, it-tobba kollha li huma mistennija jiktbu/jużaw Simponi jingħatalhom pakkett ta' informazzjoni li jkun fih li ġej:
English: • The risk of acute injection-related reactions and delayed serious systemic hypersensitivity reactions, the need for instructing patients on techniques for administration, and guidance for Health Care Professionals on how to report administration errors,
Maltese: • Ir-riskju ta' reazzjonijiet akuta relatati ma' l- injezzjoni u reazzjonijiet serji ta' sensittività eċċessiva ritardati, il-bżonn li l-pazjenti jingħataw istruzzjonijiet dwar itteknika kif jingħata, u linji gwida għall-Professjonisti fil-Qasam tal-Kura tas-Saħħa dwar kif jirrappurtaw żbalji fl-għoti,
English: • The Summary of Product Characteristics
Maltese: • Is-Sommarju Tal-Karatteristiċi tal-Prodott
English: For the suspension of medicinal products containing nalidixic acid, flumequine, pipemidic acid and cinoxacin to be lifted, the competent authorities shall ensure that the below conditions have been completed by the marketing authorisation holders
Maltese: Sabiex titneħħa s-sospensjoni ta' prodotti mediċinali li fihom l-aċidu nalidiksiku, il-flumekina, l-aċidu pipemidiku u ċ-ċinoksaċina, l-awtoritajiet kompetenti għandhom jiżguraw li d-detenturi talawtorizzazzjoni għat-tqegħid fis-suq ikunu ssodisfaw il-kundizzjonijiet ta' hawn taħt
English: The MAH should submit appropriate scientific evidence to demonstrate a positive benefit-risk balance of the medicinal product in any indication.
Maltese: Il-MAH għandu jippreżenta evidenza xjentifika xierqa biex juri bilanċ pożittiv bejn il-benefiċċju u rriskju tal-prodott mediċinali fi kwalunkwe indikazzjoni.
English: Conditions for lifting the suspension of the marketing authorisation(s)
Maltese: Kondizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjoni(jiet)
English: Annex IV Conditions for lifting the suspension of the marketing authorisations
Maltese: Anness IV
English: {Name and address} {Tel} {fax} {e-mail}
Maltese: {Isem u indirizz} {telefon} {fax} {e-mail}
English: Ethnic differences
Maltese: Differenzi etniċi
English: 1000 Ljubljana Slovenia
Maltese: 1000 Ljubljana Is-Slovenja
English: • Balance problems (vertigo)
Maltese: • Problemi tal-bilanċ (vertiġini)
English: 16000 Praha 6 Czech Republic
Maltese: 16000 Praha 6
English: POLIFARMA SPA Viale dell'Arte 69 00144 Roma Italy
Maltese: POLIFARMA SPA Viale dell'Arte 69 00144
English: Box 2043
Maltese: P.O. Box 2043
English: SANOFI-AVENTIS ESTONIA OÜ Pärnu mnt. 139 E/2 11317 Tallinn Estonia
Maltese: SANOFI-AVENTIS ESTONIA OÜ Pärnu mnt. 139 E/2 11317 Tallinn L-Estonja
English: TRIATEC COMPOSTO TRIATEC COMPOSTO FORTE
Maltese: COMPOSTO TRIATEC COMPOSTO FORTE
English: The elimination half-life is 5 to 6 hours.
Maltese: Il-half-life ta' eliminazzjoni hi ta' 5 sa 6 sigħat.
English: Tests
Maltese: Testijiet
English: SANOFI-AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris
Maltese: SANOFI-AVENTIS France 1-13, boulevard Romain Rolland 75014
English: Critical Evaluation
Maltese: Evalwazzjoni kritika
English: AstraZeneca S.p.A Palazzo Volta Via Francesco Sforza 20080 Basiglio (MI) Italy
Maltese: AstraZeneca S.p.A Palazzo Volta Via Francesco Sforza 20080
English: 56218 Mülheim-Kärlich Germany
Maltese: 56218 Mülheim-Kärlich Il-Ġermanja
English: (Invented) name
Maltese: Isem inventat
English: Slovak Republic SANOFI-AVENTIS SLOVAKIA s.r.o., Žilinská 7-9
Maltese: SANOFI-AVENTIS SLOVAKIA s.r.o., Žilinská 7-9
English: • Lithium (for mental health problems).
Maltese: • Lithium (għal problemi ta' saħħa mentali).
English: Other side effects reported:
Maltese: Effetti sekondarji oħra rrapportati:
English: • Quinine (for malaria)
Maltese: • Quinine (għal malarja)
English: SANOFI-AVENTIS GMBH OSTERREICH SATURN Tower Leonard-Bernstein-Straße 10 A-1220 Vienna Austria
Maltese: SANOFI-AVENTIS GMBH OSTERREICH SATURN Tower Leonard-Bernstein-Straße 10 A-1220 Vienna L-Awstrija
English: Pharmacotherapeutic group: ramipril and diuretics, ATC code C09BA05
Maltese: Kategorija farmakoterapewtika: ramipril u dijuretiċi, Kodiċi ATC: C09BA05
English: • Penicillin (for infections)
Maltese: • Penicillin (għall-infezjonijiet)
English: 167 14 Bromma Sweden
Maltese: 167 14 Bromma L-Isvezja
English: Metabolic and endocrine effects
Maltese: Effetti metaboliċi u endokriniċi
English: TRITACE 2.5 COMB TRITACE 5 COMB
Maltese: TRITACE 2.5 COMB TRITACE 5
English: SANOFI-AVENTIS SPA Viale Bodio, 37/b 20158 Milano Italy
Maltese: SANOFI-AVENTIS SPA Viale Bodio, 37/b 20158 Milano L-Italja
English: The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.
Maltese: Ġiet irrapportata l-possibiltà ta' aggravar jew attivazzjoni ta' systemic lupus erythematosus.
English: • Carbamazepine (for epilepsy).
Maltese: • Cabamazepine (għall-epilessija)
English: Following oral administration about 70 % of hydrochlorothiazide is absorbed from the gastrointestinal tract.
Maltese: Wara t-teħid b'mod orali, madwar 70 % ta' hydrochlorothiazide jiġi assorbit mill-passaġġ gastrointestinali.
English: Sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem Belgium
Maltese: Sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem Il-Belġju
English: The CHMP adopted the harmonised wording for the contra-indictations:
Maltese: Is-CHMP adotta t-test armonizzat għall-kontraindikazzjonijiet:
English: AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany
Maltese: Tinsdaler Weg 183 22880
English: Pharmacokinetics and Metabolism
Maltese: Farmakokinetika u Metaboliżmu
English: Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II).
Maltese: Ramiprilat, il-metabolit attiv tal-prodrug ramipril jinibixxi l-enzima dipeptidylcarboxypeptidase I (sinonimi: enzima li tikkonverti anġjotensin; kininase II).
English: Adverse reactions frequency is defined using 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: Mhux komuni (≥1/1,000 sa <1/100) ; Rari (≥1/10,000 sa <1/1,000);
English: 2970 Hørsholm Denmark
Maltese: Slotsmarken 13 2970 Hørsholm
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeltrali u talconnective tissue
English: Potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances (including Angiotensin II antagonists, trimethoprim, tacrolimus, ciclosporin):
Maltese: Potassium salts, eparina, dijuretiċi li jżommu l-pottasium u sustanzi attivi oħra li jżidu l-plażma pottasium (inklużi antagonisti ta' Anġjotensin II, trimethoprim, tacrolimus, ciclosporin):
English: SANOFI-AVENTIS PRIVATE CO LTD H-1045 Budapest Tó u. 1.-5.
Maltese: LTD H-1045 Budapest Tó u.
English: • Diuretics (water tablets) such as furosemide
Maltese: • Dijuretiċi (pilloli ta' l-ilma) bħal furosemide
English: There were however some contraindications with HCTZ labelled in some local SPC's and not proposed in the harmonised SPC.
Maltese: Madankollu kien hemm xi kontraindikazzjonijiet ma' HCTZ tikkettati f'xi SPCs lokali u mhux proposti fl-SPC armonizzat.
English: Denmark sanofi-aventis Denmark A/S Slotsmarken 13
Maltese: Id-Danimarka sanofi-aventis Denmark A/S
English: Malta Netherlands
Maltese: Malta L-Olanda
English: Czech Republic sanofi-aventis, s.r.o.
Maltese: Ir-Repubblika Ċeka sanofi-aventis, s.r.o.
English: Confusional state, restlessness, disturbance in attention
Maltese: Stat konfużjonarju, irrekwitezza, disturbi flattenzjoni
English: (NSAIDs) such as ibuprofen or indometacin and aspirin)
Maltese: Mhux Sterojdi (NSAIDs) bħal ibuprofen jew indometacin u aspirina)
English: 4.1 Therapeutic Indication
Maltese: 4.1 Indikazzjoni Terapewtika
English: • Medicines to stop the rejection of organs after a transplant such as ciclosporin
Maltese: • Mediċini li jwaqqfu r-riġettar ta' organi ttrapjantati bħal ciclosporin
English: Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, renal failure, cardiac arrhythmia, impairment of consciousness including coma, cerebral convulsions, pareses, and paralytic ileus.
Maltese: Sintomi assoċjati ma' doża eċċessiva ta' inibituri ACE jistgħu jinkludu vasodilatazzjoni periferali eċċessiva (b'ipotensjoni kbira, xokk), bradikardija, disturbi fl-elettroliti, insuffiċjenza renali, arritmja kardijaka, nuqqas ta' koxjenza li tinkludi koma, konvulżjonijiet ċerebrali, pareżi, u iljus paralitiku.
English: Myocardial infarction
Maltese: Infart mijokardjali
English: TRITAZIDE is contraindicated in severe renal impairment due to the hydrochlorothiazide component (creatinine clearance < 30 ml/min) (see section 4.3).
Maltese: TRITAZIDE huma kontra-indikati f'pazjenti b'indeboliment renali gravi minħabba l-komponent hydrochlorothiazide (tneħħija tal-krejatinina < 30 ml/min) (ara sezzjoni 4.3).
English: RAMICOR D 2.5 RAMICOR D 5
Maltese: RAMICOR D 5
English: Distribution The plasma protein binding of hydrochlorothiazide is 40 %.
Maltese: Distribuzzjoni L-irbit ta' hydrochlorothiazide mal-proteini fil-plażma hu ta' 40 %.
English: TRITACE 2.5 PLUS TRITACE 5 PLUS
Maltese: TRITACE 2.5 PLUS TRITACE 5
English: Glycosuria, metabolic alkalosis, hypochloraemia, hypomagnesaemia, hypercalcaemia, dehydration due to hydrochlorothiazide
Maltese: Glikosurja, alkalożi metabolika, ipoklorimja, ipomagnesimja, iperkalċimja, deidratazzjoni minħabba hydrochlorothiazide
English: Tabletten
Maltese: Tabletta
English: Athletes Hydrochlorothiazide may produce a positive analytic result in the anti-doping test.
Maltese: Atleti Hydrochlorothiazide jista' jipproduċi riżultat pożittiv fl-analiżi tat-test ta' l-anti-doping.
English: • Procainamide (for heart rhythm problems)
Maltese: • Procainamide (għal problemi fir-ritmu tal-qalb).
English: Estonia:
Maltese: L-Estonja :
English: Patients with renal impairment (see section 4.2)
Maltese: Pazjenti b'indeboliment renali (ara sezzjoni 4.2)
English: Myocardial ischaemia including angina pectoris, tachycardia, arrhythmia, palpitations, oedema peripheral
Maltese: Iskemija mijokardjali li tinkludi angina pectoris, takikardija, arritmja, palpitazzjonijiet, edima periferali
English: Neutropenia/agranulocytosis
Maltese: Newtropinja/agranuloċitosi
English: Ramipril/Hydrochlorothiazide
Maltese: Ramipril/hydrochlorthiazide
English: Tritazide was included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended, as the abovementioned medicinal product does not have the same SPC across EU Member States, Iceland and Norway.
Maltese: Tritazide ġie inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodotti (SPC), magħmula mill-CMD(h), skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendata, billi ilprodott mediċinali msemmi hawn fuq ma għandux l-istess SPC fl-Istati Membri kollha, fl-Iżlanda u nNorveġja.
English: Diuretic-treated patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: • Steroid medicines for inflammation such as prednisolone
Maltese: • Mediċini sterojdi għall-infjammazzjoni bħal prednisolone
English: Carbamazepine: risk of hyponatraemia due to additive effect with hydrochlorothiazide.
Maltese: Carbamazepine: riskju ta' iponatrimja minħabba l-effett addittiv ta' hydrochlorothiazide.
English: NL-2800 BD Gouda The Netherlands
Maltese: BD Gouda L-Olanda
English: Greece: Triatec Plus 2.5 mg/12.5 mg δισκία, Triatec Plus 5 mg/25 mg δισκία
Maltese: Il-Greċja: Triatec Plus 2.5 mg/12.5 mg δισκία, Triatec Plus 5 mg/25 mg δισκία
English: Hydrochlorothiazide is a thiazide diuretic.
Maltese: Hydrochlorothiazide hu dijuretiku thiazide.
English: Intestinal angioedema has been reported in patients treated with ACE inhibitors including TRITAZIDE (see section 4.8).
Maltese: Ġiet irrapportata anġjoedima intestinali f'pazjenti kkurati b'inibituri ACE inkluż TRITAZIDE (ara sezzjoni 4.8).
English: D-65926 Frankfurt am Main, Germany
Maltese: D-65926 Frankfurt am Main, Il-Ġermanja
English: Quinine : hydrochlorothiazide reduces quinine excretion.
Maltese: Quinine: hydrochlorothiazide inaqqas it-tneħħija ta' quinine.
English: This could be a sign of a kidney problem (interstitial nephritis)
Maltese: Dan jista' jkun sinjal ta' problema fil-kliewi (nefrite interstizjali)
English: EXPIRY DATE
Maltese: ANNESS I LISTA
English: Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8).
Maltese: L-anġjoedima giet irrapportata f'pazjenti kkurati b'inibituri ACE inkluż ramipril (ara sezzjoni 4.8).