FrancophonIA/ELRC3.0 huggingface dataset:
English: As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide ratiopharm and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately.
Maltese: Wara li ngħatat doża ta' leflunomide radjuattiv, ir-radjuattività kienet imneħħija ugwalment fl-ipurgar, probabbilment minn eliminazzjoni biljari, u fl-awrina.
English: Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anemia (lack of red blood cells).
Maltese: Sintomi oħra li jistgħu jeffettwaw il-ġisem kollu huma n-nuqqas t'aptit, id-deni, nuqqas ta' enerġija u anemija (nuqqas ta' taċ-ċelluli ħomor tad-demm).
English: In a carcinogenicity study in mice an increased incidence of malignant lymphoma occurred in males of the highest dose group, considered to be due to the immunosuppressive activity of leflunomide.
Maltese: Ir-riskju ta' tumuri malinni, partikolarment il-mard limfoproliferattiv, jiżdied bl-użu ta' xi uħud missustanzi immunosuppressivi.
English: Packaging Content Package size
Maltese: Content Package size
English: Strength Pharmaceutic al form
Maltese: Numru tal-UE Isem ivvintat Saħħa Forma Farmaċewtika
English: S.P.A. Italiana Laboratori Bouty
Maltese: Italiana Laboratori Bouty
English: United Kingdom Pronova Biopharma Norge As
Maltese: Il-Lussemburgu Pronova Biopharma Norge As
English: Pliva Hrvatska D.O.O.
Maltese: Pliva Hrvatska D.O.O. Corprotect
English: Fish Oil 0.5ml/Ml
Maltese: Żejt tal-Ħuta 0.5ml/Ml
English: Ibsa Farmaceutici Italia
Maltese: Ibsa Farmaceutici
English: Ibsa Pharma Kft
Maltese: Ibsa Pharma
English: 1000mg
Maltese: Kapsula 1000mg
English: United Kingdom Mercury Pharmaceuticals Ltd.
Maltese: Mercury Pharmaceuticals Ltd.
English: Oral Emulsion
Maltese: Soluzzjoni Orali
English: Omega 3-Acid-Ethyl Esters Teva Uk
Maltese: Omega 3-Acid-Ethyl Esters Teva
English: Ratiopharm Gmbh Omega-3 Ratiopharm Omega-3-Acid Ethyl Esters 90 1000mg
Maltese: Ratiopharm Gmbh Omega-3 Ratiopharm Kapsula 1000mg blAċidi Omega-3 f'forma ta' Esteri Etiliċi 90
English: Omega-3Säurenethylester 90 Heumann
Maltese: Omega-3Säurenethylester 90
English: Mylan Hrvatska D.O.O.
Maltese: Mylan Hrvatska
English: Ácidos Omega 3 Tarbis Docosahexaenoic Acid 380mg Capsule,
Maltese: Ácidos Omega 3 Tarbis Kapsula 380 mg blAċidu Dokosaeżaenojku 380mg, Kapsula 460mg bl-Aċidu
English: Docosahexaenoic Acid 265mg/5ml, Eicosapentaenoic Acid 390mg/5ml
Maltese: Aċidu Dokosaeżaenojku 265mg/5ml, Aċidu Ejkosapentenojku 390mg/5ml
English: Triglycerides Medium Chain 1qs Capsule, Lecithin Soya 1qs Capsule, Omega-3-Acid Ethyl Esters 90 1000mg Capsule
Maltese: Kapsula 1qs bi Trigliċeridi b'Katina Medja, Kapsula 1qs bisSojja tal-Leċitina, Kapsula 1000mg blAċidi Omega-3 f'forma ta' Esteri Etiliċi 90
English: I.B.N.
Maltese: D.O.O.
English: Ácidos Omega 3 Aristo Omega-3-Acid Ethyl Esters 1000mg Capsule
Maltese: Ácidos Omega 3 Aristo Kapsula 1000mg blAċidi Omega-3 f'forma ta' Esteri Etiliċi
English: Docosahexaenoic Acid 120mg Capsule, Eicosapentaenoic Acid 180mg Capsule
Maltese: Kapsula 120mg bl-Aċidu Dokosaeżaenojku, Kapsula 180mg bl-Aċidu Ejkosapentenojku
English: Docosahexaenoic Acid 527mg/5ml, Eicosapentaenoic Acid 791mg/5ml
Maltese: Aċidu Dokosaeżaenojku 527mg/5ml, Aċidu Ejkosapentenojku 791mg/5ml
English: Omega 3 Alfasigma Omega-3-Acid Ethyl Esters 90 With A
Maltese: Omega 3 Alfasigma Aċidi Omega-3 f'forma ta' Esteri Etiliċi 90
English: Docosahexaenoic Acid 527mg/5ml, Eicosapentanoic Acid/Docosahexaenoic Acid 791mg/5ml
Maltese: Aċidu Dokosaeżaenojku 527mg/5ml, Aċidu Ejkosapentenojku/Aċidu Dokosaeżaenojku 791mg/5ml
English: Acidos Omega 3 Stada Omega-3-Acid Ethyl Esters 90 1000mg
Maltese: Acidos Omega 3 Stada Kapsula 1000mg blAċidi Omega-3 f'forma ta' Esteri Etiliċi 90
English: Docosahexaenoic Acid Ethyl Ester 437mg Capsule
Maltese: Kapsula 430mg bl-Aċidu Ejkosapentenojku f'forma ta' Ester Etiliku, Kapsula 437mg bl-Aċidu Dokosaeżaenojku f'forma ta' Ester Etiliku
English: Eicosapentaenoic Acid 170μgg
Maltese: Aċidu Dokosaeżaenojku 115mgg, Aċidu Ejkosapentenojku 170μgg
English: Eicosapentaenoic Acid 791mg/5ml, Vitamin A 100 I.U.G
Maltese: Aċidu Dokosaeżaenojku 527mg/5ml, Vitamina D 10 I.U./G., Aċidu Ejkosapentenojku 791mg/5ml, Vitamina A 100 I.U./G.
English: Docosahexaenoic Acid 115mg Capsule, Eicosapentaenoic Acid 170mg Capsule
Maltese: Kapsula 115mg bl-Aċidu Dokosaeżaenojku 115mg, Kapsula 170mg bl-Aċidu
English: Docosahexaenoic Acid 115mg Capsule, Eicosapentanoic Acid/Docosahexaenoic Acid 170mg Capsule
Maltese: Kapsula 115mg bl-Aċidu Dokosaeżaenojku, Kapsula 170mg bl-Aċidu Ejkosapentenojku/Aċidu Dokosaeżaenojku
English: Eicosapentaenoic Acid 170mg Capsule, Vitamin A 100 I.U.G
Maltese: Kapsula 115mg bl-Aċidu Dokosaeżaenojku, Vitamina D 10 I.U./G., Kapsula 170mg bl-Aċidu Ejkosapentenojku, Vitamina A 100 I.U./G.
English: Eicosapentaenoic Acid 170mg Capsule, Vitamin A 1 I.U.G
Maltese: Kapsula 115mg bl-Aċidu Dokosaeżaenojku, Vitamina D 1 I.U./G., Kapsula 170mg bl-Aċidu Ejkosapentenojku, Vitamina A 1 I.U./G.
English: Portugal
Maltese: Italia
English: Docosahexaenoic Acid 60mg Capsule, Eicosapentaenoic Acid 90mg Capsule
Maltese: Kapsula 60mg bl-Aċidu Dokosaeżaenojku, Kapsula 90mg bl-Aċidu Ejkosapentenojku
English: Esters Of Unsaturated Fatty Acids 500mg Capsule
Maltese: Dokosaeżaenojku (Dha) Mhux Inqas Minn 85 % Kapsula 500mg
English: Omega-3 Fatty Acids 1000mg Capsule
Maltese: Kapsula 1000mg blAċidi Grassi Omega-3
English: Docosahexaenoic Acid Ethyl Ester 380mg Capsule
Maltese: Kapsula 460mg bl-Aċidu Ejkosapentenojku f'forma ta' Ester Etiliku, Kapsula 380mg bl-Aċidu Dokosaeżaenojku f'forma ta' Ester Etiliku
English: Esters Of Unsaturated Fatty Acids 1000mg Capsule
Maltese: Kapsula 1000mg blEsteri Ta' Aċidi Grassi Insaturati
English: Pioglitazone
Maltese: Pijoglitazonina
English: The full EPAR for Pioglitazone Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Actavis on 15 March 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Pioglitazone Actavis valida flUnjoni Ewropea kollha fil-15 ta' Marzu 2012.
English: Pioglitazone Actavis is a ‘generic medicine'.
Maltese: Pioglitazone Actavis huwa ‘mediċina ġenerika'.
English: The company that markets Pioglitazone Actavis will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Maltese: Il-kumpanija li tqiegħed Pioglitazone Actavis fis-suq se tipproduċi materjal edukattiv għat-tobba li jippreskrivu l-mediċina, li se jkopri r-riskju possibbli ta' insuffiċjenza tal-qalb u kanċer fil-bużżieqa talurina bil-kuri li fihom il-pijoglitazonina, il-kriterji għall-għażla tal-pazjenti u l-ħtieġa ta' rieżami regolari tal-kura u li l-kura titwaqqaf jekk il-pazjenti ma jibqgħux jibbenefikaw minnha.
English: The active substance in Pioglitazone Actavis, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Is-sustanza attiva f'Pioglitazone Actavis, il-pijoglitazonina, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u tal-fwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi.
English: This means that Pioglitazone Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Maltese: Dan ifisser li Pioglitazone Actavis huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Actos.
English: Pioglitazone Actavis
Maltese: Informazzjoni oħra dwar Pioglitazone Actavis
English: This is a summary of the European public assessment report (EPAR) for Pioglitazone Actavis.
Maltese: Dan huwa sommarju tar-rappport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pioglitazone Actavis.
English: Pioglitazone Actavis contains the active substance pioglitazone.
Maltese: Pioglitazone Actavis fih is-sustanza attiva l-pijoglitazonina.
English: • in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone;
Maltese: • f'kombinazzjoni kemm mal-metformina kif ukoll mas-sulfonilurea fil-pazjenti li mhumiex ikkontrollati b'mod sodisfaċenti minkejja kura b'żewġ mediċini mill-ħalq;
English: Because Pioglitazone Actavis 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: Peress li Pioglitazone Actavis 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: Because Pioglitazone Actavis is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Maltese: Peress li Pioglitazone Actavis huwa mediċina ġenerika, l-istudji f'pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza Actos.
English: Why is Pioglitazone Actavis approved?
Maltese: Għaliex ġie approvat Pioglitazone Actavis?
English: Pioglitazone Actavis is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Maltese: Pioglitazone Actavis jintuża għall-kura tad-dijabete tat-tip 2 f'adulti (minn 18-il sena 'l fuq), b'mod partikulari f'dawk li jkollhom piż eċċessiv.
English: Other information about Pioglitazone Actavis
Maltese: Kif jintuża Pioglitazone Actavis?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pioglitazone Actavis has been shown to have comparable quality and to be bioequivalent to Actos.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-Aġenzija kkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Pioglitazone Actavis għandu kwalità komparabbli u huwa bijoekwivalenti għal Actos.
English: How is Pioglitazone Actavis used?
Maltese: Kif jaħdem Pioglitazone Actavis?
English: • together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Maltese: • f'kombinazzjoni mal-insulina f'pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti bl-insulina weħidha u li ma jistgħux jieħdu l-metformina.
English: The Committee recommended that Pioglitazone Actavis be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Pioglitazone Actavis ikun approvat għall-użu fl-UE.
English: Therefore, the CHMP's view was that, as for Actos, the benefit outweighs the identified risk.
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Pioglitazone Actavis?
English: [Actavis logo]
Maltese: [Logo ta' Actavis]
English: The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42% and 58%, respectively.
Maltese: Il-bijodisponibilità assoluta ta' telmisartan f'doża ta' 40 mg u 160 mg kienet ta' 42% u 58%, rispettivament.
English: Possible side effects of Actelsar HCT:
Maltese: Effetti sekondarji possibbli ta' Actelsar HCT:
English: - Calcium supplements and/or vitamin D supplements.
Maltese: - Supplimenti tal-calcium u/jew supplimenti ta' vitamina D.
English: Syncope, paraesthesia
Maltese: Sinkope, parestesija
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists and diuretics, ATC code: C09DA07
Maltese: Sustanzi li jaġixxu fuq is-sistema renin-angiotensin: antagonisti ta' angiotensin II u dijuretiċi, Kodiċi ATC: C09DA07
English: When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed.
Maltese: Meta telmisartan ingħata flimkien ma' digoxin, kienu osservati żidiet medji f' digoxin peak plasma concentration (49%) u f' trough concentration (20%).
English: Renal clearance is about 250-300 ml/min.
Maltese: Ir-rata ta' tneħħija renali hi ta' madwar 250-300 ml/min.
English: One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively.
Maltese: 71,533 każ ta' BCC u 8,629 każ ta' SCC imqabbla ma' 1,430,833 u ma' 172,462 kontroll tal popolazzjoni, rispettivament.
English: Al/Al blister, Al/PVC/PVDC blister and HDPE tablet container with LDPE cap and HDPE desiccant with silica filling.
Maltese: Folja Al/Al, folja Al/PVC/PVDC u kontenitur tal-pilloli HDPE bl-għatu LDPE u dessikant HDPE bilmili tas-silika.
English: Telmisartan is highly bound to plasma proteins (>99.5%) mainly albumin and alpha l-acid glycoprotein.
Maltese: Telmisartan jeħel ħafna mal-proteini fil-plażma (>99.5%), l-aktar ma' l-albumina u alpha-1 acid glycoprotein.
English: Hydrochlorothiazide is 68% protein bound in the plasma and its apparent volume of distribution is 0.83-1.14 l/kg.
Maltese: Hydrochlorothiazide jeħel mal-proteini fil-plażma f'ammont ta' 68%, u l-volum apparenti taddistribuzzjoni hu ta' 0.83-1.14 l/kg.
English: Actelsar HCT 40 mg/12.5 mg tablets EU/1/13/817/043
Maltese: Actelsar HCT 40 mg/12.5 mg pilloli EU/1/13/817/043
English: Thiazides may increase the risk of adverse events caused by amantadine.
Maltese: It-thiazides jistgħu jżidu r-riskju ta' avvenimenti avversi ikkawżati minn amantadine.
English: Actavis Ltd. BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
Maltese: BLB 016, Żona Industrijali ta' Bulebel, Żejtun ZTN 3000, MALTA
English: Sialadenitis
Maltese: Sialoadenitis
English: - Severe renal impairment (creatinine clearance <30 ml/min).
Maltese: Indeboliment renali sever (rata ta' tneħħija ta' krejatinina ta' < 30 ml/min).
English: Actelsar HCT 80 mg/12.5 mg tablets EU/1/13/817/014
Maltese: Actelsar HCT 80 mg/12.5 mg pilloli EU/1/13/817/014
English: The other ingredients are magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421).
Maltese: Is-sustanzi l-oħra huma magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421).
English: Tablet 30 tablets 90 tablets 250 tablets
Maltese: Pillola 30 pillola 90 pillola 250 pillola
English: Adverse reactions have been ranked under headings of frequency 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
Maltese: Ir-reazzjonijiet avversi ġew ikklassifikati skond kategoriji ta' frekwenza bl-użu tal-konvenzjoni 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 magħrufa (ma jistgħux ikunu stmati mid-dejta disponibbli).
English: Respiratory distress (including pneumonitis and pulmonary oedema)
Maltese: Problemi respiratorji (li jinkludu pnewmonite u edima pulmonari)
English: A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Maltese: Intweriet relazzjoni bejn id-doża kumulattiva u r-rispons b'OR aġġustata ta' 2.1 (CI ta' 95%: 1.7-2.6) li tiżdied għal OR ta' 3.9 (3.0-4.9) għal użu kbir (~25,000 mg) u OR ta' 7.7 (5.7-10.5) għall-ogħla doża kumulattiva (~100,000 mg) (ara wkoll is-sezzjoni 4.4).
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100%.
Maltese: Studji farmakokinetiċi f'pazjenti b'indeboliment epatiku juru żieda fil-bijodisponibilità assoluta sa kważi 100%.
English: EXP
Maltese: EXP JIS
English: The incidence of the primary endpoint was similar in the telmisartan (16.7%) and ramipril (16.5%) groups.
Maltese: L-inċidenza tar-riżultat aħħari primarju kienet simili fil gruppi ta' telmisartan (16.7%) u ta' ramipril (16.5%).
English: Date of first authorisation: 13 March 2013 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta' Marzu 2013.
English: Interstitial lung disease3
Maltese: Mard interstizjali tal-pulmun3
English: - Refractory hypokalaemia, hypercalcaemia.
Maltese: Ipokalemija refrattarja, iperkalċemija.
English: Exacerbation or activation of systemic lupus erythematosus1 Metabolism and nutrition disorders Uncommon:
Maltese: Aggravament jew attivazzjoni ta' lupus erythematosus sistemiku1 Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni:
English: Al/Al blister: 14, 28, 30, 56, 84, 90 and 98 tablets
Maltese: Folja Al / Al: 14, 28, 30, 56, 84, 90 u 98 pillola
English: The terminal elimination half-life of hydrochlorothiazide is 10-15 hours.
Maltese: Il-half-life ta' l-eliminazzjoni terminali ta' hydrochlorothiazide hi ta' 10-15-il siegħa.
English: Xanthopsia, acute myopia, acute angle-closure glaucoma
Maltese: Xanthopsia, mijopija akuta, glawkoma ta' angolu magħluq
English: Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal products.
Maltese: Filwaqt li m'hemm l-ebda dejta epidemjoloġika kkontrollata dwar ir-riskju b'antagonisti tarriċetturi ta' angiotensin II, riskji simili jistgħu jkunu jeżistu għal din il-klassi ta' prodotti mediċinali.
English: - Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Maltese: It-tieni u t-tielet trimestri tat-tqala (ara sezzjonijiet 4.4 u 4.6).
English: Very rare (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease)**
Maltese: Ċikatriċi progressivi ta' tessut tal-pulmun (mard interstizjali tal-pulmun)**
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Al/PVC/PVDC blister
Maltese: Għal folja Al/PVC/PVDC
English: The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5% CI 0.93-1.10, p (non-inferiority)=0.0019 at a margin of 1.13).
Maltese: Il-proporzjon ta' periklu għal telmisartan metamqabbel ma' ramipril kien ta' 1.01 (97.5% CI 0.93-1.10, p (non-inferjorità)=0.0019 f'marġni ta' 1.13).
English: Actelsar HCT is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Maltese: Actelsar HCT hu taħlita ta' antagonist tar-riċettur ta' angiotensin II, telmisartan, u dijuretiku thiazide, hydrochlorothiazide.
English: Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis
Maltese: Anemija aplastika, anemija emolitika, insuffiċjenza fil- funzjoni talmudullun, lewkopenija, newtropenija, agranuloċitosi
English: Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland
Maltese: Reykjavíkurvegur 76-78, 220
English: Reykjavikurvegur 78 220 Hafnarfjörður Iceland
Maltese: Reykjavikurvegur 78 220
English: The effect of Actelsar HCT may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicyl acid or ibuprofen).
Maltese: L-effetti ta' Actelsar HCT jistgħu jitnaqqsu meta tieħu NSAIDs (non-steroidal anti-inflammatory drugs, eż. acetylsalicyl acid jew ibuprofen).
English: 3 For further description, please see sub-section “Description of selected adverse reactions”.
Maltese: 3 Għal deskrizzjoni addizzjonali, jekk jogħġbok ara sottosezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula”
English: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Maltese: Dejta minn provi kliniċi wriet li imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS) permezz tal-użu kombinat ta' inibuturi ta' ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren, hu assoċjat ma' frekwenza ogħla ta' avvenimenti avversi bħal pressjoni baxxa, iperkalimja u tnaqqis fil-funzjoni tal-kliewi (li jinkludi insuffiċjenza akuta tal-kliewi) meta mqabbel mal-użu ta' sustanza waħda li taġixxi fuq RAAS (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: Actelsar HCT 40 mg/12.5 mg tablets Actelsar HCT 80 mg/12.5 mg tablets
Maltese: Actelsar HCT 40 mg/12.5 mg pilloli Actelsar HCT 80 mg/12.5 mg pilloli
English: Based on cumulative renal excretion of hydrochlorothiazide the absolute bioavailability was about 60%.
Maltese: Ibbażat fuq ittneħħija kumulattiva renali ta' hydrochlorothiazide, il-bijodisponibilità assoluta kienet ta' madwar 60%.
English: Nervous system disorder Rare:
Maltese: Disturbi fis-sistema nervuża Rari:
English: The overall incidence of adverse reactions reported with telmisartan (41.4%) was usually comparable to placebo (43.9%) in placebo controlled trials.
Maltese: L-inċidenza totali ta' reazzjonijiet avversi rrappurtati b'telmisartan (41.4%) kienet ġeneralment komparabbli mal-plaċebo (43.9%) fil-provi li saru li kienu kkontrollati bil-plaċebo.
English: TRANSCEND randomized ACE-I intolerant patients with otherwise similar inclusion criteria as ONTARGET to telmisartan 80 mg (n=2954) or placebo (n=2972), both given on top of standard care.
Maltese: Pazjenti tat-TRANSCEND intolleranti għal ACE-I, magħżula b'mod każwali, bi kriterji ta' inklużjoni li kienu simili bħal dawk ta' ONTARGET għal telmisartan 80 mg (n = 2954) jew plaċebo (n = 2972), it tnejn mogħtija flimkien mal-kura standard.
English: It may harm them,
Maltese: Nuqqas ta' rqad, disturbi fl-irqad
English: Actelsar HCT 40 mg/12.5 mg tablets are white or almost white, 6.55 x 13.6 mm oval-shaped and biconvex tablets marked with “TH” on one side.
Maltese: Actelsar HCT 40mg/12.5 mg pilloli huma bojod jew kważi bojod, 6.55 x 13.6 mm, pilloli ovali u konvessi mmarkati b' “TH” fuq naħa waħda.
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Maltese: Telmisartan ma jinibixxix l enzima li tibdel angiotensin (kininase II), l-enzima li tiddegrada wkoll bradykinin.
English: The overall incidence of adverse reactions reported with telmisartan/hydrochlorothiazide was comparable to those reported with telmisartan alone in randomised controlled trials involving 1,471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Maltese: L-inċidenza totali ta' reazzjonijiet avversi rrappurtati b' telmisartan/hydrochlorothiazide kienet komparabbli ma' dawk irrappurtati b'telmisartan waħdu fi provi kkontrollati u randomised li saru fuq 1471 pazjent li kienu randomised biex jirċievu telmisartan flimkien ma' hydrochlorothiazide (835) jew telmisartan biss (636).
English: Actelsar HCT 80 mg/25 mg tablets
Maltese: Actelsar HCT 80 mg/25 mg pilloli
English: - Medicines associated with low blood potassium (hypokalaemia) such as other diuretics, (“water tablets”), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
Maltese: - Mediċini li fihom il-lithium għall-kura ta' xi tipi ta' dipressjoni - Mediċini marbuta ma' livell baxx ta' potassium fid-demm (ipokalemija) bħal dijuretiċi oħrajn, ('pilloli tal-awrina'), lassattivi (eż. castor oil), kortikosterojdi (eż. prednisone), ACTH (ormon), amphotericin (mediċina antifungali), carbenoxolone (jintuża għall-kura ta' ulċeri talħalq)penicillin G sodium (antibijotiku), u salicylic acid u derivattivi tiegħu.