FrancophonIA/ELRC3.0 huggingface dataset:
English: Least squares means derived from a statistical model that accounts for study site, 9 AM baseline IOP stratum, and correlated IOP measurements within patient
Maltese: Medji ta 'least squares derivati minn mudell statistiku li jieħu f'kunsiderazzjoni is-sit tal-istudju, stratum tal-IOP fil-linja bażi f'9 AM, u l-kejl korrelat tal-IOP fil-pazjent.
English: Clinical data on the use of SIMBRINZA adjunctive to travoprost-timolol maleate fixed dose combination eye drops, solution also showed superior IOP-lowering efficacy of SIMBRINZA + travoprost-timolol maleate eye drops compared with the travoprost-timolol maleate alone.
Maltese: Data klinika dwar l-użu ta' SIMBRINZA flimkien ma' qtar tal-għajnejn, soluzzjoni b'kombinazzjoni ta' doża fissa ta' travoprost-timolol maleate wriet ukoll l-effikaċja superjuri ta' SIMBRINZA + qtar tal-għajnejn travoprost-timolol maleate biex inaqqsu l-IOP meta mqabbla ma' travoprost-timolol maleate biss.
English: 2, muscle spasms
Maltese: 2, skumdità fis-sider
English: There are no data on the effect of topical ocular administration of SIMBRINZA on human fertility.
Maltese: M'hemmx dejta dwar l-effett ta 'għoti topiku fl-għajn ta 'SIMBRINZA fuq il-fertilità umana.
English: Serious side effects have been reported in children who accidently swallowed medicines containing brimonidine.
Maltese: Effetti sekondarji serji ġew irrappurtati fi tfal li bi żball belgħu mediċini li fihom brimonidine.
English: 1, dizziness
Maltese: 1, esofaġite
English: Do not use this medicine after the expiry date which is stated on the bottle and the carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-flixkun u l-kartuna wara “EXP”.
English: SIMBRINZA is therefore contraindicated in children below 2 years of age (see section 4.3).
Maltese: Għalhekk SIMBRINZA huwa kontraindikat fi tfal b'età inqas minn sentejn (ara sezzjoni 4.3).
English: Month 6
Maltese: Dublin 4
English: Nervous system disorders Common: somnolence
Maltese: Disturbi fis-sistema nervuża Komuni: ħedla ta' ngħas
English: Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Maltese: Benzalkonium chloride, jista' jigi assorbit mil-lentijiet tal-kuntatt rotob u jista ibiddel il-kulur tallentijiet tal-kuntatt.
English: In a 6-month, controlled, contribution of elements clinical study enrolling 560 patients with openangle glaucoma (including pseudoexfoliation or pigment dispersion component) and/or ocular hypertension who, in the investigator's opinion, were insufficiently controlled on monotherapy or already on multiple IOP-lowering medicinal products, and who had mean baseline diurnal IOP of 26 mmHg, the mean diurnal IOP-lowering effect of SIMBRINZA dosed twice daily was approximately 8 mmHg.
Maltese: Fi studju kliniku ta '6 xhur, ikkontrollat, dwar kontribuzzjoni tal-elementi li rreġistra 560 pazjent bi glawkoma tat-tip open-angle (inkluż psewdoeksfoljazzjoni jew komponent ta 'dispersjoni ta 'pigment) u/jew pressjoni għolja fl-għajn li, fl-opinjoni tal-investigatur, ma kinux ikkontrollati biżżejjed b'monoterapija jew diġà kienu qed jieħdu bosta prodotti mediċinali li jbaxxu l-IOP, u li kellhom
English: 2, bronchial hyperactivity 2, pharyngolaryngeal pain
Maltese: 2, iperattività tal-bronki
English: Patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin) (see section 4.5).
Maltese: Pazjenti li jirċievu terapija b'inibituri ta 'monoamine oxidase (MAO) (ara sezzjoni 4.5) Pazjenti fuq antidepressanti li jaffettwaw it-trasmissjoni noradrinerġika (eż. antidepressanti triċikliċi u mianserin) (ara sezzjoni 4.5)
English: 1, blurred vision
Maltese: 1, vista mhux normali
English: Mean percent IOP reductions from baseline with SIMBRINZA ranged from 25 to 37%.The percentages of patients with an IOP measurement less than 18 mmHg were similar across study visits for the same time point through Month 6 in the SIMBRINZA and Brinzolamide + Brimonidine groups.
Maltese: Il-perċentwali ta 'pazjenti b'kejl ta 'IOP inqas minn 18 mmHg kienu simili tul il-visti tal-istudju għall-istess punt ta 'ħin sa Xahar 6 fil-gruppi ta 'SIMBRINZA u ta' Brinzolamide + Brimonidine.
English: Read the package leaflet before use.
Maltese: Jista 'jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: SIMBRINZA contains brinzolamide, an inhibitor of carbonic anhydrase, and although administered topically, is absorbed systemically.
Maltese: SIMBRINZA fih brinzolamide, inibitur ta 'carbonic anhydrase, u għalkemm jingħata b'mod topiku, huwa assorbit sistemikament.
English: 2, eye swelling 2, eyelid oedema
Maltese: 2, uġigħ fl-estremitajiet
English: 2, blepharitis
Maltese: 2, griżmejn xotti
English: There is very limited information regarding accidental ingestion with the brimonidine component of SIMBRINZA in adults.
Maltese: Hemm informazzjoni limitata ħafna dwar teħid aċċidentali mill-ħalq bil-komponent brimonidine ta ' SIMBRINZA fl-adulti.
English: Talk to your doctor, optometrist (optician) or pharmacist before using SIMBRINZA if you have now or have had in the past: - liver problems - a type of high pressure in the eyes called narrow-angle glaucoma - dry eyes or cornea problems - coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, high or low blood pressure - depression - disturbed or poor blood circulation (such as Raynaud's disease, Raynaud's syndrome or cerebral insufficiency).
Maltese: Adulti li bi żball belgħu mediċini li fihom brimonidine kellhom rata tal-qalb aktar baxxa, tnaqqis filpressjoni tad-demm li jista' jiġi segwit minn żieda fil-pressjoni tad-demm, insuffiċjenza tal-qalb, diffikultà biex tieħu n-nifs u effetti fis-sistema nervuża.
English: 2, nasal dryness postnasal drip
Maltese: 2, skumdità addominali
English: However, the combination product is not recommended for patients with severe renal impairment (creatinine clearance <30 mL/minute).
Maltese: Madankollu, il-prodott kombinat mhux rakkomandat għal pazjenti b'indeboliment sever tal-kliewi (tneħħija ta 'krejatinina ta' < 30 mL/minuta).
English: In a topical ocular clinical study comparing the systemic pharmacokinetics of SIMBRINZA administered two or three times daily to brinzolamide and brimonidine administered individually using the same two posologies, the steady-state whole blood brinzolamide and N-desethylbrinzolamide pharmacokinetics were similar between the combination product and brinzolamide administered alone.
Maltese: Fi studju kliniku dwar għoti topiku fl-għajn li qabbel il-farmakokinetika sistemika ta 'SIMBRINZA mogħti darbtejn jew tliet darbiet kuljum ma' brinzolamide u brimonidine mogħtija b'mod individwali bl-użu tal-istess żewġ pożoloġiji, il-farmakokinetika ta 'brinzolamide u N-desethylbrinzolamide fi stat fiss fid-demm sħiħ kienu simili għall-prodott kombinat u għal brinzolamide mogħti waħdu.
English: Dose related decreases in foetal weights were observed in pups of dams given 2 to 18 mg/kg/day.
Maltese: Tnaqqis fil-piż tal-feti relatat mad-doża kien osservat fil-frieħ tal-firien nisa li ngħataw 2 sa 18 mg/kg/jum.
English: The pharmacokinetic/pharmacodynamic relationship in humans for IOP-lowering has not been established.
Maltese: Ir-relazzjoni farmakokinetika/farmakodinamika fil-bnedmin għat-tnaqqis fl-IOP ma ġietx determinata.
English: 1, ocular discomfort
Maltese: 1, disturb fil-konġuntiva
English: Uncommon: hypotension Very rare: hypertension
Maltese: Mhux komuni: sensittività eċċessiva
English: The primary metabolite is N-desethylbrinzolamide, followed by the N-desmethoxypropyl and O-desmethyl metabolites, as well as an N-propionic acid analogue formed by oxidation of the N-propyl side chain of O-desmethyl brinzolamide.
Maltese: N-desmethoxypropyl u O-desmethyl, kif ukoll analogu ta 'N-propionic acid iffurmat permezz ta' ossidazzjoni tal-katina tal-ġenb N-propyl ta 'O-desmethyl brinzolamide.
English: Maximum human plasma concentrations are <1 ng/mL and achieved within <1 hour.
Maltese: Il-konċentrazzjonijiet massimi filplażma fil-bniedem huma < 1 ng/mL u ntlaħqu fi żmein <1 siegħa.
English: 2, upper respiratory tract congestion nasal congestion
Maltese: 2, konġestjoni fl-apparat respiratorju ta 'fuq
English: Serum electrolyte levels (particularly potassium) and blood pH levels must be monitored.
Maltese: Il-livelli tal-elettroliti fis-serum (speċjalment tal-potassium) u l-livelli tal-pH fid-demm għandhom jiġu mmonitorjati.
English: 2, amnesia
Maltese: 2, aġewżja
English: Do not use SIMBRINZA - if you are allergic to brinzolamide or brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to sulphonamides (examples include medicines used to treat diabetes and infections and also diuretics (water tablets)) - if you are taking a monoamine oxidase (MAO) inhibitors (examples include medicines to treat depression or Parkinson's disease) or certain antidepressants.
Maltese: din il-mediċina (imniżżla fis-sezzjoni 6) - jekk inti allerġiku għal sulphonamides (eżempji jinkludu mediċini użati biex jikkuraw id dijabete u l-infezzjonijiet kif ukoll dijuretiċi (pilloli tal-awrina)) - jekk qed tieħu inibituri ta' monoamine oxidase (MAO) (eżempji jinkludu mediċini biex jikkuraw id-depressjoni jew il-marda ta 'Parkinson) jew ċerti antidepressanti.
English: 3, dysgeusia
Maltese: 1, sogħla
English: OUTER CARTON 5 ml BOTTLE
Maltese: Qtar għall-għajnejn, suspensjoni 1 x 5 ml
English: Table 1 Comparison of mean diurnal IOP (mmHg) change from baseline - Non-inferiority study
Maltese: Tabella 1 Paragun tal-bidla medja fl-IOP (mmHg) ta 'matul il-ġurnata mil-linja bażi - Studju dwar nuqqas ta 'inferjorità
English: • Effects in the eye: eye surface damage with loss of cells, inflammation of the eyelid, deposits on the eye surface, sensitivity to light, swelling of the eye (affecting the cornea or eyelid), dry eye, eye discharge, watery eye, eyelid redness, abnormal or decreased sensation in eye, tired eye, reduced vision, double vision, product particles in eyes.
Maltese: • Effetti fl-għajn: ħsara fis-superfiċje tal-għajn b'telf ta' ċelluli, infjammazzjoni tal-kappell talgħajn, depożiti fis-superfiċje tal-għajn, sensittività għad-dawl, nefħa fl-għajn (li taffettwa lkornea jew il-kappell tal-għajn), għajn tinħass xotta, nixxija mill-għajn, għajn iddemmgħa, ħmura fil-kappell tal-għajn, sensazzjoni mhux normali jew imnaqqsa fl-għajn, għajn tinħass għajjiena, vista mnaqqsa, vista doppja, frak tal-prodott fl-għajnejn.
English: 2, hypoaesthesia
Maltese: 2, ipoestesija
English: SIMBRINZA is contraindicated in neonates and infants aged less than 2 years in the decrease of elevated intraocular pressure (IOP) with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction because of safety concerns (see section 4.3).
Maltese: SIMBRINZA ma ġiex studjat f'pazjenti b'indeboliment tal-fwied u għalhekk hija rakkomandata attenzjoni f'din il-popolazzjoni (ara sezzjoni 4.4).
English: Signs included sleepiness, floppiness, low body temperature, paleness and breathing difficulties.
Maltese: Sinjali jinkludu ngħas, telqa, temperatura tal-ġisem baxxa, dehra pallida u diffikultajiet fit-teħid tan-nifs.
English: Caution is advised due to the possibility of an additive or potentiating effect with CNS depressants (e.g. alcohol, barbiturates, opiates, sedatives or anaesthetics).
Maltese: Hija rakkomandata attenzjoni minħabba l-possibbiltà ta 'effett addittiv jew li jsaħħaħ b'depressanti tas-CNS (eż. alkoħol, barbiturati, opiates, sedattivi jew anestetiċi).
English: Plasma levels decline with a half-life of approximately 2-3 hours.
Maltese: Il-livelli fil-plażma jonqsu b'halflife ta 'madwar 2-3 sigħat.
English: Brinzolamide and Ndesethylbrinzolamide do not inhibit cytochrome P450 isozymes at concentrations at least 100-fold above maximum systemic levels.
Maltese: Brinzolamide u N-desethylbrinzolamide ma jinibixxux l-isozimi taċ-ċitokromju P450 f'konċentrazzjonijiet ta' mill-inqas 100 darba ogħla mil-livelli sistemiċi massimi.
English: Benzalkonium chloride has been reported to cause eye irritation and symptoms of dry eyes and may affect the tear film and corneal surface.
Maltese: Benzalkonium chloride jista' jikkawża irritazzjoni fl-għajn speċjalment jekk għandek għajnejn xotti jew disturb fil-kornea (strat ċar quddiem l-għajn).
English: B. PACKAGE LEAFLET
Maltese: 2, epistassi
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: DATA TA 'REVIŻJONI TAT-TEST
English: • Chest pain, irregular heart beat
Maltese: • Uġigħ fis-sider, taħbit tal-qalb irregolari
English: The cytochrome P-450 isozymes responsible for metabolism of brinzolamide include CYP3A4 (main), CYP2A6, CYP2B6, CYP2C8 and CYP2C9.
Maltese: L-isozimi taċ-ċitokromju P-450 responsabbli għall-metaboliżmu ta 'brinzolamide jinkludu CYP3A4
English: In clinical trials involving SIMBRINZA dosed twice daily the most common adverse reactions were ocular hyperaemia and ocular allergic type reactions occurring in approximately 6-7% of patients, and dysgeusia (bitter or unusual taste in the mouth following instillation) occurring in approximately 3% of patients.
Maltese: Fi provi kliniċi li jinvolvu SIMBRINZA mogħti darbtejn kuljum l-aktar reazzjonijiet avversi komuni kienu iperimija fl-għajn u reazzjonijiet tat-tip allerġiċi fl-għajn li jseħħu f'madwar 6-7% tal-pazjenti, u disġewżja (togħma morra jew mhux tas-soltu fil-ħalq wara li jiġi applikat) li jseħħu f'madwar 3% talpazjenti.
English: If you wear soft contact lenses, do not use the drops with your lenses in. See section “Wearing contact lenses - SIMBRINZA contains benzalkonium chloride” below).
Maltese: Ara s-sezzjoni ‘Użu ta' lentijiet tal-kuntatt - SIMBRINZA fih benzalkonium chloride 'taħt).
English: Brinzolamide pharmacokinetics are inherently non-linear due to saturable binding to carbonic anhydrase in whole blood and various tissues.
Maltese: Il-farmakokinetika ta 'brinzolamide hija intrinsikament mhux lineari minħabba l-irbit saturabbli ma ' carbonic anhydrase fid-demm sħiħ u f'diversi tessuti.
English: 2, abdominal discomfort diarrhoea
Maltese: 2,amnesija indeboliment fil-memorja
English: 2, feeling jittery irritability
Maltese: 2, tħossok mhux normali tħossok nervuż 2, irritabilità
English: SIMBRINZA should be used with caution in patients with risk of renal impairment because of the possible risk of metabolic acidosis.
Maltese: SIMBRINZA għandu jintuża b'attenzjoni f'pazjenti b'riskju ta 'indeboliment renali minħabba r-riskju possibbli ta 'aċidożi metabolika.
English: The substance is also absorbed into the systemic circulation, where it binds strongly to carbonic anhydrase in red blood cells (RBCs).
Maltese: Is-sustanza hija assorbita wkoll fiċ-ċirkolazzjoni sistemika, fejn teħel b'mod qawwi ma 'carbonic anhydrase fiċ-ċelluli l-ħomor tad-demm (RBCs - red blood cells).
English: Zyllt is a ‘generic medicine'.
Maltese: Zyllt huwa ‘mediċina ġenerika'.
English: Zyllt clopidogrel EPAR summary for the public
Maltese: Zyllt clopidogrel Sommarju tal-EPAR għall-pubbliku
English: Zyllt is a medicine that contains the active substance clopidogrel.
Maltese: Zyllt huwa mediċina li fiha s-sustanza attiva clopidogrel.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zyllt to Krka, d.d., Novo mesto on 28 September 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zyllt lil Krka, d.d., Novo mesto fi-28 ta' Settembru 2009.
English: The active substance in Zyllt, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Zyllt, clopidogrel, hu inibitur tal-aggregazzjoni tal-pjastrini.
English: In acute coronary syndrome, Zyllt is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Maltese: Fis-sindromu koronarju akut, Zyllt jintuża mal-aspirina u t-trattament ġeneralment jibda b'doża ta' tagħbija (loading dose) ta' erba' pilloli ta' 75 mg.
English: This means that Zyllt is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Dan ifisser li Zyllt huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: Zyllt can be given to the following groups of patients:
Maltese: Zyllt jista' jingħata lill-gruppi ta' pazjenti li ġejjin:
English: What is Zyllt?
Maltese: X'inhu Zyllt?
English: Zyllt can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Maltese: Zyllt jista' jintuża f'pazjenti li jkollhom infart mijokardiku flimkien ma' ‘elevazzjoni fis-segment ST' (riżultat anomalu talelettrokardjogramma jew ECG) meta t-tabib ikun ikkunsidra li jkunu se jibbenefikaw mittrattament.
English: Because Zyllt is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Billi Zyllt huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw ilbijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: This is then followed by the standard 75 mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Maltese: Dan hu segwit minn doża standard ta' 75 mg darba kuljum għal tal-inqas erba' ġimgħat (f'infart mijokardiku ta' elevazzjoni tas-segment ST) jew għal mhux iktar minn 12-il xahar (fil-preżenza ta' sindromu mingħajr elevazzjoni tas-segment ST).
English: What are the benefit and risk of Zyllt?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Zyllt?
English: Zyllt is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Zyllt jintuża f'adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t-twebbis tal-arterji).
English: How has Zyllt been studied?
Maltese: Kif ġie studjat Zyllt?
English: Because Zyllt is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Billi Zyllt huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji jitqiesu li kienu l-istess bħal dawk tal-mediċina ta' referenza.
English: Other information about Zyllt:
Maltese: Aktar tagħrif dwar Zyllt:
English: Why has Zyllt been approved?
Maltese: Għaliex ġie approvat Zyllt?
English: It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave' myocardial infarction.
Maltese: Jista' jintuża wkoll f'pazjenti li ma jkollhomx dan ir-riżultat anomalu fl-ECG jekk ikollhom anġina instabbli (uġigħ sever fis-sider) jew li jkollhom infart mijokardiu ‘mhux talmewġa Q' (‘non-Q-wave').
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zyllt has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Zyllt wera li għandu kwalità komparabbli ma' u huwa bijoekwivalenti għal Plavix.
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Plavix, il-benefiċċji huma akbar mir-riskji identifikati.
English: Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Maltese: Clopidogrel iwaqqaf il-platelets milli jaggregaw billi jimblokka sustanza msejħa ADP milli tingħaqad ma' riċettur speċjali preżenti fuq is-superfiċje tagħhom.
English: EMA/40540/2013 EMEA/H/C/002676
Maltese: EMEA/H/C/002676
English: The full EPAR for Actelsar HCT 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: This summary was last updated in 03-2013.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi: 03-2013.
English: Actelsar HCT is a ‘generic medicine'.
Maltese: Actelsar HCT huwa ‘mediċina ġenerika'.
English: telmisartan / hydrochlorothiazide
Maltese: telmisartan / idroklorotijażide
English: Actelsar HCT is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide) to be taken by mouth once a day with liquid.
Maltese: Actelsar HCT jiġi f'pilloli (40 mg jew 80 mg telmisartan u 12.5 mg idroklorotijażide; 80 mg telmisartan u 25 mg idroklorotijażide) li jittieħdu oralment darba kuljum ma' likwidu.
English: Actelsar HCT contains two active substances, telmisartan and hydrochlorothiazide.
Maltese: Actelsar HCT fih żewġ sustanzi attivi, it-telmisartan u l-idroklorotijażide.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Actelsar HCT on 13 March 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Actelsar HCT fil-13 ta' Marzu 2013.
English: This is a summary of the European public assessment report (EPAR) for Actelsar HCT.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Actelsar HCT.
English: The dose of Actelsar HCT to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Maltese: Id-doża ta' Actelsar HCT li għandha tintuża tiddependi mid-doża ta' telmisartan li l-pazjent kien qiegħed jieħu qabel: il-pazjenti li kienu qed jieħdu 40 mg telmisartan għandhom jieħdu l-pilloli tal-40/12.5 mg filwaqt li l-pazjenti li kienu qed jieħdu 80 mg telmisartan għandhom jieħdu l-pilloli tat-80/12.5 mg.
English: Because Actelsar HCT is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, MicardisPlus.
Maltese: Peress li Actelsar HCT huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet li jistabbilixxu lbijoekwivalenza tiegħu mal-mediċina ta' referenza, MicardisPlus.
English: This means that Actelsar HCT is similar to a ‘reference medicine' already authorised in the European Union (EU) called MicardisPlus.
Maltese: Dan ifisser li Actelsar HCT huwa simili għall-“mediċina ta' referenza” diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem MicardisPlus.
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to Actelsar HCT.
Maltese: Il-pilloli tat-80/25 mg jintużaw minn pazjenti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata permezz tal-pilloli tat80/12.5 mg jew li l-qagħda tagħhom tkun saret stabbli permezz ta' żewġ sustanzi attivi meħuda separatament qabel ma qalbu għal Actelsar HCT.
English: What are the benefits and risks of Actelsar HCT?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Actelsar HCT?
English: How has Actelsar HCT been studied?
Maltese: Kif ġie studjat Actelsar HCT?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Actelsar HCT has been shown to have comparable quality and to be bioequivalent to MicardisPlus.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) ikkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Actelsar HCT għandu kwalità komparabbli u huwa bijoekwivalenti għal MicardisPlus.
English: Why is Actelsar HCT approved?
Maltese: Għaliex ġie approvat Actelsar HCT?