FrancophonIA/ELRC3.0 huggingface dataset:
English: feeling restless, lacking energy - nausea, vomiting, loss of appetite, stomach ache - high levels of some liver enzymes in the body which mean you have liver problems - shown in tests, high levels of “bilirubin” - this can make your skin and the whites of your eyes look yellow, hepatitis - rash, itching - pain in extremity - high levels of nitrogen in the blood - shown in tests change in urine colour - generally feeling unwell
Maltese: - aċċessjonijiet, tħossok mifxul/a, tara jew tisma' affarijiet li mhumiex veri (alluċinazzjonijiet), tħossok eċitat/a, movimenti li ma tistax tikkontrolla, tendenza li tintilef, tħossok stordut/a, uġigħ ta' ras, tħossok aġitat/a, nuqqas ta' enerġija - dardir, rimettar, nuqqas ta' aptit, uġigħ fl-istonku - livelli għoljin ta' xi enzimi tal-fwied fil-ġisem li jfisser li għandek problemi tal-fwied - jidhru f'testijiet, livelli għoljin ta' “bilirubin” - dan jista' jġiegħel il-kulur tal-ġilda tiegħek u l-abjad ta' għajnejk jidher isfar, epatite - raxx, ħakk
English: Raxone 150 mg film-coated tablets
Maltese: Raxone 150 mg pilloli miksijin b'rita
English: Film-coated tablet.
Maltese: idebenone tliet darbiet kuljum.
English: A post-hoc responder analysis was performed in RHODOS evaluating the proportion of patients who had a clinically relevant recovery of VA from baseline in at least one eye, defined as either: (i) improvement in VA from unable to read a single letter to able to read at least 5 letters on the ETDRS chart; or (ii) improvement in VA by at least 10 letters on the ETDRS chart.
Maltese: Analiżi post-hoc tar-rispondituri twettqet f'RHODOS biex tevalwa l-proporzjon ta' pazjenti li kellhom irkupru tal-VA klinikament relevanti mil-linja bażi f'tal-inqas għajn waħda, definit bħala jew: (i) titjib fil-VA minn mhux kapaċi taqra ittra waħda sa kapaċi taqra tal-inqas 5 ittri fuq it-tabella ETDRS; jew
English: Patients received either 900 mg/day Raxone or placebo for a period of 24 weeks (6 months).
Maltese: Il-pazjenti rċevew jew 900 mg/jum Raxone jew plaċebo għal perjodu ta' 24 ġimgħa (6 xhur).
English: - LHON can lead to loss of eyesight due to the inactivity of cells responsible for vision.
Maltese: - LHON tista' twassal għal telf fil-vista minħabba l-inattività ta' ċelloli responsabbli għall-vista.
English: Idebenone is used to treat vision impairment in adults and adolescents with an eye disease called Leber's Hereditary Optic Neuropathy (LHON).
Maltese: Idebenone jintuża għall-kura ta' indeboliment tal-vista f'adulti u adolexxenti b'marda tal-għajnejn imsejħa Newropatija Ottika Ereditarja ta' Leber (LHON).
English: In this small subgroup of patients (n=8), 0 of 6 patients in the idebenone group deteriorated to ≥1.0 logMAR whereas 2 of 2 patients in the placebo group showed such a deterioration.
Maltese: (n=8), 0 minn 6 pazjenti fil-grupp ta' idebenone iddeterjoraw għal ≥1.0 logMAR filwaqt li 2 minn 2
English: In order to further investigate the benefits of Raxone in the treatment of LHON patients, the MAH should conduct and submit the results of an external natural history controlled, open-label intervention study to assess the efficacy and safety of Raxone in the treatment of LHON patients, including long-term treatment.
Maltese: Sabiex ikomplu jiġu investigati il-benefiċċji ta' Raxone fil-kura ta' pazjenti b'LHON, il-MAH għandu jwettaq u jissottometti r-riżultati ta' studju ta' intervent open-label, ikkontrollat ta' storja naturali esterna biex jiġu evalwati l-effikaċja u ssigurtà ta' Raxone fil-kura ta' pazjenti b'LHON, inkluż kura fit-tul.
English: Contains lactose and sunset yellow (E110).
Maltese: Fih lattosju u sunset yellow (E110).
English: According to this biochemical mode of action, idebenone may re-activate viable-but-inactive retinal ganglion cells (RGCs) in LHON patients.
Maltese: Skont dan il-mod ta' azzjoni bijokimiku, idebenone jista' jirreattiva ċelloli tal-gangliju retinali (RGCs)
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, especially any of the following: - antihistamines to treat allergies (astemizole, terfenadine) - to treat heartburn (cisapride) - to treat muscle and speech tics associated with Tourette syndrome (pimozide) - to treat hearth rhythm disorders (quinidine) - to treat migraine (dihydroergotamine, ergotamine) - to put you to sleep called “anaesthetics” (alfentanil) - to treat inflamation in rheumatoid arthritis and psoriasis (cyclosporine) - to prevent the rejection of an organ transplant (sirolimus, tacrolimus) - to treat strong pain called “opioids” (fentanyl)
Maltese: Għid lit-tabib tiegħek jekk qiegħed tieħu, ħadt dan laħħar jew tista' tieħu xi mediċina oħra speċjalment kwalunkwe waħda minn dawn: - antistamini għall-kura ta' allerġiji (astemizole, terfenadine) - għall-kura ta' ħruq ta' stonku (cisapride) - għall-kura ta' tagħwiġ involuntarju ta' muskoli u fil-kliem assoċjati mas-sindromu Tourette
English: Common (may affect up to 1 in 10 people): - diarrhoea (mild to moderate that usually does not require discontinuation of treatment) - back pain
Maltese: Komuni (tista' taffettwa sa persuna waħda minn kull 10 persuni): - dijarea (ħafifa sa moderata li normalment ma teħtiġx twaqqif tal-kura) - uġigħ fid-dahar
English: The most commonly reported adverse reactions to idebenone are mild to moderate diarrhoea (usually not requiring the discontinuation of the treatment), nasopharyngitis, cough and back pain.
Maltese: L-iktar reazzjonijiet avversi għal idebenone rrappurtati b'mod komuni huma dijarea ħafifa sa moderata (normalment ma teħtieġx twaqqif tal-kura), nażofarinġite, sogħla u wġigħ fid-dahar.
English: - Raxone contains a colourant called “sunset yellow” (also called E110).
Maltese: - Raxone fih kolorant imsejjaħ “sunset yellow” (imsejjaħ ukoll E110).
English: In the EAP the number of responders increased with longer treatment duration, from 19 out of 62 patients (30.6%) at 6 months to 17 out of 47 patients (36.2%) at 12 months.
Maltese: 6%) wara 6 xhur sa 17 minn 47 pazjent (36.2%) wara 12-il xahar.
English: - Raxone film-coated tablets are orange, round tablets of 10 mm diameter, engraved with the
Maltese: - Pilloli miksijin b'rita Raxone huma oranġjo, tondi ta' dijametru ta' 10 mm, imnaqqxin bil-logo ta' Santhera fuq naħa waħda u ‘150' fuq in-naħa l-oħra.
English: Raxone contains sunset yellow (E110) which may cause allergic reactions.
Maltese: Raxone fih sunset yellow (E110) li jista' jikkawża reazzjonijiet allerġiċi. 4.5
English: Following oral administration pharmacologically relevant concentrations of idebenone are detectable in the aqueous humor of the eye.
Maltese: Wara amministrazzjoni orali, konċentrazzjonijiet farmakoloġikament relevanti ta' idebenone huma traċċabbli fl-umuri milwiem tal-għajn.
English: White high-density polyethylene bottles with white polypropylene child-resistant tamper-evident twist-off caps containing 180 film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Fliexken bojod tal-polietilen ta' densità għolja b'tappijiet bojod tal-polipropilen twist-off ta' tbagħbis evidenti reżistenti-għat-tfal li fihom 180 pillola miksijin b'rita.
English: No report of overdose has been received from the RHODOS study.
Maltese: Ma wasal ebda rapport ta' doża eċċessiva mill-istudju RHODOS.
English: How to store Raxone
Maltese: X'fih Raxone
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: UŻU Prodott mediċinali li jingћata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: The safety of idebenone in pregnant women has not been established.
Maltese: Is-sigurtà ta' idebenone f'nisa tqal ma ġietx stabbilita.
English: If you are breast-feeding your doctor will discuss with you whether to stop breast-feeding or to stop taking the medicine.
Maltese: Dan ifisser li minħabba li l-marda hija rari ma kienx possibbli li tinkiseb informazzjoni kompluta dwar dan il-prodott mediċinali.
English: Raxone was given as 3 daily doses of 300 mg each with meals.
Maltese: Raxone ingħata bħala 3 dożi kuljum ta' 300 mg kull doża mal-ikliet.
English: Experimental data have shown that idebenone passes the blood-brain barrier and is distributed at significant concentrations in cerebral tissue.
Maltese: Data sperimentali wriet li idebenone jgħaddi mill-barriera demm-moħħ u jiġi mqassam f'konċentrazzjonijiet sinifikanti fit-tessut ċelebrali.
English: The primary endpoint “best recovery of visual acuity (VA)” was defined as the result from the eye experiencing the most positive improvement in VA from baseline to week 24 using ETDRS charts.
Maltese: Il-punt ta' tmiem primarju “l-aqwa rkupru ta' akutezza viżiva (VA)” ġie definit bħala r-riżultat millgħajn li tesperjenza l-iktar titjib pożittiv fil-VA mil-linja bażi sa 24 ġimgħa bl-użu ta' tabelli ETDRS.
English: The safety and efficacy of Raxone in LHON patients under 12 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Raxone f'pazjenti b'LHON li għandhom inqas minn 12-il sena ma ġewx determinati s'issa.
English: One patient in the placebo group presented with ongoing spontaneous recovery of vision at baseline.
Maltese: Pazjent wieħed fil-grupp tal-plaċebo ppreżentat ma' rkupru spontanju kontinwu tal-vista fil-linja bażi.
English: Raxone contains a substance called idebenone.
Maltese: X'inhu Raxone u għal xiex jintuża Raxone fih sustanza imsejħa idebenone.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: Disturbi tad-demm u tassistema limfatika
English: The full EPAR for Zeleris can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This summary was last updated in March 2017.
Maltese: Marzu 2017.
English: Other information about Zeleris:
Maltese: Informazzjoni oħra dwar Zeleris:
English: A success rate of 67% was achieved with Zeleris compared to 65% for florfenciol.
Maltese: B'Zeleris inkisbet rata ta' suċċess ta' 67 % meta mqabbla ma' 65 % għal florfenicol.
English: Meloxicam belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: Meloxicam jappartjeni għal grupp ta' mediċini msejħa “prodotti antinfjammatorji nonsterojdali” (NSAIDs - non-steroidal anti-inflammatory drugs).
English: Zeleris contains the active substances florfenicol and meloxicam.
Maltese: Zeleris fih is-sustanzi attivi, florfenicol u meloxicam.
English: Why is Zeleris approved?
Maltese: Għaliex ġie approvat Zeleris?
English: Zeleris is a veterinary medicine used to treat cattle with bovine respiratory disease (BRD, a condition affecting the lungs) associated with a high temperature, which is due to the bacteria Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Maltese: Zeleris huwa mediċina veterinarja li jintuża biex jikkura l-ifrat b'marda respiratorja tal-bovini (BRDbovine respiratory disease, kondizzjoni li taffettwa l-pulmun) assoċjata ma' temperatura għolja, li hija kkawżata mill-batterji Mannheimia haemolytica, Pasteurella multocida u Histophilus somni.
English: These reactions are usually short lived and go away within 5 to 15 days but could last up to 49 days.
Maltese: Dawn ir-reazzjonijiet normalment ma jdumux u jitilqu fi żmien 5 sa 15-il jum iżda jistgħu jdumu sa 49 jum.
English: Florfenicol is a broad-spectrum antibiotic which stops bacteria from growing by blocking the activity of ribosomes, the part of the bacterial cells where proteins are produced.
Maltese: Florfenicol huwa antibijotiku ta' spettru wiesa' li jwaqqaf il-batterji mill jikbru billi jimblokka l-attività tar-ribosomi, il-parti taċ-ċelluli batteriċi fejn jiġu prodotti l-proteini.
English: In a field study 329 calves with bovine respiratory disease and a body temperature of 40˚C or higher were treated either with Zeleris or florfenicol alone.
Maltese: Fi studju fuq il-post ta' 329 għoġġiela b'mard respiratorju tal-bovini u b'temperatura tal-ġisem ta' 40 C jew ogħla ġew ikkurati b'jew Zeleris jew bi florfenicol waħdu.
English: Meloxicam acts by blocking an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Maltese: Meloxicam jaġixxi billi jimblokka enzima msejħa ċiklossiġenażi li hija involuta fil-produzzjoni tal-prostaglandini.
English: In addition, in the first 48 hours after the injection, Zeleris was more effective than florfenicol alone in reducing the body temperature to below 39.5˚C.
Maltese: Barra minn hekk, fl-ewwel 48 siegħa wara l-injezzjoni, Zeleris kien aktar effettiv minn florfenicol waħdu biex iniżżel it-temperatura talġisem għal taħt 39.5 C.
English: What are the risks associated with Zeleris?
Maltese: X'inhuma r-riskji assoċjati ma' Zeleris?
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Maltese: Peress li l-prostaglandini huma sustanzi li jiskattaw l-infjamazzjoni, l-uġigħ, it-tnixxija (fluwidu li joħroġ mill-vażi waqt infjamazzjoni) u d-deni, meloxicam inaqqas dawn is-sinjali tal-marda.
English: Cattle weighing more than 150 kg will need to have the dose divided and injected at more than one site.
Maltese: Frat li jiżnu aktar minn 150 kg jkollhom bżonn li jieħdu d-doża maqsuma fi tnejn u li jiġu injettati f'aktar minn sit wieħed.
English: The most common side effects with Zeleris (which may affect more than 1 in 10 animals) are reactions at the injection site (mostly swelling, hardness, heat and pain) after injection under the skin.
Maltese: L-effetti sekondarji l-aktar komuni b'Zeleris (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma reazzjonijiet fis-sit tal-injezzjoni (l-aktar nefħa, ebusija, sħana u uġigħ) wara l-injezzjoni taħt ilġilda.
English: People who are hypersensitive (allergic) to florfenicol, meloxicam or any of the other ingredients of the medicine should avoid contact with Zeleris.
Maltese: Persuni li huma ipersensittivi (allerġiċi) għal florfenicol, meloxicam jew kwalunkwe wieħed milleċċipjenti l-oħra tal-mediċina għandhom jevitaw il-kuntatt ma' Zeleris.
English: As Zeleris contains an antibiotic it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance.
Maltese: Peress li Zeleris fih antibijotiku huwa essenzjali li ssegwi mill-qrib l-istruzzjonijiet filfuljett ta' tagħrif biex jiġi minimizzat l-iżvilupp ta' reżistenza għall-antimikrobiċi.
English: This is a summary of the European public assessment report (EPAR) for Zeleris.
Maltese: ' valutazzjoni (EPAR)
English: Safety information has been included in the summary of product characteristics and the package leaflet for Zeleris, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward issigurtà ta' Zeleris, inkluż il-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti talkura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom.
English: Zeleris was as effective as florfenicol alone in improving signs of the disease (based on behaviour and breathing) on day 7.
Maltese: F'jum 7, Zeleris kien effettiv daqs florfenicol waħdu fit-titjib tas-sinjali tal-marda (abbażi tal-imġiba u tan-nifs).
English: The withdrawal period for meat from cattle treated with Zeleris is 56 days.
Maltese: Il-perjodu ta' tiżmim għal-laħam minn frat ikkurati b'Zeleris huwa ta' 56 jum.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zeleris's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Zeleris huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Aluminium/aluminium blisters (PA/Al/PVC/Al or PA/PA/Al/PVC/Al).
Maltese: Aluminju/folji ta' l-aluminju (PA/Al/PVC/Al jew PA/PA/Al/PVC/Al).
English: Cholestyramine and colestipol resins
Maltese: Cholestyramine u colestipol resins
English: Pressor amines (e.g. noradrenaline)
Maltese: Pressor amines (eż. noradrenaline)
English: Date of latest renewal: 23 April 2007
Maltese: Data tal-aħħar tiġdid: 23 ta' April, 2007
English: Sorbitol and Lactose Monohydrate
Maltese: Sorbitol u Lactose Monohydrate
English: 14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets
Maltese: 14-il pillola 28 pillola 56 pillola 98 pillola 28 x 1 pillola
English: Possible side effects of Kinzalkomb:
Maltese: Effetti sekondarji possibbli ta' Kinzalkomb:
English: Beta-blockers and diazoxide
Maltese: Imblokkaturi beta u diazoxide
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: 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: Anaemia Eosinophilia, thrombocytopenia
Maltese: Anemija Eosinofilja, tromboċitopenija
English: Investigations Rare:
Maltese: Investigazzjonijiet Rari:
English: • Severe renal impairment (creatinine clearance <30 ml/min).
Maltese: • Indeboliment renali sever (rata ta' tneħħija ta' krejatinina ta' < 30 ml/min).
English: High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.231.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
Maltese: Użu kbir ta' HCTZ (≥50,000 mg kumulattiva) ġie assoċjat ma' OR aġġustata ta' 1.29 (95% CI: 1.23-1.35) għal BCC u 3.98 (95% CI: 3.68-4.31) għal SCC.
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 filgruppi ta' telmisartan (16.7%) u ta' ramipril (16.5%).
English: Cytotoxic agents (e.g. cyclophosphamide, methotrexate)
Maltese: Mediċini ċitotossiċi (eż. cyclophosphamide, methotrexate)
English: Bronchitis, pharyngitis, sinusitis
Maltese: Bronkite, farinġite, sinusite
English: The all-cause mortality rate was 11.6 % and 11.8 % among telmisartan and ramipril treated patients, respectively.
Maltese: Ir-rata ta' mortalità mill-kawżi kollha kienet ta' 11.6% u 11.8% fost il-pazjenti kkurati b'telmisartan u b'ramipril, rispettivament.
English: • Refractory hypokalaemia, hypercalcaemia.
Maltese: • Ipokalemija refrattarja, iperkalċemija.
English: Serious angioedema may occur rarely (≥1/10,000 to <1/1,000).
Maltese: Anġjoedema serja tista' sseħħ b'mod rari (≥1/10,000 sa <1/1,000).
English: Additional information on individual components
Maltese: Informazzjoni addizzjonali dwar komponenti individwali
English: Renal clearance is about 250 - 300 ml/min.
Maltese: Ir-rata ta' tneħħija renali hi ta' madwar 250-300 ml/min.
English: NN: {number} {national reimbursement number or other national number identifying the medicinal product}
Maltese: {numru} [numru tar-rimborż nazzjonali jew numru nazzjonali tal-identifikazzjoni ieħor għallprodott mediċinali]
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 għar-rispons tad-doża kumulattiva b'OR aġġustata ta' 2.1 (95% CI: 1.7-2.6) li tiżdied għal OR 3.9 (3.0-4.9) għal użu kbir (~25,000 mg) u OR 7.7 (5.7-10.5) għallogħla doża kumulattiva (~100,000 mg) (ara wkoll is-sezzjoni 4.4).
English: Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.901.08), p (non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
Maltese: Instab li telmisartan kien effettiv b'mod simili għal ramipril fir-riżultat aħħari sekondarju speċifikat minn qabel ta' mewt kardjovaskulari, ta' infart mijokardijaku mhux fatali, u ta' puplesija mhux fatali [0.99 (97.5% CI 0.90-1.08), p (non-inferjorità) = 0.0004], il-punt aħħari primarju fl-istudju ta' referenza HOPE (The Heart Outcomes Prevention Evaluation Study), li kien investiga l-effett ta' ramipril meta mqabbel mal-plaċebo.
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 <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
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: 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: Muscle relaxing medicines, such as tubocurarine.
Maltese: - Mediċini li jirrilassaw il-muskoli, bħal tubocurarine.
English: The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5 % CI 0.931.10, p (non-inferiority) = 0.0019 at a margin of 1.13).
Maltese: Il-proporzjon ta' periklu għal telmisartan meta mqabbel ma' ramipril kien ta' 1.01 (97.5% CI 0.93-1.10, p (non-inferjorità) = 0.
English: LIST OF EXCIPIENTS Contains lactose monohydrate and sorbitol (E420).
Maltese: TA' EĊĊIPJENTI Fih lactose monohydrate u sorbitol (E420).
English: There was no evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24).
Maltese: Ma kien hemm ebda evidenza ta' benefiċċju fuq mortalità kardjovaskulari (proporzjon ta' periklu 1.03, 95% CI 0.85-1.24).
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: Other medicines and Kinzalkomb:
Maltese: Mediċini oħra u Kinzalkomb:
English: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).
Maltese: Skont data disponibbli minn studji epidemjoloġiċi, ġiet osservata assoċjazzjoni kumulattiva dipendenti mid-doża bejn HCTZ u NMSC (ara wkoll sezzjonijiet 4.4 u 5.1).
English: Anaphylactic reactions, hypersensitivity
Maltese: Reazzjonijiet anafilattiċi, sensittività eċċessiva
English: Hydrochlorothiazide exhibits linear pharmacokinetics.
Maltese: Hydrochlorothiazide juri farmakokinetika lineari.
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: Studju wieħed kien jinkludi popolazzjoni li kienet tikkonsisti minn 71,533 każ ta' BCC u 8,629 każ ta' SCC imqabbla ma' 1,430,833 u għal 172,462 kontroll talpopolazzjoni rispettivament.
English: Xanthopsia, acute myopia, acute angle-closure glaucoma
Maltese: Xanthopsia, mijopja akuta, glawkoma ta' angolu magħluq
English: The active substances are telmisartan and hydrochlorothiazide.
Maltese: Is-sustanzi attivi huma telmisartan u hydrochlorothiazide.
English: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed.
Maltese: Skont data disponibbli minn studji epidemjoloġiċi, ġiet osservata assoċjazzjoni kumulattiva dipendenti mid-doża bejn HCTZ u NMSC.