FrancophonIA/ELRC3.0 huggingface dataset:
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 0.90-1.08), 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: - Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product).
Maltese: Sensittività eċċessiva għal sustanzi oħrajn derivati minn sulphonamides (għax hydrochlorothiazide hu prodott mediċinali derivat minn sulphonamide).
English: aliskiren.
Maltese: Sturdament.
English: cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) - others (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
Maltese: III (eż. amiodarone, sotalol, dofetilide, ibutilide) xi tipi ta' mediċini anti-psikotiċi: (eż. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) oħrajn: (eż. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, sparfloxacine, terfenadine, vincamine IV.)
English: Summary of the safety profile The most commonly reported adverse reaction is dizziness.
Maltese: Sommarju tal-profil tas-sigurtà L-iktar reazzjoni avversa komuni hi sturdament.
English: Actelsar HCT 40 mg/12.5 mg tablets
Maltese: Actelsar HCT 40 mg/12.5 mg pilloli
English: For Al/PVC/PVDC blister: 1 year.
Maltese: Al/PVC/PVDC Folja:
English: Diabetes mellitus inadequate control Metabolism and nutrition disorders Common:
Maltese: Kontroll inadegwat ta' dijabete mellitus Disturbi fil-metaboliżmu u n- nutrizzjoni Komuni
English: Lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis, erythema multiforme
Maltese: Sindrome qisu tal-lupus, reazzjonijiet ta' sensittività għad- dawl, vaskulite fil-ġilda, nekrolisi epidermali tossika, eritema multiforme
English: The concomitant use of Actelsar HCT with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Maltese: dijabete mellitus jew b' indeboliment renali (GFR<60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Maltese: Prevenzjoni kardjovaskulari ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial)
English: Other medicines and Actelsar HCT
Maltese: Mediċini oħra u Actelsar HCT
English: Actelsar HCT fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
Maltese: It-taħlita fissa tad-doża ta' Actelsar HCT (40 mg telmisartan/12.5 mg ta' hydrochlorothiazide u 80 mg telmisartan/12.5 mg hydrochlorothiazide) hi indikata għal adulti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata sew b'telmisartan waħdu.
English: Therefore, it is not expected to potentiate bradykinin-mediated adverse events.
Maltese: Għalhekk mhux mistenni li jsaħħaħ l-avvenimenti avversi medjati minn bradykinin.
English: Back pain, muscle spasms, myalgia
Maltese: Uġigħ fid-dahar, spażmi fil-muskoli, majalġja
English: Hyperuricaemia, hyponatraemia
Maltese: Iperurikemija, ipernatremija
English: - Severe hepatic impairment.
Maltese: Indeboliment epatiku sever.
English: High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.23
Maltese: Użu kbir ta' HCTZ (≥50,000 mg kumulattiva) ġie assoċjat ma' OR aġġustata ta' 1.29 (CI ta' 95%: 1.23-1.35) għal BCC u 3.98 (CI ta' 95%: 3.68-4.31) għal SCC.
English: See also information under the heading “Do not take Actelsar HCT”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura ‘Tieħux Actelsar HCT'.
English: Rare cases have also been reported with angiotensin II receptor antagonists (including telmisartan/hydrochlorothiazide).
Maltese: Każijiet rari kienu irrappurtati wkoll b'antagonisti ta' riċetturi ta' angiotensin II (li jinkludu telmisartan/hydrochlorothiazide).
English: 14 tablets 28 tablets 30 tablets 56 tablets 84 tablets 90 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 56 pillola 84 pillola 90 pillola 98 pillola
English: Actelsar HCT 40 mg/12.5 mg
Maltese: Actelsar HCT 40/12.5mg
English: Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n = 8542), ramipril 10 mg (n = 8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n = 8502), and followed for a mean observation time of 4.5 years.
Maltese: (n = 8542), ramipril 10 mg (n = 8576), jew il-kombinazzjoni ta' telmisartan 80 mg flimkien ma'
English: Al/PVC/PVDC blister: 14, 28, 56, 84, 90 and 98 tablets Tablet container: 30, 90 and 250 tablets
Maltese: Folja Al / PVC / PVDC: 28, 56, 84, 90 u 98 pillola Kontenitur tal-pilloli: 30, 90 u 250 pillola
English: Abdominal pain, constipation, dyspepsia, vomiting, gastritis
Maltese: Uġigħ addominali, stitikezza, dispepsja, rimettar, gastrite
English: Actelsar HCT fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Actelsar HCT 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Maltese: It-taħlita fissa tad-doża ta' Actelsar HCT (80 mg telmisartan/25 mg ta' hydrochlorothiazide) hi indikata għal adulti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata sew b' Actelsar HCT 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) jew adulti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.
English: Non-steroidal anti-inflammatory medicinal products (NSAIDs) NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dose regimens, COX-2 inhibitors and non-selective NSAIDs) may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics and the antihypertensive effects of angiotensin II receptor antagonists.
Maltese: NSAIDs (i.e. acetylsalicylic acid f'korsijiet ta' doża kontra l-infjammazzjoni, inibituri ta' COX-2 u NSAIDs mhux selettivi) jistgħu jnaqqsu l-effetti dijuretiċi, natriuretiċi u kontra l-pressjoni għolja ta' thiazide, u l-effetti kontra l-pressjoni għolja ta' l-antagonisti tar-riċettur ta' angiotensin II.
English: In the “Prevention Regimen For Effectively avoiding Second Strokes” (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.00-2.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 %) [RR 2.07 (95 % confidence interval 1.14-3.76)].
Maltese: Fil-prova "Kors ta' Prevenzjoni Biex Tevita b'Mod Effettiv Puplesiji Oħrajn" (Prevention Regimen For Effectively avoiding Second Strokes - PRoFESS), f'pazjenti li għandhom 50 sena jew aktar, li dan laħħar kellhom puplesija, kienet osservata żieda fl-inċidenza ta' sepsis għal telmisartan meta mqabbel mal-plaċebo, 0.70 % vs. 0.49 % [RR 1.43 (95% intervall ta' kunfidenza 1.00 - 2.06)]; l-inċidenza ta' każijiet ta' sepsis fatali żdiedet għal pazjenti li kienu qed jieħdu telmisartan (0.33 %) vs. pazjenti li kienu qed jieħdu l-plaċebo (0.16 %) [RR 2.07 (95% intervall ta' kunfidenza 1.14 - 3.76)].
English: White or almost white, 6.55 x 13.6 mm oval-shaped and biconvex tablets marked with “TH” on one side.
Maltese: Bojod jew kważi bojod, 6.55 x 13.6 mm, pilloli ovali u konvessi mmarkati b' “TH” fuq naħa waħda.
English: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Maltese: qabblet l-effetti ta' telmisartan, ramipril u l-kombinazzjoni ta' telmisartan u ramipril fuq riżultati kardjovaskulari f'25,620 pazjent ta' età minn 55 sena jew aktar bi storja medika ta' mard tal-arterji koronarji, puplesija, TIA, mard fl-arterji periferali, jew dijabete mellitus ta' tip 2 flimkien ma' evidenza ta' ħsara fl-organi aħħarin (eż. retinopatija, ipertrofija ventrikulari tax-xellug, makro jew mikroalbuminurija), li hi popolazzjoni f'riskju ta' avvenimenti kardjovaskulari.
English: Actelsar HCT 80 mg/12.5 mg
Maltese: Actelsar HCT 80/12.5mg
English: Food slightly reduces the bioavailability of telmisartan with a reduction in the area under the plasma concentration time curve (AUC) of about 6% with the 40 mg tablet and about 19% after a 160 mg dose.
Maltese: L-ikel inaqqas ftit il-bijodisponibilità ta' telmisartan bi tnaqqis fl-erja taħt il-kurva tal-konċentrazzjoni tal-plażma - ħin (AUC) ta' madwar 6% bil-pillola ta' 40 mg, u madwar 19% wara doża ta' 160 mg.
English: EU/1/13/817/043 EU/1/13/817/001 EU/1/13/817/042 EU/1/13/817/002 EU/1/13/817/003 EU/1/13/817/004 EU/1/13/817/005
Maltese: EU/1/13/817/043 EU/1/13/817/001 EU/1/13/817/042 EU/1/13/817/002 EU/1/13/817/003 EU/1/13/817/004
English: Reykjavíkurvegur 78, 220 Hafnarfjörður, Iceland
Maltese: Reykjavíkurvegur 78, 220
English: Another study showed a possible association between lip cancer (SCC) and exposure to HCTZ: 633 cases of lip-cancer were matched with 63,067 population controls, using a risk-set sampling strategy.
Maltese: 633 każ ta' kanċer tax-xoffa tqabblu ma' 63,067 kontroll tal-popolazzjoni, bl-użu ta' strateġija ta' teħid ta' kampjuni b'riskju ssettjat.
English: For Al/PVC/PVDC blister Do not store above 30ºC.
Maltese: Għal folja Al/PVC/PVDC Taħżinx f'temperatura ‘l fuq minn 30ºC.
English: Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, asthenia, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting (see section 4.8).
Maltese: Sinjali ta' twissija ta' żbilanċ fil- fluwidu jew fl-elettroliti huma nixfa fil-ħalq, għatx, astenja, letarġija, ngħas, nuqqas ta' kwiet f'ġismek, uġigħ fil-muskoli jew bugħawwieġ, għeja muskolari, pressjoni baxxa, oligurja, takikardja u disturbi gastrointestinali bħal nawseja u rimettar (ara sezzjoni 4.8).
English: Al/PVC/PVDC blister: 28, 56, 84, 90 and 98 tablets Actelsar HCT 80 mg/12.5 mg tablets
Maltese: Folja Al/Al: 14, 28, 30, 56, 84, 90 u 98 pillola Actelsar HCT 40 mg/12.5 mg pilloli
English: The use of Actelsar HCT in children and adolescents up to the age of 18 years is not recommended.
Maltese: L-użu ta' Actelsar HCT fit-tfal u fl-adolexxenti sa l-età ta' 18-il sena mhuwiex rakkomandat.
English: - Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease where the body's immune system attacks the body.
Maltese: Lupus erythematosus sistemiku (imsejjaħ ukoll “lupus” jew “SLE”) marda fejn is-sistema immuni tal-ġisem tattakka lill-ġisem.
English: Inflammation of the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a disease where the body's immune system attacks the body, which causes joint pain, skin rashes and fever); sore throat, inflamed sinuses, feeling sad (depression), difficulty falling asleep (insomnia), impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick (vomiting), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Maltese: Infjammazzjoni tal-pulmun (bronkite), attivazzjoni jew aggravament ta' lupus erythematosus sistemiku (marda fejn is-sistema immuni tal-ġisem tattakka lill-ġisem, u tikkawża wġigħ fil-ġogi, raxx tal-ġilda u deni); uġigħ fil-griżmejn, sinuses infjammati, tħossok imdejjaq (dipressjoni), diffikultà biex torqod (insomnja), indeboliment fil-vista, diffikultà biex tieħu n-nifs, uġigħ addominali, stitikezza, gass żejjed (dispepsja), tħossok imdardar (rimettar), infjammazzjoni tal-istonku (gastrite), funzjoni anormali tal- fwied (hemm aktar ċans li pazjenti Ġappuniżi jkollhom dan l-effett sekondarju), ħmura talġilda (eritema), reazzjonijiet allerġiċi bħal ħakk jew raxx, żieda fl-għaraq, ħorriqija (urtikarja), uġigħ filġogi (artralġja) u uġigħ fl-estremitajiet, bugħawwieġ fil-muskoli, mard qisu influwenza, uġigħ, livelli baxxi ta' sodium, żieda fil-livelli tal-krejatinina, enzimi epatiċi jew creatine phosphokinase fid-demm.
English: The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity, increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss, and decreases in serum potassium.
Maltese: L-azzjoni dijuretika ta' hydrochlorothiazide tnaqqas il-volum tal-plażma, iżżid l-attività ta' renin fil-plażma, iżżid it-tnixxija ta' aldosterone, b'żidiet konsegwenti fittneħħija ta' potassium u bicarbonate fl-awrina, u tnaqqis ta' potassium fis-serum.
English: Actelsar HCT must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Maltese: Actelsar HCT ma jridx jintuża f'pazjenti b'indeboliment renali sever (rata ta' tneħħija tal-krejatinina ta' <30 ml/min) (ara sezzjoni 4.3).
English: 28 tablets 56 tablets 84 tablets 90 tablets 98 tablets
Maltese: 28 il pillola 56 pillola 84 pillola 90 pillola 98 pillola
English: Hyperkalaemia
Maltese: Iperkalċemija
English: Actelsar HCT 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Maltese: Actelsar HCT 80 mg/25 mg pilloli telmisartan/hydrochlorothiazide
English: How to store Actelsar HCT
Maltese: Jekk tinsa tieħu Actelsar HCT
English: Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics, including hydrochlorothiazide.
Maltese: It-tħarrix jew l-attivazzjoni ta' lupus erythematosus sistemiku kien irrappurtat blużu ta' dijuretiċi ta' thiazide, li jinkludu hydrochlorothiazide.
English: Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced arrhythmia (see section 4.4).
Maltese: L-għoti flimkien ta' lithium u Actelsar HCT mhuwiex rakkomandat (ara sezzjoni 4.4).
English: Teл.
Maltese: Gotta.
English: Actelsar HCT 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: Actelsar HCT 40 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: Medicinal products used in the treatment for gout (e.g. probenecid, sulfinpyrazone and allopurinol) Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Maltese: Prodotti mediċinali użati fil-kura għal gotta (eż. probenecid, sulfinpyrazone u allopurinol) Aġġustament fid-doża ta' prodotti mediċinali urikosuriċi jista' jkun meħtieġ għax hydrochlorothiazide jista' jżid illivell ta' uric acid fis-serum.
English: Hepatic function abnormal/liver disorder
Maltese: Funzjoni epatika anormali/disturb fil-fwied2
English: 14 tablets 28 tablets 56 tablets 84 tablets 90 tablets 98 tablets
Maltese: 14- il pillola 28 pillola 56 pillola 84 pillola 90 pillola 98 pillola
English: EU/1/13/817/020 EU/1/13/817/021 EU/1/13/817/022 EU/1/13/817/023 EU/1/13/817/024 EU/1/13/817/025
Maltese: EU/1/13/817/021 EU/1/13/817/022 EU/1/13/817/023 EU/1/13/817/024
English: Renal impairment (including acute renal failure) General disorders and administration site conditions Uncommon:
Maltese: Indeboliment renali (li jinkludi insuffiċjenza renali akuta) Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: Elimination Telmisartan: Following either intravenous or oral administration of 14C-labelled telmisartan most of the administered dose (>97%) was eliminated in faeces via biliary excretion.
Maltese: Wara l-għoti ġol-vini jew mill-ħalq ta' telmisartan ittikkettat 14C, il-biċċa l-kbira tad-doża li tingħata (>97%) kienet eliminata fl-ippurgar permezz ta' tneħħija biljari.
English: Angioedema (also with fatal outcome), erythema, pruritus, rash, hyperhidrosis, urticaria
Maltese: Anġjoedima (ukoll b'riżultat fatali), eritema, ħakk, raxx, iperidrosi,
English: EU/1/13/817/039 EU/1/13/817/040 EU/1/13/817/041
Maltese: EU/1/13/817/039 EU/1/13/817/040
English: Based on modest experience in patients with mild to moderate renal impairment (creatinine clearance of 30-60 ml/min, mean about 50 ml/min) no dose adjustment is necessary in patients with decreased renal function.
Maltese: Ibbażat fuq esperjeza modesta f'pazjenti b'indeboliment renali minn ħafif sa moderat (tneħħija tal-krejatinina ta' 30-60 ml/min, medja ta' madwar 50 ml/min), l-ebda aġġustament fid-doża mhu meħtieġ f'pazjenti b'funzjoni renali mnaqqsa.
English: In patients with impaired renal function the rate of hydrochlorothiazide elimination is reduced.
Maltese: F'pazjenti b'indeboliment fil-funzjoni renali, irrata tat-tneħħija ta' hydrochlorothiazide titnaqqas.
English: In a typical study in patients with a mean creatinine clearance of 90 ml/min the elimination half-life of hydrochlorothiazide was increased.
Maltese: Fi studju tipiku f'pazjenti b'medja ta' tneħħija talkrejatinina ta' 90 ml/min, il-half-life ta' l-eliminazzjoni ta' hydrochlorothiazide żdiedet.
English: Actelsar HCT 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: Actelsar HCT 80 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: Actelsar HCT is not indicated in patients with severe hepatic impairment.
Maltese: Actelsar HCT mhuwiex indikat f'pazjenti b'indeboliment epatiku sever.
English: After a single dose of 14C-labelled telmisartan the glucuronide represents approximately 11% of the measured radioactivity in plasma.
Maltese: Wara doża waħda ta' telmisartan ittikkettat 14C, il-glucuronide jirrappreżenta madwar 11% tar-radjuattività mkejla fil-plażma.
English: Sepsis* (often called “blood poisoning”), is a severe infection with whole-body inflammatory response, rapid swelling of the skin and mucosa (angioedema); blistering and peeling of the top layer of skin (toxic epidermal necrolysis) these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Maltese: Sepsis* (ta' spiss imsejħa “avvelenament tad-demm”), hi infezzjoni severa b'rispons infjammatorju tal ġisem kollu, nefħa mgħaġġla tal-ġilda u l-mukuża (anġjoedema); infafet u s-saff ta' fuq tal-ġilda jitqaxxar (nekrolisi tossika tal-epidermide) dawn l-effetti sekondarji huma rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000) jew ta' frekwenza mhux magħrufa (nekrolisi tossika tal-epidermide) iżda huma estremament serji u l-pazjenti għandhom jieqfu jieħdu l-mediċina u jaraw lit-tabib tagħhom immedjatament.
English: Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis,
Maltese: Anoreksja, tnaqqis fl-aptit, żbilanċ fl-elettroliti, iperkolesterolemija,
English: An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in Actelsar HCT, minimal or no effects were reported.
Maltese: Żieda fil-livelli tal-kolesterol u tat-trigliċeridi kienet assoċjata ma' terapija dijuretika b'thiazide; madankollu, bid-doża ta' 12.5 mg li hemm f' Actelsar HCT, effetti minimi kienu rrappurtati, jew l-ebda effett.
English: In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Maltese: Fi studju wieħed, l-għoti flimkien ta' telmisartan u ramipril wassal għal żieda ta' sa 2.5 darbiet fl-AUC024 u Cmax ta' ramipril u ramiprilat.
English: Periodic monitoring of serum potassium and ECG is recommended when Actelsar HCT is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Maltese: Monitoraġġ perjodiku tal-livell tal-potassium fis-serum u ECG huma rakkomandati meta Actelsar HCT jingħata ma' prodotti mediċinali affettwati minn disturbi fil-livell tal-potassium fis-serum (eż. digitalis glycosides, u anti-arritimiċi) u mal-prodotti mediċinali li ġejjin li jinduċu torsades de pointes (li jinkludu xi anti-arritimici ), bl-ipokalemija, li hi fattur li jippredisponi t-torsades de pointes.
English: Eczema, drug eruption, toxic skin eruption Musculoskeletal, connective tissue and bone disorders Rare:
Maltese: vaskulite fil-ġilda, nekrolisi epidermali tossika, eritema multiforme Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: How to store Actelsar HCT Contents of the pack and other information
Maltese: Kif jidher Actelsar HCT u l-kontenut tal-pakkett
English: 1 Based on post-marketing experience 2 For further description, please see sub-section “Description of selected adverse reactions”
Maltese: 1 Ibbażat fuq esperjenza ta' wara t-tqegħid fis-suq 2 Għal deskrizzjoni addizzjonali, jekk jogħġbok ara sottosezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula”.
English: Musculoskeletal, connective tissue and bone disorders Uncommon:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Rari:
English: “Lot”, which is printed on the carton, refers to the batch number.
Maltese: “Lot”, printjat fuq il-kartuna, jirreferi ghan-numru tal-lott.
English: Al/Al blister: 14, 28, 30, 56, 84, 90 and 98 tablets Al/PVC/PVDC blister: 28, 56, 84, 90 and 98 tablets Tablet container: 30, 90 and 250 tablets
Maltese: Folji Al/Al: 14, 28, 30, 56, 84, 90 u 98 pilloli Folji Al/PVC/PVDC: 28, 56, 84, 90 u 98 pilloli Kontenituri tal-pilloli: 30, 90 u 250 pilloli
English: Al/Al blister packs: 14, 30, 28, 56, 84, 90 and 98 tablets Al/PVC/PVDC blister packs: 14, 28, 56, 84, 90 and 98 tablets Tablet containers: 30, 90 and 250 tablets
Maltese: Folji Al/Al: 14, 28, 30, 56, 84 90 u 98 pilloli Folji Al/PVC/PVDC: 14, 28, 56, 84, 90 u 98 pilloli Kontenituri tal-pilloli: 30, 90 u 250 pilloli
English: - Anti-cholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia) such as atropine and biperiden.
Maltese: - Mediċini antikolinerġiċi (mediċini użati biex jikkuraw varjetà ta' disturbi bħal bugħawwieġ gastrointestinali, spażmu tal-bużżieqa tal-awrina, ażżma, dardir waqt il-moviment/ivvjaġġar, spażmi muskolari, il-marda tal-Parkinson u bħala għajnuna meta tingħata l-anestesija) bħal atropine u biperiden.