FrancophonIA/ELRC3.0 huggingface dataset:
English: Sleepiness, migraine, headache, tingling or numbness of the hands or feet, feeling of spinning (vertigo), slow heart rate, palpitations (awareness of your heart beat), low blood pressure (hypotension), dizziness on standing up (orthostatic hypotension), flushing, cough, stomach ache (abdominal pain), diarrhoea, feeling sick (nausea), itching, joint pain, muscle cramps, muscle pain, inability to obtain an erection, weakness, chest pain, tiredness, swelling (oedema), increased levels of hepatic enzymes.
Maltese: Irqad, emigranja, uġigħ ta' ras, tnemnim jew tmewwit tal-idejn jew saqajn, sensazzjoni li tħoss kollox idur bik (mejt), rata baxxa ta' taħbit tal-qalb, palpitazzjonijiet (tħoss it-taħbit tal-qalb tiegħek), pressjoni tad-demm baxxa (ipotensjoni), tistordi meta tqum bilwieqfa (ipotensjoni ortostatika), fwawar, sogħla, uġigħ fl-istonku (uġigħ ta' żaqq), dijarea, tħossok imdardar (nawseja), ħakk, uġigħ fil-ġogi, bugħawwieġ fil-muskoli, uġigħ fil-muskoli, ma tkunx kapaċi li jkollok erezzjoni, dgħufija, uġigħ fis-sider, għeja, nefħa (edema), żieda fil-livelli ta' enzimi tal-fwied.
English: Twynsta 40 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 5 mg alone.
Maltese: Twynsta 40 mg/5 mg hu indikat għall-uzu fl-adulti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata b'mod adegwat b'amlodipine 5 mg waħdu.
English: What Twynsta looks like and contents of the pack Twynsta 80 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the white layer.
Maltese: Il-pilloli Twynsta 80 mg/5 mg huma blu u bojod, b'forma ovali, b'żewġ saffi, imnaqqxa bil-kodiċi talprodott A3 u l-logo tal-kumpanija fuq is-saff l-abjad.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/10 mg
Maltese: Folja b'unità tad-doża ta' 10 pilloli - 40 mg/10 mg
English: Rare vomiting, gingival hypertrophy, dyspepsia, dry mouth stomach discomfort
Maltese: Rari rimettar, ipertrofija ġinġivali, dispepsja, ħalq xott skonfort fl-istonku
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/10 mg tablets telmisartan/amlodipine
Maltese: Twynsta 80 mg/10 mg pilloli telmisartan/amlodipine
English: In this same population amlodipine was associated with increased reports of pulmonary oedema.
Maltese: F'din l-istess popolazzjoni amlodipine kien assoċjat ma' żieda fir-rapporti ta' edema pulmonari.
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets)
Maltese: EU/1/10/648/022 (14-il pillola) EU/1/10/648/023 (28 pillola) EU/1/10/648/024 (30 x 1 pillola) EU/1/10/648/025 (56 pillola) EU/1/10/648/026 (90 x 1 pillola) EU/1/10/648/027 (98 pillola)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/5 mg
Maltese: Folja b'unità tad-doża ta' 10 pilloli - 40 mg/5 mg
English: Twynsta 80 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled on Twynsta 40 mg/10 mg or Twynsta 80 mg/5 mg.
Maltese: Twynsta 80 mg/10 mg jista' jingħata lil pazjenti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata b'mod adegwat bi Twynsta 40 mg/10 mg jew Twynsta 80 mg/5 mg.
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets)
Maltese: EU/1/10/648/015 (14-il pillola) EU/1/10/648/016 (28 pillola) EU/1/10/648/017 (30 x 1 pillola) EU/1/10/648/018 (56 pillola) EU/1/10/648/019 (90 x 1 pillola) EU/1/10/648/020 (98 pillola)
English: The most prominent manifestations of telmisartan overdose are expected to be hypotension and tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Maltese: L-iktar manifestazzjonjiet prominenti ta' doża eċċessiva ta' telmisartan huma mistennija li jkunu pressjoni tad-demm baxxa u takikardja; bradikardja, sturdament, rimettar, żieda fil-livell talkrejatinina fis-serum, u insuffiċjenza akuta tal-kliewi kienu wkoll irrappurtati.
English: ketoconazole).
Maltese: temsirolimus u everolimus).
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets)
Maltese: EU/1/10/648/008 (14-il pillola) EU/1/10/648/009 (28 pillola) EU/1/10/648/010 (30 x 1 pillola) EU/1/10/648/011 (56 pillola) EU/1/10/648/012 (90 x 1 pillola) EU/1/10/648/013 (98 pillola)
English: What Twynsta looks like and contents of the pack Twynsta 80 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the white layer.
Maltese: Il-pilloli Twynsta 80 mg/10 mg huma blu u bojod, b'forma ovali, b'żewġ saffi, imnaqqxa bil-kodiċi tal-prodott A4 u l-logo tal-kumpanija fuq is-saff l-abjad.
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Maltese: EU/1/10/648/022 (14-il pillola) EU/1/10/648/023 (28 pillola) EU/1/10/648/024 (30 x 1 pillola) EU/1/10/648/025 (56 pillola) EU/1/10/648/026 (90 x 1 pillola) EU/1/10/648/027 (98 pillola) EU/1/10/648/028 (360 (4 x 90 x 1) pillola)
English: Furthermore it was shown that some patients not adequately controlled with Twynsta 40 mg/10 mg had additional blood pressure reduction by up-titration to Twynsta 80 mg/10 mg.
Maltese: Flimkien ma' dan, intwera li xi pazjenti li ma kinux ikkontrollati b'mod mhux adegwat bi Twynsta 40 mg/10 mg, kellu tnaqqis addizzjonali talpressjoni tad-demm permezz ta' titrazzjoni 'l fuq għal Twynsta 80 mg/10 mg.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/5 mg tablets telmisartan/amlodipine
Maltese: Twynsta 40 mg/5 mg pilloli telmisartan/amlodipine
English: Medicinal products with blood pressure lowering potential Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including this medicinal product, e.g. baclofen, amifostine, neuroleptics or antidepressants.
Maltese: Prodotti mediċinali li għandhom il-potenzjal li jbaxxu l-pressjoni tad-demm Ibbażat fuq il-proprjetajiet farmakoloġiċi tagħhom, jista' jkun mistenni li l-prodotti mediċinali li ġejjin jistgħu jżidu l-effetti ipotensivi tal-mediċini kollha kontra l-pressjoni għolja, li jinkludu dan ilprodott mediċinali, eż. baclofen, amifostine, newroleptiċi jew antidipressanti.
English: There is a risk of increased tacrolimus blood levels when co-administered with amlodipine but the pharmacokinetic mechanism of this interaction is not fully understood.
Maltese: Hemm riskju ta' żieda fil-livelli ta' tacrolimus fid-demm meta jingħata flimkien ma' amlodipine, iżda l-mekkaniżmu farmakokinetiku ta' din l-interazzjoni mhuwiex mifhum għal kollox.
English: Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Maltese: Kull pillola fiha 40 mg ta' telmisartan u 5 mg ta' amlodipine (bħala amlodipine besilate).
English: Twynsta 80 mg/5 mg is indicated in adults whose blood pressure is not adequately controlled with Twynsta 40 mg/5 mg .
Maltese: Twynsta 80 mg/5 mg hu indikat għall-uzu fl-adulti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata b'mod adegwat bi Twynsta 40 mg/5 mg.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/648/014 (360 (4 x 90 x 1) pillola)
English: What Twynsta looks like and contents of the pack Twynsta 40 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the white layer.
Maltese: Il-pilloli Twynsta 40 mg/5 mg huma blu u bojod, b'forma ovali, b'żewġ saffi, imnaqqxa bil-kodiċi talprodott A1 u l-logo tal-kumpanija fuq is-saff l-abjad.
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Maltese: EU/1/10/648/001 (14-il pillola) EU/1/10/648/002 (28 pillola) EU/1/10/648/003 (30 x 1 pillola) EU/1/10/648/004 (56 pillola) EU/1/10/648/005 (90 x 1 pillola) EU/1/10/648/006 (98 pillola) EU/1/10/648/007 (360 (4 x 90 x 1) pillola)
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets)
Maltese: EU/1/10/648/001 (14-il pillola) EU/1/10/648/002 (28 pillola) EU/1/10/648/003 (30 x 1 pillola) EU/1/10/648/004 (56 pillola) EU/1/10/648/005 (90 x 1 pillola) EU/1/10/648/006 (98 pillola)
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Maltese: EU/1/10/648/008 (14-il pillola) EU/1/10/648/009 (28 pillola) EU/1/10/648/010 (30 x 1 pillola) EU/1/10/648/011 (56 pillola) EU/1/10/648/012 (90 x 1 pillola) EU/1/10/648/013 (98 pillola) EU/1/10/648/014 (360 (4 x 90 x 1) pillola)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg/10 mg
Maltese: PAKKETTI TA' 90 X 1 PILLOLA) BUNDLED - LI JINKLUDU L-KAXXA L-BLU - 80 mg/ 10 mg
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Maltese: EU/1/10/648/015 (14-il pillola) EU/1/10/648/016 (28 pillola) EU/1/10/648/017 (30 x 1 pillola) EU/1/10/648/018 (56 pillola) EU/1/10/648/019 (90 x 1 pillola) EU/1/10/648/020 (98 pillola) EU/1/10/648/021 (360 (4 x 90 x 1) pillola)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/648/021 (360 (4 x 90 x 1) pillola)
English: Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.
Maltese: Imblokkaturi tal-kanali tal-calcium, inkluż amlodipine, għandhom jintużaw b'kawtela f'pazjenti b'insuffiċjenza konġestiva tal-qalb, għax dawn jistgħu jżidu r-riskju ta' avvenimenti kardjovaskulari u mortalità fil-futur.
English: Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Twynsta containing the same component doses.
Maltese: Pazjenti adulti li jkunu qed jirċievu telmisartan u amlodipine minn pilloli separati jistgħu minflok jirċievu pilloli Twynsta li fihom l-istess dożi tal-komponenti.
English: Uncommon asthenia, chest pain, fatigue, oedema pain
Maltese: Mhux komuni astenja, uġigħ fis-sider, għeja kbira, edema uġigħ
English: Due to risk of hyperkalemia, it is recommended that the coadministration of calcium channel blockers such as amlodipine be avoided in patients susceptible to malignant hyperthermia and in the management of malignant hyperthermia.
Maltese: Minħabba r-riskju ta' iperkalimja, huwa rakkomandat li l-għoti flimkien ta' imblokkaturi tal-kanal tal-calcium bħal amlodipine jiġi evitat f'pazjenti suxxettibbli għal ipertermija malinna u fl-immaniġġjar ta' ipertermija malinna.
English: After 8 weeks of treatment, each of the combination treatments was statistically significantly superior to amlodipine monotherapy in reducing diastolic and systolic blood pressure ( 11.1/ 9.2 mmHg, 11.3/ 9.3 mmHg with 40 mg/10 mg, 80 mg/10 mg versus 7.4/ 6.5 mmHg with amlodipine 10 mg) and higher diastolic blood pressure normalisation rates compared to monotherapy were achieved (63.7 %, 66.5 % with 40 mg/10 mg, 80 mg/10 mg versus 51.1 % with amlodipine 10 mg).
Maltese: 4/-6.5 mmHg b'amlodipine 10 mg) u nkisbu rati ogħla ta' normalizzazzjoni tal-pressjoni tad-demm dijastolika meta mqabbla ma' meta ngħata waħdu (63.7 %, 66.5 % b'40 mg/10 mg, 80 mg/10 mg kontra 51.1 % b'amlodipine 10 mg).
English: This is confirmed by trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies.
Maltese: Dan hu kkonfermat mill-proporzjonijiet bejn il-livelli l-aktar baxxi mqabbla malogħla livelli, li kienu aktar minn 80 % b'mod konsistenti, osservati wara li ngħataw dożi ta' 40 u 80 mg ta' telmisartan fi provi kliniċi b'telmisartan ikkontrollati bi plaċebo.
English: Very rare side effect (may affect up to 1 in 10,000 people):
Maltese: Effett sekondarju rari ħafna (jista' jaffettwa sa 1 minn kull 10,000 ruħ):
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Maltese: Fi studji fuq l-annimali, kien osservat effett tossiku fuq is-sistema riproduttiva b'dożi għoljin (ara sezzjoni 5.3).
English: Animal reproductive toxicity studies with telmisartan/amlodipine have not been performed.
Maltese: Ma sarux studji dwar tossiċità riproduttiva fl-annimali b'telmisartan/amlodipine.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg /10 mg tablets telmisartan/amlodipine
Maltese: Twynsta 40 mg /10 mg pilloli telmisartan/amlodipine
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/5 mg
Maltese: PAKKETTI TA' 90 X 1 PILLOLA) BUNDLED - LI JINKLUDU L-KAXXA L-BLU - 40 mg/ 5 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/648/028 (360 (4 x 90 x 1) pillola)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/10 mg
Maltese: PAKKETTI TA' 90 X 1 PILLOLA) BUNDLED - LI JINKLUDU L-KAXXA L-BLU - 40 mg/ 10 mg
English: What Twynsta looks like and contents of the pack Twynsta 40 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the white layer.
Maltese: Il-pilloli Twynsta 40 mg/10 mg huma blu u bojod, b'forma ovali, b'żewġ saffi, imnaqqxa bil-kodiċi tal-prodott A2 u l-logo tal-kumpanija fuq is-saff l-abjad.
English: Package leaflet: Information for the user Twynsta 80 mg/10 mg tablets Telmisartan/Amlodipine
Maltese: Informazzjoni għall-utent Twynsta 80 mg/10 mg pilloli Telmisartan/Amlodipine
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Maltese: Hemm evidenza li l-użu fl-istess ħin ta' inibituri ta' ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren iżid ir-riskju ta' pressjoni baxxa, iperkalemija u tnaqqis fil-funzjoni tal-kliewi (li jinkludi insuffiċjenza renali akuta).
English: Twynsta tablets contain two active substances called telmisartan and amlodipine.
Maltese: Il-pilloli Twynsta fihom żewġ sustanzi attivi msejħa telmisartan u amlodipine.
English: Mutagenicity studies revealed no drug related effects at either the gene or chromosome levels.
Maltese: Studji dwar il-mutaġeniċità ma wrew l-ebda effetti relatati mal-mediċina la fil-livelli tal-ġene u lanqas fil-livelli tal-kromożomi.
English: How to store Twynsta
Maltese: Kif gћandek tieћu Twynsta
English: Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switched to Twynsta 40 mg/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.
Maltese: Pazjenti kkurati b'10 mg ta' amlodipine li jesperjenzaw kwalunkwe reazzjonijiet avversi li jillimitaw id-doża bħal edema, jistgħu jaqilbu għal Twynsta 40 mg/5 mg darba kuljum, u jnaqqsu d-doża ta' amlodipine mingħajr ma jnaqqsu r-rispons totali mistenni kontra l-pressjoni għolja.
English: Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Maltese: Kull pillola fiha 80 mg ta' telmisartan u 5 mg ta' amlodipine (bħala amlodipine besilate).
English: Package leaflet: Information for the user Twynsta 80 mg/5 mg tablets Telmisartan/Amlodipine
Maltese: Informazzjoni għall-utent Twynsta 80 mg/5 mg pilloli Telmisartan/Amlodipine
English: Interactions linked to amlodipine
Maltese: Interazzjonijiet marbuta ma' amlodipine
English: Pregnancy
Maltese: Ventrikulari
English: In another rat study in which male rats were treated with amlodipine besilate for 30 days at a dose comparable with the human dose based on mg/kg, decreased plasma follicle-stimulating hormone and testosterone were found as well as decreases in sperm density and in the number of mature spermatids and Sertoli cells.
Maltese: Fi studju ieħor fil-firien li fih firien irġiel kienu ttrattati b'amlodipine besilate għal 30 ġurnata b'doża komparabbli mad-doża umana bbażata fuq mg/kg, instabu tnaqqis fl-ormon li jistimula l-follikulu u fit-testosterone fil-plażma kif ukoll tnaqqis fid-densità tal-isperma u fin-numru ta' spermatidi u ta' ċelluli Sertoli maturi.
English: Package leaflet: Information for the user Twynsta 40 mg/5 mg tablets Telmisartan/Amlodipine
Maltese: Informazzjoni għall-utent Twynsta 40 mg/5 mg pilloli Telmisartan/Amlodipine
English: Package leaflet: Information for the user Twynsta 40 mg/10 mg tablets Telmisartan/Amlodipine
Maltese: Informazzjoni għall-utent Twynsta 40 mg/10 mg pilloli Telmisartan/Amlodipine
English: These pharmacologically-mediated undesirable effects, known from preclinical studies with both angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists, were prevented by oral saline supplementation.
Maltese: Dawn il-bidliet, anke effett ta' klassi ta' inibituri ta' enzimi li jibdlu angiotensin u antagonisti oħrajn tar-riċetturi ta' angiotensin II, ma jidhirx li għandhom sinifikat kliniku.
English: For telmisartan the posology should not exceed 40 mg once daily (see section 4.4).
Maltese: Għal telmisartan, il-pożoloġija m'għandhiex taqbeż 40 mg darba kuljum (ara sezzjoni 4.4).
English: EMA/643644/2014 EMEA/H/C/000476
Maltese: EMEA/H/C/000476
English: The full EPAR for Dukoral 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: Other information about Dukoral:
Maltese: Informazzjoni oħra dwar Dukoral:
English: Dukoral cholera vaccine (inactivated, oral)
Maltese: Vaċċin għall-kolera (inattivat, orali)
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dukoral on 28 April 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Dukoral valida fl-Unjoni Ewropea kollha fit-28 ta' April 2004.
English: This document is a summary of the European public assessment report (EPAR) for Dukoral.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Dukoral.
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: headache, diarrhoea, and abdominal (tummy) pain, cramps, gurgling (gas) or discomfort.
Maltese: Madankollu, l-effetti sekondarji li ġejjin jidhru f'bejn pazjent 1 u 10 minn kull 1,000: uġigħ ta' ras, dijarea, u wġigħ addominali (uġigħ ta' żaqq), bugħawwieġ, gass jew skumdità.
English: Dukoral is a vaccine.
Maltese: Dukoral huwa vaċċin.
English: The CHMP noted that the risk of cholera for regular tourists is minor, but that Dukoral could be important for certain groups, such as healthcare workers in cholera epidemics.
Maltese: Is-CHMP innota li r-riskju tal-kolera għal turisti regolari huwa wieħed baxx, iżda li Dukoral jista' jkun importanti għal ċerti gruppi ta' nies, bħall-ħaddiema fil-kura tas-saħħa waqt l-epidemiji tal-kolera.
English: The vaccine contains four different inactivated strains (types) of the bacterium Vibrio cholerae (V. cholerae) serotype O1, and part of a toxin from one of these strains as active substances.
Maltese: Il-vaċċin fih erba' razez (tipi) inattivati differenti tal-batterju Vibrio cholerae (V. cholerae) serotip O1, u parti minn tossin minn waħda minn dawn ir-razez bħala sustanzi attivi.
English: Dukoral should not replace standard protective measures against cholera, including advice on diet and hygiene.
Maltese: Dukoral m'għandux jieħu post il-miżuri ta' protezzjoni standard kontra l-kolera, inkluż ilkonsultazzjoni dwar id-dieta u l-iġjene.
English: The people in the final study also received a booster dose 10 to 12 months later.
Maltese: In-nies flistudju finali ngħataw ukoll doża booster bejn 10 u 12-il xahar wara.
English: The first study involved over 89,000 people in Bangladesh and compared Dukoral with the same vaccine without the toxin and with placebo.
Maltese: Lewwel studju involva ‘l fuq minn 89,000 persuna f'Bangladexx u qabbel Dukoral mal-istess vaċċin mingħajr it-tossin u ma' plaċebo.
English: Why has Dukoral been approved?
Maltese: Għaliex ġie approvat Dukoral?
English: The company also presented information on the use of Dukoral for the prevention of a severe type of traveller's diarrhoea caused by a bacterium called ‘enterotoxigenic Escherichia coli'.
Maltese: Il-kumpanija ppreżentat ukoll informazzjoni dwar l-użu ta' Dukoral għallprevenzjoni ta' tip sever ta' dijarea tal-vjaġġaturi kkawżata minn batterju magħruf bħala ‘Escherichia coli enterotossiġeniku'.
English: In the study in Bangladesh, the protective effectiveness of Dukoral was 85% over the first six months of follow-up.
Maltese: Fl-istudju fil-Bangladexx, l-effikaċja protettiva ta' Dukoral kienet 85% matul l-ewwel sitt xhur ta' sorveljanza.
English: Side effects with Dukoral are not common.
Maltese: Mhumiex komuni effetti sekondarji fl-użu ta' Dukoral.
English: Dukoral contains small amounts of inactivated (killed) cholera bacteria and a part of the cholera toxin called the ‘B subunit'.
Maltese: Dukoral fih ammonti żgħar tal-batterji tal-kolera inattivat (maqtul) u parti mit-tossin tal-kolera magħruf bħala ‘B subunit'.
English: How has Dukoral been studied?
Maltese: Kif ġie studjat Dukoral?
English: The three main studies involved a total of almost 113,000 people.
Maltese: It-tliet studji ewlenin involvew total ta' kważi 113,000 persuna.
English: The length of protection was different for adults and children, lasting for six months in children and for two years in adults.
Maltese: Kemm idum l-effett tal-protezzjoni kien differenti għall-adulti u għat-tfal, u jdum sitt xhur fit-tfal u sentejn fl-adulti.
English: This summary was last updated in 10-2014.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f': 10-2014.
English: What is Dukoral?
Maltese: X'inhu Dukoral?
English: The course should be completed at least one week before potential exposure to cholera.
Maltese: Il-kors għandu jitlesta mill-anqas ġimgħa qabel ma l-persuni jkunu potenzjalment esposti għall-kolera.
English: The other study in Peru showed that after a booster dose, the protective effectiveness of Dukoral during the second year of follow-up was 61%.
Maltese: L-studju l-ieħor li sar fil-Perù wera li wara doża booster, l-effikaċja protettiva ta' Dukoral matul it-tieni sena ta' sorveljanza kienet ta' 61%.
English: Dukoral is used in adults, adolescents and children from two years of age who will be visiting high-risk areas.
Maltese: Dukoral jintuża fl-adulti, adoloxxenti u fit-tfal li jkunu għalqu s-sentejn li jkunu sejrin f'postijiet b'riskju serju.