FrancophonIA/ELRC3.0 huggingface dataset:
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 Onduarp, 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 Onduarp, eż. baclofen, amifostine, newroleptiċi jew antidipressanti.
English: What Onduarp looks like and contents of the pack Onduarp 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 other side.
Maltese: Il-pilloli Onduarp 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 in-naħa l-oħra.
English: Amlodipine In patients taking amlodipine alone the following additional side effects have been reported:
Maltese: F'pazjenti li kienu qed jieħdu amlodipine waħdu, l-effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
English: Other conditions with stimulation of the renin-angiotensin-aldosterone system In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Maltese: Kundizzjonijiet oħrajn bl-istimulazzjoni tas-sistema renin-angiotensin-aldosterone F'pazjenti fejn it-ton vaskulari u l-funzjoni tal-kliewi jiddependu b'mod predominanti fuq l-attività tas-sistema renin-angiotensin-aldosterone (eż. pazjenti b'insuffiċjenza konġestiva severa tal-qalb jew li għandhom mard diġà eżistenti tal-kliewi, li jinkludi stenosi tal-arterja tal-kliewi), il-kura bi prodotti mediċinali oħrajn li jaffettwaw din is-sistema kienet assoċjata ma' pressjoni baxxa akuta, iperażotemija, oligurja, jew, b'mod rari, ma' insuffiċjenza tal-kliewi akuta (ara sezzjoni 4.8).
English: Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as besylate).
Maltese: Kull pillola fiha 40 mg ta' telmisartan u 10 mg ta' amlodipine (bħala besylate).
English: Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours consistent with once daily dosing.
Maltese: It-tneħħija ta' amlodipine mill-plażma hi bifażika, b'half-life tat-tneħħija terminali ta' madwar 30 sa 50 siegħa, li hi konsistenti ma' dożaġġ ta' darba kuljum.
English: Differences in plasma concentrations of telmisartan were observed, with Cmax and AUC being approximately 3- and 2-fold higher, respectively, in females compared to males.
Maltese: L-ogħla konċentrazzjoni fil-plażma (Cmax) u, fi grad anqas, iż-żona taħt ilkurva ta' konċentrazzjoni fil-plażma-ħin (AUC), tiżdied b'mod sproporzjonat mad-doża.
English: General disorders and administration site conditions peripheral oedema asthenia, chest pain, fatigue, oedema malaise
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata edema periferali astenja, uġigħ fis-sider, għeja kbira, edema
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Maltese: L-użu ta' antagonisti tar-riċetturi ta' angiotensin II hu kontraindikat matul ittieni u t-tielet trimestri tat-tqala (ara sezzjonijiet 4.3 u 4.4).
English: Very rare side effects (may affect up to 1 in 10,000 people):
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000 ruħ):
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: 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 filġogi, 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: • Biliary obstructive disorders and severe hepatic impairment
Maltese: • Disturbi ostruttivi biljari u indeboliment sever tal-fwied
English: Concomitant administration of 240 ml of grapefruit juice with a single oral dose of 10 mg amlodipine in 20 healthy volunteers did not show a significant effect on the pharmacokinetic properties of amlodipine.
Maltese: Għalhekk, id-doża ta' simvastatin għandha tiġi limitata għal 20 mg kuljum f'pazjenti fuq amlodipine.
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets telmisartan/amlodipine
Maltese: Onduarp 40 mg/5 mg pilloli telmisartan/amlodipine
English: Amlodipine has not been associated with any adverse metabolic effects or changes in plasma lipids and is suitable for use in patients with asthma, diabetes, and gout.
Maltese: Amlodipine ma kienx assoċjat ma' kwalunkwe effetti metaboliċi avversi jew tibdil fil-lipidi filplażma, u hu adattat għall-użu f'pazjenti b'ażżma, dijabete, u gotta.
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets telmisartan/amlodipine
Maltese: Onduarp 80 mg/5 mg pilloli telmisartan/amlodipine
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets telmisartan/amlodipine
Maltese: Informazzjoni għall-utent Onduarp 80 mg/10 mg pilloli Telmisartan/Amlodipine
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets telmisartan/amlodipine
Maltese: Informazzjoni għall-utent Onduarp 40 mg/10 mg pilloli Telmisartan/Amlodipine
English: What Onduarp looks like and contents of the pack Onduarp 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 other side.
Maltese: Il-pilloli Onduarp 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 in-naħa l-oħra.
English: Dual blockade of the renin-angiotensin-aldosterone system (e.g. by administering telmisartan with other blockers of the renin-angiotensin-aldosterone system) is therefore not recommended.
Maltese: Imblokk doppju tas-sistema renin-angiotensin-aldosterone (eż. billi tagħti telmisartan ma' imblokkaturi oħrajn tas-sistema renin-angiotensin-aldosterone) hu għalhekk mhux rakkomandat.
English: Hyperkalaemia
Maltese: Sindrome extrapiramidali
English: Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Maltese: Pressjoni baxxa sistemika notevoli u probabbilment fittul, sa, u li tinkludi xokk b'riżultat fatali, kienet irrappurtata.
English: Flatulence Stomach discomfort
Maltese: Pazjenti b'indeboliment tal-fwied
English: • if you have severe liver problems or biliary obstruction (problems with drainage of the bile from the liver and gall bladder).
Maltese: • jekk għandek problemi severi tal-fwied jew ostruzzjoni biljari (problemi fit-tnixxija tal-bila mill-fwied jew mill-marrara).
English: In a follow-up, long term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure without clinical symptoms or objective findings suggestive of underlying ischaemic disease, on stable doses of ACE inhibitors, digitalis, and diuretics, amlodipine had no effect on total cardiovascular mortality.
Maltese: III u IV, mingħajr sintomi kliniċi jew sejbiet oġġettivi li jissuġġerixxu mard iskemiku diġà eżistenti, li kienu fuq dożi stabbli ta' inibituri ta' ACE, digitalis, u dijuretiċi, amlodipine ma kellu l-ebda effett fuq il-mortalità kardjovaskulari totali.
English: Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Maltese: Għandha tinbeda kura ta' appoġġ. Calcium gluconate ġol-vini jista' jkun utli biex ireġġa' lura l-effetti tal-imblokk tal-kanal tal-calcium.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/006 (360 (4 x 90 x 1) tablets)
Maltese: EU/1/11/729/006 (36 (4 x 90 x 1) pillola)
English: Gynaecomastia General disorders and administration site conditions Uncommon:
Maltese: Disturbi tad-demm u tas-sistema limfatika Rari ħafna:
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-BLU80 mg/10 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/10 mg
Maltese: Folja ta' 7 pilloli - 40 mg/10 mg
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/5 mg
Maltese: PAKKETTI TA' 90 X 1 PILLOLA) BUNDLED - LI JINKLUDU L-KAXXA L-BLU80 mg/5 mg
English: In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.
Maltese: F'pazjenti bi pressjoni għolja b'funzjoni normali tal-kliewi, dożi terapewtiċi ta' amlodipine rriżultaw fi tnaqqis fir-reżistenza vaskulari tal-kliewi u żieda fir-rata ta' filtrazzjoni glomerulari u fluss effettiv tal-plażma fil-kliewi, mingħajr tibdil fil-porzjon ta' filtrazzjoni jew proteinuria.
English: Serum potassium should be monitored closely in these patients (see section 4.5).
Maltese: Il-livell ta' potassium fis-serum għandu jiġi mmonitorjat mill-qrib f'dawn il-pazjenti (ara sezzjoni 4.5).
English: It cannot be ruled out that strong inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent than diltiazem.
Maltese: (i.e. ketoconazole, itraconazole, ritonavir) jistgħu jżidu lkonċentrazzjonijiet ta' amlodipine fil-plażma fi grad ikbar minn dak ta' diltiazem.
English: What Onduarp looks like and contents of the pack Onduarp 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 other side.
Maltese: Il-pilloli Onduarp 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 in-naħa l-oħra.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/5 mg
Maltese: Folja ta' 7 pilloli - 40 mg/5 mg
English: Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switched to Onduarp 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 Onduarp 40 mg/5 mg darba kuljum, u jnaqqsu d-doża ta' amlodipine mingħajr ma jnaqqsu r-rispons totali mistenni kontra l-pressjoni għolja.
English: Furthermore it was shown that some patients not adequately controlled with Onduarp 40 mg/10 mg had additional blood pressure reduction by uptitration to Onduarp 80 mg/10 mg.
Maltese: Flimkien ma' dan, intwera li xi pazjenti li ma kinux ikkontrollati b'mod mhux adegwat b'Onduarp 40 mg/10 mg, kellu tnaqqis addizzjonali talpressjoni tad-demm permezz ta' titrazzjoni 'l fuq għal Onduarp 80 mg/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: MARKETING AUTHORISATION NUMBERS EU/1/11/729/003 (28 tablets) EU/1/11/729/004 (360 (4 x 90 x 1) tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/729/004 (360 (4 x 90 x 1) pillola)
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: Wara 8 ġimgħat ta' kura, kull waħda mill-kuri bilkumbinazzjoni ta' mediċini kienet superjuri b'mod statistikament sinifikanti għal terapija b'amlodipine waħdu fit-tnaqqis tal-pressjoni tad-demm dijastolika u sistolika (-11.1/-9.2 mmHg, -11.3/-9.3 mmHg b'40 mg/10 mg, 80 mg/10 mg kontra -7.
English: With concomitant use with the CYP3A4 inhibitor erythromycin in young patients and diltiazem in elderly patients respectively, the plasma concentration of amlodipine increased by 22 % and 50 % respectively.
Maltese: Bl-użu fl-istess ħin mal-inibitur ta' CYP3A4 erythromycin f'pazjenti żgħażagħ u diltiazem f'pazjenti anzjani rispettivament, il-konċentrazzjoni ta' amlodipine fil-plażma żdiedet bi 22% u 50% rispettivament.
English: Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of Onduarp containing the same component doses.
Maltese: Pazjenti adulti li jkunu qed jirċievu telmisartan u amlodipine minn pilloli separati jistgħu minflok jirċievu pilloli Onduarp li fihom l-istess dożi tal-komponenti.
English: Interactions linked to amlodipine
Maltese: F'pazjenti mhux ikkontrollati li kienu fuq amlodipine
English: The safety and efficacy of Onduarp in children aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Onduarp fit-tfal li għandhom inqas minn 18-il sena għadhom ma ġewx stabbiliti.
English: What Onduarp looks like and contents of the pack Onduarp 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 other side.
Maltese: Il-pilloli Onduarp 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 in-naħa l-oħra.
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Maltese: Telmisartan jieħu post angiotensin II b'affinità għolja ħafna mis-sit fejn jeħel fis-sottotip tar-riċettur AT1, li hu responsabbli għall-azzjonijiet magħrufa ta' angiotensin II. Telmisartan ma juri l-ebda attività agonista parzjali fir-riċettur AT1.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/005 (28 tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/729/005 (28 pillola)
English: Ear and labyrinth disorders vertigo
Maltese: Disturbi fil-widnejn u fis-sistema labirintika mejt
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: • Narrowing of the blood vessels to one or both kidneys (renal artery stenosis).
Maltese: • Tidjiq tal-vini/arterji lejn kilwa waħda jew lejn iż-żewġ kliewi (stenosi tal-arterji tal-kliewi).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/10 mg
Maltese: Folja ta' 7 pilloli - 80 mg/10 mg
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/005 (28 tablets) EU/1/11/729/006 (36 (4 x 90 x 1) tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/729/006 (360 (4 x 90 x 1) pillola)
English: The maximum recommended dose is Onduarp 80 mg/10 mg, one tablet per day.
Maltese: Id-doża massima rakkomandata hi Onduarp 80 mg/10 mg, pillola waħda kuljum.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal -Aġenzija Ewropea għall -Mediċini http://www.ema.europa.eu/.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/5 mg
Maltese: Folja ta' 7 pilloli - 80 mg/5 mg
English: Renal impairment including acute renal failure General disorders and administration site conditions Rare:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Rari:
English: Package leaflet: Information for the user Onduarp 40 mg/5 mg tablets Telmisartan/Amlodipine
Maltese: Informazzjoni għall-utent Onduarp 40 mg /5 mg pilloli Telmisartan/Amlodipine
English: STATEMENT OF ACTIVE SUBSTANCE(S) 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). Eċċipjent(i) b'effett magħruf:
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/001 (28 tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/729/001 (28 pillola)
English: MARKETING AUTHORISATION NUMBERS EU/1/11/729/002 (28 tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/729/002 (28 pillola)
English: These pharmacologicallymediated 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: STATEMENT OF ACTIVE SUBSTANCE(S) 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). Eċċipjent(i) b'effett magħruf:
English: In patients with mild to moderate and severe renal impairment, doubling of plasma concentrations of telmisartan was observed.
Maltese: F'pazjenti b'indeboliment tal-kliewi minn moderat sa sever, l-irduppjar tal-konċentrazzjonijiet ta' telmisartan fil-plażma kien osservat.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/003 (28 tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/729/003 (28 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 tal-krejatinina fis-serum, u insuffiċjenza akuta tal-kliewi kienu wkoll irrappurtati.
English: Clinical Study #002 (Dundee Adolescent Study)
Maltese: Studju Kliniku #002 (Studju Dundee tal-Adoloxxenti)
English: Prevention of Adult Caries Study (PACS)
Maltese: Studju tal-Prevenzjoni tal-Karje fl-Adulti (PACS)
English: Clinical Study #001 (Adult Xerostomia Study)
Maltese: Studju Kliniku #001 (Studju ta' Adulti bi Xerostomia)
English: The medicinal product, Prevora 100 mg/ml is a 10% w/v chlorhexidine dental solution indicated to reduce dental caries in permanent teeth of adolescents and adults.
Maltese: Il-prodott mediċinali, Prevora 100 mg/ml huwa soluzzjoni dentali ta' 10% w/v chlorhexidine indikat għat-tnaqqis tal-karje tas-snien fi snien permanenti fl-adoloxxenti u fl-adulti.
English: The study population consisted of 983 adults ranging in age from 18 and 80 years and with a mean age of 43 years.
Maltese: Il-popolazzjoni tal-istudju ikkonsistiet f'983 adult li jvarjaw fl-età bejn 18 u 80 sena u b'età medja ta' 43 sena.
English: It consists of a chlorhexidine coating solution (Stage 1) and an inert sealant coating (Stage 2) which is applied after the application of the chlorhexidine solution.
Maltese: Huwa jikkonsisti f'soluzzjoni ta' chlorhexidine għall-kisi (Stadju 1) u kisi ta' siġillar inert (Stadju 2) li jiġi applikat wara l-applikazzjoni tas-soluzzjoni ta' chlorhexidine.
English: The pivotal study included a total of 79 subjects on active.
Maltese: L-istudju pivotali nkluda total ta' 79 soġġett attiv.
English: A 24.5% reduction for all tooth surfaces (root plus coronal surfaces) was seen with a p-value of 0.0322 [95% confidence interval (CI) of 0.62 - 0.98].
Maltese: Deher tnaqqis ta' 24.5% għall-uċuh tas-snien kollha (uċuh tal-għeruq u koronali) b'valur-p ta' 0.0322 [95% interval ta' fiduċja (CI) ta' 0.62 - 0.98].
English: The study enrolled 983 at-risk adults and the study objectives were: determine the efficacy of Prevora in reducing cavities in at-risk adults, evaluate its safety, and evaluate the emergence if any, of chlorhexidineresistant Streptococcus mutans post treatment in study participants, and the emergence, if any, of opportunistic infections in the form of Candida albicans post treatment in study participants.
Maltese: L-istudju rreġistra 983 adult f'riskju u l-miri tal-istudju kienu: determinazzjoni tal-effikaċja ta' Prevora fit-tnaqqis ta' tħassir f'adulti f'riskju, evalwazzjoni tas-sigurtà tiegħu, u evalwazzjoni talħruġ jekk preżenti ta' mutanti ta' Streptococcus reżistenti għal chlorhexidine wara l-kura filparteċipanti tal-istudju, u l-ħruġ jekk preżenti ta' infezzjonijiet opportunistiċi fil-forma ta' Candida albicans wara l-kura fil-parteċipanti tal-istudju.
English: Benefit-risk assessment
Maltese: Valutazzjoni tal-benefiċċju-riskju
English: For root surfaces, a 40.8% reduction with a p-value 0.0206 (95% CI of 0.23 - 0.78) and for coronal surfaces, no significant difference was seen between placebo and Prevora (p-value
Maltese: Għall-uċuh tal-għeruq, deher tnaqqis ta' 40.8% b'valur-p ta' 0.0206 (95% CI of 0.23 - 0.78) u ma dehret ebda differenza sinifikanti għal uċuh koronali, bejn il-plaċebo u Prevora (valur-p ta' 0.0644).
English: Prevora has been evaluated in two randomised, double-blinded, placebo-controlled clinical trials (RCTs) conducted according to GCP.
Maltese: Prevora ġie evalwat f'żewġ provi kliniċi kkontrollati bi plaċebo, double-blinded, randomizzati (RCTs) magħmula skont il-GCP.
English: The following indication was agreed by the CHMP:
Maltese: Intlaħaq ftehim dwar l-indikazzjoni li ġejja mis-CHMP:
English: The MAH, CHX Technologies Europe Ltd submitted to CHMP for consideration the results of another study, the Prevention of Adult Caries Study (PACS), to confirm the results seen to date.
Maltese: Il-MAH, CHX Technologies Europe Ltd issottometta lis-CHMP ir-riżultati ta' studju ieħor għall-kusiderazzjoni, lIstudju tal-Prevenzjoni tal-Karje fl-Adulti (PACS), sabiex jikkonferma r-riżultati li deher sa dakinhar.
English: A 3-year randomised double-blind trial in at-risk adolescent patients to evaluate the efficacy and safety of Prevora 100mg/ml Dental Solution in reducing caries increment.
Maltese: Prova ta' 3 snin randomizzata, double blinded, f'pazjenti adoloxxenti f'riskju biex tevalwa l-effikaċja u s-sigurtà ta' Prevora 100mg/ml Soluzzjoni Dentali fit-tnaqqis taż-żieda tal-karje.