FrancophonIA/ELRC3.0 huggingface dataset:
English: Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces (approximately 61% of the dose) and to a lesser extent in the urine (approximately 36% of the dose).
Maltese: Tadalafil jitneħħa prinċipalment bħala metaboli mhux attivi, l-aktar fl-ippurgar (madwar 61% taddoża) u b'ammont inqas fl-awrina (madwar 36% tad-doża).
English: Tadalafil was studied in 4 clinical studies of 12 weeks duration enrolling over 1500 patients with signs and symptoms of benign prostatic hyperplasia.
Maltese: Tadalafil ġie studjat f'4 studji kliniċi li damu 12-il ġimgħa u li fihom ħadu sehem 'il fuq minn 1500 pazjent b'sinjali u sintomi ta' iperplażja beninna tal-prostata.
English: In the primary efficacy studies, 75% of intercourse attempts were successful in tadalafil treated patients as compared to 32% with placebo.
Maltese: Fl-istudji dwar effikaċja primarja, 75% tal-attentati għall-kopulazzjoni kienu b'suċċess f'pazjenti li ħadu tadalafil meta mqabbel ma' 32% li ħadu lplaċebo.
English: 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets
Maltese: 2 pilloli miksijin b'rita 4 pilloli miksijin b'rita 8 pilloli miksijin b'rita 12-il pillola miksijin b'rita 24 pillola miksijin b'rita
English: PDE5 inhibitors, such as Tadalafil Mylan, have been shown to increase the hypotensive effects of this medicine.
Maltese: Ġie muri li inibituri ta' PDE5, bħal Tadalafil Mylan, iżidu l-effetti ipotensivi ta' din ilmediċina.
English: However, as a formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when tadalafil is co-administered with 5-ARIs.
Maltese: Madankollu peress li ma sarx studju formali ta' interazzjoni bejn mediċina u oħra li jevalwa l-effetti ta' tadalafil u l-inibituri ta' 5-alpha reductase (5-ARIs), wieħed għandu joqgħod attent meta tadalafil jingħata flimkien ma' 5-ARIs.
English: Uncommon (may affect up to 1 in 100 people) - dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna) - sturdament, uġigħ fl-istonku, tħossok imdardar, tirremetti, rifluss, vista mċajpra, uġigħ flgħajnejn, diffikulta biex tieħu n-nifs, il-presenza ta' demm fl-awrina, erezzjoni fit-tul, sensazzjoni li l-qalb qed tħabbat ħafna, rata tal-qalb mgħaġġla, pressjoni għolja tad-demm, pressjoni baxxa tad-demm, infriġ, żanżin fil-widnejn, nefħa tal-idejn, tas-saqajn jew talgħekiesi, u tħossok għajjien.
English: Gastro-oesophageal reflux,
Maltese: Rifluss gastroesofagali
English: EU/1/14/961/012 EU/1/14/961/013 EU/1/14/961/014 EU/1/14/961/015 EU/1/14/961/016 EU/1/14/961/017
Maltese: EU/1/14/961/012 EU/1/14/961/013 EU/1/14/961/014
English: McDermott Laboratories Limited t/a Gerard Laboratories Unit 35/36 Baldoyle Industrial Estate Grange Road, Dublin 13
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott McDermott Laboratories Limited t/a Gerard Laboratories Unit 35/36 Baldoyle Industrial Estate
English: Other inducers of CYP3A4 such as phenobarbital, phenytoin and carbamazepine, may also decrease plasma concentrations of tadalafil.
Maltese: Indutturi oħrajn ta' CYP3A4 bħall-phenobarbital, phenytoin u carbamazepine, jistgħu wkoll inaqqsu ilkonċentrazzjonijiet ta' tadalafil fil-plażma.
English: Hypotension Hypertension Respiratory, thoracic and mediastinal disorders Nasal congestion
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Konġestjoni nażali
English: Once-a-day dosing of 2.5 or 5 mg tadalafil both for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment (see sections 4.4 and 5.2).
Maltese: Dożaġġ ta' darba kuljum ta' 2.5 jew 5 mg tadalafil għall-kura kemm tad-disfunzjoni erettili u kemm tal-iperplażja beninna tal-prostata m'huwiex rakkomandat f'pazjenti b'indeboliment renali sever (ara sezzjonijiet 4.4 u 5.2).
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: The improvements in the erectile function domain of the international index of erectile function and the total international prostate symptom score in this study were 6.5 and -6.1 with tadalafil 5 mg compared to 1.8 and -3.8 with placebo, respectively.
Maltese: It-titjib fil-kamp tal-funzjoni erettili tal-indiċi internazzjonali tal-funzjoni erettili u t-total tal-punteġġ internazzjonali għas-sintomi tal24 prostata f'dan l-istudju kienu ta' 6.5 u -6.1 b'tadalafil 5 mg meta mqabbel ma' 1.8 u -3.8 bi plaċebo, rispettivament.
English: The maintenance of the effect was evaluated in an open-label extension to one of the studies, which showed that the improvement in total international prostate symptom score seen at 12 weeks was maintained for up to 1 additional year of treatment with tadalafil 5 mg.
Maltese: Il-manteniment tal-effett kien evalwat f'estensjoni open label ta' wieħed mill-istudji li wera li t-titjib fit-total tal-punteġġ internazzjonali għas-sintomi tal-prostata li deher fit-12-il ġimgħa kien mantnut sa sena addizzjonali ta' kura b'tadalafil 5 mg.
English: Each tablet contains 2.5 mg tadalafil.
Maltese: Kull pillola fiha 2.5 mg tadalafil.
English: Haematuria
Maltese: Ematurija
English: There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Maltese: Hemm informazzjoni klinika limitata dwar is-sigurta' ta' teħid ta' doża waħda ta' tadalafil f'pazjenti b'insuffiċjenza severa tal-fwied (Child-Pugh Klassi C).
English: A light yellow, film-coated, round, biconvex tablet (6.3 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL over 2' on the other side.
Maltese: Pillola miksija b'rita, ta' lewn isfar ċar, tonda u bikonvessa (6.3 ± 0.3 mm), imnaqqxa b'‘M' fuq naħa waħda tal-pillola u ‘TL over 2' fuq in-naħa l-oħra.
English: Tadalafil Mylan is available as 2.5, 5, 10, and 20 mg film-coated tablets for oral use.
Maltese: Tadalafil Mylan hu disponibbli bħala pilloli miksija b'rita ta' 2.5, 5, 10 u 20mg għall-użu orali. 4.3 Kontraindikazzjonijiet
English: Stevens-Johnson syndrome Exfoliative dermatitis Hyperhydrosis (sweating)
Maltese: Sindrome ta' StevensJohnson
English: In dogs given tadalafil daily for 6 to 12 months at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7---18.6] than seen in humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs.
Maltese: Fi klieb li ngħataw tadalafil kuljum għal 6 sa 12-il xahar f'dożi ta' 25 mg/kg/jum (li jirriżulta f'esponiment mill-inqas 3 darbiet akbar [skala 3.7 - 18.6] milli jidher fil-bnedmin li ngħataw doża waħda ta' 20 mg) u aktar, kien hemm rigressjoni tal-epitelju tubulari seminiferu li rriżulta fi tnaqqis tal-ispermatoġenesi f'xi klieb.
English: In one of the studies, which also included tamsulosin 0.4 mg as an active comparator, the improvement in total international prostate symptom score with tadalafil 5 mg, tamsulosin and placebo were -6.3, -5.7 and -4.2 respectively.
Maltese: F'wieħed mill-istudji, li kien jinkludi wkoll lil tamsulosin 0.4 mg bħala komparatur attiv, it-titjib fit-total tal-punteġġ internazzjonali għas-sintomi tal-prostata b'tadalafil 5 mg, tamsulosin u plaċebo kienu ta' -6.3, -5.7 u -4.2 rispettivament.
English: Tadalafil Mylan contains lactose
Maltese: Tadalafil Mylan fih il-lactose
English: A light yellow, film-coated, round, biconvex tablet (5.1 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL over 1' on the other side.
Maltese: Pillola miksija b'rita, ta' lewn isfar ċar, tonda u bikonvessa (5.1 ± 0.3 mm), imnaqqxa b'‘M' fuq naħa waħda tal-pillola u ‘TL over 1' fuq in-naħa l-oħra.
English: Each tablet contains 10 mg tadalafil.
Maltese: Kull pillola fiha 10 mg tadalafil.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/
English: Medicinal product subject to medical prescription
Maltese: Prodotti mediċinali antidijabetiċi
English: In another clinical pharmacology study tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives.
Maltese: Fi studju ieħor ta' farmakoloġija klinika, kien studjat tadalafil (20mg) flimkien ma' sa 4kl assijiet ta' prodotti mediċinali li jintużaw kontra l-pressjoni għolja.
English: There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Maltese: Hemm informazzjoni klinika limitata dwar is-sigurta' ta' teħid ta' doża waħda ta' tadalafil f'pazjenti b'insuffiċjenza severa tal-fwied (Child-Pugh Klassi C); It-teħid ta' doża darba kuljum ma ġietx evalwata f'pazjenti b'insuffiċjenza epatika.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH )għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Each tablet contains 20 mg tadalafil
Maltese: Kull pillola fiha 20 mg tadalafil
English: A light yellow, film-coated, round, biconvex tablet (8.1 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL3' on the other side.
Maltese: Pillola miksija b'rita, ta' lewn isfar ċar, tonda u bikonvessa (8.1 ± 0.3 mm), imnaqqxa b'‘M' fuq naħa waħda tal-pillola u ‘TL3' fuq in-naħa l-oħra.
English: What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 2.5 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL over 1' on the other side.
Maltese: Kif jidher Tadalafil Mylan u l-kontenut tal-pakkett Tadalafil Mylan 2.5 mg hi pillola miksija b'rita, ta' lewn isfar ċar, tonda u bikonvessa, immarkata b'‘M' fuq naħa waħda tal-pillola u ‘TL over 1' fuq in-naħa l-oħra.
English: Tadalafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Maltese: Tadalafil huwa kontra-indikat f'pazjenti li tilfu d-dawl f'għajn waħda minħabba newropatija ottika iskemika anterjuri li m'hijiex arteritika (NAION), indipendetement mill-fatt jekk dan l-episodju kienx marbut jew le ma' użu preċedenti ta' inibitur ta' PDE5 (ara sezzjoni 4.4).
English: BLISTER
Maltese: SN
English: If tadalafil is prescribed once-a-day, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il-benefiċċju u r-riskju tal-prodott mediċinali.
English: A light yellow, film-coated, round, biconvex tablet (10.7 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL4' on the other side.
Maltese: Pillola miksija b'rita, ta' lewn isfar ċar, tonda u bikonvessa (10.7 ± 0.3 mm), imnaqqxa b'‘M' fuq naħa waħda tal-pillola u ‘TL4' fuq in-naħa l-oħra.
English: Tadalafil is > 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
Maltese: Tadalafil huwa >1 0,000 darba aktar potenti għal PDE5 milli għal PDE3, li hija enżima li tinsab fil-qalb u fil-vini u l-arterji.
English: Do not take Tadalafil Mylan if you are already taking nitrates.
Maltese: Tiħux Tadalafil Mylan jekk diġà qed tieħu n-nitrati.
English: Healthy elderly subjects (65 years or over), had a lower oral clearance of tadalafil, resulting in 25% higher exposure (AUC) relative to healthy subjects aged 19 to 45 years.
Maltese: Anzjani b'saħħithom (65 sena jew akbar) kellhom tneħħija aktar baxxa ta' tadalafil meħud oralment, li rriżulta f 25% aktar esponiment (AUC) meta mqabbel ma' individwi b'saħħithom ta' età minn 19 sa 45 sena.
English: Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP450 isoforms.
Maltese: Tadalafil mhux mistenni li b'mod klinikament sinifikanti jinibixxi jew jinduċi it-tneħħija ta' prodotti mediċinali metabolizzati minn iżoformi ta' CYP450.
English: Each tablet contains 2.5 mg tadalafil
Maltese: Kull pillola fiha 2.5 mg tadalafil
English: Package leaflet: Information for the patient
Maltese: Kontenut tal-pakket u informazzjoni oħra
English: In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive medicinal products was examined.
Maltese: Fi studji ta' farmakoloġija klinika, ġie eżaminat il-potenzjal biex tadalafil iżid l-effetti ipotensivi ta' prodotti mediċinali li jintużaw kontra l-pressjoni.
English: - a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
Maltese: - inibitur ta' 5-alpha reductase (użat fil-kura ta' iperplażja beninna tal-prostata). - mediċini bħall-pilloli ketoconazole (biex tikkura infezzjonijiet tal-moffa) u inibituri ta' protease għall-kura tal-AIDS u tal-HIV.
English: Each tablet contains 5 mg tadalafil.
Maltese: Kull pillola fiha 5 mg tadalafil.
English: What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 20 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL4' on the other side.
Maltese: Kif jidher Tadalafil Mylan u l-kontenut tal-pakkett Tadalafil Mylan 20 mg hi pillola miksija b'rita, ta' lewn isfar ċar, tonda u bikonvessa, immarkata b'‘M' fuq naħa waħda tal-pillola u ‘TL4' fuq in-naħa l-oħra.
English: Prior to initiating treatment with tadalafil for benign prostatic hyperplasia patients should be examined to rule out the presence of carcinoma of the prostate and carefully assessed for cardiovascular conditions (see section 4.3).
Maltese: F'pazjenti li qed jieħdu alpha1bl ockers, l-amministrazzjoni konkomitanti ta' tadalafil jista' jwassal għal pressjoni baxxa sintomatika f'xi pazjenti (ara sezzjoni 4.5).
English: What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 5 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL over 2' on the other side.
Maltese: Kif jidher Tadalafil Mylan u l-kontenut tal-pakkett Tadalafil Mylan 5mg hi pillola miksija b'rita, ta' lewn isfar ċar, tonda u bikonvessa, immarkata b'‘M' fuq naħa waħda tal-pillola u ‘TL over 2' fuq in-naħa l-oħra.
English: The recommended starting dose is one 10 mg tablet before sexual activity.
Maltese: Id-doża rakkomandata tal-bidu hija pillola ta' 10 mg qabel l-attivita' sesswali.
English: In clinical trials with tadalafil 5 mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.
Maltese: F'studji kliniċi b'tadalafil 5 mg meħud darba kuljum għall-kura tal-iperplażja beninna tal-prostata, l-isturdament u ddijarea ġew irrapportati b'mod aktar frekwenti f'pazjenti 'l fuq minn 75 sena.
English: If you have taken or are planning to take Tadalafil Mylan, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.
Maltese: Jekk ħadt jew ser tieħu Tadalafil Mylan, evita li tixrob alkoħol eċċessiv (livell ta' alkoħol fid-demm ta' 0.08% jew aktar), minħabba li dan jista' jżid ir-riskju ta' sturdament meta tkun bil-wieqfa.
English: In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of alpha blockers -see above-) is, in general, minor and not likely to be clinically relevant.
Maltese: F'pazjenti li jirċievu prodotti mediċinali għall-pressjoni għolja flimkien ma' tadalafil 20 mg, dan jista' jinduċi tnaqqis fil-pressjoni tad-demm, li (bl-eċċezzjoni ta' imblokkaturi tar-riċetturi alpha - ara hawn fuq-) huwa ġeneralment ħafif u x' aktarx ma jkunx klinikament rilevanti.
English: What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 10 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL3' on the other side.
Maltese: Kif jidher Tadalafil Mylan u l-kontenut tal-pakkett Tadalafil Mylan 10 mg hi pillola miksija b'rita, ta' lewn isfar ċar, tonda u bikonvessa, immarkata b'‘M' fuq naħa waħda tal-pillola u ‘TL3' fuq in-naħa l-oħra.
English: Each tablet contains 10 mg tadalafil
Maltese: Kull pillola fiha 10 mg tadalafil
English: Tel: + 34 900 102 712
Maltese: Mylan Pharmaceuticals, S.L. Tel: + 34 900 102 712
English: 28 film-coated tablets 56 film-coated tablets
Maltese: 28 pillola miksijin b'rita 56 pillola miksijin b'rit
English: Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check you for prostate cancer before starting treatment with tadalafil for benign prostatic hyperplasia.
Maltese: Fi studji ta' farmakoloġija klinika, il-potenzjal biex tadalafil iżid l-effetti ipotensivi ta' prodotti mediċinali li jintużaw kontra l-pressjoni għolja kien eżaminat.
English: These effects were not associated with changes in other parameters such as motility, morphology and FSH.
Maltese: Dawn l-effetti ma ġewx assoċjati ma' tibdil fil-parametri l-oħra bħal motilità, morfoloġija u FSH.
English: Each tablet contains 5 mg tadalafil
Maltese: Kull pillola fiha 5 mg tadalafil
English: You may experience side effects described in section 4.
Maltese: Jista' jkollok xi effetti sekondarji kif deskritt f'sezzjoni 4.
English: • on the risk factors for and prevention of peritonitis in PD (peritoneal dialysis) patients.
Maltese: • Il-fatturi ta' riskju għal u l-prevenzjoni ta' peritonite f'pazjenti b'dijalisi peritoneali.
English: The National Competent Authorities shall agree the details of an education programme for patients and health care professionals with the MAH, who must implement such programme nationally to ensure provision of educational material to patients and health professionals containing information:
Maltese: L-Awtoritajiet Kompetenti Nazzjonali għandhom jiftehmu d-dettalji ta' programm edukattiv għal pazjenti u professjonisti fil-qasam tal-kura tas-saħħa mad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, li għandu jimplimenta programm bħal dan fuq firxa nazzjonali sabiex jiżgura l-għoti ta' materjal edukattiv lil pazjenti u professjonisti fil-qasam tal-kura tas-saħħa u li jkun jikkonsisti minn:
English: • on the risk factors for and prevention of arterio-venous fistula site complications in HD
Maltese: • Il-fatturi ta' riskju għal prevenzjoni ta' kumplikazzjonijiet fis-sit tal-fistula arterjo-venuża f'pazjenti fuq emodijalisi
English: • on the increased risk of vitamin deficiency in chronic kidney disease patients and the need for vitamin supplementation
Maltese: • Ir-riskju ogħla ta' żbilanċ ta' vitamini f'pazjenti b'mard tal-kliewi kroniku u l-bżonn ta'
English: 10 vials
Maltese: 10 vjali
English: 1 bottle + 1 oral syringe of 5 ml + 1 oral syringe of 10 ml + 1 bottle adaptor
Maltese: 1 flixkun + 1 siringa orali ta' 5 ml + 1 siringa orali ta' 10 ml + 1 adaptor talflixkun
English: Intravenous use vial (glass)
Maltese: Soluzzjoni għallinjezzjoni/infużjoni
English: Oral use bottle (glass)
Maltese: Użu minn ġolvina vjala (ħġieġ)
English: EMA/92771/2016 EMEA/H/C/004127
Maltese: EMA/92771/2016 EMA/H/C/004127
English: The full EPAR for Zonisamide Mylan 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: Zonisamide Mylan is a ‘generic medicine'.
Maltese: Zonisamide Mylan huwa ‘mediċina ġenerika'.
English: The usual maintenance dose is between 300 and 500 mg a day for children weighing more than 55 kg and 6 to 8 mg per kg of body weight in children weighing less than 55 kg.
Maltese: Id-doża ta' manteniment normali hija bejn 300 u 500 mg kuljum għal tfal li jiżnu iktar minn 55 kg u 6 sa 8 mg għal kull kg tal-piż tal-ġisem fi tfal li jiżnu inqas minn 55 kg.
English: The usual maintenance dose is 300 mg a day.
Maltese: Id-doża ta' manteniment normali hija 300 mg kuljum.
English: The active substance in Zonisamide Mylan, zonisamide, is an anti‑epileptic.
Maltese: Is-sustanza attiva f'Zonisamide Mylan, iz-zonisamide, hija anti-epilettika.
English: The usual maintenance dose is between 300 and 500 mg a day.
Maltese: Id-doża ta' manteniment normali hija bejn 300 u 500 mg kuljum.
English: This is a summary of the European public assessment report (EPAR) for Zonisamide Mylan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zonisamide Mylan.
English: Other information about Zonisamide Mylan
Maltese: Informazzjoni oħra dwar Zonisamide Mylan
English: Zonisamide Mylan also acts on the neurotransmitter gamma‑aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other).
Maltese: Zonisamide Mylan jaġixxi wkoll fuq in-newrotrażmettitur aċidu gamma-aminobutiriku (GABA, sustanza kimika li tippermetti liċ-ċelluli tan-nervituri jikkomunikaw ma' xulxin).
English: Zonisamide Mylan contains the active substance zonisamide.
Maltese: Zonisamide Mylan fih is-sustanza attiva zonisamide.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku zonisamide
English: Why is Zonisamide Mylan approved?
Maltese: Għaliex ġie approvat Zonisamide Mylan?
English: What are the benefits and risks of Zonisamide Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Zonisamide Mylan?
English: Zonisamide is thought to work by blocking specific pores on the surface of nerve cells called sodium channels and calcium channels, through which sodium or calcium normally enter nerve cells.
Maltese: Zonisamide huwa maħsub li jaħdem billi jimblokka pori speċifiċi fuq is-superfiċje taċ-ċelluli tannervituri li jissejħu kanali tas-sodju u kanali tal-kalċju, li minnhom is-sodju jew il-kalċju normalment jidħlu fiċ-ċelluli tan-nervituri.
English: The medicine can only be obtained with a prescription and is available as capsules (25, 50 and 100 mg).
Maltese: Il-mediċina tista' tinkiseb biss b'riċetta ta' tabib u tiġi bħala kapsuli (25, 50, u 100 mg).
English: Because Zonisamide Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Zonegran.
Maltese: Minħabba li Zonisamide Mylan huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet biex tiġi determinata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Zonegran.
English: This means that Zonisamide Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zonegran.
Maltese: Dan ifisser li Zonisamide Mylan huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Zonegran.
English: Because Zonisamide Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Zonisamide Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.