FrancophonIA/ELRC3.0 huggingface dataset:
English: 1, eye pain
Maltese: 1, vista mċajpra
English: • Effects in the eye: eye allergy, disturbance of vision, damage to the optic nerve, increased pressure in eye, deposits on the eye surface, decreased eye sensation, inflammation or infection of the conjunctiva (white of the eye), abnormal, double or reduced vision, increased pigmentation of the eye, growth on surface of eye, eye swelling, sensitivity to light, decreased growth or number of eyelashes, drooping of the upper eyelids (making the eye stay half closed), inflammation of the eyelid and eye lid glands, inflammation in the cornea and detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity.
Maltese: • Effetti fl-għajn: allerġija fl-għajn, disturb fil-vista, ħsara lin-nerv ottiku, żjieda tal-pressjoni flgħajn, depożiti fuq is-superfiċje tal-għajn, tnaqqis fis-sensazzjoni tal-għajn, infjammazzjoni jew infezzjoni tal-konġuntiva (l-abjad tal-għajn), vista mhux normali, doppja jew imnaqqsa, żjieda fil-pigmentazzjoni tal-għajn, tkabbir fuq is-superfiċje tal-għajn, nefħa fl-għajn, sensittività għad-dawl, tnaqqis fit-tkabbir jew fil-kwantità ta' xagħar tal-għajnejn, kappell ta' fuq tal-għajn baxx (jagħmel l-għajn tibqa' nofsa magħluqa), infjammazzjoni tal-kappell tal-għajn u talglandoli tal-kappell tal-għajn, infjammazzjoni tal-korneja u distakk tas-saff taħt ir-retina li fih kanali tad-demm wara kirurġija ta' filtrazzjoni li jista' jikkawża disturbi fil-vista, tnaqqis fissensittività tar-retina.
English: • Heart and circulation: changes in rhythm or rate of the heartbeat, slow heart rate, palpitations, a type of heart rhythm disorder, abnormal increase in heart rate, chest pain, reduced heart function, heart attack, increased blood pressure, reduced blood supply to the brain, stroke, oedema (fluid build up), congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up), swelling of the extremities, low blood pressure, discoloration of the fingers, toes, and occasionally other areas of the body (Raynaud's phenomenon), cold hands and feet.
Maltese: • Qalb u ċirkolazzjoni: bidliet fir-ritmu jew fir-rata ta' taħbit tal-qalb, qalb tħabbat bil-mod, palpitazzjonijiet, tip ta' disturb fir-ritmu tal-qalb, żieda mhux normali fir-rata tal-qalb, uġigħ fis-sider, tnaqqis fil-funzjoni tal-qalb, attakk tal-qalb, żjieda fil-pressjoni tad-demm, tnaqqis flammont ta' demm li jmur għall-moħħ, puplesija, edima (akkumulazzjoni ta' fluwidu), insuffiċjenza konġestiva tal-qalb (marda tal-qalb bi qtugħ ta' nifs u nefħa tas-saqajn u tarriġlejn minħabba akkumulazzjoni ta' fluwidu), nefħa fl-estremitajiet, pressjoni baxxa, bidla filkulur tas-swaba tal-idejn, tas-swaba tas-saqajn, u kultant ta' partijiet oħra tal-ġisem (fenomenu ta' Raynaud), idejn u saqajn kesħin.
English: Manufacturer S.A. Alcon-Couvreur N.V. Rijksweg 14
Maltese: Il-Manifattur S.A. Alcon-Couvreur N
English: During lactation, the no adverse effect level in the offspring was 5 mg/kg/day.
Maltese: Waqt ittreddigħ, il-livelli ta' l-ebda effett avvers kien 5 mg/kg/kuljum.
English: , irregular heart rate 3, arrhythmia palpitations
Maltese: Ir-rotot metaboliċi għall-metaboliżmu ta' brinzolamide jinvolvi
English: Mental alertness
Maltese: Viġilanza mentali
English: Beta-blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4).
Maltese: Imblokkaturi tar-riċetturi Beta jistgħu jaħbu s-sinjali u s-sintomi ta' ipogliċemija (ara sezzjoni 4.4).
English: 3, scleral pigmentation subconjunctival cyst 3, visual disturbance
Maltese: 3, purgar ta' spiss3, disturb gastro-intestinali3, ipoestesija fil-ħalq3, parestesija fil-ħalq
English: Surgical anaesthesia
Maltese: Reazzjonijiet anafilattiċi
English: Timolol is metabolised by two pathways.
Maltese: Timolol huwa metabolizzat minn żewġ rotot.
English: Plasma protein binding of brinzolamide is moderate (about 60%).
Maltese: It-twaħħil mal-proteini fil-plażma ta' brinzolamide huwa moderat (madwar 60%).
English: Acid/base disturbances
Maltese: Disturbi fl-aċidi/bażi
English: 5 ml round opaque low density polyethylene bottles with a dispensing plug and white polypropylene screw cap (DROP-TAINER) containing 5 ml suspension.
Maltese: Fliexken tal-polyethylene, tondi, opaki, ta' densità baxxa, ta' 5 ml, b'tapp għall-għoti u b'għatu bilkamin abjad tal-polyethylene (DROP-TAINER) li fih 5 ml ta' suspensjoni.
English: One ml of suspension contains 10 mg of brinzolamide and 5 mg of timolol (as maleate).
Maltese: Ml ta' suspensjoni fih 10 mg ta' brinzolamide u 5 mg ta' timolol (bħal maleate).
English: Timolol is a non-selective adrenergic-blocking agent that has no intrinsic sympathomimetic, direct myocardial depressant or membrane-stabilising activity.
Maltese: Timolol huwa mblokkatur adrinerġiku mhux selettiv li m'għandux attività simpatomimetika intrinsika, attività ta' depressjoni mijokardijaka diretta jew attività ta' stabilizzazzjoni tal-membrana.
English: This may cause similar adverse reactions as seen with systemic beta-blocking medicinal products.
Maltese: Dan jista' jikkawża reazzjonijiet avversi simili għal dawk osservati bi prodotti mediċinali sistemiċi li jimblokkaw ir-riċetturi beta.
English: The use of two topical beta-adrenergic blocking agents or two local carbonic anhydrase inhibitors is not recommended (see section 4.5).
Maltese: L-użu ta' żewġ sustanzi mblokkaturi beta-adrenerġiċi topiċi jew ta' żewġ inibituri ta' carbonic anhydrase lokali mhux irrakkomandat (ara sezzjoni 4.5).
English: Rare side effects (may affect up to 1 in 1,000 people)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1000)
English: 2, decreased libido
Maltese: 3, tnaqqis fil-libido
English: 3, throat irritation
Maltese: 3, tħossok nervuż 3, irritabilità
English: The non-inferiority of AZARGA as compared to dorzolamide 20 mg/ml + timolol 5 mg/ml in the mean IOP reduction was demonstrated across all time-points at all visits.
Maltese: In-nuqqas ta' inferjorità ta' AZARGA kif imqabbel ma' dorzolamide 20 mg/ml + timolol 5 mg/ml fit-tnaqqis medju tal-IOP kien dimostrat tul il-punti ta' ħin kollha, fil-visti kollha.
English: How to store AZARGA
Maltese: Tużax AZARGA
English: Due to brinzolamide, electrolyte imbalance, development of an acidotic state, and possibly central nervous system effects may occur.
Maltese: Minħabba brinzolamide jista' jkun hemm żbilanċ ta' l-elettroliti, żvilupp ta' stat ta' aċidożi, u possibilment effetti fuq is-sistema nervuża ċentrali.
English: • General side effects: difficulty sleeping (insomnia), throat pain, running nose
Maltese: • Effetti sekondarji ġenerali: diffikultà biex torqod (insomnja), uġigħ fil-griżmejn, imnieħer iqattar
English: Hyperthyroidism
Maltese: Disturbi psikjatriċi
English: Tabulated summary of adverse reactions
Maltese: Sommarju tar-reazzjonijiet avversi f'tabella
English: The cytochrome P-450 isozymes responsible for metabolism of brinzolamide include CYP3A4 (main), CYP2A6, CYP2B6, CYP2C8 and CYP2C9.
Maltese: L-isożimi taċ-ċitokromju P-450 responsabbli għall-metaboliżmu ta' brinzolamide jinkludu CYP3A4
English: One route yields an ethanolamine side chain on the thiadiazole ring and the other giving an ethanolic side chain on the morpholine nitrogen and a second similar side chain with a carbonyl group adjacent to the nitrogen.
Maltese: Rotta minnħom tipproduċi katina tat-tarf ta' ethanolamine fuq iċ-ċirku thiadiazole u l-oħra tagħti katina tat-tarf etanolika fuq morpholine nitrogen u katina tat-tarf oħra simili bi grupp carbonyl viċin nitrogen.
English: Uncommon side effects (may affect up to 1 in 100 people)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100).
English: 3, reduced visual acuity
Maltese: 3, akutezza tal-vista mnaqqsa
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal
Maltese: Ir-rekwiżi biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali li huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe appornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: 3, peripheral oedema medication residue
Maltese: 3, fdal tal mediċina
English: • Hypersensitivity reactions common to all sulphonamide derivates can occur in patients receiving AZARGA as it is absorbed systemically.
Maltese: • Reazzjonijiet ta' sensittività eċċessiva komuni għ ad-derivattivi ta' sulphonamide kollha jistgħ u jseħ ħ u f'pazjenti li jkunu qed jirċievu AZARGA peress li jiġi assorbit b'mod sistemiku.
English: In case of accidental ingestion, symptoms of overdose from beta blockade may include bradycardia, hypotension, cardiac failure and bronchospasm.
Maltese: F'każ ta' inġestjoni aċċidentali, sintomi ta' doża eċċessiva mill-imblokk tar-riċetturi beta jistgħu jinkludu bradikardija, pressjoni baxxa, insuffiċjenza kardijaka u bronkospażmu.
English: • If you have severe hay fever
Maltese: • Jekk għandek hay fever severa.
English: • Metabolism: low blood sugar levels.
Maltese: • Metaboliżmu: livelli baxxi ta' zokkor fid-demm.
English: , chest discomfort
Maltese: Disturbi vaskulari
English: 3, upper respiratory tract congestion
Maltese: 3, konġestjoni fl-apparat respiratorju ta'
English: • diabetes as timolol may mask signs and symptoms of low blood sugar
Maltese: • dijabete peress li timolol jista' jgħatti sinjali u sintomi ta' zokkar baxx fid-demm
English: 3, eyelid disorder
Maltese: 3, disfunzjoni sesswali
English: Brinzolamide is a potent inhibitor of human carbonic anhydrase II (CA-II), the predominant isoenzyme in the eye. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humour secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport.
Maltese: L-inibizzjoni ta' carbonic anhydrase fil-proċessi ċiljari ta' l-għajn tnaqqas is-sekrezzjoni ta' laqueous humour, preżumibbilment billi tnaqqas il-formazzjoni ta' ijoni ta' bicarbonate bi tnaqqis sussegwenti fit-trasport ta' sodju u ta' fluwidu.
English: • Reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
Maltese: • Marda reattiva tal-passaġġi tal-arja inkluż ażżma tal-bronki jew passat ta' ażżma tal-bronki, jew marda severa kronika ostruttiva tal-pulmun.
English: Talk to your doctor before you use AZARGA.
Maltese: Kellem lit-tabib tiegħek qabel tuża AZARGA.
English: Studies in animals have shown that following oral administration brinzolamide is excreted in breast milk, see section 5.3.
Maltese: Studji fuq lannimali wrew li wara għoti orali brinzolamide jitneħħa fil-ħ alib tas-sider, ara sezzjoni 5.3.
English: 1, urticaria 2, pruritus
Maltese: 1, urtikarja
English: Opened:
Maltese: Sími:
English: , glare 3, photopsia
Maltese: 3, fotopsija
English: AZARGA contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses.
Maltese: AZARGA fih preservattiv (benzalkonium chloride) li jista' jiġi assorbit mil-lentijiet tal-kuntatt rotob u jista' jbiddel il-kulur tal-lentijiet tal-kuntatt.
English: 3, oral hypoaesthesia
Maltese: 3, artralġja
English: AZARGA contains two active substances, brinzolamide and timolol, which work together to reduce pressure within the eye.
Maltese: AZARGA fih żewġ sustanzi attivi, brinzolamide and timolol, li jaħdmu flimkien biex innaqqsu lpressjoni fl-għajn.
English: Developmental toxicity studies in rabbits with oral doses of brinzolamide of up to 6 mg/kg/day (214 times the recommended daily clinical dose of 28 µg/kg/day) revealed no effect on foetal development despite significant maternal toxicity.
Maltese: Studji dwar it-tossiċità fl-iżvilupp fil-fniek b'dożi orali ta' brinzolamide sa 6 mg/kg/kuljum (214 darba d-doża klinika rrakkomandata kuljum ta' 28 µg/kg/kuljum) ma' wrew l-ebda effett fuq l-iżvilupp tal-fetu minkejja tossiċità sinifikanti għall-omm.
English: , abdominal pain upper
Maltese: , skomdu addominali
English: 1, pterygium 3, ocular discomfort
Maltese: 1, pteriġjum 3, skomdu fl-għajn keratokonġuntivite xotta
English: No effects on male or female fertility are anticipated from the use of AZARGA.
Maltese: L-ebda effetti fuq il-fertilità maskili jew femminili ma huma antiċipati mill-użu ta' AZARGA.
English: The concomitant administration of AZARGA and oral carbonic anhydrase inhibitors has not been studied and is not recommended (see section 4.5).
Maltese: L-għoti ta' AZARGA flimkien ma' inibituri ta' carbonic anhydrase orali ma' ġiex studjat u mhux irrakkomandat (ara sezzjoni 4.5).
English: (predominantly in patients with preexisting bronchospastic disease), dyspnoea
Maltese: Twissijiet speċjali u prekawzjonijiet għall-użu), keratopatija
English: Approximately 20% of a timolol dose is excreted in the urine unchanged and the remainder excreted in urine as metabolites.
Maltese: Madawar 20% tad-doża ta' timolol tiġi mneħħija mhux mibdula fl-awrina u l-bqija tiġi mneħħija fl-awrina bħala metaboliti.
English: One ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate).
Maltese: Ml ta' suspensjoni fiha 10 mg brinzolamide u 5 mg timolol (bħala timolol maleate). Eċċipjent b'effett magħruf:
English: No specific drug interaction studies have been performed with AZARGA.
Maltese: Ma sarux studji speċifiċi ta' interazzjoni b'AZARGA.
English: • Respiratory: Constriction of the airways in the lungs (predominantly in patients with preexisting disease) shortness of breath or difficulty breathing, cold symptoms, chest congestion, sinus infection, sneezing, stuffy nose, dry nose, nose bleeds, asthma, throat irritation.
Maltese: Tidjiq tal-passaġġi tal-arja fil-pulmun (primarjament f'pazjenti b'marda eżistenti minn qabel), qtugħ ta' nifs jew diffikultà biex tieħu n-nifs, sintomi ta' riħ, konġestjoni fis-sider, infezzjoni fis-sinus, għatis, imnieħer fgat, imnieħer xott, fsada mill-imnieħer, ażżma, irritazzjoni fil-griżmejn.
English: • Effects in the eye: corneal disorder, sensitivity to light, increased tear production, eyelid crusting
Maltese: • Effetti fl-għajn: disturb tal-kornea, sensittività għad-dawl, żieda fid-dmugħ, qxur fil-kappell tal-għajn
English: 3, tinnitus
Maltese: 3, imnieħer xott
English: A statistically superior reduction in mean IOP was observed compared to both brinzolamide and timolol at all timepoints and visits throughout the study.
Maltese: Kien osservat tnaqqis statistikament superjuri fl-IOP medja meta mqabbel kemm ma' brinzolamide kif ukoll ma' timolol tul il-punti ta' ħin u l-visti kollha tul l-istudju.
English: Caution is recommended in the concomitant use of this medicinal product with clonidine.
Maltese: Attenzjoni hija rrakkomandata waqt l-użu ta' dan il-prodott mediċinali flimkien ma' clonidine.
English: At steady-state, timolol is detected in human plasma for up to 12 hours after administration of AZARGA.
Maltese: Fi stat fiss, timolol jinstab fil-plażma umana sa 12-il siegħa wara l-għoti ta' AZARGA.
English: 1, asthma
Maltese: 1, ażżma epistassi
English: Non clinical data do not show any effects of either brinzolamide or timolol on male or female fertility following oral dosing.
Maltese: Dejta mhux klinika ma wriet l-ebda effetti ta' brinzolamide jew ta' timolol fuq il-fertilità maskili jew femminili wara dożaġġ orali.
English: AZARGA should be used with caution in patients with severe hepatic impairment (see section 4.4).
Maltese: Għandu jkun hemm attenzjoni speċjali f'pazjenti b'passat ta' atopija jew anafilassi (ara sezzjoni 4.4).
English: • Muscular: generalised back, joint, or muscle pain not caused by exercise, muscle spasms, pain in extremities, muscle weakness/tiredness, increases in the signs and symptoms of myasthenia gravis (muscle disorder).
Maltese: spażmi muskolari, uġigħ fl-estremitajiet, debbulizza fil-muskoli/għeja, żjieda fis-sinjali u sintomi ta' majastenija gravis (disturb fil-muskoli)
English: 3, corneal epithelium defect 3, corneal epithelium disorder
Maltese: 2, ħedla ta' ngħas3, disfunzjoni motorja3, telf tal-memorja3, tnaqqis talmemorja
English: • Reproduction: sexual dysfunction, decreased libido, male sexual difficulty.
Maltese: • Riproduzzjoni: disfunzjoni sesswali, libido imnaqqas, diffikultà sesswali fl-irġiel
English: 1, nausea 1, oesophagitis
Maltese: 3, uġigħ fl-estremitajiet
English: Concomitant therapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Uncommon: cough Rare: oropharyngeal pain
Maltese: Mhux komuni: sogħla Rari: uġigħ fil-ħalq u fil-farinġi
English: Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
Maltese: Il-livelli ta' l-elettroliti fis-serum (speċjalment talpotassju) u l-livelli tal-pH fid-demm għandhom jiġu sorveljati.
English: 3, pharyngitis
Maltese: 3, dermatite
English: Following topical ocular administration, brinzolamide and timolol are absorbed through the cornea and into the systemic circulation.
Maltese: Wara għoti topika fl-għajn, brinzolamide u timolol huma assorbiti mill-korneja u għal ġewwa ċċirkolazzjoni sistemika.
English: 3, keratoconjunctivitis sicca 3, hypoaesthesia of the eye
Maltese: 3, pigmentazzjoni tal-isklera
English: 1, muscle spasms 3, arthralgia
Maltese: 3, uġigħ fid dahar
English: Since brinzolamide and its main metabolite are excreted predominantly by the kidney, AZARGA is therefore contraindicated in patients with severe renal impairment (see section 4.3).
Maltese: Peress li brinzolamide u l-metabolit prinċipali tiegħu jitneħħew fil-biċċa l-kbira mill-kliewi, AZARGA huwa kontra-indikat f'pazjenti b'indeboliment sever tal-kliewi (ara sezzjoni 4.3).
English: • Skin: rash, skin redness or inflammation, abnormal or decreased skin sensation, hair loss, rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis.
Maltese: • Ġilda: raxx, ħmura jew infjammazzjoni fil-ġilda, sensazzjoni mhux normali jew imnaqqsa filġilda, telf ta' xagħar, raxx b'dehra ta' lewn abjad fil-fidda (raxx psoriasiform) jew irkadar ta' psorajasi.
English: • if you have problems with your kidneys.
Maltese: • jekk għandek problemi tal-fwied.
English: Dysgeusia (bitter or unusual taste in the mouth following instillation) was a frequently reported systemic adverse reaction associated with the use of AZARGA during clinical trials.
Maltese: Disġewżja (togħma qarsa jew mhux tas-soltu fil-ħalq wara li jitqattar il-qtar) kienet reazzjoni sistemika avversa irrapportata b'mod frekwenti assoċjata ma' l-użu ta' AZARGA waqt il-provi kliniċi.
English: Brinzolamide is not an inhibitor of cytochrome P-450 isozymes.
Maltese: Brinzolamide mhux inibitur ta' isożimi taċ-citokromju P-450.
English: There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and brinzolamide eye drops.
Maltese: Hemm potenzjal ta' effett addittiv fuq l-effetti sistemiċi magħ rufa ta' inibizzjoni ta' carbonic anhydrase f'pazjenti li jirċievu inibitur orali ta' carbonic anhydrase u qtar għ all-għ ajnejn ta' brinzolamide.
English: Ocular tissue distribution data in rabbits showed that timolol can be measured in aqueous humour up to 48 hours after administration of AZARGA.
Maltese: Reazzjonijiet avversi addizzjonali assoċjati mal-użu tal-komponenti individwali li potenzjalment jistgħu jseħħu b'AZARGA huma nklużi fit-tabella fuq.
English: 1, pain
Maltese: 1, uġigħ
English: Brinzolamide is sequestered in RBCs due to its high affinity binding to CA-II and to a lesser extent to CA-I. Its active N-desethyl metabolite also accumulates in RBCs where it binds primarily to CA-I.
Maltese: Dan il-prodott mediċinali għ andu jintuża b'attenzjoni f'pazjenti b'riskju ta' indeboliment renali minħ abba r-riskju possibbli ta' aċidożi metabolika.
English: 1, asthenia
Maltese: 3, arritmija
English: Ref. EMEA/CHMP/660222/2009 EMEA/H/A-30/999
Maltese: EMEA/CHMP/706046/2009 EMEA/H/A-30/999
English: London, 14 October 2009 Doc.
Maltese: Londra, 14 ta' Ottubru 2009 Dok. ta' Ref.
English: It is available as tablets (25 mg, 50 mg, 100 mg and 200 mg) and capsules (15 mg, 25 mg and 50 mg).
Maltese: Jiġi bħala pilloli (25 mg, 50 mg, 100 mg u 200 mg) u kapsuli (15 mg, 25 mg u 50 mg).
English: The review was carried out under an ‘Article 30' referral1.
Maltese: Ir-reviżjoni twettqet skont referenza tal-‘Artikolu 30'1.
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by Member States
Maltese: L-Artikolu 30 tad-Direttiva 2001/83/KE kif emendat, referenza fuq il-bażi tad-deċiżjonijiet diverġenti adottati mill-Istati Membri
English: What is Topamax?
Maltese: X'inhu Topamax?
English: The company that markets Topamax is Johnson & Johnson Pharma R & D.
Maltese: Il-kumpanija li tpoġġi Topamax fis-suq hija Johnson & Johnson Pharma R & D.
English: Topamax is also available in the EU under other trade names: Topimax, Epitomax, Topiramat-Cilag, Topiramat-Janssen, Topamax Migräne and Topamac.
Maltese: Topamax huwa disponibbli wkoll fl-UE taħt ismijiet kummerċjali oħrajn: Topimax, Epitomax, Topiramat-Cilag, Topiramat-Janssen, Topamax Migräne u Topamac.
English: Topiramate is not intended for acute treatment.'
Maltese: Topiramate mhuwiex intenzjonat għall-kura akuta.'
English: Topamax is an antiepileptic medicine.
Maltese: Topamax huwa mediċina antiepilettika.
English: Dr Concepción Prieto Yerro
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: • ‘monotherapy in adults, adolescents and children over six years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures;
Maltese: • ‘monoterapija fl-adulti, fl-adoloxxenti u fit-tfal li għandhom aktar minn 6 snin b'aċċessjonijiet parzjali b'aċċessjonijiet sekondarji ġeneralizzati jew mingħajrhom, u aċċessjonijiet primarji ġeneralizzati tonic-clonic;
English: • adjunctive therapy in children aged 2 years and above, adolescents and adults for partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome;
Maltese: • terapija miżjuda fit-tfal mill-età ta' sentejn 'il fuq, fl-adoloxxenti u fl-adulti b'attakki ta' aċċessjonijiet parzjali b'ġeneralizzazzjoni sekondarja jew mingħajrha jew aċċessjonijiet primarji ġeneralizzati tonic-clonic u għall-kura ta' aċċessjonijiet assoċjati mas-sindrome ta' LennoxGastau;
English: Topamax has been identified as needing harmonisation by the Co-ordination Group on the Mutual Recognition and Decentralised Procedures - Human (CMD(h)).
Maltese: Topamax ġie identifikat bħala li jeħtieġ l-armonizzazzjoni mill-Grupp ta' Kordinazzjoni fuq ir-Rikonoxximent Reċiproku u l-Proċeduri ta' Deċentralizzazzjoni - Uman (CMD(h)).
English: For monotherapy in adults the CHMP recommended 100 mg to 200 mg a day as the initial dose and a maximum daily dose of 500 mg a day, divided into two doses.
Maltese: Għal monoterapija fl-adulti, is-CHMP irrakkomanda 100 mg sa 200 mg kuljum bħala d-doża inizjali u doża massima ta' kuljum ta' 500 mg kuljum, diviża f'żewġ dożi.
English: The CHMP agreed on a harmonised wording for the contra-indications.
Maltese: Is-CHMP qabel fuq formolazzjoni armonizzata għall-kontra-indikazzjonijiet.
English: • in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options.
Maltese: • fl-adulti għall-profilassi tal-uġigħ ta' ras tal-emigranja wara evalwazzjoni magħmula b'reqqa ta' għażliet possibli ta' kuri alternattivi.
English: Questions and answers on the referral for Topamax and associated names topiramate tablets and capsules
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Topamax u ismijiet assoċjati topiramate pilloli u kapsuli