FrancophonIA/ELRC3.0 huggingface dataset:
English: Tasmar is indicated in combination with levodopa/benserazide or levodopa/carbidopa for use in patients with levodopa-responsive idiopathic Parkinson's disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-O-methyltransferase COMT inhibitors (see section 5.1).
Maltese: Tasmar jiġi indikat flimkien ma' levodopa/benserazide jew levodopa/carbidopa għall-użu f'pazjenti bil-marda Parkinson idjopatika u li tirrispondi għal-levodopa u b'varjazzjonijiet tal-movimenti, li ma jittollerawx jew li naqsu milli jirrispondu għal inibituri catechol-O-methyltransferase COMT oħrajn (ara sezzjoni 5.1).
English: s. r.o.
Maltese: OĦRAJN
English: Each film-coated tablet contains 200 mg tolcapone.
Maltese: Kull pillola miksija b'rita fiha 200 mg tolcapone.
English: Toxicity to reproduction: Tolcapone, when administered alone, was shown to be neither teratogenic nor to have any relevant effects on fertility.
Maltese: Meta amministrat waħdu tolcapone wera li la huwa teratoġeniku u lanqas ma għandu effetti relevanti fuq il-fertilità.
English: Patients with severe renal impairement (creatinine clearance <30 ml/min) should be treated with caution.
Maltese: Pazjenti bi ħsara tal-kliewi severa (tneħħija ta' kreatinina <30 ml/min) għandhom jiġu trattati b'attenzjoni.
English: Excipients with known effect: Each tablet contains 15 mg lactose For the full list of excipients, see section 6.1.
Maltese: Kull pillola fiha 15mg lactose Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Diarrhoea associated with Tasmar usually began 2 to 4 months after initiation of therapy.
Maltese: Id-dijarrea assoċjata ma' Tasmar ġeneralment bdiet xahrejn sa 4 xhur wara l-bidu tat-terapija.
English: What Tasmar contains The active substance is tolcapone (200 mg in each film- coated tablet) The other ingredients are: Tablet core: Calcium hydrogen phosphate, Microcrystalline cellulose, Povidone K30, Sodium starch glycollate, Lactose monohydrate, Talc, Magnesium stearate.
Maltese: Calcium hydrogen phosphate (anhydrous), Microcrystalline cellulose, Polvidone K30, Sodium starch glycollate, Lactose monohydrate, Talc, Magnesium stearate.
English: Patients with hepatic impairment (see section 4.3) Tasmar is contraindicated for patients with liver disease or increased liver enzymes.
Maltese: Pazjenti b'indeboliment epatiku (ara sezzjoni 4.3) Tasmar huwa kontra-indikat għal pazjenti b'mard tal-fwied jew b'żieda fl-enzimi tal-fwied.
English: Impulse control disorders* (Libido increased, hypersexuality, pathological gambling, compulsive spending or buying, binge eating, compulsive eating (see section 4.4))
Maltese: Disturbi fil-kontroll ta' impulsi (Żieda fil-libido, ipersesswalità, logħob tal-ażżard patologiku, infiq jew xiri kompulsiv, teħid ta' ammonti kbar ta' ikel b'mod frekwenti, teħid ta' ikel b'mod kompulsiv (ara sezzjoni 4.4))
English: Common: chest pain, constipation, dyspepsia, stomach ache, vomiting, dry mouth, fainting increased sweating, influenza-like symptoms reduced voluntary and involuntary movement (hypokinesia) upper respiratory tract infection increase of specific liver enzymes, urine discoloration
Maltese: Komuni: - uġigħ fis-sider, - stitikezza, uġigħ fl-istonku, rimettar, ħalq jinħass xott, - ħass ħażin, - żjieda fl-għaraq, - sintomi li jixbħu lill-influwenza, - moviment volontarju u involontarju mnaqqas (ipokinesja), - infezzjoni fil-passaġġ respiratorju ta' fuq
English: How to store Tasmar
Maltese: X'fih Tasmar
English: What do you need to know before you take Tasmar Do not take Tasmar: if you have liver disease or increased liver enzymes if you have severe involuntary movement (dyskinesia) if you have a previous history of severe symptoms of muscle stiffening, fever or mental confusion (Neuroleptic Malignant Syndrome (NMS) Symptom Complex) and /or if you have damage of skeletal muscle tissue (non-traumatic Rhabdomyolysis) if you are hypersensitive (allergic) to the active substance tolcapone or to any of the other ingredients of Tasmar.
Maltese: - jekk għandek passat ta' sintomi severi ta' twebbis tal-muskoli, deni u konfużjoni mentali (Kumpless ta' sintomi ta' Sindrome Newrolettiku Malinn (NMS)) u/jew għandek ħsara fit-tessut talmuskoli skeletriċi (Rabdomijolisi mhux trawmatika) jew ipertermja (deni). - jekk għandek sensittività eċċessiva (allerġiku/a) għas-sustanza attiva tolcapone jew għal xi sustanza oħra ta' Tasmar. - jekk għandek tip ta' tumur speċjali fil-medulla adrenali (Phaeochromocytoma) - jekk qed tieħu ċertu mediċina għall-kura tad-depressjoni u l-ansjetà, imsejjħa inibitur mhux selettiv ta' mono amino oxidase (MAO).
English: Dyskinesia
Maltese: Dijarrea
English: Before beginning treatment: To reduce the risk of liver injury you should not use Tasmar if you have a liver disease in case of elevated liver function tests in the blood test done before starting treatment (tests of alanine amino transferase (ALT) and aspartate amino transferase (AST)).
Maltese: Biex tnaqqas ir-riskju ta' ħsara fil-fwied m'għandekx tuża Tasmar jekk - għandek mard tal-fwied - f'kaz ta' riżultat tat-testijiet tal-funzjoni tal-fwied għoli fit-test tad-demm magħmul qabel il-bidu tal-kura (testijiet ta' alanine amino transferase (ALT) u aspartate amino transferase (AST)).
English: Do not use Tasmar if you notice that the tablets are damaged.
Maltese: L-effetti ta' Tasmar ma ġewx studjati fit-trabi.
English: Lactose intolerance: Tasmar contains lactose.
Maltese: Tasmar fih lactose.
English: Tasmar is supplied as film-coated tablets containing 200 mg tolcapone.
Maltese: Tasmar huwa fornut bħala pilloli miksija b'rita li fihom 200 mg tolcapone.
English: In clinical trials, patients receiving Tasmar/levodopa preparations reported a similar adverse reaction profile independent of whether or not they were also concomitantly administered selegiline (a MAO-B inhibitor).
Maltese: Fi provi kliniċi, pazjenti li kienu qegħdin jingħataw preparazzjonijiet ta' Tasmar/levodopa rrappurtaw profil ta' reazzjonijiet avversi simili indipendentament minn jekk kienu qegħdin jingħataw ukoll isselegilina (inibitur MAO-B).
English: Levodopa adjustments when Tasmar is discontinued:
Maltese: Aġġustamenti ta' Levodopa meta Tasmar jitwaqqaf:
English: Przemysłowa 2
Maltese: Ħin talġurnata
English: Tasmar 100 mg film-coated tablets
Maltese: Tasmar 100 mg pilloli miksija b'rita
English: Experience with Tasmar obtained in parallel placebo-controlled randomised studies in patients with Parkinson's disease is shown in the following table, which lists adverse reactions with a potential relationship to Tasmar.
Maltese: L-esperjenza b'Tasmar miksuba fi studji sperimentali paralleli magħmula għall-għarrieda fuq pazjenti tal-marda ta' Parkinson jidhru fit-tabella segwenti, li tellenka r-reazzjonijiet avversi b'relazzjoni potenzjali ma' Tasmar.
English: Tasmar is supplied as film-coated tablets containing 100 mg tolcapone.
Maltese: Tasmar huwa fornut bħala pilloli miksija b'rita li fihom 100 mg tolcapone.
English: However, when Tasmar therapy is being discontinued for reasons other than too much levodopa, levodopa dose may have to be increased to levels equal to or greater than before initiation of Tasmar therapy, especially if the patient had large decreases in levodopa when starting Tasmar.
Maltese: Madanakollu, meta t-terapija Tasmar titwaqqaf għal raġunijiet oħra, li ma huwiex eċċess ta' levodopa, jista' jkun li d-doża ta' levodopa ikollha tiżdied għal livelli daqs jew akbar minn qabel ma tkun inbdiet it-terapija b'Tasmar, speċjalment jekk il-pazjent ikollu nuqqasijiet kbar fil-levodopa meta jinbeda Tasmar.
English: High levels of plasma 3-OMD have been associated with poor response to levodopa in Parkinson's disease patients.
Maltese: Livelli ta' plażma 3-OMD għoljin ġew assoċjati ma' rispons fqir għal-levodopa f'pazjenti jsofru millmarda ta' Parkinson.
English: Tasmar has an effect on the symptoms of your Parkinson's disease.
Maltese: Tasmar għandu effett fuq is-sintomi tal-marda ta' Parkinson tiegħek.
English: Since clinical information is limited regarding the combination of warfarin and tolcapone, coagulation parameters should be monitored when these drugs are co-administered.
Maltese: Peress li informazzjoni klinika rigward il-ko-amministrazzjoni ta' warfarin flimkien ma' tolcapone, il-parametri tal-koagulazzjoni għandhom ikunu monitorati meta dawn il-mediċini huma koamministrati.
English: NMS (Neuroleptic Malignant Syndrome): Symptoms of Neuroleptic Malignant Syndrome (NMS) may occur during Tasmar treatment.
Maltese: NMS (Sindrome Newrolettiku Malinn):
English: Only in exceptional circumstances, when the anticipated incremental clinical benefit justifies the increased risk of hepatic reactions, should the dose be increased to 200 mg three times daily (see sections 4.4 and 4.8).
Maltese: F'ċirkostanzi eċċezzjonali biss, meta lbenefiċċju kliniku inkrimentali antiċipat jiġġustifika iż-żjieda tar-riskju ta' reazzjonijiet fil-fwied, itterapija għandha tiżdied għal 200 mg tliet darbiet kuljum (ara sezzjoni 4.4 u 4.8).
English: 30 film-coated tablets 60 film-coated tablets
Maltese: 30 pillola miksija b'rita 60 pillola miksija b'rita
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Tasmar in association with levodopa.
Maltese: Il-pazjenti u dawk li jieħdu ħsiebhom għandhom jiġu mgħarrfa li sintomi ta' mġiba ta' disturbi fil-kontroll tal-impuls inkluż logħob tal-azzard patoloġiku, żjieda fillibido, ipersesswalità, xiri jew bejgħ koerċittiv, teħid ta' ammonti kbar ta' ikel b'mod frekwenti u teħid ta' ikel b'mod koerċittiv jistgħu jseħħu f'pazjenti kkurati b'agonisti ta' dopamine u/jew kura dopaminerġika oħra bħal Tasmar f'assoċjazzjoni ma' levodopa.
English: Film-coated tablet.
Maltese: Taqsamx u tfarrakx il-pilloli.
English: Nausea, vomiting and dizziness were observed, particularly in combination with levodopa.
Maltese: Ġew osservati nawżea, remettar u sturdament, partikolarment meta mogħti flimkien mal-levodopa.
English: Tasmar 200 mg film coated tablets
Maltese: Tasmar 200 mg pilloli miksija b'rita
English: Hypersensitivity to tolcapone or any of its other ingredients listed in section 6.1.
Maltese: • Sensittività eċċessiva għal tolcapone jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: However, it is generally believed that early detection of medicine-induced hepatic injury along with immediate withdrawal of the suspect medication enhances the likelihood for recovery.
Maltese: Iżda huwa ta' kunsens ġenerali li detezzjoni kmieni tad-dannu tal-fwied kkawżat mill-mediċina flimkien ma' twaqqif immeddjat tal-mediċina suspettata ttejjeb il-probabilità ta' rkupru.
English: Rare cases of severe hepatocellular injury resulting in death have been reported during marketed use (see section 4.4).
Maltese: Waqt l-użu fis-suq ġew irrappurtati każijiet rari ta' dannu epatoċellulari li rriżulta fil-mewt (ara sezzjoni 4.4).
English: Tasmar blocks this enzyme and thus slows the breakdown of levodopa.
Maltese: Tasmar jimblokka din l-enzima u b'hekk irażżan it-tkissir tal-levodopa.
English: Hypokinesia Syncope
Maltese: Mutaġnesi:
English: Isolated cases of either accidental or intentional overdose with tolcapone tablets have been reported.
Maltese: Każi iżolati ta' doża eċċessiva intenzjonali jew aċċidentali bil-pilloli tolcapone kienu rrapportati.
English: A double-blind trial compared Tasmar with entacapone in Parkinson's disease patients who had at least three hours of OFF time per day while receiving optimised levodopa therapy.
Maltese: Prova double-blind qabblet Tasmar ma' entacapone fil-pazjenti jsofru mill-marda ta' Parkinson li kellhom mill-inqas tliet sigħat ta' ħin OFF kuljum waqt li kienu qegħdin jingħataw terapija ta' levodopa ottimizzata.
English: The active substance is tolcapone (100 mg in each film- coated tablet) The other ingredients are:
Maltese: - Is-sustanza attiva hi tolcapone (100 mg f'kull pillola miksija b'rita) - Is-sustanzi l-oħra huma:
English: Tolcapone does not accumulate with three times daily dosing of 100 or 200 mg. At these doses, Cmax is approximately 3 and 6 µg/ml, respectively.
Maltese: B'dawn id-dożi, Cmax ikun ta' madwar 3 u 6 µg/ml, rispettivament.
English: Orange yellow to brown yellow, hexagonal, biconvex, film-coated tablet.
Maltese: Safra fl-oranġjo li jkanġi għal isfar fil-kannella, b'sitt naħat u biconvex.
English: Tasmar is not recommended for use in children below the age of 18 due to insufficient data on safety or efficacy.
Maltese: Tasmar mhux irrakkomandat għall-użu fi tfal b'età inqas minn 18-il peress li m'hemmx dejta suffiċjenti dwar is-sigurtà jew l-effikaċja.
English: Overall, the frequency of adverse reactions increased slightly.
Maltese: Ġeneralment, il-frekwenza ta' eventi avversi żdiedet bi ftit.
English: Meda Pharma SIA 101 Mūkusalas str. Rīga LV‐1004
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali 5 snin
English: A temporary increase in body temperature of 1-2°C can occur.
Maltese: Jista' jkun hemm żieda temporarja fit-temperatura tal-ġisem ta' 1-2°C.
English: Live myxoma vectored RHD virus strain 009
Maltese: Razza tal-virus ħaj myxoma vectored RHD 009
English: It contains a weakened strain of the myxoma virus which has been genetically modified so that it can produce a protein of the RHD virus.
Maltese: Fih razza mdgħajfa tal-virus myxoma li ġie ġenetikament immodifikat sabiex ikun jista' jipproduċi proteina tal-virus RHD.
English: Nobivac Myxo-RHD is a vaccine that contains live myxoma vectored RHD virus strain 009.
Maltese: Nobivac Myxo-RHD huwa vaċċin li fih razza tal-virus ħaj myxoma vectored RHD 009.
English: Nobivac Myxo-RHD is used in rabbits aged five weeks or more to reduce number of deaths and clinical signs due to myxomatosis (skin tumours caused by the myxoma virus) and to prevent death due to rabbit haemorrhagic disease (RHD), a disease resulting in blood clot formation caused by the RHD virus.
Maltese: Nobivac Myxo-RHD jintuża fil-fniek li jkollhom aktar minn ħames ġimgħat biex inaqqas l-għadd ta' mwiet u s-sinjali kliniċi ta' myxomatosis (tumuri tal-ġilda kkawżati mill-virus myxoma) u għallprevenzjoni tal-mewt minħabba l-marda emorraġika tal-fniek (RHD), marda li twassal għal formazzjoni ta' għoqiedi tad-demm ikkawżat mill-virus RHD.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobivac Myxo-RHD to Intervet International BV on 7 September 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Nobivac Myxo-RHD lil Intervet International BV fi 07/09/2011.
English: Nobivac Myxo-RHD, like all vaccines, works by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Nobivac Myxo-RHD, bħall-vaċċini kollha, jaħdem billi ‘jgħallem' lis-sistema immunitarja (id-difiża naturali tal-ġisem) kif għandha tiddefendi lilha nnifisha kontra marda.
English: Fifteen field and laboratory studies were carried out, in which rabbits vaccinated with Nobivac MyxoRHD were compared with unvaccinated rabbits to establish the onset and duration of immunity against myxoma and RHD viruses.
Maltese: Saru ħmistax-il studju fil-post u fil-laboratorju, li fihom il-fniek ivvaċċinati bi Nobivac Myxo-RHD tqabblu ma' fniek li ma kinux ġew ivvaċċinati biex jiġi stabbilit il-bidu u d-dewmien tal-immunità kontra myxoma u l-Virus RHDes.
English: It is available as a lyophilisate (freeze-dried substance) and a solvent that are made up into a suspension for injection.
Maltese: Huwa disponibbli f'lajofiliżejt (sustanza lijofilizzata) u f'solvent li jiġu magħmula f'sospensjoni għal injezzjoni.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Myxo-RHD exceed the risks when used to reduce the number of deaths and clinical signs due to myxomatosis and prevent death due to rabbit haemorrhagic disease.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Nobivac Myxo-RHD jiżbqu r-riskji tiegħu meta jintuża biex inaqqas l-għadd ta' mwiet u s-sinjali kliniċi minħabba myxomatosis u għall-prevenzjoni ta' mewt minħabba l-marda emorraġika tal-fniek.
English: What is Nobivac Myxo-RHD?
Maltese: X'inhu Nobivac Myxo-RHD?
English: Other information about Nobivac Myxo-RHD:
Maltese: Tagħrif ieħor dwar Nobivac Myxo-RHD:
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ talbenefiċċju-riskju jinstab fil-modulu tad-diskussjoni xjentifika ta' dan l-EPAR.
English: Rabbits that were vaccinated with Nobivac Myxo-RHD had fewer signs of myxomatosis, more antibodies against RHD virus in their blood and a lower death rate than unvaccinated rabbits.
Maltese: Il-fniek li kienu tlaqqmu bi Nobivac Myxo-RHD kellhom anqas sinjali ta' myxomatosis, aktar antikorpi kontra l-virus RHD fid-demm tagħhom u rata aktar baxxa ta' mwiet mill-fniek li ma kinux imlaqqma.
English: Why has Nobivac Myxo-RHD been approved?
Maltese: Għaliex ġie approvat Nobivac Myxo-RHD?
English: The studies showed that Nobivac Myxo-RHD was effective in providing immunity against myxomatosis and RHD three weeks after vaccination and that the immunty was still present after one year.
Maltese: L-istudji wrew li Nobivac Myxo-RHD kien effikaċi biex jipprovdi immunità kontra myxomatosis u RHD tliet ġimgħat wara l-vaċċinazzjoni u li l-immunità kienet għadha preżenti wara sena.
English: Data derived from a meta-analysis (including registries and cohort studies) has shown that 10.73% of children of epileptic women exposed to valproate monotherapy during pregnancy suffer from congenital malformations (95% CI: 8.16 -13.29).
Maltese: Dejta miksuba minn meta-analiżi (inkluż reġistri u studji ta' koorti) uriet li 10.73% ta' tfal ta' nisa li għandhom l-epilessija u kienu esposti għal monoterapija b'valproate waqt it-tqala jsofru minn formazzjonijiet konġenitali difettużi (95% CI: 8.16 -13.29).
English: Congenital malformations
Maltese: Formazzjonijiet konġenitali difettużi
English: • It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may have problems with early childhood development.
Maltese: • Huwa stmat li sa 30-40% ta' tfal qabel l-età tal-iskola li ommijiethom ħadu valproate waqt ittqala jista' jkollhom problemi bl-iżvilupp bikri tat-tfulija.
English: The most common types of malformations include neural tube defects, facial dysmorphism, cleft lip and palate, craniostenosis, cardiac, renal and urogenital defects, limb defects (including bilateral aplasia of the radius), and multiple anomalies involving various body systems.
Maltese: L-aktar tipi komuni ta' formazzjonijiet difettużi jinkludu difetti fil-passaġġ tan-nervituri, dismorfiżmu fil-wiċċ, qasma fix-xoffa u s-saqaf tal-ħalq, stenożi tal-kranju, difetti kardijaċi, renali u uroġenitali, difetti fid-dirgħajn u r-riġlejn (inkluż aplasja bilaterali tar-radius), u ħafna anomaliji li jinvolvu sistemi varji tal-ġisem.
English: Intelligence quotient (IQ) measured in school aged children (age 6) with a history of valproate exposure in utero was on average 7-10 points lower than those children exposed to other antiepileptics.
Maltese: Il-kwozjent ta' intelliġenza (IQ - Intelligence quotient) imkejjel fi tfal ta' età tal-iskola (6 snin) bi storja ta' esponiment għal valproate fil-ġuf bħala medja kien 7-10 punti inqas minn ta' dawk it-tfal eposti għal mediċini oħra kontra l-epilessija.
English: Section 4.8 Undesirable effects
Maltese: Section 4.8 Effetti mhux mixtieqa
English: Congenital malformations and developmental disorders (see section 4.4 and section 4.6).
Maltese: Formazzjonijiet difettużi konġenitali u disturbi fl-iżvilupp (ara sezzjoni 4.4 u sezzjoni 4.6).
English: • Valproate carries a risk if taken during pregnancy.
Maltese: • Valproate iġorr riskju jekk jittieħed waqt it-tqala.
English: Valproate is excreted in human milk with a concentration ranging from 1% to 10% of maternal serum levels.
Maltese: Valproate jiġi eliminat fil-ħalib tas-sider tal-bneidem b'konċentrazzjoni fuq firxa minn 1% sa 10% tallivelli tas-serum tal-omm.
English: This compares to 2-3 babies in ever 100 born to women who don't have epilepsy.
Maltese: Dan b'paragun ma' 2-3 itrabi minn kull 100 imwielda minn nisa li ma jkollhomx epilessija.
English: - Withdrawal syndrome (such as, in particular, agitation, irritability, hyper-excitability, jitteriness, hyperkinesia, tonicity disorders, tremor, convulsions and feeding disorders) may occur in neonates whose mothers have taken valproate during the last trimester of their pregnancy.
Maltese: - Sindrome ta' twaqqif ta' sustanza li tivvizzja (bħal, b'mod partikolari, aġitazzjoni, irritabiltà, eċċitabilità eċċessiva, nervożiżmu, iperkajnesija, disturbi ta' toniċità, rogħda, konvulżjonijiet u disturbi fil-mod kif jixorbu) jista' jseħħ fi trabi tat-twelid li ommijiethom ikunu ħadu valproate waqt l-aħħar trimestru tat-tqala tagħhom.
English: Amenorrhoea, polycystic ovaries and increased testosterone levels have been reported in women using valproate (see section 4.8).
Maltese: Amenorrea, ovarji poliċistiċi u żieda fil-livelli tat-testosterone ġew irrappurtati f'nisa li jużaw valproate (ara sezzjoni 4.8).
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni tal-prodott tista' sussegwentement tiġi aġġornata mill-awtoritajiet kompetenti tal-Istat Membru, bi ftehim mal-Istat Membru ta' Riferenza, kif xieraq, skont il-proċeduri mniżżla F'Kapitlu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: This is a greater risk of major malformations than for the general population, for whom the risk is about 2-3%.
Maltese: Dan huwa riskju akbar ta' formazzjonijiet difettużi kbar minn dak għall-popolazzjoni ġenerali li għaliha r-riskju huwa madwar 2-3%.
English: • The need to use effective contraception.
Maltese: • Il-bżonn li tuża kontraċezzjoni effettiva.
English: Female children/Female adolescents/Women of childbearing potential/Pregnancy:
Maltese: Tfal bniet/Adolexxenti nisa/Nisa f'età li jista' jkollhom it-tfal/Tqala:
English: • Make sure you are using an effective method of contraception
Maltese: • Aċċerta ruħek li inti qed tuża metodu effettiv ta' kontraċezzjoni
English: • Prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate (see sections 4.4 and 4.6).
Maltese: • Profilassi ta' attakki tal-emigranja fit-tqala u f'nisa li jista' jkollhom it-tfal li mhumiex qed jużaw metodi effettivi ta' kontraċezzjoni waqt il-kura b' valproate (ara sezzjonijiet 4.4 u 4.6).
English: Treatment should only be initiated if other treatments are ineffective or not tolerated (see section 4.3, 4.4 and 4.6) and the benefit and risk should be carefully reconsidered at regular treatment reviews.
Maltese: Il-kura għandha tinbeda biss jekk kuri oħra ma jkunux effettivi jew ittollerati tajjeb (ara sezzjoni 4.3, 4.4 u 4.6) u l-benefiċċju u r-riskju għandhom jitqiesu bir-reqqa mill-ġdid b'mod regolari meta tiġi riveduta l-kura.
English: Limited data suggests that children exposed to valproate in utero may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD).
Maltese: Dejta limitata tissuġġerixxi li tfal esposti għal valproate fil-ġuf għandhom probabbiltà akbar li jiżviluppaw sintomi ta' disturb ta' nuqqas ta' attenzjoni/attività eċċessiva (ADHD).