FrancophonIA/ELRC3.0 huggingface dataset:
English: When ProteqFlu-Te is given to horses, the animals' immune system recognises the specific proteins from the equine influenza strains and the tetanus toxoid as ‘foreign' and makes antibodies against them.
Maltese: Meta ProteqFlu-Te jingħata liż-żwiemel, is-sistema immunitarja tal-annimali tagħraf il-proteini speċifiċi mir-razez tal-influwenza ekwina u t-tossojd tat-tetnu bħala ‘barranin' u tipproduċi antikorpi kontrihom.
English: This should be followed by revaccination 5 months later, and afterwards by booster vaccinations every two years for protection against tetanus or for protection against influenza vaccination every year alternating with ProteqFlu or ProteqFlu-Te, respecting an interval of maximum two years for tetanus.
Maltese: Din għandha tkun segwita minn tilqima mill-ġdid 5 xhur aktar tard, u wara minn tilqim buster kull sentejn għall-protezzjoni kontra t-tetnu jew għall-protezzjoni kontra tilqim tal-influwenza kull sena bi ProtqFlu jew ProteqFlu-Te jalternaw bejniethom, filwaqt li jiġi rispettat intervall ta' mhux aktar minn sentejn għat-tetnu.
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Ppubbliku Ewropew ta' Valutazzjoni.
English: This will help to protect against equine influenza and tetanus.
Maltese: Dan jgħin fil-protezzjoni kontra l-influwenza ekwina u t-tetnu.
English: ProteqFlu-Te is used to vaccinate horses from 4 months of age against equine influenza and tetanus.
Maltese: ProteqFlu-Te jintuża sabiex jitlaqqmu żwiemel ta' 4 xhur u aktar kontra l-influwenza ekwina u kontra t-tetnu.
English: The immune system will then be able to make those protective antibodies more quickly when the animal is naturally exposed to the equine flu viruses and the tetanus bacterium.
Maltese: Is-sistema immunitarja mbagħad tkun tista' tipproduċi dawk lantikorpi protettivi iżjed malajr meta l-annimal ikun espost b'mod naturali għall-virusis talinfluwenza ekwina u għall-batterju tat-tetnu.
English: The duration of protection was 5 months after primary vaccination and one year for the equine influenza and two years for the tetanus after the third vaccination.
Maltese: It-tul tal-protezzjoni kien ta' 5 xhur wara tilqima primarja u sena għallinfluwenza ekwina u sentejn għat-tetnu wara t-tielet tilqima.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 January 2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 ta' Jannar 2018
English: The company that applied for authorisation is Renable Pharma Limited.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija Renable Pharma Limited.
English: EnCyzix is a medicine that contains the active substance enclomifene.
Maltese: EnCyzix huwa mediċina li fiha s-sustanza attiva enclomifene.
English: Refusal of the marketing authorisation for EnCyzix (enclomifene) EMA/CHMP/54473/2018
Maltese: EMA/CHMP/54473/2018
English: It may request a reexamination of the opinion within 15 days of receipt of notification of this negative opinion.
Maltese: Din tista' titlob eżaminazzjoni mill-ġdid tal-opinjoni fi żmien 15-il jum minn meta tirċievi n-notifika ta' din l-opinjoni negattiva.
English: What is EnCyzix?
Maltese: X'inhu EnCyzix?
English: The company presented the results of 4 main studies involving a total of 588 patients.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' 4 studji ewlenin li involvew total ta' 588 pazjent.
English: Refusal of the marketing authorisation for EnCyzix (enclomifene)
Maltese: EnCyzix(enclomifene-T)
English: EnCyzix blocks the excess oestrogen enabling release of gonadotrophins and normal testicular function.
Maltese: EnCyzix jimblokka l-estroġenu żejjed u b'hekk jippermetti r-rilaxx tal-gonadotrofini u funzjoni testikolari normali.
English: On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product EnCyzix, intended for the treatment of hypogonadotropic hypogonadism in men.
Maltese: Fil-25 ta' Jannar 2018, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali EnCyzix, maħsub għall-kura tal-ipogonadiżmu ipogonadotropiku fl-irġiel.
English: In addition, there is a risk of venous thromboembolism (problems due to the formation of blood clots in the veins) with the medicine.
Maltese: Barra minn hekk, hemm riskju ta' tromboemboliżmu venuż (problemi minħabba l-formazzjoni ta' koagulazzjoni tad-demm fil-vini) b'din il-mediċina.
English: The main measures of effectiveness were the amount of sperm produced and testosterone levels.
Maltese: Il-kejl ewlieni tal-effettività kien l-ammont ta' sperma prodott u l-livelli tat-testosteron.
English: What was EnCyzix expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża EnCyzix?
English: The CHMP noted that although the studies showed an increase in testosterone levels with EnCyzix, they did not look at whether EnCyzix would improve symptoms such as bone strength, weight gain, impotence and libido.
Maltese: Is-CHMP innota li għalkemm l-istudji wrew żieda fil-livelli tat-testosteron b'EnCyzix, dawn ma ħarsux lejn jekk EnCyzix itejjibx sintomi bħas-saħħa tal-għadam, piż tal-ġisem, impotenza u libido.
English: Overweight men with hypogonadotropic hypogonadism produce too much of the hormone oestrogen.
Maltese: Irġiel b'piż żejjed b'ipogonadiżmu ipogonadotropiku jipproduċu żżejjed mill-ormon tal-estroġenu.
English: EnCyzix was expected to be used to treat hypogonadotropic hypogonadism in men.
Maltese: EnCyzix kien mistenni li jintuża biex jikkura l-ipogonadiżmu ipogonadotropiku fl-irġiel.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with EnCyzix.
Maltese: Il-kumpanija għarrfet lis-CHMP li fil-preżent m'hemm ebda prova klinika li għadha għaddejja jew programm ta' użu b'kompassjoni b'EnCyzix.
English: In this condition, the sex organs (the testes in men) do not work properly resulting in symptoms such as infertility, low libido, impotence, weakened bones and weight gain.
Maltese: F'din ilkondizzjoni, l-organi sesswali (it-testikoli fl-irġiel) ma jaħdmux kif suppost u b'hekk jirriżultaw f'sintomi bħal infertilità, libido baxx, impotenza, għadam imdgħajjef u żieda fil-piż. EnCyzix kellu jintuża f'irġiel b'piż żejjed b'indiċi tal-massa tal-ġisem (BMI) ta' mill-inqas 25 kg/m2.
English: Therefore, the CHMP was of the opinion that the benefits of EnCyzix did not outweigh its risks and recommended that it be refused marketing authorisation.
Maltese: Għaldaqstant, is-CHMP kien tal-opinjoni li l-benefiċċji ta' EnCyzix ma kinux akbar mir-riskji tiegħu u rrakkomanda li l-awtorizzazzjoni għat-tqegħid fis-suq tiegħu tiġi rrifjutata.
English: The full EPAR for Thyrogen 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: Thyrogen thyrotropin alfa
Maltese: Thyrogen tireotropina alfa
English: The iodine is given 24 hours after the last Thyrogen injection and scan is performed 48 to 72 hours later.
Maltese: Il-jodju jingħata 24 siegħa wara l-aħħar injezzjoni ta' Thyrogen u mbagħad issir skansjoni 48 sa 72 siegħa wara.
English: This is a summary of the European public assessment report (EPAR) for Thyrogen.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Thyrogen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Thyrogen on 9 March 2000.
Maltese: Il-Kummissjoni Ewropea tat-awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Thyrogen fid-9 ta' Marzu 2000.
English: It contains the active substance thyrotropin alfa.
Maltese: Fih is-sustanza attiva tireotropina alfa.
English: This included 25 patients using Thyrogen and 18 whose replacement therapy was stopped.
Maltese: Dan kien jinkludi 25 pazjent li użaw Thyrogen u 18 li kienet twaqqfitilhom it-terapija ta' sostituzzjoni.
English: Thyrotropin alfa is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes the cell able to produce the hormone.
Maltese: Thyrotropin Alfa jiġi prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': jiġi magħmul minn ċellola li tkun irċeviet ġene (DNA).
English: The active substance in Thyrogen, thyrotropin alfa, is a copy of TSH and is used to stimulate any remaining thyroid tissue in the body, including cancerous tissue.
Maltese: Is-sustanza attiva fi Thyrogen, it-tireotropina alfa, hija kopja tat-TSH u tintuża biex tistimula xi tessut tat-tirojde li jkun għad baqa' fil-ġisem, inkluż tessut tal-kanċer.
English: To do this, measurements of thyroid stimulation (production of thyroglobulin and uptake of radioactive iodine) were taken twice: once after treatment with Thyrogen and once after the patients had stopped taking the replacement therapy that inhibits their natural TSH production.
Maltese: Biex dan isir, il-kejl tal-istimulazzjoni tat-tirojde (ilproduzzjoni tat-tireoglobulina u t-teħid ta' jodju radjuattiv) ittieħed darbtejn: darba wara kura bi Thyrogen u darba wara li l-pazjenti kienu waqfu jieħdu t-terapija ta' sostituzzjoni li xxekkel ilproduzzjoni naturali tat-TSH tagħhom.
English: Thyrogen was used in two studies to detect any remaining thyroid tissue in 381 patients who had had thyroidectomy (thyroid surgery).
Maltese: Thyrogen intuża f'żewġ studji biex jiskopri xi tessut residwu tat-tirojde fi 381 pazjent li kienet saritilhom tirojdektomija (kirurġija tat-tirojde).
English: The company also presented the results of 13 studies from the published literature, including one key study that compared the effect of Thyrogen and the effect of stopping replacement therapy in 394 patients who were followed up for around two and a half years.
Maltese: Il-kumpanija ppreżentat ukoll ir-riżultati ta' 13-il studju minn dokumentazzjoni medika ppubblikata, inkluż studju ewlieni li qabbel l-effett ta' Thyrogen u l-effett tat-twaqqif ta' terapija ta' sostituzzjoni fi 394 pazjent li ġew segwiti tul madwar sentejn u nofs.
English: However, patients who have had their thyroid gland removed receive medication (thyroid hormone replacement therapy) that stops their production of TSH.
Maltese: Madankollu pazjenti li tkun tneħħitilhom it-tirojde jirċievu mediċina (terapija ta' sostituzzjoni tal-ormon tat-tirojde) li twaqqfilhom il-produzzjoni tat-TSH.
English: What is the risk associated with Thyrogen?
Maltese: X'inhu r-riskju assoċjat ma' Thyrogen?
English: What is Thyrogen?
Maltese: X'inhu Thyrogen?
English: Following this, 51 of the patients went on to be followed up for an average of three and a half more years.
Maltese: Wara dan 51 mill-pazjenti komplew jiġu segwiti tul medja ta' tliet snin u nofs.
English: Why has Thyrogen been approved?
Maltese: Għaliex ġie approvat Thyrogen?
English: The presence of thyroid tissue can be checked by a blood test (showing that the thyroid protein thyroglobulin is being produced by any remaining thyroid tissue) or, if the patient has been given radioactive iodine, by a scan (showing that the remaining thyroid tissue is actively taking up the iodine).
Maltese: Il-preżenza ta' tessut tat-tirojde tista' tiġi identifikata b'test tad-demm (li juri li l-proteina tat-tirojde tireoglobulina tkun qiegħda tiġi prodotta minn xi tessut residwu tat-tirojde) jew, jekk il-pazjent ikun ingħata jodju radjuattiv, bi skansjoni (li turi li tessut residwu tat-tirojde jkun qiegħed jieħu l-jodju b'mod attiv).
English: Other information about Thyrogen
Maltese: Informazzjoni oħra dwar Thyrogen:
English: The thyroglobulin test is an alternative to the radioactive iodine scan for detecting remaining thyroid tissue which involves measuring thyroglobulin produced by the thyroid tissue in the blood.
Maltese: It-test tat-tireoglobulina huwa alternattiva għall-iskansjoni bil-jodju radjuattiv li tfittex tessut residwu tat-tirojde li tinvolvi l-kejl tat-tireoglobulina prodotta mit-tessut tat-tirojde fid-demm.
English: The company also presented the results of studies from the published literature looking at Thyrogen's effect when it was used with a thyroglobulin test, but without a radioactive iodine scan.
Maltese: Ilkumpanija ppreżentat ukoll ir-riżultati ta' studji mid-dokumentazzjoni medika ppubblikata li stħarrġu leffett ta' Thyrogen meta ntuża ma' test tal-tireoglobulina, imma mingħajr skansjoni b'jodju radjuattiv.
English: However, Thyrogen has the advantage of allowing patients to remain on their replacement therapy before the test is carried out, resulting in a better quality of life, as the temporary withdrawal of the replacement therapy has transient sideeffects which cannot always be tolerated easily.
Maltese: Dan itejbilhom il-kwalità tal-ħajja peress li l-waqfien temporanju tat-terapija ta' sostituzzjoni għandu effetti sekondarji temporanji li mhux dejjem jistgħu jiġu ttollerati faċilment.
English: The most common side effect with Thyrogen (seen in more than 1 patient in 10) is nausea (feeling sick).
Maltese: L-aktar effett sekondarju komuni rrapportat bl-użu ta' Thyrogen (li deher f'aktar minn pazjent 1 minn kull 10) huwa n-nawżja (ħass ħażin).
English: For eliminating remaining thyroid tissue following thyroid cancer surgery, both treatments were 100% successful after eight months.
Maltese: Iż-żewġ trattamenti kellhom suċċess ta' 100% fl-eliminazzjoni ta' tessut residwu tat-tirojde wara kirurġija tal-kanċer tat-tirojde wara tmien xhur.
English: Two further published studies involving 1,190 patients were carried out with Thyrogen using lower doses of radioactive iodine.
Maltese: Saru żewġ studji ulterjuri ppubblikati fuq 1,190 pazjent bi Thyrogen bl-użu ta' dożi aktar baxxi ta' jodju radjuattiv.
English: The larger published studies confirmed that Thyrogen had a similar effect to stopping replacement therapy in patients whose cancer had not spread to other parts of the body.
Maltese: L-akbar studji ppubblikati kkonfermaw li Thyrogen kellu effett simili bħat-twaqqif tatterapija ta' sostituzzjoni f'pazjenti li l-kanċer tagħhom ma kienx infirex lejn partijiet oħra tal-ġisem.
English: For thyroid tissue to be detected, it needs to be active, and this requires the presence of a hormone called thyroid stimulating hormone (TSH).
Maltese: Dan jeħtieġ il-preżenza ta' ormon magħruf bħala ormon tirostimulanti (TSH).
English: Thyrogen is used in patients who have had thyroidectomy (thyroid surgery) because of cancer, to detect any thyroid tissue that might have been left over after the surgery.
Maltese: Thyrogen jintuża f'pazjenti li tkun saritilhom tirojdektomija (kirurġija tat-tirojde) minħabba kanċer, biex jinstab xi tessut residwu tat-tirojde li seta' kien għad fadal wara l-kirurġija.
English: Using Thyrogen to detect left over thyroid tissue following surgery was comparable with using the patients' own TSH after their replacement therapy was stopped.
Maltese: L-użu ta' Thyrogen biex isib xi tessut residwu tat-tirojde wara li tkun saret kirurġija kien komparabbli mal-użu tat-TSH tal-pazjenti wara li kienet twaqqfitilhom it-terapija ta' sostituzzjoni.
English: It is given as two injections into the buttock muscle, 24 hours apart.
Maltese: Jingħata f'żewġ injezzjonijiet fil-muskolu tal-warrani, waħda 24 siegħa wara l-oħra.
English: When Thyrogen is used to eliminate left-over thyroid tissue, radioactive iodine is also given 24 hours after the last Thyrogen injection.
Maltese: Dan għaliex Thyrogen jistimula liċ-ċelluli fit-tessut ħalli jieħdu l-jodju radjuattiv, li mbagħad jeliminahom.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 May 2015 EMA/325007/2015
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 ta' Mejju 2015
English: • Irritable Bowel Syndrome (IBS).
Maltese: • Sindrome ta' Musrana Irritabbli (IBS).
English: Monoamino Oxidase Inhibitors (MAOIs)
Maltese: Inibituri ta' Monoamino Oxidase (MAOIs)
English: 20 tablets 30 tablets 60 tablets 90 tablets
Maltese: 20 pillola 30 pillola 60 pillola 90 pillola
English: PVC/ALU blister
Maltese: PVC/ALU folji
English: BIAL - Portela & Cª , S.A. À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Maltese: BIAL - Portela & Cª , S.A. À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Il-Portugall
English: • The other ingredients are povidone K29/32, croscarmellose sodium and magnesium stearate.
Maltese: • Is-sustanzi attivi l-oħra huma povidone K29/32, croscarmellose sodium u magnesium stearate.
English: Linearity / non-linearity
Maltese: Stat lineari/stat mhux lineari
English: • The active substance is eslicarbazepine acetate.
Maltese: • Is-sustanza attiva hi eslicarbazepine acetate.
English: BATCH NUMBER Lot
Maltese: NUMRU TAL-LOTT LOT
English: Thrombocytopenia, leukopenia
Maltese: Tromboċitopenija lewkopenija
English: Antiepileptic medicinal products may contribute to folic acid deficiency, a possible contributory cause of foetal abnormality.
Maltese: Prodotti mediċinali antiepilettiċi jistgħu jikkontribwixxu għal nuqqas ta' folic acid, kawża kontributorja possibbli ta' anormalità fetali.
English: Adults There are two dosing regimes for adults:
Maltese: Hemm żewġ reġimi ta' iddożar għall-adulti:
English: Diplopia*, vision blurred
Maltese: Diplopija*, vista mċajpra
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21.04.2009
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data l-ewwel awtorizzazzjoni: 21.04.2009
English: Menstruation irregular
Maltese: Mestrwazzjoni irregolari
English: Croscarmellose sodium
Maltese: Croscarmellose sodium Magnesium stearate
English: Valproate and levetiracetam
Maltese: Valproate u levetiracetam
English: Interactions with other antiepileptic medicinal products Carbamazepine
Maltese: Interazzjonijiet ma' prodotti mediċinali antiepilettiċi oħrajn Carbamazepine
English: The binding of eslicarbazepine to plasma proteins is relatively low (<40%) and independent from concentration.
Maltese: L-irbit ta' eslicarbazepine mal-proteini fil-plażma huwa relattivament baxx (<40%) u indipendenti mill-konċentrazzjoni.
English: The percentage of subjects with a 50% reduction in seizure frequency over all phase III studies was 19% for placebo, 21% for eslicarbazepine acetate 400 mg, 34% for eslicarbazepine acetate 800 mg and 36% for eslicarbazepine acetate 1200 mg daily.
Maltese: III kollha kien ta' 19% għal plaċebo, 21% għal eslicarbazepine acetate 400 mg, 34% għal eslicarbazepine acetate 800 mg u 36% għal eslicarbazepine acetate 1200 mg kuljum.
English: In the table below all adverse reactions, which occurred at an incidence greater than placebo and numerically present in more than 1 patient are listed by System Organ Class and frequency: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥1/1,000 to <1/100, rare ≥1/10,000 to <1/1,000.
Maltese: Reazzjonijiet avversi, li seħħew f'inċidenza ikbar milli bi plaċebo u numerikament preżenti f'iktar minn pazjent 1, huma kklassifikati skond is-sistema tal-klassifika tal-organi u frekwenza: komuni ħafna ≥1/10, komuni ≥1/100 sa <1/10, mhux komuni ≥1/1,000 sa <1/100, rari ≥1/10,000 sa <1/1,000 fit-tabella hawn taħt.
English: Elderly (over 65 years of age)
Maltese: L-anzjani (età aktar minn 65 sena)
English: Minor metabolites in plasma are R-licarbazepine and oxcarbazepine, which were shown to be active, and the glucuronic acid conjugates of eslicarbazepine acetate, eslicarbazepine, R-licarbazepine and oxcarbazepine.
Maltese: Metaboliti minuri fil-plażma huma Rlicarbazepine u oxcarbazepine, li dehru li kienu attivi, u l-konġugati ta' glucuronic acid ta' eslicarbazepine acetate, eslicarbazepine, R-licarbazepine u oxcarbazepine.
English: Eslicarbazepine acetate was tested at doses of 400 mg, 800 mg and 1200 mg, once daily.
Maltese: Eslicarbazepine acetate kien ittestjat f'dożi ta' 400 mg, 800 mg u 1200 mg, darba kuljum.
English: 60 tablets
Maltese: 90 pillola
English: Warfarin
Maltese: Warafarina
English: Results from patient studies showed that concomitant treatment increased the risk of the following adverse reactions: diplopia (11.4% of subjects with concomitant carbamazepine, 2.4% of subjects without concomitant carbamazepine), abnormal coordination (6.7% with concomitant carbamazepine, 2.7% without concomitant carbamazepine), and dizziness (30.0% with concomitant carbamazepine, 11.5% without concomitant carbamazepine).
Maltese: Riżultati minn studji li saru fuq pazjenti wrew li kura fl-istess żiedet ir-riskju tar-reazzjonijiet avversi li ġejjin: diplopja (11.4% tal-persuni li ħadu carbamazepine fl-istess ħin, 2.4% tal-persuni li ma ħadux carbamazepine fl-istess ħin), koordinazzjoni anormali (6.7% tal-persuni li ħadu carbamazepine flistess ħin, 2.7% tal-persuni li ma ħadux carbamazepine fl-istess ħin), u sturdament (30.0% tal-persuni li ħadu carbamazepine fl-istess ħin, 11.5% tal-persuni li ma ħadux carbamazepine fl-istess ħin).
English: In placebo-controlled studies involving 1,192 adult patients with partial-onset seizures (856 patients treated with eslicarbazepine acetate and 336 treated with placebo), 45.3% of patients treated with eslicarbazepine acetate and 24.4% of patients treated with placebo experienced adverse reactions.
Maltese: Fi studji ikkontrollati bi plaċebo li jinvolvu 1,192 pazjent adult b'aċċessjonijiet ta' bidu parzjali (856 pazjent ikkurati b'eslicarbazepine acetate u 336 ikkurati bi plaċebo), 45.3% tal-pazjenti ikkurati b'eslicarbazepine acetate u 24.4% ta' pazjenti kkurati bi plaċebo esperjenzaw reazzjonijiet avversi.
English: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Maltese: À Av. da Siderurgia Nacional 4745-457 S.
English: Exalief may decrease the effectiveness of hormonal contraceptives.
Maltese: Exalief jista' jnaqqas l-effikaċja ta' kontraċettivi ormonali.
English: Insomnia, apathy, depression, nervousness, agitation, irritability, attention deficit/ hyperactivity disorder, confusional state, mood swings, crying, psychomotor retardation, stress, psychotic disorder
Maltese: Insomnja, apatija, depressjoni, nervożiżmu, aġitazzjoni, irritabilità, disturb ta' nuqqas ta' attenzjoni/iperattività, stat konfużjonali, tixjir fil-burdata, biki, dewmien psikomotorili, tensjoni, disturb psikotiku
English: Presence of HLA-B*1502 allele in individuals of Han Chinese and Thai origin has been shown to be strongly associated with the risk of developing Stevens-Johnson syndrome (SJS) when treated with carbamazepine.
Maltese: Il-preżenza ta' allel ta' HLA-B*1502 f'individwi ta' oriġini Ħan Ċiniża u Thai intweriet li hija assoċjata ħafna mar-riskju ta' żviluppar tas-sindromu ta' Stevens-Johnson (SJS) meta ikkurati b'carbamazepine.
English: Pharmacotherapeutic group: Antiepileptics, Carboxamide derivatives, ATC code: N03AF04
Maltese: Mediċini antiepilettiċi, Derivattivi ta' carboxamide, Kodiċi ATC:
English: Eslicarbazepine tmax is attained at 2 to 3 h post-dose.
Maltese: Eslicarbazepine tmax jinkiseb 2 sa 3 sigħat wara d-doża.
English: Eslicarbazepine acetate is rapidly and extensively biotransformed to its major active metabolite eslicarbazepine by hydrolytic first-pass metabolism.
Maltese: Eslicarbazepine acetate huwa rapidament u estensivament bijotransformat fil-metabolit attiv maġġuri tiegħu eslicarbazepine permezz ta' metaboliżmu first-pass idrolitiku.
English: • Tell your doctor if you are taking hormonal/oral contraceptives.
Maltese: • Għid lit-tabib tiegħek jekk qed tieħu kontraċettivi ormonali/orali.
English: The binding of warfarin, diazepam, digoxin, phenytoin and tolbutamide was not significantly affected by the presence of eslicarbazepine.
Maltese: L-irbit ta' warfarin, diazepam, digoxin, phenytoin u tolbutamide ma kinux sinifikattivament effettwati mill-preżenza ta' eslicarbazepine.
English: Additional non-hormonal forms of contraception are recommended when using Exalief (see section 4.5 and 4.6).
Maltese: Forom addizzjoni ta' kontraċezzjoni mhux ormonali huma rakkomandati meta jkun qed jintuża Exalief (ara sezzjoni 4.5 u 4.6).
English: Dysphonia, epistaxis, chest pain
Maltese: Disfonija, epistassi, uġigħ fis-sider