FrancophonIA/ELRC3.0 huggingface dataset:
English: The doctor may need to adjust the dose or change one of the medicines to something else: - theophylline (used to treat breathing difficulties) - doxapram (used to treat breathing difficulties) - cimetidine (used to treat gastric disease) - ketoconazole (used to treat fungine infections) - phenobarbital (used to treat epilepsy) - phenytoin (used to treat epilepsy)
Maltese: It-tabib għandu mnejn ikollu bżonn jaġġusta d-doża jew ibiddel xi waħda mill-mediċini għal xi mediċina oħra: - theophylline (jintuża biex jikkura diffikultajiet fit-teħid tan-nifs) - doxapram (jintuża biex jikkura diffikultajiet fit-teħid tan-nifs) - cimetidine (jintuża biex jikkura mard ta' l-istonku) - ketoconazole (jintuża biex jikkura infezzjonijiet mill-fungu)
English: Each 1 ml ampoule contains 20 mg caffeine citrate (equivalent to 10 mg of caffeine base).
Maltese: Kull ampulla ta' 1 ml fiha 20 mg caffeine citrate (ekwivalenti għal 10 mg caffeine)
English: Common reported side effects (may affect up to 1 in 10 people) - local inflammatory reactions at the infusion site - cardiac disorders such as fast heart beat (tachycardia) - changes of sugar in blood or serum (hyperglycaemia)
Maltese: Effetti sekondarji fejn il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli - marda serja tal-imsaren b'demm fl-ippurgar (enterokolite nekrotika)
English: In newborns previously treated with theophylline, baseline plasma caffeine concentrations should be measured prior to initiation of treatment with caffeine citrate because preterm infants metabolise theophylline to caffeine.
Maltese: Sabiex tkun evitata tossiċità f'din il-popolazzjoni, d-dożi għandhom jiġu aġġustati permezz ta' monitoraġġ tal-konċentrazzjonijiet ta' caffeine fil-plażma.
English: Higher maintenance doses of 10 mg/kg body weight could be considered in case of insufficient response, taking into account the potential for accumulation of caffeine due to the long half- life in preterm newborn infants and the progressively increasing capacity to metabolise caffeine in relation to post-menstrual age (see section 5.2).
Maltese: Caffeine għandu half-life mtawwla fi trabi tat-twelid prematuri u hemm il-potenzjal ta' akkumulazzjoni li jista' jeħtieġ monitoraġġ tat-trabi kkurati għall-perijodu mtawwal (ara sezzjoni 5.2).
English: Cardiac disorders (tachycardia, including one single case of arrhythmia) were mostly reported.
Maltese: (takikardija, inkluż każ wieħed ta' arritmija).
English: Although few data exist on interactions of caffeine with other active substances in preterm newborn infants, lower doses of caffeine citrate may be needed following co-administration of active substances which are reported to decrease caffeine elimination in adults (e.g., cimetidine and ketoconazole) and higher caffeine citrate doses may be needed following co-administration of active substances that increase caffeine elimination (e.g., phenobarbital and phenytoin).
Maltese: (eż., cimetidine u ketoconazole) u jista' jkun hemm bżonn ta' dożi ogħla ta' caffeine citrate wara l-għoti fl-istess waqt ta' sustanzi attivi li jżidu l-eliminazzjoni ta' caffeine (eż., phenobarbital u phenytoin).
English: Hypoglycaemia, failure to thrive, feeding intolerance
Maltese: Ipogliċemija, nuqqas ta' tkabbir, intolleranza għall-ikel
English: Infants randomised to caffeine citrate received an intravenous loading dose of 20 mg/kg, followed by a daily maintenance dose of 5 mg/kg.
Maltese: Trabi li ntgħażlu b'mod każwali għal caffeine citrate, irċivew doża gġolja tal-bidu fil-vini ta' 20 mg/kg, segwita minn doża tal-manteniment ta' kuljum ta' 5 mg/kg.
English: Vaniqa eflornithine
Maltese: Vaniqa eflornitina
English: The full EPAR for Vaniqa can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Vaniqa jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Vaniqa is a white cream that contains the active substance eflornithine (115 mg).
Maltese: Vaniqa huwa krema bajda li fiha s-sustanza attiva eflornitina (115mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Vaniqa on 20 March 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vaniqa fl-20 ta' Marzu 2001.
English: This summary was last updated in 04-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'04-2013.
English: This is a summary of the European public assessment report (EPAR) for Vaniqa.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Vaniqa.
English: The active substance in Vaniqa, eflornithine, works by blocking the action of an enzyme called ornithine decarboxylase.
Maltese: Is-sustanza attiva f'Vaniqa, jiġifieri l-eflornitina, taħdem billi timblokka l-azzjoni ta' enzim imsejjaħ ornitin-dekarbossilażi.
English: Vaniqa has been studied in two clinical trials involving 596 women treated for up to 24 weeks with Vaniqa or placebo (a dummy treatment, in this case the cream without any active substance).
Maltese: L-effikaċja ta' Vaniqa ġiet studjata f'żewġ provi kliniċi li fihom ħadu sehem 596 mara ttrattati tul massimu ta' 24 ġimgħa b'Vaniqa, jew bi plaċebo (trattament finta, f'dan il-każ kien krema mingħajr issustanza attiva).
English: When the results were combined, a successful outcome (graded as ‘clear/almost clear' or ‘marked improvement') was seen in 35% of the women treated with Vaniqa, compared with 9% of those treated with placebo.
Maltese: Meta r-riżultati ngħaddu flimkien, deher riżultat ta' suċċess (‘ċar/kważi ċar' jew ‘titjib sinjifikanti') f'35% tan-nisa ttrattati b'Vaniqa, apparagun ma' 9% ta' dawk li kienu ttrattati bi plaċebo.
English: The effectiveness of the treatment was assessed at the end of the study by a doctor who graded the hirsutism as ‘clear/almost clear', ‘marked improvement', ‘improved' or ‘no improvement/worse', 48 hours after women had shaved the treated areas of the face and under the chin.
Maltese: L-effikaċja tat-trattament ġiet ivvalutata minn tabib li fi tmiem l-istudju ta punteġġ għall-irsutiżmu bħala ‘ċar/kważi ċar', ‘titjib notevoli', ‘titjib' jew ‘l-ebda titjib/agħar', 48 siegħa wara li n-nisa kienu qaxxru ż-żoni ttratati tal-wiċċ u tal-ilħit.
English: What is the risk associated with Vaniqa?
Maltese: X'inhu r-riskju assoċjat ma' Vaniqa?
English: What is Vaniqa?
Maltese: Kif jintuża Vaniqa?
English: What measures are being taken to ensure the safe use of Vaniqa?
Maltese: Għaliex ġie approvat Vaniqa?
English: Vaniqa is used for the treatment of facial hirsutism in women.
Maltese: Vaniqa jintuża għat-trattament tal-irsutiżmu tal-wiċċ fin-nisa.
English: The CHMP decided that Vaniqa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Vaniqa huma akbar mir-riskji tiegħu u għaldaqstant irrikkomanda li tingħata awtorizzazzjoni biex jitpoġġa fis-suq.
English: How has Vaniqa been studied?
Maltese: Kif ġie studjat Vaniqa?
English: Other information about Vaniqa
Maltese: Iżjed tagħrif dwar Vaniqa
English: In both studies, significant improvement was seen with Vaniqa compared with placebo.
Maltese: Fiż-żewġ studji deher titjib sinifikanti b'Vaniqa apparagun mal-plaċebo.
English: What benefit has Vaniqa shown during the studies?
Maltese: Liema benefiċċju wera Vaniqa waqt dawn l-istudji?
English: For the full list of all the side effects reported with Vaniqa, see the package leaflet.
Maltese: Biex tara l-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Vaniqa, aqra lfuljett ta' tagħrif.
English: 3 x 30 tablets
Maltese: 3 x 30 pilloli
English: EU number
Maltese: Numru ta' l-EU Numru tal-MA
English: Other information about Apoquel:
Maltese: Informazzjoni oħra dwar Apoquel:
English: Apoquel tablets are available in three different strengths (3.5 mg, 5.4 mg and 16 mg) to cover a range of dog weights.
Maltese: Il-pilloli ta' Apoquel huma disponibbli fi tliet qawwiet differenti (3.5 mg, 5.4 mg u 16 mg) biex ikopru firxa ta' klieb b'piżijiet differenti.
English: One study involved 220 dogs and the second involved 299 dogs.
Maltese: Studju minnhom involva 220 kelb u t-tieni wieħed involva 299 kelb.
English: Apoquel is a veterinary medicine that contains the active substance oclaticinib.
Maltese: Apoquel hija mediċina li fiha s-sustanza attiva oclaticinib.
English: In the pruritus study comparing Apoquel with prednisolone, both medicines were shown to be effective, with a successful response seen in 68% of dogs treated with Apoquel, and 76% of those treated with prednisolone.
Maltese: Fl-istudju tal-prurite, fejn Apoquel tqabbel ma' prednisolone, iż-żewġ mediċini ntwerew li huma effettivi, b'rispons li kellu suċċess f'68 % tal-klieb ikkurati b'Apoquel, u 76 % ta' dawk ikkurati bi prednisolone.
English: For atopic dermatitis the treatment success rate for Apoquel-treated dogs in the first study was 66% compared with 4% in placebo-treated dogs using pruritus assessment; the results for CADESI scores were 49% and 4% respectively.
Maltese: Għad-dermatite atopika, ir-rata ta' suċċess tal-kura għall-klieb ikkurati b'Apoquel fl-ewwel studju kienet ta' 66 % meta mqabbel ma' 4 % fil-klieb ikkurati bi plaċebo permezz ta' valutazzjoni tal-prurite; ir-riżultati għall-punteġġi tas-CADESI kienu ta' 49 % u 4 % rispettivament.
English: The active substance in Apoquel, oclacitinib, is an immunomodulator (a medicine that changes the activity of the immune system) that works by blocking the action of enzymes known as Janus kinases.
Maltese: Is-sustanza attiva f'Apoquel, oclacitinib, hija immunomodulator (mediċina li tbiddel l-attività tassistema immunitarja) li taħdem billi timblokka l-azzjoni tal-enzimi magħrufa bħala kinażi ta' Janus.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Apoquel on 12/09/2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea, għal Apoquel fit-12 ta' Settembru 2013.
English: In one, Apoquel was compared with prednisolone (an immunosuppressant) in 220 dogs, and in the other Apoquel was compared with placebo (dummy treatment) in 436 dogs.
Maltese: F'wieħed minnhom, Apoquel tqabbel ma' prednisolone (immunosuppressant) f'220 kelb, filwaqt li flistudju l-ieħor Apoquel tqabbel ma' plaċebo (kura finta) f'436 kelb.
English: When compared with placebo, the success rate was 67% for Apoquel-treated dogs and 29% for placebo-treated dogs.
Maltese: Meta mqabbla ma' plaċebo, ir-rata ta' suċċess kienet ta' 67 % għall-klieb ikkurati b'Apoquel u 29 % għall-klieb ikkurati bi plaċebo.
English: The most common side effects were diarrhoea, vomiting and loss of appetite in decreasing order of frequency.
Maltese: L-effetti sekondarji l-iktar komuni kienu dijarea, rimettar u nuqqas ta' aptit f'ordni dixxendenti ta' frekwenza.
English: What is Apoquel?
Maltese: X'inhu Apoquel?
English: What is the risk associated with Apoquel?
Maltese: X'riskji huma assoċjati ma' Apoquel?
English: Studies in atopic dermatitis also used assessment of skin lesions on a score known as the canine atopic dermatitis extent and severity index (CADESI).
Maltese: Listudji dwar id-dermatite atopika użaw ukoll valutazzjoni tal-leżjonijiet fil-ġilda b'punteġġ magħruf bħala l-indiċi tas-severità u l-estent tad-dermatite atopika fil-klieb (CADESI).
English: Apoquel is used in dogs to treat pruritus (itching) associated with allergic dermatitis (inflammation of the skin).
Maltese: Apoquel jintuża biex tiġi kkurata l-prurite assoċjata ma' dermatite allerġika (infjammazzjoni tal-ġilda) fil-klieb.
English: These enzymes play an important role in the processes of inflammation and itchiness including those involved in allergic dermatitis and atopic dermatitis in dogs.
Maltese: Dawn l-enzimi għandhom rwol importanti fil-proċess tal-infjammazzjoni u l-ħakk inklużi dawk involuti f'deramatite allerġika u dermatite atopika fil-klieb.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċji u r-riskji jista' jinstab fil-modulu ta' diskussjoni xjentifika ta' dan l-EPAR.
English: Treatment should be started at a dose of 0.4 - 0.6 mg per kilogram bodyweight twice a day for up to two weeks.
Maltese: Il-kura għandha tinbeda b'doża ta' 0.4-0.6 mg għal kull kilogramma ta' piż tal-ġisem, darbtejn kuljum għal sa ġimagħtejn.
English: How has Apoquel been studied?
Maltese: Kif ġie studjat Apoquel?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Apoquel exceed the risks for the approved indications and recommended that Apoquel be given a marketing authorisation.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Apoquel jisbqu r-riskji għall-indikazzjoni approvata u rrakkomanda li Apoquel jingħata awtorizzazzjoni għattqegħid fis-suq.
English: Apoquel should not be given to dogs less than one year of age or weighing less than 3 kg. Apoquel should not be given to dogs with signs of immune suppression or progressive cancer as Apoquel has not been studied in such cases.
Maltese: Apoquel ma għandux jingħata lill-klieb b'sinjali ta' soppressjoni immunitarja jew kanċer progressiv peress li Apoquel ma ġiex studjat f'każijiet bħal dawn.
English: The atopic dermatitis indication was also investigated in two field studies.
Maltese: L-indikazzjoni ta' dermatite akuta ġiet investigata wkoll f'żewġ studji fuq il-post.
English: For a full list of all side-effects reported with Apoquel, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Apoquel, ara l-fuljett ta' tagħrif.
English: Why has Apoquel been approved?
Maltese: Għal xiex ġie appruvat Apoquel?
English: The action of Apoquel in pruritus associated with allergic dermatitis was studied in two field studies.
Maltese: Jintuża wkoll biex tiġi kkurata dermatite atopika fil-klieb.
English: How does Apoquel work?
Maltese: Għal xiex jintuża Apoquel?
English: 5612 AP, Eindhoven The Netherlands
Maltese: 5612 AP, Eindhoven L-Olanda
English: Ioflupane is a cocaine analogue.
Maltese: Ioflupane huwa analogu tal-kokaina.
English: Remaining organs Effective Dose (µSv/MBq)
Maltese: Doża effettiva (µSv/MBq)
English: 4.5 x 10
Maltese: 2.5 sa 4.5 x 10
English: See also section 6.6.
Maltese: Ara ukoll sezzjoni 6.6.
English: Iodine-123 has a physical half-life of 13.2 hours.
Maltese: Iodine-123 għandu half life fiżika ta'13.2 sigħat.
English: Slovenská republika MGP, spol.
Maltese: Slovenská republika MGP, spol. s r. o.
English: Bq/mmol) at reference time.
Maltese: Bq/mmol) mill-ħin ta' referenza.
English: Uncommon: Dizziness, formication (paraesthesia), dysgeusia
Maltese: Mhux komuni: Sturdament, formikazzjoni (paraesteżija), disgwesja
English: These include amfetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline.
Maltese: Dawn jinkludu amphetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine u sertraline.
English: Each dose contains up to 197 mg alcohol.
Maltese: Kull doża fiha sa 197 mg ta' alkoħol.
English: Muscles
Maltese: Muskoli
English: DaTSCAN contains alcohol (ethanol) 5 % by volume.
Maltese: DaTSCAN fih l-alkoħol (ethanol) 5% skont il-volum.
English: It decays emitting gamma radiation with a predominant energy of 159 keV and X-rays of 27 keV.
Maltese: Jitmermer waqt li jarmi radjazzjoni gamma b'enerġija predominanti ta' 159 keV u raġġi-X ta' 27 keV.
English: 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), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: 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); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Acetic acid Sodium acetate Ethanol
Maltese: Sodium acetate, Ethanol,
English: Excipient(s) with known effect This medicinal product contains 39.5 g/l ethanol.
Maltese: Dan il-prodott mediċinali fih 39.5 g/l ta' ethanol.
English: Absorbed radiation dose Gy/MBq
Maltese: Doża ta' radjazzjoni assorbita Gy/MBq
English: Česká republika M.G.P.
Maltese: Česká republika M.G.P. spol. s r.o.
English: Clinical efficacy has been demonstrated across the range 111 to 185 MBq.
Maltese: L-effikaċja klinika ntweriet fil-limiti ta' 111 sa 185 MBq.
English: Date of first authorisation: 27 July 2000 Date of latest renewal: 28 July 2010
Maltese: Data ta' l-aħħar tiġdid: 28 ta' Lulju 2010
English: EU/1/00/135/001 (2.5 ml) EU/1/00/135/002 (5 ml)
Maltese: EU/1/00/135/002 (5 ml)
English: Medicines shown during clinical trials not to interfere with DaTSCAN imaging include amantadine, trihexyphenidyl, budipine, levodopa, metoprolol, primidone, propranolol and selegiline.
Maltese: Mediċini li fil-provi kliniċi wrew li ma jxekklux il-viżjoni permezz tad-DaTSCAN jinkudu amantadine, benzhexol, budipine, levodopa, metoprolol, primidone, propranolol u selegiline.
English: I) (specific activity range 2.5 to
Maltese: I) (medda ta' attività speċifika minn 2.5 sa 4.5 x 10
English: GE Healthcare d.o.o.
Maltese: GE Healthcare A.E.
English: Oesophagus
Maltese: Esofagu
English: The positive predictive value ranged from 78.9% to 84.4% and the negative predictive value from 86.1% to 88.7%.
Maltese: 4% u l-valur predikattiv negattiv minn 86.1% sa 88.7%.
English: Distribution Ioflupane (
Maltese: Distribuzzjoni Ioflupane (
English: Angular sampling should preferably be not less than 120 views over 360 degrees.
Maltese: Preferibbilment għandhom jittieħdu mhux inqas minn 120 ritratt f'madwar 360 grad.
English: - Hypersensitivity (allergic) - Shortness of breath - Redness of the skin - Itching - Rash - Hives (urticaria) - Excessive sweating - Vomiting - Low blood pressure - Feeling hot
Maltese: - Sensittività eċċessiva (allerġiċi) - Qtugħ ta' nifs - Ħmura tal-ġilda - Ħakk - Raxx - Ħorriqija (urtikarja) - Għaraq eċċessiv - Rimettar - Pressjoni baxxa - Tħoss is-sħana
English: • The active substance is ioflupane (
Maltese: • Is-sustanza attiva hi ioflupane (
English: Other medicines and DaTSCAN
Maltese: Mediċini oħra u DaTSCAN
English: In a pivotal clinical trial including evaluation of 288 subjects with dementia with Lewy bodies (DLB) (144 subjects), Alzheimer's disease (124 subjects), vascular dementia (9 subjects) or other (11 subjects), the results of an independent, blinded visual assessment of the DaTSCAN images were compared to the clinical diagnosis as determined by physicians experienced in the management and diagnosis of dementias.
Maltese: Fi prova klinika ewlenija li kienet tinkludi l-evalwazzjoni ta' 228 pazjent b'dimenzja b'korpi Lewy (DLB) (144 pazjent), il-marda ta' Alzheimer (124 pazjent), dimenzja vaskulari (9 pazjenti) jew oħrajn (11-il pazjent), ir-riżultati ta' immaġini DaTSCAN indipendenti u ta' l-eżami viżwali b'inkonsapevolezza ġew imqabbla mad-dijanjosi klinika kif stabbilit mit-tobba b'esperjenza filġestjoni u d-dijanjosi ta' dimenzji.
English: The effective dose (E) resulting from administration of 185 MBq of DaTSCAN injection is 4.63 mSv (per 70 kg individual).
Maltese: Id-doża effettiva (E) li tirriżulta meta jingħata DaTSCAN ta' 185 MBq f'injezzjoni hija ta' 4.63 mSv (għal kull individwu ta' 70 kg).
English: As the effective dose is 4.63 mSv when the maximal recommended activity of 185 MBq is administered these adverse events are expected to occur with a low probability.
Maltese: Minħabba li d-doża effettiva hija 4.63 mSv meta tingħata l-attività rakkomandata massimali ta' 185 MBq, dawn l-avvenimenti avversi huma mistennija li jseħħu bi probabbiltà baxxa.
English: Uptake in the brain is rapid, reaching about 7% of injected activity at 10 minutes post-injection and decreasing to 3% after 5 hours.
Maltese: Il-prodott malajr imur fil-moħħ, u jilħaq 7% ta' l-attivita` injettata 10 minuti wara l-injezzjoni u jonqos għal 3% wara 5 sigħat.
English: The recommended radioactivity given by injection is between 111 to 185 MBq (megabequerel or MBq is a unit used to measure radioactivity).
Maltese: Ir-radjuattività rakkomandata mogħtija permezz ta' injezzjoni hi bejn 111 sa 185 MBq (megabequerel jew MBq hi unità li tintuża biex tkejjel ir-radjuattività).
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-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi dwar l- aġġornament tas-sigurtà għal dan ilprodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: The sensitivity ranged from 60.6% to 63.4% and specificity from 88.6% to 91.4% when the possible DLB patients were included as DLB patients.
Maltese: Issensittività kienet mifruxa bejn 60.6% sa 63.4% u l-ispeċifiċità minn 88.6% sa 91.4% meta l-pazjenti li possibbilment kellhom
English: Pharmacotherapeutic group: Diagnostic radiopharmaceutical central nervous system, ATC code: V09AB03.
Maltese: Radjufarmaċewtiku tas-sistema nervuża ċentrali, Kodiċi ATC:
English: I) 74 MBq at reference time (0.07 to 0.13 μg/ml of ioflupane).
Maltese: riferiment (minn 0.07 sa 0.13 μg/ml ta' ioflupane).
English: • methylphenidate (used to treat hyperactivity in children and narcolepsy (excessive sleepiness))
Maltese: • methylphenidate (jintuża biex jikkura iperattività fit-tfal u narkolepsija, (irqad eċċessiv))
English: This medicinal product contains 39.5 g/l (5% volume) ethanol (alcohol), up to 197 mg per dose, equivalent to 5 ml beer or 2 ml wine.
Maltese: Dan il-prodott mediċinali fih 39.5 g/l (5% tal-volum) ta' ethanol (alkoħol), li jitla għal 197 mg għal kull doża, li hu ekwivalenti għal 5 ml ta' birra jew 2 ml imbid.
English: For the full list of excipients see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi ara sezzjoni 6.1.
English: Ioflupane binds to the dopamine transporter.
Maltese: Ioflupane jingħaqad mat-trasportatur tad-dopamine.
English: I) at 1200 CET on DD/MM/YYYY
Maltese: I) fi 1200 CET fil-JJ/XX/SSSS.
English: Biomedis M.B.
Maltese: Teħid mill-organu
English: EXP: 7 h post-ref. Ref.: 185 MBq/2.5 ml ioflupane (
Maltese: Ref.: 185 MBq/2.5 ml ioflupane (
English: Clinical categorisation into the respective dementia group was based on a standardised and comprehensive clinical and neuropsychiatric evaluation.
Maltese: Il-kategorizzazzjoni klinika fil-grupp rispettiv ta' dimenzja kienet ibbażżata fuq standardizzazzjoni u evalwazzjoni klinika komprensiva u newropsikjattrika.
English: Studies on reproductive toxicity and to assess the carcinogenic potential of ioflupane have not been performed.
Maltese: Ma sarux studji dwar it-tossiċità riproduttiva u biex jiġi vvalutat il-potenzjal karċinoġeniku ta' ioflupane.
English: GE Healthcare A.E. Τηλ: +30 210 8930600
Maltese: Τηλ: +30 210 8930600
English: 5% ethanol (see leaflet for further information), acetic acid, sodium acetate, water for injections.
Maltese: 5% ethanol (ara l-fuljett fil-pakkett għal aktar tagħrif), acetic acid, sodium acetate, ilma għallinjezzjonijiet.
English: Immune system disorders Not known: Hypersensitivity
Maltese: Disturbi fis-sistema immuni Mhux magħruf: Sensittività eċċessiva
English: DaTSCAN is unable to discriminate between Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy.
Maltese: DaTSCAN ma jistax jagħraf bejn il-Marda ta' Parkinson, Atrofija Multipla tas-Sistema u Paraliżi Progressiva Supranukleari.