FrancophonIA/ELRC3.0 huggingface dataset:
English: In CYP2D6 poor metabolisers, concomitant use of potent inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.When considering concomitant administration of ketoconazole or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient.
Maltese: F'metabolizzaturi dgħajfa ta' CYP2D6, l-użu konkomitanti ta'inibituri qawwija ta' CYP3A4 jista' jirriżulta f'konċentrazzjoni ogħla fil-plażma ta' aripiprazole, meta mqabbel ma' dak ta' metabolizzaturi estensivi ta' CYP2D6.
English: Wessling Hungary, Anonymus u. 6., Budapest, 1045, Hungary
Maltese: Wessling Hungary, Anonymus u.
English: Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41 % and AUC by about 51 %, suggesting that charcoal may be effective in the treatment of overdose.
Maltese: Faħam attivat (50 g), li ngħata siegħa wara aripiprazole, naqqas is- Cmax ta' aripiprazole bejn wieħed u ieħor b'41 % u l-AUC bejn wieħed u ieħor b'51 %, li jissuġġerixxi li l-faħam jista jkun effettiv għallkura ta' doża eċċessiva.
English: Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva, ikkaratterizzati minn sintomi allerġiċi, jistgħu jseħħu b'aripiprazole (ara sezzjoni 4.8).
English: Aripiprazole Accord is effective in a dose range of 10 to 30 mg/day.
Maltese: Aripiprazole Accord hu effettiv f'medda ta' dożi ta' 10 sa 30 mg/kuljum.
English: However, the concentrations of the sulphate conjugates of hydroxy aripiprazole in human bile at the highest dose proposed, 30 mg per day, were no more than 6 % of the bile concentrations found in the monkeys in the 39-week study and are well below (6 %) their limits of in vitro solubility.
Maltese: Iżda l-konċentrazzjoni tal-konjugi sulfatizzati ta' idroxi aripiprazole fil-bile tal-bniedem fl-ogħla doża proposta, dik ta' 30 mg kuljum, ma kienux iktar minn 6 % tal-konċentrazzjoni fil-bile li nstabet fixxadini fl-istudju li dam 39 ġimgħa u huwa ħafna inqas (6 %) mill-limiti li taħthom jinħallu in vitro.
English: Temperature regulation disorder (e.g. hypothermia, pyrexia) Chest pain
Maltese: Disturb fir-regolazzjoni tattemperatura (eż ipotermja, deni) Uġigħ fis-sider
English: Oculogyric crisis
Maltese: Ir-Renju Unit
English: Pathological gambling and other impulse control disorders
Maltese: Logħob tal-azzard patoloġiku u disturbi oħra fil-kontroll tal-impuls
English: Developmentaltoxicity, including dose-dependent delayed foetal ossification and possible teratogenic effects, were observed in rats at doses resulting in subtherapeutic exposures (based on AUC) and in rabbits at doses resulting in exposures 3 and 11 times the mean steady-state AUC at the maximum recommended clinical dose.
Maltese: Effett tossiku fuq l-iżvilupp, li jinkludu, tardjar ta' lossifikazzjoni tal-fetu skond id-doża u effetti teratoġeniċi possibli ġew osservati f'firien b'dożi li jirriżultaw f'espożizzjonijiet taħt il-livelli terapewtiċi (ibbażati fuq l-AUC) u fi fniek b'dożi li jirriżultaw f'espożizzjonijiet ta' 3 u 11-il darba iktar mill-medja ta' l-AUC fi stat stabbli fid-doża massima klinika rakkomandata.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of aripiprazole.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola għandha 10 mg ta' aripiprazole.
English: Additionally, aripiprazole and dehydroaripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro.
Maltese: aripiprazole u dehydro-aripiprazole ma wrewx li jistgħu ibiddlu il-metaboliżmu li jiġi effettwat misCYP1A2 fi studji in vitro.
English: • Keep this leaflet.
Maltese: Stat ta' tipjip
English: Suicide attempt, suicidal ideation and completed suicide (see section 4.4)
Maltese: Tentattiv ta' suwiċidju, formazzjoni ta' ħsieb biex jitwettaq suwiċidju, u t-twettiq ta' suwiċidju (ara sezzjoni 4.4)
English: EU/1/15/1045/019 14x1 tablets EU/1/15/1045/020 28x1 tablets EU/1/15/1045/026 49x1 tablets EU/1/15/1045/021 56x1 tablets EU/1/15/1045/022 98x1 tablets
Maltese: EU/1/15/1045/019 14x1 pilloli EU/1/15/1045/020 28x1 pilloli EU/1/15/1045/026 49x1 pilloli EU/1/15/1045/021 56x1 pilloli EU/1/15/1045/022 98x1 pilloli
English: EU/1/15/1045/013 14x1 tablets EU/1/15/1045/014 28x1 tablets EU/1/15/1045/025 49x1 tablets EU/1/15/1045/015 56x1 tablets EU/1/15/1045/016 98x1 tablets
Maltese: EU/1/15/1045/013 14x1 pilloli EU/1/15/1045/014 28x1 pilloli EU/1/15/1045/025 49x1 pilloli EU/1/15/1045/015 56x1 pilloli EU/1/15/1045/016 98x1 pilloli
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Aripiprazole Accord 5 mg tablets Each tablet contains 5 mg of aripiprazole.
Maltese: U KWANTITATTIVA Aripiprazole Accord 5 mg pilloli Kull pillola għandha 5 mg ta' aripiprazole.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola għandha 30 mg ta' aripiprazole.
English: The safety profile of a long-term, double-blind placebo controlled trial was also similar except for the following reactions that were reported more frequently than paediatric patients taking placebo: weight decreased, blood insulin increased, arrhythmia, and leukopenia were reported commonly (≥ 1/100, <
Maltese: Il-profil tas-sigurtà ta' prova double blind u bil-plaċebo bħala kontroll, fuq perijodu ta' żmien twil, kienet simili wkoll għajr għar-reazzjonijiet li ġejjin li kienu rrapportati bi frekwenza aktar spissa milli f'pazjenti pedjatriċi li kienu qed jieħdu plaċebo: tnaqqis fil-piż, żieda fil-livell ta' insulina fid-demm, arritmija, u lewkopenija kienu rrapportati b'mod komuni (≥ 1/100, < 1/10).
English: EU/1/15/1045/001 14x1 tablets EU/1/15/1045/002 28x1 tablets EU/1/15/1045/023 49x1 tablets EU/1/15/1045/003 56x1 tablets EU/1/15/1045/004 98x1 tablets
Maltese: EU/1/15/1045/001 14x1 pilloli EU/1/15/1045/002 28x1 pilloli EU/1/15/1045/023 49x1 pilloli EU/1/15/1045/003 56x1 pilloli EU/1/15/1045/004 98x1 pilloli
English: Schizophrenia: the recommended starting dose for Aripiprazole Accord is 10 or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals.
Maltese: Skiżofrenja: id-doża tal-bidu rakkomandata għal Aripiprazole Accord hija ta' 10 jew 15 mg/jum b'doża ta' manteniment ta' 15 mg/jum mogħtija fuq skeda ta' waħda kull jum mingħajr attenzjoni lejn l-ikliet.
English: EU/1/15/1045/007 14x1 tablets EU/1/15/1045/008 28x1 tablets EU/1/15/1045/024 49x1 tablets EU/1/15/1045/009 56x1 tablets EU/1/15/1045/010 98x1 tablets
Maltese: EU/1/15/1045/007 14x1 pilloli EU/1/15/1045/008 28x1 pilloli EU/1/15/1045/024 49x1 pilloli EU/1/15/1045/009 56x1 pilloli EU/1/15/1045/010 98x1 pilloli
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose for Aripiprazole Accord is 10 mg/day administered on a once-a-day schedule without regard to meals.
Maltese: Episodji manijaċi f'Disturb Bipolari I f'adolexxenti li għandhom 13-il sena jew aktar: id-doża rakkomandata għal Aripiprazole Accord hi ta' 10 mg/kuljum li tingħata fuq skeda ta' darba kuljum mingħajr ma jingħata kas tal-ikel.
English: Diabetes mellitus Hyperglycaemia
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased (see section 4.5).
Maltese: Meta ma jibqax jingħata l-inibitur ta' CYP3A4 jew CYP2D6, id-doża ta' aripiprazole għandha tiżdied (ara sezzjoni 4.5).
English: • muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.
Maltese: • ebusija tal-muskoli, u ħedla jew ngħas, tieħu n-nifs aktar bil-mod, tifga', pressjoni għolja jew baxxa, ritmi mhux normali tal-qalb.
English: The overall completion rate was significantly higher for patients on aripiprazole (43 %) than for haloperidol (30 %).
Maltese: Ir-rata globali ta' dawk li spiċċaw il-kors kienet sinifikament ogħla għallpazjenti fuq aripiprazole (43 %) milli għall-haloperidol (30 %).
English: INFORMATION IN BRAILLE Aripiprazole Accord 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Aripiprazole Accord 15 mg
English: Potential for other medicinal products to affect aripiprazole A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this effect is deemed not clinically relevant.
Maltese: Imblokkatur ta' l-aċidu fl-istonku, l-antagonista ta' l-H2 fomatidine, inaqqas ir-rata li biha jiġi assorbit aripiprazole, iżda dan l-effett m'huwiex meqjus bħala wieħed klinikament relevanti.
English: Animal studies could not exclude potential developmental toxicity (see section 5.3).
Maltese: Studji fuq lannimali ma setgħux jeskludu il-potenzjal ta' tossiċità fl-iżvilupp (ara sezzjoni 5.3).
English: Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia.
Maltese: Aripiprazole għandu jintuża b'attenzjoni fuq pazjenti b'riskju ta' pnewmonja minn aspirazzjoni.
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli attwalment hi deskritta fis-sezzjoni 5.1, imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: A, aripiprazole should be used with caution in patients with a family history of QT prolongation (see section 4.8).
Maltese: Aripiprazole għandu jintuża b'kawtela f'pazjenti b'titwil tal-QT fl-istorja tal-familja (ara sezzjoni 4.8).
English: Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69 % and 71 % lower, respectively, than those following treatment with aripiprazole alone.
Maltese: Hekk ukoll għad-dehydro-aripiprazole, il-medji ġeometriċi tas- Cmax u lAUC wara l-għoti flimkien ta' carbamazepine kienu ta' 69 % u 71 % inqas, rispettivament, minn dawk ta' wara l-kura b'aripiprazole waħdu.
English: • thoughts of suicide, suicide attempt and suicide,
Maltese: • tentattiv ta' suwiċidju, suwiċidju,
English: When concomitant administration of strong CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, the aripiprazole dose should be reduced.
Maltese: Meta aripiprazole jingħata ma' inibituri qawwija ta' CYP3A4 jew CYP2D6, id-doża ta' aripiprazole għandha titnaqqas.
English: Treatment should be initiated at 2 mg (using aripiprazole oral solution 1 mg/ml) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg.
Maltese: Il-kura għandha tinbeda f'doża ta' 2 mg (bl-użu ta' aripiprazole soluzzjoni orali 1 mg/ml) għal jumejn, ittitrata għal 5 mg għal jumejn addizzjonali biex tilħaq id-doża rakkomandata ta' kuljum ta' 10 mg.
English: Aripiprazole Accord 30 mg tablets Each tablet contains 30 mg of aripiprazole.
Maltese: Aripiprazole Accord 30 mg pilloli Kull pillola għandha 30 mg ta' aripiprazole.
English: Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.
Maltese: Minħabba l-antagoniżmu tiegħu għar-reċettur adrenerġiku α1, aripiprazole għandu l-potenzjali li jista' jkabbar l-effett ta' xi prodotti mediċinali kontra l-pressjoni għolja.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1045/005- 30 tablets EU/1/15/1045/006- 100 tablets
Maltese: EU/1/15/1045/006- 100 pilloli
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 30 mg tablets aripiprazole
Maltese: Aripiprazole Accord 30 mg pilloli aripiprazole
English: Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and symptoms for this condition can occur especially in cases of concomitant use with other serotonergic medicinal products, such as SSRI/SNRI, or with medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Maltese: Każijiet ta' sindromu ta' serotonin ġew irrapportati f'pazjenti li kienu qed jieħdu aripiprazole u sinjali u sintomi possibbli għal din il-kundizzjoni jistgħu jseħħu speċjalment f'każijiet ta' użu fl-istess ħin ma' mediċini serotonerġiċi oħrajn, bħal SSRI/SNRI, jew ma' mediċini li huma magħrufa li jżidu lkonċentrazzjonijiet ta' aripiprazole (ara sezzjoni 4.8).
English: When aripiprazole was administered concomitantly with either valproate, lithium or lamotrigine, there was no clinically important change in valproate, lithium or lamotrigine concentrations.
Maltese: Meta aripiprazole ngħata b'mod konkomitanti mal-valproate, litju jew lamotrigine ma kien hemm lebda bidla klinikament importanti fil-konċentrazzjonijiet ta' valproate, litju jew lamotrigine.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of aripiprazole.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola għandha 5 mg ta' aripiprazole.
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 10 mg tablets aripiprazole
Maltese: Aripiprazole Accord 10 mg pilloli aripiprazole
English: • life-threatening irregular heart beat,
Maltese: • aktar riq fil-ħalq mis-soltu,
English: (for 100's count) Open date:
Maltese: Data ta' ftuħ:
English: Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated, and a daily dose of 30 mg is associated with a substantially higher incidence of significant adverse reactions including EPS related events, somnolence, fatigue and weight gain (see section 4.8).
Maltese: Ma ntwera l-ebda titjib fl-effikaċja f'dożi ogħla minn doża ta' kuljum ta' 10 mg, u doża ta' kuljum ta' 30 mg hija assoċjata ma' inċidenza ogħla b'mod sinifikanti ta' reazzjonijiet avversi marbuta ma' sindromu ekstrapiramidali, ħedla, għeja u żieda fil-piż (ara sezzjoni 4.8).
English: Urinary incontinence Urinary retention
Maltese: Inkontinenza tal-awrina Żamma tal-awrina
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola għandha 15 mg ta' aripiprazole.
English: Pink colored, approximately 9.1 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A30” on one side and another side is plain.
Maltese: Pilloli mhux miksija, bikonvessi, b'xifer imżerżaq, b'forma tonda, b'dijametru ta' madwar 9.1 mm, ta' kulur roża, b'“A30” imnaqqxa fuq naħa minnhom u bin-naħa l-oħra sempliċi.
English: Despite the high comorbidity frequency of Bipolar I Disorder and ADHD, very limited safety data are available on concomitant use of aripiprazole and stimulants; therefore, extreme caution should be taken when these medicinal products are co-administered.
Maltese: Minkejja l-frekwenza għolja ta' komorbidità għal Disturb Bipolari I u ADHD, hemm dejta limitata ħafna dwar l-użu fl-istess ħin ta' aripiprazole u stimulanti; għalhekk għandha tingħata attenzjoni kbira ħafna meta dawn il-mediċni jingħataw fl-istess ħin.
English: EMEA/H/C/000169/WS/132/G
Maltese: EMEA/H/C/000169/WS/132/G EMEA/H/C/000255/WS/132/G
English: The full European Public Assessment Report for Prometax 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: What are Exelon and Prometax?
Maltese: X'inhuma Exelon u Prometax?
English: Exelon and Prometax are medicines containing the active substance rivastigmine.
Maltese: Exelon u Promteax huma mediċini li fihom is-sustanza attiva rivastigmina.
English: The active substance in Exelon and Prometax, ri blocking the enzymes that break down acetylcholine: acetylcholin By blocking these enzymes, rivastigmine allows levels of acetyl
Maltese: Is-sustanza attiva f'Exelon u Prometax, ir-rivastigmina, taħdem billi timblokka l-enzimi li jkissru l-aċetikolina: aċetilkolinesterażi u butirilkolinesterażi.
English: capsules, an oral solution and transdermal patches (patches tha Exelon and Prometax have been authorised in the EU since May 1998.
Maltese: Exelon u Prometax ġew awtorizzati fl-UE sa minn Mejju 1998.
English: This means that the CHMP had eval documentation provided by the company and formulated lists of questions.
Maltese: Dan ifisser li s-CHMP kien evalwa d-dokumentazzjoni pprovduta mill-kumpanija u fformula lista ta' mistoqsijiet.
English: es this withdrawal have for patients in clinical trials?
Maltese: X'inhuma l-konsegwenzi ta' dan l-irtirar għall-pazjenti fi provi kliniċi?
English: On 14 March 2012, Novartis Europ and Prometax, to add the use of the transdermal patch for the treatment of mild to dementia in patients with Parkinson's disease.
Maltese: Fl-14 ta' Marzu 2012, Novartis Europharm Ltd. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għal estensjoni ta' indikazzjoni għal Exelon u Prometax, sabiex iżid l-użu tar-roqgħa transdermali għall-kura ta' dimensja ħafifa sa moderata f'pazjenti bil-marda ta' Parkinson.
English: The transdermal patches are expected to work in the same way as the capsules patients with dementia associated with Parkinson's disease, certain nerve cells die i resulting in low levels of the neurotransmitter acetylcholine (a substance that allo communicate with each other).
Maltese: F'pazjenti bid-dimensja minħabba l-marda ta' Parkinson, ċerti ċelluli tan-nervituri jmutu fil-moħħ, u dan jirriżulta f'livelli baxxi tan-newrotrażmettitur aċetilkolina (sustanza li tippermetti sabiex iċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin).
English: The full European Public Assessment Report for Exelon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
Maltese: E-mail info@ema.europa.eu
English: s of the medicine can be entia, a progressive lly affects memory, intellectual ability and behaviour.
Maltese: Il-forom kollha tal-mediċina jistgħu jintużaw għat-trattament ta' pazjenti bid-dimensja ta' Alzheimer ħafifa sa moderatament severa, disturb progressiv tal-moħħ li gradwalment jaffettwa l-memorja, l-abilità intellettwali u l-imġiba.
English: The Committee therefore considered that the pharmacokinetic data were not sufficient to draw conclusions on the effectiveness of the patch and that additional data would be required.
Maltese: Għaldaqstant, ilKumitat qies li d-dejta farmakokinetika ma kinitx biżżejjed sabiex jasal għal konklużjonijiet dwar leffikaċja tar-roqgħa u li kien hemm bżonn ta' dejta addizzjonali.
English: The capsules and oral solution can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Maltese: Il-kapsuli u s-soluzzjoni orali jistgħu jintużaw ukoll sabiex jittrattaw dimensja moderatament severa f'pazjenti bil-marda ta' Parkinson.
English: The company had presented pharmacokinetic data showing that, when using the patch, rivastigmine levels in patients with Parkinson's disease were similar to the levels seen in patients with Alzheimer's, but the CHMP noted that the dementia in the two diseases was different and could respond differently to treatment.
Maltese: Il-kumpanija kienet ippreżentat dejta farmakokinetika li turi li, meta jużaw ir-roqgħa, il-livelli tar-rivastigmina fil-pazjenti bil-marda ta' Parkinson kienu simili għal-livelli li dehru f'pazjenti bl-Alzheimer, iżda s-CHMP osserva li d-dimensja fiżżewġ mardiet kienu differenti u setgħu jirrispondu b'mod differenti għat-trattament.
English: y informed the CHMP that there are no consequences for patients currently included in clinical trials with Exelon or Prometax.
Maltese: Kif huma mistennija jaħdmu Exelon u Prometax?
English: There are no consequences on the use of Exelon and Prometax in their author
Maltese: Għalxiex kienu mistennija jintużaw Exelon u Prometax?
English: Withdrawal of the application for a change to the marketing authorisation for Exelon and Prometax harm Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for an extension of indication for Exelon moderately severe
Maltese: L-irqajja' transdernali ta' Exelon u Prometax kienu mistennija li jintużaw ukoll sabiex jittrattaw dimensja ħafifa sa moderatament severa assoċjata mal-marda ta' Parkinson, li diġà tista' tiġi ttrattata billi jintużaw il-kapsuli u s-soluzzjoni orali.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Exelon/Prometax transdermal patch in the treatment of mild to moderately severe dementia associated with Parkinson's disease were uncertain and did not outweigh its risks.
Maltese: Għaldaqstant, fi żmien l-irtirar, is-CHMP kien tal-fehma li l-benefiċċji tar-roqgħa transdermali Exelon/Prometax fit-trattament ta' dimensja ħafifa sa moderatament severa assoċjata mal-marda Parkinson ma kinux ċerti u ma kinux jegħlbu r-riskji tagħha.
English: The company presented the results of a study designed to assess the long-t and transdermal patch in 583 patients with mild to moderately severe dementia ass Parkinson's disease.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju mfassal sabiex jiġu vvalutati l-effetti fit-tul tal-kapsula u tar-roqgħa transdermali f'583 pazjent b'dimensja ħafifa sa moderatament severa assoċjata mal-marda ta' Parkinson.
English: The compan
Maltese: Mistoqsijiet u tweġibiet
English: For darbepoetin alfa:
Maltese: Għal darbepoetin alfa:
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 July 2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20
English: For all epoetins - 4.4.
Maltese: Għall-epoetini kollha - 4.4.
English: Adopted at the 3-6 July 2017 PRAC
Maltese: July 2017
English: Amoxicillin + clavulanic acid
Maltese: Amoksiċillina + aċidu klavulaniku
English: • Vasopressin analogues include: Desmopressin, oxytocin, vasopressin, terlipressin
Maltese: Desmopressin, oxytocin, vasopressin, terlipressin
English: Fulvestrant - Anaphylactic reaction (EPITT no 18832)
Maltese: - Reazzjoni anafilattika (EPITT nru 18832)
English: For all epoetins except darbepoetin alfa and methoxy polyethylene glycol-epoetin beta: 4.8.
Maltese: Għall-epoetini kollha ħlief darbepoetin alfa u methoxy polyethylene glycol-epoetin beta: 4.8.
English: Section Possible side effects
Maltese: Sezzjoni Effetti sekondarji possibbli
English: Darbepoetin alfa; epoetin alfa; epoetin beta; epoetin theta; epoetin zeta; methoxy polyethylene glycol-epoetin beta - Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (EPITT no 18846)
Maltese: 3. Darbepoetin alfa; epoetin alfa; epoetin beta; epoetin theta; epoetin zeta; methoxy polyethylene glycol-epoetin beta - Reazzjonijiet avversi serji tal-ġilda (SCARs) fosthom is-sindrome ta' Stevens-Johnson (SJS) u nekroliżi epidermali tossika (TEN) (EPITT nru 18846)
English: The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%)
Maltese: L-aktar riskju baxx kien irrapportat f'pazjenti bi sklerożi sistemika limitata (2%) u bi sklerożi sistemika li tiżviluppa fit-tfulija (1%)
English: Prednisolone; prednisone - Induced scleroderma renal crisis (EPITT no 18888)
Maltese: Prednisolone; prednisone - Kriżi indotta ta' skleroderma tal-kliewi (EPITT nru 18888)
English: Frequency ‘unknown': Scleroderma renal crisis* *see section c)
Maltese: Kriżi ta' skleroderma tal-kliewi* *ara sezzjoni c)
English: Medicinal products concerned: systemic formulations of prednisolone-containing medicinal products and prednisone-containing medicinal products in doses which provide a systemic concentration equivalent to more than 15 mg prednisolone daily
Maltese: Prodotti mediċinali kkonċernati: formulazzjonijiet sistemiċi ta' prodotti mediċinali li fihom prednisolone u prodotti mediċinali li fihom prednisone f'dożi li jipprovdu konċentrazzjoni sistemika ekwivalenti għal aktar minn 15 mg ta' prednisolone kuljum
English: Immune system disorders Frequency ‘Common': Hypersensitivity reactions Frequency ‘Uncommon': Anaphylactic reactions
Maltese: Frekwenza ‘Komuni': Reazzjonijiet ta' sensittività eċċessiva Frekwenza ‘Mhux komuni': Reazzjonijiet anafilattiċi