FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/11/695/001 [7 transdermal patches] EU/1/11/695/003 [28 transdermal patches] EU/1/11/695/004 [30 transdermal patches]
Maltese: EU/1/11/695/001 [7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/11/695/003 [28 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/11/695/004 [30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda]
English: hypersexuality, libido increased), insomnia, sleep disorder, abnormal dreams, impulse-control disorders a,d
Maltese: ħolm anormali, disturbi filkontrol talimpulsia,d (li jinkludi logħob ta' l-ażżard
English: Orthostatic hypotension
Maltese: Raxx ġeneralizza
English: EU/1/11/695/019 [7 transdermal patches] EU/1/11/695/021 [28 transdermal patches] EU/1/11/695/022 [30 transdermal patches]
Maltese: EU/1/11/695/019 [7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/11/695/021 [28 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/11/695/022 [30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda]
English: Convulsion Dropped head syndrome c
Maltese: Sindrome ta' Ras Baxxutac
English: Because of possible additive effects, caution should be advised when patients are taking sedating medicinal products or other CNS (central nervous system) depressants (e.g. benzodiazepines, antipsychotics, antidepressants) or alcohol in combination with rotigotine.
Maltese: Minħabba l-possibbiltà ta' effetti addittivi, il-pazjenti għandhom jingħataw parir biex joqogħdu attenti meta jkunu jieħu prodotti mediċinali li huma sedattivi jew anti-dipressanti tas-CNS (central nervous system) oħrajn (eż. benzodiazepines, mediċini antipsikotiċi, anti-dipressanti) jew alkoħol flimkien ma' rotigotine.
English: EU/1/11/695/037 [7 transdermal patches] EU/1/11/695/039 [28 transdermal patches] EU/1/11/695/040 [30 transdermal patches]
Maltese: EU/1/11/695/037 [7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/11/695/039 [28 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/11/695/040 [30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda]
English: Pruritus
Maltese: Dijarea
English: Leganto 6 mg/24 h transdermal patch EU/1/11/695/037
Maltese: Leganto 6 mg/24 h impjastra li tipprovdi mediċina li tgħaddi minn taħt il-ġilda EU/1/11/695/037
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: jistgħu jaffettwaw sa 1 minn kull 100 pazjent
English: Leganto 3 mg/24 h transdermal patch EU/1/11/695/019
Maltese: Leganto 3 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda EU/1/11/695/019
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu/.
English: Leganto 4 mg/24 h transdermal patch EU/1/11/695/028
Maltese: Leganto 4 mg/24 h impjastra li tipprovdi mediċina li tgħaddi minn taħt il-ġilda EU/1/11/695/028
English: This is because
Maltese: Tista'
English: loss of muscle movement (akinesia), rigid muscles, fever, unstable blood pressure, increased heart rate (tachycardia), confusion, low level of consciousness (such as a coma).
Maltese: Issinjali jinkludu telf tal-moviment tal-muskoli (akinesja ), muskoli riġidi, deni, pressjoni tad-demm mhux stabbli, żieda fit-taħbit tal-qalb (takikardja ), konfużjoni, livell iżjed baxx ta' koxxenza (bħal koma)
English: • generalised rash
Maltese: • raxx ġeneralizzat
English: Leganto 4 mg/24 h
Maltese: Leganto 4 mg/24 siegħa
English: • you may get skin problems caused by the patch - see ‘Skin problems caused by the patch' in section 4.
Maltese: • Jista' jkun ikollok xi problemi tal-ġilda kkawżati bl-impjastra - ara ‘Problemi tal-ġilda ikkawżati bl-impjastra' f'sezzjoni 4.
English: EU/1/11/695/007 [84 transdermal patches (3 packs of 28)]
Maltese: FIS-SUQ EU/1/11/695/007 [84 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda ( 3 pakketti ta' 28)]
English: High Level Term b
Maltese: GĦAMLA KWALITATTIVA
English: • delirium
Maltese: • palpitazzjoni
English: The effects of rotigotine on reproduction have been investigated in rats, rabbits and mice.
Maltese: L-effetti ta' rotigotine fuq ir-riproduzzjoni kienu investigati fil-firien, fniek u ġrieden.
English: Obsessivecompulsive disorder, agitation d
Maltese: Mard kompulsiv ossessiv, aġitazzjonid
English: In clinical trial studies with rotigotine, syncope has been observed at a rate that was similar to that observed in patients treated with placebo.
Maltese: F'provi kliniċi b' rotigotine, sinkope kien osservat, b' rata li kienet simili ta' dik osservata f'pazjenti li kienu kkurati bil-plaċebo.
English: • For most patients, the right dose is between 6 mg and 8 mg each day.
Maltese: • Għall-biċċa l-kbira tal-pazjenti, id-doża korretta hija ta' bejn 6 mg u 8 mg kuljum.
English: Nausea, vomiting Constipation, dry mouth, dyspepsia
Maltese: Mhux magħruf diskinesjae, sturdament posturalie, letarġijae, konvulżjonie
English: Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is excreted in faeces.
Maltese: Madwar 71% tad-doża ta' rotigotine titneħħa fl-awrina u parti iżgħar ta' madwar 23% titneħħa flippurgar.
English: • feeling dizzy
Maltese: • tħossok aġitat
English: 7 transdermal patches of Leganto 8 mg/24 h
Maltese: INFORMAZZJONI BIL-BRAILLE Leganto 8 mg/24 siegħa
English: • dropped head syndrome
Maltese: (‘Dropped Head')
English: • falling
Maltese: • sturdament
English: 7 transdermal patches of Leganto 6 mg/24 h
Maltese: INFORMAZZJONI BIL-BRAILLE Leganto 6 mg/24 siegħa
English: EU/1/11/695/046 [7 transdermal patches] EU/1/11/695/048 [28 transdermal patches] EU/1/11/695/049 [30 transdermal patches]
Maltese: FIS-SUQ EU/1/11/695/046 [7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/11/695/048 [28 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/11/695/049 [30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda]
English: Self adhesive matrix layer
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-QARTAS
English: Thin, matrix-type, square-shaped with rounded edges, consisting of three layers.
Maltese: Irqiqa, matrix-type, b'forma kwadra bi truf jagħtu fit-tond, li tikkonsisti fi tliet saffi.
English: erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation,
Maltese: Eritemae, iperidrożie, pruritus ġeneraliżżatae, irritazzjoni talġildae, dermatite talkuntatte, raxx ġeneralizzate,
English: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine (see section 4.4).
Maltese: Logħob ta' l-ażżard patoloġiku, żieda fil-libido, ipersesswalità, infiq u xiri kompulsiv jistgħu iseħħu f'pazjenti ttrattati b'agonisti ta' dopamine li jinkludi rotigotine, (ara sezzjoni 4.4 ‘Twissijiet speċjali u prekawzjonijiet').
English: Transparent fluoropolymer coated polyester film.
Maltese: Saff ta' polyester miksi b'fluoropolimer trasparenti
English: The daily dose should be reduced in steps of 2 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Leganto (see section 4.4).
Maltese: Id-doża ta' kuljum għandha titnaqqas f'inkrementi ta' 2 mg/24 siegħa bi tnaqqis tad-doża preferibbilment darba kull jumejn, sakemm Leganto jitwaqqaf għal kollox (ara sezzjoni 4.4).
English: Leganto 1 mg/24 h transdermal patch Leganto 3 mg/24 h transdermal patch
Maltese: INFORMAZZJONI BIL-BRAILLE Leganto 3 mg/24 siegħa
English: leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h
Maltese: INFORMAZZJONI BIL-BRAILLE Leganto 2 mg/24 siegħa, 4 mg/24 siegħa, 6 mg/24 siegħa, 8 mg/24 siegħa.
English: • increased levels of creatine phosphokinase (CPK) in blood in Japanese patients (CPK is an enzyme found mainly in skeletal muscles), no information is available in other populations.
Maltese: • żieda fil-livelli ta' creatine phosphokinase (CPK) fid-demm f'pazjenti Ġappuniżi (CPK hija enzima li tinsab prinċipalment fil-muskoli skeletriċi), l-ebda informazzjoni mhija disponibbli f'popolazzjonijiet oħra.
English: Leganto 2 mg/24 h Leganto 4 mg/24 h Leganto 6 mg/24 h Leganto 8 mg/24 h Transdermal patch
Maltese: Il-qawwiet huma 2 mg/24 siegħa, 4 mg/24 siegħa, 6 mg/24 siegħa u 8 mg/24 siegħa għat-trattament tal-Marda ta' Parkinson.
English: CPK levels have not been routinely measured in other populations.
Maltese: Livelli ta' CPK ma kienux mkejla b'rutina f'popolazzjonijiet oħrajn.
English: Leganto 4 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 4 mg/24 h'.
Maltese: Fil-bidu tat-tieni ġimgħa, inti għandek tieħu Leganto 4 mg (pakkett immarkat “Ġimgħa 2”).
English: For doses higher than 8 mg/24 h multiple patches may be used to achieve the final dose e.g. 10 mg/24 h may be reached by combination of a 6 mg/24 h and a 4 mg/24 h patch.
Maltese: Per eżempju, id-doża ta kuljum ta' 10 mg tista' tintlaħħaq billi tuża impjastru ta' 6 mg/24 h u impjastru ta 4 mg/24 h flimkien.
English: Patients being treated with rotigotine and presenting with somnolence and/or sudden sleep episodes must be informed not to drive or engage in activities (e.g. operating machines) where impaired alertness may put themselves or others at risk of serious injury or death until such recurrent episodes and somnolence have resolved (see also sections 4.4 and 4.5).
Maltese: Pazjenti li qed jiġu kkurati b'rotigotine u li jkollhom nagħas u/jew episjodi ta' rqad li jiġi għal għarrieda, għandhom ikunu infurmati biex ma jsuqux jew jagħmlu attivitajiet (eż. jħaddmu l-magni) fejn in-nuqqas ta' attenzjoni jista' jpoġġi lilhom jew lill-oħrajn f'riskju ta' korriment serju jew mewt, sakemm dawn l-episodji rikorrenti u nagħas jiġu riżoluti (ara wkoll sezzjonijiet 4.4 u 4.5).
English: EU/1/11/695/052 [84 transdermal patches (3 packs of 28)]
Maltese: FIS-SUQ EU/1/11/695/052 [84 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (3 pakketti ta' 28)]
English: On the first day of treatment, start with Leganto 2 mg (package marked “Week 1”), and use one Leganto 2 mg transdermal patch daily.
Maltese: Fl-ewwel jum tat-trattament, ibda b'Leganto 2 mg (pakkett immarkat “Ġimgħa 1”), uża impjastru wieħed ta' Leganto 2 mg kuljum.
English: EU/1/11/695/016 [84 transdermal patches (3 packs of 28)]
Maltese: FIS-SUQ EU/1/11/695/016 [84 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (3 pakketti ta' 28)]
English: • abnormal heart rhythm
Maltese: • ritmu tal-qalb abnormali
English: The safety profile was comparable, with the exception of application site reactions.
Maltese: Il-profil ta' sigurta` kien komparabli, ħlief fir-reazzjonijiet tas-sit fejn jingħata.
English: Observed in 2011 data pool of double-blind placebo-controlled studies
Maltese: Waqgħa a Terminu ta' Livell Għoli b Osservat f'studji open-label c Osservat wara t-tqegħid fis-suq d Osservat f'ġabra minn dejta mil 2011minn studji double-blind ikkontrollati minn plaċebo
English: EU/1/11/695/025 [84 transdermal patches (3 packs of 28)]
Maltese: FIS-SUQ EU/1/11/695/025 [84 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (3 pakketti ta' 28)]
English: The signs include:
Maltese: Kellem lit-tabib tiegħek jekk inti qed tieħuli:
English: Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
Maltese: Ma sarux studji addizzjonali biex issir evalwazzjoni ulterjuri tal-patoloġija speċifika.
English: • constipation, dry mouth, heartburn
Maltese: • konstipazzjoni, ħalq niexef, ħruq ta stonku
English: Open the sachet.
Maltese: reazzjoni severa.
English: Renal impairment
Maltese: Reazzjonijiet Allerġiċi
English: The incidence of some dopaminergic adverse reactions, such as hallucinations, dyskinesia, and peripheral oedema generally is higher when given in combination with L-dopa in Parkinson's patients.
Maltese: L-inċidenza ta' xi avvenimenti avversi dopaminerġiċi, bħal alluċinazzjonijiet, diskinesija, u edema periferali, ġeneralment hi ogħla meta l-mediċina tingħata flimkien ma' L-dopa, fil-pazjenti bil-marda ta' Parkinson.
English: Neuroleptics
Maltese: Palpitazzjonijie
English: EU/1/11/695/043 [84 transdermal patches (3 packs of 28)]
Maltese: FIS-SUQ EU/1/11/695/043 [84 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (3 pakketti ta' 28)]
English: pruritus generalisede, skin irritation e,
Maltese: Ħakk ġeneralizzat, irritazzjoni talġilda dermatite talkuntatt,
English: This is normally reached within 3 to 4 weeks.
Maltese: Din tintlaħaq normalment fi żmien 3 sa 4 ġimgħa.
English: Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Maltese: Leganto jista' jikkawża aġir u ħsibijiet abnormali oħra.
English: EU/1/11/695/010 [7 transdermal patches] EU/1/11/695/012 [28 transdermal patches] EU/1/11/695/013 [30 transdermal patches]
Maltese: FIS-SUQ EU/1/11/695/010 [7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/11/695/012 [28 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/11/695/013 [30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda]
English: • your eyes need checking regularly while using Leganto.
Maltese: • Għajnejk għandhom bżonn jiġu ċċekkjati regolarment waqt li tuża Leganto.
English: Dopamine dysregulation syndrome c
Maltese: Sindromu ta' disregulazz joni ta' dopaminec
English: Leganto 4 mg/24 h transdermal patch Leganto 6 mg/24 h transdermal patch Leganto 8 mg/24 h transdermal patch
Maltese: In-naħa ta' barra hi ta' kulur kannella ċar u għandha l-kliem Leganto 4 mg/24 h, Leganto 6mg/ h and Leganto 8 mg/ h stampat fuqha.
English: EU/1/11/695/028 [7 transdermal patches] EU/1/11/695/030 [28 transdermal patches] EU/1/11/695/031 [30 transdermal patches]
Maltese: FIS-SUQ EU/1/11/695/028 [7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/11/695/030 [28 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/11/695/031 [30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda]
English: Leganto 8 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Leganto 8 mg/24 h'.
Maltese: Leganto 8 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda Kull impjastru jerħi 8 mg ta' rotigotine kull 24 siegħa.
English: UCB Pharma S.A. Tél: +33-(0)1 47 29 44 35
Maltese: Tél: + 33 / (0)1 47 29 44 35
English: The daily dose should be reduced in steps of 1 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Leganto (see section 4.4).
Maltese: Id-doża ta' kuljum għandha titnaqqas f'inkrementi ta' 1 mg/24 siegħa bi tnaqqis tad-doża preferibbilment darba kull jumejn, sakemm Leganto jitwaqqaf għal kollox (ara sezzjoni 4.4).
English: Leganto is available in different strength patches which release the medicine over 24 hours.The strengths are 1 mg/24 h, 2 mg/24 h and 3 mg/24 h for the treatment of Restless Leg Syndrome.
Maltese: Il-qawwiet huma ta' 1 mg/24 siegħa, 2 mg/24 siegħa, u 3 mg/24 siegħa għat-trattament ta' Restless Leg Synrome.
English: EU/1/11/695/034 [84 transdermal patches (3 packs of 28)]
Maltese: FIS-SUQ EU/1/11/695/034 [84 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda ( 3 pakketti ta' 28)]
English: Leganto treatment initiation pack contains 4 different packages (one for each strength) with 7 patches each, for the first four weeks of therapy.
Maltese: Il-pakkett tal-bidu tal-kura ta' Leganto fih 4 pakketti differenti (wieħed għal kull qawwa) b'7 impjastri kull wieħed, għall-ewwel erba' ġimgħat tat-terapija.
English: Observed in patients with Restless Legs Syndrome
Maltese: Osservata f'pazjenti bis-Sindromu ta' Restless Legs
English: SACHET LABEL
Maltese: Mard kardijaku
English: However, a contribution of these metabolites to clinical effects is unlikely.
Maltese: Madankollu, mhux mistenni li jkun hemm kontribuzzjoni ta' dawn il-metaboliti lill-effetti kliniċi.
English: 7 transdermal patches of Leganto 4 mg/24 h
Maltese: INFORMAZZJONI BIL-BRAILLE Leganto 4 mg/24 siegħa
English: Treatment of Parkinson's disease
Maltese: Trattament tal-Marda ta' Parkinson
English: In clinical studies with rotigotine, syncope has been observed at a rate that was similar to that observed in patients treated with placebo.
Maltese: F'studji kliniċi b' rotigotine, is-sinkope kien osservat b' rata li kienet simili ta' dik osservata f'pazjenti li kienu kkurati bil-plaċebo.
English: Common: may affect up to 1 in 10 people
Maltese: Komuni: jistgħu jaffettwaw sa 1 minn kull 10 pazjenti
English: Rotigotine did not influence male fertility in rats, but clearly reduced female fertility in rats and mice, because of the effects on prolactin levels which are particularly significant in rodents.
Maltese: Rotigotine ma influwenzax il-fertilità fil-firien irġiel, iżda naqqas b'mod ċar ilfertilità fil-firien u ġrieden nisa, minħabba l-effetti fuq il-livelli ta' prolactin li huma partikularment sinifikanti f'annimali gerriema.
English: 7 transdermal patches 28 transdermal patches 30 transdermal patches
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA TA' 7 [28] [30 IMPJASTRU
English: Efficacy/safety data is insufficient to establish a relation between exposure and response (see also paediatric information in section 4.2).
Maltese: Dejta dwar l-effikaċja/ sigurta` ma kienitx biżżejjed biex tisstabbilixxi relazzjoni bejn esponiment u rispons (ara wkoll informazzjoni pedjatrika f'sezzjoni 4.2)
English: In trials where the application sites were rotated as reflected in the instructions provided in SmPC and package leaflet, 35.7% of 830 patients using the Leganto transdermal patch, experienced application site reactions.
Maltese: Fi provi fejn iż-zoni ta' l-applikazzjoni nbidlu kif indikat fl-istruzzjonijiet ipprovduti fl-SmPC u filfuljett ta' tagħrif, 35.7% tat-830 pazjent li kienu jużaw il-garża Leganto li tipprovdi mediċina li tgħaddi minn ġol-ġilda, ġarrbu reazzjonijiet fiż-żona ta' l-applikazzjoni.
English: Lifepharma (Z.A.M.)
Maltese: Is-sustanzi l-oħra huma
English: Rotigotine has been associated with somnolence and episodes of sudden sleep onset.
Maltese: Rotigotine kien assoċjat man-nagħas u episodji ta' rqad li jiġi f'daqqa.
English: In two openlabel, follow-up studies over a subsequent 12 months, the rate of clinically relevant augmentation was 2.9%.
Maltese: F'żewġ studji follow up open-label fuq it-12-il xahar ta' wara, ir-rata ta' awmentazzjoni klinikament rilevanti kienet ta' 2.9%.
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathologic gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine.
Maltese: Il-pazjenti u dawk li jieħdu ħsiebhom għandhom jiġu mgħarrfa li s-sintomi ta' mġiba ta' disturbi filkontrol tal-impulsi jinkludu logħob patoloġiku ta' l-ażżard, żieda fil-libido, ipersesswalità, infieq u xiri kompulsiv, iffangar u ikel bla kontrol jistgħu jiġru f'pazjenti kkurati b'agonisti ta' dopamine, li jinkludu rotigotine.
English: This mutagenic effect could be attributed to a clastogenic effect of rotigotine.
Maltese: dawn il-metaboliti lill-effetti kliniċi.
English: If you still get problems with your skin because of the patch, please see ‘Skin problems caused by the patch' in section 4 for more information.
Maltese: Jekk xorta jkollok il-problemi fil-ġilda minħabba l-impjastru, jekk jogħġbok ara ‘Problemi fil-ġilda kkawżati mill-impjastru' f'sezzjoni 4 għal iktar informazzjoni.
English: This leaflet was last revised in {MM/YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST {XX/SSSS}
English: Erythema, hyperhidrosis, pruritus
Maltese: Nagħas, Sturdament, Uġigħ ta' ras
English: • increased or abnormal liver test results
Maltese: Korriment, avellinament u komplikazzjonij iet proċedurali
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) CEPROTIN EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEA (EPAR) CEPROTIN Sommarju ta' l-EPAR għall-pubbliku
English: This summary was last updated in 08-2007.©EMEA 2007
Maltese: ©EMEA 2007
English: This document is a summary of the European Public Assessment Report (EPAR).
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropea (EPAR).
English: CEPROTIN is given by intravenous injection (injection into a vein) at a maximum injection rate of 2 ml per minute except for children with a body weight of less than 10 kg, where the injection rate should not exceed 0.2 ml per kilogram body weight per minute.
Maltese: CEPROTIN jingħata permezz ta' injezzjoni intravenuża (injezzjoni ġol-vina) f'rata massima ta' injezzjoni ta' 2 ml kull minuta ħlief fi tfal b'piż korporali ta' anqas minn 10 kg, fejn ir-rata ta' injezzjoni m'għandhiex taqbeż 0.2 ml għal kull kilogramma tal-piż korporali kull minuta.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abba\i tar-rakkommandazzjonijiet tas-CHMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR)
English: CEPROTIN has been studied in a total of 79 patients, 22 of whom had a diagnosis of the more severe forms of congenital protein C deficiency.
Maltese: CEPROTIN ġie studjat f'total ta' 79 pazjent, li 22 minnhom kellhom dijanjożi ta' forom aktar severi ta' defiċjenza konġenitali tal-proteina Ċ.
English: CEPROTIN is used in patients with severe congenital (hereditary) protein C deficiency to treat purpura fulminans (extensive clotting of blood within the blood vessels, which causes the death of the tissues just beneath the skin, often leading to organ failure and amputations) and coumarin-induced skin necrosis (a complication of anticoagulant treatment with medicines such as warfarin, causing skin death).
Maltese: CEPROTIN jintuża f'pazjenti b'defiċjenza konġenitali (ereditarja) ta' proteina Ċ severa biex jikkura purpura fulminans (tgħaqqid tad-demm estensiv fil-vini u l-arterji tad-demm, li tikkaġuna l-mewt tat-tessuti eżatt taħt ilġilda, li ta' spiss iwassal għal falliment ta' l-organi u amputazzjonijiet) u nekrożi tal-ġilda mqanqla mill-coumarin (kumplikazzjoni ta' kura b'mediċini bħal ma' huma warfarin, li tikkaġuna mewt talġilda).
English: The main measures of the study were normalisation of protein C levels and other indicators of coagulation (clotting) activation.
Maltese: Il-miżuri prinċipali ewlenin ta' l-istudju kienu normalizzazzjoni ta' livelli ta' proteina Ċ u indikaturi oħra ta' attivazzjoni tal-koagulazzjoni (tgħaqqid tad-demm).
English: What is CEPROTIN?
Maltese: X'inhu CEPROTIN?
English: Why has CEPROTIN been approved?
Maltese: Għaliex ġie approvat CEPROTIN?
English: The European Commission granted a marketing authorisation valid throughout the European Union for CEPROTIN to Baxter AG on 16 July 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal CEPROTIN lil Baxter AG fis-16 ta' Lulju 2001.
English: Protein C is a natural substance in the blood that controls clotting.
Maltese: Proteina Ċ hija soluzzjoni naturali fid-demm li tikkontrolla t-tgħaqqid tad-demm.
English: CEPROTIN contains human protein C, extracted and purified from human plasma (the liquid part of the blood).
Maltese: CEPROTIN fih proteina Ċ tal-bniedem, estratta u ippurifikata minn plażma tal-bniedem (il-parti likwida tad-demm).
English: Protein C slows down the production of thrombin, and therefore slows down further clotting.
Maltese: Il-proteina Ċ tittardja l-produzzjoni ta' trombin, u għaldaqstant tittardja aktar it-tgħaqqid tad-demm.
English: In patients with severe congenital protein C deficiency, CEPROTIN improved all 16 cases of purpura fulminans and all six episodes of coumarin-induced skin necrosis.
Maltese: F'pazjenti b'defiċjenza konġenitali ta' proteina Ċ severa, CEPROTIN tejjeb is-16-il każ kollha ta' purpura fulminans u s-sitt episodji kollha ta' nekrożi tal-ġilda imqanqla mill-coumarin.
English: How has CEPROTIN been studied?
Maltese: Kif ġie studjat CEPROTIN?
English: If CEPROTIN is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop.
Maltese: Jekk CEPROTIN jintuża f'pazjenti b'defiċjenza konġenitali ta' proteina Ċ severa, jistgħu jiżviluppaw antikorpi li jimpedixxu l-proteina Ċ.