FrancophonIA/ELRC3.0 huggingface dataset:
English: It primarily acts through reducing excessive endothelial cell (EC) activation (endothelial dysfunction), modulating endothelial homeostasis as well as restoring thrombo-fibrinolytic balance.
Maltese: Jaġixxi b'mod primarju billi jnaqqas l-attivazzjoni eċċessiva taċ-ċellula endoteljali (EC, endothelial cell) (disfunzjoni endoteljali), billi jimmodula l-omeostażi endoteljali kif ukoll jerġa' jistabbilixxi l-bilanċ trombo-fibrinolitiku.
English: Catheter site haemorrhage Pyrexia
Maltese: Ematoma ċerebrali
English: Pharmacokinetic modelling simulation analysis showed that Defitelio plasma concentrations do not accumulate upon multiple dose administration and with doses up to 4-fold the therapeutic dose.
Maltese: L-analiżi tas-simulazzjoni tal-mudellar farmakokinetiku uriet li l-konċentrazzjonijiet ta' Defitelio filplasma ma jakkumulawx wara amministrazzjoni ta' diversi dożi u b'dożi li huma sa 4 darbiet id-doża terapewtika.
English: The tabulated list of adverse reactions incorporates the ADRs observed in study 2005-01 [ADR = any event reported as possibly related on at least two occasions] and TEAEs observed in T-IND 2006-05 study [TEAE = any AE that started or worsened in severity after the first dose of defibrotide].
Maltese: [ADR = kull avveniment rapportat bħala possibilment relatat f'tal-inqas żewġ okkażjonijiet] u t-TEAEs osservati fl-istudju TIND 2006-05
English: Haemothorax
Maltese: Raxx
English: Tel.: +48 17 865 51 00
Maltese: Valeant Pharma Poland sp. z o.o. Tel.: +48 17 865 51 00
English: Updated analysis from CIBMTR to be submitted by end of December 2020.
Maltese: L-analiżi aġġornata minn CIBMTR għandha tiġi ppreżentata salaħħar ta' Diċembru 2020.
English: Other medicines and Defitelio
Maltese: Kif taħżen Defitelio
English: Forty-four children and 58 adult patients with severe VOD post-HSCT, were treated with Defitelio 25 mg/kg/day intravenous by infusion, and compared with 32 historical control patients.
Maltese: Erbgħa u erbgħin tifel/tifla u 58 pazjent adult b'VOD severa wara HSCT, ġew ikkurati b'Defitelio 25 mg/kg/jum ġol-vini b'infużjoni, u mqabbla ma' 32 pazjent b'kontroll storiku.
English: In 52 healthy volunteers, after a single 6.25 mg/kg dose of Defitelio given as a 2-hour infusion, the pharmacokinetic parameters were as follows:
Maltese: Fi 52 voluntier b'saħħtu, wara doża waħda ta' 6.25 mg/kg ta' Defitelio mogħtija bħala infużjoni fuq sagħtejn, il-parametri farmakokinetiċi kienu kif ġejjin:
English: Alive at Day +100 VOD resolved by Day +100
Maltese: Ħajjin f'Jum +100 VOD għaddiet sa Jum +100
English: The efficacy data from this pivotal study are supported and confirmed with data from a dose-finding study (25 mg/kg arm) and the Open Label Treatment-IND study, as presented in Tables 1.
Maltese: Id-dejta tal-effikaċja minn dan l-istudju pivotali hija appoġġata u kkonfermata mid-dejta minn studju tat-tisjib tad-doża (fergħa ta' 25 mg/kg) u l-istudju tal-Kura-IND b'Tikketta Mikxufa, kif ippreżentata fit-Tabella 1.
English: These data are from an open label registry and the subjects were not randomised.
Maltese: Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: After the infusion is complete, the intravenous line should be flushed with sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion.
Maltese: Wara li titlesta l-infużjoni, il-linja intravenuża għandha tiġi flaxxjata b'sodium chloride 9 mg/mL (0.9%) soluzzjoni għal infużjoni jew bi glucose 5% soluzzjoni għal infużjoni.
English: In the Segment II reproductive studies in rats and rabbits, defibrotide has shown maternal toxicity by inducing a high rate of haemorrhagic abortion when infused intravenously over two hours at all dose levels tested including doses close to the human dose.
Maltese: Fl-istudji riproduttivi tas-Segment II fil-firien u l-fniek, defibrotide wera tossiċità materna billi induċa rata għolja ta' abort emorraġiku meta ġie infużjat ġol-vini fuq sagħtejn f'kull livell tad-dożi ttestjati inkluż dożi qrib id-doża umana.
English: In addition, although in the defibrotide studies in VOD there have been no reports of hypersensitivity, cases of hypersensitivity including anaphylaxis were reported from a previously marketed formulation of defibrotide, consequently hypersensitivity is included as an ADR.
Maltese: Barra minn hekk, għalkemm fl-istudji ta' defibrotide fil-VOD ma kien hemm ebda rapport ta' sensittività eċċessiva, każijiet ta' sensittività eċċessiva inkluż anafilassi ġew irrapportati minn formulazzjoni kkummerċjalizzata preċedentament ta' defibrotide, konsegwentament, is-sensittività eċċessiva hija inkluża bħala ADR.
English: Side effects in children (1 month to 18 years old) are expected to be similar in type, severity and frequency and no other special precautions are needed.
Maltese: Effetti sekondarji fit-tfal (xahar sa 18-il sena) huma mistennija li jkunu simili fit-tip, severità u frekwenza u ma hemm bżonn ta' ebda prekawzjoni speċjali oħra.
English: A bolus administration of Defitelio may cause flushing or a sensation of “generalised heat”.
Maltese: Amministrazzjoni bolus ta' Defitelio tista' tikkawża fwawar jew sensazzjoni ta' "sħana ġeneralizzata".
English: Defibrotide protects ECs from damage and promotes tissue homeostasis by decreasing fludarabine-mediated apoptosis of EC while maintaining its anti-leukemic effect and by inhibiting the expression of heparanase, shown in in vitro and in vivo studies respectively.
Maltese: Defibrotide jipproteġi ċ-ċelluli endoteljali mill-ħsara u jippromwovi l-omeostażi tat-tessut billi jnaqqas l-apoptożi medjata bi fludarabine taċ-ċellula endoteljali, filwaqt li jżomm l-effett anti-lewkemiku tiegħu u billi jinibixxi l-espressjoni ta' heparanase, kif muri fi studji in vitro u in vivo rispettivament.
English: Conjunctival haemorrhage
Maltese: Mhux komuni
English: Non-defibrotide treated Defibrotide treated
Maltese: Ikkurati b'defibrotide
English: Due to this maternal toxicity, no conclusion can be drawn regarding the effects of defibrotide on embryo-foetal development.
Maltese: Minħabba din it-tossiċità maternali, ma tista' tinstilet ebda konklużjoni dwar l-effetti ta' defibrotide fuq l-iżvilupp embriju-fetali.
English: There is currently no reported experience in patients on the concomitant treatment with Low Molecular Weight Heparins (LMWHs), warfarin or the concomitant treatment with direct thrombin inhibitors (e.g., dabigatran) or direct Factor Xa inhibitors (e.g., rivaroxaban and apixaban).
Maltese: Baxx (LMWHs), warfarina jew il-kura konkomittanti b'inibituri ta' trombin diretti (eż. dabigatran) jew inibituri ta' Fattur Xa diretti (eż. rivaroxaban u apixaban).
English: Table 1: Treatment Study Results: Complete Response and Survival Rate of Severe VOD at Day+100
Maltese: Tabella 1: Riżultati tal-Istudju tal-Kura: Rispons Sħiħ u Rata ta' Sopravivenza ta' VOD Severa f'Jum+100
English: US Registry data
Maltese: Informazzjoni għall-utent
English: Repeated intravenous administration of defibrotide, at doses below and close to the human therapeutic dose, to juvenile rats resulted in a delay in the mean age of preputial separation, suggesting a delay in the onset of male puberty in rats.
Maltese: Għoti ġol-vini ripetut ta' defibrotide, f'dożi inqas u qrib id-doża terapewtika umana, għal firien ġuvenili rriżulta f'dewmien fl-età medja tas-separazzjoni preputjali, u dan jissuġġerixxi dewmien filbidu tal-pubertà maskili fil-firien.
English: Valeant Pharma S.R.L Tel.: +40 374 102 600 Romania.info@valeant.com
Maltese: Valeant Pharma S.R.L Tel.: +40
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP
English: Defitelio has been used in clinical trials in patients with hepatic impairment without dose adjustment with no major safety issues identified (see section 4.2).
Maltese: Defitelio ilu jintuża fi provi kliniċi f'pazjenti b'indeboliment epatiku mingħajr aġġustament tad-doża mingħajr kwistjonijiet maġġuri relatati mas-sigurtà identifikati (ara sezzjoni 4.2).
English: One carton contains 10 glass vials with 2.5 mL of concentrate each.
Maltese: Kartuna waħda fiha 10 kunjetti tal-ħġieġ b'2.5 mL ta' konċentrat kull wieħed.
English: Hepatic impairment
Maltese: Mediċini oħra u Defitelio
English: How to store Defitelio
Maltese: Indeboliment tal-fwied
English: It is recommended that the diluted Defitelio solution be administered to patients using an infusion set equipped with a 0.2 μm in-line filter.
Maltese: Huwa rrakkomandat li s-soluzzjoni ta' Defitelio dilwita tingħata lil pazjenti li jużaw sett ta' infużjoni mgħammar b'0.2 μm filtri in-line.
English: It can be diluted with 5% glucose solution for infusion or sodium chloride 9 mg/mL (0.9%) solution for infusion, to a suitable concentration to permit infusion over 2 hours.
Maltese: Dan jista' jiġi dilwit ma' 5% glucose soluzzjoni għal infużjoni jew sodium chloride 9 mg/mL (0.9%) soluzzjoni għal infużjoni, għal konċentrazzjoni xierqa sabiex tkun tista' ssir infużjoni fuq sagħtejn.
English: Adverse reactions observed are listed below, by system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi osservati huma elenkati taħt, skont is-sistema tal-klassifika tal-organi u lfrekwenza.
English: Therefore, the use of defibrotide with antithrombotic/fibrinolytic medicinal products is not recommended.
Maltese: Għalhekk, l-użu ta' defibrotide ma' prodotti mediċinali antitrombotiċi/fibrinolitiċi mhuwiex rakkomandat.
English: NAME OF THE MEDICINAL PRODUCT Defitelio 80 mg/mL concentrate for solution for infusion
Maltese: Defitelio 80 mg/mL konċentrat għal soluzzjoni għal infużjoni
English: No formal pharmacokinetic studies have been performed in hepatic impaired patients.
Maltese: Ma sarux studji farmakokinetiċi formali f'pazjenti b'indeboliment tal-fwied.
English: Medicinal products that affect platelet aggregation (e.g. non-steroidal anti-inflammatory agents) should be administered with care, under close medical supervision, during Defitelio administration.
Maltese: Prodotti mediċinali li jaffettwaw l-aggregazzjoni tal-plejtlits (eż. sustanzi anti-infjammatorji mhux sterojdali) għandhom jingħataw b'attenzjoni, taħt superviżjoni medika mill-qrib, matul l-għoti ta' Defitelio.
English: The recommended dose for children aged 1 month to 18 years is the same mg/kg dose as for adults i.e. 6.25 mg/kg body weight every 6 hours.
Maltese: Id-doża rakkomandata għal tfal ta' bejn xahar u 18-il sena hija l-istess doża mg/kg bħal dik fl-adulti, jiġifieri 6.25 mg/kg piż tal-ġisem kull 6 sigħat.
English: Page 2/2
Maltese: PaġNA 2/2
English: 19 May 2010
Maltese: 19 ta' Mejju 2010
English: It was to be available as capsules.
Maltese: Kellu jkun disponibbli bħala kapsuli.
English: What is Beprana?
Maltese: X'inhu Beprana?
English: Withdrawal of the marketing authorisation application for Beprana (naproxcinod) EMA/364651/2011
Maltese: Irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Beprana (naproxcinod) EMA/364651/2011
English: Beprana is a medicine that contains the active substance naproxcinod.
Maltese: Beprana huwa mediċina li fiha s-sustanza attiva naproxcinod.
English: Two of the studies involved 1,929 patients with knee osteoarthritis while the third study involved 810 patients with hip osteoarthritis.
Maltese: Tnejn mill-istudji involvew 1,929 pazjent b'osteoartrite tal-irkoppa filwaqt li t-tielet studju involva 810 pazjenti b'osteoartrite tal-ġenbejn.
English: The active substance in Beprana, naproxcinod, is converted in the body into the drug naproxen and a chemical that releases nitric oxide.
Maltese: Is-sustanza attiva f'Beprana, naproxcinod, tinqeleb fil-ġisem fil-mediċina naproxen u f'sustanza kimika li terħi n-nitric oxide.
English: Naproxen is a non-steroidal anti-inflammatory drug (NSAID).
Maltese: Naproxen hija mediċina kontra l-infjammazzjoni mhux sterojdali (NSAID).
English: It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Maltese: Jaħdem billi jimblokka enzima msejħa cyclo-oxygenase, li tipproduċi prostaglandins, sustanzi li huma involuti fil-proċess ta' infjammazzjoni.
English: On 19 April 2011, NicOx S. A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Beprana in adults for the relief of signs and symptoms of osteoarthritis of the knee and hip.
Maltese: Fid-19 ta' April 2011, NicOx S. A. innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal Beprana fl-adulti għas-serħan minn sinjali u sintomi ta' osteoartrite tal-irkoppa u l-ġenbejn.
English: What was Beprana expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Beprana?
English: Withdrawal of the marketing authorisation application for Beprana (naproxcinod)
Maltese: Irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Beprana (naproxcinod)
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Maltese: Dan ifisser li s-CHMP kien evalwa d-dokumentazzjoni pprovduta mill-kumpanija u fformula lista ta' mistoqsijiet.
English: Beprana was expected to be used to relieve the signs and symptoms of osteoarthritis (swelling and pain in the joints) of the knee and hip in adults.
Maltese: Beprana kien mistenni li jintuża biex iserraħ mis-sinjali u sintomi ta' osteoartrite tal-irkoppa u lġenbejn (nefħa u uġigħ fil-ġogi) fl-adulti.
English: Three main studies in patients were carried out, comparing Beprana with naproxen (another medicine used in osteoarthritis) and placebo (a dummy treatment).
Maltese: Saru tliet studji ewlenin f'pazjenti, liema studji qabblu Beprana ma' naproxen (mediċina oħra użata flosteoartrite) u plaċebo (kura finta).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials.
Maltese: Il-kumpanija infurmat lis-CHMP li ma kien hemm ebda konsegwenza għal pazjenti li fil-preżent huma inklużi fi provi kliniċi.
English: The effects of Beprana were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Beprana ġew l-ewwel ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbnedmin.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Beprana could not have been approved for the relief of signs and symptoms of osteoarthritis of the knee and hip.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta u t-tweġibiet tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fil-ħin tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Beprana ma setax jiġi approvat għas-serħan tas-sinjali u sintomi ta' osteoartrite tal-irkoppa u tal-ġenbejn.
English: The CHMP noted that while there was evidence showing that Beprana was effective in relieving the signs and symptoms of osteoarthritis of the knee and hip, its benefits were not sufficient to outweigh the identified risks.
Maltese: Is-CHMP innota li filwaqt li kien hemm evidenza li turi li Beprana kien effettiv fis-serħan mis-sinjali u sintomi ta' osteoartrite tal-irkoppa u tal-ġenbejn, il-benefiċċji tiegħu ma kinux biżżejjed biex jegħlbu rriskji identifikati.
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Maltese: L-ittra mill-kumpanija li tgħarraf lill-Aġenzija bl-irtirar tal-applikazzjoni tista' tinstab taħt il-buttuna ‘All documents' (All documents).
English: Nitric oxide is a vasodilator, a substance that causes the widening of blood vessels.
Maltese: Nitric oxide huwa vażodilatur, sustanza li tikkawża t-twessigħ tal-vażi tad-demm.
English: It is available as capsules (1.5, 3, 4.5 and 6 mg).
Maltese: Jiġi bħala kapsuli (1.5, 3, 4.5 u 6 mg).
English: Rivastigmine Actavis rivastigmine
Maltese: Rivastigmine Actavis rivastigmina
English: The full EPAR for Rivastigmine Actavis 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: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom benefiċċju, iżda jekk il-pazjenti jkollhom xi effetti sekondarji tista' titnaqqas id-doża jew jitwaqqaf ittrattament.
English: This summary was last updated in 06-2015.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi: 06-2015.
English: Rivastigmine Actavis is a ‘generic medicine'.
Maltese: Rivastigmine Actavis huwa ‘mediċina ġenerika'.
English: This is a summary of the European public assessment report (EPAR) for Rivastigmine Actavis.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rivastigmine Actavis.
English: In patients who tolerate this dose, it can be increased in 1.5 mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Maltese: Il-pazjenti li jittolleraw din id-doża tista' tiżdidilhom b'1.5 mg wara 1.5 mg, iżda mhux iżjed spiss minn kull ġimagħtejn, sakemm tintlaħaq doża regolari ta' 3 sa 6 mg darbtejn kuljum.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine Actavis on 16 June 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rivastigmine Actavis fis-16 ta' Ġunju 2011.
English: This means that Rivastigmine Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exelon.
Maltese: Dan ifisser li Rivastigmine Actavis huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Exelon.
English: The CHMP concluded that, in accordance with EU requirements, Rivastigmine Actavis has been shown to have comparable quality and to be bioequivalent to Exelon.
Maltese: Is-CHMP ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Rivastigmine Actavis għandu kwalità kumparabbli ma' Exelon u li huwa bijoekwivalenti għalih.
English: The active substance in Rivastigmine Actavis, rivastigmine, is a dementia medicine.
Maltese: Is-sustanza attiva f'Rivastigmine Actavis, ir-rivastigmina, hija mediċina kontra d-demenzja.
English: It can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Maltese: Jista' jintuża wkoll għat-trattament tad-demenzja minn ħafifa għal moderatament gravi f'pazjenti bilmarda ta' Parkinson.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Maltese: Fil-pazjenti b'demenzja tat-tip Alzheimer jew b'demenzja kkaġunata mill-marda ta' Parkinson ċerti ċelluli nervużi tal-moħħ imutu, u dan jikkawża livelli baxxi tan-newrotrażmettitur aċetilkolina (sustanza kimika li tippermetti ċ-ċelluli nervużi jikkomunikaw ma' xulxin).
English: Rivastigmine Actavis is a medicine containing the active substance rivastigmine.
Maltese: Rivastigmine Actavis huwa mediċina li fiha s-sustanza attiva rivastigmina.
English: Rivastigmine Actavis is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Maltese: Rivastigmine Actavis jintuża għall-kura ta' pazjenti li jbatu bid-demenzja ta' Alzheimer minn ħafifa għal moderatament gravi, li hija diżordni progressiva fil-moħħ li bil-mod il-mod taffettwa il-memorja, il-ħila intellettwali u l-imġiba.
English: Because Rivastigmine Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exelon.
Maltese: Peress li Rivastigmine Actavis huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet li jistabbilixxu l-bijoekwivalenza tiegħu għall-mediċina ta' referenza Exelon.
English: Because Rivastigmine Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Rivastigmine Actavis huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: By blocking these enzymes, Rivastigmine Actavis allows levels of acetylcholine to increase in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Maltese: Billi jimblokka dawn l-enzimi, Rivastigmine Actavis jippermetti żieda fil-livelli ta' aċetilkolina fil-moħħ u b'dan il-mod jgħin fit-tnaqqis tas-sintomi tad-demenzja tat-tip Alzheimer u tad-demenzja kkaġunata mill-marda ta' Parkinson.
English: What are the benefits and risks of Rivastigmine Actavis?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Rivastigmine Actavis?
English: What is Rivastigmine Actavis?
Maltese: X'inhu Rivastigmine Actavis?
English: Why has Rivastigmine Actavis been approved?
Maltese: Għaliex ġie approvat Rivastigmine Actavis?
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Maltese: L-EPAR sħiħ għall-mediċina ta' referenza jinstab ukoll fis-sit web tal-Aġenzija.
English: How does Rivastigmine Actavis work?
Maltese: Għal xiex jintuża Rivastigmine Actavis?
English: Treatment with Rivastigmine Actavis should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Maltese: It-trattament b'Rivastigmine Actavis għandu jinbeda u jiġi mmonitorjat minn tabib b'esperjenza fiddijanjożi u fit-trattament tal-marda ta' Alzheimer jew fid-demenzja f'pazjenti bil-marda ta' Parkinson.
English: EU (MA) number
Maltese: Numru tal- MA (UE) Isem kummerċjali
English: • different reconstitution requirements for Velcade 3.5mg IV or SC use
Maltese: • ħtiġijiet ta' rikostituzzjoni differenti għall-użu ta' Velcade 3.5 mg IV jew SC
English: Prior to launch of Velcade 3.5mg new dual route of administration (subcutaneous and intravenous) package, in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Maltese: Qabel it-tnedija ta' Velcade 3.5 mg, bil-pakkett ġdid għall-mod doppju minn fejn jista' jingħata (taħt il-ġilda u ġol-vina), f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħd fis-Suq (MAH) għandu jaqbel fuq il-kontenut u l-format tal-materjal edukattiv ma' kull awtorità nazzjonali kompetenti.
English: Dosing Slide Rule shall contain the following key elements:
Maltese: Id-Dosing Slide Rule għandu jkun fiha l-elementi ewlenien li ġejjin:
English: • Velcade 3.5mg can be administered both intravenously and subcutaneously while Velcade 1mg can be administered only intravenously
Maltese: • Velcade 3.5 mg jista' jingħata kemm ġol-vina u anke taħt il-ġilda filwaqt li Velcade 1 mg jista' jingħata biss ġol-vina
English: • that Velcade 1mg is only for IV use
Maltese: • li VELCADE 1 mg għandu jingħata b'mod IV biss
English: The educational material shall consist of the following:
Maltese: Il-materjal edukattiv għandu jikkonsisti minn dan li ġej: