FrancophonIA/ELRC3.0 huggingface dataset:
English: Irbesartan/Hydrochlorothia zid Heumann 150 mg/12.5 mg Filmtabletten mg/12,5 mg
Maltese: Irbesartan/Hydrochlor othiazid Heumann 150 mg/12.5 mg Filmtabletten mg/12,5 mg
English: Nebivolol Generis tablet
Maltese: Nebivolol Generis
English: Alendronic acid Alendroninezuur Accord 70mg Tabletten
Maltese: Aċidu alendroniku Alendronic acid Accord 70 mg Pillola
English: Fexofenadine 120 mg filmcoated tablets
Maltese: Fexofenadine 120 mg film-coated tablets
English: Escitalopram ESCITALOPRAM BROWN 15 mg, comprimé pelliculé sécable
Maltese: Exxitalopram ESCITALOPRAM BROWN 15 mg, comprimé pelliculé sécable
English: Farmaprojects 37,5 mg, capsules met verlengde afgifte, hard
Maltese: Venlafaxine Farmaprojects 37,5 mg, capsules met verlengde afgifte, hard
English: Valsartan HCT Fair-Med 160 mg/12,5 mg
Maltese: Valsartan HCT FairMed mg/12,5 mg
English: Quetiapine
Maltese: Ċipru
English: Esomeprazole Mylan 20 mg Gastro-resistant Capsules, hard
Maltese: Esomeprazole Mylan 20 mg Gastroresistant Capsules, hard
English: Fexofenadine 180 mg filmcoated tablets
Maltese: Fexofenadine 180 mg film-coated tablets
English: AAA-Pharma GmbH Liebknechstrasse 33 70565 Stuttgart Germany
Maltese: Il-Ġermanja AAA-Pharma GmbH Liebknechstrasse 33
English: Donepezil Mylan 5 mg orodisperzibilne tablete
Maltese: Donepeżil kloridrat Donepezil Mylan 5 mg orodisperzibilne tablete
English: D-20354 Hamburg Germany
Maltese: D-20354
English: Candesartan cilexetil
Maltese: Kandesartan ċileksetil
English: Rizatriptan Mylan
Maltese: Fexofenadina Mylan
English: Escitalopram ESCITALOPRAM BROWN 10 mg, comprimé pelliculé sécable
Maltese: Exxitalopram ESCITALOPRAM BROWN 10 mg, comprimé pelliculé sécable
English: Levetiracetam Levetiracetam Lupin 1000mg Film-coated tablets
Maltese: Levetiraċetam Levetiracetam Lupin 1000mg Film-coated tablets
English: Esomeprazole Mylan 40 mg Gastro-resistant Capsules, hard
Maltese: Esomeprazole Mylan 40 mg Gastroresistant Capsules, hard
English: Escitalopram ESCITALOPRAM BROWN 5 mg, comprimé pelliculé sécable
Maltese: Exxitalopram ESCITALOPRAM BROWN 5 mg, comprimé pelliculé sécable
English: Donepezil Mylan 10 mg orodisperzibilne tablete
Maltese: Donepeżil kloridrat Donepezil Mylan 10 mg orodisperzibilne tablete
English: Irbesartan/Hydrochlorothia zide 300mg/12.5mg filmcoated tablets mg/12,5 mg
Maltese: Irbesartan/Hydrochlor othiazide Fairmed 300mg/12.5mg filmcoated tablets mg/12,5 mg
English: Desloratadine Labormed 5 mg
Maltese: Desloratadine Apotex 5 mg
English: Fexofenadine
Maltese: Pijoglitażon
English: Irbesartan/Hydrochlorothia zide 150mg/12.5mg filmcoated tablets mg/12,5 mg
Maltese: Irbesartan/Hydrochlor othiazide Fairmed 150mg/12.5mg filmcoated tablets mg/12,5 mg
English: Aciclovir
Maltese: Idrokortiżon
English: 200 mg Capsule, hard Oral use
Maltese: 200 mg Kapsula, iebsa
English: Tacpan 0.5 mg Hartkapseln 0,5 mg Capsule, hard Oral use
Maltese: Tacpan 0.5 mg Hartkapseln
English: Czech Republic Bluefish Pharmaceuticals AB Torsgatan 11
Maltese: Ir-Renju Unit Bluefish Pharmaceuticals AB Torsgatan 11
English: Irbesartan/Hydrochlorothia zid Heumann 300 mg/25 mg Filmtabletten
Maltese: Irbesartan/Hydrochlor othiazid Heumann 300 mg/25 mg
English: Tyvera 100mg Tablets
Maltese: Tijamina kloridrata Tyvera 100mg Tablets 100 mg Pillola
English: Pioglitazone
Maltese: Dipiridamol
English: Farmaprojects 75 mg Hartkapseln, retardiert
Maltese: Venlafaxin Farmaprojects 75 mg Hartkapseln, retardiert
English: Rizatriptan Mylan dura 10 mg Schmelztabletten
Maltese: Rizatriptan Mylan dura 10 mg
English: Kandrozid tablet
Maltese: Schmelztabletten
English: Donepezil
Maltese: Il-Kroazja
English: Donepezil Mylan 10 mg 10 mg
Maltese: Donepezilo Mylan 5 mg
English: Escitalopram Escitalopram-Micro Labs 5 mg Filmtabletten
Maltese: Exxitalopram Escitalopram-Micro Labs 5 mg
English: Alendronic acid ALENDRONIC ACID ACCORD 70mg
Maltese: Aċidu alendroniku ALENDRONIC ACID ACCORD 70MG
English: Alendronic acid ALENDRONIC ACID ACCORD 70MG
Maltese: Aċidu alendroniku ALENDRONIC ACID ACCORD 70mg
English: US Pharmacia Sp. z o.o.
Maltese: US Pharmacia Sp. z o.o. ul.Ziębicka 40
English: Annex IB: Products for which the marketing authorisations are recommended for suspension Member State (in EEA)
Maltese: Anness IB: Prodotti li l-awtorizzazzjonijiet għat-tqegħid fis-suq tagħhom huma rakkomandati li jiġu sospi¿i
English: Tyvera 50mg Tablets
Maltese: Tijamina kloridrata Tyvera 50mg Tablets 50 mg Pillola
English: EBASTINA BROWN 10 mg COMPRIMIDOS
Maltese: EBASTINA BROWN 10 mg COMPRIMIDOS BUCODISPERSABLES EFG
English: Desloratadine Apotex
Maltese: DESLORATADINE ARROW
English: Rizatriptan Mylan dura 5 mg Schmelztabletten
Maltese: Rizatriptan Mylan dura 5 mg
English: Levocetirizine hydrochloride
Maltese: Levoċetiriżina kloridrata
English: Quetiapina Daquimed
Maltese: Benżoat tarriżatriptan
English: Mylan Pharmaceuticals, S.L.
Maltese: Generis Farmacêutica, S. A.
English: Fexofenadine hydrochloride
Maltese: Feksofenadina kloridrata
English: Capsule, hard Oral use
Maltese: Kapsula, iebsa
English: Farmaprojects 150 mg Hartkapseln, retardiert
Maltese: Venlafaxin Farmaprojects 150 mg Hartkapseln, retardiert
English: Alendronic acid Alendroninezuur Accord 10mg Tabletten
Maltese: Aċidu alendroniku Alendroninezuur Accord 10mg
English: Alendronic acid ALENDRONATO AHCL
Maltese: Aċidu alendroniku Alendronic Acid Accord
English: Venlafaxin AAA 37,5 mg Hartkapseln, retardiert
Maltese: Venlafaxin Farmaprojects 37,5 mg Hartkapseln, retardiert
English: Escitalopram oxalate
Maltese: Ossalat talexxitalopram
English: VALSARTAN/HIDROCLORO TIAZIDA CODRAMOL 320/12.5 mg
Maltese: VALSARTAN/HIDROCL OROTIAZIDA CODRAMOL 320/12.5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
English: TRAMADOL PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Maltese: 37,5 mg/325 mg comprimé pelliculé mg/325 mg
English: Telmisartan/Hydrochlorothi azide 40mg/12.5mg Tablets
Maltese: Telmisartan/Hydrochl orothiazide 40mg/12.
English: Escitalopram Escitalopram-Micro Labs 10 mg Filmtabletten
Maltese: Exxitalopram Escitalopram-Micro Labs 10 mg
English: Ropinirole 0.25 mg Filmcoated Tablets
Maltese: Ropinirol kloridrat Ropinirole 0.25 mg Film-coated Tablets
English: Auden McKenzie Limited McKenzie House Bury Street, Ruislip Middlesex HA4 7TL United Kingdom
Maltese: Ir-Renju Unit Auden McKenzie Limited McKenzie House
English: Ropinirole 1 mg Filmcoated Tablets
Maltese: Ropinirol kloridrat Ropinirole 1 mg Filmcoated Tablets
English: Hydrocortisone
Maltese: Trimetażidina
English: Potactasol topotecan
Maltese: Potactasol topotekan
English: Potactasol is a ‘generic medicine'.
Maltese: Potactasol huwa ‘mediċina ġenerika'.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Potactasol to on 06 January 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Potactasol fis-06 ta' Jannar 2011.
English: The company has provided data from the published literature on topotecan.
Maltese: Il-kumpannija pprovdiet data minn kitbiet ippubblikati dwar it-topotekan.
English: The active substance in Potactasol, topotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Maltese: Is-sustanza attiva f'Potactasol, it-topotekan, hija mediċina kontra l-kanċer li tappartjeni għall-grupp tal-‘inibituri tat-topojsomerażi'.
English: Other information about Potactasol
Maltese: Aktar informazzjoni dwar Potactasol
English: This is a summary of the European public assessment report (EPAR) for Potactasol.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Potactasol.
English: The full EPAR for Potactasol can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Potactoasol jinstab fis-sit web tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Għal aktar informazzjoni rigward il-kura b'Potactasol, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: Potactasol is a medicine that contains the active substance topotecan.
Maltese: Potactasol huwa mediċina li fih s-sustanza attiva topotekan.
English: The CHMP concluded that, in accordance with EU requirements, Potactasol has been shown to be comparable to Hycamtin.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Potactasol intwera li huwa komparabbli ma' Hycamtin.
English: Why has Potactasol been approved?
Maltese: Għaliex ġie approvat Potactasol?
English: This means that Potactasol is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin.
Maltese: Dan ifisser li Potactasol huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Hycamtin.
English: What is Potactasol?
Maltese: X'inhu Potactasol?
English: When used with cisplatin in cervical cancer, Potactasol is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Maltese: Meta użat maċ-ċisplatin fil-kanċer taċ-ċerviċi, Potactasol jingħata bħala infużjoni fil-jiem nru 1, 2 u 3 (biċ-ċisplatin jingħata fil-jum 1).
English: Because Potactasol 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: Minħabba li Potactasol huwa mediċina ġenerika u bijoekwivalenti għall-mediċini ta' referenza, ilbenefiċċji u r-riskji tiegħu huma meqjusa li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Potactasol is a cancer medicine.
Maltese: Potactasol huwa mediċina kontra l-kanċer.
English: When Potactasol is used on its own for ovarian cancer, it is given by infusion over 30 minutes.
Maltese: Meta Potactasol jintuża waħdu għall-kanċer tal-ovarji, jingħata permezz ta' infużjoni fuq perjodu ta' 30 minuta.
English: How has Potactasol been studied?
Maltese: Kif ġie studjat Potactasol?
English: What are the benefits and risks of Potactasol?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Potactasol?
English: No additional studies were needed as Potactasol is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Maltese: Ma kien jinħtieġ l-ebda studju addizzjonali billi Potactasol huwa mediċina ġenerika mogħtija permezz ta' infużjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Hycamtin.
English: This is repeated every 21 days for six courses or until the disease gets worse.
Maltese: Dan jiġi ripetut kull 21 jum għal sitt ċikli jew sa ma taggrava l-marda.
English: It is available as a powder to be made up into a solution for infusion (drip) into a vein.
Maltese: Jiġi bħala trab li jitħallat f'soluzzjoni għallinfużjoni (dripp fil-vina).
English: MA (EU) number
Maltese: Numru ta' l-EU (MA)
English: Immediate Packaging Pack size bister (PCTFE/PVC/alu) 56 tablets
Maltese: Il-pakkett li jmiss mal-prodott
English: Route of Administration
Maltese: Daqs tal-pakkett
English: • The risk of opportunistic infections, in particular CMV viraemia • Recommendation to avoid vaccination with live vaccines for at least 12 months following o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
Maltese: CMV viraemia • Rakkomandazzjoni li ma jingħatawx vaċċinazzjonijiet b'vaċċini ħajjin għal ta' lanqas 12-il o Li trattament għal reazzjonijiet ta' sensittività eċċessiva, li jinkludu miżuri ta' risuxxitazzjoni għandhom ikunu disponibbli waqt l-għoti o Li l-ogħla riskju ta' reazzjonijiet ta' l-infużjoni huma fl-ewwel ġimgħa ta' terapija o Li jekk ir-reazzjoni hija moderata jew qawwija, id-doża għandha tibqa' fl-istess livell (ie. id-doża m'għandiex togħla) sakemm kull doża tkun ittollerata sew o Jekk ma tingħatax terapija għal aktar minn 7 ijiem allura MabCampath għandu jerġa' jibda jingħata b'doża gradwali dejjem togħla
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Maltese: • Sommarju tal-Karatteristiċi tal-Prodott (SKP), Fuljett ta' l-Informazzjoni u
English: Key elements to be included in the educational brochure
Maltese: Elementi ewlenin li jridu jiġu inklużi fil-fuljett edukattiv
English: The Member States shall ensure that the MAH provides all doctors who are expected to prescribe MabCampath with a healthcare professional information pack containing the
Maltese: L-Istati Membri għandhom jiżguraw li l-MAH jipprovdi lit-tobba kollha li huma mistennija li jiktbu MabCampath li dawn jingħataw pakkett ta' l-informazzjoni għal professjonisti tal-kura tas-saħħa li jkun jikkonsisti minn:
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product as described below are implemented:
Maltese: KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TA' L-UŻU MINGĦAJR PERIKLU U EFFETTIV TAL-PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI
English: Dexdomitor dexmedetomidine
Maltese: Dexdomitor dexmedetomidina
English: It is a solution for injection (0.1 mg/ml and 0.5 mg/ml).
Maltese: Hu soluzzjoni għall-injezzjoni (0.1 mg/ml u 0.5 mg/ml).
English: This summary was last updated on 30/08/2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 30/08/2012.
English: Dexmedetomidine is an alpha2-adrenoceptor agonist.
Maltese: Id-dexmedetomidina hija agonista tal-alpha2-adrenoceptor.
English: The marketing authorisation was renewed on 2 August 2007.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq iġġedded fit-2 ta' Awwissu 2007.
English: What is the risk associated with Dexdomitor?
Maltese: X'inhu r-riskju assoċjat ma' Dexdomitor?
English: • For deep sedation and analgesia in dogs in combination with butorphanol (a sedative and analgesic) for procedures including minor surgery.
Maltese: • Għat-traqqid fil-fond u l-analġeżija fil-klieb flimkien ma' butorphanol (sedattiv u analġeżiku) għall-proċeduri inkluż l-kirurġija minuri.
English: Dexdomitor contains the active substance dexmedetomidine, which belongs to a class of medicines having a psycholeptic (sedative) action.
Maltese: Dexdomitor fih is-sustanza attiva dexmedetomidina, li tappartjeni għal klassi ta' mediċini li għandhom azzjoni psikoeleptika (sedattiva).
English: What is Dexdomitor?
Maltese: X'inhu Dexdomitor?
English: In addition, the blood pressure will increase before returning to normal or below normal.
Maltese: Barra minn hekk, ilpressjoni tad-demm tiżdied qabel terġa' lura għan-normal jew inqas min-normal.
English: Why has Dexdomitor been approved?
Maltese: Għaliex ġie approvat Dexdomitor?
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Maltese: Id-dexmedetomidina hija relatata mill-qrib ma' sustanza oħra użata fit-traqqid tal-annimali, il-medetomidina, li ila tintuża fil-mediċini veterinarji għal ħafna snin.
English: Since noradrenaline is involved in maintaining alertness and arousal, reducing its release decreases the level of consciousness, including the sensation of pain.
Maltese: Peress li n-noradrenalina żżomm lill-persuna żvelta, it-tnaqqis tar-rilaxx inaqqas il-livell ta' koxjenza, inkluża s-sensazzjoni tal-uġigħ.
English: Dexdomitor was also compared with medetomidne for premedication (sedation prior to anaesthesia) in cats about to undergo general anaesthesia with ketamine and for deep sedation of dogs in combination with butorphanol.
Maltese: Dexdomitor tqabbel ukoll mal-medetomidina bħala mediċina ta' qabel (sedazzjoni qabel l-anestesija) fi qtates li kienu se jingħataw anasteżija ġenerali bil-ketamina u għas-sedazzjoni fil-fond fi klieb flimkien ma' butorphanol.
English: • Before inducing general anaesthesia.
Maltese: • Qabel l-għoti tal-anestesija ġenerali.
English: In dogs, Dexdomitor is given by intravenous or intramuscular injection.
Maltese: Fil-klieb, Dexdomitor jingħata b'injezzjoni intravenuża jew intramuskolari.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Dexdomitor on 30 August 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Dexdomitor fit-30 ta' Awwissu 2002.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Maltese: Innewrotrasmettituri huma kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju jinstab fil-modulu tad-diskussjoni xjentifika ta' dan l-EPAR.
English: How does Dexdomitor work?
Maltese: Għal xiex jintuża Dexdomitor?
English: As for medetomidine, ‘good' or ‘excellent' analgesia was reached in about 40 to 50 % of the animals, supporting its used in non-invasive mildly to moderately painful procedures.
Maltese: Bħal bil-medetomidina, inkisbet analġeżija ‘tajba' jew ‘eċċellenti' f'madwar 40 sa 50 % tal-annimali, u dan jappoġġja l-użu tagħha fi proċeduri mhux invażivi li jikkawżaw uġigħ ħafif jew moderat.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: Informazzjoni dwar l-istatus tal-preskrizzjoni ta' dan il-prodott tista' tinstab fuq it-tikketta/ilqoxra tal-pakkett.
English: The dose is chosen according to the species being treated, the use, whether it is given by intravenous (into a vein) or intramuscular (into a muscle) injection and any other medicines that are also being used.
Maltese: Id-doża tintgħażel skont l-ispeċi l-qed tiġi ttrattata, l-użu, jekk tingħatax b'injezzjoni intravenuża (filvina) jew intramuskolari (fil-muskolu) u kwalunkwe mediċina oħra li qed tintuża wkoll.
English: Other side effects can occur when Dexdomitor is used with other medicines.
Maltese: Jistgħu jseħħu effetti sekondarji oħra meta Dexdomitor jintuża ma' mediċini oħra.
English: Dexdomitor also showed adequate effectiveness for deep sedation of dogs in combination with butorphanol, and for premedication in dogs and cats before induction of general anaesthesia, reducing the amount of anaesthetic that the dogs and cats require.
Maltese: Dexdomitor wera wkoll effikaċja adegwata għas-sedazzjoni fil-fond tal-klieb flimkien ma' butorphanol, u bħala mediċina ta' qabel fil-klieb u l-qtates qabel il-bidu tal-anestesija ġenerali, u b'hekk inaqqas l-ammont ta' loppju li jkollhom bżonn il-klieb u l-qtates.
English: Muscle tremors (shaking) and corneal opacities (cloudy spots in the cornea, the clear part of the eye in front of the pupil) may occur during sedation.
Maltese: Waqt is-sedazzjoni jista' jkun hemm rogħda fil-muskoli u opaċitajiet korneali (tikek imċajpra fil-kornea, il-parti ċara tal-għajn quddiem il-ħabba).
English: Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicine for many years.
Maltese: Dan id-dokument ma jistax jieħu post diskussjoni wiċċ imb wiċċ mal-veterinarju tiegħek.
English: Dexdomitor was investigated in studies involving dogs and cats in which its effectiveness was compared with that of medetomidine.
Maltese: Dexdomitor ġie investigat fi studji fuq klieb u qtates li fihom l-effikaċja tiegħu tqabblet ma' dik talmedetomidina.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni dwar ir-rakkomandazzjonijiet tas-CVMP, aqra ddiskussjoni xjentifika (parti wkoll mill-EPAR).
English: Dexdomitor is used to sedate (calm down) dogs and cats in the following situations:
Maltese: Dexdomitor jintuża sabiex jilloppja (jikkalma) klieb u qtates fis-sitwazzjonijiet li ġejjin:
English: For a full list of all side effects reported with Dexdomitor, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Dexdomitor, ara l-fuljett ta' tagħrif.
English: Dexdomitor was at least as effective as medetomidine in inducing general anaesthesia in cats in combination with ketamine.
Maltese: Dexdomitor kien effettiv tal-inqas daqs il-medetomidine fil-bidu tal-anasteżija ġenerali fil-qtates flimkien mal-ketamina.
English: It should not be used in animals that have problems with their heart or blood vessels, with severe systemic (whole body) disease, that are moribund (close to death) or that are known to be hypersensitive (allergic) to dexmedetomidine or any of the other ingredients.
Maltese: M'għandux jingħata lil annimali li jkollhom problemi bil-qalb jew bl-arterji jew bil-vini, li jkollhom mard sistemiku sever (li jaffettwa lill-ġisem kollu), li jkunu qed imutu u li jkunu magħrufin li huma ipersensittivi (allerġiċi) għad-dexmedetomidina jew għal xi sustanza oħra tiegħu.
English: Vomiting may occur five to 10 minutes after injection or at the time of recovery.
Maltese: Jista' jkun hemm remettar bejn ħamsa u għaxar minuti wara l-injezzjoni jew fil-ħin talirkupru.
English: 60 sachets + 2 syringes (1 ml) + 2 syringes (3 ml) + 2 syringes (10 ml) + 2 mixing cups
Maltese: 60 qartas + 2 siringi (1 ml) + 2 siringi (3 ml) + 2 siringi (10 ml) + 2 tazzi għat-taħlit
English: Granules for oral suspension sachet (PET/Alu/LLDPE)
Maltese: Qartas (PET/Alu/LLDPE)
English: Refusal of the marketing authorisation for Masican (masitinib) EMA/167920/2014
Maltese: Rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq ta' Masican (masitinib) EMA/167920/2014
English: 21 March 2014 EMA/167920/2014 EMEA/H/C/002670
Maltese: EMA/167920/2014
English: It was to be available as tablets.
Maltese: Din kellha tkun disponibbli bħala pilloli.
English: The active substance in Masican, masitinib, is a tyrosine-kinase inhibitor.
Maltese: Is-sustanza attiva ta' Masican, masitinib, hija inibitur tat-tyrosine kinase.
English: What is Masican?
Maltese: X'inhu Masican?
English: The company that applied for authorisation is AB Science.
Maltese: Ilkumpanija li applikat għall-awtorizzazzjoni hija AB Science.
English: On 21 November 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masican, intended for the treatment of malignant gastrointestinal stromal tumour (GIST).
Maltese: Fil-21 ta' Novembru 2013, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li tirrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Masican, maħsub għall-kura ta' tumur stromali gastro-intestinali malinn (GIST).
English: Masican is an anticancer medicine that contains the active substance masitinib.
Maltese: Masican hija mediċina kontra l-kanċer li fiha s-sustanza attiva masitinib.
English: Masican was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 21 December 2004 for the treatment of malignant GIST.
Maltese: Masican ġie kklassifikat bħala 'mediċina orfni' (mediċina li tintuża f'mard rari) fil-21 ta' Diċembru 2004 għall-kura ta' GIST malinn.
English: The study included a group of patients treated with Masican and one group treated with sunitinib, another medicine of the same class.
Maltese: L-istudju inkluda grupp ta' pazjenti kkurati b'Masican u grupp wieħed kkurat b'sunitinib, mediċina oħra tal-istess klassi.
English: This means that it blocks certain enzymes known as tyrosine kinases.
Maltese: Dan ifisser li jimblokka ċerti enzimi magħrufa bħala ‘tyrosine kinases'.
English: What was Masican expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Masican?