FrancophonIA/ELRC3.0 huggingface dataset:
English: Camprodon s/n "la Riba" 17813 Vall de Bianya Girona
Maltese: Camprodon s/n "la Riba" 17813 Vall de Bianya
English: Al3+ (as hydroxide)
Maltese: Al3+ (bħala hydroxide)
English: Inactivated bluetongue virus, serotype 4, strain SPA-1/2004
Maltese: Bluetongue virus inattivat, serotip 4, strejn SPA-1/2004
English: 100 ml (50 doses) 240 ml (120 doses)
Maltese: 100 ml (50 doża) 240 ml (120 doża)
English: 20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses)
Maltese: 20 ml (10 dożi) 100 ml (50 doża) 240 ml (120 doża)
English: There is evidence of BTV-1 seroneutralising antibodies indicative of protection for up to 21 months after primary vaccination.
Maltese: Hemm evidenza ta' antikorpi seronewtralizanti li tindika protezzjoni sa 21 xahar wara it-tilqim primarja.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali ttrattati li juru effett(i) mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ttrattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ttrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ttrattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ttrattat, inklużi rapporti iżolati).
English: Date of first authorisation: 25/04/2017.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25/04/2017.
English: Lot {number}
Maltese: Nagħaġ u ifrat
English: Al3+ (as hydroxide), Quil-A (Quillaja saponaria saponin extract), thiomersal.
Maltese: Al3+ (bħala hydroxide), Quil-A (Quillaja saponaria estratt tas-saponin), thiomersal
English: Quil-A (Quillaja saponaria saponin extract)
Maltese: Quil-A (Quillaja saponaria estratt tas-saponin)
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Aluminium hydroxide
English: High density polyethylene (HDPE) bottles of 20, 100 or 240 ml with chlorobutyl elastomer stopper and aluminium seal.
Maltese: Flieken tal-high density polyethylene (HDPE) ta' 20,100 jew 240 ml b'tapp tal-chlorobutyl elastomer b'siġill tal-aluminju.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR(I) RESPONSABBLI
English: Bluetongue virus, serotype 8: 25 days after completion of the primary vaccination scheme.
Maltese: Bluetongue virus, serotip 8: 25 ġurnata wara li jintemm il-kors primarju ta' tilqim.
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Maltese: BTV-1/ALG2006/01 E1 RP* ≥ 1 Bluetongue virus inattivat, serotip 8, strejn BTV-8/BEL2006/02
English: A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of a two-fold overdose.
Maltese: Żieda temporanja fit-temperatura tar-rektum, ta' mhux aktar minn 2°C tista' sseħħ f'10% tal-annimali matul it-24 siegħa ta' wara li tingħata doża eċċessiva doppja.
English: A transient increase in rectal temperature, not exceeding 2.7 °C, was commonly observed during the 48 hours following vaccination in field safety studies.
Maltese: Fi studji tas-sigurtà, żieda temporanja fit-temperatura tar-rektum, li ma teċċedix 2.7°C, kienet komuni waqt it-48 siegħa ta' wara t-tilqima.
English: Disposal: read package leaflet.
Maltese: Segwi proċeduri asettiċi tas-soltu.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Zulvac BTV suspension for injection for sheep
Maltese: Zulvac BTV suspensjoni għall-injezzjoni għan-nagħaġ u l-ifrat
English: Inactivated BTV, serotype 1 Inactivated BTV, serotype 8
Maltese: BTV inattivat, serotip 1 BTV inattivat, serotip 8
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml (BTV-4 for sheep)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun 1 x 20 ml, 1 x 100 ml u 1 x 240 ml (BTV-4 għan-nagħaġ)
English: Aluminium hydroxide
Maltese: EFFETTI MHUX MIXTIEQA
English: Pharmacotherapeutic group: Immunologicals for Bovidae, inactivated viral vaccines for cattle.
Maltese: Imunoloġiċi għal Bovidae, vaċċini virali inattivati għal-ifrat.
English: Bluetongue virus, serotype 1: 15 days after completion of the primary vaccination scheme.
Maltese: Bluetongue virus, serotip 1: 15-il ġurnata wara li jintemm il-kors primarju ta' tilqim.
English: Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: After administration with a double dose (4 ml), reactions in sheep are similar to those seen after administration of a single dose, but injection site reactions may persist for a longer time (general swelling at the injection site persisting for not more than 9 days or subcutaneous granuloma possibly persisting for more than 63 days).
Maltese: Ir-reazzjonijiet fin-nagħaġ wara li tingħata doża doppja (4 ml) kienu simili għal dawk li jidhru wara doża waħda imma r-reazzjonijiet fis-sit tal-injezzjoni jistgħu jippersistu għal żmien itwal (nefħa ġenerali tas-sit tal-injezzjoni li ma ddumx aktar minn 9 ijiem jew granuloma taħt il-ġilda li tista' tippersisti għal aktar minn 63 ġurnata).
English: These reactions take the form in most cases of a diffuse swelling of the injection site (persisting for not more than 7 days) or of palpable nodules up to a size of 60 cm2 (subcutaneous granuloma, decreasing in size over time but possibly persisting for more than 50 days).
Maltese: Fil-maġġoranza tal-każijiet dawn ir-reazzjonijiet jieħdu l-forma ta' nefħa ġenerali tas-sit tal-injezzjoni (li ddum mhux aktar minn 7 ijiem) jew bħala għoqiedi li jinħassu b'daqs sa' 60 cm2 (granuloma taħt il-ġilda, li tiċkien fid-daqs maż-żmien imma li tista' tippersisti għal aktar minn 50 ġurnata).
English: Cardboard box with 1 bottle of 10 doses (20 ml).
Maltese: Kaxxa tal-kartun b'flixkun 1 ta' 10 dożi (20 ml).
English: Method of administration (sheep and cattle)
Maltese: Metodu ta' amministrazzjoni (nagħaġ u ifrat)
English: Inactivated BTV, serotype 4
Maltese: BTV inattivat, serotip 4
English: Zero days.
Maltese: 15-il jum.
English: Inactivated BTV, serotype 8
Maltese: BTV inattivat, serotip 8
English: Inactivated BTV, serotype 1
Maltese: BTV inattivat, serotip 1
English: Pack sizes:
Maltese: Tilqima mil-ġdid:
English: Cardboard box with 1 bottle of 50 doses (100 ml).
Maltese: Kaxxa tal-kartun b'flixkun 1 ta' 50 doża (100 ml).
English: *Below the level of detection of <3.9 log10 genome copies/ml by the validated RT-qPCR method,
Maltese: *Taħt il-livell li jinqabad ta' <3.9 log10 genome copies/ml bil-metodu validat tal-RT-qPCR, li jindika li m'hemmx preżenza tal-ġenom virali.
English: **Below the level of detection of < 3.4 log10 genome copies/ml by a validated RT-qPCR method, indicating no presence of viral genome.
Maltese: **Taħt il-livell li jinqabad ta' <3.4 log10 genome copies/ml bil-metodu validat tal-RT-qPCR, li jindika li m'hemmx preżenza tal-ġenom virali.
English: A transient increase in rectal temperature, not exceeding 1.6 °C, may very commonly occur during the 48 hours following vaccination.
Maltese: Waqt l-ewwel 48 siegħa wara t-tilqima huwa komuni ħafna li sseħħ żjieda temporanja fit-temperatura tar-rektum ta' mhux aktar minn 1.6 °C.
English: In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or national competent authorities on the current vaccination policies against bluetongue virus (BTV).
Maltese: F'din il-kategorija ta' annimali il-vaċċin għandu jintuża biss skont stima tal-benefiċċju-riskju mill-veterinarju responsabbli u/jew mill-awtoritajiet nazzjonali kompetenti skont il-politika kurrenti dwar tilqim kontra l-bluetongue virus (BTV).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml (BTV-1 for sheep and cattle; BTV-8 for sheep and cattle)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun 1 x 20 ml, 1 x 100 ml u 1 x 240 ml (BTV-1 għan-nagħaġ u l-ifrat; BTV-8 għan-nagħaġ u l-ifrat)
English: EU/2/17/207/009 (240 ml) BTV 8
Maltese: EU/2/17/207/009 (240 ml)
English: To stimulate active immunity of sheep and cattle against bluetongue virus serotype(s) related to those contained in the vaccine.
Maltese: Biex jistimola l-imunità attiva tan-nagħaġ u l-ifrat kontra s-serotip(i) tal-bluetongue virus relatati ma' dawk li hemm fil-vaċċin.
English: Cattle:
Maltese: VETERINARJU
English: Cardboard box with 1 bottle of 120 doses (240 ml).
Maltese: Kaxxa tal-kartun b'flixkun 1 ta' 120 doża (240 ml).
English: Active immunisation of sheep from 6 weeks of age for the prevention* of viraemia caused by bluetongue virus, serotype 1 or serotype 8.
Maltese: Tilqim attiv ta' nagħaġ minn età ta' 6 ġimgħat għall-prevenzjoni* ta' viremija kkawżata mill bluetongue virus, serotip 1 jew serotip 8.
English: Cattle: Active immunisation of cattle from 12 weeks of age for the prevention** of viraemia caused by bluetongue virus, serotype 1 or serotype 8.
Maltese: Tilqim attiv tal-ifrat minn età ta' 12-il ġimgħa għall-prevenzjoni** ta' viremija kkawżata mill bluetongue virus, serotip 1 jew serotip 8.
English: EU/2/17/207/001-009
Maltese: EU/2/17/207/001 (20 ml)
English: SC (sheep) / IM (cattle)
Maltese: MOD(I) TA' AMMINISTRAZZJONI SC (taħt il-ġilda) (nagħaġ) / IM (ġol-muskoli) (ifrat)
English: Active immunisation of sheep from 6 weeks of age for the reduction* of viraemia caused by bluetongue virus, serotype 4.
Maltese: Tilqim attiv ta' nagħaġ minn età ta' 6 ġimgħat għat-tnaqqis* ta' viremija kkawżata mill-bluetongue virus, serotip 4.
English: Potassium chloride
Maltese: Tilqima mil-ġdid
English: Bluetongue virus, serotype 1: 12 months after completion of the primary vaccination scheme.
Maltese: Bluetongue virus, serotip 1: 12-il xahar wara li jintemm il-kors primarju ta'
English: indicating no presence of viral genome.
Maltese: Ilma għall-injezzjonijiet
English: SPAIN
Maltese: Girona SPANJA
English: For protection against serotype 1 or serotype 8, administer one dose of 2 ml, every 12 months.
Maltese: Għal protezzjoni kontra serotip 1 jew serotip 8, amministra doża waħda ta' 2 ml, kull 12-il xahar.
English: EU/2/17/207/005 (100 ml) BTV 4 EU/2/17/207/006 (240 ml) BTV 4
Maltese: EU/2/17/207/006 (240 ml)
English: For protection against serotype 8, administer two doses of 2 ml three weeks apart, every 12 months.
Maltese: Għal protezzjoni kontra serotip 8, amministra żewġ dożi ta' 2 ml 3 ġimgħat minn xulxin, kull 12-il xahar.
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi injection type vaccination system when larger dose presentations are used.
Maltese: Sabiex tiġi evitata kontaminazzjoni aċċidentali tal-vaċċin waqt l-użu, huwa rrakkomandat li tintuża sistema ta' tilqim tat-tip ta' “aktar minn injezzjoni waħda” meta jintużaw preżentazzjonijiet ta' dożi kbar.
English: For protection against serotype 4, administer two doses of 2 ml three weeks apart, every 12 months.
Maltese: Għal protezzjoni kontra serotip 4, amministra żewġ dożi ta' 2 ml 3 ġimgħat minn xulxin, kull 12-il xahar.
English: **Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep.
Maltese: ** Qawwa relattiva skont test ta' qawwa fil-ġrieden imqabbel ma' tilqima ta' referenza li hija effikaċi fin-nagħaġ
English: Special precautions for use in animals:
Maltese: Kodiċi ATC veterinarju:
English: Revaccination: For protection against serotype 1 or serotype 8, administer one dose of 2 ml, every 12 months.
Maltese: Għal-protezzjoni kontra serotip 1 jew serotip 8, amministra doża waħda ta' 2 ml, kull 12-il xahar.
English: For protection against serotype 1, administer one dose of 2 ml, every 12 months.
Maltese: Għal protezzjoni kontra serotip 1, amministra doża waħda ta' 2 ml kull 12-il xahar.
English: EU/2/17/207/001 (20 ml) BTV 1 EU/2/17/207/002 (100 ml) BTV 1 EU/2/17/207/003 (240 ml) BTV 1 EU/2/17/207/007 (20 ml) BTV 8 EU/2/17/207/008 (100 ml) BTV 8
Maltese: NUMRI TAL-AWTORIZZAZZJONIJIET GĦAT-TQEGĦID FIS-SUQ EU/2/17/207/001-009
English: Bluetongue virus, serotype 8: 12 months after completion of the primary vaccination scheme.
Maltese: Bluetongue virus, serotip 8: 12-il xahar wara li jintemm il-kors primarju ta'
English: Suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għall-injezzjoni.
English: Subcutaneous use.
Maltese: Żero ġranet.
English: Manufacturer responsible for batch release:
Maltese: Sustanza mhux attiva:
English: The full EPAR for Reconcile can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: It contains the active substance fluoxetine.
Maltese: Fih is-sustanza attiva fluoxetine.
English: Fluoxetine is an antidepressant.
Maltese: Fluoxetine hija antidipressant.
English: Other common side effects with Reconcile (which may affect up to 1 in 10 dogs) are urinary problems (inflammation of the bladder, lack of control in passing urine, inability to completely empty the bladder, and pain and difficulty in passing urine), and lack of coordination and disorientation.
Maltese: Effetti sekondarji komuni oħra b'Reconcile (li jistgħu jaffettwaw aktar minn kelb 1 minn kull 10) huma problemi urinarji (infjammazzjoni tal-bużżieqa tal-awrina, nuqqas ta' kontroll fl-awrina, defiċjenza li l-bużżieqa tal-awrina titbattal kompletament, u wġigħ u diffikultà fl-awrina), u nuqqas ta' koordinazzjoni u diżorjentazzjoni.
English: Reconcile is available as tablets (8, 16, 32 and 64 mg) and can only be obtained with a prescription.
Maltese: Reconcile jiġi bħala pilloli (8, 16, 32 u 64 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: This is a summary of the European public assessment report (EPAR) for Reconcile.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Reconcile.
English: Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5545
Maltese: Telephone +44 (0)20
English: Fluoxetine works by increasing the levels of the neurotransmitter serotonin in the central nervous system.
Maltese: Fluoxetine taħdem billi żżid il-livelli tan-newrotrażmettitur serotonin fis-sistema ċentrali nervuża.
English: Other information about Reconcile?
Maltese: Informazzjoni oħra dwar Reconcile?
English: What are the risks associated with Reconcile?
Maltese: X'inhuma r-riskji assoċjati ma' Reconcile?
English: It must also not be used in dogs which are hypersensitive (allergic) to the active substance, any other ingredients or medicines in the same class as fluoxetine (serotonin-reuptake inhibitors).
Maltese: Lanqas ma għandu jintuża fi klieb li huma ipersensittivi (allerġiċi) għas-sustanza attiva, kwalunkwe ingredjent jew mediċina oħra fl-istess klassi ta' fluoxetine (inibituri tas-serotonin-reuptake).
English: The European Commission granted a marketing authorisation valid throughout the EU for Reconcile on 8 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Reconcile valida fl-Unjoni Ewropea kollha fit-8 ta' Lulju 2008.
English: Since low levels of serotonin can be linked to depression and anxiety, increasing them can help dogs feel calmer so improving the behaviour in dogs with separation-related problems.
Maltese: Peress li livelli baxxi ta' serotonin jistgħu jkunu marbuta mad-dipressjoni u l-ansjetà, iż-żieda tagħhom tista' tgħin lill-klieb biex iħossuhom aktar kalmi u għaldaqstant itejbu s-sinjali ta' mġiba bi problemi relatati ma' separazzjoni .
English: The study showed that Reconcile was as effective as clomipramine.
Maltese: L-istudju wera li Reconcile kien effettiv daqs il-klomipramina.
English: The most common side effects with Reconcile (which may affect more than 1 in 10 dogs) are loss of appetite and lethargy (lack of energy).
Maltese: L-effetti sekondarji l-aktar komuni b'-Reconcile (li jistgħu jaffettwaw aktar minn kelb 1 minn kull 10) huma nuqqas ta' aptit u għeja (nuqqas ta' enerġija).
English: For the full list of all side effects and restrictions reported with Reconcile, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u tar-restrizzjonijiet irrappurtati b'Reconcile, ara l-fuljett ta' tagħrif.
English: Why is Reconcile approved?
Maltese: Għaliex ġie approvat Reconcile?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Reconcile's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Reconcile huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Reconcile should only be given in combination with behavioural therapy.
Maltese: Reconcile għandu jingħata biss flimkien mat-terapija tal-imġiba.
English: Such problems may include destruction of property, excessive barking or howling and inappropriate defecation and urination in the home.
Maltese: Tali problemi jistgħu jinkludu t-tkissir tal-proprjetà, inbigħ eċċessiv u jgħaddu l-awrina jew jippurgaw mhux kif suppost fid-dar.
English: Reconcile is a veterinary medicine used as an aid to treat dogs with behavioural problems caused by separation from their owners or homes or from other dogs (separation anxiety).
Maltese: Reconcile huwa mediċina veterinarja użata bħala għajnuna fil-kura tal-klieb bi problemi ta' mġiba kkawżati minħabba separazzjoni minn ma' sidhom jew djarhom jew minn klieb oħra (ansjetà ta' separazzjoni).
English: All dogs received behavioural therapy and were treated either with Reconcile or with clomipramine (another medicine used to treat dogs with separation-related disorders).
Maltese: Il-klieb kollha rċevew it-terapija tal-imġiba u ġew ikkurati jew b'Reconcile jew bil-klomipramina (mediċina oħra użata fil-kura tal-klieb gal disturbi relatati mas-separazzjoni).
English: After 8 weeks of treatment, two separation anxiety behaviours were significantly improved in the Reconcile group (inappropriate defecation and destructive behaviour).
Maltese: Wara 8 ġimgħat ta' kura, żewġ disturbi tal-ansjetà tas-separazzjoni tjiebu sinifikattivament fil-grupp ta' Reconcile (ippurgaw mhux kif suppost u tkissir tal-proprjetà).
English: A neurotransmitter is a substance that nerve cells use to communicate with neighbouring cells.
Maltese: Newrotrażmettitur huwa sustanza kimika li ċ-ċelloli tan-nervituri jużaw sabiex jikkomunikaw maċ-ċelloli tal-qrib.
English: Reconcile must not be given to dogs weighing less than 4 kg or to dogs with epilepsy or a history of fits.
Maltese: Reconcile ma għandux jingħata lill-klieb li jiżnu inqas minn 4 kg jew lill-klieb bl-epilessija jew passat ta' fits.
English: 15 September 2017 EMA/599464/2017 EMEA/H/C/004159
Maltese: 15 ta' Settembru 2017 EMA/599464/2017 EMEA/H/C/004159
English: Masipro is a medicine that contains the active substance masitinib.
Maltese: Masipro huwa mediċina li fiha s-sustanza attiva masitinib.
English: It was to be available as tablets.
Maltese: Dan kellu jiġi bħala pilloli.
English: The company that applied for authorisation is AB Science.
Maltese: Il-kumpanija li applikat għal awtorizzazzjoni hija AB Science.
English: Refusal of the marketing authorisation for Masipro (masitinib)
Maltese: Masipro (masitinib)
English: Masipro was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 16 November 2004 for mastocytosis.
Maltese: Masipro kien ikklassifikat bħala “mediċina orfni” (mediċina li tintuża f'mard rari) fis16 ta' Novembru 2004 għall-mastoċitożi.
English: The active substance in Masipro, masitinib, is a tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Masipro, il-masitinib, hija ‘inibitur tat-tirożina kinażi'.
English: Masipro was expected to be used to treat adults with systemic mastocytosis, a disease in which there are too many mast cells (a type of white blood cell) in the skin, bones and various body organs, causing symptoms such as itchy skin, hot flushes, palpitations, fainting, bone pain, tiredness, vomiting, diarrhoea and depression.
Maltese: Masipro kien mistenni li jintuża biex jikkura adulti li għandhom il-mastoċitożi sistemika, marda li fiha jkun hemm wisq ċelluli mastoċiti (tip ta' ċellula tad-demm bajda) fil-ġilda, fl-għadam u f'diversi organi tal-ġisem, li tikkawża sintomi bħal ħakk fil-ġilda, fwawar ta' sħana, palpitazzjonijiet, iħossok ħażin, uġigħ fl-għadam, għeja, rimettar, dijarea u depressjoni.
English: On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masipro, intended for the treatment of systemic mastocytosis.
Maltese: Fit-18 ta' Mejju 2017, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Masipro, maħsub għall-kura tal-mastoċitożi sistematika.
English: What is Masipro?
Maltese: X'inhu Masipro?
English: What was Masipro expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Masipro?
English: Refusal of the marketing authorisation for Masipro (masitinib) EMA/599464/2017
Maltese: EMA/599464/2017
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Maltese: Wara li kkunsidra r-raġunijet għal din it-talba, is-CHMP reġa' eżamina l-opinjoni, u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fissuq fl-14 ta' Settembru 2017.
English: The applicant presented data from a main study involving 135 patients with systemic mastocytosis who had severe symptoms including at least one of the following four: itching, hot flushes, depression and tiredness.
Maltese: L-applikant ippreżenta data minn studju ewlieni li kien jinvolvi 135 pazjent bil-mastoċitożi sistemika li kellhom sintomi severi li jinkludu mill-inqas wieħed mill-erba' li ġejjin: ħakk, fwawar tas-sħana, depressjoni u għeja.
English: Finally, data on the safety of the medicine were limited and there were concerns regarding the medicine's side effects, including neutropenia (low levels of white blood cells) and harmful effects on the skin and liver, which were of relevance particularly because the medicine was to be used long term.
Maltese: Fl-aħħar nett, id-data dwar is-sigurtà tal-mediċina kienet limitata u kien hemm tħassib dwar l-effetti sekondarji tal-mediċina, li kienu jinkludu newtropenja (livelli baxxi taċ-ċelluli tad-demm bojod) u effetti ta' ħsara lill-ġilda u l-fwied, li kienu ta' rilevanza partikolarment minħabba li l-mediċina kienet maħsuba biex tintuża fit-tul.
English: By blocking these enzymes, Masipro is thought to help slow down the growth of the mast cells.
Maltese: Bl-imblukkar ta' dawn l-enzimi, Masipro huwa maħsub li jgħin inaqqas ir-ritmu tat-tkabbir taċ-ċelluli mastoċiti.