FrancophonIA/ELRC3.0 huggingface dataset:
English: National Competent Authorities (NCAs) of Member State(s) or Reference Member State(s) (RMS) where applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-Awtoritajiet Nazzjonali Kompetenti (NCAs) tal-Istat(i) Membru/i jew l-Istat(i) Membru/i ta' Referenza (RMS) fejn xieraq, għandhom jiżguraw li l-MAH(s) jissodisfa(w) il-kundizzjonijiet li ġejjin:
English: Condition to the marketing authorisation
Maltese: Id-data ta'
English: Deadline for submission of the Final study reports: 31 December 2016.
Maltese: 31 ta' Diċembru 2016.
English: • The MAH should perform a drug utilization study to evaluate the effectiveness of the implemented risk minimisation measures in terms of the mitigation of off-label use and adherence of prescribers to the SmPC.
Maltese: • Il-MAH għandu jwettaq studju dwar l-użu tal-mediċina biex jevalwa l-effikaċja tal-miżuri implimentati għall-minimizzazzjoni tar-riskji f'termini tal-mitigazzjoni ta' użu għal indikazzjonijiet mhux approvati u l-aderenza ta' dawk li jieħdu l-mediċina għall-SmPC.
English: • Conduct of a drug utilization study to describe the characteristics of new users of cilostazol and the duration of the use of cilostazol and discontinuation patterns.
Maltese: • It-twettiq ta' studju dwar l-użu tal-mediċina biex jiġu deskritti l-karatteristiċi ta' dawk li jkunu għadhom kif bdew jużaw il-kolostażolu u d-durata tal-użu tal-kolostażolu u l-mudelli ta' twaqqif tal-mediċina.
English: The MAHs shall submit an EU risk management plan for the products according to the EU Good Vigilance Practices and including the following measures:
Maltese: Il-MAHs għandhom jissottomettu pjan ta' ġestjoni tar-riskji fl-UE għall-prodotti skont il-Prattiki Tajbin ta' Viġilanza tal-UE u li jinkludi l-miżuri li ġejjin:
English: The study will also aim to quantify off-label use, describe dosage patterns and identify the medical specialties of physicians prescribing cilostazol.
Maltese: L-istudju ser ikollu l-għan li jikkwantifika l-użu għal indikazzjonijiet mhux approvati wkoll, jiddeskrivi x-xejriet tad-dożaġġ u jidentifika l-ispeċjalitajiet mediċi tat-tobba li jippreskrivu l-kolostażolu.
English: The full EPAR for Bretaris Genuair 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: The active substance in Bretaris Genuair, aclidinium bromide, is an antimuscarinic bronchodilator.
Maltese: Is-sustanza attiva fi Bretaris Genuair, il-bromur tal-aklidinju, hija bronkodilatur antimuskariniku.
English: Bretaris Genuair aclidinium bromide
Maltese: Bretaris Genuair bromur tal-aklidinju
English: Other information about Bretaris Genuair
Maltese: Aktar informazzjoni dwar Bretaris Genuair
English: On average, after six months of treatment, the FEV1 in patients who used 200 and 400 micrograms Bretaris Genuair increased compared with placebo by 99 ml and 128 ml respectively.
Maltese: Bħala medja, wara sitt xhur ta' kura, l-FEV1 filpazjenti li użaw 200 u 400 mikrogramma ta' Bretaris Genuair żdied b'99 ml u 128 ml rispettivament meta mqabbel ma' plaċebo.
English: The CHMP also noted that there were no major safety concerns with Bretaris Genuair, with side effects being reversible and similar to other antimuscarinic bronchodilator medicines.
Maltese: Is-CHMP innota wkoll li ma kien hemm l-ebda tħassib serju ta' sigurtà bi Bretaris Genuair, bl-effetti sekondarji jkunu riversibbli u simili għal medicini bronkodilaturi antimuskariniċi oħra.
English: This is a summary of the European public assessment report (EPAR) for Bretaris Genuair.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Bretaris Genuair.
English: The dose of 400 micrograms Bretaris Genuair corresponds to an inhalation providing 322 micrograms of aclidinium.
Maltese: Id-doża ta' 400 mikrogramma ta' Bretaris Genuair tikkorrispondi għal inalazzjoni li tipprovdi 322 mikrogramma ta' aklidinju.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bretaris Genuair on 20 July 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Bretaris Genuair fl-20 ta' Lulju 2012.
English: Bretaris Genuair is used for maintenance (regular) treatment.
Maltese: Bretaris Genuair jintuża għall-kura ta' manutenzjoni (regolari).
English: Bretaris Genuair contains the active substance aclidinium bromide.
Maltese: Bretaris Genuair fih is-sustanza attiva bromur tal-aklidinju.
English: What are the risks associated with Bretaris Genuair?
Maltese: X'inhuma r-riskji assoċjati ma' Bretaris Genuair?
English: Why is Bretaris Genuair approved?
Maltese: Għaliex ġie approvat Bretaris Genuair?
English: Bretaris Genuair is available as an inhalation powder in a portable inhaler device.
Maltese: Bretaris Genuair jiġi bħala trab għall-inalazzjoni f'inalatur portabbli.
English: The study compared two doses of Bretaris Genuair (200 and 400 micrograms) inhaled twice a day with placebo.
Maltese: L-istudju qabbel żewġ dożi ta' Bretaris Genuair (200 u 400 mikrogramma) inalati darbtejn kuljum, ma' plaċebo.
English: As antimuscarinic bronchodilator medicines may have an effect on the heart and blood vessels, the company will closely monitor the medicine's cardiovascular effects and will carry out a further study in patients to identify any potential risks.
Maltese: Billi mediċini bronkodilaturi antimuskariniċi jista' jkollhom effett fuq il-qalb u l-arterji u l-vini taddemm, il-kumpanija ser tissorvelja mill-qrib l-effetti kardjovaskulari tal-mediċina u ser twettaq studju ieħor f'pazjenti biex tidentifika kwalunkwe riskju potenzjali.
English: A main study involving 828 patients with COPD found that Bretaris Genuair was more effective than placebo (a dummy treatment) at improving how well the lungs work.
Maltese: Studju ewlieni li kien jinvolvi 828 pazjent b'COPD sab li Bretaris Genuair kien iktar effettiv minn plaċebo (kura finta) għat-titjib ta' kemm jaħdmu tajjeb il-pulmuni.
English: The CHMP noted that Bretaris Genuair was shown to be effective at improving the symptoms of COPD, and its beneficial effects are maintained for up to a year.
Maltese: Is-CHMP innota li Bretaris Genuair intwera li kien effettiv fit-titjib tas-sintomi ta' COPD, u l-effetti ta' benefiċċju tiegħu jibqgħu sa sena.
English: The most common side effects with Bretaris Genuair (which may affect more than 5 patients in 100) are headache and nasopharyngitis (inflammation of the nose and throat).
Maltese: L-effetti sekondarji l-aktar komuni bi Bretaris Genuair (li jistgħu jaffettwaw aktar minn 5 pazjenti minn kull 100) huma wġigħ ta' ras u nażofarinġite (infjammazzjoni tal-imnieħer u tal-griżmejn).
English: The main measure of effectiveness was how Bretaris Genuair improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Maltese: Il-kejl ewlieni taleffikaċja kien dwar kif Bretaris Genuair tejjeb il-volumi espiratorji furzati tal-pazjenti (FEV1, il-volum massimu ta' arja li persuna tista' toħroġ f'sekonda).
English: For the full list of all side effects and restrictions with Bretaris Genuair, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha bi Bretaris Genuair, ara l-fuljett ta' tagħrif.
English: Therefore, the CHMP decided that Bretaris Genuair's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Għaldaqstant, is-CHMP iddeċieda li l-benefiċċji ta' Bretaris Genuair huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Muscarinic receptors control the contraction of muscles and when aclidinium bromide is inhaled, it relaxes the muscles of the airways.
Maltese: Ir-riċetturi muskariniċi jikkontrollaw il-kontrazzjoni tal-muskoli u meta l-bromur tal-aklidinju jkun inalat, dan jirrilassa lmuskoli tal-passaġġi tal-arja.
English: Bretaris Genuair is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Bretaris Genuair huwa mediċina użata biex ittaffi s-sintomi tal-marda pulmonari ostruttiva kronika (COPD- chronic obstructive pulmonary disease) fl-adulti. COPD hija marda fit-tul li fiha l-passaġġi talarja u l-boroż tal-arja ġewwa l-pulmuni ssirilhom ħsara jew jiġu mblukkati, u dan iwassal għal diffikultà fit-teħid tan-nifs.
English: 23 rd Klm National Road Athens-Lamia 145 65 Agios Stefanos Athens - GREECE
Maltese: 23 rd Klm National Road Athens-Lamia 145 65 Agios Stefanos Athens
English: Virbac Danmark A/S Filial Sverige, c/o Incognito AB, Box 1027,
Maltese: Virbac Danmark A/S Filial Sverige, c/o Incognito AB,
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance :
Maltese: U KWANTITATTIVA Sustanza Attiva:
English: Disodium phosphate - Potassium dihydrogen phosphate - Glutamic acid - Saccharose - GelatinTryptone - Lactalbumin hydrolysate - Sodium chloride - Water for injection
Maltese: Disodium phosphate - Potassium dihydrogen phosphate - Glutamic acid - Saccharose - GelatinTryptone - Lactalbumin hydrolysate - Sodium chloride - Ilma għall-injezzjoni
English: 02-819 Warszawa
Maltese: Puławska 314 02-819 Warszawa
English: 8 log10 - CCID50*/dose
Maltese: 8 log10 - CCID50*/doża
English: Appetent matrix (bait) :
Maltese: Matriċi appetenti (lixka):
English: 06516 Carros - France tel: + 33 4 92 08 73 04 fax: + 33 4 92 08 73 48 e-mail: darprocedure@virbac.com
Maltese: 06516 Carros - Franza tel: + 33 4 92 08 73 04 fax: + 33 4 92 08 73 48 e-mail: darprocedure@virbac.com
English: Store in a freezer at -40°C to -20°C.
Maltese: Aħżen fil-friża f'temperatura ta' bejn -40°Ċ sa -20°Ċ.
English: Panchris Feeds (Veterinary) Ltd Industrial Area Aradippou, 7100, Larnaca, Cyprus Tel: +357 24813333
Maltese: Panchris Feeds (Veterinary) Ltd Industrial Area Aradippou, 7100, Larnaca, Cyprus (P.O.Box 40261, 6302 Larnaca, Cyprus) Tel: + 357 24813333
English: 06516 Carros - France
Maltese: 06516 Carros - Franza
English: Rhodor 7046R antifoam - Tetracycline (Hcl) HD - EVA (Ethyl Vinyl Acetate) - White soft paraffinParaffin 50/52° C - Seah Saur - Natural fish aroma
Maltese: HD - EVA (Ethyl Vinyl Acetate) - White soft paraffinParaffin 50/52° C - Seah Saur - Natural fish aroma
English: The baits are successively packed in boxes of: - 200 units (4x50) - 400 units (2x200)
Maltese: Il-lixka hija suċċessivament ippakkjati ġo kaxxi ta': - 200 unit (4x50) - 400 unit (2x200)
English: 2 years at -20°C and 2 days at +25°C.
Maltese: Sentejn f'temperatura ta' -20°Ċ u jumejn f'temperatura ta' +25°Ċ.
English: * CCID50: Cell Culture Infective Dose 50%
Maltese: * CCID50: Doża Infettiva tal-Kulturi taċ-Ċelloli 50%
English: EU/2/00/021/001 EU/2/00/021/002
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/00/021/001
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' sustanzi ara s-sezzjoni 6.1.
English: Live attenuated rabies virus, SAG2 strain
Maltese: Virus inattivat tar-rabbja, tal-grupp SAG2
English: PACKAGE SIZE 400 (2 x 200) vaccinal baits.
Maltese: Kaxxa li fiha 400 (2 x 200) lixka tal-vaċċin.
English: Red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).
Maltese: Volpijiet ħomor (Vulpes vulpes) u klieb raccoon (Nyctereutes procyonoides).
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA Informazzjoni dettaljata ta' dan il-prodott mediċinali u veterinarju jinsab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 400 UNIT BOX
Maltese: TIKKETTAR GĦAL KAXXA LI FIHA 400 UNIT
English: ul.
Maltese: Biss.
English: Avenue 2065 M L.I.D 06516 Carros France
Maltese: Avenue 2065 M L.I.D 06516 Carros Franza
English: L.I.D.
Maltese: 1 L-ISEM
English: The active ingredient is a double low virulence mutant isolated from the SAD Bern strain of rabies virus by two successive selection steps in order to avoid natural reversion to the parental strain.
Maltese: Is-sustanza attiva huwa mutant doppju ta' virulenza baxxa li ġie iżolat minn razza ta' grupp tal-virus tar-rabbja SAD Bern, permezz ta' żewġ proċeduri ta' selezzjoni suċċessivi sabiex jiġi evitat li jkun hemm riverżjoni naturali għall-virus parentali.
English: PACKAGE SIZE 200 (4 x 50) vaccinal baits.
Maltese: Kaxxa li fija 200 (4 x 50) lixka ta' tilqim.
English: RABIES VACCINE DO NOT TOUCH Informative phone number: + 33 4 92 08 73 04
Maltese: Numru tat-telefon informattiv: + 33 4 92 08 73 04
English: 1ère avenue 2065 m LID 06516 Carros
Maltese: 1ère avenue 2065 m LID 06516 Carros France
English: The duration of protection is of at least 6 months.
Maltese: Il-protezzjoni ddum minn ta' lanqas 6 xhur.
English: Rabigen SAG2 is a live modified rabies vaccine for oral administration to red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).
Maltese: Rabigen SAG2 huwa vaċċin kontra l-virus tar-rabbja inattivat li jittieħed mill-ħalq mill-volpijiet ilħomor (Vulpes vulpes) u klieb raccoon (Nyctereutes procyonoides).
English: Puławska 314
Maltese: Esperantolaan 4
English: For the active immunisation of red foxes and raccoon dogs to prevent infection by rabies virus.
Maltese: Immunizzazzjoni attiva tal-volpijiet ħomor u klieb raccoon sabiex tilqa' għal infezzjoni bil-virus tarrabbja.
English: Keep out of the reach and sight of children Store in a freezer at -40°C to -20°C.
Maltese: Żomm fejn ma jintlaħaqx u ma jidhirx mit-tfal Aħżen fil-friża f'temperatura ta' bejn -40°C sa -20°C.
English: * CCID50 : Cell Culture Infective Dose 50% Excipients :
Maltese: 8 log10 CCID50*/doża * CCID50: Doża Infettiva tal-Kulturi taċ-Ċelloli 50% Eċipjenti:
English: As this vaccine presentation contains traces of gentamicin and contains tetracycline as biomarker, occasional hypersensitivity reactions may be observed in domestic animals that have accidentally ingested the bait.
Maltese: Peress li l-preżentazzjoni ta' dan il-vaċċin fih traċċi ta' ġentamiċin u fiha tetraċiklina bħala bijoindikatur, kultant jistgħu jiġu osservati xi reazzjonijiet ta' ipersensitività f'annimali domestiċi li inċidentalment ikunu belgħu il-lixka.
English: Live attenuated rabies virus, SAG2 strain minimum 8 log10 CCID50*/dose
Maltese: minimu ta' 8 log 10 CCID 50* / doża * CCID50: Doża Infettiva tal-Kulturi taċ-Ċelloli 50% Sustanzi oħra:
English: MANUFACTURER'S BATCH NUMBER BN: {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott {numru}
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
Maltese: VETERINARJU Rabigen SAG2 suspensjoni orali ttieħed mill-ħalq, għall-volpijiet ħomor u klieb raccoon.
English: Palatable matrix (bait) containing a tetracycline biomarker
Maltese: U SID(IEN) TALAWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: Restricted to duly designated competent administrative authorities.
Maltese: Ristrett għal awtoritajiet amministrattivi kompetenti maħtura.
English: 1ère Avenue - 2065 m 06516 Carros,
Maltese: L.I.D. 1ère Avenue - 2065 m 06516 Carros, Franza
English: Pharmacotherapeutic group: Live viral vaccines ATCvet code: QI07BD.
Maltese: Is-sigurtà tal-vaċċin ma ġietx investigata fil-każ ta' bhejjem tqal jew li huma fi żmien il-ħalib.
English: ES-8950 Esplugues de Llobregat (Barcelona) Tél.
Maltese: E-08950 - Esplugues de Llobregat (Barcelona) Tel: + 34 93 470 79 40
English: This minimum distribution rate is: - 13 baits per square km over the areas where fox / raccoon dog density indexes were equal or less than 3 foxes / raccoon dogs seen per 10 km.
Maltese: Din ir-rata minima ta' tqassim hija: - 13-il lixka għal kull km kwadru fiż-żoni fejn l-indiċi tad-densità tal-volpijiet / kelb raccoon kienu daqs jew inqas minn 3 volpijiet / klieb raccoon li dehru għal kull 10 km. - 20 lixka għal kull km kwadru fiż-żoni fejn l-indiċi tad-densità tal-volpijiet / kelb raccoon kienu iktar minn 3 volpijiet / klieb raccoon li dehru għal kull 10 km.
English: The minimum distribution rate is: - 13 baits per square km over the areas where fox /raccoon dog density indexes were equal or less than 3 foxes / raccoon dogs seen per 10 km.
Maltese: Ir-rata minima ta' tqassim hija: - 13-il lixka għal kull km kwadru fiż-żoni fejn l-indiċi tad-densità tal-volpijiet kelb raccoon kienu daqs jew inqas minn 3 volpijiet / klieb raccoon li dehru f'kull 10 km.. - 20 lixka għal kull km kwadru fiż-żoni fejn l-indiċi tad-densità tal-volpijiet / klieb raccoon kienu iktar minn 3 volpijiet / klieb raccoon li dehru għal kull 10 km.
English: However rabies virus and attenuated rabies vaccine viruses do not usually accumulate in reproductive organs and are not known to directly affect reproductive functions.
Maltese: Imma l-virus tar-rabbja u virusijiet tal-vaċċin attenwat kontra r-rabbja normalment ma jakkumulawx fl-organi riproduttivi u mhumiex magħrufa li jaffettwaw direttament il-funzjonijiet riproduttivi.
English: It is recommended to wear rubber gloves.
Maltese: Mhux applikabbli.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active substance:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Sustanza attiva:
English: Manufacturing Authorisation issued on December 22 santé et de la protection sociale - Direction de la Pharmacie et du médicament - République Française.
Maltese: L-Awtorizzazzjoni tal-Kummerċ ġiet maħruġa fit-22 ta' Diċembru 1997 mill-Ministeru tasSolidarjetà, tas-Saħħa u tal-Ħarsien Soċjali - Direttorat tal-Farmaċija u tal-Mediċini - Repubblika Franċiża.
English: Veterinary medicinal product subject to prescription.
Maltese: Għandu jingħata biss bi preskrizzjoni medika.
English: The full EPAR for Fabrazyme 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: Fabrazyme has been investigated in three studies involving a total of 73 adults.
Maltese: Fabrazyme ġie studjat fi tliet studji li involvew total ta' 73 adult.
English: EPAR summary for the public agalsidase beta
Maltese: Sommarju tal-EPAR għall-pubbliku agalsidażi beta
English: Fabrazyme is an enzyme replacement therapy.
Maltese: Fabrazyme hu terapija enżimatika sostituttiva.
English: Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (GL-3 or Gb3).
Maltese: Din l-enżima normalment tkisser is-sustanza xaħmija msejħa globotrijaosilċeramide (globotriaosylceramide) (GL-3 jew Gb3).
English: This is a summary of the European public assessment report (EPAR) for Fabrazyme.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Fabrazyme.
English: The active substance in Fabrazyme, agalsidase beta, is a copy of the human enzyme, produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme.
Maltese: Is-sustanza attiva f'Fabrazyme, l-agalsidażi beta, hija kopja tal-enżima umana li tinħadem b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': hija magħmula minn ċelloli li jkunu rċevew ġene (DNA), li jagħmilhom kapaċi jipproduċu l-enżima.
English: Why has Fabrazyme been approved?
Maltese: Għaliex ġie approvat Fabrazyme?
English: Children treated with Fabrazyme also had decreases in levels of GL-3 in the blood, with all children having normal levels after 20 weeks of treatment.
Maltese: Tfal ikkurati b'Fabrazyme ukoll kellhom tnaqqis fil-livelli tal-GL-3 fid-demm, bit-tfal kollha jkollhom livelli normali wara 20 ġimgħa kura.
English: Fabrazyme is a medicine that contains the active substance agalsidase beta.
Maltese: Fabrazyme huwa mediċina li fiha s-sustanza attiva agalsidażi alfa.
English: The starting infusion rate should be no more than 0.25 mg per minute (15 mg per hour) to reduce the risk of infusion-related side effects.
Maltese: Ir-rata tal-bidu tal-infużjoni ma għandhiex tkun ogħla minn 0.25 mg kull minuta (15 mg kull siegħa)
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fabrazyme on 3 August 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Fabrazyme fit-3 ta' Awwissu 2001.
English: The effectiveness of Fabrazyme was also tested in 16 children aged between eight and 16 years who had Fabry disease.
Maltese: L-effikaċja ta' Fabrazyme ġiet ukoll ittestjata f'16-il tifel u tifla ta' bejn tmien snin u 16-il sena li jbatu bil-marda ta' Fabry.
English: How has Fabrazyme been studied?
Maltese: Kif ġie studjat Fabrazyme?
English: In the main study, Fabrazyme was compared with placebo (a dummy treatment) in 58 patients.
Maltese: Fl-istudju prinċipali, Fabrazyme tqabbel ma' plaċebo (trattament finta) fi 58 pazjent.
English: Fabrazyme is given once every two weeks as an infusion of 1 mg per kilogram body weight.
Maltese: Fabrazyme jingħata darba kull ġimagħtejn bħala infużjoni ta' 1 mg għal kull kilogramm piż tal-ġisem.
English: In the main study, Fabrazyme produced a highly significant and almost complete clearance of GL-3 in the kidney cells after 20 weeks of treatment: 69% of the patients treated with Fabrazyme had the best score for clearance, compared with none of the patients in the placebo group.
Maltese: Fl-istudju prinċipali, Fabrazyme neħħa b'mod sinifikanti ħafna u kważi komplut il-GL-3 miċ-ċelluli talkliewi wara 20 ġimgħa trattament: 69% tal-pazjenti ttrattati b'Fabrazyme irreġistraw l-aħjar livelli ta' tneħħija, meta mqabbla mal-qagħda tal-pazjenti tal-grupp tal-plaċebo li fih ma ġie rreġistrat l-ebda effett.
English: What is Fabrazyme?
Maltese: X'inhu Fabrazyme?
English: These include fever, chills, headache, paraesthesia (abnormal sensations like pins and needles), nausea (feeling sick), vomiting and feeling cold. For the full list of all side effects reported with Fabrazyme, see the package leaflet.
Maltese: Dawn jinkludu deni, irjiħat, uġigħ ta' ras, paraestesija (sensazzjonijiet anomali bħat-tnemnim), nawżja (dardir), remettar, fwawar u bard.
English: What is the risk associated with Fabrazyme?
Maltese: X'inhu r-riskju assoċjat ma' Fabrazyme?
English: It is available as a powder to be made into a solution for infusion (drip) into a vein.
Maltese: Jiġi bħala trab li jitħallat f'soluzzjoni għal infużjoni (dripp) fil-vina.
English: The CHMP decided that Fabrazyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Fabrazyme huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The CHMP decided that, for patients with Fabry disease, treatment with Fabrazyme might provide longterm clinical benefits.
Maltese: Is-CHMP ddeċieda li, f'pazjenti morda bil-marda ta' Fabry, il-kura b'Fabrazyme tista' tipprovdi benefiċċji kliniċi fit-tul.
English: The most common side effects with Fabrazyme (seen in more than 1 patient in 10) are caused by the infusion rather than the medicine.
Maltese: L-effetti sekondarji l-aktar komuni bl-użu ta' Fabrazyme (li dehru f'aktar minn pazjent 1 minn 10) jiġu kkawżati mill-infużjoni aktar milli mill-mediċina nfisha.
English: People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems and stroke.
Maltese: Il-persuni li jbatu minn din il-marda jista' jkollhom firxa sħiħa ta' sinjali u sintomi, li jinkludu kundizzjonijiet gravi bħal insuffiċjenza renali, problemi fil-qalb u attakki ta' puplesija.
English: EU/1/12/751/001
Maltese: EU/1/12/751/001 Zelboraf
English: (Invented) name
Maltese: Numru ta' l-EU Isem (inventat)
English: Oral use blister (alu/alu) 56 tablets
Maltese: Folja (alu/alu) 56 pillola
English: Zelboraf
Maltese: Użu orali
English: 240 mg Film-coated tablet
Maltese: 240 mg Pillola miksija b'rita
English: 0.5 ml 1.0 ml 2.0 ml 4.0 ml
Maltese: 0.5 ml 1.0 ml 2.0 ml 4.0 ml 8.0 ml
English: 100 LD50 units
Maltese: INDIVIDWALI 100 LD50 unità