FrancophonIA/ELRC3.0 huggingface dataset:
English: Step 5: Patient inhales 160 mg (4x40 mg capsules), FEV1 is measured and SpO2 is monitored Step 6: Patients FEV1 is measured 15 minutes post initiation dose.
Maltese: Il-pazjent jieħu 160 mg man-nifs (erba' kapsuli x40 mg), l-FEV1 jitkejjel u l-SpO2 jiġi mmonitorjat
English: MARKETING AUTHORISATION HOLDER
Maltese: KONDIZZJONIJIET OĦRA U REKWIŻITI
English: - ≥10% fall from baseline in SpO2 at any point of the assessment; - FEV1 fall from baseline is ≥20% at 240 mg cumulative dose; - FEV1 has fallen 20-<50% (from baseline) at the end of the assessment and does not return to
Maltese: - tnaqqis ta' ≥10 fl-SpO2 % mil-linja bażi fi kwalunkwe punt tal-evalwazzjoni; - it-tnaqqis tal-FEV1 mil-linja bażi jkun ta' ≥20% f'doża kumulattiva ta' 240 mg; - l-FEV1 ikun naqas b'20-<50% (mil-linja bażi) fit-tmiem tal-valutazzjoni u ma jerġax lura għal <20% fi żmien 15-il minuta; - l-FEV1 ikun naqas b'≥50% (mil-linja bażi) fit-tmiem tal-valutazzjoni.
English: The most commonly observed adverse reaction associated with the use of Bronchitol during the initiation dose assessment with the paediatric population is cough (4.8% of patients).
Maltese: Matul il-valutazzjoni tad-doża tal-bidu l-aktar reazzjoni avversa komuni osservata assoċjata mal-użu ta' Bronchitol fil-popolazzjoni pedjatrika hija s-sogħla (4.8% tal-pazjenti ).
English: Repeat steps 3 to 10 for each capsule - Perform these steps for each of the ten capsules.
Maltese: Irrepeti l-passi 3 sa 10 għal kull kapsula - Wettaq dawn il-passi għal kull waħda mill-għaxar kapsuli.
English: Bronchitol should not be used by children and adolescents under the age of 18.
Maltese: Bronchitol m'għandux jintuża minn tfal u adoloxxenti taħt l-età ta' 18-il sena.
English: Uncommon Acne, Cold sweat, Pruritus, Rash, Rash pruritic
Maltese: Mhux komuni Akne, Għaraq kiesaħ, Prurite, Raxx, Raxx bil-ħakk
English: The patient's initiation dose of Bronchitol must be used under the supervision and monitoring of an experienced physician or another health care professional appropriately trained and equipped to perform spirometry, monitor oxygen saturation (SpO2), and manage acute bronchospasm (see sections 4.4 and 4.8) including appropriate use of resuscitation equipment.
Maltese: Id-doża tal-bidu ta' Bronchitol għall-pazjent għandha tintuża taħt is-superviżjoni u l-monitoraġġ ta' tabib esperjenzat jew ta' professjonista ieħor tal-kura tas-saħħa mħarreġ kif xieraq u mgħammar biex iwettaq spirometrija, jimmonitorja s-saturazzjoni tal-ossiġnu (SpO2), u jimmaniġġja bronkospażmu akut (ara sezzjonijiet 4.4 u 4.8) inkluż l-użu xieraq ta' apparat ta' risuxxitazzjoni.
English: Cough, Condition aggravated, Haemoptysis, Oropharyngeal pain, Chest discomfort, Wheezing, Asthma, Productive cough
Maltese: Sogħla, Emoptisi, Uġigħ orofarinġali, Tħarħir
English: As a precautionary measure, it is preferable to avoid the use of Bronchitol during pregnancy.
Maltese: Bħala miżura ta' prekawzjoni, l-użu ta' Bronchitol għandu preferibbilment jiġi evitat waqt it-tqala.
English: Ear and labyrinth disorders Uncommon Ear pain Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: The most commonly observed adverse reaction associated with the use of Bronchitol is cough (see section 4.4).
Maltese: L-aktar reazzjoni avversa komuni osservata assoċjata mal-użu ta' Bronchitol hija s-sogħla (ara sezzjoni 4.4).
English: This was observed in 8.3% of patients compared to 4.0% of patients in the control arm.
Maltese: Din kienet osservata fi 8.3% tal-pazjenti meta mqabbla ma' 4.0% tal-pazjenti fil-fergħa ta' kontroll.
English: Cartons containing 10 or 280 capsules for initial dose and treatment use respectively.
Maltese: Pakketti li fihom 10 jew 280 kapsula għad-doża tal-bidu u għall-użu ta' kura rispettivament.
English: Adverse reactions that occurred only with the initiation dose assessment (MTT) are dehydration, forced expiratory volume decreased, hypoxia, diarrhoea, abdominal pain upper, aphthous stomatitis, odynophagia, chest pain and blood alkaline phosphatase increased.
Maltese: Ir-reazzjonijiet avversi li seħħew biss bil-valutazzjoni tad-doża tal-bidu (MTT) huma deidratazzjoni, tnaqqis filvolum espiratorju sfurzat, ipossija, dijarea, uġigħ fil-parti ta' fuq tal-addome, stomatite aftuża, odinofaġija, uġigħ fis-sider u żieda fil-fosfatażi alkalina tad-demm
English: Treatment dose (2-week packs) - You must use Bronchitol every day.
Maltese: Doża tal-kura (pakketti ta' ġimagħtejn) - Għandek tuża Bronchitol kuljum.
English: The potential risk of cough related sequelae during treatment o The need to train the patient to minimise cough during administration in using the correct inhalation technique.
Maltese: Ir-riskju potenzjali ta' konsegwenzi relatati ma' sogħla waqt il-kura o Il-ħtieġa li l-pazjent jiġi mħarreġ biex tiġi minimizzata s-sogħla waqt l-għoti permezz tal-użu tat-teknika korretta ta' inalazzjoni.
English: - Never place a capsule directly into the mouth-piece of your inhaler.
Maltese: - Qatt ma għandek tħalli kapsula użata fil-kompartiment tal-inalatur tiegħek.
English: Haemoptysis
Maltese: Mouthpiece
English: Post-tussive vomiting, Vomiting Uncommon Nausea, Diarrhoea, Eructation, Flatulence, Gastrooesophageal reflux disease, Glossodynia, Retching, Stomatitis, Abdominal pain upper, Aphthous Stomatitis, Odynophagia
Maltese: Rimettar wara s-sogħla, Rimettar Mhux komuni Nawseja, Dijarea, Tifwiq, Gass fl-istonku, Marda ta' rifluss gastroesofagali, Glossodinja, Tqalligħ, Stomatite, Uġigħ ta' żaqq fin-naħa ta' fuq, Stomatite bl-afte Odinofaġja
English: The patient should be pre-medicated with a bronchodilator 5-15 minutes prior to the initiation dose but after the baseline FEV1 and SpO2 (Oxygen saturation in the blood) measurement.
Maltese: Il-pazjent għandu jiġi mmedikat minn qabel permezz ta' bronkodilatur 5-15-il minuta qabel id-doża tal-bidu iżda wara li jitkejjel l-FEV1 fil-linja bażi u l-SpO2 (saturazzjoni tal-ossiġnu fid-demm).
English: Refer to package leaflet for inhaler device instructions.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: Uncommon Blood alkaline phosphatase increased, Bacteria or fungus sputum test positive
Maltese: Mhux komuni Żieda fl-alkaline phosphatase fid-demm Batterji jew test pożittiv għal fungus flisputum
English: Do not use Bronchitol - if you are allergic to mannitol - if you are sensitive to mannitol.
Maltese: Tużax Bronchitol - jekk inti allerġiku għal mannitol - jekk inti sensittiv/a għall-mannitol.
English: Bronchitol capsules can only be used with the inhaler provided in the pack.
Maltese: Il-kapsuli Bronchitol jistgħu jintużaw biss malinalatur li hemm ipprovdut fil-pakkett.
English: Other medicines and Bronchitol
Maltese: Kif jaħdem Bronchitol
English: Inhalation use only.
Maltese: Mhux applikabbli.
English: Bronchitol 40 mg, inhalation powder, hard capsules Mannitol
Maltese: Bronchitol 40 mg, trab li jittieħed man-nifs, kapsuli iebsin mannitol
English: Bronchitol 40 mg, inhalation powder, hard capsules mannitol
Maltese: Bronchitol 40 mg, trab li jittieħed man-nifs, kapsuli iebsin Mannitol
English: The most important adverse reaction associated with the use of Bronchitol is haemoptysis.
Maltese: L-aktar reazzjoni avversa importanti osservata assoċjata mal-użu ta' Bronchitol hija l-emoptisi.
English: This includes any possible side effects not listed in this leaflet.
Maltese: Ħawwdu sakemm ma jkunx hemm qtar tal-ilma kbar fl-inalatur.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: Emoptisi (Taqta' d-demm)
English: Refer to enclosed leaflet for inhaler device instructions.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONI RIGWARD ILPROVVISTA
English: Hyperresponsive patients should not be prescribed the therapeutic dose regimen of Bronchitol (see section 4.3).The usual precautions regarding bronchial hyperresponsiveness monitoring apply (see section 4.2).
Maltese: Waqt il-valutazzjoni tad-doża tal-bidu l-aktar reazzjoni avversa importanti osservata bl-użu ta' Bronchitol hija l-bronkospażmu (ara sezzjoni 4.4).
English: - The usual dose is 10 capsules (400 mg) inhaled in the morning, and 10 capsules inhaled in the evening.
Maltese: - Id-doża tas-soltu hija 10 kapsuli (400 mg) li jittieħdu man-nifs filgħodu, u 10 kapsuli li jittieħdu man-nifs filgħaxija.
English: Merial Laboratoire Lyon Gerland, 254 rue Marcel Merieux 69007 Lyon
Maltese: Merial Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 Lyon
English: Date of first authorisation: 09/08/2002 Date of last renewal: 06/07/2012
Maltese: Data ta' l-aħħar tiġdid: 06/07/2012
English: Casein hydrolysate Phenol red 1% solution Salts
Maltese: Kaseina hydrolysate Phenol aħmar soluzzjoni ta'1%
English: Diluent:
Maltese: Dilwent:
English: Dimethyl sulfoxide Dilution medium
Maltese: Dimethyl sulfoxide Medium tad-dilwit
English: Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest France
Maltese: Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800
English: Store below 30°C.
Maltese: Aħżen taħt it-30°C.
English: 1000 doses 2000 doses
Maltese: 2000 doża
English: This diluent may be used with the following products: Vaxxitek HVT+IBD (EU/2/02/032/001-002)
Maltese: Vaxxitek HVT+IBD (EU/2/02/032/001-002)
English: STERILE DILUENT
Maltese: DILWENT STERILIZZAT
English: - (polyvinylchloride) bag of 200ml, 400ml, 600ml, 800ml, 1000ml, 1200ml, 1400ml, 1600ml,
Maltese: - borża (tal-polyvinychloride) ta' 200 ml,400ml,600ml, 800ml, 1000ml, 1200ml,1400ml, 1600ml,
English: Live vHVT013-69 recombinant virus, at least ....................................................... 3.6 to 5.0 log10 PFU* Excipients .................................................................................................................................... qs 1 dose Diluent:
Maltese: Vajrus rikombinat attiv vHVT013-69, mill-inqas. ................................................. 3.6 sa 5.0 log10 PFU* Sustanzi mhux attivi ........................................................................................................... qs doża waħda
English: Diluent ......................................................................................................................................... qs 1 dose *Plaque forming unit
Maltese: Dilwent .............................................................................................................................. .qs doża waħda *Plaque forming unit
English: ATCvet code QI01AD15
Maltese: KWALITAJIET IMMUNOLOĠIĊI Kodici ATĊ veterinarja Q101AD15
English: - (glass) ampoule of 1,000 doses of vaccine, 5-ampoule carrier.
Maltese: - ampullett (tal-ħġieġ) ta' 1000 doża ta' vaċċin, kontenitur ta' 5 ampulletti.
English: The vaccine strain is a recombinant Herpesvirus of turkeys (HVT) expressing the protective antigen (VP2) of the Infectious Bursal Disease Virus (IBDV) strain Faragher 52/70.
Maltese: It-tip ta' vaċċin huwa il-Herpesvirus rikombinat tad-dundjani (HVT) li jesprimi l-antiġen protettiv (VP2) tal- Faragher 52/70 strain tal-virus (IBDV) tal-Marda Infettiva Bursal.
English: Ampoule carriers are stored in canister, and in liquid nitrogen containers.
Maltese: Il-kontenituri tal-ampulletti huma maħzuna ġo kanister, u ġo kontenituri bin-nitroġenu likwidu.
English: Apply the usual aseptic precautions to all administration procedures.
Maltese: Applika il-prekawzzjonijiet asettiċi tas-soltu għall-proċeduri kollha ta' amministrazzjoni.
English: For active immunisation of chickens:
Maltese: Għall-immunizzazzjoni attiva tal-flieles:
English: - (polypropylene) bottle of 200ml of diluent.
Maltese: - Flixkun (tal-polypropylene) ta' 200 ml ta' dilwent.
English: - (glass) ampoule of 2,000 doses of vaccine, 4-ampoule carrier.
Maltese: - ampullett (tal-ħġieġ) ta' 2000 doża ta' vaċċin, kontenitur ta' 4 ampulletti.
English: • Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of ampoules to be reconstituted in the diluent; either 1 ampoule of 1,000 doses of vaccine per 200 ml of diluent (or 1 ampoule of 2,000 doses of vaccine per 400 ml of diluent) for subcutaneous administration, or 4 ampoules of 1,000 doses of vaccine per 200 ml of diluent (or 4 ampoules of 2,000 doses of vaccines per 400 ml of diluent) for in ovo administration.
Maltese: • Irrepeti l-operazzjonijiet tat-tidwib, tal-ftuħ, tat-trasferiment u tat-tlaħliħ, ghan-numru approprijat ta' ampulletti li għandhom jiġu rikostitwiti fid-dilwent; jew ampullet ta' 1,000 doza ta' vaċċin għal kull 200 ml ta' dilwent (jew ampullet ta' 2,000 doża ta' vaċċin għal kull 400 ml ta' dilwent) għall-użu taħt il-ġilda, jew 4 ampulletti ta' 1,000 doża ta' vaċċin għal kull 200 ml ta' dilwent (jew 4 ampulletti ta' 2,000 doża ta' vaċċin għal kull 400 ml ta' dilwent) għall-użu in ovo.
English: The onset of protection is from 2 weeks and the protection extends to 9 weeks.
Maltese: Il-protezzjoni tibda minn ġimgħatejn u testendi sa 9 ġimgħat.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Merial attenuated vaccines against Newcastle disease and Infectious bronchitis.
Maltese: Hemm informazzjoni ta' sigurta u effikaċja li turi li din it-tilqima tista' tiġi amministrata fl-istess ġurnata imma mhux imħallta ma vaċċini attenwati tal-Merial kontra il-marda ta' Newcastle u lBronkite Infettiva.
English: SC or in ovo route
Maltese: SC jew in ovo
English: 1800ml or 2400ml of diluent
Maltese: 1800ml-jew_-2400ml ta' dilwent
English: Store the vaccine in liquid nitrogen.
Maltese: Aħżen il-vaċċin fin-nitroġenu likwidu.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skond l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill kif emendata, Stat Membru jista, skont il-liġijiet nazzjonal tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, l-pussess, il-bejgħ, il forniment u/jew l-użu ta' prodotti immunoloġiċi mediċinali veterinarji fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Vaxxitek HVT+IBD Suspension and solvent for suspension for injection
Maltese: Vaxxitek HVT+IBD suspensjoni u solvent għal suspensjoni għal injezzjoni
English: • Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.
Maltese: • Ladarba l-ampullett jinfetaħ, iġbed il-kontenut tiegħu f'siringa sterilizzata ta' 5 ml.
English: Name and address of the manufacturers of the biological active substance(s)
Maltese: Isem u indirizz tal manufatturi - tas-sustanza(i) bioloġika(ċi) attiva(i)
English: Repeat the rinsing operation once or twice.
Maltese: Irrepeti l-operazzjoni tat-tlaħliħ darba jew tnejn.
English: • To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.
Maltese: • Biex tipprevjeni mwiet u biex tnaqqas sinjali kliniċi u leżjonijiet tal-marda infettiva
English: • Draw up 2 ml of the contents of the diluent into the syringe.
Maltese: • Iġbed 2 ml tal-kontenut tad-dilwent għal ġo s-siringa.
English: For in ovo route:
Maltese: Bil-metodu in ovo:
English: • Thaw rapidly the contents of the ampoules by agitation in water at 25°C-30°C.
Maltese: • Dewweb il-kontenut tal-ampulletti malajr billi tħawwad fl-ilma f'temperatura ta' bejn 25°C-30°C.
English: Store the diluent below 30°C.
Maltese: Aħżen id-dilwent taħt it-30°C.
English: Live recombinant vaccine against Infectious Bursal Disease and Marek's Disease.
Maltese: Vaccin attiv rikombinat kontra il-Marda Infettiva Bursal u l-Marda ta' Marek.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIOLOĠIKA ATTIVA U L-MANIFATTUR RESPONSABBLI
English: • To reduce mortality, clinical signs and lesions of Marek's disease.
Maltese: • Biex tnaqqas l-imwiet, sinjali kliniċi u leżjonijiet tal-marda ta'Marek.
English: The onset of protection is from 4 days.
Maltese: Il-protezzjoni tibda minn erbat ijiem.
English: Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest France
Maltese: Laboratorju ta' Lyon Porte des Alpes Rue de l'Aviation
English: Active ingredient:
Maltese: Ingredjent attiv:
English: Day-old chickens and 18 days embryonated eggs.
Maltese: Flieles ta' ġurnata u bajd embrijonat ta' 18-il ġurnata.
English: Open ampoules holding them at arm's length in order to prevent any risk of injury should an ampoule break.
Maltese: Armi dawk l-ampulletti li ġew imdewwba bi żball.
English: PACKAGE LEAFLET FOR: Vaxxitek HVT+IBD suspension and solvent for suspension for injection
Maltese: VETERINARJU Vaxxitek HVT+IBD Suspensjoni u solvent għal suspensjoni għal injezzjoni
English: Store the reconstituted vaccine at a temperature below 25°C.
Maltese: Aħżen il-vaċċin imħallat f'temperatura taħt il-25°C.
English: Shelf life of the diluent in polyvinylchloride bags: 36 months at a temperature below 30°C.
Maltese: Żmien li d-dilwent f'boroż tal-polyvinychloride jibqa tajjeb: 36 xahar f'temperatura taħt it-30°C.
English: The vaccine induces an active immunity and a serological response against Infectious Bursal Disease and Marek's Disease in chickens.
Maltese: Il- vaċċin jinduċi immunita' attiva u azzjoni seroloġika kontra il-Marda Infettiva Bursal u kontra il
English: Sucrose
Maltese: Dilwent
English: Chickens.
Maltese: Biss.
English: Suspension and solvent for suspension for injection
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni u solvent għal suspensjoni għal injezzjoni
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: Is-sustanzi mhux attivi,( inklużi l-adjuvanti), elenkati f'sezzjoni 6.1 tal-SPC huma jew sustanzi permessi li għalihom Tabella 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Numru 37/2010
English: In ovo route: one single injection of 0.05 ml per egg at 18 days of embryonation.
Maltese: Injezzjoni waħda ta' 0.05 ml għal kull bajda fit-18-il ġurnata ta' embrijoniżżazzjoni
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U L-MANIFATTUR
English: 1 bag of 1000 ml.
Maltese: AMPULLETT 1000 u 2000 doża
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial attenuated vaccines against Marek's disease Rispens strain.
Maltese: Hemm informazzjoni ta'sigurtà u effikaċja li turi li dan il-vaċċin jista imħallta ma vaċċini attenwati tal-Merial kontra l-istrejn Rispens tal-marda ta' Marek.
English: Manufacturer responsible for batch release
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL-PROVISTA
English: • Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent.
Maltese: • Laħlaħ l-ampullett b'dawn iż-2 ml u mbagħad ittrasferixxi il-likwidu li laħlaħt bih fid-dilwent.
English: Shelf life of the diluent in polypropylene bottles: 12 months at a temperature below 30°C.
Maltese: Żmien li d-dilwent fi fliexken tal-polypropylene jibqa tajjeb: 12-il xahar f'temperatura taħt it-30°C.
English: • As soon as they are thawed, open ampoules holding them at arm's length in order to prevent any risk of injury should an ampoule break.
Maltese: • Ilbes ingwanti protettivi u nuċċali waqt li l-kontenut ta' l-ampullett ikun qed idub u waqt il-ftuħ.
English: • Remove from the liquid nitrogen container only those ampoules which are to be used immediately.
Maltese: • Neħħi mil-kontenitur tan-nitroġenu likwidu dawk l-ampulletti biss ji se tuża immedjatament.
English: Use sterile and antiseptic-free and/or disinfectant-free equipment for injections purposes.
Maltese: Uża apparat sterilizzat u mingħajr antisettiku u/jew diżinfettant għal skop ta' injezzjonijiet.
English: Use immediately after preparation.
Maltese: Uża mmedjatament wara l-preparazzjoni.
English: - (polypropylene) bottle of 200ml of diluent - (polyvinylchloride) bag of 200ml, 400ml, 600ml, 800ml, 1000ml, 1200ml, 1400ml, 1600ml,
Maltese: flixkun ta' 200 ml borża ta' 200 ml borża ta' 400 ml borża ta' 600 ml borża ta' 800 ml borża ta' 1000 ml borża ta' 1200 ml borża ta' 1400 ml borża ta' 1600 ml borża ta' 1800 ml borża ta' 2400 ml
English: • Transfer the suspension into the diluent (Do not use if cloudy).
Maltese: • Ittrasferixxi s-suspensjoni għal ġol-dilwent (Tużax jekk imdardar).
English: The full EPAR for Palonosetron Accord 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 Palonosetron Accord, palonosetron, is a ‘5HT3 antagonist'.
Maltese: Is-sustanza attiva f'Palonosetron Accord, palonosetron, hija ‘antagonista 5HT3'.
English: Palonosetron Accord contains the active substance palonosetron.
Maltese: Palonosetron Accord fih is-sustanza attiva palonosetron.
English: This is a summary of the European public assessment report (EPAR) for Palonosetron Accord.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Palonosetron Accord.
English: Other information about Palonosetron Accord
Maltese: Informazzjoni oħra dwar Palonosetron Accord
English: In children, the solution should be given by infusion into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.
Maltese: tingħata b'infużjoni fil-vina tul 15-il minuta b'doża ta' 20 mikrogramma għal kull kilogramma ta' piż talġisem.
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
Maltese: Dan ifisser li twaqqaf kimika fil-ġisem imsejħa 5-hydroxytryptamine (5HT, magħrufa wkoll bħala serotonin) milli teħel ma' riċetturi ta' 5HT3 fil-musrana.
English: It is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin).
Maltese: Jintuża f'adulti u fi tfal fl-età ta' xahar jew akbar għall-kimoterapija ma' mediċini li jew jikkawżaw tqanqil qawwi ta' nawżja u rimettar (bħal cisplatin) jew tqanqil moderat (bħal cyclophosphamide, doxorubicin jew carboplatin).
English: This means that Palonosetron Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aloxi.
Maltese: Dan ifisser li Palonosetron Accord huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Aloxi.
English: Palonosetron Accord is a medicine used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer).
Maltese: Palonosetron Accord jintuża sabiex jipprevjeni d-dardir (tħossok ma tiflaħx) u r-rimettar li huma kkawżati mill-kimoterapija (mediċini użati fil-kura tal-kanċer).
English: It is available as a solution for injection or infusion (drip) into a vein, which should be given by a healthcare professional about 30 minutes before the start of chemotherapy.
Maltese: Dan huwa disponibbli bħala soluzzjoni għall-injezzjoni jew infużjoni (dripp) li għandha tingħata minn professjonista tal-kura tas-saħħa madwar 30 minuta qabel tinbeda l-kimoterapija.
English: Because Palonosetron Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Palonosetron Accord huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: No additional studies were needed as Palonosetron Accord is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Aloxi.
Maltese: Ma kien jinħtieġ lebda studju addizzjonali peress li Palonosetron Accord huwa mediċina ġenerika mogħtija permezz ta' injezzjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Aloxi.