FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holders submitted at the request of CVMP: - an exhaustive list of differences between the SPCs of the product authorized in the member states; - a proposal for a harmonised product information (SPC, labelling and package leaflet), taking into account the latest guidance; - the available relevant data substantiating such proposed harmonised product information.
Maltese: Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ippreżentaw fuq talba tas-CVMP: - lista eżawrjenti tad-differenzi bejn l-SPCs tal-prodott awtorizzat fl-Istati Membri; - proposta għal informazzjoni tal-prodott armonizzata (SPC, tikkettar u fuljett ta' tagħrif), li tikkunsidra l-aħħar gwida; - id-dejta rilevanti disponibbli li tissostanzja tali informazzjoni tal-prodott armonizzata proposta.
English: This referral was related to the divergent national decisions taking by member states in relation with the SPC of the products Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated name, raised by Belgium.
Maltese: Din ir-referenza kienet relatata mad-deċiżjonijiet nazzjonali diverġenti li ttieħdu minn Stati Membri rigward l-SPC tal-prodotti Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix u l-isem assoċjat, imqajma mill-Belġju.
English: ad us. vet.
Maltese: Xejn li hu magħruf.
English: Belgium Eli Lilly Benelux N.V. Elanco Animal Health Rue de l'Etuve 52-Bte Stoofstraat 52
Maltese: Eli Lilly Benelux N.V. Elanco Animal Health Rue de l'Etuve 52-Bte Stoofstraat 52
English: • Contraindications: include a new statement in relation to the hypersensitivity to tilmicosin;
Maltese: • Kontraindikazzjonijiet: inkludi dikjarazzjoni ġdida rigward l-ipersensittività għal tilmicosin
English: Tilmicosin plasma concentrations decreased to 0.1 µg/ml within 2 hours and to 0.02 µg/ml after 8 hours.
Maltese: Il-konċentrazzjonijiet ta' tilmikosina fil-plażma naqsu għal 0.1 µg/ml fi żmien sagħtejn u għal 0.02 µg/ml wara 8 sigħat.
English: - The efficacy against infections caused by Haemophilus parasuis in pigs has not been substantiated; - Contraindications should include a statement in relation to the hypersensitivity to tilmicosin; - Due to the likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended; - The special precautions to be taken by the person administering the veterinary medicinal product to animals need modification; - Information should be provided on pre-mixing before pelleting and pelleting temperature; - The inclusion rate in feed established would differ for each product strength; - The reference to rice hulls should be removed; - The shelf life after first opening of the immediate packaging should be added; - The proven shelf life after incorporation into meal or pelleted feed is 1 month; - The description of the nature and composition of immediate packaging should be harmonised; - The complete SPC should be harmonised in the framework of this referral procedure,
Maltese: - Il-prekawzjonijiet speċjali li għandhom jittieħdu mill-persuna li sejra tagħti l-prodott mediċinali veterinarju lill-annimali jeħtieġu emendi; - Għandha tkun ipprovduta informazzjoni dwar it-taħlit minn qabel, qabel il-pelleting u t-temperatura tal-pelleting; - Ir-rata ta' inklużjoni fl-għalf stabbilita tkun differenti għal kull dożaġġ tal-prodott; - Ir-referenza għall-qxur tar-ross għandha titneħħa; - Għandu jitniżżel kemm il-prodott idum tajjeb wara li jinfetaħ l-ewwel darba l-imballaġġ ta' ġewwa; - It-tul tal-ħajja pprovat wara l-inkorporazzjoni fl-ikel jew fl-għalf f'għamla ta' pelits huwa ta' xahar wieħed; - Id-deskrizzjoni tan-natura u l-kompożizzjoni tal-imballaġġ ta' ġewwa għandha tkun armonizzata;
English: 2 kg Pulmotil 100Vet Premix/tonne
Maltese: 2 kg Pulmotil 100Vet Premix/tunnellata
English: Prevention and treatment of respiratory disease
Maltese: Prevenzjoni u trattament ta' mard respiratorju
English: The CVMP can accept:
Maltese: Is-CVMP jista' jaċċetta:
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No symptoms of overdose have been seen in pigs fed a ration containing levels of tilmicosin up to 80 mg/kg bodyweight (equivalent to 2000 ppm in the feed or ten times the recommended dose) for 15 days.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti) jekk ikun hemm bżonn Ma deher l-ebda sintomu ta' doża eċċessiva fil-ħnieżer li ngħataw razzjon li kien fih livelli ta' tilmikosina sa 80 mg/kg piż tal-ġisem (ekwivalenti għal 2000 ppm fl-għalf jew għaxar darbiet id-doża rakkomandata) għal 15-il jum.
English: Soya-bean oil
Maltese: Il-Belġju
English: 5-10 kg Pulmotil 40 Vet Premix/tonne
Maltese: 5-10 kg Pulmotil 40 Vet Premix/ tunnellata
English: Horses fed with tilmicosin medicated feeds may present signs of toxicity with lethargy, anorexia, reduction of feed consumption, loose stools, colic, distension of the abdomen and death.
Maltese: Iż-żwiemel li jingħatalhom għalf medikat bit-tilmikosina jistgħu juru sinjali ta' tossiċità b'letarġija, anoressija, tnaqqis fil-konsum tal-ikel, feċi maħlula, kolika, distensjoni addominali u mewt.
English: 1 kg Pulmotil 200 Vet Premix /tonne
Maltese: 1 kg Pulmotil 200 Vet Premix /tunnellata
English: Pulmotil VET Premix for medicated feeding stuff is currently registered in 19 EU Member States with three different strengths (40g, 100g and 200g per kg) available.
Maltese: Fil-preżent, Pulmotil VET Premix għal oġġetti tal-għalf medikati huwa rreġistrat fi 19-il Stat Membru u huwa disponibbli fi tliet dożaġġi differenti (40g, 100g u 200g kull kg).
English: WITHDRAWAL PERIOD Pigs: 21 days
Maltese: Ħnieżer: 21 jum
English: 2-4 kg Pulmotil 100 Vet Premix /tonne
Maltese: 2-4 kg Pulmotil 100 Vet Premix / tunnellata
English: Withdrawal periods
Maltese: Eliminazzjoni:
English: The highest concentration in the serum (0.23 ±0.08 µg/ml) was recorded on day 10 of medication, but concentrations above the limit of quantification (0.10 µg/ml) were not found in 3 out of 20 animals examined.
Maltese: L-ogħla konċentrazzjoni fis-serum (0.23 ±0.08 µg/ml) ġiet irreġistrata fl-10 jum tattrattament, iżda ma nstabux konċentrazzjonijiet ogħla mil-limitu ta' kwantifikazzjoni (0.10 µg/ml) fi 3 minn kull 20 annimal eżaminat.
English: Fattening pigs
Maltese: Ħnieżer u fniek
English: Whereas:
Maltese: Bijotrasformazzjoni:
English: 5kg Pulmotil 40 Vet Premix /tonne
Maltese: 5 kg Pulmotil 40 Vet Premix /tunnellata
English: Besides, temperature in the pelleting conditions have not exceeded 75 ºC;
Maltese: Barra minn hekk, it-temperatura fil-kundizzjonijiet tal-pelleting ma qabżitx 75 ºC
English: Wash hands after use.
Maltese: Perjodi ta' rtirar
English: When administered at a dose of 200 mg tilmicosin/kg feed (equivalent to approximately 11.0 mg/kg/day), plasma concentrations above the limit of quantification (0.10 µg/ml) were found in 3 out of 20 animals examined.
Maltese: Meta ngħata f'doża ta' 200 mg tilmikosina/kg għalf (ekwivalenti għal madwar 11.0 mg/kg/jum), instabu konċentrazzjonijiet fil-plażma ogħla mil-limitu ta' kwantifikazzjoni (0.10 µg/ml) fi 3 minn kull 20 annimal eżaminat.
English: Tilmicosin has been shown to inhibit in vitro the replication of the Porcine Reproductive and Respiratory Syndrome virus in alveolar macrophages in a dose dependent fashion.
Maltese: It-tilmikosina wriet li jinibixxi in vitro ir-replikazzjoni tal-virus tas-Sindromu Riproduttiv u Respiratorju tal-Ħnieżer f'makrofaġi alveolari b'mod li jiddependi mid-doża.
English: Rabbits: Prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin.
Maltese: Prevenzjoni u trattament ta' mard respiratorju kkawżat minn Pasteurella multocida u Bordetella bronchiseptica, suxxettibbli għal tilmikosina.
English: In respect of the benefit/risk balance for target species rabbit, the CVMP considers that benefit/risk balance is positive: - notwithstanding the fact that the clinical field study using dosage of the product have some shortcomings, the pre-clinical studies and the recent MICs data suggest the effective dosage in feed is 12.5 mg/kg for 7 days in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica in rabbits; - rabbit is minor species, with specific problems on availability of authorised veterinary products; - the history of use and the various management steps now set out in the harmonised SPC (bacteriological sampling and susceptibility testing are recommended).
Maltese: F'dak li jirrigwarda l-bilanċ tal-benefiċċju u r-riskju għall-ispeċi fil-mira fniek, is-CVMP jikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju huwa wieħed pożittiv: - minkejja l-fatt li l-istudju kliniku fil-prattika bl-użu ta' dożaġġ tal-prodott għandu xi nuqqasijiet, listudji prekliniċi u d-dejta reċenti dwar il-MICs jissuġġerixxu li d-doża effikaċja fl-għalf hija ta' 12.5 mg/kg għal 7 ijiem fil-prevenzjoni u t-trattament ta' mard respiratorju kkawżat minn Pasteurella multocida u Bordetella bronchiseptica fil-fniek; - il-fenek huwa speċi minuri, bi problemi speċifiċi dwar id-disponibbiltà ta' prodotti veterinarji awtorizzati; - l-istorja tal-użu u diversi passi ta' ġestjoni issa stipulati fl-SPC armonizzat (teħid ta' kampjuni batterjoloġiċi u ttestjar tas-suxxettibbiltà huma rakkomandati).
English: For products containing 40 and 100g tilmicosin/kg:
Maltese: Il-prodotti li fihom 40 u 100g tilmikosina/kg huma ppakkjati jew:
English: The CVMP accepts that a claim for efficacy at a dose of 8 to 16 mg/kg bw/day of tilmicosin (equivalent to 200 to 400 ppm in the feed) for a period of 15 to 21 days for prevention and treatment of respiratory infections in pigs has been demonstrated.
Maltese: Is-CVMP aċċetta li ġiet murija ipoteżi għall-effikaċja f'doża ta' 8 sa 16 mg/kg piż tal-ġisem/kuljum ta' tilmicosin (ekwivalenti għal 200 sa 400 ppm fl-għalf) għal perjodu ta' 15 sa 21 ġurnata għallprevenzjoni u t-trattament ta' infezzjonijiet respiratorji fil-ħnieżer.
English: a) The indication for use in rabbits: prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica susceptible to tilmicosin.
Maltese: a) l-indikazzjoni għall-użu fil-fniek: Prevenzjoni u trattament ta' mard respiratorju kkawżat minn Pasteurella multocida u Bordetella bronchiseptica suxxettibbli għal tilmicosin.
English: 40 g tilmicosin per 1000 g Member State Marketing Authorisation Holder
Maltese: 100 g tilmikosina kull 1000 g Stat Membru Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq
English: Absorption: When administered to pigs via the oral route at a dose of 400 mg tilmicosin/kg feed (equivalent to approximately 21.3 mg tilmicosin/kg bodyweight/day), tilmicosin moves rapidly out of the serum into areas of low pH.
Maltese: Meta jingħata oralment lill-ħnieżer f'doża ta' 400 mg tilmikosina/kg għalf (ekwivalenti għal madwar 21.3 mg tilmikosina/kg piż tal-ġisem/jum), it-tilmikosina toħroġ malajr mis-serum fiżżoni b' pH baxx.
English: Belgium Eli Lilly Benelux N.V. Elanco Animal Health Rue de l'Etuve 52
Maltese: Eli Lilly Benelux N.V. Elanco Animal Health Rue de l'Etuve 52 Stoofstraat 52
English: The main sections of disharmony of the existing SPCs (non exhaustive) are:
Maltese: Is-sezzjonijiet ewlenin ta' diskrepanza tal-SPCs eżistenti (mhux eżawrjenti) huma:
English: Pigs: Prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin.
Maltese: Prevenzjoni u trattament ta' mard respiratorju kkawżat minn Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida u organiżmi oħrajn sensittivi għal tilmikosina.
English: A preformed block bottomed 1 kg bag constructed using a paper/polyethylene/aluminium/polyethylene/paper laminate either stitched closed or heat-sealed Not all pack sizes may be marketed.
Maltese: F'borża preformata ta' kilo b'qiegħ kwadrat magħmula minn laminat karta/polietilene/aluminju/polietilene/karta meħjuta jew issiġillat bis-sħana
English: Administer in the feed at a dose of 8 to 16 mg/kg body weight/day of tilmicosin activity (equivalent to 200 to 400 ppm in the feed) for a period of 15 to 21 days.
Maltese: Agħti fl-għalf f'doża ta' 8 sa 16 mg/kg piż tal-ġisem/jum ta' attività ta' tilmikosina (ekwivalenti għal 200 sa 400 ppm fl-għalf) għal perjodu ta' 15 sa 21 jum.
English: Tilmicosin (as phosphate)
Maltese: Effikaċja fil-fniek
English: Environmental properties
Maltese: TAL-PRODOTTI MEDIĊINALI
English: Administer in the feed at 12 mg/kg body weight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days.
Maltese: Agħti fl-għalf 12 mg/kg piż tal-ġisem/jum ta' tilmikosina (ekwivalenti għal 200 ppm fl-għalf) għal 7 ijiem.
English: Polyethylene/polyamide/polyethylene (inner layer) bags containing 10 kg of product, or, 2.
Maltese: F'boroż tal-polietilene/poliamide/polietilene (saff ta' ġewwa) li fihom 10 kg ta' prodott, jew, 2.
English: Pulmotil G 20% AMV Premix for medicated feeding stuff
Maltese: Pulmotil G 20% AMV Premix għal oġġetti tal-għalf medikati
English: Pharmaceutical form Strength
Maltese: Għamla farmaċewtika
English: A yellowish tan to reddish tan free-flowing granular material.
Maltese: Materjal granulari ta' kulur safrani għal ħamrani li jiċċirkola liberament.
English: the CVMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III for Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names.
Maltese: III għal Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix u l-ismijiet assoċjati.
English: 6.5 Nature and composition of immediate packaging Products containing 40 and 100g tilmicosin/kg are packed in either:
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Għall-prodotti li fihom 40 u 100g tilmikosina/kg:
English: The CVMP has assessed a PK/PD approach to support use in respiratory disease in rabbit and one clinical trial, as well as bibliographic and pharmacovigilance data provided by the
Maltese: Is-CVMP evalwa approċċ farmakokinetiku/farmokodinamiku li jappoġġja lużu f'mard respiratorju fil-fniek u prova klinika waħda, kif ukoll dejta bibljografika u farmakoviġilanti pprovduta mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: Rabbits
Maltese: Fniek
English: Administer in the feed at a dose of 8 to 16 mg/kg body weight/day of tilmicosin (equivalent to 200 to 400 ppm in the feed) for a period of 15 to 21 days.
Maltese: Agħti fl-għalf f'doża ta' 8 sa 16 mg/kg piż tal-ġisem/jum ta' tilmikosina (ekwivalenti għal 200 sa 400 ppm fl-għalf) għal perjodu ta' 15 sa 21 jum.
English: Tilmicosin degrades/declines slowly in the soil.
Maltese: Dan l-effett huwa temporanju.
English: • Indication for pigs: delete the microorganism Haemophilus parasuis;
Maltese: Jitneħħa l-mikrorganiżmu Haemophilus parasuis
English: 1-2 kg Pulmotil 200 Vet Premix /tonne
Maltese: 15 sa 21 jum 1-2 kg Pulmotil 200 Vet Premix /tunnellata
English: Distribution: Following oral administration, tilmicosin is distributed throughout the body with especially high levels found in the lung and in lung tissue macrophages.
Maltese: Wara amministrazzjoni orali, it-tilmikosina tinfirex mal-ġisem b'livelli partikolarment għoljin misjuba fil-pulmun u fil-makrofaġi tat-tessut tal-pulmun.
English: Read the package leaflet on reverse of the bag before use.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu jitpoġġew fis-suq.
English: b) The amounts to be administered and administration route: administered in the feed at 12 mg/kg bodyweight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days.
Maltese: Agħti fl-għalf f'doża ta' 12 mg/kg piż tal-ġisem/jum ta' tilmikosina (ekwivalenti għal 200 ppm flgħalf) għal 7 ijiem.
English: Pulmotil G 20% Premix for medicated feeding stuff
Maltese: Pulmotil G 20% Premix għal oġġetti tal-għalf medikati
English: 4.2 Indications for use, specifying the target species Pigs: Prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin Rabbits: Prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin.
Maltese: Prevenzjoni u trattament ta' mard respiratorju kkawżat minn Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida u organiżmi oħrajn sensittivi għal tilmicosin fil-ħnieżer.
English: Pulmotil G 40 AMV Premix for medicated feeding stuff
Maltese: Pulmotil G 40 AMV Premix għal oġġetti tal-għalf medikati
English: Invented name
Maltese: ISEM
English: However, marketing authorisations were also granted via two separate Mutual Recognition Procedures with Italy and Ireland as the Reference Member States.
Maltese: Madankollu, ingħataw ukoll awtorizzazzjonijiet għat-tqegħid fis-suq permezz ta' żewġ Proċeduri ta' Rikonoxximent Reċiproku separati, bl-Italja u l-Irlanda jkunu l-Istati Membri ta' Referenza.
English: Pulmotil G 100 AMV Premix for medicated feeding stuff
Maltese: Pulmotil G 100 AMV Premix għal oġġetti tal-għalf medikati
English: Byetta exenatide
Maltese: Byetta eksenatide
English: The full EPAR for Byetta 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: Byetta was as effective as injected insulin.
Maltese: Byetta kien effettiv daqs l-insulina injettatat.
English: It can be used with metformin, sulphonylureas, thiazolidinediones, metformin and a sulphonylurea, or metformin and a thiazolidinedione.
Maltese: Jista' jintuża mal-metformina, is-sulfonilureas, it-tiazolidinediones, ilmetformina u s-sulfonilurea, jew il-metformina u t-tiazolidinedione.
English: This document is a summary of the European public assessment report (EPAR) for Byetta.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Byetta.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Byetta on 20 November 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Byetta fl-20 ta' Novembru 2006.
English: The active substance in Byetta, exenatide, is an ‘incretin mimetic'.
Maltese: Is-sustanza attiva f'Byetta, l-eksenatide, hija ‘inkretin mimetiku'.
English: The 10-microgram dose of Byetta decreased HbA1c by an average of 1.13% after 26 weeks, compared with an average of 1.10% with insulin glargine.
Maltese: Id-doża ta' 10 mikrogrammi ta' Byetta naqqset il-livelli ta' HbA1c b'medja ta' 1.13% wara 26 ġimgħa, meta mqabbla ma' medja ta' 1.10% bil-glargina talinsulina.
English: When it was added to metformin and/or sulphonylureas, the 5-microgram dose of Byetta decreased HbA1c levels by an average of 0.59% after 30 weeks, and the 10-microgram dose decreased them by an average of 0.89%.
Maltese: Meta ġie miżjud mal-metformina u/jew is-sulfonilureas, id-doża ta' 5 mikrogrammi ta' Byetta naqqset il-livelli ta' HbA1c b'medja ta' 0.59% wara 30 ġimgħa, u d-doża ta' 10 mikrogrammi naqqsithom b'medja ta' 0.89%.
English: Byetta was more effective than placebo when it was given as add-on to insulin glargine (with or without other antidiabetes medications), as Byetta decreased HbA1c by an average of 1.7% compared with an average of 1.0% in patients taking placebo.
Maltese: Byetta kien aktar effettiv mill-plaċebo meta ngħata flimkien mal-glargina tal-insulina (b'mediċini antidijabetiċi oħra jew mingħajrhom), peress li Byetta naqqas l-HbA1c b'medja ta' 1.7% meta mqabbla ma' medja ta' 1.0% f'pazjenti li ħadu l-plaċebo.
English: Why has Byetta been approved?
Maltese: Għaliex ġie approvat Byetta?
English: In the final study, the 10-microgram dose of Byetta decreased HbA1c by an average of 1.01% after 52 weeks, compared with an average of 0.86% with biphasic insulin.
Maltese: Fl-istudju finali, id-doża ta' 10 mikrogrammi ta' Byetta naqqset il-livelli ta' HbA1c b'medja ta' 1.01% wara 52 ġimgħa, meta mqabbla ma' medja ta' 0.86% bl-insulina bifażika.
English: What is Byetta?
Maltese: X'inhu Byetta?
English: The dose can then be increased to 10 micrograms twice a day.
Maltese: 10 mikrogrammi darbtejn kuljum.
English: In five of the studies, Byetta was compared with placebo (a dummy treatment), as an add-on to metformin (336 patients), sulphonylureas with or without metformin (1,110 patients) or thiazolidinediones with or without metformin (398 patients).
Maltese: F'ħamsa minn dawn l-istudji, Byetta tqabbel ma' plaċebo (trattament finta), bħala ‘żieda' malmetformina (336 pazjent), mas-sulfonilureas flimkien mal-metformina jew mingħajrha (1,110 pazjenti) jew mat-tiazolidinediones flimkien mal-metformina jew mingħajrha (398 pazjent).
English: In another study involving 259 patients, Byetta was compared with placebo, as an add-on to insulin glargine.
Maltese: Fi studju ieħor li kien jinvolvi 259 pazjent, Byetta tqabbel mal-plaċebo, bħala żieda mal-glargina talinsulina.
English: At the start of the studies, the patients' HbA1c levels were around 8.4%.
Maltese: Il-livelli tal-HbA1c fil-bidu tal-istudji kienu madwar 8.4%.
English: How has Byetta been studied?
Maltese: Kif ġie studjat Byetta?
English: Byetta is used to treat type 2 diabetes.
Maltese: Byetta jintuża fil-kura tad-dijabete tat-tip 2.
English: Byetta can also be given to patients taking basal insulin (long-acting insulin such as insulin glargine) with or without metformin and/or pioglitazone (a thiazolidinedione) and whose blood glucose levels are not adequately controlled with these medicines.
Maltese: Byetta jista' jintuża wkoll fuq pazjenti li jieħdu l-insulina bażali (insulina li taġixxi fit-tul bħall-glargina tal-insulina flimkien mal-metformina u/jew il-pijoglitażonu (tiazolidinedione) jew mingħajrhom u li ma għandhomx il-livelli taz-zokkor fid-demm ikkontrollati kif xieraq b'dawn il-mediċini.
English: What is the risk associated with Byetta?
Maltese: Għal xiex jintuża Byetta?
English: When added to thiazolidinediones with or without metformin, the 10-microgram dose of Byetta reduced HbA1c levels by an average of 0.74% after 16 weeks and 0.84% after 26 weeks.
Maltese: Meta Byetta żdied mat-tiazolidinediones bil-metformina jew mingħajrha, id-doża ta' 10 mikrogrammi ta' Byetta naqqset l-HbA1c b'medja ta' 0.74% wara 16-il ġimgħa u 0.84% wara 26 ġimgħa.
English: In studies, the most common side effects with Byetta (seen in more than 1 patient in 10) were hypoglycaemia (when Byetta was used with sulphonylurea with or without metformin), nausea (feeling sick), vomiting and diarrhoea.
Maltese: Fl-istudji, l-effetti sekondarji l-aktar komuni b'Byetta (li dehru f'aktar minn pazjent 1 minn 10) kienu ipogliċemija (meta Byetta ngħata mas-sulfonilurea bil-metformina jew mingħajrha), nawżea (dardir), remettar u dijarrea.
English: In one study, Byetta was compared with insulin glargine in 456 patients and in the other study it was compared with biphasic insulin in 483 patients.
Maltese: Fi studju wieħed, Byetta tqabbel mal-glargina tal-insulina f'456 pazjent u fl-istudju l-ieħor tqabbel malinsulina bifażika f'483 pazjent.
English: Byetta is a solution for injection that contains the active substance exenatide.
Maltese: Byetta huwa soluzzjoni għall-injezzjoni li fih is-sustanza attiva l-eksenatide.
English: Byetta was more effective than placebo in reducing the levels of HbA1c when used in combination with other antidiabetes medicines.
Maltese: Byetta kien iktar effettiv mill-plaċebo fit-tnaqqis tal-livelli ta' HbA1c meta ntuża flimkien ma' mediċini antidijabetiċi oħra.
English: Adding Byetta to metformin or pioglitazone is not associated with this risk.
Maltese: Iż-żieda ta' Byetta mal-metformina jew ittiazolidinedione mhijiex assoċjata ma' dan ir-riskju.
English: It is available as prefilled injection pens that provide either 5 or 10 micrograms of exenatide in each dose.
Maltese: Jiġi bħala pinen ta' injezzjoni mimlija minn qabel li jkun fihom 5 jew 10 mikrogrammi ta' eksenatide f'kull doża.