FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Glidipion
Maltese: X'fih Glidipion
English: In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg and added to a sulphonylurea of 2.8 kg.
Maltese: Fi provi ta' taħlita fuq medda ta' sena, pioglitazone miżjud ma' metformin wassal għal żieda medja fil-piż ta' 1.5 kg, u miżjud ma' sulphonylurea għal żieda ta' 2.8 kg.
English: Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator.
Maltese: Fratturi kienu osservati f'2.6% ta' nisa li kienu qed jieħdu pioglitazone meta mqabbla ma' 1.7% tannisa kkurati bi prodott paragun.
English: - hypersensitivity to the active substance or to any of the excipients - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria.
Maltese: - sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi. - insuffiċjenza kardijaka attwali jew fil-passat (NYHA stadju I sa IV).
English: Glidipion 15 mg tablets are white, round, flat, bevelled, 5.5 mm in diameter and engraved with ‘TZ15' on one side.
Maltese: Id-Dehra ta' Glidipion u l-kontenuti tal-pakkett Glidipion15 mg huma pilloli bojod, tondi, bbuzzati b'dijametru ta' 5.5 mm u immarkati b'‘TZ15' fuq naħa waħda .
English: In a placebo controlled trial, patients with inadequate glycaemic control despite a three month insulin optimisation period were randomised to pioglitazone or placebo for 12 months.
Maltese: Fi prova kkontrollata bil-plaċebo, pazjenti b'kontroll gliċemiku inadegwat minkejja perijodu ta' ottimizzazzjoni b'insulina ta' 3 xhur, kienu randomised għal pioglitazone jew plaċebo għal 12-il xahar.
English: HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity.
Maltese: HOMA juri li pioglitazone itejjeb il-funzjoni taċ-ċelloli beta kif ukoll iżid is-sensittività għallinsulina.
English: Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Maltese: Sorveljanza mill-viċin tal-kontroll gliċemiku għandha tiġi kkunsidrata (ara sezzjoni 4.4). ġie rrappurtat li l-għotja ta' pioglitazone flimkien ma' rifampicin (induttur taċ-ċitokromju P450 2C8) twassal għal tnaqqis ta' 54% fl-AUC ta' pioglitazone.
English: This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree.
Maltese: Dan isir primarjament permezz taċ-ċitokromju P450 2C8, għalkemm isoformi oħra jistgħu jkunu involuti f'ammont inqas.
English: Glidipion may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Maltese: Glidipion jista' jintuża waħdu f'pazjenti li ma jistgħux jieħdu metformin, u fejn trattament ma' dieta u eżercizzju naqas milli jikkontrolla z-zokkor fid-demm jew jista' jittieħed flimkien ma'terapiji oħra (bħal metformin, sulphonylurea jew insulina) li naqsu milli jipprovdu kontroll biżżejjed taz-zokkor fid-demm.
English: Kaplan-Meier analysis showed shorter time to treatment failure in patients treated with gliclazide, compared with pioglitazone.
Maltese: Analiżi Kaplan-Meier uriet ħin iqsar għall-falliment tal-kura f'pazjenti kkurati b'gliclazide, meta mqabbla ma' pioglitazone.
English: Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.
Maltese: Qabel id-distribuzzjoni tal-gwida riċetta f'kull Stat Membru, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jaqbel mal-awtorità kompetenti nazzjonali dwar il-kontenut u format tal-materjal edukattiv, kif ukoll ma' pjan ta' komunikazzjoni.
English: When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy.
Maltese: Meta l-attività, konċentrazzjonijiet u twaħħil mal-proteini jittieħdu f'konsiderazzjoni, pioglitazone u l-metabolita
English: Each tablet contains 30 mg pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 30 mg pioglitazone (bħala hydrochloride)
English: Glidipion 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Glidipion 30 mg
English: Each tablet contains 15 mg pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 15 mg pioglitazone (bħala hydrochloride)
English: • Patient selection criteria including that Pioglitazone should not be used as first line therapy and emphasising the need for regular review of treatment benefit.
Maltese: • kriterji għall-għażla tal-pazjent inkluż li Pioglitazone m'għandux jintuża bħala kura primarja u tenfasizza l-ħtieġa għal reviżjoni regolari tal-benefiċċju tat-trattament.
English: As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual or triple oral therapy with a sulphonylurea or in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea or insulin may be necessary.
Maltese: Bħala konsegwenza ta' żieda fis-sensittività għall-insulina, pazjenti li qed jirċievu pioglitazone f'terapija mill-ħalq doppja jew trippla ma' mediċina tat-tip sulphonylurea jew f'terapija doppja malinsulina jistgħu jkunu f'riskju ta' ipogliċemija relatata mad-doża, u jista' jkun hemm bżonn tnaqqis fid-doża tal-mediċina tat-tip sulphonylurea jew tal-insulina.
English: If jaundice is observed, the medicinal product should be discontinued.
Maltese: Jekk ikun hemm suffejra, il-mediċina għandha titwaqqaf.
English: In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged ≥65 years compared with those less than 65 years (9.7% compared to 4.0%).
Maltese: F'dan l-istudju f'pazjenti li qed jirċievu pioglitazone u l-insulina, kien osservat persentaġġ ogħla ta' pazjenti b'insuffiċjenza tal-qalb f'pazjenti li għandhom ≥ 65 sena meta mqabbla ma'dawk iżgħar minn 65 sena (9.7% meta mqabbla ma'4.0%).
English: After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c).
Maltese: Wara bidu tat-terapija b'pioglitazone, il-pazjenti għandhom jiġu riveduti wara 3 sa 6 xhur biex ikun evalwat jekk ir-rispons għat-trattament (eż. tnaqqis fl-HbA1c) hux adegwat.
English: Carmellose calcium Hydroxypropylcellulose Lactose monohydrate Magnesium stearate
Maltese: Hydroxypropylcellulose
English: Each tablet contains 45 mg pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 45 mg pioglitazone (bħala hydrochloride)
English: PC:
Maltese: Tel:
English: Reproductive system and breast disorders erectile dysfunction common
Maltese: Disturbi fissistema riproduttiva u fis-sider
English: Each tablet contains 45 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 45 mg ta' pioglitazone (bħala hydrochloride).
English: Environmental Risk Assessment: no environmental impact is anticipated from the clinical use of pioglitazone.
Maltese: Valutazzjoni tar-Riskju Ambjentali: l-ebda impatt ambjentali m'huwa antiċipat mill-użu kliniku ta' pioglitazone.
English: Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 30 mg ta' pioglitazone (bħala hydrochloride).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Maltese: Dieta ta' aċidifikazzjoni naqqset b'mod sinifikanti, iżda ma neħħitx, l-inċidenza ta' tumuri.
English: It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.
Maltese: Disturbi viżwali ġew irrappurtati l-aktar fil-bidu tal-kura u huma relatati ma' tibdil fil-glucose fiddemm minħabba alterazzjoni temporanja fit-turġidità u fl-indiċi refrattiv tal-lenti kif osservat b'aġenti ipogliċemiċi oħra.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: DETENTUR(I) TA' L-AWTORIZZAZZJONI TALMANIFATTURA RESPONSABBLI
English: After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups.
Maltese: Wara li ġew esklużi pazjenti li għalihom l-espożizzjoni għall-mediċina fl-istudju kien inqas minn sena fil-ħin taddijanjosi ta' kanċer tal-bużżieqa tal-urina, kien hemm 7 każijiet (0.06%) fuq pioglitazone u 2 każijiet
English: Pregnancy
Maltese: Hafnarfjörður
English: No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Maltese: Ma kinitx osservata żieda fir-rata ta' fratturi f'irġiel ikkurati b'pioglitazone (1.7%) meta mqabbla ma' prodott paragun (2.1%).
English: Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when pioglitazone is used in combination with insulin.
Maltese: Pazjenti għandhom jiġu osservati għal sinjali u sintomi ta' insuffiċjenza talqalb, żieda fil-piż jew edima meta pioglitazone jingħata flimkien ma' insulina.
English: This is the diabetes that usually develops in adulthood.
Maltese: Din hija d-dijabete li ġeneralment tiżviluppa fl-adulti.
English: Gastrointestinal disorders flatulence uncommon common
Maltese: Żieda fl-aptit mhux komuni
English: Alanine aminotransferase increased7
Maltese: Mard fl-għajnejn
English: Glidipion 15 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Glidipion 15 mg
English: Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily.
Maltese: Pioglitazone jista' jinbeda b'15 mg jew 30 mg darba kuljum.
English: It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus, when metformin is not suitable or has failed to work adequately.
Maltese: Huwa mediċina anti-dijabetika wżata biex tikkura dijabete mellitus tat-tip 2 (mhux dipendenti mill-insulina) meta metformin ma jkunx xieraq jew ikun naqas li jaħdem b'mod adegwat.
English: Renal and urinary disorders haematuria common glycosuria uncommon proteinuria uncommon
Maltese: Sorveljanza xierqa tal-kontroll gliċemiku għandha tiġi kkunsidrata (ara sezzjoni 4.4).
English: Other medicines and Glidipion
Maltese: Jekk tinsa tieħu Glidipion
English: EU/1/12/756/003 EU/1/12/756/004 EU/1/12/756/005 EU/1/12/756/006 EU/1/12/756/007 EU/1/12/756/008 EU/1/12/756/009 EU/1/12/756/010 EU/1/12/756/011 EU/1/12/756/012 EU/1/12/756/013 EU/1/12/756/014 EU/1/12/756/015 EU/1/12/756/016 EU/1/12/756/017 EU/1/12/756/018 EU/1/12/756/019 EU/1/12/756/020 EU/1/12/756/021 EU/1/12/756/022 EU/1/12/756/023 EU/1/12/756/024 EU/1/12/756/025 EU/1/12/756/026 EU/1/12/756/027
Maltese: EU/1/12/756/005 EU/1/12/756/006 EU/1/12/756/007 EU/1/12/756/008 EU/1/12/756/009 EU/1/12/756/010
English: Monotherapy
Maltese: Monoterapij a
English: The presence of microcrystals exacerbated the hyperplastic response but was not considered to be the primary cause of hyperplastic changes.
Maltese: Ilpreżenza ta'microkristalli ħarrxet ir-rispons iperplastiku imma ma kienx meqjus bħala l-kawża primarja ta' bidliet f'iperplasja.
English: Pioglitazone effects may be mediated by a reduction of insulin resistance.
Maltese: L-effetti ta' pioglitazone jistgħu jkunu medjati minn tnaqqis fir-reżistenza għall-insulina.
English: - Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Maltese: - Pioglitazone huwa indikat ukoll għall-użu flimkien ma' insulina f'pazjenti adulti b'dijabete mellitus tip 2 b'kontroll gliċemiku insuffiċjenti bl-insulina li għalihom metformin ma jkunx adegwat minħabba xi kontraindikazzjonijiet jew intolleranza (ara sezzjoni 4.4).
English: When Glidipion is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Maltese: Meta jittieħed flimkien ma' mediċini oħra wżati għall-kura tad-dijabete (bħal insulina, chlorpropamide, glibenclamide, gliclazide, tolbutamide), it-tabib tiegħek jgħidlek jekk għandekx bżonn tieħu doża inqas tal-mediċini tiegħek.
English: Glidipion 45 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Glidipion 45 mg
English: Fri.
Maltese: Tqala
English: This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth.
Maltese: Dan kien attribwit għall-azzjoni ta' pioglitazone li tnaqqas l-iperinsulinemija fl-omm u għaż-żieda tar-reżistenza għall-insulina li sseħħ waqt it-tqala, li ġġib nuqqas ta'disponibilità ta' substrati metaboliċi għat-tkabbir tal-fetu.
English: The usual starting dose is one tablet of 15 mg or 30 mg of pioglitazone to be taken once daily.
Maltese: Id-doża normali tal-bidu hi pillola waħda ta' 15 mg jew 30 mg ta' pioglitazone darba kuljum.
English: The full EPAR for Imrestor 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: The relative reduction in mastitis incidence was 26%.
Maltese: It-tnaqqis relattiv fl-inċidenza tal-mastite kien ta' 26%.
English: It contains the active substance pegbovigrastim.
Maltese: Fih is-sustanza attiva pegbovigrastim.
English: In a field trial involving 2465 cows the incidence of clinical mastitis during days 3 to 30 of milk production was 9.1% (113/1235) in the Imrestor-treated group compared with 12.4% (152/1230) in the group given a dummy injection.
Maltese: Fi prova fuq il-post li involviet 2465 baqra, l-inċidenza ta' mastite klinika waqt il-jum 3 sa 30 talproduzzjoni tal-ħalib kienet ta' 9.1% (113/1235) fil-grupp ikkurat b'Imrestor meta mqabbel ma' 12.4% (152/1230) fil-grupp li ngħata injezzjoni finta.
English: Other information about Imrestor
Maltese: Informazzjoni oħra dwar Imrestor
English: Pegbovigrastim is a modified form of a natural protein, bovine granulocyte colony stimulating factor (bG-CSF), that stimulates the production and activity of a type of white blood cells called neutrophils.
Maltese: Pegbovigrastim huwa forma modifikata ta' proteina naturali, fattur stimulanti tal-kolonja talgranuloċiti tal-bovini (bovine granulocyte colony stimulating factor, bG-CSF), li jistimula l
English: Why is Imrestor approved?
Maltese: Għaliex ġie approvat Imrestor?
English: This is a summary of the European public assessment report (EPAR) for Imrestor.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Imrestor.
English: The most common side effects with Imrestor (which may affect up to 1 in 100 cows) are non-typical anaphylactoid (allergic) reactions seen as swelling of mucous membranes (notably vulva and eyelid), skin reactions, increased respiration rate and salivation.
Maltese: L-effetti sekondarji l-aktar komuni b'Imrestor (li jistgħu jaffettwaw aktar minn 1 minn kull 100 baqra) huma reazzjonijiet (allerġiċi) anafilattiċi mhux tipiċi li jidhru bħala nefħa tal-membrani mukużi (b'mod partikolari l-vulva u tebqet l-għajn), reazzjonijiet tal-ġilda, żieda fir-rata ta' respirazzjoni u salivazzjoni.
English: Symptomatic treatment may be required.
Maltese: Tista' tkun meħtieġa kura sintomatika.
English: What are the risks associated with Imrestor?
Maltese: X'inhuma r-riskji assoċjati ma' Imrestor?
English: Neutrophils are part of the immune system (the body's natural defences) and help to fight infection.
Maltese: In-newtrofili huma parti mis-sistema immuni (id-difiżi naturali tal-ġisem) u jgħinu fil-ġlieda kontra l-infezzjoni.
English: A second injection is given within 24 hours after calving.
Maltese: It-tieni injezzjoni tingħata 24 siegħa wara t-twelid.
English: The intervals between the two injections should not be less than 3 days or more than 17 days.
Maltese: L-intervalli bejn iż-żewġ injezzjonijiet ma għandhomx ikunu ta' anqas minn 3 ijiem jew ta' aktar minn 17-il jum.
English: Imrestor is a veterinary medicine used as an aid in a herd management programme, to reduce the risk of clinical mastitis (inflammation of the udder) in dairy cows and heifers (cows that have not produced a calf) during the 30 days following calving.
Maltese: Imrestor huwa mediċina veterinarja użata bħala għajnuna fi programm tal-ġestjoni tal-merħla, biex tnaqqas ir-riskju ta' mastite klinika (infjammazzjoni tal-beżżula) fil-baqar tal-ħalib u l-erħiet (baqar li ma welldux għoġol) waqt it-30 jum wara li jwelldu.
English: The content of a single pre-filled syringe is given by injection under the skin (subcutaneously) to a dairy cow/heifer preferably 7 days before the anticipated date of calving.
Maltese: Il-kontenut ta' siringa mimlija għal-lest waħda jingħata b'injezzjoni taħt ilġilda ta' baqra tal-ħalib/erħa preferibbilment 7 ijiem qabel id-data antiċipata tat-twelid.
English: This summary was last updated in October 2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Ottubru 2015.
English: Personal protective equipment consisting of gloves should be worn when handling broken or damaged syringes.
Maltese: Tagħmir personali protettiv li jikkonsisti minn ingwanti għandu jintlibes waqt li jintmessu siringi miksura jew bil-ħsara.
English: People who are hypersensitive (allergic) to pegbovigrastim should avoid contact with Imrestor.
Maltese: Persuni li huma ipersensittivi (allerġiċi) għal pegbovigrastim għandhom jevitaw il-kuntatt ma' Imrestor.
English: How does Imrestor work?
Maltese: Kif jaħdem Imrestor?
English: For the full list of all side effects reported with Imrestor, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Imrestor, ara l-fuljett ta' tagħrif.
English: The European Commission granted a marketing authorisation valid throughout the EU for Imrestor on
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Imrestor fi
English: There may also be other effects including nausea (feeling sick), and rashes or other hypersensitivity reactions (e.g. breathing difficulties and low blood pressure).
Maltese: Jista' jkun hemm ukoll effetti oħra li jinkludu dardir (tħossok ma tiflaħx), u raxx jew reazzjonijiet ta' ipersensittività oħra (eż. diffikultà fit-teħid tan-nifs u pressjoni tad-demm baxxa).
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Imrestor'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 ddeċieda li l-benefiċċji ta' Imrestor huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: By giving Imrestor, the number of neutrophils in the blood is increased, which is an aid to reduce the risk of infections of the udder that might lead to mastitis.
Maltese: Permezz tal-għoti ta' Imrestor, in-numru ta' newtrofili fid-demm jiżdied, u dan jgħin sabiex inaqqas ir-riskju ta' infezzjonijiet tal-beżżula li jistgħu jwasslu għal mastite.
English: Dexmedetomidine is an alpha2-adrenoceptor agonist.
Maltese: Dexmedetomidine hija agonista tal-alpha2-adrenoceptor.
English: The full EPAR for Sedadex 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: The European Commission granted a marketing authorisation valid throughout the EU for Sedadex on 12 August 2016.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Sedadex fit-12 ta' Awissu 2016.
English: Sedadex contains the active substance dexmedetomidine and is a ‘generic medicine'.
Maltese: Sedadex fih is-sustanza attiva dexmedetomidine u huwa “mediċina ġenerika”.
English: This is a summary of the European public assessment report (EPAR) for Sedadex.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Sedadex.
English: In cats, it is given by intramuscular injection.
Maltese: Fil-qtates, jingħata b'injezzjoni intramuskolari.
English: The company provided information on the quality and manufacture of Sedadex.
Maltese: Il-kumpanija pprovdiet informazzjoni dwar il-kwalità u l-manifattura ta' Sedadex.
English: This summary was last updated in June 2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Ġunju 2016.
English: Other information about Sedadex?
Maltese: Informazzjoni oħra dwar Sedadex?
English: Why is Sedadex approved?
Maltese: Għaliex ġie approvat Sedadex?
English: Since noradrenaline is involved in maintaining alertness and arousal, reducing its release decreases the level of consciousness, including the sensation of pain.
Maltese: Peress li noradrenaline iżomm lill-annimal żvelt, it-tnaqqis tar-rilaxx tiegħu jnaqqas il-livell ta' kuxjenza, inkluża s-sensazzjoni tal-uġigħ.
English: This means that Sedadex is similar to a ‘reference medicine' already authorised in the EU called Dexdomitor.
Maltese: Dan ifisser li Sedadex huwa simili għal “mediċina ta' referenza” diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Dexdomitor.
English: What are the benefits and risks of Sedadex?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Sedadex?
English: Because Sedadex is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Sedadex huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Sedadex is a medicine used to sedate (calm down) and relieve pain in dogs and cats:
Maltese: Sedadex huwa mediċina użata għas-sedazzjoni (ikkalmar) u serħan mill-uġigħ fil-klieb u fil-qtates:
English: • Sedadex can also be used in dogs to provide pain relief and deep sedation when carrying out medical procedures and minor surgery where it is used in combination with butorphanol (a sedative and analgesic).
Maltese: • Sedadex jista' jintuża wkoll fil-klieb sabiex jipprovdi serħan mill-uġigħ u sedazzjoni fil-fond meta jitwettqu proċeduri mediċi u kirurġija minuri fejn jintuża f'kombinament ma' butorphanol (sedattiv u analġeżiku).
English: Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicine for many years.
Maltese: Dexmedetomidine hija relatata mill-qrib ma' sustanza oħra użata fis-sedazzjoni tal-annimali, medetomidine, li ilha tintuża fil-mediċini veterinarji għal ħafna snin.
English: No additional studies were needed as Sedadex is a generic medicine that is given by injection, is similar in composition to, and contains the same active substance as, the reference medicine, Dexdomitor.
Maltese: Ma kien meħtieġ l-ebda studju addizzjonali peress li Sedadex huwa mediċina ġenerika mogħtija permezz ta' injezzjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Dexdomitor.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Sedadex has been shown to have comparable quality to Dexdomitor.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li, skont ir-rekwiżiti tal-UE, Sedadex wera li għandu kwalità komparabbli għal Dexdomitor.