FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency requires every patient and consumer organisation that it works with to provide financial statements, including details on donors and their contributions.
Maltese: L-Aġenzija titlob li kull organizzazzjoni tal-pazjenti jew tal-konsumaturi li taħdem magħha tipprovdi dikjarazzjonijiet finanzjarji, inklużi d-dettalji dwar id-donaturi u l-kontribuzzjonijiet tagħhom.
English: Medical devices are evaluated by the medicines regulatory authorities in each Member State.
Maltese: L-apparat mediku jiġi vvalutat mill-awtoritajiet regolatorji tal-mediċini f'kull Stat Membru.
English: Can the Agency recommend academic courses?
Maltese: L-Aġenzija tista' tirrakkomanda korsijiet akkademiċi?
English: Is the Agency's website available in languages other than English?
Maltese: Is-sit elettroniku tal-Aġenzija huwa disponibbli f'lingwi oħrajn barra lIngliż?
English: To stay up to date with the latest news, features and publications from the Agency, you can subscribe to our RSS feeds or follow EMA on Twitter.
Maltese: Biex iżżomm ruħek aġġornat/a bl-aħħar aħbarijiet, funzjonijiet u pubblikazzjonijiet mill-Aġenzija, tista' tabbona għall-RSS feeds jew issegwi lill-EMA fuq Twitter.
English: Although medicines evaluated by EMA receive an authorisation valid in the whole of the EU, decisions on where a medicine is marketed are made by the company that markets the medicine (the marketing-authorisation holder).
Maltese: Għalkemm il-mediċini vvalutati mill-EMA jirċievu awtorizzazzjoni valida fl-UE kollha kemm hi, iddeċiżjonijiet dwar fejn mediċina titqiegħed fis-suq isiru mill-kumpanija li tqiegħed il-mediċina fis-suq (id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq).
English: These spontaneous reports of suspected side effects by healthcare professionals, patients or carers are used to continuously monitor the safety of medicines on the market and to ensure that their benefits continue to outweigh their risks.
Maltese: Irresponsabbiltajiet tal-Aġenzija huma limitati għall-valutazzjoni ta' mediċini għal raġunijiet ta' awtorizzazzjoni u s-superviżjoni tagħhom ladarba jkunu awtorizzati.
English: are prepared by the Committee on Herbal Medicinal Products (HMPC) and contain information about what a herbal medicine is used for, restrictions on its use, its undesirable effects and its interactions with other medicines.
Maltese: Biex issib informazzjoni dwar mediċini awtorizzati fuq livell nazzjonali, ikkuntattja lill-aġenzija regolatorja tal-mediċini fil-pajjiż tiegħek;
English: Please note that this is an unofficial acronym.
Maltese: Jekk jogħġbok kun af li dan l-akronimu mhuwiex uffiċjali.
English: The Agency publishes information about all the medicines it assesses as a European public assessment report (EPAR).
Maltese: L-Aġenzija tippubblika informazzjoni dwar il-mediċini kollha li tivvaluta bħala rapport pubbliku Ewropew ta' valutazzjoni (EPAR).
English: How can I search for a medicine on the Agency's website?
Maltese: Kif nista' nfittex mediċina fis-sit elettroniku tal-Aġenzija?
English: To find out if a medicine is currently available in your country through a compassionate-use programme, check with your national medicines regulatory authority or the company responsible for the medicine.
Maltese: Jista' jkun li l-awtoritajiet regolatorji tal-mediċini fl-Istati Membri jkunu jistgħu jipprovdu l-informazzjoni dwar il-bejgħ ta' mediċina.
English: The Agency's old acronym of 'EMEA' should not be used any longer.
Maltese: L-akronimu l-antik tal-Aġenzija, 'EMEA', m'għandux jintuża aktar.
English: Does the Agency control advertising of medicines?
Maltese: L-Aġenzija tista' tipprovdili informazzjoni dwar il-privattivi dwar mediċini?
English: The Agency's main responsibility is the protection and promotion of public and animal health, by carrying out scientific evaluations of medicines for human and veterinary use.
Maltese: Ir-responsabbiltà prinċipali tal-Aġenzija hija l-protezzjoni u l-promozzjoni tas-saħħa pubblika u talannimali, billi twettaq valutazzjonijiet ta' mediċini għall-użu tal-bniedem u għall-użu veterinarju.
English: The Agency suggests that you discuss these issues with a healthcare professional, such as your doctor or pharmacist.
Maltese: Jista' jkun li l-awtoritajiet regolatorji tal-mediċini fl-Istati Membri jkunu jistgħu jipprovdulek din linformazzjoni.
English: The members of the Agency's Management Board and scientific committees, and its experts and staff are not permitted to have financial or other interests in the pharmaceutical industry that could affect their impartiality.
Maltese: Il-membri tal-Bord ta' Tmexxija tal-Aġenzija u l-kumitati xjentifiċi, u l-esperti u l-persunal tagħha ma jistgħux ikollhom interessi finanzjarji jew interessi oħrajn fl-industrija farmaċewtika li jistgħu jaffettwaw l-imparzjalità tagħhom.
English: You may wish to consult the EU Clinical Trials Register for information on authorised clinical trials that are ongoing.
Maltese: Tista' tikkonsulta r-Reġistru tal-Provi Kliniċi tal-UE għal informazzjoni dwar provi kliniċi awtorizzati li għaddejjin bħalissa.
English: However, some medicines can be supplied to individual patients under special conditions before they have been authorised.
Maltese: Il-mediċini ma jistgħux jitqiegħdu fis-suq mingħajr awtorizzazzjoni.
English: Are all medicines approved via the Agency?
Maltese: Tista' tgħinni nikseb mediċina?
English: The Agency suggests that you discuss your treatment with a healthcare professional, such as a doctor or pharmacist.
Maltese: Madanakollu, l-Aġenzija tista' tiġi kkonsultata dwar apparat mediku li fih sustanzi mediċinali.
English: • not classified as a medicine but as a medical device or a nutritional supplement, both of which are authorised at national level.
Maltese: • ma tkunx ikklassifikata bħala mediċina iżda bħala apparat mediku jew suppliment nutrittiv, it-tnejn li huma awtorizzati fuq livell nazzjonali.
English: This document provides answers to the most frequently asked questions received by the European Medicines Agency (EMA).If the answer to your question is not here, please use our online form: Send a question to EMA.
Maltese: L-Aġenzija mhijiex responsabbli mill-privattivi dwar mediċini: kwistjonijiet dwar il-liġi tal-privattivi ma jaqgħux taħt ir-responsabbiltà tal-Aġenzija.
English: The full EPAR for Ivabradine Zentiva 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 Ivabradine Zentiva, ivabradine, blocks the ‘If current' in the sinus node, the natural ‘pacemaker' that regulates the heart rate.
Maltese: Is-sustanza attiva f'Ivabradine Zentiva, ivabradine, timblokka l-‘kurrent If' fin-nod tas-sinus, il-‘pacemaker' naturali li jirregola r-rata ta' taħbit tal-qalb.
English: Ivabradine Zentiva is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Maltese: Ivabradine Zentiva jiġi bħala pilloli (5 u 7.5 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Maltese: Id-doża inizjali rrakkomandata hija 5 mg darbtejn kuljum mal-ikliet, li t-tabib jista' jżid għal 7.5 mg darbtejn kuljum jew inaqqas għal 2.5 mg (nofs pillola ta' 5 mg) darbtejn kuljum skont ir-rata ta' taħbit tal-qalb talpazjent u s-sintomi.
English: This means that Ivabradine Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Procoralan.
Maltese: Dan ifisser li Ivabradine Zentiva huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Procoralan.
English: This is a summary of the European public assessment report (EPAR) for Ivabradine Zentiva.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ivabradine Zentiva.
English: Ivabradine Zentiva is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (heart disease caused by blockage of the blood vessels that supply the heart muscle).
Maltese: Ivabradine Zentiva huwa mediċina tal-qalb li tintuża għall-kura tas-sintomi ta' anġina stabbli fit-tul (uġigħ fis-sider, ix-xedaq u d-dahar, ikkaġunat minn sforz fiżiku) f'adulti b'marda tal-arterja koronarja (marda fil-qalb ikkawżata minn imblukkar fl-arterji u fil-vini tad-demm li jfornu lill-muskolu tal-qalb).
English: It is used in combination with standard therapy including beta-blockers, or in patients who cannot be treated with beta-blockers.
Maltese: Jintuża flimkien ma' terapija standard li tinkludi l-beta-blokkaturi, jew f'pazjenti li ma jistgħux jiġu kkurati b'beta-blokkaturi.
English: The medicine is used in patients with a normal heart rhythm whose heart rate is at least 70 beats per minute.
Maltese: Il-mediċina tintuża f'pazjenti b'ritmu tal-qalb normali li r-rata ta' taħbit tal-qalb tagħhom hija tal-inqas 70 taħbita fil-minuta.
English: In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used.
Maltese: F'pazjenti li għandhom 'l fuq minn 75 sena, tista' tintuża doża inizjali iżjed baxxa ta' 2.5 mg darbtejn kuljum.
English: In stable angina, these symptoms occur during physical effort.
Maltese: Fl-anġina stabbli, dawn is-sintomi jseħħu waqt sforzi fiżiċi.
English: Because Ivabradine Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Procoralan.
Maltese: Minħabba li Ivabradine Zentiva huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet biex tiġi determinata l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Procoralan.
English: Why is Ivabradine Zentiva approved?
Maltese: Għaliex ġie approvat Ivabradine Zentiva?
English: Other information about Ivabradine Zentiva
Maltese: Informazzjoni oħra dwar Ivabradine Zentiva
English: Ivabradine Zentiva contains the active substance ivabradine.
Maltese: Ivabradine Zentiva fih is-sustanza attiva ivabradine.
English: The Committee recommended that Ivabradine Zentiva be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Ivabradine Zentiva ikun approvat għall-użu fl-UE.
English: Because Ivabradine Zentiva 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 Ivabradine Zentiva 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: Ivabradine Zentiva ivabradine
Maltese: Kif jintuża Ivabradine Zentiva?
English: Also, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing symptoms or reducing the heart rate.
Maltese: Barra minn hekk, it-tabib għandu jikkunsidra li jwaqqaf il-kura jekk il-mediċina għandha biss effett limitat fuq it-tnaqqis tas-sintomi jew fuq it-tnaqqis fir-rata ta' taħbit talqalb.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine Zentiva has been shown to have comparable quality and to be bioequivalent to Procoralan.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Ivabradine Zentiva wera li għandu kwalità komparabbli u huwa bijoekwivlenti għal Procoralan.
English: When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Maltese: Meta tintuża għall-anġina, il-kura għandha titwaqqaf jekk ma jkun sar lebda titjib fis-sintomi wara 3 xhur.
English: Ivabradine Zentiva is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) and a normal heart rhythm whose heart rate is at least 75 beats per minute.
Maltese: Ivabradine Zentiva jintuża wkoll f'pazjenti b'insuffiċjenza tal-qalb fit-tul (meta l-qalb ma tkunx tista' tippompja biżżejjed demm lill-bqija tal-ġisem) u b'ritmu tal-qalb normali li r-rata tal-qalb tagħhom hija tal-inqas 75 taħbita fil-minuta.
English: It is used either in patients who cannot take beta-blockers (another type of medicine to treat angina) or in combination with a beta-blocker in patients whose disease is not controlled by a beta-blocker alone.
Maltese: Tintuża jew f'pazjenti li ma jistgħux jieħdu betablokkaturi (tip ta' mediċina oħra għall-kura tal-anġina), jew flimkien ma' beta-blokkatur f'pazjenti li l-marda tagħhom ma tkunx ikkontrollata b'beta-blokkatur biss.
English: Str. Maravet nr.1 Tel: +40262211964
Maltese: Maravet nr.1 Tel: +40262211964
English: België/Belgique/Belgien Kela Veterinaria N.V./S.A.
Maltese: België/Belgique/Belgien Kela Veterinaria N.V./S.
English: LIVISTO Sp. z o.o.
Maltese: LIVISTO Sp. z o.o. ul.
English: Box 374
Maltese: P.O. Box 374
English: Tel. +43 7242 4900 office@richter-pharma.at
Maltese: +43 7242 4900 office@richter-pharma.at
English: Address: Forellenweg 16 4941 SJ Raamsdonksveer The Netherlands
Maltese: Forellenweg 16 4941 SJ Raamsdonksveer The Netherlands
English: C/O Oriola Oy P.O.
Maltese: C/O Oriola Oy P.O. Box 8
English: Est. Consiglieri Pedroso, 80 Queluz Park - Queluz de Baixo P-2730-053 Barcarena Tel: +351 21 4368251
Maltese: Consiglieri Pedroso, 80 Queluz Park - Queluz de Baixo P-2730-053 Barcarena Tel: +351 21 4368251
English: Tel.: +36-22/516402 vevoszolgalat@alpha-vet.hu
Maltese: +36-22/516402 vevoszolgalat@alpha-vet.hu
English: TATEMEN ntains: detomidine hy ent to dexme
Maltese: U L-INDIRIZZ TAD-DETENTUR TAL- AWTORIZZAZZJONI GĦATTQEGĦID FIS-SUQ
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains:
Maltese: U KWANTITATTIVA 1 ml fih:
English: UANTITY ml
Maltese: KWANTITÀ ml
English: Dechra Veterinary Products AB Stora Wäsby Orangeriet 3 19437 Upplands Väsby Tel: +46 (0) 8 32 53 55
Maltese: Wäsby Orangeriet 3 19437 Upplands Väsby Tel: +46 (0) 8 32 53 55
English: Állatgyógyászati Kft.
Maltese: Állatgyógyászati
English: Dechra Veterinary Products SAS 60 Avenue du Centre 78180 Montigny-le-Bretonneux Tél: +33 1 3048 7140
Maltese: Avenue du Centre 78180 Montigny-le-Bretonneux Tél: +33 1 3048 7140
English: 1 ml con Dexmed (equivale
Maltese: 1 ml fih: Dexmed (ekwival
English: MINISTRA
Maltese: TAMMINISTRA
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/198/001
Maltese: FIS-SUQ EU/2/16/198/001
English: Pharmacotherapeutic group: Psycholeptics, hypnotics and sedatives ATCvet code: QN05CM18
Maltese: Psikoleptiċi, ipnotiċi u sedattivi Kodiċi ATC veterinarja: QN05CM18.
English: Dogs: IV Cats: IM
Maltese: Klieb: IV Qtates: I
English: Tel: +372-6709006 zoovet@zoovet.ee
Maltese: +372-6709006 zoovet@zoovet.ee
English: Sodium hydroxide (E 524) (for pH adjustment) Hydrochloric acid (E507) (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (E 524) (għall-aġġustament tal-pH) Hydrochloride acid (E507) (għall-aġġustament tal-pH) Ilma għall-injezzjonijiet
English: Overdose (symptoms, emergency procedures, antidotes) Dogs:
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti) Klieb:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/198/002
Maltese: EU/2/16/198/002
English: Q 0.5 mg/m
Maltese: K 0.5 mg/m
English: MANUFACTURER'S BATCH NUMBER Lot.
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott.
English: PHARMACEUTICAL PARTICULARS
Maltese: TA' PRODOTTI MEDIĊINALI
English: Q 0.1 mg/m
Maltese: K 0.1 mg/m
English: 0.1 m 0.08 m
Maltese: 0.5 m 0.
English: Litostrojska c. 44E 1000 Ljubljana SLOVENIA Tel: +386 1 505 58 82 info@medvet.si
Maltese: 44E 1000 Ljubljana SLOVENIA Tel: +386 1 505 58 82 info@medvet.si
English: Litostrojska c. 44E 1000 Ljubljana Tel: +386 1 505 58 82 info@medvet.si
Maltese: 44E 1000 Ljubljana Tel: +386 1 505 58 82 info@medvet.si
English: HE VETER injection ydrochloride
Maltese: 0 ml PRODOTT M injezzjoni ydrochloride
English: None known.
Maltese: e dine
English: OUTE(S) O V , IM M
Maltese: MOD TA' AM V, IM
English: The apparent volume of distribution (Vd) is 2.2 l/kg and the elimination half-life (t1⁄2) is one hour.
Maltese: Ilvolum ta' distribuzzjoni (Vd) jidher li huwa ta' 2.2 l/kg u l-half life ta' eliminazzjoni (t1⁄2) hija ta' siegħa.
English: N(S)
Maltese: NUMRU(I)
English: BY NUMBE
Maltese: NUMRU/I
English: B. PACKAGE LEAFLET
Maltese: L-PAKKET
English: Sedation may be reversed with atipamezole (see section 4.10).
Maltese: L-irqad jista' jiġi mregga' lura b'atipamezole (ara sezzjoni 4.10).
English: Dogs: IM Cats: IM
Maltese: Klieb: IM Qtates: I
English: Advice to physicians: Sedadex is an α2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
Maltese: Sedadex huwa α2-adrenoreceptor agonist, sintomi wara assorbiment jistgħu jinvolvu effetti kliniċi inkluż sedazzjoni dipendenti fuq id-doża, dipressjoni respiratorja, bradikardja, pressjoni għolja b'mod anormali, ħalq xott, u ipergliċemija.
English: When dexmedetomidine and butorphanol are used concomitantly in dogs, bradypnoea, tachypnoea, an irregular respiratory pattern (20-30 sec apnoea followed by several rapid breaths), hypoxaemia, muscle twitch or tremor or paddling, excitation, hypersalivation, retching, vomiting, urination, skin erythema, a sudden arousal, or prolonged sedation may occur.
Maltese: Meta dexmedetomidine u butarfanol jintużaw flimkien fil-klieb, jista' jkun hemm nifs bil-mod jew mgħaġġel, xejra respiratorja irregolari (20-30 sekonda qtugħ ta' nifs, segwiti minn ħafna nifsijiet mgħaġġla), nuqqas ta' ossiġnu fid-demm, ġibda jew rogħda fil-muskoli, qdif bir-riġlejn, eċċitament, produzzjoni għolja ta' bżieq, tqalligħ, remettar, tluq tal-urina, eritima tal-ġilda, tistembaħ f'daqqa jew irqad fit-tul.
English: Sedation may be reversed with atipamezole (see section 12 overdose).
Maltese: L-irqad jista' jiġi rriversjat b'atipamezole (ara sezzjoni 12 Doża eċċessiva).
English: Finos Film Road, Thesi Xousmiza 19004 Spata-Attikis Τηλ: +30-(0)210 6069800 info@petline.gr
Maltese: Spata-Attikis Τηλ: +30-(0)210 6069800 info@petline.gr
English: ydrochloride edetomidine
Maltese: ydrochloride xmedetomid
English: CKAGING U
Maltese: U LUŻU
English: FIN-02101 Espoo Puh/Tel: +358 45 2300 665 info@faunapharma.fi
Maltese: +358 45 2300 665 info@faunapharma.fi
English: RINARY ME injection for
Maltese: FA oni għal injez
English: The bioavailability of dexmedetomidine is 60% and the apparent volume of distribution (Vd) is 0.9 l/kg.
Maltese: Il-bijodisponiibilità fil-ġisem ta' dexmedetomidine hija ta' 60% u l-volum ta' distribuzzjoni (Vd) jidher li huwa ta' 0.9 l/kg.
English: e
Maltese: I
English: TA Dogs an
Maltese: *IM biss
English: Excipients: Methyl parahydroxybenzoate (E 218)
Maltese: Ingredjenti: Methyl parahydroxybenzoate (E 218)
English: ONTENTS
Maltese: WTIKA
English: After concurrent exposure to an overdose of dexmedetomidine (3 times the recommended dose) and 15 mg ketamine/ kg, atipamezole can be administered at the recommended dose level for reversal of effects induced by dexmedetomidine.
Maltese: Wara li tingħata doża eċċessiva ta' dexmedetomidine (3 darbiet id-doża rakkomandata), flimkien ma' 15 mg ketamina/ kg, atimpamezole tista' tingħata fil-livell ta' doża rakkomandata biex treġġa' lura l-effetti ta' dexmedetomidine.
English: Excipient(s): Methyl parahydroxybenzoate (E 218)
Maltese: Ingredjent(i): Methyl parahydroxybenzoate (E 218)
English: 0.5 m 0.42 m
Maltese: 42 m
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.1 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride
Maltese: VETERINARJU Sedadex 0.1 mg/ml soluzzjoni għal injezzjoni għall-klieb u għall-qtates dexmedetomidine hydrochloride
English: EXP {m Once bro
Maltese: EXP {xa Ladarba
English: Major biotransformations in the dog include hydroxylation, glucuronic acid conjugation and N-methylation in the liver.
Maltese: Bio-trasformazzjonijiet maġġuri fil-kelb jinkludu idrossilazzjoni, konjugazzjoni mal-aċidu glukoroniku u N-methylation fil-fwied.
English: The premedication dose of dexmedetomidine is 125 - 375 micrograms/square metre body surface area, administered 20 minutes prior to induction for procedures requiring anaesthesia.
Maltese: Id-doża ta' premedikazzjoni ta' dexmedetomidine hija ta' 125 - 375 mikrogrammi/metru kwadru tal-wiċċ talġisem, mogħtija 20 minuta qabel jinbdew proċeduri li jeħtieġu l-anestesija.
English: BSTANCES
Maltese: Klieb
English: It is recommended that animals are fasted for 12 hours prior to Sedadex administration.
Maltese: Huwa rakkomandat li l-annimali jkunu sajmin għal 12-il siegħa qabel jiġi amministrat Sedadex.
English: ARGET SP d cats
Maltese: PEĊI GĦAL qtates
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Dechra Veterinary Products AB Stora
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.5 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride
Maltese: VETERINARJU Sedadex 0.5 mg/ml soluzzjoni għal injezzjoni għall-klieb u għall-qtates dexmedetomidine hydrochloride
English: NDICATION
Maltese: NDIKAZZJO
English: AME OF TH x 0.5 mg/ml s etomidine hy
Maltese: TAL-P x 0.5 mg/ml s etomidine hy
English: AME OF TH x 0.1 mg/ml s etomidine hy
Maltese: TAL-P x 0.1 mg/ml s etomidine hy
English: 10 DATE OF REVISION OF THE TEXT <{MM/YYYY}>
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA <{XX/SSSS}>
English: T OF ACTI
Maltese: T SPEĊJALI
English: Dogs:
Maltese: Eċċipjenti:
English: HT, BY VOL
Maltese: OĦRA, JE
English: SIZE
Maltese: ONI
English: EDICINAL
Maltese: Kunjett
English: In cases of overdose, or if the effects of dexmedetomidine become potentially life- threatening, the appropriate dose of atipamezole is 10 times the initial dose of dexmedetomidine (micrograms/ kg bw or micrograms/ square meter body surface area).
Maltese: F'każijiet ta' doża eċċessiva, jew fejn l-effetti ta' dexmedetomidine jistgħu ikunu ta' theddida għallħajja, id-doża xierqa ta' atipamezole hija 10 darbiet aktar mid-doża inizjali ta' dexmedetomidine (mikrogrammi/ kg piż jew mikrogrammi/ metru kwadru tal-wiċċ tal-ġisem).
English: HARMACE n for injection
Maltese: MEDIĊINA ħal injezzjon
English: OUTE(S) O M, IV M
Maltese: M, IV
English: BSTANCE(S
Maltese: INDIKAZZJONI(JIET)
English: TH For anim
Maltese: MOD TA' AM
English: NA
Maltese: À
English: ATCH NUM mber}
Maltese: M JEW NUM
English: Dogs: in Cats: int Read the
Maltese: Klieb: in Qtates: i Aqra l-fu
English: In cases of overdose, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose: 5 times the initial dose dexmedetomidine in micrograms/kg bw.
Maltese: F'każijiet ta' doża eċċessiva, jew fejn l-effetti ta' dexmedetomidine jistgħu ikunu ta' theddida għallħajja, l-antagonista xieraq huwa atipamezole, amministrat b'injezzjoni fil-muskolu bid-doża kif ġej: 5 darbiet aktar mid-doża inizjali ta' dexmedetomidine f'mikrogrammi/kg piż.
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-tenth (1/10) the volume of Sedadex 0.1 mg/ml that was given to the cat.
Maltese: Il-volum tad-doża ta' atipamezole fil-konċentrazzjoni ta' 5 mg/ml huwa wieħed minn kull għaxra (1/10) mill-volum ta' Sedadex 0.1 mg/ml li ngħata lill-qattus.
English: W
Maltese: TW
English: Brady- and tachyarrhythmias have been reported and include profound sinus bradycardia, 1st and 2nd degree AV block and sinus arrest.
Maltese: Taħbit tal-qalb bil-mod jew mgħaġġel ġew irrapportati u jinkludu sinus bradycardia filfond, AV block tal-ewwel u tat-tieni grad u waqfien tas-sinus.
English: STRATION
Maltese: IKJARAZZ
English: OD
Maltese: DI
English: MBER
Maltese: RRA