FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effect with Sustiva (seen in more than 1 patient in 10) is rash.
Maltese: L-effett sekondarju l-aktar komuni b'Sustiva (li deher f'aktar minn pazjent 1 minn 10) hu raxx.
English: By blocking this enzyme, Sustiva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Billi jimblokka din l-enzima, Sustiva, meħud flimkien ma' mediċini antivirali oħra, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: In patients aged 3 months to 17 years, the dose depends on body weight.
Maltese: F'pazjenti ta' 3 xhur sa 17il sena, id-doża tiddependi mill-piż tal-ġisem.
English: How is Sustiva used?
Maltese: Kif jaħdem Sustiva?
English: 1000 Ljubljana Cesta vGorice 8
Maltese: 1000 Ljubljana Cesta v Gorice 8
English: ATCvet code: QN05CM18.
Maltese: QN05CM18.
English: QR code to be included + www.sileodog.com
Maltese: Kodiċi QR li għandu jiġi inkluż + www.sileodog.com
English: Orion Corporation Orionintie 1
Maltese: ORIONCORPORATION Orionintie 1
English: Tel: +49 (0)3834 83 584 0 Email : info@ecuphar.de
Maltese: Tel: +49 (0)3834 83 584 0 E-mail : info@ecuphar.de
English: 2300 København S Tlf: +45 86 14 00 00
Maltese: DK-2300 København S Tlf: +45 86 14 00 00
English: EU/2/15/181/002 (3 (1 x 3 ml) oral syringes) EU/2/15/181/003 (5 (1 x 3 ml) oral syringes) EU/2/15/181/004 (10 (1 x 3 ml) oral syringes) EU/2/15/181/005 (20 (1 x 3 ml) oral syringes)
Maltese: EU/2/15/181/003 (5 (1 x 3 ml) siringi orali) EU/2/15/181/004 (10 (1 x 3 ml) siringi orali) EU/2/15/181/005 (20 (1 x 3 ml) siringi orali)
English: Verlengde Poolseweg 16, 4818 CL Breda Tel: +31 (0)88 003 38 00 Email : info@ecuphar.nl
Maltese: Verlengde Poolseweg 16 4818 CL Breda Tel: +31 (0)88 003 38 00 E-mail : info@ecuphar.nl
English: Pharmacotherapeutic group: psycholeptics, hypnotics and sedatives.
Maltese: Grupp farmako-terapewtiku: psikolettiċi, ipnotiċi u sedattivi.
English: Orion Pharma Poland Sp. z o.o.
Maltese: Orion Pharma Poland Sp. z o.o. ul.
English: Other ingredients: Brilliant blue (E133) and tartrazine (E102).
Maltese: Sustanzi oħra: Brilliant blue (E133) u tartrazine (E102).
English: PACKAGE SIZE 1 x 3 ml oral syringe
Maltese: DAQS TAL-PAKKETT 1 x 3 ml siringa orali
English: 3 packs of (3 ml) oral syringes 5 packs of (3 ml) oral syringes 10 packs of (3 ml) oral syringes 20 packs of (3 ml) oral syringes
Maltese: 3 pakketti ta' siringi orali (3 ml) 5 pakketti ta' siringi orali (3 ml) 10 pakketti ta' siringi orali (3 ml) 20 pakkett ta' siringi orali (3 ml)
English: (for 5 x 1, 10 x 1 and 20 x 1 multipacks only)
Maltese: (għal pakketti multipli ta' 5 x 1, 10 x 1 u 20 x 1 biss)
English: Icepharma hf Lynghálsi 13 1100 Reykjavík Sîmi: 540 8080
Maltese: Lynghálsi 13 110 Reykjavík Sími: 540 8080
English: Dexmedetomidine hydrochloride 0.1 mg (equivalent to 0.09 mg dexmedetomidine).
Maltese: Dexmedetomidine hydrochloride 0.1 mg (ekwivalenti għal 0.09 mg ta' dexmedetomidine).
English: N-methylation, N-glucuronidation and oxidation in the imidazole ring have also been observed.
Maltese: N-methylation, N-glucuronidation u ossidazzjoni fl-imidazole ring ġew osservati wkoll.
English: Box 4366 Nydalen N-0402 Oslo
Maltese: Orion Pharma AS Animal Health P.O. Box 4366 Nydalen N-0402 Oslo
English: Sodium hydroxide (for pH-adjustment) Hydrochloric acid (for pH-adjustment)
Maltese: Sodium hydroxide (għal aġġustament tal-pH) Hydrochloric acid (għal aġġustament tal-pH)
English: Pack sizes: single pack of 1 oral syringe and multipacks of 3 (3 packs of one), 5 (5 packs of one), 10 (10 packs of one) and 20 (20 packs of one).
Maltese: Daqsijiet tal-pakkett: pakkett wieħed ta' 1 siringa orali u pakketti multipli ta' 3 (3 pakketti ta' siringa waħda), 5 (5 pakketti ta' siringa waħda), 10 (10 pakketti ta' siringa waħda) u 20 (20 pakketti ta' siringa waħda).
English: Avenida Río de Janeiro, 60-66, planta 13 08016 Barcelona (España) Tel: + 34 93 5955000
Maltese: Río de Janeiro, 60-66, planta 13 08016 Barcelona
English: Dexmedetomidine, the active ingredient of Sileo is an alpha-2 adrenoceptor agonist.
Maltese: Dexmedetomidine, l-ingredjent attiv ta' Sileo, hu agonist ta' alpha-2 adrenoceptor.
English: Ružová dolina 6, 821 08 Bratislava, SR Tel: +421 250 221 215
Maltese: 821 08 Bratislava, SR Tel: +421 250 221 215
English: In rodents alpha-2 adrenoceptor agonists reduce synthesis of NA, DA, 5-HT and the 5-HT precursor, 5-HTP (5-hydroxytryptophan), in the frontal cortex, hippocampus, striatum and hypothalamus and as a result decreases motor behaviour and signalling associated with distress.
Maltese: F'annimali gerriema, agonisti ta' alpha-2 adrenoceptor jnaqqsu s-sintesi ta' DA, 5-HT u l-prekursur ta' 5-HT, 5-HTP (5hydroxytryptophan), fil-kortiċi ta' quddiem, hippocampus, striatum u ipotalamu, u b'riżultat inaqqsu limġiba tal-moviment u s-senjalazzjoni assoċjati ma' biża'/ansjetà.
English: Oral bioavailability of dexmedetomidine is poor due to extensive first-pass metabolism.
Maltese: Il-bijodisponibilità orali ta' dexmedetomidine hi batuta minħabba metaboliżmu ‘first-pass estensiv'.
English: Common reactions: - paleness of the mucous membranes at the application site - tiredness (sedation) - vomiting - uncontrolled urination.
Maltese: Reazzjonijiet komuni: - sfurija tal-membrani mukużi fis-sit tal-applikazzjoni - għeja (sedazzjoni) - rimettar - awrina bla kontroll.
English: PHARMACEUTICAL FORM Oromucosal gel.
Maltese: GĦAMLA FARMAĊEWTIKA Ġell oromukożali.
English: Pre-filled 3 ml HDPE oral syringes with graduations from 0.25 ml (1 dot) to 3 ml (12 dots).
Maltese: Siringi orali mimlija għal-lest ta' 3 ml, tal-HDPE, bi gradwazzjonijiet minn 0.25 ml (1 tikka) sa 3 ml (12 tikek).
English: The major metabolic routes in dogs are hydroxylation of a methyl substituent and further oxidation to a carboxylic acid or O-glucuronidation of the hydroxylated product.
Maltese: Ir-rotot metaboliċi maġġuri fil-klieb huma hydroxylation ta' sostitwent ta' methyl u ossidazzjoni addizzjonali għal carboxylic acid jew O-glucuronidation tal-prodott hydroxylated.
English: Oromucosal use.
Maltese: Mhux applikabbli.
English: In a pharmacokinetic study in dogs the oromucosal mean bioavailability of dexmedetomidine was 28%.
Maltese: Fi studju farmakokinetiku fil-klieb, il-medja tal-bijodisponibilità oromukożali ta dexmedetomidine kienet ta' 28%.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/181/001 (1 x 3 ml oral syringe)
Maltese: FIS-SUQ EU/2/15/181/001 (1 x 3 ml siringa orali)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (iktar minn 1 minn kull 10 annimali li juru r- reazzjoni(jiet) avversa matul il-kors ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: Information for the veterinary surgeon:
Maltese: Informazzjoni għat-tabib veterinarju:
English: Atipamezole (at the concentration of 5 mg/ml) dose in millilitres is one sixteenth (1/16th) of the dose volume of Sileo gel.
Maltese: Id-doża ta' atipamezole (fil-konċentrazzjoni ta' 5 mg/ml) f'millilitri hi ta' 1/16 (1/16th) tal-volum tad-doża tal-ġell Sileo.
English: Uncommon adverse reactions in clinical trials were anxiety, periorbital oedema, drowsiness and signs of gastroenteritis.
Maltese: Reazzjonijiet avversi mhux komuni fil-provi kliniċi kienu ansjetà, edema periorbitali, ħedla u sinjali ta' gastroenterite.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Dexmedetomidine hydrochloride 0.1 mg/ml
Maltese: TAS-SUSTANZA(i) ATTIVA(I) Dexmedetomidine hydrochloride 0.1 mg
English: The product can be dosed up to 5 times during each event.
Maltese: Il-prodott jista' jingħata sa 5 darbiet matul kull avveniment.
English: Respiratory and haemodynamic symptoms should be treated symptomatically.
Maltese: Sintomi respiratorji u emodinamiċi għandhom jiġu kkurati b'mod sintomatiku.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sileo 0.1 mg/ml oromucosal gel dexmedetomidine HCl
Maltese: VETERINARJU Sileo 0.1 mg/ml ġell oromukożali dexmedetomidine HCl
English: Deutschland Ecuphar GmbH, Brandteichstraße 20, 17489 Greifswald, Deutschland
Maltese: 17489 Greifswald Deutschland
English: LT-08234 Vilnius Tel: +370 5 276 9499
Maltese: Vilnius Tel: +370 5 276 9499
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Sileo is a translucent, green oromucosal gel containing 0.1 mg/ml dexmedetomidine hydrochloride (active substance), equivalent to 0.09 mg/ml dexmedetomidine.
Maltese: U INGREDJENT(I) OĦRA Sileo hu ġell oromukożali, trasluċidu u aħdar, li fih 0.1 mg/ml ta' dexmedetomidine hydrochloride (sustanza attiva), ekwivalenti għal 0.09 mg/ml ta' dexmedetomidine.
English: The effects of dexmedetomidine can be eliminated using a specific antidote, atipamezole (alpha-2 adrenoceptor antagonist).
Maltese: L-effetti ta' dexmedetomidine jistgħu jiġu eliminati bl-użu antidot speċifiku, atipamezole (antagonist ta' alpha-2 adrenoceptor) .
English: Blood pressure decreases slightly below normal levels.
Maltese: Il-pressjoni tad-demm tonqos ftit taħt il-livelli normali.
English: Pack sizes: single pack of 1 oral syringe and multipacks of 3 (3 packs of one oral syringe).
Maltese: Daqsijiet tal-pakkett: pakkett wieħed b'1 siringa orali u pakketti multipli ta' 3 (3 pakketti ta' siringa orali waħda).
English: ZOETIS France 10 rue Raymond David 92240 MALAKOFF Tel: + 33 (0) 810 734 937
Maltese: ZOETIS France 10 rue Raymond David 92240
English: The effects of dexmedetomidine can be eliminated using a specific antidote (reversal medicine).
Maltese: L-effetti ta' dexmedetomidine jistgħu jiġu eliminati bl-użu antidot speċifiku (mediċina li treġġa' lura).
English: Sileo contains dexmedetomidine (as the hydrochloride salt) as the active substance.
Maltese: Sileo fih dexmedetomidine (bħala melħ ta' hydrochloride) bħala s-sustanza attiva.
English: Dexmedetomidine is a potent and selective alpha-2 adrenoceptor agonist that inhibits the release of noradrenaline (NA) from noradrenergic neurons, blocks the startle reflex and thus counteracts arousal.
Maltese: Dexmedetomidine hu agonist potenti u selettiv ta' alpha-2 adrenoceptor li jinibixxi l-ħruġ ta' noradrenaline (NA) minn newroni noradrenerġiċi, jimblokka l-istartle reflex u b'hekk iservi ta' kontrobilanċ għall-biża'.
English: Symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
Maltese: Sintomi wara lassorbiment jistgħu jinvolvu effetti kliniċi li jinkludu sedazzjoni dipendenti mid-doża, tnaqqis respiratorju, bradikardija, pressjoni baxxa, ħalq xott, u ipergliċemija.
English: Other commonly observed adverse events in clinical trials were sedation, emesis and urinary incontinence.
Maltese: Avvenimenti avversi oħrajn osservati b'mod komuni fil-provi kliniċi kienu sedazzjoni, emesi u inkontinenza urinarja.
English: Viale Francesco Restelli, 3/7 20124 Milano (Italia) Tel: + 39 0282950604
Maltese: Viale Francesco Restelli, 3/7 20124
English: Multipacks of 5, 10 and 20 oral syringes are intended to be supplied only to veterinarians.
Maltese: Pakketti multipli ta' 5, 10 u 20 siringi orali huma intenzjonati li jiġu fornuti biss lil veterinarji.
English: If the oromucosal gel is swallowed it will become ineffective.
Maltese: Jekk il-ġell oromukożali jinbela', dan se jsir ineffettiv.
English: Pull
Maltese: Klieb
English: The Sileo oral syringe is capable of delivering the product in 0.25 ml increments.
Maltese: Is-siringa orali ta' Sileo hi kapaċi li tforni l-prodott f'inkrementi ta' 0.25 ml.
English: Higher than recommended doses of Sileo gel may also induce a number of other alpha-2 adrenoceptor mediated effects, which include mydriasis, depression of motor and secretory functions of the gastrointestinal tract, temporary AV-blocks, diuresis and hyperglycaemia.
Maltese: Dożi tal-ġell Sileo li jkunu ogħla minn dwk rakkomandati jistgħu jinduċu wkoll numru ta' effetti oħrajn medjati minn alpha-2 adrenoreceptor, li jinkludu midrijasi, tnaqqis fil-funzjonijiet tal-moviment u tas-sekrezzjoni tal-passaġġ gastrointestinali , imblokki temporanji tal-AV, dijuresi u ipergliċemija.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sileo 0.1 mg/ml oromucosal gel for dogs dexmedetomidine hydrochloride
Maltese: VETERINARJU Sileo 0.1 mg/ml ġell oromukożali għall-klieb dexmedetomidine hydrochloride
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: A slight decrease in body temperature may be observed.
Maltese: Tnaqqis żgħir fit-temperatura tal-ġisem tista' tiġi osservata.
English: Belphar LDA
Maltese: KONTENUT BĦALA
English: MANUFACTURER'S BATCH NUMBER Lot
Maltese: NUMRU TAL-LOTT
English: The Sileo oral syringe delivers the product in small increments (0.25 ml).
Maltese: Is-siringa orali ta' Sileo tforni l-prodott f'inkrementi żgħar (0.25 ml).
English: PHARMACEUTICAL FORM Oromucosal gel
Maltese: GĦAMLA FARMAĊEWTIKA Ġell oromukożali
English: Dexmedetomidine as an alpha-2 adrenoceptor agonist alters the levels of NA, serotonin (5-HT) and dopamine (DA) in the hippocampus and frontal cortex, indicating that such compounds affect also the regions of the brain involved in creating and maintaining complex anxieties.
Maltese: Dexmedetomidine bħala agonist ta' alpha-2 adrenoceptor jibdel il-livelli ta' NA, serotonin (5-HT) u dopamine (DA) fil-hippocampus u kortiċi ta' quddiem, li jindika li dawn il-komposti jaffettwaw ukoll ir-reġjuni tal-moħħ involuti fil-ħolqien u ż-żamma ta' ansjetajiet kumplessi.
English: When administered via the oral mucosa, enhanced bioavailability is observed as a result of absorption in the oral cavity and the avoidance of first-pass metabolism in the liver.
Maltese: Meta jingħata mill-mukuża orali, tiġi osservata bijodisponibbiltà mtejba b'riżultat tal-assorbiment fil-kavità orali u l-evitar ta' metaboliżmu ‘first-pass' fil-fwied.
English: Orion Pharma Kft.
Maltese: Orion Pharma
English: UNLOCK
Maltese: Imbotta
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/).
English: Metabolism accounts for more than 98% of the elimination.
Maltese: Il-metaboliżmu jammonta għal aktar minn 98% tat-tneħħija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton (3 x 1, 5 x 1, 10 x 1 and 20 x 1 pre-filled syringes)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kartuna (3 x 1, 5 x 1, 10 x 1 u 20 x 1 siringi mimlija għal-lest)
English: In the circulation, dexmedetomidine is largely bound to plasma proteins (93%).
Maltese: Fil-ċirkolazzjoni, dexmedetomidine hu fil-biċċa l-kbira tiegħu mwaħħal mal-proteini tal-plażma (93%) .
English: Dosing should be performed by an adult.
Maltese: Id-dożaġġ għandu jsir minn persuna adulta.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 1 ml: Dexmedetomidine hydrochloride 0.1 mg
Maltese: OĦRA 1 ml: Dexmedetomidine hydrochloride 0.1 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/181/001-005 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10/06/2015
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 10/06/2015
English: The product should be administered onto the oral mucosa between dog's cheek and gum at a dose of 125 micrograms/m2.
Maltese: Il-prodott għandu jingħata fuq il-mukuża orali bejn ħaddejn il-kelb u l-ħanek f'doża ta' 125 mikrogramma/m2.
English: Typical signs of anxiety and fear are panting, trembling, pacing (frequent change of place, running around, restlessness), seeking people (clinging, hiding behind, pawing, following), hiding (under furniture, in dark rooms), trying to escape, freezing (absence of movements), refusing to eat food or treats, inappropriate urination, inappropriate defecation, salivation, etc.
Maltese: Sinjali tipiċi ta' ansjetà u biża' huma li l-kelb jilheġ, jirtgħod, jimxi (tibdil frekwenti tal-post, jiġri ' l hawn u ' l hemm, ma jkollox kwiet ġo ġismu), ifittex in-nies (jaqbad ma' persuna, jistaħba warajha, imissha b'saqajh, isegwiha), jistaħba (taħt l-għamara, fi kmamar mudlama), jippruvaw jaħrab, jiffriża (nuqqas ta' movimenti), jirrifjuta li jiekol, jagħmel l-awrina bl-addoċċ u fejn ġie ġie, jipporga bl-addoċċ u fejn ġie ġie, salivazzjoni, eċċ.
English: In extremely nervous, excited or agitated animals, the levels of endogenous catecholamines are often high.
Maltese: F'annimali estremament nervużi, eċċitati u aġitati, il-livelli ta' catecholamines endoġeni ta' spiss ikunu għoljin.
English: In addition to anxiolytic effect, dexmedetomidine has other well-known dose dependent pharmacological effects such as lowering of heart rate and rectal temperature, and peripheral vasoconstriction.
Maltese: Flimkien maleffett ‘anxiolytic', dexmedetomidine għandu effetti farmakoloġiċi oħrajn magħrufa li jiddependu fuq id-doża, bħat-tnaqqis fit-rata ta' taħbit tal-qalb u tat-temperatura tar-rektum, u tidjiq tal-vini/arterji periferali.
English: Bodyweight of dog (kg) Number of dots
Maltese: Piż tal-ġisem tal-kelb (kg) Numru ta' tikek
English: Known metabolites show no or negligible activity.
Maltese: Metaboliti magħrufa ma juru l-ebda attività, jew attività negliġibbli.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oromucosal use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu għall-mukuża tal-ħalq.
English: HOLD PLUNGER
Maltese: U LUŻU
English: Hydroxypropylcellulose Sodium laurilsulfate Brilliant blue (E133) Tartrazine (E102)
Maltese: Hydroxypropylcellulose Sodium laurilsulfate
English: Water, purified
Maltese: Ilma, ppurifikat
English: Dogs
Maltese: MHUX
English: The specific alpha-2 adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans but only experimentally to antagonize dexmedetomidine-induced effects.
Maltese: L-antagonist ta' alpha-2 adrenoreceptor, atipamezole, li hu approvat għall-użu fl-annimali, intuża fil-bnedmin, iżda b'mod sperimentali biss bie jantagonizza l-effetti indotti minn dexmedetomidine.
English: Ventricular arrhythmias have also been reported.
Maltese: Arritmiji ventrikulari ġew irrappurtati wkoll.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sileo 0.1 mg/ml oromucosal gel for dogs
Maltese: VETERINARJU Sileo 0.1 mg/ml ġell oromukożali għall-klieb
English: Do not use this veterinary medicinal product after the expiry date which is stated on the oral syringe label and outer carton after “EXP”.
Maltese: Tużax dan il-prodott mediċinali veterinarju wara d-data ta' skadenza murija fuq it-tikketta tas-siringa orali u l-kartuna ta' barra wara “JIS”.
English: Translucent, green gel.
Maltese: Tiġbidx il-planġer!
English: PULL CAP (TIGHT)
Maltese: PERJODU TA' TIŻMIM
English: The apparent volume of distribution of dexmedetomidine in dogs is 0.9 l/kg.
Maltese: Il-volum apparenti tad-distribuzzjoni ta' dexmedetomidine fil-klieb hu ta' 0.9 l/kg.
English: NOT SWALLOWED
Maltese: Iġbed
English: In case of overdose, the appropriate dose of atipamezole calculated in micrograms is 3 times (3X) the dose of administered dexmedetomidine hydrochloride in Sileo gel.
Maltese: F'każ ta' doża eċċessiva, id-doża adattata ta' atipamezole ikkalkulata f'mikrogrammi hi ta' 3 darbiet (3X) tad-doża mogħtija ta' dexmedetomidine hydrochloride fil-ġell
English: 1139 Budapest, Pap Károly u. 4-6 Tel: +36 1 886 3015
Maltese: 1139 Budapest, Pap Károly u.
English: PHARMACOLOGICAL PROPERTIES
Maltese: FARMAĊEWTIKU
English: Push to break yellow seal.
Maltese: Tużax fi klieb b'disturbi kardjovaskulari severi.
English: Uterine contractions and decreased foetal blood pressure may occur after systemic exposure to dexmedetomidine.
Maltese: Kontrazzjonijiet tal-utru u tnaqqis fil-pressjoni taddemm tal-fetu jistgħu jseħħu wara esponiment sistemika għal dexmedetomidine.
English: ROUTE(S) OF ADMINISTRATION Oromucosal use.
Maltese: MOD(I) TA' AMMINISTRAZZJONI Użu għall-mukuża tal-ħalq.
English: Do not use in dogs with severe systemic disease (graded as ASA III-IV) e.g. end stage renal or liver failure.
Maltese: Tużax fi klieb b'mard sistemiku sever (ikklassifikat bħala ASA III-IV) eż. mard tal-kliewi fl-aħħar stadju jew insuffiċjenza tal-fwied.
English: The pharmacological response elicited by alpha-2 agonists (e.g. dexmedetomidine) in such animals may be reduced.
Maltese: Ir-rispons farmakoloġiku kkawżat minn agonisti ta' alpha-2 (eż. dexmedetomidine) f'annimali bħal dawn jista' jitnaqqas.
English: These and other effects are described in more detail in section 4.10 on overdose.
Maltese: Dawn u effetti oħra huma deskritti f'aktar dettall f'sezzjoni 4.10 dwar doża eċċessiva.
English: B. PACKAGE LEAFLET
Maltese: 11. LURA FIL-PAKKETT
English: If the oromucosal gel is swallowed it will become less effective.
Maltese: Jekk il-ġell oromukożali jinbela', dan se jsir inqas effettiv.
English: Hold the oral syringe so that you can see the dot markings on the oral syringe plunger.
Maltese: Erġa' poġġi s-siringa orali fil-kartuna ta' barra immedjatament wara kull użu.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Maltese: Żmien kemm idum tajjeb l-prodott mediċinali veterinarju kif ippakkjat għall-bejgħ: 3 snin.
English: Sileo may cause the following adverse reactions.
Maltese: Sileo jista' jikkawża r-reazzjonijiet avversi li ġejjin.
English: Wear impermeable disposable gloves when handling the veterinary medicinal product and handling the oral syringe.
Maltese: Ilbes ingwanti impermeabbli li jintremew wara li jintużaw meta timmaniġġja l-prodott mediċinali veterinarju u meta timmaniġġja ssiringa orali.
English: EU/2/11/136/001 TruScient 0.66 mg Kit for implant
Maltese: EU/2/11/136/001 TruScient 0.66 mg Kit għallimpjantazzjoni
English: 1 vial + 1 vial + 2 sterile matrices syringes needles
Maltese: Vjala 1 + Vjala 1 + 2 matriċi sterili + 3 siringi + 3 labar
English: Strength Pharmaceutical Form
Maltese: Saħħa Għamla Farmaċewtika
English: Route of Administration
Maltese: Speċi Metodu ta' Amministrazzjoni
English: Dogs Peri-osseous use
Maltese: Perjodu ta' Tiżmim
English: EU Number
Maltese: Numru ta' l-UE Isem talProdott
English: The full EPAR for Janumet 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: It is available as tablets (50 mg sitagliptin / 850 mg metformin hydrochloride; and 50 mg sitagliptin / 1,000 mg metformin hydrochloride).
Maltese: Jiġi bħala pilloli (50 mg sitagliptina / 850 mg metformina idrokloridrat; u 50 mg sitagliptina / 1,000 mg metformina idrokloridrat).
English: Sitagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Maltese: Is-sitagliptina hija inibitur dipeptidyl peptidase 4 (DPP-4).
English: Janumet sitagliptin / metformin hydrochloride
Maltese: Janumet sitagliptina / metformina idrokloridrat
English: The maximum dose of sitagliptin is 100 mg a day.
Maltese: Id-doża massima ta' sitagliptina hi 100 mg kuljum.
English: This is a summary of the European public assessment report (EPAR) for Janumet.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Janumet.
English: • in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin
Maltese: • flimkien ma' sulfonilurea, agonista PPAR gamma, bħal thiazolidinedione jew insulina (tipi oħra ta'