FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted that Abraxane was more effective than conventional paclitaxel-containing medicines in patients with metastatic breast cancer whose first treatment had stopped working, and that, unlike other paclitaxel-containing medicines, patients to be treated with Abraxane do not need pre-treatment with other medicines to prevent hypersensitivity reactions.
Maltese: Is-CHMP innota li Abraxane kien iktar effikaċi mill-mediċini konvenzjonali li fihom il-paklitaksel f'pazjenti b'kanċer metastatiku tas-sider li l-ewwel kura tagħhom ma baqgħetx taħdem, u li, b'differenza għal mediċini oħra li fihom il-paklitaksel, il-pazjenti li għandhom jiġu kkurati b'Abraxane ma għandhomx bżonn kura minn qabel b'mediċini oħra għall-prevenzjoni ta' reazzjonijiet ipersensittivi.
English: A risk management plan has been developed to ensure that Abraxane is used as safely and effectively as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Abraxane jintuża bl-aktar mod sigur possibbli.
English: The recommended dose is 260 mg per square metre of body surface area (calculated using the patient's height and weight).
Maltese: Id-doża rakkomandata hija 260 mg għal kull metru kwadru tal-erja tas-superfiċje tal-ġisem (ikkalkulata permezz tat-tul u l-piż tal-pazjent).
English: For the full list of restrictions with Abraxane, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet b'Abraxane, ara l-fuljett ta' tagħrif.
English: • non-small cell lung cancer, as a first treatment in combination with the cancer medicine carboplatin when the patient cannot have surgery or radiotherapy.
Maltese: • kanċer tal-pulmun ta' ċellola mhux żgħira (non-smalll cell lung cancer) bħala l-ewwel kura flimkien mal-mediċina kontra l-kanċer carboplatin meta l-pazjent ma jistax jiġi operat jew ma jistax jirċievi radjoterapija.
English: For metastatic adenocarcinoma of the pancreas, Abraxane was studied in one main study involving 861 patients who received either Abraxane in combination with gemcitabine or gemcitabine alone.
Maltese: Għall-adenokarċinoma metastatika tal-frixa, Abraxane ġie studjat fi studju ewlieni li kien jinvolvi 861 pazjent li kienu rċevew jew Abraxane f'kombinazzjoni ma' gemcitabine jew gemcitabine waħdu.
English: For metastatic breast cancer, Abraxane has been studied in one main study involving 460 women, around three-quarters of whom had received an anthracycline in the past.
Maltese: Għall-kanċer tas-sider metastatiku, Abraxane ġie studjat fi studju ewlieni li kien jinvolvi 460 mara, li madwar tliet kwarti minnhom kienu ngħataw l-antraċiklina fil-passat.
English: Abraxane is used to treat the following cancers in adults:
Maltese: Abraxane jintuża f'adulti għall-kura tal-kanċers li ġejjin:
English: In addition, Abraxane given in combination with gemcitabine was shown to improve survival in patients with metastatic adenocarcinoma of the pancreas compared with treatment with gemcitabine alone and was effective in combination with carboplatin in the treatment non-small cell lung cancer.
Maltese: Barra minn hekk, intwera li Abraxane mogħti flimkien ma' gemcitabine jtejjeb is-sopravivenza ta' pazjenti b'adenokarċinoma metastatika tal-frixa meta mqabbel ma' kura b'gemcitabine waħdu u kien effikaċi f'kombinazzjoni ma' carboplatin fil-kura tal-kanċer tal-pulmun ta' ċellola mhux żgħira.
English: In contrast, Abraxane was more effective than conventional paclitaxel-containing medicines in patients who had taken other treatments for metastatic breast cancer before.
Maltese: B'kuntrast ta' dan, Abraxane kien aktar effikaċi mill-mediċini konvenzjonali li fihom il-paklitaksel f'pazjenti li kienu ħadu kura oħra qabel għall-kanċer metastatiku tas-sider.
English: Abraxane should only be given under the supervision of a specialist cancer doctor in units that are specialised in giving ‘cytotoxic' (cell-killing) medicines.
Maltese: Abraxane għandu jingħata biss taħt is-sorveljanza ta' tabib speċjalizzat fil-kanċer fi kmamar li huma magħmulin apposta għall-għoti ta' mediċini ‘ċitotossiċi' (cytotoxic - li joqtlu ċ-ċelluli).
English: Excipients: Benzyl alcohol (E1519)
Maltese: Eċċipjenti: Benzyl alcohol (E1519)
English: Dechra Veterinary Products Srl Via Agostino da Montefeltro 2 10134 Torino
Maltese: Dechra Veterinary Products Srl Via Agostino da Montefeltro 2 10134
English: ATCvet code: QA04AD90
Maltese: QA04AD90
English: Finos Film Road, Thesi Xousmiza 19004 Spata-Attikis Ελλάδα
Maltese: Finos Film Road, Thesi Xousmiza 19004
English: 4941 SJ Raamsdonksveer The Netherlands
Maltese: 4941 SJ Raamsdonksveer In-Netherlands
English: Betadex sulfobutyl ether sodium Benzyl alcohol (E1519) Citric acid, anhydrous Sodium hydroxide Water for injections
Maltese: Betadex sulfobutyl ether sodium Benzyl alcohol (E1519) Citric acid monohydrate Idrossidu tas-sodju Ilma għall-injezzjonijiet
English: 3421 TV Oudewater The Netherlands
Maltese: 3421 TV Oudewater In-Netherlands
English: 11.1 mg For the full list of excipients, see section 6.1.
Maltese: 11.1 mg Għal-lista sħiħa tal-eċċipjenti, ara s-sezzjoni 6.1.
English: Luxembourg/Luxemburg Kela Vetarinaria NV/SA Industriepark West 68 B 9100 Sint-Niklaas Belgium
Maltese: Luxembourg/Luxemburg Kela Vetarinaria NV/SA Industriepark West 68 B 9100
English: Dechra Veterinary Products SAS 60 Avenue du Centre 78180 Montigny-le-Bretonneux Tél: +33 1 30 48 71 40
Maltese: Avenue du Centre 78180 Montigny-le-Bretonneux Tél: +33 1 30 48 71 40
English: ROUTE(S) OF ADMINISTRATION SC, IV
Maltese: MOD(I) TA' AMMINISTRAZZJONI SC, IV
English: Pack sizes of 1 vial of 10 ml, 20 ml, 25 ml or 50 ml.
Maltese: Daqsijiet tal-pakkett ta' kunjett 1 ta' 10 ml, 20 ml, 25 ml jew 50 ml.
English: METHOD AND ROUTE(S) OF ADMINISTRATION SC, IV
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI SC, IV
English: Manufacturer responsible for batch release: Produlab Pharma B.V.
Maltese: Manifattur responsabbli mill-ħrug tal-lott: Produlab Pharma B.V.
English: The anti-emetic efficacy of maropitant against central and peripheral emetics was demonstrated in experimental studies including apomorphine, cisplatin and syrup of ipecac (dogs) and xylazine (cats).
Maltese: L-effikaċja antiemetika ta' maropitant kontra emetiċi ċentrali u periferali ntweriet fi studji sperimentali inkluż apomorphine, cisplatin u xiropp ta' ipecac (klieb) u xylazine (qtates).
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 10 mg/ml
Maltese: ATTIVA(I) 10 mg/ml
English: Maropitant is effective against vomiting.
Maltese: Maropitant huwa effettiv kontra r-remettar.
English: c/ Balmes 202, 6a 08006 Barcelona
Maltese: Dechra Veterinary Products S.L.U. c/ Balmes 202, 6a 08006 Barcelona
English: 10 DATE OF REVISION OF THE TEXT <{MM/YYYY}>
Maltese: DATA TA' REVIŻJONI TAT-TEST {XX/SSSS}
English: Dechra Veterinary Products Ltd. Sansaw Business Park Hadnall, Shrewsbury Shropshire SY4 4AS United Kingdom Tel.: +44 (0)1939 211200
Maltese: Sansaw Business Park Hadnall, Shrewsbury Shropshire SY4 4AS United Kingdom Tel.: +44 (0)1939 211200
English: For the major metabolite 10.4% of the maropitant dose was recovered in urine and 9.3% in faeces.
Maltese: Għall-metabolit maġġuri 10.4 % tad-doża ta' maropitant ġie rkuprat fl-awrina u 9.3 % fl-ippurgar.
English: B 9100 Sint-Niklaas Tel. : +32 3 7806390
Maltese: Sint-Niklaas Tel. : +32 3 7806390
English: Maropitant undergoes cytochrome P450 (CYP) metabolism in the liver.
Maltese: Maropitant jgħaddi mill-metaboliżmu taċ-ċitokromu P450 (CYP) fil-fwied.
English: CYP2D15 and CYP3A12 were identified as the canine isoforms involved in the hepatic biotransformation of maropitant.
Maltese: CYP2D15 u CYP3A12 ġew identifikati bħala l-iżoforom tal-klieb involuti filbijotrasformazzjoni epatika ta' maropitant.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals, including isolated reports treated).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurati) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurati) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurati) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurati, inklużi rapporti iżolati).
English: Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 8.84 hours.
Maltese: Il-konċentrazzjonijiet massimi ġew segwiti minn tnaqqis fl-esponiment sistemiku b'nofs ħajja (half-life) ta' eliminazzjoni evidenti (t1/2) ta' 8.84 siegħa.
English: The volume of distribution at steady-state (Vss) was 2.3 l/kg and systemic clearance was 0.51 l/h/kg.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss (Vss) kien ta' 2.3 l/kg u t-tneħħija sistemika kienet ta' 0.51 l/h/kg.
English: CYP1A and CYP3A-related enzymes were identified as the feline isoforms involved in the hepatic biotransformation of maropitant.
Maltese: Enzimi relatati ma' CYP1A u CYP3A ġew identifikati bħala l-iżoformi talqtates involuti fil-bijotrasformazzjoni epatika ta' maropitant.
English: Dechra Veterinary Products S.L.U.
Maltese: Dechra Veterinary Products Ltd.
English: STATEMENT OF ACTIVE SUBSTANCES 10 mg/ml maropitant
Maltese: DIKJARAZZJONI TAS-SUSTANZI ATTIVI 10 mg/ml maropitant
English: The volume of distribution at steady-state (Vss) was 9.3 l/kg and systemic clearance was 1.5 l/h/kg.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss (Vss) kien ta' 9.3 l/kg u t-tneħħija sistemika kienet ta' 1.5 l/h/kg.
English: A variety of in vitro assays have demonstrated that maropitant binds selectively at the NK1 receptor with dose-dependent functional antagonism of substance P activity.
Maltese: Varjetà ta' assaġġi in vitro wrew li maropitant jorbot b'mod selettiv fir-riċettur NK1 b'antagoniżmu funzjonali dipendenti fuq id-doża tal-attività tas-sustanza P.
English: Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 16.8 hours.
Maltese: Ilkonċentrazzjonijiet massimi ġew segwiti minn tnaqqis fl-esponiment sistemiku b'nofs ħajja ta' eliminazzjoni evidenti (t1/2) ta' 16.8 sigħat.
English: The elimination t1/2 following intravenous dosing was approximately 5.8 h.
Maltese: L-eliminazzjoni t1/2 wara dożaġġ ġol-vini kienet ta' madwar 5.8 sigħat.
English: Use only according to the benefit-risk assessment by the responsible veterinarian.
Maltese: Uża biss skont ilvalutazzjoni tal-benefiċċju u r-riskju mill-veterinarju responsabbli.
English: This centre consists of several brainstem nuclei (area postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus) that receive and integrate sensory stimuli from central and peripheral sources and chemical stimuli from the circulation and the cerebro-spinal fluid.
Maltese: Dan iċ-ċentru jikkonsisti f'diversi nuklei taz-zokk enċefaliku (area postrema, nukleu tractus solitarius, nukleu mutur dorsali tal-vagu) li jirċievu u jintegraw stimuli sensorji minn sorsi ċentrali u periferali u stimuli kimiċi miċ-ċirkolazzjoni u l-fluwidu ċerebrospinali.
English: In very rare cases, anaphylactic type reactions (allergic oedema, urticaria, erythema, collapse, dyspnoea, pale mucous membranes) may occur.
Maltese: F'każijiet rari ħafna, jistgħu jseħħu effetti ta' tip anafilattiku (edema allerġika, urtikarja, eritema, ħass ħażin, dispnea, membrani mukużi pallidi).
English: In laboratory studies, maropitant has been shown to be a potential eye irritant.
Maltese: Fl-istudji fil-laboratorju, maropitant intwera li huwa irritant tal-għajnejn potenzjali.
English: • For the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the μ-opiate receptor agonist morphine.
Maltese: • Għall-prevenzjoni ta' nawżja u remettar perioperatorji u titjib fl-irkupru minn anestesija ġenerali wara l-użu ta' riċettur μ-opijat morfina agonista.
English: Maropitant is a neurokinin 1 (NK1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family.
Maltese: Maropitant huwa antagonist tar-riċettur neurokinin 1 (NK1), li jaġixxi billi jinibixxi l-irbit ta' sustanza P, newropeptid tal-familja takikinin.
English: Following a single intravenous dose at 1 mg/kg the initial plasma concentration was 363 ng/ml.
Maltese: Wara doża waħda ġol-vini ta' 1 mg/kg, il-konċentrazzjoni inizjali tal-plażma kienet ta' 363 ng/ml.
English: 6.1 List of excipients
Maltese: Lista ta' eċċipjenti
English: Plasma protein binding of maropitant in cats was estimated to be 99.1%.
Maltese: L-irbit tal-proteini tal-plażma ta' maropitant fil-qtates kien stmat li huwa 99.1 %.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains:
Maltese: U KWANTITATTIVA 1 ml fih: Sustanza attiva:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml injection maropitant
Maltese: Prevomax 10 mg/ml injezzjoni Maropitant
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 is-sit elettroniku talAġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/).
English: Following a single intravenous dose at 1 mg/kg the initial plasma concentration was 1040 ng/ml.
Maltese: Wara doża waħda ġol-vini ta' 1 mg/kg, il-konċentrazzjoni inizjali tal-plażma kienet ta' 1040 ng/ml.
English: The veterinary medicinal product should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.
Maltese: Il-prodott mediċinali veterinarju m'għandux jintuża fl-istess ħin ma' antagonisti tal-kanal Ca peress li maropitant għandu affinità mal-kanali ta' Ca.
English: Amber glass type I vial closed with a coated bromobutyl rubber stopper and aluminium cap in a cardboard box.
Maltese: Kunjett tal-ħġieġ kulur l-ambra ta' tip I b'tapp tal-gomma bromobutyl miksi u għatu tal-aluminju f'kaxxa tal-kartun.
English: Following repeated subcutaneous administration of once-daily doses of 1 mg/kg bodyweight for five consecutive days, accumulation was 146%.
Maltese: Wara għoti repetut taħt il-ġilda ta' dożi ta' darba kuljum ta' 1 mg/kg piż tal-ġisem għal ħamest ijiem konsekuttivi, l-akkumulazzjoni kienet ta' 146 %.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/211/001-004 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/06/2017
Maltese: FIS-SUQ EU/2/17/211/001-004
English: Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed.
Maltese: Ir-remettar jista' jkun assoċjat ma' kondizzjonijiet serji severament debilitanti inkluż ostruzzjonijiet gastrointestinali; għaldaqstant, għandhom jitwettqu evalwazzjonijiet dijanjostiċi xierqa.
English: The bioavailability of maropitant after subcutaneous administration in cats was 91.3%.
Maltese: Il-bijodisponibbiltà ta' maropitant wara għoti taħt il-ġilda fil-qtates kienet ta' 91.3 %.
English: Maropitant is highly bound to plasma proteins and may compete with other highly bound medicines.
Maltese: Maropitant jeħel ħafna mal-proteini tal-plażma u jista' jikkompeti ma' mediċini oħrajn li jeħlu ħafna.
English: Vendel Park, Tomasrét u. 12 H-2051 Biatorbagy Tel. +36-(0) 23530540
Maltese: 12 H-2051 Biatorbagy Tel.
English: Finos Film Road, Thesi Xousmiza 19004 Spata-Attikis Τηλ: +30-(0)210 6069800
Maltese: Spata-Attikis Τηλ: +30-(0)210 6069800
English: The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 92 ng/ml; this was achieved within 0.75 hours post-dosing (Tmax).
Maltese: Il-profil farmakokinetiku ta' maropitant meta jingħata bħala doża waħda taħt il-ġilda ta' 1 mg/kg piż tal-ġisem lill-klieb ġie kkaratterizzat mill-konċentrazzjoni massima (Cmax) fil-plażma ta' madwar 92 ng/ml; din inkisbet f'0.75 siegħa wara d-dożaġġ (Tmax).
English: As maropitant is accumulated in the body during a 14 day treatment period due to metabolic saturation, careful monitoring of liver function and any adverse events should be implemented during long term treatment.
Maltese: Peress li maropitant jiġi akkumulat fil-ġisem waqt il-perjodu ta' kura ta' 14-il jum minħabba saturazzjoni metabolika, għandu jiġi implimentat monitoraġġ b'attenzjoni tal-funzjoni tal-fwied u ta' kwalunkwe avveniment avvers waqt il-kura fit-tul.
English: The bioavailability of maropitant after subcutaneous administration in dogs was 90.7%.
Maltese: Il-bijodisponibbiltà ta' maropitant wara għoti taħt il-ġilda fil-klieb kienet ta' 90.7 %.
English: Česká republika Sevaron ltd Palackeho trida 163 a 61200 Brno Tel. +420 541 426 370
Maltese: Palackeho trida 163 a 61200 Brno Tel.
English: EXPIRY DATE EXP {month/year} Once broached use within 56 days.
Maltese: Ladarba jittaqqab, uża fi żmien 56 jum.
English: Dogs:
Maltese: Kumment:
English: Vomiting is a complex process coordinated centrally by the emetic centre.
Maltese: Ir-remettar huwa proċess kumpless ikkoordinat ċentralment miċ-ċentru emetiku.
English: Following repeated subcutaneous administration of once-daily doses of 1 mg/kg bodyweight for five consecutive days, accumulation was 250%.
Maltese: Wara għoti repetut taħt il-ġilda ta' dożi ta' darba kuljum ta' 1 mg/kg piż tal-ġisem għal ħamest ijiem konsekuttivi, l-akkumulazzjoni kienet ta' 250 %.
English: Prevomax solution for injection should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg of maropitant/kg body weight (1 ml/10 kg body weight).
Maltese: Prevomax soluzzjoni għall-injezzjoni għandha tiġi injettata taħt il-ġilda jew ġol-vini, darba kuljum, f'doża ta' 1 mg ta' maropitant / kg piż tal-ġisem (1 ml/10 kg piż tal-ġisem).
English: The veterinary medicinal product solution for injection should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg of maropitant / kg bodyweight (1 ml/10 kg bodyweight) for up to 5 consecutive days.
Maltese: Is-soluzzjoni għall-injezzjoni tal-prodott mediċinali veterinarju għandha tiġi injettata taħt il-ġilda jew ġol-vini, darba kuljum, f'doża ta' 1 mg ta' maropitant / kg piż tal-ġisem (1 ml/10 kg piż tal-ġisem) sa 5 ijiem konsekuttivi.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Produlab Pharma B.V.
Maltese: MILL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott Produlab Pharma B.V.
English: Renal clearance is a minor route of elimination, with less than 1% of a 1 mg/kg subcutaneous dose appearing in the urine as either maropitant or its major metabolite.
Maltese: It-tneħħija renali hija rotta minuri ta' eliminazzjoni, b'inqas minn 1 % ta' doża taħt il-ġilda 1 mg/kg li tidher fl-awrina bħala jew maropitant jew il-metabolit maġġuri tagħha.
English: Apart from transient reactions at the injection site following subcutaneous administration, maropitant was well tolerated in dogs and young cats injected daily with up to 5 mg/kg (5 times the recommended dose) for 15 consecutive days (3-times the recommended duration of administration).
Maltese: Minbarra reazzjonijiet tranżitorji fis-sit tal-injezzjoni wara għoti taħt il-ġilda, maropitant kien ittollerat tajjeb fil-klieb u fi qtates żgħar li ġew injettati b'sa 5 mg/kg (5 darbiet tad-doża rakkomandata) kuljum għal 15-il jum konsekuttiv (3 darbiet tad-durata rakkomandata tal-għoti).
English: The elimination t1/2 following intravenous dosing was approximately 4.9 h. There appears to be an age-related effect on the pharmacokinetics of maropitant in cats with kittens having higher clearance than adults.
Maltese: L-eliminazzjoni t1/2 wara dożaġġ ġol-vini kienet ta' madwar 4.9 sigħat.
English: Products such as Prevomax should be used in conjunction with other supportive measures such as dietary control and fluid replacement therapy, as recommended by your veterinary surgeon.
Maltese: Prodotti bħal Prevomax għandhom jintużaw flimkien ma' miżuri oħra ta' għajnuna, bħal kontroll tad-dieta u terapija ta' sostituzzjoni ta' fluwidi, kif rakkomandat mill-kirurgu veterinarju tiegħek.
English: Plasma protein binding of maropitant in dogs is more than 99%.
Maltese: L-irbit tal-proteini tal-plażma ta' maropitant fil-klieb huwa aktar minn 99 %.
English: Maropitant displays linear kinetics when administered subcutaneously within the 0.25-3 mg/kg dose range.
Maltese: Maropitant juri kinetiċi lineari meta jingħata taħt il-ġilda fil-medda tad-doża 0.25-3 mg/kg.
English: Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting.
Maltese: Prattika veterinarja tajba titlob li mediċini kontra remettar għandhom jintużaw flimkien ma' miżuri oħra veterinarji u ta' għajnuna bħal kontroll tad-dieta u terapija ta' sostituzzjoni ta' fluwidi waqt li jiġu indirizzati l-kawżi ta' remettar.
English: The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to cats was characterised by a maximum concentration (Cmax) in plasma of approximately 165 ng/ml; this was achieved on average 0.32 hours (19 min) post-dosing (Tmax).
Maltese: Il-profil farmakokinetiku ta' maropitant meta jingħata bħala doża waħda taħt il-ġilda ta' 1 mg/kg piż tal-ġisem lill-qtates ġie kkaratterizzat mill-konċentrazzjoni massima (Cmax) fil-plażma ta' madwar 165 ng/ml; bħala medja din inkisbet f'0.32 siegħa (19-il min) wara d-dożaġġ (Tmax).
English: Comment: Given the small vial size(s), would it not be preferable to replace these by “SC, IV"
Maltese: Minħabba d-daqs(ijiet) żgħir(żgħar) tal-kunjett, mhux iktar preferibbli li dawn jiġu sostituti minn “SC, IV”
English: Renal and faecal clearances are minor routes of elimination for maropitant, with less than 1% of a 1 mg/kg subcutaneous dose appearing in the urine or faeces as maropitant.
Maltese: It-tneħħijiet renali u tal-ippurgar huma rotot minuri tal-eliminazzjoni ta' maropitant, b'inqas minn 1 % ta' doża taħt il-ġilda ta' 1 mg/kg li tidher fl-awrina jew fl-ippurgar bħala maropitant.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products in the same syringe.
Maltese: Fin-nuqqas ta' studji dwar kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra fl-istess siringa.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
Maltese: KONDIZZJONIJIET U REKWIŻITI OĦRA TAL-AWTORIZZAZZJONI GĦATTQEGĦID FIS-SUQ
English: Use only according to the benefit-risk assessment by the responsible veterinarian, because conclusive reproductive toxicity studies have not been conducted in any animal species.
Maltese: Uża biss skont il-valutazzjoni tal-benefiċċju u r-riskju mill-veterinarju responsabbli, għax ma sarux studji konklużivi dwar it-tossiċità riproduttiva fi kwalunkwe speċi ta' annimal.
English: Prevomax must not be mixed with other veterinary medicinal products in the same syringe as its compatibility with other products has not been tested.
Maltese: Prevomax ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra fl-istess siringa peress li l-kompatibilità tiegħu ma' prodotti oħra ma ġietx ittestjata.
English: Maropitant displays linear kinetics when administered subcutaneously within the 0.5-2 mg/kg dose range.
Maltese: Maropitant juri kinetiċi lineari meta jingħata taħt il-ġilda fil-medda tad-doża 0.5-2 mg/kg.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats maropitant
Maltese: VETERINARJU Prevomax 10 mg/ml soluzzjoni għall-injezzjoni għall-klieb u l-qtates maropitant