FrancophonIA/ELRC3.0 huggingface dataset:
English: Rua Galileu Galilei, Nº2 Piso 7 Fracção A/D 1500 - 392 LISBOA
Maltese: Torre Ocidente Rua Galileu Galilei, Nº2 Piso 7 Fracção A/D
English: Banbury, Oxfordshire, OX16 4RS United Kingdom.
Maltese: Cherwell Middleton Close Banbury, Oxfordshire, OX16 4RS Ir-Renju Unit.
English: Priestley Road Basingstoke, Hampshire RG24 9NL United Kingdom
Maltese: Priestley Road Basingstoke, Hampshire RG24 9NL Ir-Renju Unit.
English: Italia (Italy) Eli Lilly Italia S.p.A Via Gramsci, 731- 733 SestoFiorentino I-50019 Firenze Tel.: +39 0 55 42 57031 Italy
Maltese: Italia (Italy) Eli Lilly Italia S.p.A Via Gramsci, 731- 733 SestoFiorentino I-50019 Firenze Tel.:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Fentanyl 50 mg/ml
Maltese: TAS-SUSTANZA ATTIVA Fentanyl 50 mg/ml
English: Recuvyra also contains octyl salicylate and isopropyl alcohol.
Maltese: Recuvyra fih ukoll octyl salicylate u alkoħol tal-isopropil.
English: (ng/ml)
Maltese: Cmax (ng/ml)
English: de la Industria, 30 E-28108 Alcobendas (Madrid) Tel.: +34 91 663 5000
Maltese: España (Spain) Elanco Valquimica S.A. Avda. de la Industria, 30 E-28108 Alcobendas (Madrid) Tel.: +34 91 663 5000
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/127/001
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/11/127/001
English: Pharmacotherapeutic group: Analgesic, opioid, phenylpiperidene derivative.
Maltese: Analgeżiku, opjojdi, derivat ta' phenylpiperidene.
English: United Kingdom
Maltese: United Kingdom republic)
English: 1 vial (10 ml) 1 vial adaptor 15 syringes 15 applicator tips
Maltese: Kunjett 1 (10 ml) Adapter tal-kunjett 1 15-il siringa 15-il ras t'applikatur
English: Cherwell 2
Maltese: ANNESS II
English: 3.0 to 4.2 4.3 to 6.1 6.2 to 8.0 8.1 to 9.9 10.0 to 11.7 11.8 to 13.6 13.7 to 15.5 15.6 to 17.4 17.5 to 19.3 19.4 to 21.2 21.3 to 23.1 23.2 to 25.0 25.1 to 26.9 27.0 to 28.8 28.9 to 30.6 30.7 to 32.5 32.6 to 34.4 34.5 to 36.3 36.4 to 38.2 38.3 to 40.1 40.2 to 42.0 42.1 to 43.9 44.0 to 45.8 45.9 to 47.7 47.8 to 49.6 49.7 to 51.4 51.5 to 53.3 53.4 to 55.2 55.3 to 57.0
Maltese: 30.7 sa 32.5 32.6 sa 34.4 34.5 sa 36.3 36.4 sa 38.2 38.3 sa 40.1
English: Instructions for use:
Maltese: Preparazzjoni tal-parti:
English: Rarely (i.e. in 0,01 to 0,1% of treated dogs) • Dysphoria and urinary retention.
Maltese: Rarament (dan ifisser 0.01 sa 0.1 % ta' klieb trattati)
English: METHOD AND ROUTE(S) OF ADMINISTRATION For transdermal use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għall-użu transdermali.
English: Fentanyl is a potent anaesthetic sparing substance.
Maltese: Fentanyl huwa sustanza anestetika qawwija.
English: The duration of action of naloxone ranges between 45 minutes and 3 hours in the dog.
Maltese: It-tul tal-effett tan-naloxene huwa ta' bejn 45 minuta u 3 sigħat fil-kelb.
English: Higher oral doses may induce anaesthetic effects and cardiopulmonary depression.
Maltese: Dożi orali ogħla jistgħu jinduċu effetti anestetiċi u dipressjoni kardjopulmonari.
English: • Mild sedation (sleepiness) for up to 24 hours after Recuvyra has been applied by your veterinarian.
Maltese: • Sedazzjoni ħafifa (ngħas) għal sa 24 siegħa wara Recuvyra tkun ġiet applikata mill veterinarju tiegħek.
English: 02-092 Warszawa Tel.: +48 22 440 33 00 Austria
Maltese: Żwirki i Wigury 18a 02-092 Warszawa Tel.: +48 22 440 33 00 Poland
English: PHARMACEUTICAL FORM Transdermal solution.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni transdermali.
English: Attaching adaptor (see Figure 1):
Maltese: It-twaħħil tal-adapter (ara Figura 1):
English: Cladirea D, et 2, 013713, sector 1, Bucuresti, Tel:
Maltese: Cladirea D, et 2, 013713, sector 1, Bucuresti, Tel: +40-21-4023000, fax: +40-21-4023001
English: (hrs)
Maltese: (ml)
English: The mean plasma fentanyl concentration from time 0 through 96 hours post-dose administration is approximately 1.32 ng/ml.
Maltese: Il- konċentrazzjoni medja ta' fentanyl fil-plażma mill-ħin 0 sa 96 siegħa wara d-doża amministrata hija ta' madwar 1.32 ng/ml.
English: The clearance of fentanyl ranges from 1.7 to 4.7 l/h/kg in dogs.
Maltese: It-tneħħija ta' fentanyl tvarja minn 1.7 sa 4.7 l/h/kg fil-klieb.
English: Gastrointestinal stasis can result in serious complications and consideration should be given to opiate reversal in case of excessive narcosis (see section 4.10).
Maltese: Stasi gastrointestinali tista' tirriżulta f'kumplikazzjonijiet serji u għandha tingħata konsiderazzjoni għall-kura riversibbli tal-loppju f'każ ta' narkożi eċċessiva (ara sezzjoni 4.10).
English: Mild side effects such as sedation, may occur after a single accidental oral administration of more than 20 µg/kg of fentanyl (0.4 µl/kg Recuvyra).
Maltese: Il-prodott jista' joħloq effetti kollaterali ħfief bħal sedazzjoni wara għotja aċċidentali orali unika ta' aktar minn 20 µg/kg fentanyl (0.4 µl/kg Recuvyra).
English: • A polycarbonate Robertsite vial adaptor (allowing needleless luer connection to the vial).
Maltese: • Adapter ta' kunjett tal-polikarbonat Robertsite (li jippermetti konnessjoni luer ta' mingħajrlabra malkunjett).
English: The frequency of adverse reactions is defined using the following convention:
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija definita bil-konvenzjoni li ġejja:
English: In field trials, 2 % of dogs treated with the veterinary medicinal product required reversal of adverse opiate effects with naloxone.
Maltese: Fi provi fil-kamp, 2 % ta' klieb trattati bil-prodott mediċinali veterinarju kienu jeħtieġu li jkun hemm treġġigħ lura ta' effetti avversi tal-loppju b'naloxone.
English: Facilities for the maintenance of a patent airway, intermittent positive pressure ventilation (IPPV) and oxygen supplementation should be available.
Maltese: Faċilitajiet għall-manteniment ta' passaġġ patenti, ventilazzjoni għal pressjoni pożittiva intermittenti (intermittent positive pressure ventilation (IPPV)) u supplimentazzjoni ta' ossiġnu għandhom ikunu disponibbli.
English: 50 mg/ml For a full list of excipients, see section 6.1.
Maltese: 50 mg/ml Għal-lista sħiħa ta' sustanzi (mhux attivi), ara s-sezzjoni 6.1.
English: • A 2-pronged polycarbonate applicator tip.
Maltese: • Ras ta' applikatur tal-polikarbonat b'tarf doppju.
English: • Vomiting and diarrhoea.
Maltese: • Rimettar u dijarea.
English: Recuvyra like any other medicine may cause adverse reactions.
Maltese: Recuvyra bħal ħafna mediċini oħra jista' jikkaġuna reazzjonijiet avversi.
English: The recommended dose is 2.6 mg fentanyl/kg bodyweight (i.e. 0.052 ml/kg bw), applied topically to the dorsal scapular area 2 to 4 hours prior to surgery and according to the dosing table below.
Maltese: Id-doża rakkomandata hi ta' 2.6 mg fentanyl/kg piż korporali (dan ifisser 0.052 ml/kg piż korporali), li tingħata b'mod topiku fil-parti skapulari dorsali minn sagħtejn sa 4 sigħat qabel il-kirurġija u skont it
English: The maximum plasma fentanyl concentrations of 0.7 to 4.7 ng/ml are reached within 10 to 18 hours of dose administration.
Maltese: Il-konċentrazzjonijiet massimi ta' fentanyl fil-plażma ta' bejn 0.7 sa 4.7 ng/ml jintlaħqu fi żmien 10 sa 18-il siegħa wara l-għoti tad-doża.
English: The effects of the concomitant use of the veterinary medicinal product and α-adrenergic agonists have not been studied.
Maltese: L-effetti tal-użu konġunt tal-prodott mediċinali veterinarju ma' agonisti α-adrenerġiċi ma ġewx studjati.
English: If there is a risk of contact with the application site, suitable protective gloves must be worn.
Maltese: Jekk ikun hemm riskju ta' kuntatt mal-post tal-applikazzjoni, għandhom jintlibsu ngwanti protettivi xierqa.
English: Do not use in dogs with cardiac failure, hypotension, hypovolaemia, respiratory depression, hypertension, a history of epilepsy, non age related corneal pathology or those who have or are suspected of having a paralytic ileus.
Maltese: Tużax fuq klieb b'falliment kardijaku, pressjoni baxxa, ipovolemija, dipressjoni respiratorja, pressjoni għolja, storja ta' epilessija, patoloġija korneali li mhix marbuta mal-età jew dawk li għandhom jew huma suspettati li għandhom ileju paralitiku.
English: At the moment of drying, approximately 2 to 5 minutes after application, fentanyl and octyl salicylate are absorbed into the stratum corneum.
Maltese: Fil-mument li jkun qed jinxef, madwar żewġ minuti sa 5 minuti wara l-applikazzjoni, il-fentanyl u l-octyl salicylate jiġu assorbiti fisistratum corneum.
English: Attaching the Applicator Tip
Maltese: Applikazzjoni tal-prodott
English: Fentanyl is extensively metabolised and excreted into the urine.
Maltese: Fentanyl huwa metabolizzat b'mod estensiv u eliminat fl-awrina.
English: tlag
Maltese: TIKKETTA
English: • Has heart failure, low or high blood pressure, low blood volume, impaired breathing, has a history of epilepsy, non-aged related corneal pathology or has or might have a partial or completely stationary bowel.
Maltese: • għandu falliment kardijaku, pressjoni tad-demm baxxa jew għolja, volum tad-demm baxx, nifsijiet indeboliti, storja ta' epilessija, patoloġija korneali mhix marbuta mal-età jew jekk ikollu musrana parzjali jew kompletament stazzjonarja.
English: • A 3 ml polypropylene syringe with a silicone O-ring fitted to the plunger.
Maltese: • Siringa tal-polipropelin tat-3 ml b'O-ring tas-silikon mqiegħed fuq il-planġer.
English: Ireland (Ireland)
Maltese: Ísland (Iceland)
English: The ranges (90% interval) of pharmacokinetic parameters in dogs are given below:
Maltese: Il-firxa (intervall ta' 90%) tal-parametri farmakokinetiċi fil-klieb huma mogħtija hawn taħt:
English: INDICATION(S)
Maltese: SID(/S-SIDIEN)
English: • very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: • rari ħafna (aktar minn annimal 1 iżda anqas minn 10,000 annimal, inkluż rapporti iżolati).
English: The pharmacokinetic profile of the veterinary medicinal product is primarily characterised by the long period of systemic absorption.
Maltese: Il-profil farmakokinetiku tal-prodott mediċinali veterinarju huwa prinċipalment ikkaratterizzat minn perjodu twil ta' assorbiment sistemiku.
English: Time
Maltese: Data
English: For transdermal use.
Maltese: Mhux applikabbli.
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 tinsab disponibbli fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: • Decreased stool production and some temporary weight loss.
Maltese: • Disforja u ritenzjoni tal-awrina.
English: Commonly (i.e. in 1 to 10% of treated dogs)
Maltese: Komuni (dan ifisser 1 sa 10% ta' klieb trattati)
English: Two to four hours before your dog has surgery, the recommended dose (2.6 mg fentanyl/kg bodyweight) of Recuvyra solution is applied directly on the skin between the dog's shoulder blades.
Maltese: Minn sagħtejn sa erba' sigħat qabel ma l-kelb tiegħek ikollu intervent kirurġiku, id-doża rakkomandata (2.6 mg fentanyl/kg piż korporali) ta' soluzzjoni ta' Recuvyra tiġi applikata direttament fuq il-ġilda fejn il-ġwienaħ tal-kelb.
English: The most common symptoms associated with fentanyl overdose in people include respiratory depression, sedation and myosis.
Maltese: L-aktar sintomi komuni assoċjati ma' doża eċċessiva ta' fentanyl fin-nies jinkludu dipressjoni respiratorja, sedazzjoni u mijosi.
English: Plasma fentanyl concentrations reach 1.0 ng/ml, (which is generally considered analgesic) in more than 60% of dogs within 4 hours of administration.
Maltese: Il-konċentrazzjoni ta' fentanyl filplażma tilħaq 1.0 ng/ml, (li ġeneralment hi kkonsidrata bħala analġeżika) f'aktar minn 60% tal-klieb fi żmien 4 sigħat minn meta tingħata.
English: • Has an allergy to the active substance (fentanyl) or to any of the excipients.
Maltese: • għandu allerġija għas-sustanza attiva (fentanyl) jew xi sustanza mhix attiva.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Recuvyra 50 mg/ml transdermal solution for dogs
Maltese: VETERINARJU Recuvyra 50 mg/ml soluzzjoni transdermali għall-klieb
English: Isopropyl alcohol
Maltese: Octyl salicylate Alkoħol tal-isopropil
English: If the volume to be administered is greater than 0.5 ml, move the applicator tip at least 2.5 cm from the initial site and apply up to 0.5 ml.
Maltese: Jekk il-volum li jrid jiġi applikat hu aktar minn 0.5 ml, ċaqlaq l-applikatur tal-anqas 2.5 ċm mil-post inizjali u applika sa 0.5 ml.
English: As a precaution, RECUVYRA should not be administered by pregnant women.
Maltese: Bħala prekawzjoni, RECUVYRA m'għandux jiġi amministrat min-nisa tqal.
English: Type I amber glass vial containing 10 ml solution, closed with a grey butyl rubber stopper sealed with a two piece aluminium seal with a grey flip-off plastic disc.
Maltese: Kunjett tal-ħġieġ lewn l-ambra Tip I li fih soluzzjoni ta' 10 ml, magħluq b'tapp griż tal-lastiku tal-butil issiġillat b'siġill f'żewġ biċċiet tal-aluminju b'diska tal-plastik griża li tinqala' bis-saba'.
English: Manufacturer for batch release:
Maltese: Kodiċi ATCvet:
English: It is important that you do not allow any other dogs or pets you may have to lick or come into contact with the area between your dog's shoulder blades where your veterinarian has applied Recuvyra for at least 3 days (72 hours) following treatment, as this might cause adverse reactions in these animals.
Maltese: Huwa importanti li inti ma tippermettix xi klieb oħra jew annimali domestiċi oħra jista' jkollok li jilgħaqu jew jiġu f'kuntatt mal-parti ta' bejn il-ġwienaħ tal-kelb tiegħek fejn il-veterinarju tiegħek ikun applika Recuvyra għal mill-inqas 3 ijiem (72 siegħa) wara t-trattament, peress li dan jista' jikkawża reazzjonijiet avversi f'dawn l-annimali.
English: For animal treatment only - to be supplied only on veterinary prescription.
Maltese: Għat-trattament ta' annimali biss - jiġi mogħti biss bi preskrizzjoni veterinarja.
English: Elanco Santé Animale 24 Boulevard Vital Bouhot 92200 Neuilly sur Seine Paris Tel. : +33/(0)1 55 49 35 29 France
Maltese: Elanco Santé Animale 24 Boulevard Vital Bouhot 92200
English: PACKAGE LEAFLET Recuvyra 50 mg/ml transdermal solution for dogs
Maltese: Recuvyra 50 mg/ml soluzzjoni transdermali għall-klieb
English: As a class, opioids, including this veterinary medicinal product, may cause low body temperature, slow respiratory rate, low blood pressure or slow heart rate.
Maltese: Bħala klassi, l-opijodi, li jinkludu dan il-prodott mediċinali veterinarju, jistgħu joħolqu temperatura baxxa tal-ġisem, rata respiratorja baxxa, pressjoni tad-demm baxxa jew qalb li tħabbat aktar bil-mod.
English: Should subsequent surgery be intended in a dog previously treated with the veterinary medicinal product, a minimum of a 7 day dosing interval must be observed before administering another dose.
Maltese: Jekk ikun hemm bżonn ta' kirurġija sussegwenti f'kelb li jkun ġie kkurat qabel bil-prodott mediċinali veterinarju, għandu jkun hemm intervall minimu ta' 7 ijiem qabel ma tingħata doża oħra.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Octyl salicylate
Maltese: 6.1 Lista ta' ingredjenti
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab disponibbli fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini (EMA) http://www.ema.europa.eu/
English: • very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Maltese: • komuni ħafna (aktar minn 1 kull 10 annimali juru reazzjonijiet avversi matul trattament wieħed)
English: The use of the veterinary medicinal product is intended as a single application administered 2 to 4 hours prior to surgery to provide analgesia for at least 4 days.
Maltese: L-użu tal-prodott mediċinali veterinarju hu maħsub għall-applikazzjoni li tingħata darba biss minn sagħtejn sa 4 sigħat qabel l-intervent kirurġiku sabiex jipprovdi analġeżja għal tal-inqas 4 t'ijiem.
English: Dogs that are moderately sedated, and are not drinking water and eating voluntarily at an appropriate level for the condition that required surgery, should be evaluated for dehydration and administered supplemental fluid and nutrition support as necessary.
Maltese: Il-klieb li jkunu taħt sedazzjoni moderata u mhumiex qed jixorbu ilma u jieklu b'mod volontarju għandhom jiġu evalwati għal dejidrazzjoni u għandhom jingħataw fluwidu supplimentari u appoġġ nutrizzjonali kif meħtieġ.
English: Do not allow other animals contact with the application site for at least 72 hours after application.
Maltese: Tħallix annimali oħra jmissu l-post talapplikazzjoni għal mill-anqas 72 siegħa wara l-applikazzjoni.
English: Dogs weighing 20 kg or more will be kept at the veterinary clinic for at least 48 hours after treatment with Recuvyra.
Maltese: Klieb li jiżnu 20 kg jew aktar jinżammu fil-klinika veterinarja għal tal-inqas 48 siegħa wara t- trattament b'Recuvyra.
English: Restrain the dog for approximately 2 minutes and avoid contact with the application site for 5 minutes to allow complete drying of the solution.
Maltese: 3.Irristrinġi l-kelb għal madwar 2 minuti u evita li tmiss il-post tal-applikazzjoni għal 5 minuti sabiex tippermetti li s-soluzzjoni tinxef kollha.
English: Österreich (Ostrich) Eli Lilly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10
Maltese: Österreich (Austria) Eli Lilly Regional Operations GmbH Elanco Animal Health Kölblgasse 8-10
English: Each pack is supplied with one vial adaptor, 15 syringes and 15 applicator tips, as well as 15 package leaflets for animal owners, and 1 SPC (for the veterinarian).
Maltese: Kull pakkett jiġi fornut b'adapter tal-kunjett, 15-il siringa u 15-il ras t'applikatur, kif ukoll 15-il fuljett ta' tagħrif għal sidien tal-annimali u KPQ (għall-veterinarju).
English: Withdrawing the solution from the vial Attaching the applicator tip (see Figure 3):
Maltese: Applikazzjoni tal-prodott (ara Figura 4):
English: The product should only be applied by a veterinarian.
Maltese: Il-prodott għandu jiġi applikat minn veterinarju.
English: Dogs of more than 20 kg bodyweight should remain in the hospital for a minimum of 48 hours following application.
Maltese: Klieb li għandhom piż korporali akbar minn 20 kg għandhom jibqgħu fl-isptar għal minimu ta' 48 siegħa wara l- applikazzjoni.
English: The above side effects can occur up to 3 days (72 hours) after Recuvyra was given to your dog.
Maltese: L-effetti sekondarji ta' hawn fuq jistgħu jseħħu sa 3 ijiem (72 siegħa) wara Recuvyra jkun ingħata lill-kelb tiegħek.
English: Dogs.
Maltese: ul.
English: INDICATION(S) Recuvyra controls pain in dogs that have undergone major orthopaedic or soft tissue surgery.
Maltese: Recuvyra jikkontrolla l-uġigħ fi klieb li kellhom intervent kirurġiku ortopediku maġġur jew tat-tessuti rotob.
English: The effects of transdermal fentanyl could last longer than the effects of the opioid reversal agent.
Maltese: L-effetti ta' fentanyl transdermali jistgħu jdumu aktar mill-effetti tassustanza riversibbli tal-loppju.
English: For the control of post-operative pain associated with major orthopaedic and soft tissue surgery in dogs.
Maltese: Għall-kontroll tal-uġigħ wara intervent kirurġiku assoċjat ma' kirurġija ortopedika maġġura u tat-tessut artab fil-klieb.
English: Fentanyl plasma protein binding is estimated at approximately 60% in dogs.
Maltese: Ir-rabta ta' fentanyl mal-proteini fil-plażma huwa stmat li hu madwar 60% fil-klieb.
English: Cmax
Maltese: Klieb
English: Before using the product it is recommended to consider the availability of an opiate antagonist, e.g. naloxone, in case reversal is required (see sections 4.6 and 4.10).
Maltese: F'każ li jkun meħtieġ li ssir riverżjoni, huwa rakkomandat li tikkonsidra d-disponibilità ta' antagonista talloppju eż. naloxone, (ara sezzjonijiet 4.6 u 4.10) qabel tuża l-prodott.
English: In case of accidental spillage onto skin, immediately flush the area with water, then wash the area with copious amounts of soap and water and seek prompt medical advice, showing the physician this warning, the package leaflet or the label.
Maltese: F'każ ta' tixrid aċċidentali fuq il-ġilda, laħlaħ minnufih il-parti b'ħafna ilma, u mbagħad aħsel il-parti b'ammonti kbar ta' ilma u sapun u fittex parir mediku minnufih, billi turi t-tabib din it-twissija, il-fuljett tat-tagħrif jew it-tikketta.
English: The veterinary medicinal product is strictly limited for use in dogs.
Maltese: Il-prodott mediċinali veterinarju huwa strettament limitat għall-użu fuq klieb.
English: Personal protective equipment consisting of latex or nitrile gloves, eye protection and suitable protective clothing should be worn when handling this veterinary medicinal product.
Maltese: Tagħmir protettiv personali li jikkonsisti minn ingwanti tal-latex jew nitril, protezzjoni għall-għajnejn u ħwejjeġ xierqa ta' protezzjoni għandhom jintlibsu meta jkun ser jintuża dan il-prodott mediċinali veterinarju.
English: Once applied to the skin, the veterinary medicinal product rapidly dries resulting in percutaneous absorption of fentanyl.
Maltese: Ukoll, il-prodott mediċinali veterinarju jista' jikkawża irritazzjoni tal-ġilda.
English: If your dog weighs more than 20 kg, then it will remain in hospital for at least 48 hours following application of Recuvyra.
Maltese: Jekk il-kelb tiegħek ikun jiżen aktar minn 20 kg, dan ikollu jibqa' l-isptar għal mill-inqas 48 siegħa oħra wara l-applikazzjoni ta' Recuvyra.
English: Your dog will only be allowed to go home once it has recovered from its surgery, and is drinking and eating normally.
Maltese: Il-kelb tiegħek se jingħata permess imur id-dar wara li jkun irkupra mill-kirurġija tiegħu biss, u dejjem jekk ikun qed jixrob u jiekol normalment.
English: This product should only be administered by a veterinary surgeon.
Maltese: Sabiex jiġu mogħti biss bi preskrizzjoni veterinarja.
English: Appropriate eye lubrication should therefore be applied prior to and following surgery and continued until the dog resumes normal blinking function.
Maltese: Lgħajnejn għandhom jiġu llubrikati b'mod adegwat qabel u wara l-intervent kirurġiku u dan għandu jitkompla sakemm il-kelb jibda jpetpet għajnejh b'mod normali.
English: Laboratory studies conducted in rats have not shown any evidence of teratogenic effect, or any adverse effect on fertility or embryo-foetal development.
Maltese: Studji tal-laboratorju li saru fil-firien ma wrewx xi evidenza ta' effett teratoġeniku, jew xi effett avvers fuq il-fertilità jew żvilupp embrijo-fetali.
English: Severe overdose may result in renal failure secondary to hypotension produced by gastrointestinal hypomobility.
Maltese: Doża eċċessiva severa tista' twassal għall-falliment tal-kliewi li hi sekondarja għal pressjoni baxxa prodotta b'ipomobilità gastrointestinali.
English: Administration of naloxone at 0.04 mg/kg may be used to reverse adverse reactions associated with topical fentanyl.
Maltese: Sabiex treġġa' lura r-reazzjonijiet avversi assoċjati ma' fentanyl topiku tista' tamministra naloxone f'doża ta' 0.04 mg/kg.
English: 4.11 Withdrawal period
Maltese: 4.11 Perjodu ta' Żamma
English: España (Spain) Elanco Valquimica S.A. Avda.
Maltese: Wara applikazzjoni fuq il-ġilda, il-fentanyl jiġi assorbit malajr ġol-ġilda.
English: Mild reductions in body temperature and heart and respiratory rates for up to 3 days following use are common.
Maltese: Tnaqqis ħafif fit-temperatura tal-ġisem u fir-rata tal-qalb u tat-teħid tan-nifs għal sa 3 ijiem wara l-użu huwa komuni.
English: Shelf life after first broaching the vial: 30 days.
Maltese: La darba jinfetaħ, uża fi żmien 30 jum.
English: Should subsequent surgery be intended in a dog previously treated with Recuvyra, a minimum of a 7 day dosing interval must be observed before administering another dose.
Maltese: Jekk ikun hemm bżonn ta' kirurġija sussegwenti f'kelb li jkun ġie kkurat qabel b'Recuvyra, għandu jkun hemm intervall minimu ta' 7 ijiem qabel ma terġa' tingħata doża oħra.
English: Dosing device:
Maltese: Tqala u treddigħ: