FrancophonIA/ELRC3.0 huggingface dataset:
English: Ropinirole is mainly eliminated by hepatic metabolism.
Maltese: Ropinirole jiġi eliminat primarjament permezz ta' metaboliżmu epatiku.
English: Your dog must not be given this medicine if it: - has decreased consciousness, seizures or other similar neurologic symptoms or difficulties in breathing or swallowing that could make the dog inhale a part of the vomit potentially causing aspiration pneumonia - has ingested sharp foreign objects, acids or alkalis (e.g. drain or toilet bowl cleaners, household detergents, battery fluids), volatile substances (e.g. petroleum products, essential oils, air fresheners) or organic solvents (e.g. antifreeze, windshield wiper fluids, nail polish remover) - is hypersensitive to ropinirole or to any of the excipients.
Maltese: Il-kelb tiegħek ma jridx jingħata din il-mediċina jekk: - ma jkunx f'sensih biżżejjed, għandu aċċessjonijiet jew sintomi newroloġiċi simili oħra, jew diffikultajiet biex jieħu n-nifs jew jibla', li jistgħu jikkawżaw li l-kelb jiġbed 'il ġewwa man-nifs parti tar-rimettar, li potenzjalment jista' jikkawża pnewmonja ta' aspirazzjoni - ikun bela' oġġetti jaqtgħu u bil-ponta, aċidi jew alkali (eż. drain jew toilet bowl cleaners, deterġenti tad-djar, fluwidi tal-batterija), sustanzi volatili (eż. prodotti tal-petroleum, żjut essenzjali, fresheners tal-arja) jew solventi organiċi (eż. antifreeze, windshield wiper fluids, nail polish remover) - ikun sensittiv b'mod eċċessiv għal ropinirole jew xi sustanzi mhux attivi.
English: These doses have been tested in dogs weighing between 1.8 kg and 100 kg (0.15-2.21 m2 body surface area).
Maltese: Dawn id-dożi ġew ittestjati fil-klieb li jiżnu bejn 1.8 u 100 kg (0.15-2.21 m2 ta' erja ta' superfiċje tal-ġisem).
English: Sodium hydroxide (to adjust pH) Hydrochloric acid (to adjust pH) Water for injections
Maltese: Sodium hydroxide (biex jaġġusta l-pH) Hydrochloric acid (biex jaġġusta l-pH) Ilma għall-injezzjonijiet
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 30 mg/ml ropinirole
Maltese: ATTIVA(I) 30 mg/ml ropinirole
English: Increased mean heart rate was observed one hour after treatment with all three doses (1X, 3X, 5X) and went back to normal levels after 6 hours.
Maltese: Żieda fir-rata medja tal-qalb ġiet osservata siegħa wara ttrattament bit-tliet dożi (1X, 3X, 5X) u reġgħet lura għal-livelli normali wara 6 sigħat.
English: The systemic bioavailability of the drug by this ocular route of administration is 23%.
Maltese: Il-bijodisponibilità sistematika tal-mediċina minn din ir-rotta okulari tal-għoti hi ta' 23%.
English: The time to last vomit ranged from 30 to 82 minutes following ocular administration in a pharmacokinetic study in dogs.
Maltese: Il-ħin sal-aħħar rimettar varja minn 30 sa 82 minuta wara l-għoti okulari fi studju farmakokinetiku fil-klieb.
English: The tolerance of this veterinary medicinal product was investigated in a target animal safety study at all dose levels up to 5 times the clinical dose (that is, up to 124.6 µl/kg) when given on two occasions, 1520 minutes apart, every day for 3 days.
Maltese: It-tolleranza ta' dan il-prodott mediċinali veterinarju ġiet investigata fi studju dwar is-sigurtà talannimal fil-mira fil-livelli kollha tad-doża sa 5 darbiet id-doża klinika (jiġifieri sa 124.6 µl/kg) meta mogħti f'żewġ okkażjonijiet, f'intervall ta' 15-20 minuta, kuljum għal 3 ijiem.
English: ADMINISTRATION:
Maltese: TAMMINISTRA
English: Maropitant does not reverse the clinical signs related to the pharmacological action of ropinirole.
Maltese: Maropitant ma jreġġax lura is-sinjali kliniċi relatati mal-azzjoni farmakoloġika ta' ropinirole.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Clevor is a very slightly yellow to yellow clear solution containing 30 mg/ml ropinirole, equivalent to 34.2 mg/ml ropinirole hydrochloride.
Maltese: U INGREDJENT(I) OĦRA Clevor hu soluzzjoni ċara minn safra ċara ħafna sa safra li fiha ropinirole 30 mg/ml, ekwivalenti għal 34.2 mg/ml ta' ropinirole hydrochloride.
English: Within 30 minutes 95% of the dogs vomited.
Maltese: Fi żmien 30 minuta, 95% tal-klieb irremettew.
English: Please refer to sections 4.9 and 5.1 for further information.
Maltese: Jekk jogħġbok irreferi għal sezzjonijiet 4.9 u 5.1 għal aktar informazzjoni.
English: Dopamine antagonists (such as metoclopramide), neuroleptics (e.g., chlorpromazine, acepromazine) and other medicinal products with antiemetic properties (e.g., maropitant or antihistamines) may reduce the effectiveness of this veterinary medicinal product.
Maltese: Antagonisti ta' dopamine (bħal metoclopramide), newrolettiċi (eż., chlorpromazine, acepromazine) u prodotti mediċinali oħra bi propjetajiet antiemetiċi (eż., maropitant jew antihistamines) jistgħu jnaqqsu l-effettività ta' dan il-prodott mediċinali veterinarju.
English: Ropinirole is rapidly distributed and has a relatively high apparent volume of distribution.
Maltese: Ropinirole jiġi distribwit b'mod mgħaġġel għandu volum ta' distribuzzjoni apparenti relattivament għoli.
English: The dose is equivalent to 2-15 µl/kg bw in dogs.
Maltese: Id-doża hi ekwivalenti għal 2-15 µl/kg piż tal-ġisem fi klieb.
English: Uncommon adverse reactions: Corneal ulceration.
Maltese: Reazzjonijiet avversi mhux komuni: ulċerazzjoni tal-kornea.
English: Instructions for administration
Maltese: U METODU TA' AMMINISTRAZZJONI
English: The clinical signs (lethargy, tachycardia, tremors, ataxia, uncoordinated movement, hyperaemia of the eye, ocular discharge, protrusion of the 3rd eyelid and blepharospasm) were comparable in frequency and severity between the different dose groups.
Maltese: Is-sinjali kliniċi (letarġija, takikardija, rogħda, atassija, moviment mhux ikkoordinat, iperemija tal-għajnejn, tnixxija okulari, protrużjoni tat-3et tebqet il-għajn u blefarospażmu) kienu komparabbli fil-frekwenza u sseverità bejn il-gruppi ta' doża differenti.
English: STATEMENT OF ACTIVE SUBSTANCES 30 mg/ml ropinirole
Maltese: OĦRA 30 mg/ml ropinirole
English: (µg/kg)
Maltese: Ropinirole (µg/kg)
English: The fraction bound to plasma proteins in dogs is low (37%).
Maltese: Il-frazzjoni li teħel mal-proteini tal-plażma fil-klieb hi baxxa (37%).
English: Ropinirole (µg/body surface area)
Maltese: Ropinirole (µg/ erja tassuperfiċje talġisem)
English: EU/2/17/222/006 - 8 single-dose containers EU/2/17/222/007 - 10 single-dose containers EU/2/17/222/008 - 3 single-dose containers
Maltese: EU/2/17/222/006 - 8 kontenituri b'doża waħda
English: Transient, mild conjunctival swelling, itching of the eyes, tachypnoea, tremors, diarrhoea, ataxia and uncoordinated movement.
Maltese: Nefħa temporanja fil-konġuntiva, ħakk tal-għajnejn, takipnoea, rogħda, dijarea, atassija u moviment mhux ikkoordinat.
English: Each eye drop contains 810 µg of ropinirole.
Maltese: Kull qatra għall-għajnejn fiha 810 µg ta' ropinirole.
English: 5% of the dogs in the clinical study received anti-emetic treatment (metoclopramide) since their vomiting persisted for more than 60 minutes.
Maltese: Il-5% tal-klieb fl-istudju kliniku rċivew trattament anti-emetiku (metoclopramide) billi r-rimettar tagħhom ippersista għal aktar minn 60 minuta.
English: For example, for the administration of 6 drops: administer 2 drops into the right eye and 2 drops into the left eye, then after 1-2 minutes pause administer a further 1 drop into each eye.
Maltese: Pereżempju, għall-għoti ta' 6 qatriet: agħti 2 qatriet ġol-għajn tallemin u 2 qatriet ġol-għajn tax-xellug, imbagħad wara li tistenna 1-2 minuti, agħti 1 qatra oħra ġo kull għajn.
English: Three dogs (3%) did not vomit at all despite an additional dose.
Maltese: Tliet klieb (3%) ma rremettew xejn minkejja doża addizzjonali.
English: In dogs, the volume of distribution (Vz) is 5.6 l/kg after intravenous administration.
Maltese: Fil-klieb, il-volum tad-distribuzzjoni (Vz) hu ta' 5.6 l/kg wara l-għoti ġol-vini.
English: The volume of one drop is approximately 27 µl.
Maltese: Il-volum ta' kull qatra hu ta' madwar 27 µl.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Ocular use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu għall-għajnejn.
English: This veterinary medicinal product can cause eye irritation.
Maltese: Dan il-prodott veterinarju mediċinali jista' jikkawża irritazzjoni fl-għajnejn.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor ropinirole
Maltese: Clevor ropinirole
English: The safety of the product has not been studied in dogs with diagnosed cardiac disease/dysfunction.
Maltese: Is-sigurtà tal-prodott ma ġietx studjata fi klieb b'mard/disfunzjoni kardijaka ddijanjostikati.
English: Ropinirole is a full dopamine agonist with high selectivity for the dopamine D2-like receptor family (D2, D3 and D4 receptors).
Maltese: Ropinirole hu agonist sħiħ ta' dopamine b'selettività għolja għall-familja tar-riċetturi li jixbhu lil dopamine D2 (riċetturi D2, D3 u D4).
English: Other medicines that have antiemetic properties, such as metoclopramide, chlorpromazine, acepromazine, maropitant or antihistamines may diminish the effectiveness of ropinirole.
Maltese: Mediċini oħra li għandhom propjetajiet anti-emetiċi, bħal metoclopramide, chlorpromazine, acepromazine, maropitant jew antihistamines, jistgħu jnaqqsu l-effettività ta' ropinirole.
English: Do not use in cases of the ingestion of sharp foreign objects, corrosive agents (acids or alkalis), volatile substances or organic solvents.
Maltese: Tużax f'każijiet ta' inġestjoni ta' oġġetti li jaqtgħu, sustanzi korrużivi (aċidi jew alkalis), sustanzi volatili jew solventi organiċi.
English: In dogs with protracted vomiting (more than 60 minutes) and other clinical signs related to the pharmacological action of the active substance (e.g. ocular hyperaemia, tachycardia, tremors or shaking), dopamine antagonists such as metoclopramide or domperidone may be used to manage these clinical signs.
Maltese: Fi klieb b'rimettar fit-tul (aktar minn 60 minuta) u sinjali kliniċi oħra relatati mal-azzjoni farmakoloġika tas-sustanza attiva (eż. iperemija okulari, takikardija, rogħda jew tertir), antagonisti ta' dopamine, bħal metoclopramide jew domperidone, jista' jintuża biex jimmaniġġja dawn is-sinjali kliniċi.
English: Clevor 30 mg/ml eye drops, solution is supplied in single-dose containers containing 0.6 ml.
Maltese: Clevor 30 mg/ml, qtar għall-għajnejn, soluzzjoni, hu fornut f'kontenitur b'doża waħda ta' 0.6 mL.
English: Squeeze the prescribed number of drops into the eye(s).
Maltese: Agħfas in-numru preskritt ta' qtar ġol-għajn(ejn).
English: In a clinical field trial including 100 clinically healthy dogs treated with Clevor, the time from administration to first vomit was 3-37 minutes with a mean time of 12 minutes and median time of 10 minutes.
Maltese: Fi prova klinika fuq il-post li kienet tinkludi 100 kelb klinikament b'saħħithom ikkurati bi Clevor, il-ħin mill-għoti sal-ewwel rimettar kien ta' 3-37 minuta, b'ħin medju ta' 12-il minuta u ħin medjan ta' 10 minuti.
English: Use only according to the benefit-risk assessment by the responsible veterinarian.
Maltese: Uża biss skont il-valutazzjoni tal-benefiċċju u r-riskju mill-veterinarju responsabbli.
English: People with known hypersensitivity to ropinirole should avoid contact with the veterinary medicinal product.
Maltese: Nies li huma sensittivi għal ropinirole għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: - 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 treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu 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: Pharmacotherapeutic group: Dopaminergic agents, dopamine agonists ATC vet code: QN04BC04
Maltese: Aġenti dopaminerġiċi, agonisti ta' dopamine Kodici ATC veterinarja:
English: Extended vomiting (for more than 60 minutes) which should be evaluated by the responsible veterinarian as it might need appropriate treatment.
Maltese: Rimettar fit-tul (għal aktar minn 60 minuta) li għandu jiġi evalwat mill-veterinarju għax jista' jkun jeħtieġ trattament xieraq.
English: Discard any opened individual pouch or container with any remaining liquid after 30 minutes.
Maltese: Armi kwalunkwe borża individwali miftuħa jew kontenitur bi kwalunkwe likwidu li jkun fadal, wara 30 minuta.
English: Dogs
Maltese: Klieb
English: Pharmacodynamic properties
Maltese: Kwalitajiet farmakodinamiċi
English: The time between the first to the last vomit was 0-108 minutes (0 if the dog vomited only once) with a mean duration of 23 minutes and a median duration of 16 minutes.
Maltese: Il-ħin bejn l-ewwel u l-aħħar rimettar kien ta' 0-108 minuti (0 jekk il-kelb ikun irremetta darba biss), b'tul medju ta' 23 minuta u tul medjan ta' 16-il minuta.
English: The pouches are further packed in outer cardboard cartons which contain 1, 2, 3, 4, 5, 6, 8 or 10 single-dose containers, together with the corresponding number of package leaflets.
Maltese: Il-boroż imbagħad ikunu ppakkjati b'mod addizzjonali f'kaxxi tal-kartun ta' barra li jkun fihom 1, 2, 3, 4, 5, 6, 8 jew 10 kontenituri ta' doża waħda, flimkien man-numru korrispondenti ta' fuljetti ta' tagħrif.
English: EU/2/17/222/001 - 1 single-dose container EU/2/17/222/002 - 2 single-dose containers EU/2/17/222/003 - 4 single-dose containers EU/2/17/222/004 - 5 single-dose containers EU/2/17/222/005 - 6 single-dose containers
Maltese: EU/2/17/222/004 - 5 kontenituri b'doża waħda
English: Ropinirole inhibits prolactin secretion by activation of dopamine D2 receptors located in the striatum and on lactotroph cells of pituitary gland.
Maltese: Ropinirole jinibixxi t-tnixxija ta' prolactin bl-attivazzjoni tar-riċetturi ta' dopamine D2 li jinsabu fl-istriatum fuq iċ-ċelluli lactotroph tal-glandola pitwitarja.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops ropinirole
Maltese: VETERINARJU Clevor 30 mg/ml qtar għall-għajnejn, soluzzjoni għal klieb ropinirole
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution in single-dose container for dogs Ropinirole (ropinirol)
Maltese: VETERINARJU Clevor 30 mg/ml qtar għall-għajnejn, soluzzjoni, f'kontenitur b'doża waħda għal klieb Ropinirole
English: EXPIRY DATE EXP {month/year} Once opened use within 30 minutes.
Maltese: Ladarba jinfetaħ uża fi żmien 30 minuta.
English: Each plastic container is packed in an individual aluminium foil laminate pouch.
Maltese: Kull kontenitur tal-plastik hu ppakkjat f'borża individwali laminata tal-fojl tal-aluminju.
English: Administer the veterinary medicinal product with caution.
Maltese: Agħti l-prodott mediċinali veterinarju b'attenzjoni.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD ILPROVVISTA
English: Common reactions: temporary, mild swelling of the mucous membranes of the eyelids, itching of the eyes, rapid breathing, shivering, diarrhoea and/or irregular or uncoordinated bodily movements.
Maltese: Reazzjonijiet komuni: nefħa ħafifa temporanja tal-membrani mukużi tat-tebqet il-għajn, ħakk talgħajnejn, nifs mgħaġġel, tertir, dijarea u/jew movimenti irregolari jew mhux ikkoordinati tal-ġisem.
English: Ropinirole might reduce the level of prolactin, a hormone that stimulates milk production in pregnant or breast-feeding women.
Maltese: Ropinirole jista' jnaqqas il-livell ta' prolactin, ormon li jistimula lproduzzjoni tal-ħalib f'nisa tqal jew li jkunu qed ireddgħu.
English: The veterinary medicinal product should only be administered by a veterinarian or under their close supervision.
Maltese: Il-prodott mediċinali veterinarju m'għandux jiġi amministrat minn nisa tqal jew li jkunu jreddgħu.
English: Very common reactions: temporary mild or moderate redness of the eye, increased tear production, increased visibility of the third eyelid and/or squinting; temporary mild tiredness and/or increased heart rate.
Maltese: Reazzjonijiet komuni ħafna: ħmura temporanja ħafifa jew moderata tal-għajn, żieda fil-produzzjoni tad-dmugħ, żieda fil-viżibilità tat-tielet tebqet il-għajn u/jew jitwerreċ; għeja ħafifa temporanja u/jew żieda fir-rata tal-qalb.
English: Ropinirole might reduce the level of prolactin, a hormone that stimulates milk production in pregnant or suckling females.
Maltese: Ropinirole jista' jnaqqas il-livell ta' prolactin, ormon li jistimula l-produzzjoni tal-ħalib f'nisa tqal jew li jkunu qed ireddgħu.
English: Excretion in the urine occurs mainly as metabolites.
Maltese: It-tneħħija fl-awrina sseħħ primarjament bħala metaboliti.
English: The number of eye drops in each body weight group corresponds to the target dose of 3.75 mg/m2 body surface area (dose range 2.7- 5.4 mg/m2) .
Maltese: In-numru ta' qtar għall-għajnejn f'kull grupp ta' piż tal-ġisem jikkorrispondi għad-doża fil-mira ta' 3.75 mg/m2 ta' erja ta' superfiċje tal-ġisem (medda tad-doża 2.7-5.4 mg/m2) qrib kemm jista' jkun.
English: Each container is sealed in an individual aluminium foil laminate pouch.
Maltese: Kull kontenitur hu ssiġillat f'borża individwali laminata tal-fojl tal-aluminju.
English: It induces emesis by activating the D2-like receptors in the chemoreceptor trigger zone, located in the area postrema, which transmits the information to the emesis centre to trigger vomiting.
Maltese: Jinduċi l-emesi billi jattiva r-riċetturi li jixbhu lil D2 fiż-żona talchemoreceptor trigger, li tinsab fiż-żona postrema, tittrasmetti l-informazzjoni liċ-ċentru tal-emesi biex tinduċi r-rimettar.
English: Transient mild lethargy and increased heart rate.
Maltese: Induzzjoni tar-rimettar fil-klieb.
English: Do not use in dogs with depression of the central nervous system, seizures or other marked neurologic impairments that could lead to aspiration pneumonia.
Maltese: Tużax fi klieb b'depressjoni tas-sistema nervuża ċentrali, aċċessjonijiet, jew b'indebolimenti newroloġiċi notevoli oħrajn li jistgħu jwasslu għal pnewmonja ta' aspirazzjoni.
English: Number of eye drops
Maltese: EFFETTI MHUX MIXTIEQA
English: Dog bodyweight (kg)
Maltese: Piż talġisem talkelb (kg)
English: Very common adverse reactions: Transient mild or moderate hyperaemia of the eye, ocular discharge, protrusion of the 3rd eyelid and blepharospasm.
Maltese: Iperemija temporanja ħafifa jew moderata tal-għajn, tnixxija okulari, protrużjoni tat-3et tebqet il-għajn u blefarospażmu.
English: Ropinirole might reduce the level of prolactin due to its inhibitory effect on prolactin secretion as a dopamine agonist.
Maltese: Ropinirole jista' jnaqqas il-livell ta' prolactin minħabba l-effett inibitorju tiegħu fuq it-tnixxija ta' prolactin bħala agonist ta' dopamine.
English: The effects of ropinirole can be reversed using a specific antidote such as metoclopramide or domperidone.
Maltese: L-effetti ta' ropinirole jistgħu jitreġġgħu lura bl-użu ta' antidot speċifiku bħal metoclopramide jew domperidone.
English: When a quantity of 2 to 4 drops is to be administered, the dose should be divided between both eyes.
Maltese: Meta kwantità ta' 2 sa 4 qtar tkun trid tingħata, id-doża għandha tinqasam bejn iż-żewġ għajnejn.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution in single-dose container for dogs
Maltese: VETERINARJU Clevor 30 mg/ml qtar għall-għajnejn, soluzzjoni, f'kontenitur b'doża waħda għal klieb
English: Human albumin.
Maltese: Albumina umana
English: Lot {XXXXX-XXXXX-XXX}
Maltese: Lott {XXXXX-XXXXX-XXX}
English: EXP {XX-XXX-XXXX at XX:XX CET}
Maltese: JIS {XX-XXX-XXXX f'XX:XX CET}
English: Parque Tecnológico de Madrid 28760 Tres Cantos, Madrid Spain
Maltese: Parque Tecnológico de Madrid 28760 Tres Cantos, Madrid Spanja
English: 72 hours.
Maltese: 30 sekonda.
English: 6 mL 30 million cells
Maltese: 6 mL 30 miljun ċellola
English: P value
Maltese: Valur p
English: Date of first authorisation: 23 March 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' Marzu 2018
English: Alofisel group (Alofisel+standard of care*) N= 103
Maltese: Il-grupp ta' Alofisel (Alofisel+standard ta' kura*) N = 103
English: C/ Marconi, 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, Spain
Maltese: TIGENIX, S.A.U. C/ Marconi, 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, Spanja
English: Control group (Placebo+standard of care*) N= 102
Maltese: Il-grupp ta' kontroll (Plaċebo+standard ta' kura*) N = 102
English: • inject Alofisel.
Maltese: • jinjetta Alofisel.
English: Also contains: Dulbecco's Modified Eagle´s Medium (DMEM) and Human albumin.
Maltese: Fih ukoll: Dulbecco's Modified Eagle´s Medium (DMEM) u Albumina umana.
English: Dulbecco's Modified Eagle´s Medium (DMEM) (containing amino acids, vitamins, salts and carbohydrates).
Maltese: Dulbecco's Modified Eagle´s Medium (DMEM) (li fih amino acids, vitamini, imluħa u karboidrati).
English: Store between 15ºC and 25ºC.
Maltese: Aħżen f'temperatura bejn 15ºC u 25ºC
English: Darvadstrocel is an expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (expanded adipose stem cells - eASC).
Maltese: Darvadstrocel hu ċelluli staminali adulti alloġeneiċi mesenkimali umani estratti mit-tessut adipożu (ċelloli staminali adipużi mkabbra - eASC, expanded adipose stem cells).
English: Suspension for injection 1 dose consists of 4 vials of 6 mL (in total 24 mL)
Maltese: Suspensjoni għall-injezzjoni Doża waħda tikkonsisti f'4 kunjetti ta' 6 mL (total ta' 24 mL)
English: • anal fistula
Maltese: • fistula anali
English: The most common treatment-emergent adverse events were anal abscess (Alofisel: 19.4% patients; control group: 13.7% patients), proctalgia (Alofisel: 14.6% patients; control group: 11.8% patients) and anal fistula (Alofisel: 10.7% patients; control group: 7.8% patients).
Maltese: L-aktar effetti komuni mhux mixtieqa li joħorġu mill-kura kienu l-axxess anali (Alofisel: 19.4% tal-pazjenti; il-grupp ta' kontroll: 13.7% tal-pazjenti), proctalgia (Alofisel: 14.6% tal-pazjenti; il-grupp ta' kontroll: 11.8% tal-pazjenti) u fistula anali (Alofisel: 10.7% tal-pazjenti; il-grupp ta' kontroll: 7.8% tal-pazjenti).
English: The recommended dose is 120 million cells.
Maltese: Id-doża rakkomandata hija ta' 120 miljun ċellola.
English: Alofisel 5 million cells/mL suspension for injection Darvadstrocel
Maltese: ALOFISEL 5 miljun ċellola/mL suspensjoni għall-injezzjoni Darvadstrocel
English: The active ingredient of Alofisel is darvadstrocel which consists of human stem cells obtained from the fat tissue of a healthy adult donor that are subsequently grown (expanded) in the laboratory and provided at a concentration of 5 million cells per millilitre in vials which each contain 6 millilitres, i.e. 30 million cells per vial.
Maltese: Is-sustanza attiva ta' Alofisel hi darvadstrocel li jikkonsisti f'ċelloli staminali umani miksuba mit-tessut tax-xaħam ta' donatur adult b'saħħtu li sussegwentement jitkabbru fil-laboratorju u fornuti f'konċentrazzjoni ta' 5 miljun ċellola għal kull millilitru f'kunjetti li kull wieħed fih 6 millilitri, jiġifieri 30 miljun ċellola kull kunjett.
English: Adverse reactions System Organ Class
Maltese: Sistema tal-Klassifika tal-Organi
English: At Week 12, 23/63 (36%) showed anti-donor antibody production.
Maltese: F'ġimgħa 12, 23/63 (36%)urew produzzjoni ta' antikorp kontra d-donatur fil-Ġimgħa 12.
English: 2.1 General description
Maltese: 2.1 Deskrizzjoni ġenerali
English: For further information on the use of Alofisel see section 4.2.
Maltese: Għal aktar informazzjoni dwar l-użu ta' Alofisel ara sezzjoni 4.2.
English: Anal fistula
Maltese: Fistula anali
English: In the ADMIRE-CD study, 63/103 of the eASC-treated patient population were analysed for the presence of donor-specific antibodies (DSA) at baseline and Week 12.
Maltese: Fl-istudju ADMIRE-CD, 63/103 tal-popolazzjoni ta' pazjenti ttrattati b'e-ASC kienu analizzati għall-preżenza ta' antikorpi speċifiċi għad-donatur (DSA, donor-specific antibodies) fil-linja bażi u Ġimgħa 12.
English: Alofisel 5 million cells/mL suspension for injection
Maltese: Alofisel 5 miljun ċellola/mL suspensjoni għall-injezzjoni