FrancophonIA/ELRC3.0 huggingface dataset:
English: Bravecto Plus was as effective as another medicine containing emodepside and praziquantel.
Maltese: Bravecto Plus kien effettiv daqs mediċna oħra li fiha emodepside u praziquantel.
English: • to treat roundworms and hookworms in the gut
Maltese: • biex tikkura r-roundworms u l-hookworms fl-imsaren
English: Two laboratory studies involving healthy cats which were artificially infected with heartworm larvae showed Bravecto Plus to be 100% effective in preventing heartworm disease during 8 weeks.
Maltese: Żewġ studji tal-laboratorju li jinvolvu qtates b'saħħithom li ġew infettati b'mod artifiċjali bil-larva talheartworm urew li Bravecto Plus huwa 100 % effettiv fil-prevenzjoni tal-marda tal-heartworm matul 8 ġimgħat.
English: • to treat ear mite infestations
Maltese: • biex tikkura infestazzjonijiet ta' qurdien
English: The active substances in Bravecto Plus, fluralaner and moxidectin, work via different routes to kill parasites.
Maltese: Is-sustanzi attivi fi Bravecto Plus, il-fluralaner u l-mossidektina, jaħdmu permezz ta' rotot differenti biex joqtlu l-parassiti.
English: Moxidectin kills parasites present in the body of animals such as roundworms, hookworms and heartworm as well as ear mites.
Maltese: Il-mossidektina toqtol il-parassiti preżenti fil-ġisem tal-annimali bħar-roundworms, il-hookworms u lheartworm kif ukoll id-dud tal-widnejn.
English: Bravecto Plus was as effective as selamectin, another medicine already licensed for the treatment of ear mites in cats.
Maltese: Bravecto Plus kien effettiv daqs selamectin, mediċina oħra diġà liċenzjata għall-kura tad-dud tal-widnejn fil-qtates.
English: • to treat tick infestations
Maltese: • biex tikkura infestazzjonijiet tad-dud tal-widnejn
English: The most common side effects with Bravecto Plus (which may affect up to 1 in 10 animals) are mild and short-lived reactions at the application site such as hair loss, flaking skin and scratching.
Maltese: L-effetti sekondarji l-aktar komuni bi Bravecto Plus (li jistgħu jaffettwaw aktar minn annimal 1 minn kull 10) huma reazzjonijiet ħfief u li ma jdumux fis-sit tal-applikazzjoni bħal telf ta' xagħar, tqaxxir talġilda u ħakk.
English: The veterinarian will decide if additional treatment is needed.
Maltese: Ilveterinarju jiddeċiedi jekk ikunx hemm bżonn kura addizzjonali.
English: Bravecto Plus is a veterinary medicine used in cats to treat mixed infestations with both ticks or fleas and ear mites and/or worms that live inside the body.
Maltese: Bravecto Plus huwa mediċina veterinarja li tintuża fil-qtates biex tikkura infestazzjonijiet imħallta kemm bil-qurdien jew briegħed u dud tal-widnejn u/jew dud li jgħix fil-ġisem.
English: Fluralaner and moxidectin are already authorised on their own for the treatment of parasitic infestations.
Maltese: Il-fluralaner u l-mossidektina diġà huma awtorizzati waħidhom għall-kura ta' infestazzjonijiet parassitiċi.
English: For the full list of side effects and restrictions of Bravecto Plus, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha ta' Bravecto Plus, ara l-fuljett ta' tagħrif.
English: Contact with the application site should be avoided until it is no longer noticeable.
Maltese: Il-kuntatt mas-sit tal-applikazzjoni għandu jiġi evitat sakemm ma jkunx għadu jista' jiġi nnutat.
English: A field study involving cats naturally infested with ticks and/or fleas showed treatment with Bravecto Plus to reduce tick and flea counts by more than 95% and to be as effective as treatment using fipronil, another medicine already licensed for the treatment of ticks and fleas.
Maltese: Studju fuq il-post li jinvolvi l-qtates infestati b'mod naturali bil-qurdien u/jew bil-briegħed wera li l-kura bi Bravecto Plus tnaqqas l-ammonti ta' qurdien u briegħed b'aktar minn 95 % u li bħala kura huwa effettiv daqs l-użu tal-fipronil, mediċina oħra liċenzjata diġà għall-kura tal-qurdien u l-briegħed.
English: Bravecto Plus is effective at preventing heartworm disease for 8 weeks.
Maltese: Bravecto Plus huwa effettiv fil-prevenzjoni tal-marda tal-heartworm għal 8 ġimgħat.
English: • to treat flea infestations.
Maltese: • biex tikkura infestazzjonijiet ta' briegħed.
English: Bravecto Plus kills fleas and ticks within 48 hours.
Maltese: Bravecto Plus joqtol ilbriegħed u l-qurdien fi żmien 48 siegħa.
English: Another field study involving cats naturally infected with roundworms and/or hookworms showed treatment with Bravecto Plus to reduce faecal egg counts by 100%.
Maltese: Studju fuq il-post ieħor li jinvolvi l-qtates infestati b'mod naturali bir-roundworms u/jew il-hookworms wera li l-kura bi Bravecto Plus tnaqqas l-ammont ta' bajd tal-ħmieġ tal-imsaren b'100 %.
English: The content of one full Bravecto Plus pipette is applied to the cat's skin at the base of the skull.
Maltese: Bravecto Plus jiġi bħala soluzzjoni f'pipetta li tiġi applikata direttament fuq il-ġilda.
English: The medicine should be kept in the original package until use, in order to prevent children directly accessing the medicine.
Maltese: Il-mediċina għandha tinżamm fil-pakkett oriġinali sakemm tiġi biex tintuża, sabiex jiġi evitat li t-tfal jaċċessaw il-mediċina b'mod dirett.
English: It can also be used as part of a treatment for flea allergy dermatitis (an allergic reaction to flea bites)
Maltese: Din tista' tintuża wkoll bħala parti minn kura għal dermatite allerġika għall-briegħed (reazzjoni allerġika għall-gdim tal-briegħed)
English: Moxidectin causes paralysis and death of these parasites by interfering with the way signals are passed between nerve cells (neurotransmission) in the parasites' nervous system.
Maltese: Il-mossidektina tikkawża l-paraliżi u l-mewt ta' dawn ilparassiti billi tinterferixxi mal-mod kif is-sinjali jgħaddu bejn iċ-ċelloli tan-nervituri (newrotrażmissjoni) fis-sistema nervuża tal-parassiti.
English: The spot-on solution is available in different strengths for cats of different weights.
Maltese: Is-soluzzjoni li tiġi applikata direttament fuq il-ġilda hija disponibbli f'qawwiet differenti għall-qtates ta' piżijiet differenti.
English: In case of spillage on table or floor surfaces, excess Bravecto Plus spot-on solution should be removed using paper tissue and the area cleaned with a detergent.
Maltese: Jekk ikun hemm reazzjonijiet tal-ġilda, għandu jitfittex parir mediku immedjatament u jintwera l-fuljett ta' tagħrif jew it-tikketta lit-tabib.
English: Tijdsch.for Diergeneeskunde deel 131 Maart aflevering 6 2006.
Maltese: Tijdsch.for Diergeneeskunde deel 131 Maart atlevring 6 2006.
English: Europa, 20 B. Parque Empresarial La Moraleja, 28108 Alcobendas (Madrid), SPAIN
Maltese: 20 B. Parque Empresarial La Moraleja, 28108 Alcobendas (Madrid), SPANJA
English: Conclusions
Maltese: 3. Konklużjonijiet
English: Orion Corporation animal health
Maltese: Orion Corporation animal helth
English: NL Xylazine 20 Inj.
Maltese: NL Xylazine 20
English: PT Romidys 1 mg/ml Solução Injectável para cães e gatos Romifidine
Maltese: PT Romidys 1 mg/ml Solução Injectável para cães e gatos
English: Organização Técnica Agro Pecuária, S.A R. Alto B Vista Pavilhão 40 AgualvaCacém, 2735-340 Agualva, Cacém, Lisbon, PORTUGAL
Maltese: Organização Técnica Agro Pecuária, S.A R. Alto B Vista Pavilhão 40, Agualva-Cacém 2735-340 Agualva, Cacém, Lisbon, PORTUGAL
English: The maximal exposure was estimated to 0.3 ml Sedivet (3 mg romifidine).
Maltese: L-esponiment massimu kien stmat għal 0.3 ml Sedivet (3 mg romifidine).
English: 161895/3 of 06.12.2002 (expired)
Maltese: 161895/3 of 06.12.2002 (skaduta)
English: Bayer, Viale Certosa 130, 20156 Milano, ITALY
Maltese: Bayer, Viale Certosa 130, 20156
English: PFIZER GLOBAL MANUFACTURING, Rue Laid Burniat 1, 1348 Louvain La Nueve, BELGIUM (Variation IA,1 - pending Pfizer Animal Health MA EEIG Ramsgate Road, Sandwich, Kent CT13 9NJ UNITED KINGDOM)
Maltese: PFIZER GLOBAL MANUFACTURING, Rue Laid Burniat 1, 1348 Louvain La Nueve, BELGIUM (Variation IA,1pending Pfizer Animal Health MA EEIG Ramsgate Road, Sandwich, Kent CT13 9NJ RENJU UNIT)
English: Boehringer Ingelheim, Località Prulli 103/c, 50066 Regello, FINLAND
Maltese: Boehringer Ingelheim, Località Prulli 103/c, 50066
English: Farma BV, Willeskop 206a, 4321 GW Oudewater, THE NETHERLANDS
Maltese: S.T. Farma BV, Willeskop 206a, 4321 GW Oudewater, THE NETHERLANDS
English: NL Sedazine 20 Inj.
Maltese: NL Sedazine 20
English: Globalmed Ltd, Ground Floor, 134 Church Hill, Loughton, Essex IG10 1LH, UNITED KINGDOM
Maltese: Globalmed Ltd, Ground Floor, 134 Church Hill, Loughton Essex IG10 1LH, RENJU UNIT
English: Chanelle Animal Health Ltd, 7 Rodney Street, Liverpool L1 9HZ, UNITED KINGDOM
Maltese: Chanelle Animal Health Ltd, 7 Rodney Street, Liverpool L1 9HZ, RENJU UNIT
English: Animal Health Division, Bayer House, Strawberry Hill Newbury, Berkshire RG14 1JA, UNITED KINGDOM
Maltese: Animal Health Division Bayer House Strawberry Hill Newbury Berkshire RG14 1JA, RENJU UNIT
English: • Irritation, sensitisation, contact dermatitis and systemic effects cannot be excluded after skin contact.
Maltese: • Irritazzjoni, sensitizzazzjoni, dermatite ta' kuntatt u effetti sistemiċi ma jistgħux ikunu esklużi wara kuntatt mal-ġilda.
English: SCIENTIFIC CONCLUSIONS 1.
Maltese: KONKLUŻJONIJIET XJENTIFIĊI 1.
English: 44613/22-11-00 BOEHRINGER INGELHEIM VETMEDICA GMBH., GERMANY
Maltese: 44613/22-11-00 BOEHRINGER INGELHEIM
English: Boehringer Ingelheim España S.A., Prat de la Riva s/n., 08190 Sant Cugat del Valles.
Maltese: Boehringer Ingelheim España S.A., Prat de la Riva s/n, 08190 Sant Cugat del Valles, Barcelona, SPANJA
English: Orion Corporation, Orionintie 1, FUB-0220 Espoo, FINLAND
Maltese: Orion Corporation, Orionintie 1, 0220 Espoo, FINLAND
English: Country
Maltese: FRANCE
English: Pfizer Co. Ltd., 1123 Budapest, Alkotás u. 53, HUNGARY
Maltese: Ltd., 1123 Budapest Alkotás u. 53, HUNGARY
English: Pfizer S.A.
Maltese: Pfizer S.A. Avda.
English: 96/025/00-C ALFASAN INTERNATIONAL B.V., P.O.
Maltese: 96/025/00-C ALFASAN
English: Barcelona, SPAIN
Maltese: Milano, ITALJA
English: EudraVigilance Veterinary Case Ref No NLBBD 1368).
Maltese: Nru. ta' Ref. tal-Każ Veterinarju fl-EudraViġilanza NLBBD 1368).
English: Equi Products Holland BV, Hermelijnkoog 44, 1822 CB Alkmaar, THE NETHERLANDS
Maltese: BV, Hermelijnkoog 44, 1822 CB Alkmaar, THE NETHERLANDS
English: Boehringer Ingelheim Ltd, Ellesfield, Avenue Bracknell, Berkshire RG12 8YS, UNITED KINGDOM
Maltese: Boehringer Ingelheim Ltd, Ellesfield, Avenue Bracknell, Berkshire RG12 8YS, RENJU UNIT
English: The pharmacovigilance data evaluated included the published suspected adverse reaction (SAR) in a human being, reporting cardiovascular and central nervous system effects (Hoyer, M.J., 2006).
Maltese: Id-data ta' farmakoviġilanza ivvalutata inkludiet ir-reazzjoni mhux mixtieqa ssuspettata (SAR) fi bniedem li ġiet ippubblikata, li rrapportat effetti kardjovaskulari u tas-sistema nervuża ċentrali (Hoyer, M.J., 2006).
English: A.S.T.
Maltese: A.
English: Respiratory and haemodynamic symptoms should be treated symptomatically.
Maltese: Sintomi respiratorji u emodinamiċi għandhom jiġu kkurati sintomatikament.
English: Quvera Ltd, Unit 8, Brember Road, Harrow, Middlesex HA2 8AX, UNITED KINGDOM
Maltese: Quvera Ltd Unit 8, Brember Road Harrow, Middlesex HA2 8AX, RENJU UNIT
English: Alfasan Nederland BV, Postbus 78, 3440 AB Woerden, THE NETHERLANDS
Maltese: Alfasan Nederland BV, Postbus 78, 3440 AB Woerden, NETHERLANDS
English: It was concluded that systemic effects after dermal exposure could not be excluded.
Maltese: Kien konkluż li effetti sistemiċi wara esponiment dermali ma jistgħux jiġu esklużi.
English: Both these dose levels are above the NOEL for acute pharmacologic effects.
Maltese: Il-livelli ta' dawn iż-żewġ dożi huwa ogħla minn NOEL għall-effetti farmakoloġiċi akuti.
English: Orion oyj, P.O.
Maltese: INTERNATIONAL B.V., P.O.
English: Precautionary measures:
Maltese: Miżuri prekawzjonari:
English: The NOEL was 0.5 mg/kg bw/day based on maternal toxicity.
Maltese: In-NOEL kien 0.5 mg/kg piż tal-ġisem/kuljum ibbażat fuq tossiċità materna.
English: 4, 40472 Düsseldorf, GERMANY
Maltese: CEVA TIERGESUNDHEIT GmbH, Kanzlerstr. 4, 40472 Düsseldorf, GERMANY
English: In the Summary of Product Characteristics (SPC) for a medicinal product for use in humans, Catapresan, containing the alpha2-adrenoreceptor agonist clonidine (injectable and tablets), the dermal adverse reactions after an unknown route of exposure are listed as skin-rash, urticaria, pruritus, and hairloss with an incidence rate of 1/100 - 1/10000 in patients.
Maltese: Fis-Sommarju tal-Karatteristiċi tal-Prodott (SPC) għall-prodott mediċinali għall-użu tal-bniedem, Catapresan, li fih l-alpha2-adrenoreceptor agonist clonidine (injettabbli u pilloli), ir-reazzjonijiet mhux mixtieqa dermali wara mod ta' esponiment mhux magħruf huma elenkati bħala raxx fil-ġilda, urtikarja, prurite, u telf ta' xagħar b'rata ta' inċidenza ta' 1/100 - 1/10000 fil-pazjenti.
English: Chanelle Pharmaceuticals Manufacturing Ltd., Dublin Road, Loughrea Co. Galway, IRELAND
Maltese: Chanelle Pharmaceuticals Manufacturing Ltd., Dublin Road, Loughrea Co.
English: Box 65, 02201 Espoo, FINLAND
Maltese: Orion oyj, P.O. Box 65, 02201 Espoo, FINLAND
English: Xylazine induced sedation, muscle relaxation and analgesia after a single intravenous dose of 0.27 or 0.68 mg/kg bw or after a single oral dose of 0.54 mg/kg bw.
Maltese: Xylazine wassal għal sedazzjoni, rilassament tal-muskoli u analġeżija wara doża waħda intravenuża ta' 0.27 or 0.68 mg/kg piż tal-ġisem jew wara doża orali waħda ta' 0.54 mg/kg piż tal-ġisem.
English: The competent regulatory authority for medicinal products for veterinary use of the Netherlands College Ter Beoordeling van Geneesmiddelen (Medicines Evaluation Board) Bureau Diergeneesmiddelen, notified the EMEA on 21 August 2006 in accordance with Article 78(1) of Directive 2001/82/EC, as amended by Directive 2004/28/EC, of its intention to vary 21 marketing authorisations These authorisations are for veterinary medicinal products containing an alpha2-adrenoreceptor agonist (romifidine, xylazine, detomidine or medetomidine) as the active substance and approved for use via a parenteral (injectable) route.
Maltese: Fil-21 ta' Awissu 2006, l-awtorità regolatorja kompetenti għall-prodotti mediċinali għal użu veterinarju talCollege Ter Beoordeling van Geneesmiddelen (Bord tal-Valutazzjoni tal-Mediċini) Bureau Diergeneesmiddelen ta' l-Olanda, innotifikat lill-EMEA f'konformità ma' l-Artikolu 78(1) tad-Direttiva 2001/82/KE, kif emendata bid-Direttiva 2004/28/KE, bl-intenzjoni tagħha li tvarja 21 awtorizzazzjoni għattqegħid fis-suq.
English: The CVMP agreed on 14 September 2006 to communicate the proposed precautionary measures and information on human adverse reactions to the concerned Marketing Authorisation Holders (MAHs).
Maltese: Fl-14 ta' Settembru 2006 il-CVMP qabel li jikkomunika l-miżuri prekawzjonarji proposti u l-informazzjoni dwar reazzjonijiet mhux mixtieqa filbniedem lid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAHs).
English: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, IRELAND
Maltese: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co.
English: The Products listed in Annex I are approved in various MS for use via the parental route, containing alpha2adrenoreceptor agonists romifidine, xylazine, detomidine, medetomidine.
Maltese: Il-Prodotti elenkati fl-Anness I, li fihom alpha2-adrenoreceptor agonists romifidine, xylazine, detomidine, medetomidine, huma approvati f'diversi
English: NRP/VFP-01453-07 Alfasan International B.V., Kuipersweg 9, P.O.
Maltese: NRP/VFP-01453-07 Alfasan International B.V., Kuipersweg 9, P.O. Box 78, 3440 AB Woerden, THE NETHERLANDS
English: A revised list of questions addressed to the Marketing Authorisation Holders concerned was adopted on 16 July 2008.
Maltese: Lista riveduta ta' mistoqsijiet indirizzati lid-Detenturi ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ikkonċernati ġiet adottata fis-16 ta' Lulju 2008.
English: ALFASAN INTERNATIONAL B.V. Kuipersweg 9, 3449 Ja Woerden, THE NETHERLANDS
Maltese: INTERNATIONAL B.V., Kuipersweg 9, 3449, JA Woerden, THE NETHERLANDS
English: Teratogenic effects were, however, not observed following administration of dexmedetomidine at subcutaneous doses up to 200 µg/kg in rats from day 5 to day 16 of gestation and intravenous doses up to 96 µg/kg in rabbits from day 6 to day 18 of gestation.
Maltese: Madankollu, effetti teratoġeniċi ma ġewx osservati wara lgħoti ta' dexmedetomidine f'dożi mogħtijin taħt il-ġilda sa 200 µg/kg fil-firien mill-ħames sas-sittax il-jum tal-ġestazzjoni u dożi intravenużi sa 96 µg/kg fil-fniek miss-sitt sat-timintax il-jum 18 tal-ġestazzjoni.
English: The set of precautionary measures then served as basis for the proposals made by the Dutch competent regulatory authority for this procedure under Article 78 of Directive 2001/82/EC, as amended.
Maltese: Imbagħad, is-sett ta' miżuri prekawzjonarji serva bħala bażi għall-proposti magħmulin mill-awtorità regolatorja kompetenti Olandiża għal din il-proċedura skont l-Artikolu 78 tad-Direttiva 2001/82/KE, kif emendata.
English: The CVMP further considered the published Maximum Residue Limit (MRL) Summary Reports for xylazine, detomidine and romifidine.
Maltese: Barra minn hekk il-CVMP ikkunsidra r-Rapporti fil-qosor dwar il-Limitu Massimu tar-Reżidwi (LMR) għal xylazine, detomidine u romifidine.
English: In the rabbit study, detomidine was non-teratogenic and non-foetotoxic up to 2 mg/kg bw.
Maltese: Fl-istudju fil-fenek, detomidine ma kienx teratoġeniku u fetuġeniku sa 2 mg/kg piż tal-ġisem.
English: The CVMP considered publicly available data on systemic toxicity after ocular exposure to xylazine hydrochloride in a human; corneal toxicity of xylazine and clonidine, in combination with ketamine, in the rat; and acute reversible cataract induced by xylazine and by ketamine-xylazine anesthesia in rats and mice.
Maltese: Il-CVMP ikkunsidra data disponibbli pubblikament dwar tossiċità sistemika wara esponiment okulari għal xylazine hydrochloride fi bniedem; tossiċità korneali għal xylazine u clonidine, f'kombinazzjoni ma' ketamine, fil-firien; u katarretta riversibbli akuta indotta minn xylazine u minn loppju permezz ta' ketaminexylazine fil-firien u l-ġrieden.
English: Ventricular arrhythmias have also been reported.
Maltese: Ġew ukoll irrapportati arritmiji ventrikulari.
English: The CVMP considered published data on the effects of xylazine hydrochloride on intrauterine pressure in the cow, the oxytocic effect of xylazine on the canine uterus, effects of detomidine, romifidine and xylazine on intrauterine pressure and sedation in horses, and the effects of xylazine on intrauterine pressure, uterine blood flow, maternal and foetal cardiovascular and pulmonary function in pregnant goats.
Maltese: Il-CVMP ikkunsidra data ppubblikata dwar l-effetti ta' xylazine hydrochloride fuq il-pressjoni ġewwa l-utru fil-baqra, l-effett ossitoċiku ta' xylazine fuq l-utru tal-kelb, effetti ta' detomidine, romifidine u xylazine fuq il-pressjoni ġewwa l-utru u sedazzjoni fiż-żwiemel, u l-effetti ta' xylazine fuq pressjoni ġewwa l-utru, nixxija tad-demm fl-utru, funzjoni kardjovaskulari u pulmonari materna u fetali fil-mogħżiet tqal.
English: The pharmacovigilance data evaluated by the Dutch competent regulatory authority that resulted in its intention to vary the authorisations is a published suspected adverse reaction (SAR) in a human being, reporting cardiovascular and central nervous system effects over a period of 3 days after accidental selfinjection of Sedivet (Reference: Hoyer, Mark J. Alpha2-agonisten, alledaagse verdovingsmiddelen in de diergeneeskunde praktijk, maar verre van ongevaarlijk - de gevolgen van een accidentele zelfinjectie.
Maltese: Id-data ta' farmakoviġilanza valutata mill-awtorità regolatorja kompetenti Olandiża li rriżultat fl-intenzjoni tagħha li tvarja l-awtorizzazzjonijiet hija reazzjoni mhux mixtieqa ssuspettata (SAR) fi bniedem li ġiet ippubblikata, li tirrapporta effetti kardjovaskulari u tas-sistema nervuża ċentrali fuq perijodu ta' 3 ijiem wara injezzjoni aċċidentali ta' Sedivet mogħtija lilu nnifsu (Referenza:
English: Having considered the matter, the CVMP concluded on the following recommendation:
Maltese: Għaldaqstant, il-CVMP ikkonkluda fuq ir-rakkomandazzjoni li ġejja:
English: In another reproductive study when dexmedetomidine was administered subcutaneously to pregnant rats from gestation day 16 through nursing, it caused lower pup weights at 8 and 32 µg/kg as well as foetal and embryocidal toxicity of second generation offspring at a dose of 32 µg/kg.
Maltese: Fi studju riproduttiv ieħor meta dexmedetomidine ngħata taħt il-ġilda lill-firien tqal miss-sittax il--jum tal-ġestazzjoni sat-treddigħ, huwa kkaġuna piżijiet iktar baxxi fil-ġriewi bi 8 u 32 µg/kg kif ukoll tossiċità fetali u embrijoċidali tal-wild tattieni ġenerazzjoni f'doża ta' 32 µg/kg.
English: The CVMP also considered other publicly available data for the scientific evaluation.
Maltese: Il-CVMP ikkunsidra wkoll data oħra disponibbli pubblikament għall-valutazzjoni xjentifika.
English: Since systemic effects may occur in rather low doses of romifidine in humans (0.2 mg/person), the CVMP concluded that the effects experienced by a person accidentally having injected a maximum of 0.3 ml Sedivet (3 mg romifidine) could be related to the active substance of the product.
Maltese: Minħabba li l-effetti sistemiċi jistgħu jseħħu f'dożi kemmxejn baxxi ta' romifidine fil-bnedmin (0.2 mg/persuna), il-CVMP ikkonkluda li l-effetti esperjenzati minn persuna li jinjetta aċċidentalment massimu ta' 0.3 ml Sedivett (3 mg romifidine) jistgħu jkunu relatati għas-sustanza attiva tal-prodott.
English: UK Domosedan 10 mg/ml Injection
Maltese: UK Domosedan 10 mg/ml Injection Detomidine hydrochloride
English: <The substance> is an alpha2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
Maltese: <Is-sustanza> hija alpha2-adrenoreceptor agonist, sintomi wara l-assorbiment jistgħu jinvolvu effetti kliniċi inklużi sedazzjoni dipendenti fuq id-doża, depressjoni respiratorja, bradikardija, pressjoni baxxa, ħalq niexef, u ipergliċemija.
English: In the rat study, a NOEL of 0.1 mg/kg bw/day was based on foetal and maternal toxicity and teratogenicity.
Maltese: Fl-istudju fil-far, NOEL ta' 0.1 mg/kg piż tal-ġisem/kuljum kien ibbażat fuq tossiċità fetali u materna u teratoġeniċità.
English: Having considered the data and the comments from the MAHs, the CVMP agreed on the following recommendation:
Maltese: Meta kkunsidra d-data u l-kummenti mill-MAHs, il-CVMP qabel fuq ir-rakkomandazzjoni li ġejja:
English: Ventricular arrhythmias are stated to have been reported, probably after accidental self-injection, but such was not reported in the published report on the human adverse reaction (Hoyer, M.J., 2006).
Maltese: Arritmiji ventrikulari huma ddikjarati li kienu rrapportati, probabbilment wara injezzjoni aċċidentali lillpersuna nfisha, iżda dan ma kienx irrapportat fir-rapport ippubblikat dwar ir-reazzjoni mhux mixtieqa filbniedem (Hoyer, M.J., 2006).
English: The proposed precautionary measures relate to different user safety concerns.
Maltese: Il-miżuri prekawzjonarji proposti jirrelataw ma' tħassib differenti dwar is-sigurtà għall-utenti.
English: Oral exposure was not reported.
Maltese: Ma kienx irrapportat esponiment orali.
English: Medetomidine, structurally related to detomidine, at an intravenous dose 0.67 µg/kg bw caused hypotension and sedation that lasted for at least 8 hours, as reported in the MRL Summary Report for detomidine.
Maltese: Medetomidine, strutturalment relatat ma' detomidine, f'doża intravenuża ta' 0.67 µg/kg piż tal-ġisem ikkawża pressjoni baxxa u sedazzjoni li damet għal ta' l-inqas 8 sigħat, kif irrapportat fir-Rapport fil-qosor ta' LMR għal detomidine.
English: 2.1 Systemic effect on sedation and hypotension
Maltese: 2.1 Effett sistemiku fuq sedazzjoni u pressjoni baxxa