FrancophonIA/ELRC3.0 huggingface dataset:
English: Chickens
Maltese: Ippakkjar
English: Ocular use LDPE bottle 30ml
Maltese: Flixkun LDPE 30ml
English: EU/2/11/126/001 MS-H Vaccine
Maltese: EU/2/11/126/001 Vaċċine MS-H unitajiet li jibdlu l-kulur minn 10 5.7 sa
English: Eye drop, suspension
Maltese: Taqtir fl-għajn, sospensjoni
English: Target species Route of administration
Maltese: Mod ta' Amministrazzj oni
English: 1 spot-on applicator
Maltese: Applikatur lokalizzat 1
English: Member State (EU/EEA)
Maltese: Membru (EU/EEA)
English: Discussion of data available
Maltese: Diskussjoni dwar id-dejta disponibbli
English: • UK/V/0325/001 - Closamectin Pour-On (UK, Ireland);
Maltese: • UK/V/0325/001 - Closamectin Pour-On (ir-Renju Unit, l-Irlanda);
English: • Closivet Solución Pour-On (Spain); and
Maltese: • Closivet Solución Pour-On (Spanja); u
English: Closivet Solución Pour- On Ivermectin Closantel
Maltese: Closivet Solución Pour- On Closantel u Ivermectin
English: • UK/V/0368/001 - Closiver 5mg/ml & 200 mg/ml Pour-On (UK); Closamectin 5mg/ml & 200 mg/ml Pour-On (Austria, Belgium, Czech Republic, Denmark, Germany, Greece, Italy, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden);
Maltese: • UK/V/0368/001 - Closiver 5mg/ml u 200 mg/ml Pour-On (ir-Renju Unit); Closamectin 5mg/ml u 200 mg/ml Pour-On (l-Awstrija, il-Belġju, ir-Repubblika Ċeka, id-Danimarka, il-Ġermanja, ilGreċja, l-Italja, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja, Spanja u l-Isvezja);
English: − intensified data collection relating to pharmacovigilance reports; and
Maltese: − ġbir intensifikat ta' dejta relatata mar-rapporti ta' farmakoviġilanza; u
English: CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS is a veterinary medicinal product which has been authorised in France since 25 May 2011 following a decentralised procedure (DCP) (UK/V/0369/001) with the United Kingdom (UK) as reference Member State.
Maltese: SPOUR-ON SOLUTION POUR BOVINS huwa prodott mediċinali veterinarju li ilu awtorizzat fi Franza mill-25 ta' Mejju 2011 wara proċedura deċentralizzata (DCP) (UK/V/0369/001) mar-Renju Unit (UK) bħala Stat Membru ta' referenza.
English: • Closivet Pour-On Solution for Cattle (Ireland);
Maltese: • Closivet Pour-On Solution for Cattle (l-Irlanda);
English: Other treatment options have limited activity against immature fluke.
Maltese: Għażliet oħra ta' kura għandhom attività limitata kontra trematodi immaturi.
English: Higher incidence values were reported in Sweden (0.011%) and France (0.007%).
Maltese: Valuri ogħla ta' inċidenza kienu rrapportati fl-Isvezja (0.011%) u fi Franza (0.007%).
English: SPC section 4.6 Adverse reactions (Frequency and Seriousness)
Maltese: Sezzjoni 4.6 tal-SPC Reazzjonijiet avversi (Frekwenza u Gravità)
English: − education, training and guidance for end-users.
Maltese: − edukazzjoni, taħriġ u gwida għall-utenti finali.
English: The data reviewed did not indicate age, sex, breed or geographical distribution as potential risk factors for the adverse events observed.
Maltese: Id-dejta riveduta ma indikatx l-età, is-sess, ir-razza jew id-distribuzzjoni ġeografika bħala fatturi potenzjali ta' riskju għallavvenimenti avversi osservati.
English: The overall EU incidence of adverse events, in relation to sales volumes was classified as ‘very rare' (0.003%) and considered within acceptable limits.
Maltese: L-inċidenza globali ta' avvenimenti avversi fl-UE, b'rabta mal-volum ta' bejgħ kienet ikklassifikata bħala 'rari ħafna' (0.003%) u tqieset fil-limiti aċċettabbli.
English: From 2000 until 30 June 2015, a total of 371 adverse events reports were reported in the EU, 65% of which, according to the MAH, concerned animal toxicity, mainly in France (120 reports) and the UK (91 reports).
Maltese: Mis-sena 2000 sat-30 ta' Ġunju 2015, fl-UE ġew irrapportati total ta' 371 avveniment avvers, li skont lMAH, 65% minnhom kienu jikkonċernaw tossiċità fl-annimali, prinċipalment fi Franza (120 rapport) u fir-Renju Unit (91 rapport).
English: A comparative review of the safety profile in cattle of other products containing ivermectin and/or closantel held by the MAH (including the injectable combination product) was conducted.
Maltese: Saret reviżjoni komparattiva tal-profil tas-sigurtà fuq l-ifrat ta' prodotti oħra li fihom ivermectin u/jew closantel miżmumim mill-MAH (inkluż il-prodott ikkombinat injettabbli).
English: • Vermax Pour-On 5mg/ml & 200 mg/ml Soluzione Pour-On per bovini (Italy).
Maltese: • Vermax Pour-On 5mg/ml u 200 mg/ml Soluzione Pour-On per bovini (l-Italja).
English: The ANMV received a total of 123 adverse event reports involving CLOSAMECTIN POUR-ON POUR BOVINS between 25 May 2011 and 31 May 2015 in which 401 animals were affected and 121 died.
Maltese: Bejn il-25 ta' Mejju 2011 u l-31 ta' Mejju 2015 l-ANMV irċeviet total ta' 123 rapport ta' avvenimenti avversi li kienu jinvolvu lil CLOSAMECTIN POURON POUR BOVINS li fihom kien hemm 401 annimali affettwati u 121 kienu mietu.
English: It was proposed that third parties involved in pharmacovigilance activities related to these products (e.g distributors) be made aware of the risk management measures proposed.
Maltese: Ġie propost li partijiet terzi involuti f'attivitajiet ta' farmakoviġilanza relatati ma' dawn il-prodotti (eż. distributuri) jiġu mgħarrfa dwar il-miżuri għall-ġestjoni tar-riskju proposti.
English: Although the overall incidence of adverse events was considered to be within acceptable limits (0.006% in the last annual periodic safety update report (PSUR)) the continued occurrence of serious adverse events and the severity of subsequent losses on farms in France were considered significant, which led to the suspension of the marketing authorisation in France on 6 July 2015.
Maltese: Għalkemm l-inċidenza globali ta' avvenimenti avversi tqieset li kienet fil-limiti aċċettabbli (0.006% fl-aħħar rapport perjodiku ta' aġġornament dwar issigurtà (PSUR)) l-okkorrenza kontinwa ta' avvenimenti avversi serji u s-severità tat-telf sussegwenti fil-farms fi Franza tqiesu bħala sinifikanti, li wassal għas-sospensjoni tal-awtorizzazzjoni għat-tqegħid fis-suq fi Franza fis-6 ta' Lulju 2015.
English: Closamectin Pour-On Solution should be administered topically at a dose of 500 mg ivermectin per kg body weight and 20 mg closantel per kg body weight (1 mL per 10 kg body weight).
Maltese: Closamectin Pour-On Solution għandu jingħata b'mod topiku f'doża ta' 500 mg ta' ivermectin għal kull kg ta' piż tal-ġisem u f'doża ta' 20 mg ta' closantel għal kull kg ta' piż tal-ġisem (1 mL għal kull 10 kg ta' piż tal-ġisem).
English: SPC section 4.5 Special precautions for use: Special precautions for use in animals:
Maltese: Sezzjoni 4.5 tal-SPC Prekawzjonijiet speċjali għall-użu:
English: Laboratories Ltd.
Maltese: Mnjen jingħata
English: Additionally the MAH proposed to implement a risk management plan comprising submission of annual ‘combined' PSUR reports for the products concerning Closamectin Pour-On Solution and associated names (as detailed in Annex I of the Opinion); detailed investigation of future pharmacovigilance reports which should include data collection from treated un-affected animals within the same herd (including farm history and herd health status, assessment of animal health and nutritional status involving biochemistry and micronutrient analysis; investigation of potential closantel toxicity (via blood plasma sampling and post-mortem examinations); and ‘education, training and guidance' for end-users to ensure that the risks of the products and the precautions for use are fully understood.
Maltese: Barra minn hekk l-MAH ippropona l-implimentazzjoni ta' pjan għall-ġestjoni tar-riskju li jinkludi s-sottomissjoni ta' rapporti annwali 'kkombinati' ta' PSUR għall-prodotti li jirrigwardaw Closamectin Pour-On Solution u ismijiet assoċjati (kif dettaljat fl-Anness I tal-Opinjoni); investigazzjoni dettaljata ta' rapporti futuri ta' farmakoviġilanza li għandhom jinkludu l-ġbir tad-dejta minn annimali mhux affettwati li ngħataw kura fl-istess merħla (inkluż l-istorja tal-farm u l-istatus tas-saħħa tal-merħla, valutazzjoni tas-saħħa talannimali u tal-istatus nutrittiv inkluż analiżi tal-bijokimika u tal-mikronutrijenti; investigazzjoni dwar ittossiċità potenzjali ta' closantel (permezz ta' kampjunar tal-plasma tad-demm u eżamijiet postmortem); u 'edukazzjoni, taħriġ u gwida' għall-utenti finali biex jiġi żgurat li r-riskji tal-prodotti u lprekawzjonijiet għall-użu ikunu mifhuma sew.
English: This included a review of scientific literature regarding the pharmacology and toxicology of ivermectin and closantel, cumulative pharmacovigilance experience following use of the products in the European Union (EU) since 2009, a comparison with ivermectin-based products and with ivermectin/closantel injectable formulations held by the MAH, investigations carried out by the MAH to identify possible factors involved in reported adverse events and proposals for risk mitigation measures and actions.
Maltese: Din kienet tinkludi reviżjoni tal-letteratura xjentifika dwar il-farmakoloġija u t-tossikoloġija ta' ivermectin u ta' closantel, l-esperjenza kumulattiva dwar ilfarmakoviġilanza wara l-użu tal-prodotti fl-Unjoni Ewropea (UE) mill-2009, tqabbil ma' prodotti bbażati fuq ivermectin u ma' formulazzjonijiet injettabbli ta' ivermectin/closantel miżmumin mid-detentur talawtorizzazzjoni għat-tqegħid fis-suq, l-investigazzjonijiet imwettqin mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq biex jiġu identifikati fatturi possibbli involuti fl-avvenimenti avversi rapportati u proposti għal miżuri u azzjonijiet għall-mitigazzjoni tar-riskji.
English: The nature of the reported clinical signs was considered by ANMV to be indicative of the clinical signs associated with overdose toxicity of closantel.
Maltese: L-ANMV qieset li n-natura tas-sinjali kliniċi rapportati kienet indikattiva tas-sinjali kliniċi assoċjati ma' tossiċità minħabba doża eċċessiva ta' closantel.
English: Closamectin Pour-On Solution and associated names is authorised in several EU Member States.
Maltese: Closamectin Pour-On Solution u ismijiet assoċjati huwa awtorizzat f'diversi Stati Membri tal-UE.
English: The adverse events principally related to neurological signs (ataxia, recumbency, paresis/paralysis and blindness) and/or gastrointestinal disorders (diarrhoea, anorexia etc.) some of which had a fatal outcome.
Maltese: L-avvenimenti avversi kienu prinċipalment relatati ma' sinjali newroloġiċi (atassja, rikombenza, paresi/paraliżi u għama) u/jew disturbi gastrointestinali (dijarea, anoressija, eċċ.) li uħud minnhom kellhom eżitu fatali.
English: The CVMP considered the additional data relating to the adverse event reports provided by the MAH to investigate potential risk factors associated with the adverse events in animals and possible explanations for the higher incidence of fatal adverse events reported in France compared with other EU Member States.
Maltese: Is-CVMP qies id-dejta addizzjonali relatata mar-rapporti ta' avvenimenti avversi pprovduti middetentur tal-awtorizzazzjoni għat-tqegħid fis-suq biex jinvestiga fatturi potenzjali ta' riskju assoċjati mal-avvenimenti avversi fl-annimali u spjegazzjonijiet possibbli għall-inċidenza ogħla ta' avvenimenti avversi fatali rrapportati fi Franza meta mqabbla ma' Stati Membri oħra tal-UE.
English: CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS
Maltese: POUR-ON SOLUTION POUR BOVINS
English: Therefore, it was considered difficult to ascertain whether the clinical signs observed indicative of toxicity may be due to the ivermectin and/or the closantel components of the combination product Closamectin Pour-On.
Maltese: Għalhekk, kien ikkunsidrat diffiċli li jiġi aċċertat jekk is-sinjali kliniċi osservati indikattivi ta' tossiċità jistgħux ikunu minħabba l-komponent ivermectin u/jew closantel tal-prodott ikkombinat Closamectin Pour-On.
English: The products are effective for use in beef cattle for the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to roundworms, lungworms, eyeworms, warbles, mites and lice.
Maltese: Il-prodott huwa effikaċi għall-użu fil-frat għallkura ta' infestazzjonijiet imħalltin ta' trematode (trematodi) u nematodi jew antropodi minħabba roundworms, lungworms, eyeworms, warbles, dud u qamel.
English: The principal risks associated with the product relate to the potential for adverse events involving neurological signs (ataxia, recumbency, paresis/paralysis and blindness) and/or gastrointestinal disorders (diarrhoea, anorexia etc.) in treated animals some of which have been fatal.
Maltese: Ir-riskji prinċipali assoċjati mal-prodott huma relatati mal-potenzjal għal avvenimenti avversi li jinvolvu sinjali newroloġiċi (atassja, rikombenza, paresi/paraliżi u għama) u/jew disturbi gastrointestinali (dijarea, anoressija, eċċ.) f'annimali li ngħataw kura li uħud minnhom kienu fatali.
English: The CVMP considered the clinical profile of injectable and pour-on combined formulations to be comparable, except for signs of blindness/impaired vision (reported only with the pour-on products) and application site and respiratory signs (reported only with the injectable product).
Maltese: Il-CVMP qies li l-profil kliniku ta' formulazzjonijiet ikkombinati injettabbli u li jitferrgħu huwa komparabbli, ħlief għal sinjali ta' għama/indeboliment fil-vista (rapportati biss bil-prodotti li jitferrgħu) u sinjali fis-sit tal-applikazzjoni u respiratorji (rapportati biss bil-prodott injettabbli).
English: Closantel is an alternative flukicide to triclabendazole to which resistance is emerging.
Maltese: Closantel huwa aġent li joqtol it-trematodi (flukicide) alternattiv għal triclabendazole li għalih qiegħda tinħoloq reżistenza.
English: Other veterinary medicinal products with the same qualitative and quantitative composition which belong to the same marketing authorisation holder (MAH), Norbrook Laboratories Ltd, are also authorised under two other DCP and three national procedures, as follows:
Maltese: Prodotti mediċinali veterinarji oħra bl-istess għamla kwalitattiva u kwantitattiva li jappartjenu għallistess detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH), Norbrook Laboratories Ltd, huma awtorizzati wkoll taħt żewġ DCPs oħra u tliet proċeduri nazzjonali, kif ġej:
English: Sales volumes should also be reported separately for specific products for each Member State.
Maltese: Il-volumi ta' bejgħ għandhom ukoll jiġu rrapportata separatament għal prodotti speċifiċi għal kull Stat Membru.
English: • on the basis of the pharmacovigilance and additional data reviewed, including risk minimisation measures, the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products (see Annex I) subject to amendments in the product information;
Maltese: • abbażi tal-farmakoviġilanza u d-dejta addizzjonali riveduta, inkluż il-miżuri għall-imminimizzar tarriskju, is-CVMP qies li l-bilanċ ġenerali tal-benefiċċju-riskju huwa pożittiv għall-prodotti mediċinali veterinarji (ara Anness I) soġġett għall-emendi fl-informazzjoni dwar il-prodott.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holder in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, speċi ta' annimali, mnejn għandhom jingħataw, detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: • implementation of a risk management plan addressing the following risk mitigation and surveillance measures:
Maltese: • l-implimentazzjoni ta' pjan għall-ġestjoni tar-riskju li jindirizza l-miżuri ta' mitigazzjoni tar-riskju u ta' sorveljanza li ġejjin:
English: The proposal for annual PSUR submissions, covering all products related to Closamectin Pour-On Solution and associated names was supported.
Maltese: Ġiet approvata l-proposta għas-sottomissjonijiet ta' PSUR annwali, li jkopri l-prodotti kollha relatati ma' Closamectin Pour-On Solution u ismijiet assoċjati.
English: Although the pharmacovigilance reports indicated potential closantel toxicity as an underlying cause, it was noted that reports of neurological events (including a case of blindness) and diarrhoea occurred with the ivermectin-only formulations.
Maltese: Għalkemm ir-rapporti ta' farmakoviġilanza indikaw tossiċità potenzjali ta' closantel bħala l-kawża sottostanti, ġie nnotat li rrapporti ta' avvenimenti newroloġiċi (inkluż każ ta' għama) u dijarea seħħew bil-formulazzjonijiet ta' ivermectin biss.
English: These deficiencies and poor nutritional status in general were considered potential factors associated with the adverse events observed following treatment and considered possible explanations for the higher frequency of reported adverse events in France.
Maltese: Dawn id-defiċjenzi u l-istatus nutrittiv baxx inġenerali kienu tqiesu fatturi potenzjali assoċjati mal-avvenimenti avversi osservati wara l-kura u kienu kkunsidrati spjegazzjonijiet possibbli għall-frekwenza ogħla ta' avvenimenti avversi rapportati fi Franza.
English: In very rare cases (less than 1 animal in 10,000 animals, including isolated reports), neurological signs such as blindness, ataxia, and recumbency may occur after administration of the product.
Maltese: F'każijiet rari ħafna (inqas minn annimal 1 minn kull 10,000 annimal, inklużi rapporti iżolati), jistgħu jseħħu sinjali newroloġiċi bħal għama, atassja, u rikombenza wara l-għoti tal-prodott.
English: It was recommended that additional data be collected for the adverse events occurring in future to determine the potential role of the products, including potential closantel toxicity, and also investigate potential risk factors associated with the adverse events reported following treatment.
Maltese: Ġie rrakkomandat li tinġabar dejta addizzjonali għall-avvenimenti avversi li jseħħu fil-futur sabiex jiġi stabbilit ir-rwol potenzjali tal-prodotti, inkluż it-tossiċità potenzjali ta' closantel, u barra minn hekk issir investigazzjoni ta' fatturi ta' riskju potenzjali assoċjati mal-avvenimenti avversi rapportati wara l-kura.
English: Additional investigations were initiated in animals affected in 2015, involving monitoring vitamins A, E and selenium blood levels in samples from both affected and unaffected animals.
Maltese: Fl-2015 inbdew investigazzjonijiet addizzjonali fuq annimali affettwati, li kienu jinkludu monitoraġġ tallivelli tal-vitamini A, E u tas-selenju fid-demm f'kampjuni kemm minn annimali affettwati u dawk mhux affettwati.
English: Slovenia Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Maltese: Is-Slovenja Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP LIrlanda ta' Fuq
English: The average number of affected animals per adverse event report in the EU was 3.9.
Maltese: Fl-UE l-għadd medju ta' annimali affettwati għal kull rapport ta' okkorrenza kien ta' 3.9.
English: Romania Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Maltese: Ir-Rumanija Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP LIrlanda ta' Fuq
English: It was emphasised that analysis and incidence calculations should be performed on the overall data however also ensuring precise identification of the concerned product for individual adverse event reports.
Maltese: Ġie enfasizzat li għandha ssir analiżi u kalkoli ta' inċidenzi fuq id-dejta globali filwaqt li tiġi żgurata wkoll identifikazzjoni preċiża tal-prodott konċernat għal rapporti individwali ta' avvenimenti avversi.
English: Belgium Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Maltese: Il-Belġju Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP LIrlanda ta' Fuq
English: However further investigations were considered necessary to confirm or refute nutritional status and specific micro-nutrient deficiencies as risk factors for the adverse effects observed in animals following use of Closamectin Pour-on Solution and associated names.
Maltese: Madanakollu tqies li kien hemm ilħtieġa ta' iktar investigazzjonijiet biex jiġi konfermat jew rifjutat l-istatus nutrittiv u d-defiċjenzi ta' mikro-nutrijenti speċifiċi bħala fatturi ta' riskju għall-effetti avversi osservati fl-annimali wara l-użu ta' Closamectin Pour-on Solution u ismijiet assoċjati.
English: To investigate the potential relation between the adverse events observed and Closamectin Pour-On Solution and associated names, the CVMP considered the data provided by the MAH, Norbrook
Maltese: Biex jinvestiga r-relazzjoni potenzjali bejn l-avvenimenti avversi osservati u Closamectin Pour-On Solution u ismijiet assoċjati, is-CVMP qies id-dejta pprovduta mid-detentur tal-awtorizzazzjoni għattqegħid fis-suq, Norbrook Laboratories Ltd.
English: ATC vet code:QI06AD08.
Maltese: Q106AD08.
English: Potassium chloride Sodium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections
Maltese: Potassium chloride Sodium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Ilma għall-injezzjonijiet
English: Date of first authorisation: 18/02/2011 Date of last renewal: 02/12/2015
Maltese: Data tal-ewwel awtorizzazzjoni: 18/02/2011 Data tal-aħħar tiġdid: 02/12/2015
English: Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 LYON FRANCE
Maltese: Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 Lyon
English: Store and transport refrigerated (2 °C-8 °C).
Maltese: Aħżen u ttrasporta ġo friġġ (2 °C-8 °C)
English: Duration of immunity after revaccination: 3 years.
Maltese: Tul ta' immunità wara r-ripetizzjoni tal-vaċċin: 3 snin.
English: 1 ml contains: Rabies recombinant canarypox virus (vCP65) ................................................................. ≥ 106.8 FAID50
Maltese: 1 ml fih: Virus rikombinat tar-Rabies canarypox (vCP65) ............................................................... ≥ 106.8 FAID50
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with MERIAL non-adjuvanted vaccines containing various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components.
Maltese: Hemm informazzjoni ta' sigurtà u effikaċja li turi li din it-tilqima tista' tiġi mħallta u amministrata ma' tilqim tal-MERIAL mingħajr aġġuvanti li fihom diversi taħlit ta' komponenti ta' rinotrakeite virali fil-qtates, kalċivirosi, panlewkopenja u klamidjosi.
English: Overdose:
Maltese: Doża eċċessiva :
English: EU/2/10/117/001 (10 vials) EU/2/10/117/002 (50 vials) EU/2/10/117/003 (2 vials)
Maltese: EU/2/10/117/003 (2 kunjetti)
English: Purevax Rabies suspension for injection
Maltese: VETERINARJU Purevax Rabies suspensjoni għal injezzjoni
English: Veterinary surgeons may wish to consider two vaccinations.
Maltese: Il veterinarji jistgħu jikkunsidraw żewġ vaċċini.
English: The vaccine strain vCP65 is a recombinant Canarypox virus expressing the glycoprotein G gene of rabies virus.
Maltese: L-istrejn li jinsab fil-vaċċin vCP65 huwa virus rikombinat tal-Canarypox li jesprimi l-ġene glycoproteina G tal-virus tar-Rabies.
English: Very rarely, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Maltese: Rarament ħafna, jista' jkun hemm reazzjoni ta' ipersensittività, li tista' tirrikjedi kura sintomatika xierqa.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 10 vials of suspension for injection Box of 50 vials of suspension for injection Box of 2 vials of suspension for injection
Maltese: Kaxxa ta' 10 kunjetti ta' suspensjoni għal injezzjoni Kaxxa ta' 50 kunjett ta' suspensjoni għal injezzjoni Kaxxa ta' 2 kunjetti ta' suspensjoni għal injezzjoni
English: A transient local reaction may very rarely occur (pain at palpation, limited swelling that may become nodular, heat at the injection site, and in some cases erythema), that usually disappears within 1 or 2 weeks at most.
Maltese: Jista' jkun hemm rarament ħafna reazzjoni lokali (uġigħ meta tingħafas il-parti eżaminata, nefħa limitata li jista' jkun issir għoqda, il-post tal-injezzjoni jkun jaħraq u f'xi kazijiet eritema) li tmur normalment fi żmien ġimgħa jew ġimgħatejn l-iżjed.
English: 1 dose
Maltese: 3 snin.