FrancophonIA/ELRC3.0 huggingface dataset:
English: In conclusion, the precautionary measures should be reflected in the product literature of the concerned veterinary medicinal products containing alpha2-adrenoreceptor agonists.
Maltese: F'konklużjoni, ilmiżuri prekawzjonarji għandhom ikunu riflessi fil-fuljett ta' tagħrif tal-prodott tal-prodotti mediċinali veterinarji kkonċernati li fihom alpha2-adrenoreceptor agonists.
English: Avda.
Maltese: Inj.
English: NRP/VFP-00544-05 Alfasan International B.V., Kuipersweg 9, P.O.
Maltese: NRP/VFP-00544-05
English: However, foetal toxicity, as evidenced by increased postimplantation losses and reduced live pups, was observed in rats at subcutaneous dose of 200 µg/kg.
Maltese: Madankollu, tossiċità fetali, kif evidenzjata minn żieda fit-telfiet ta' wara l-impjantazzjoni u tnaqqis filġriewi ħajjin, kienet osservata fil-firien f'doża taħt il-ġilda ta' 200 µg/kg.
English: No information on eye exposure was available in the reported human adverse reaction (Hoyer, M.J., 2006).
Maltese: Ma kien hemm l-ebda informazzjoni disponibbli dwar esponiment ta' l-għajnejn fir-reazzjoni mhux mixtieqa fill-bniedem irrapportata (Hoyer, M.J., 2006).
English: ADVICE TO DOCTORS: <The substance> is an alpha2-adrenoreceptor agonist whose toxicity may cause clinical effects including sedation, respiratory depression and coma, bradycardia and hypotension and hyperglycaemia.
Maltese: <Is-sustanza> hija alpha2-adrenoreceptor agonist li t-tossiċità tagħha tista' tikkaġuna effetti kliniċi nklużi sedazzjoni, depressjoni respiratorja u koma, bradikardija u pressjoni baxxa u ipergliċemija.
English: The information on the approved United States New Drug Application (NDA) label for Precedex was considered, stating that dexmedetomidine should be used during pregnancy only if the potential benefits justify the potential risk to the foetus.
Maltese: L-informazzjoni fuq it-tikketta approvata ta' Applikazzjoni għall-Mediċina Ġdida (NDA) fl-Istati Uniti għal Precedex kienet ikkunsidrata, li tiddikjara li dexmedetomidine għandu jintuża waqt it-tqala biss jekk il-benefiċċji potenzjali jiġġustifikaw ir-riskju potenzjali lill-fetu.
English: In reference to the MRL Summary Report for detomidine, the effects of detomidine on pregnant cows seemed less than those described for xylazine, but in horses treated with 20 µg/kg bw, 4 out of 10 pregnancies showed diverse abnormalities with unclear significance.
Maltese: B'referenza għar-Rapport fil-qosor ta' LMR għal detomidine, l-effetti ta' detomidine fuq baqar tqal dehru inqas minn dawk deskriti għal xylazine, iżda fi żwiemel ikkurati b'20 µg/kg piż tal-ġisem, 4 minn 10 tqaliet urew diversi anormalitajiet b'sinifikat mhux ċar.
English: The CVMP concluded that the recommended general statements on precautionary measures are final recommendations given in response to the notification received from the Netherlands.
Maltese: Il-CVMP ikkonkluda li d-dikjarazzjonijiet ġenerali rakkomandati dwar miżuri prekawzjonarji huma rakkomandazzjonijiet finali mogħtijin bħala risposta għan-notifika riċevuta mill-Olanda.
English: Although the exact accidental injected exposure (dose) of the reported human adverse reaction (Hoyer, M.J., 2006) was unknown, it was concluded that the observed clinical effects - on day 1 being loss of consciousness (arousable), hallucinations, low heart rate and low blood pressure, vasoconstriction, and vasodilation; and on day 2 drowsiness, mild headache, loss of memory and tiredness - can be attributable to the product (Sedivet).
Maltese: Għalkemm l-esponiment (doża) eżatt injettat aċċidentalment tar-reazzjoni mhux mixtieqa fil-bniedem irrapportata (Hoyer, M.J., 2006) ma kienx magħruf, kien konkluż li l-effetti kliniċi osservati - fl-ewwel jum kien telf mis-sensi (li jitqajjem), alluċinazzjonijiet, rata tat-tħabbit tal-qalb baxxa u pressjoni tad-demm baxxa, vażokonstrizzjoni, u vażodilatazzjoni u fit-tieni jum ħedla tan-ngħas, uġigħ ta' ras ħafif, telf ta' memorja u għeja - jistgħu jiġu attribwiti għall-prodott (Sedivet).
English: Furthermore, the results of the outcome of a European survey for alpha2-adrenoreceptor agonists were considered.
Maltese: Barra minn hekk, kienu kkunsidrati r-riżultati ta' stħarriġ Ewropew għal alpha2adrenoreceptor agonists.
English: The CVMP concluded that these scientific recommendations concerning the precautionary measures apply also to other injectable products containing alpha2-adrenoreceptor agonists.
Maltese: Il-CVMP ikkonkluda li dawn ir-rakkomandazzjonijiet xjentifiċi li jikkonċernaw il-miżuri prekawzjonarji japplikaw ukoll għal prodotti injettabbli oħrajn li fihom alpha2-adrenoreceptor agonists.
English: In the MRL Summary Report for detomidine, two oral teratology studies were reported (rat and rabbit).
Maltese: Fir-Rapport fil-qosor ta' LMR għal detomidine, ġew rrapportati żewġ studji ta' teratoloġija orali (far u fenek).
English: Therefore, the CVMP in the July 2008 plenary meeting agreed on 16 July 2008 to complete the procedure under Article 78 of Directive 2001/82/EC, as amended, for all marketing authorisations held in the EU for the 21 products containing alpha2-adrenoreceptor agonists initially notified and to revise the initial previous opinion accordingly.
Maltese: Għaldaqstant, il-CVMP, fil-laqgħa plenarja ta' Lulju 2008, qabel fis-16 ta' Lulju 2008 li jtemm il-proċedura taħt l-Artikolu 78 tad-Direttiva 2001/82/KE, kif emendata, għall-awtorizzazzjonijiet għat-tqegħid fis-suq kollha miżmumin fl-UE għall-21 prodott li fihom alpha2-adrenoreceptor agonists kif inizjalment innotifikati u biex jirrevedi l-opinjoni inizjali preċedenti kif meħtieġ.
English: The CVMP, having considered the risk to human health, the proposed precautionary measures and information on human adverse reactions in light of the data available, concluded that the following information should be reflected in the product literature of the concerned products within a reasonable timeframe:
Maltese: Il-CVMP, wara li kkunsidra r-riskju għas-saħħa tal-bniedem, il-miżuri prekawzjonarji proposti u linformazzjoni dwar reazzjonijiet mhux mixtieqa fil-bniedem fid-dawl ta' data disponibbli, ikkonkluda li linformazzjoni li ġejja għandha tkun riflessa fil-fuljetti ta' tagħrif tal-prodott tal-prodotti kkonċernati f'perijodu ta' żmien speċifiku raġonevoli:
English: In the absence of sufficient data concerning the human adverse reactions studies the CVMP did not support a recommendation concerning addition of information on irritation, sensitisation, contact dermatitis and systemic effects after skin contact.
Maltese: Fin-nuqqas ta' data suffiċjenti li tikkonċerna studji ta' reazzjonijiet mhix mixtieqa fil-bniedem, il-CVMP ma appoġġjax rakkomandazzjoni li tikkonċerna ż-żieda ta' informazzjoni dwar irritazzjoni, sensitizzazzjoni, dermatite ta' kuntatt u effetti sistemiċi wara kuntatt mal-ġilda.
English: The CVMP further considered proprietary data provided by another MAH concerning three of the products.
Maltese: Minbarra hekk il-CVMP ikkunsidra wkoll data denominata ipprovduta minn MAH ieħor li tikkonċerna tlieta mill-prodotti.
English: The sentence was clearly considered a precautionary measure applicable to all alpha2-adrenoreceptor agonists and therefore not related to one specific product or substance.
Maltese: Alpha2-agonisten, alledaagse verdovingsmiddelen in de diergeneeskunde praktijk, maar verre van ongevaarlijk - de gevolgen van een accidentele zelfinjectie.
English: In addition, Article 78 of Directive 2001/82/EC applies only to the addition of precautionary measures in this procedure.
Maltese: Barra minn hekk, l-Artikolu 78 tad-Direttiva 2001/82/KE japplika biss għaż-żieda ta' miżuri prekawzjonarji f'din ilproċedura.
English: The CVMP considered information provided by one MAH concerning the product's characteristics in relation to sensitisation and contact dermatitis.
Maltese: Il-CVMP ikkunsidra l-informazzjoni ipprovduta minn wieħed mill-MAHs li tikkonċerna l-karatteristiċi talprodott fir-rigward tas-sensitizzazzjoni u dermatite ta' kuntatt.
English: Precedex is a product containing dexmedetomidine, the active enantiomer of medetomidine, that is approved for use in humans in the United States.
Maltese: Precedex huwa prodott li fih dexmedetomidine, l-enantiomer attiv ta' medetomidine, li huwa approvat għall-użu fil-bnedmin fl-Istati Uniti.
English: 17493 Greifswald - Insel Riems Germany
Maltese: 17493 Greifswald - Insel Riems Il-Ġermanja
English: HAZARD WARNING Rabies vaccine.
Maltese: Rabies vaccine.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Rabitec
Maltese: VETERINARJU Rabitec
English: Gelatin (porcine) Disodium phosphate dihydrate Potassium dihydrogen phosphate Neomycin sulfate
Maltese: Ġelatina (tal-ħnieżer) Disodium phosphate dihydrate Fosfat tad-diidroġenu tal-potassju Sulfat tan-neomiċina
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.7 ml) contains:
Maltese: U KWANTITATTIVA Doża 1 (1.7 ml) fiha:
English: IDT Biologika (Riems) GmbH & Co. KG An der Wiek 7
Maltese: IDT Biologika (Riems) GmbH & Co.
English: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Germany
Maltese: FIS-SUQ IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Il-Ġermanja
English: 1 x 800 units 4 x 200 units 40 x 20 units
Maltese: 1 x 800 unità 4 x 200 unità 40 x 20 unità
English: Stability after distribution in the environment was shown for 7 days at temperatures up to 25 °C.
Maltese: L-istabbiltà wara d-distribuzzjoni fl-ambjent intweriet għal sebat ijiem f'temperaturi sa 25°C.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/Aluminium blister
Maltese: Folja tal-PVC/Aluminju
English: Restricted to duly designated competent administrative authorities.
Maltese: Ristrett għal awtoritajiet amministrattivi kompetenti maħturin debitament.
English: EXP {month/year}
Maltese: EXP: {xahar/sena}
English: Bait:
Maltese: Lixka:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box containing 800 baits (1 x 800 units, 4 x 200 units or 40 x 20 units)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun li fiha 800 lixka (1 x 800 unità, 4 x 200 unità jew 40 x 20 unità)
English: A differentiation of this vaccine virus from any other rabies virus strains is possible, including its parental strain, for example by PCR methods.
Maltese: Huwa possibbli li dan il-virus tal-vaċċin jiġi differenzjat minn kwalunkwe razza oħra tal-virus tarrabbja, inkluża r-razza parentali tiegħu, pereżempju b'metodi ta' PCR.
English: Pharmacotherapeutic group: Immunologicals for canidae, live viral vaccines.
Maltese: Prodotti immunoloġiċi għal canidae, vaċċini ħajjin virali.
English: Store and transport frozen, below -15 °C.
Maltese: Aħżen u ttrasporta ffriżat, f'temperatura taħt -15°C.
English: The genome carries mutations in the G-protein (glycoprotein) located at 2 independent loci of the genome (at amino acid positions 194 and 333 in Gprotein), where all three nucleotides ‘codon' were exchanged resulting in amino acid changes at both positions.
Maltese: Il-ġenoma ġġor mutazzjonijiet fil-proteina-G (glikoproteina) li jinsabu f'żewġ pożizzjonijiet indipendenti tal-ġenoma (fil-pożizzjoni 194 u 333 tal-aċidu amminiku fuq il-proteina-G), fejn it-tliet nukleotidi ‘kodon' kollha jiġu skambjati li jwassal għal tibdil fl-aċidu amminiku fiż-żewġ pożizzjonijiet.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Rabitec oral suspension for foxes and raccoon dogs
Maltese: VETERINARJU Rabitec suspensjoni orali għal volpijiet u klieb rakkun
English: PACKAGE SIZE 1 x 800 units
Maltese: 1 x 800 unità
English: None known.
Maltese: Mhux magħruf.
English: The active ingredient is a quadruple highly attenuated genetically modified rabies virus construct, derived from the SAD B19 vaccine strain.
Maltese: L-ingredjent attiv huwa mudell kwadruplu attenwat ħafna tal-virus ġenetikament modifikat tar-rabbja, derivat mill-varjetà tal-vaċċin SAD B19.
English: Excipients:
Maltese: Vaċċin:
English: Name and address of the manufacturer responsible for batch release IDT Biologika GmbH
Maltese: Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott IDT Biologika GmbH
English: For the active immunization of foxes and raccoon dogs against rabies to prevent infection and mortality.
Maltese: Għall-immunizzazzjoni attiva ta' volpijiet u ta' klieb rakkun kontra r-rabbja għall-prevenzjoni ta' infezzjoni u ta' mortalità.
English: WITHDRAWAL PERIOD (S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: Rabitec is used for the induction of the protective immunity in foxes and raccoon dogs by the oral route characterised by the induction of rabies virus specific (neutralising) antibodies induced primarily by the G-protein (glycoprotein).
Maltese: Rabitec jintuża għall-induzzjoni tal-immunità protettiva fil-volpijiet u fil-klieb rakkun permezz tarrotta orali karatterizzata mill-induzzjoni ta' antikorpi speċifiċi (newtralizzanti) tal-virus tar-rabbja kkawżati prinċipalment mill-proteina G-(glikoproteina).
English: 40 x 20 units
Maltese: 4 x 200 unità 40 x 20 unità
English: In addition, the genome carries an exact duplicate of the modified immune-relevant Gprotein (glycoprotein) gene, which results in the significant higher expression of the G protein gene.
Maltese: Barra minn hekk, il-ġenoma ġġor duplikat eżatt tal-ġene immodifikat tal-proteina-G (glikoproteina) rilevanti għall-immunità, li twassal għall-espressjoni sinfikantement ogħla tal-ġene tal-proteina G.
English: As an exception, the thawed vaccine may be stored for up to 7 days at 2 °C - 8 °C before use.
Maltese: Bħala eċċezzjoni, it-tilqima maħlula tista' tinħażen għal mhux aktar minn sebat ijiem f'temperatura ta' 2°C - 8°C qabel l-użu.
English: Gastrointestinal signs (potentially due to the indigestible blister material) have been reported in dogs following accidental ingestion of the bait.
Maltese: Ġew irrapportati sinjali gastrointestinali (potenzjalment minħabba l-materjal indiġestibbli tal-folja) filklieb wara inġestjoni aċċidentali tal-lixka.
English: Foxes, raccoon dogs
Maltese: Volpijiet, klieb rakkun
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti mhux attivi, ara sezzjoni 6.1.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/219/001-003
Maltese: FIS-SUQ EU/2/17/219/001-003
English: Attenuated live rabies vaccine virus, strain SPBN GASGAS 106.8 FFU*/dose - 108.1 FFU*/dose (* Focus Forming Units)
Maltese: Vaċċin ħaj attenwat tal-virus tar-rabbja, razza SPBN GASGAS FFU*/doża - 10
English: Proposed first aid measures immediately after direct human exposure to the vaccine fluid should follow the recommendations of the WHO as outlined in the “WHO Guide for Rabies Pre- and PostExposure Prophylaxis (PEP) in Humans”.
Maltese: Il-miżuri proposti tal-ewwel għajnuna immedjatament wara esponiment dirett tal-bniedem għallfluwidu tal-vaċċin għandhom isegwu r-rakkomandazzjonijiet tad-WHO kif deskritti fil-“Gwida għallProfilassi ta' Qabel u Wara l-Esponiment għar-Rabbja (PEP) fil-Bnedmin” (“WHO Guide for Rabies Pre- and Post-Exposure Prophylaxis (PEP) in Humans”).
English: In contrast to its parental strain SAD B19, the Rabitec vaccine's active ingredient proved to be apathogenic for immunocompetent mice, the most sensitive species for rabies virus infection.
Maltese: B19 tiegħu, l-ingredjent attiv tal-vaċċin wera li kien apatoġeniku għal ġrieden immunokompetenti, l-aktar speċijiet sensittivi għall-infezzjoni bil-virus tar-rabbja.
English: The intake of single bait is sufficient to ensure active immunisation to prevent infection by rabies virus.
Maltese: It-teħid ta' lixka waħda huwa biżżejjed biex tiġi żgurata immunizzazzjoni attiva biex tiġi evitata infezzjoni bil-virus tar-rabbja.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 1 dose (1.7 ml) embedded in bait contains:
Maltese: Doża 1 (1.7 ml) inkorporata f'lixka fiha:
English: The distribution rate depends on the topography, on the population density of the target species and on the epizootiological situation.
Maltese: Ir-rata ta' distribuzzjoni tiddependi fuq it-topografija, fuq id-densità tal-popolazzjoni tal-ispeċi fil-mira, u fuq is-sitwazzjoni epiżootjoloġika.
English: The vaccination should be preferably carried out biannually (e.g. in spring and autumn), for a number of consecutive years, for at least two years after the last confirmed case of rabies in the region; however vaccination should not be attempted when temperatures are expected to reach 25 °C or more, and never during the summer season.
Maltese: Preferibbilment it-tilqim għandu jsir kull sentejn (eż. firrebbiegħa u fil-ħarifa), għal għadd ta' snin konsekuttivi, għal tal-anqas sentejn wara l-aħħar każ ikkonfermat ta' rabbja fir-reġjun; madankollu t-tilqim ma għandux jingħata meta t-temperaturi jkunu mistennija jaqbżu l-25°C, u qatt matul l-istaġun tas-sajf.
English: Vaccine baits are not suitable for vaccination of domestic animals.
Maltese: Il-lixki tal-vaċċini mhumiex adatti għat-tilqim ta' annimali domestiċi.
English: Vaccination should not be attempted when temperatures are expected to reach 25 °C or more, and never during the summer season.
Maltese: It-tilqim ma għandux jingħata meta t-temperaturi jkunu mistennija jaqbżu l-25 °C, u qatt matul listaġun tas-sajf.
English: Fishmeal Palm fat Coconut fat Paraffin
Maltese: FULJETT TA' TAGĦRIF
English: As each of these modifications on the genome were shown to further attenuate the SAD B19 virus strain, their multiple effect helps to avoid the reversion to the parental strain.
Maltese: Peress li kull modifika fuq il-ġenoma ntweriet li tkompli tattenwa r-razza tal-virus SAD B19, l-effett multiplu tagħhom jgħin biex tiġi evitata r-riverżjoni għarrazza parentali.
English: The vaccination should be preferably carried out biannually (e.g. in spring and autumn), for a number of consecutive years, for at least two years after the last confirmed case of rabies in the region, however vaccination should not be attempted when temperatures are expected to reach 25 °C or more, and never during the summer season.
Maltese: Preferibbilment it-tilqim għandu jsir kull sentejn (eż. fir-rebbiegħa u fil-ħarifa), għal għadd ta' snin konsekuttivi, għal tal-anqas sentejn wara l-aħħar każ ikkonfermat ta' rabbja fir-reġjun, madankollu t-tilqim ma għandux isir meta t-temperaturi jkunu mistennija jaqbżu l25°C, u qatt matul l-istaġun tas-sajf.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years at/below -15 °C.
Maltese: Żmien kemm idum tajjeb il-prodott mediċinali veterinarju kif ippakkjat għall-bejgħ: Sentejn f'temperatura ta' -15°C jew inqas.
English: Plastic foil sleeves or bags in cardboard boxes of:
Maltese: Pakketti jew boroż tal-plastik f'kaxxi tal-kartun ta':
English: The vaccination campaigns in rabies-free areas should be designed in such a way that the area covers a 50 km belt ahead of the rabies front.
Maltese: Il-kampanji ta' tilqim f'żoni ħielsa mir-rabbja għandhom ikunu ddisinjati b'tali mod li ż-żona tkopri medda ta' 50 km madwar iż-żona tar-rabbja.
English: Oxytetracycline hydrochloride (may be added as biomarker if requested by authorities)
Maltese: Kloridrat tal-oxitetraċiklina (jista' jiżdied bħala bijomarkatur jekk l-awtoritajiet jitolbu hekk)
English: A higher distribution density is recommended in areas with a high population density of foxes/raccoon dogs.
Maltese: Densità ogħla ta' distribuzzjoni hija rrakkomandata f'żoni b'densità għolja tal-popolazzjoni ta' volpijiet/klieb rakkun.
English: Therefore the recommendations / request of the duly designated competent authority are followed concerning distribution rate, vaccination area, distribution/baiting method and other local/areal conditions as specified by the competent authority.
Maltese: Għalhekk għandhom jiġu segwiti r-rakkomandazzjonijiet / talba tal-awtorità kompetenti debitament desinjata fir-rigward tar-rata ta' distribuzzjoni, iż-żona tat-tilqim, il-metodu ta' distribuzzjoni/lixkar u l-kundizzjonijiet lokali/tażżona kif speċifikat mill-awtorità kompetenti.
English: Restricted to duly designated competent authorities.
Maltese: Ristrett għal awtoritajiet kompetenti debitament deżinjati.
English: Aerial distribution of the baits by any suitable flight devices (such as airplane, helicopter, drones or similar) is recommended for open or sparsely populated areas, and manual distribution in areas with a high human population.
Maltese: Fil-każ ta' żoni miftuħin jew b'popolazzjoni baxxa hija rakkomandata distribuzzjoni tal-lixki mill-ajru b'apparat xieraq ta' titjir (bħal ajruplan, ħelikopter, drones jew simili), u distribuzzjoni manwali f'żoni b'popolazzjoni umana kbira.
English: Water for injections Sucrose
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA
English: Immunized animals are protected against field rabies virus infection and do not transmit rabies.
Maltese: L-annimali immunizzati huma protetti kontra infezzjoni bil-virus tar-rabbja fuq il-post u ma jittrażmettux ir-rabbja.
English: Rabitec is a live modified rabies vaccine for oral administration to foxes and raccoon dogs.
Maltese: Rabitec huwa vaċċin ħaj modifikat tar-rabbja għall-għoti orali lill-volpijiet u lill-klieb rakkun.
English: The vaccine suspension is filled in polymer/aluminium blisters which are embedded in a bait matrix attractive for the target species.
Maltese: Tilqima likwida ġewwa folji tal-polimeru/aluminju li hija inkorporata f'matriċi ta' lixka attraenti għall-ispeċi fil-mira.
English: NAME OF THE MARKETING AUTHORISATION HOLDER IDT Biologika, Germany
Maltese: FIS-SUQ IDT Biologika, Il-Ġermanja
English: Aerial baiting is not recommended in the vicinity of water (lakes, rivers, water reservoirs) neither in densely populated areas.
Maltese: Lixkar mill-ajru mhuwiex rakkomandat f'żoni qrib l-ilma (għadajjar, xmajjar, ġibjuni tal-ilma) u lanqas f'żoni b'popolazzjoni densa.
English: The thawed vaccine may be stored for up to 7 days at 2 °C - 8 °C before use; however baits for which the cooling chain was disrupted, because they were not stored in a refrigerator, should be destroyed.
Maltese: It-tilqima maħlula tista' tinħażen għal mhux aktar minn sebat ijiem f'temperatura ta' bejn 2°C - 8°C qabel l-użu, iżda lixki li l-katina tat-tkessiħ tagħhom tkun ġiet imfixkla, minħabba li ma jkunux ġew maħżuna fi friġġ, għandhom jinqerdu.
English: Vaccine:
Maltese: Paraffina
English: TARGET SPECIES Foxes, raccoon dogs
Maltese: HUWA INDIKAT IL-PRODOTT Volpijiet, klieb rakkun
English: Medicines should not be disposed of via wastewater or household waste.
Maltese: Il-lixki tal-vaċċini mhumiex intiżi għat-tilqim ta' annimali domestiċi.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/08/443/001 Thalidomide Celgene 50 mg Capsule, hard
Maltese: EU/1/08/443/001 Thalidomide Celgene 50 mg Kapsula, iebsa Użu orali folja (PCTFE/PVC/aluminju) 28 kapsula
English: Oral use blister (PCTFE/PVC/alu) 28 capsules
Maltese: Qawwa Għamla farmaċewtika
English: Clopidogrel Sandoz clopidogrel EPAR summary for the public
Maltese: Clopidogrel Sandoz clopidogrel Sommarju tal-EPAR għall-pubbliku
English: The active substance in Clopidogrel Sandoz, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Clopidogrel Sandoz, clopidogrel, hu inibitur ta' l-aggregazzjoni tal-platelets.
English: Other information about Clopidogrel Sandoz:
Maltese: Informazzjoni oħra dwar Clopidogrel Sandoz:
English: This means that Clopidogrel Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Clopidogrel Sandoz huwa ‘mediċina ġenerika' li jfisser li Clopidogrel Sandoz huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries); The medicine can only be obtained with a prescription.
Maltese: • pazjenti b'mard fl-arterji periferiku (problemi bil-fluss tad-demm fl-arterji); Il-mediċina tista' tinkiseb biss b'riċetta tat-tabib.
English: Clopidogrel Sandoz is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Clopidogrel Sandoz jintuża f'adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t-twebbis tal-arterji).