FrancophonIA/ELRC3.0 huggingface dataset:
English: Component of a multipack, can't be sold separately.
Maltese: Parti minn pakkett multiplu, ma jistgħux jinbiegħu b'mod separat.
English: 200 mg once daily followed by 200 mg twice daily
Maltese: 200 mg darba kuljum segwita minn
English: No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and one subject with HCV genotype 1b infection experienced relapse.
Maltese: L-ebda individwu b'infezzjoni tal-ġenotip 1b HCV ma esperjenza nuqqas viroloġiku fil-kura u individwu wieħed b'infezzjoni tal-ġenotip 1b HCV esperjenza rikaduta.
English: MA (EU) number (Invented) name Strength
Maltese: Numru tal-MA (UE)
English: EU/2/11/129/001 1 x 1 dose EU/2/11/129/002 2 x 1 dose EU/2/11/129/003 5 x 1 dose EU/2/11/129/004 10 x 1 dose
Maltese: EU/2/11/129/001 1 x doża EU/2/11/129/002 2 x doża EU/2/11/129/003 5 x doża EU/2/11/129/004 10 x doża
English: 1 x 1 dose 2 x 1 dose 5 x 1 dose 10 x 1 dose
Maltese: 1 x doża 2 x doża 5 x doża 10 x doża
English: Sodium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Maltese: Sodium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Ilma għall-injezzjonijiet
English: Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 Lyon
Maltese: MERIAL, Laboratorju ta' Lyon Gerland 254, rue Marcel Mérieux 69007 Lyon
English: ATC vet code: QI05AX.
Maltese: Q105AX.
English: CONTRAINDICATION
Maltese: KONTRAINDIKAZZJONIJIET
English: West Nile (vCP2017) ........................................................................................ 6.0 to 7.8 log10 CCID50
Maltese: West Nile (vCP2017) ........................................................................................ 6.0 sa 7.8 log 10 CCID50
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest France
Maltese: Laboratoire Porte des Alpes Rue de l'Aviation 69800
English: Store and transport refrigerated (2 °C-8 °C).
Maltese: Aħżen u ttrasporta ġo friġġ (2 °C-8 °C).
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, 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: Date of first authorisation: 05/08/2011 Date of last renewal: 17/05/2016
Maltese: Data tal-aħħar tiġdid: 17/05/2016
English: To stimulate active immunity against West Nile virus.
Maltese: Biex jistimola immunità attiva kontra l-West Nile Virus.
English: Active substance:
Maltese: Sustanzi Attivi:
English: Box of 1, 2, 5 or 10 vial(s) of 1 dose.
Maltese: Kaxxa ta' 1, 2, 5 jew 10 fjal(i) ta' doża.
English: Vaccination may interfere with existing sero-epidemiological surveys.
Maltese: It-tilqim jista' ifixkel indaġini eżistenti sero-epidemioloġiċi.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Pharmacotherapeutic group: Immunologicals for equidae, other immunologicals.
Maltese: Immunoloġiċi għall-equidæ.
English: Horses.
Maltese: Biss.
English: Carbomer ......................................................................................................................................... 4 mg For the full list of excipients, see section 6.1.
Maltese: Carbomer ............................................................................................................................................ 4 mg Għall-lista sħiħa ta' l-ingredjenti mhux attivi, ara s-sezzjoni 6.1.
English: Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Maltese: Sid l-Awtorizzazzjoni tal-Kummerċ : Boehringer Ingelheim Vetmedica GmbH 55216
English: The vaccine strain vCP2017 is a recombinant canarypox virus expressing the preM/E genes of West Nile virus.
Maltese: L-istrejn vCP2017 tal-vaċċin huwa virus rikombinat tal-canarypox li jesprimi il-ġeni .preM/E tal-virus West Nile.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U MANIFATTUR
English: Any person intending to manufacture, import, possess, sell, supply and use Proteq West Nile must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Maltese: Kull persuna li turi l-intenzjoni li timmanifattura, timporta,tippossjedi, tbigħ, tipprovdi u tuża Proteq West Nile għandha tikkonsulta ma' l-Awtorità Kompetenti ta' l-Istat Membru dwar ilprogrammi ta' tilqim kurrenti qabel timmanifattura, timporta, tippossjedi, tbigħ, tipprovdi u/jew tuża.
English: EXP {month/year}
Maltese: EXP.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U LMANIFATTUR RESPONSABBLI
English: Proteq West Nile suspension for injection
Maltese: Proteq West Nile suspensjoni għall-injezzjoni.
English: Homogeneous opalescent suspension.
Maltese: Suspensjoni omoġenja opalexxenti.
English: As a consequence, these proteins induce protective immunity against equine West Nile disease.
Maltese: Konsegwentement, dawn il-proteini jinduċu immunità protettiva kontra -marda West Nile fiż-żwiemel.
English: A transient swelling (max. diameter 5 cm) which resolves within 4 days may appear commonly at the injection site.
Maltese: Normalment jista' jkun hemm nefħa transitorja fil-post tal-injezzjoni (dijametru massimu ta' 5 cm) li tinżel fi żmien erbat ijiem.
English: Proteq West Nile suspension for injection for horses
Maltese: VETERINARJU Proteq West Nile suspensjoni għall-injezzjoni għaż-żwiemel.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Maltese: M'hemmx informazzjoni dwar is-sigurtà u l-effikaċja ta' din it-tilqima meta tintuża flimkien ma kwalunkwe prodott mediċinali veterinarju ieħor.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Tħallatx ma prodotti oħra mediċinali veterinarji
English: • Primary vaccination course: first injection from 5 months of age, second injection 4-6 weeks later,
Maltese: • L-ewwel kors ta' tilqim: l-ewwel injezzjoni minn 5 xhur, it-tieni injezzjoni 4-6 ġimgħat wara.
English: Intramuscular use.
Maltese: Immunoloġiċi oħra.
English: However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile Virus.
Maltese: IgM-ELISA huwa indikatur qawwi ta' infezzjoni naturali bil-West Nile Virus.
English: A. LABELLING
Maltese: A.TIKKETTA
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma jew sustanzi ammissibbli li għalihom it-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 tindika li m'hemmx bżonn ta' l-ebda LRM jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju
English: No adverse reactions other than those already mentioned in the section “Adverse Reactions” have been observed after the administration of more than 10 doses.
Maltese: L-ebda effetti mhux mixtieqa, ħlief dawk deskritti taħt sezzjoni “Effetti mhux mixtieqa”, ma ġew osservati wara li ġew amministrati iżjed minn 10 dożi.
English: Pain and local hyperthermia can occur in rare cases.A slight increase in temperature (max. 1.5 °C) may occur in rare cases for 1 day, exceptionally 2 days.
Maltese: Għal ġurnata waħda u rarament għal tnejn, jista jkun hemm ħarira deni (massimu 1.5 ˚C) f'każijiet rari.
English: After inoculation, the virus does not multiply in the horse but expresses the protective proteins.
Maltese: Wara l-innokulazzjoni, il-virus ma jimmoltiplikax fiż-żiemel iżda jesprimi il-proteini protettivi.
English: West Nile recombinant canarypox virus (vCP2017) ....................................... 6.0 to 7.8 log10 CCID*50 * Cell culture infectious dose 50 %
Maltese: West Nile virus rikombinat tal-Canarypox (vCP2017) ......................................................................................................................... 6.0 sa 7.8 log 10 CCID*50
English: If infection is suspected as a result of a positive IgM response, additional testing would need to be conducted to conclusively determine whether the animal was infected or vaccinated.
Maltese: Jekk hemm suspett ta' infezzjoni b'risultat tar-rispons posittiv IgM, testijiet ulterjuri ikollhom isiru biex tiddetermina konklussivament jekk l-annimal kienx infettat jew imlaqqam.
English: Apathy, usually resolving within two days, and reduced appetite may be observed in rare cases the day after vaccination.
Maltese: Apatija u nuqqas ta' l-aptit jistgħu jiġu osservati f'każijiet rari l-għada tal-vaċċinazzjoni.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skond l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, Stat Membru jista' skont il-leġislazzjoni nazzjonali jipprojbixxi il-manifattura, l-importazzjoni, il-pussess, il-bejgħ,
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Maltese: .8 Effetti fuq prodotti mediċinali oħra jew effetti oħra M'hemmx informazzjoni dwar is-sigurtà u l-effikaċja ta' din it-tilqima meta tintuża flimkien ma kwalunkwe prodott mediċinali veterinarju ieħor.
English: The manufacture, import, possession, sale, supply and/or use of Proteq West Nile may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: Il-manifattura,l-importazzjoni, il-pussess, bejgħ, provvista u / jew l-użu ta' Proteq West Nile jista' jkun ipprojbit fi Stat Membru kollu jew ġo parti mit-Territorju tiegħu minħabba l-leġiżlazzjoni nazzjonali.
English: Active immunisation of horses from 5 months of age against West Nile disease by reducing the number of viraemic horses.
Maltese: Immunizzazzjoni attiva ta' żwiemel ta' 5xhur jew akbar kontra l-marda West Nile billi tnaqqas innumru ta' żwiemel li għandhom il-virus fid-demm.
English: Administer one dose of 1 ml, by intramuscular injection, preferably in the neck region, according to the following schedule:
Maltese: Amministra doża waħda ta' ml b'injezzjoni fil-muskolu, preferibbilment fl-għonq, skond din l-iskeda li ġejja:
English: Onset of immunity: 4 weeks after the first dose of the primary vaccination course.
Maltese: Bidu ta' l-immunità: 4 ġimgħat wara l-ewwel kors ta' tilqim.
English: For intramuscular use.
Maltese: Uża immedjatament la darba miftuħ.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanza(i) bioloġika(ċi) attiva(i)
English: GALDERMA ITALIA S.P.A VIA DELL'ANNUNCIATA, 21 20121 MILANO Italia
Maltese: S.P.A VIA DELL'ANNUNCIATA, 21 20121 MILANO Italia
English: Annex I List of medicinal products and presentations
Maltese: Anness I Lista ta' prodotti mediċinali u preżentazzjonijiet
English: Laboratorios Galderma S.A. Sucursal em Portugal Rua Alexandre Herculano, nº 8, 2799-554 Linda-a-Velha PORTUGAL
Maltese: Laboratorios Galderma S.A. Sucursal em Portugal Rua Alexandre Herculano, nº 8, 2799-554
English: BENZAC 10% Gel 10% Gel
Maltese: BENZAC 10% Gel 10% Ġell
English: Belgium Galderma Benelux B.V. Gravinnen van Nassauboulevard 91 4811 BN Breda
Maltese: Gravinnen van Nassauboulevard 91 4811 BN Breda
English: Italy
Maltese: GALDERMA ITALIA
English: Austria
Maltese: Spain
English: The Netherlands Galderma Benelux B.V. Gravinnen van Nassauboulevard 91 4811 BN Breda
Maltese: In-Netherlands Galderma Benelux B.V.
English: Luxembourg Galderma Benelux B.V. Gravinnen van Nassauboulevard 91 4811 BN Breda
Maltese: Il-Lussemburgu Galderma Benelux B.V.
English: Lot: {number}
Maltese: Lot {numru}
English: EXP {month/year}
Maltese: EXP {xahar/sena}
English: Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Maltese: Meloxicam huwa metabolizzat għal alkoħol, derivattiv ta' l-aċidu u għal diversi metaboliti polari.
English: QUANTITY OF THE ACTIVE SUBSTANCE
Maltese: Sustanza attiva:
English: Reduction of post-operative pain (over a period of 24 hours):
Maltese: Tnaqqis ta' l-uġigħ ta' wara l-operazzjoni (matul perjodu ta' 24 siegħa):
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class, which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Maltese: Meloxicam hu mediċina anti-infjammatorja mhux sterojdika(NSAID) tal-klassi oxicam li taġixxi bl-inibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita effetti anti-infjammatorji, analġesiċi, kontra t-tnixxija u antipiretiċi.
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' l-ingredjenti mhux attivi, ara s-sezzjoni 6.1.
English: Ethanol anhydrous 150 mg/ml.
Maltese: Ethanol 150 mg/ml.
English: Ethanol anhydrous Poloxamer 188 Glycofurol Meglumine Glycine
Maltese: Ethanol anhydrous Poloxamer 188
English: − very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: − rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: Excipients: Ethanol, anhydrous 150 mg.
Maltese: Sustanza(i) mhux attiva(i): Ethanol, anhydrous 150 mg.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06
Maltese: Prodotti anti-infjammatorji u anti-rewmatiċi, mhux sterojdi (oxicams)
English: Cats: single administration of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg).
Maltese: Qtates: għoti ta' darba ta' 0.3 mg meloxicam / kg ta' piż tal-ġisem (i.e. 0.06 ml/kg).
English: Active substance: Meloxicam 5 mg.
Maltese: Meloxicam 5 mg.
English: Sodium Chloride Sodium Hydroxide Water for injection
Maltese: Sodium hydroxide Glycofurol Meglumine Ilma għall-injezzjoni
English: Campifarma LDA Rua José Félix, Nº 5, Alfragide PT- 2610-094 Amadora Tel: + 351 211 929 009 info@campifarma.com
Maltese: Campifarma LDA Rua José Félix, Nº 5, Alfragide PT- 2610-094
English: In dogs, in very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been reported.
Maltese: Fil-klieb, f'każijiet rari ħafna, dijarea emorraġika, ematemesi u ulċerazzjoni gastrointestinali ġew irrappurtati.
English: Dogs: single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg).
Maltese: Klieb: għoti ta' darba ta' 0.2 mg meloxicam / kg ta' piż tal-ġisem (i.e. 0.4 ml/10 kg).
English: − uncommon (more than 1 but less than 10 animals in 1,000 animals)
Maltese: − mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal)
English: In the case of over dosage symptomatic treatment should be initiated.
Maltese: F'każ ta' doża eċċessiva, għandu jinbeda trattament sintomatiku.
English: Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 μg/ml in dogs and 1.1 μg/ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.
Maltese: Wara l-għoti taħt il-ġilda, meloxicam hu kompletament bijodisponibbli, u l-ogħla medja ta' konċentrazzjonijiet fil-plażma ta' 0.73 µg/ml, fil-klieb u 1.1 µg/ml fil-qtates intlaħqu wara madwar 2.5 sigħat u 1.5 sigħat wara l-għoti rispettivament.
English: − rare (more than 1 but less than 10 animals in 10,000 animals)
Maltese: − rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal)
English: METHOD AND ROUTES OF ADMINISTRATION
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: See section “Contraindications”.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Do not use after the expiry date stated on the carton and the vial.
Maltese: Tużax wara d-data ta' l-iskadenza (EXP) fuq il-kartuna u l-flixkun.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported.
Maltese: Reazzjonijiet avversi tipiċi ta' NSAIDs bħal nuqqas ta' aptit, rimettar, dijareja, demm moħbi fl-ippurgar, letarġija u insuffiċjenza tal-kliewi ġew irrappurtati xi kultant.
English: PACKAGE LEAFLET Acticam 5 mg/ml solution for injection for dogs and cats
Maltese: VETERINARJU Acticam 5 mg/ml soluzzjoni għall-injezzjoni għall-klieb u l-qtates.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia.
Maltese: Biex itaffi l-uġigħ ta' wara l-operazzjoni fil-qtates, is-sigurtà kienet dokumentata biss wara loppju b'thiopental/halothane.
English: Ecuphar NV Legeweg 157-i B-8020 Oostkamp Belgium
Maltese: United Kingdom Ecuphar NV Legeweg 157-i
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Maltese: Evita l-użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta' tossiċità tal-kliewi.
English: Date of first authorisation: 09/12/2008 Date of last renewal:09/12/2013
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 09.
English: People with known hypersensitivity to meloxicam should avoid contact with the veterinary medicinal product.
Maltese: Persuni li jafu li għandhom sensittività eċċessiva għal meloxicam għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: Read the package leaflet before use.
Maltese: DIKJARAZZJONI TA' L-MRLs Mhux applikabbli.
English: Pack sizes: Single 10 ml injection vial.
Maltese: Kunjett ta' l-injezzjoni ta' 10 ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Maltese: Prekawzjonijiet speċjali għall-użu
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see 4.3).
Maltese: Is-sigurtà tal-prodott mediċinali veterinarju ma ġietx stabbilita waqt it-tqala u fi żmien il-ħalib (Ara 4.3).
English: Legeweg 157-i BE-8020 Oostkamp Puh/Tel: + 32 (0)50 31 42 69 info@ecuphar.be
Maltese: Oostkamp Puh/Tel: + 32 (0)50 31 42 69 info@ecuphar.be
English: For animal treatment only - to be supplied only on veterinary prescription.
Maltese: Għal trattament ta' l-annimali biss - għandu jingħata biss bi preskrizzjoni veterinarja.
English: Acticam 5 mg/ml solution for injection for dogs and cats.
Maltese: Acticam 5 mg/ml soluzzjoni għall-injezzjoni għall-klieb u l-qtates.
English: Legeweg 157-i BE-8020 Oostkamp Tél/Tel: + 32 (0)50 31 42 69 info@ecuphar.be
Maltese: Oostkamp Tél/Tel: + 32 (0)50 31 42 69 info@ecuphar.be
English: Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).
Maltese: Injezzjoni waħda taħt il-ġilda b'dożaġġ ta' 0.2 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e. 0.4 ml/10 kg ta' piż tal-ġisem).
English: Legeweg 157-i BE-8020 Oostkamp Sími: + 32 (0)50 31 42 69 info@ecuphar.be
Maltese: Oostkamp Sími: + 32 (0)50 31 42 69 info@ecuphar.be
English: Musculo-skeletal disorders: single subcutaneous injection.
Maltese: Mard muskolu-skeletriku: injezzjoni waħda taħt il-ġilda.
English: Legeweg 157-i BE-8020 Oostkamp Tel.: + 32 (0)50 31 42 69 info@ecuphar.be
Maltese: Oostkamp Tel.: + 32 (0)50 31 42 69 info@ecuphar.be
English: Manufacturer for batch release
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD
English: Colourless type I glass injection vial of 10 ml, closed with a grey EPDM rubber stopper and sealed with a flip off aluminium seal.
Maltese: Għal kull tagħrif dwar dan il-prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir-rappreżentant lokali tad-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.
Maltese: Injezzjoni waħda ġol-vina jew taħt il-ġilda b'dożaġġ ta' 0.2 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e. 0.4 ml/10 kilogrammi ta' piż tal-ġisem), qabel l-operazzjoni, pereżempju meta jkun qed jingħata l-loppju.
English: Ecuphar NV Legeweg 157-i BE-8020 Oostkamp Tlf: + 32 (0)50 31 42 69 info@ecuphar.be
Maltese: Oostkamp Tlf: + 32 (0)50 31 42 69 info@ecuphar.be
English: Ecuphar NV Legeweg 157-i BE-8020 Oostkamp Τηλ: + 32 (0)50 31 42 69 info@ecuphar.be
Maltese: Oostkamp Τηλ: + 32 (0)50 31 42 69 info@ecuphar.be
English: Packaging
Maltese: Ilpakkett
English: MA (EU) Number
Maltese: Numru tal-proċedura ta' l-MA (EU)
English: 3 inhalers (3 x 30 doses) (multipack)
Maltese: 3 inalaturi (3 x 30 doża) (pakkett multiplu)
English: 7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg tablets
Maltese: Pillola miksija b'rita Użu orali folja (aluminju-PVC/PE/PVDC) 7 x 5 mg + 7 x 10 mg +
English: (Invented) name Strength Pharmaceutical form
Maltese: Qawwa Għamla farmaċewtika
English: Vyxeos liposomal N=153
Maltese: Vyxeos liposomali N=153
English: Tel: +44 8450305089 Email: medinfo-int@jazzpharma.com
Maltese: Tel: +44 8450305089 Indirizz elettroniku: medinfo-int@jazzpharma.com
English: Distearoylphosphatidylcholine Distearoylphosphatidylglycerol Cholesterol
Maltese: Distearoylphosphatidylcholine Distearoylphosphatidylglycerol Kolesterol
English: ADRs/Frequency (%)
Maltese: L-ADRs/Frekwenza (%)
English: Hypersensitivity (including rash)
Maltese: Komuni Sensittività eċċessiva (inkluż raxx)
English: Cardiotoxicity (72) Arrhythmia a
Maltese: Komuni Ħafna Kardjotossiċità (72) Aritmija a
English: Incidence of fatal cardiotoxicity events is 0.5%.
Maltese: L-inċidenza ta' avvenimenti ta' kardjotossiċità fatali hija 0.5 %.
English: The incidence of fatal infections was 6.9%.
Maltese: L-inċidenza ta' infezzjonijiet fatali kienet 6.9 %.
English: Dyspepsia (9.6)
Maltese: Komuni Dispepsja (9.6)
English: Arrhythmia a
Maltese: Komuni Aritmija a