FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with von Willebrand disease, especially Type 3, may very rarely develop neutralising antibodies (inhibitors) to von Willebrand factor.
Maltese: Pazjenti bil-marda ta' von Willebrand, speċjalment ta' Tip 3, jistgħu jiżviluppaw b'mod rari ħafna, antikorpi (inibituri) newtralizzanti għall-fattur von Willebrand.
English: Check the expiry date, and ensure that the VEYVONDI powder and water for injections (solvent) are at room temperature prior to preparation.
Maltese: Iċċekkja d-data ta' skadenza, u żgura li t-trab ta' VEYVONDI u l-ilma għall-injezzjonijiet (solvent) ikunu fit-temperatura tal-kamra qabel il-preparazzjoni.
English: After reconstitution with the 10 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.
Maltese: Wara r-rikostituzzjoni bis-solvent ta' 10 mL ipprovdut, VEYVONDI jkun fih madwar 130 IU/mL vonicog alfa.
English: 2304 Orth an der Donau AUSTRIA
Maltese: Orth an der Donau L-AWSTRIJA
English: Treatment of bleeding episodes (On-demand treatment) Dosage and frequency must be individualized based on clinical judgment, taking into account of severity of bleeding episode, site of bleeding, patient's medical history, monitoring of appropriate clinical and laboratory measures (both VWF:RCo and FVIII:C levels).
Maltese: Id-dożaġġ u l-frekwenza jridu jiġu individwalizzati skont il-ġudizzju kliniku, waqt li jiġu kkunsidrati s-severità tal-episodju tal-ħruġ ta' demm, is-sit tal-ħruġ ta' demm, l-istorja medika tal-pazjent, il-monitoraġġ tal-kejl kliniku u tal-laboratorju xierqa (kemm tal-livelli ta' VWF:RCo kif ukoll tal-livelli ta' FVIII:C).
English: Administration of VEYVONDI allows correction of the haemostatic abnormalities exhibited by patients who suffer from von Willebrand factor deficiency (von Willebrand's disease) at two levels: - VEYVONDI re-establishes platelet adhesion to the vascular sub-endothelium at the site of vascular damage (as it binds both to the vascular sub-endothelium matrix (e.g. collagen) and to the platelet membrane), providing primary haemostasis as shown by the shortening of the bleeding time.
Maltese: - VEYVONDI jerġa' jistabbilixxi l-adeżjoni tal-plejtlits mas-sottoendotilju vaskulari fis-sit tal-ħsara vaskulari (billi jeħel kemm mal-matriċi tas-sottoendotilju vaskulari (eż. collagen) kif ukoll mal-membrana tal-plejtlits), u b'hekk jipprovdi emostasi primarja kif muri mit-tqassir tal-ħin ta' ħruġ ta' demm.
English: Thromboembolic events may occur in case of major overdose.
Maltese: Avvenimenti tromboemboliċi jistgħu jseħħu fil-każ ta' doża eċċessiva maġġuri.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with VEYVONDI in all subsets of the paediatric population in the treatment of von Willebrand Disease (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'VEYVONDI f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fit-trattament tal-Marda ta' von Willebrand (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Pregnancy and breast-feeding
Maltese: Parestesija fis-sit tal-infużjoni
English: The complete dose of VEYVONDI should be administered followed by rFVIII within 10 minutes.
Maltese: Id-doża sħiħa ta' VEYVONDI għandha tingħata, segwita minn rFVIII fi żmien 10 minuti.
English: PC:
Maltese: Eċċipjenti:
English: If your FVIII level is inadequate your doctor may give you a dose of 40-60 IU/kg VEYVONDI 12-24 hours (pre-operative dose) prior to initiating elective surgery in order to raise FVIII levels to the target level (0.4 IU/mL for minor and at least 0.8 IU/mL for major surgery).
Maltese: IU/kg ta' VEYVONDI 12-24 siegħa (doża qabel l-operazzjoni) qabel il-bidu tal-operazzjoni mhux obbligatorja sabiex jogħlew il-livelli ta' FVIII għal-livell fil-mira (0.4
English: The contents of each vial of rVWF and rFVIII can be drawn into a single syringe by using a separate unused reconstitution device (see 6.2 for incompatibilities).
Maltese: Il-kontenut ta' kull kunjett ta' rVWF u rFVIII jista' jinġibed ġo siringa waħda billi jintuża tagħmir separat u mhux użat għar-rikostituzzjoni (ara 6.2 għal inkompatibbiltajiet).
English: Vertigo
Maltese: Sturdament
English: c[(IU/dL)/(U VWF:RCo/kg)]
Maltese: AUC0-inf/Dożae a[sigħat], b[dL/kg/sigħat], c[(IU/dL)/(U VWF:RCo/kg)] d[(h*IU/dL)] e[(h*IU/dL)/(IU VWF:RCo/kg)] [intużaw assaġġi ta' VWF:RCo b'meded differenti ta' sensittività u operat:
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA/I) BIJOLOĠIKA(ĊI) ATTIVA/I
English: Level a surgery) (IU VWF:RCo required)
Maltese: Doża tal-Bidu a (IU VWF:RCo/kg ta' piż tal-ġisem)
English: Use in children and adolescents VEYVONDI is not approved for use in children and adolescents below 18 years.
Maltese: Tfal u adolexxenti VEYVONDI mhuwiex approvat għall-użu fit-tfal jew fl-adolexxenti ta' taħt it-18-il sena.
English: To ensure pre-operative endogenous FVIII levels of at least 0.4 IU/mL for minor and oral and 0.8 IU/mL for major surgery, a dose of 40-60 IU/kg VEYVONDI may be administered 12-24 hours (pre-operative dose) prior to initiating elective surgery.
Maltese: IU/mL għal operazzjoni minuri u orali u - mill-inqas 0.8 IU/mL għal operazzjoni maġġuri, doża ta' VEYVONDI waħdu għandha tingħata fi żmien siegħa (1) qabel il-proċedura.
English: In major bleeding episodes, maintain trough levels of VWF:RCo greater than 50% for as long as deemed necessary.
Maltese: F'episodji maġġuri ta' ħruġ ta' demm, livelli minimi ta' VWF:RCo ta' aktar minn 50% għandhom jinżammu għal sakemm ikun ikkunsidrat li hu meħtieġ.
English: Side effects are similar in children.
Maltese: Fittfal kien hemm effetti sekondarji simili.
English: EMA/695864/2013 EMEA/H/C/001200
Maltese: EMEA/H/C/001200
English: The vaccine contains a flu strain called A/VietNam/1203/2004 (H5N1).
Maltese: Il-vaċċin fih razza ta' influwenza msejħa A/VietNam/1203/2004 (H5N1).
English: The full EPAR for Pandemic Influenza Vaccine H5N1 Baxter AG can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għall-vaċċin tal-Influwenza Pandemika H5N1 Baxter AG jista' jinstab fuq is-sit talAġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: At 21 days after the second injection, 72% of the adults below 60 years of age (192 out of 265) and 74% of those above 60 years of age (200 out of 270) had levels of antibodies that would protect them against H5N1.
Maltese: Wara 21 jum mit-tieni injezzjoni, 72 % tal-adulti ta' taħt is-60 sena (192 minn 265) u 74 % ta' dawk 'il fuq minn 60 sena (200 minn 270) kellhom livelli ta' antikorpi li kienu jippoteġuhom kontra l-H5N1.
English: Similarly in children, after the second 7.5-microgram dose, 85% of children aged 9 to 17 years, 73% of those 3 to 8 years, and 69% of those aged 6 to 35 months had protective levels of antibodies 21 days after the second injection.
Maltese: B'mod simili fit-tfal, wara t-tieni doża ta' 7.5 mikrogrammi, 85% tat-tfal ta' bejn id-9 u s-17-il sena, 73% minn dawk ta' bejn it-3 snin u t-8 snin, u 69% ta' dawk bejn 6 xhur u 35 xahar kellhom livelli protettivi ta' antikorpi 21 jum wara t-tieni injezzjoni.
English: One main study in adults included 561 healthy volunteers, 281 of whom were over the age of 60 years.
Maltese: Studju ewlieni minnhom inkluda 561 voluntier f'saħħtu, 281 minnhom kellhom 'il fuq minn 60 sena.
English: Pandemic Influenza Vaccine H5N1 Baxter AG
Maltese: Vaċċin tal-Influwenza Pandemika H5N1 Baxter AG
English: The second main study involved 305 children aged 9 to 17 years, 306 aged 3 to 8 years and 73 aged 6 to 35 months, and also examined the effect of two 7.5 microgram doses of the vaccine 21 days apart.
Maltese: It-tieni studju ewlieni involva 305 itfal ta' bejn id-9 u s-17-il sena, 306 itfal li kellhom bejn 3 snin u 8 snin u 73 tarbija li kellhom bejn 6 xhur u 35 xahar, kif ukoll eżamina l-effetti ta' żewġ dożi ta' 7.5 mikrogrammi tal-vaċċin 21 jum ‘il bogħod minn xulxin.
English: whole virion influenza virus, propagated in vero cells (continuous cell line of mammalian origin), inactivated, containing antigen of pandemic strain
Maltese: Virus tal-influwenza virjon sħiħ, propagat f'ċelloli vero (linja kontinwa taċċelloli ta' oriġini mammifera, mhux attivat, li jkun fih antiġen ta' razza pandemika
English: The main measure of effectiveness was the production of protective levels of antibodies 21 days after the second vaccination.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-produzzjoni ta' livelli protettivi ta' antikorpi wara 21 jum mit-tieni vaċċinazzjoni.
English: The study looked at the ability of two 7.5 microgram doses of the vaccine, given 21 days apart, to trigger the production of antibodies (‘immunogenicity').The main measures of effectiveness were the levels of antibodies against the flu virus in the blood before vaccination, on the day of the second injection (day 21), and 21 days after the second vaccination (day 42).
Maltese: Listudju eżamina l-abilità ta' żewġ dożi ta' 7.5-mikrogrammi tal-vaċċin, mogħtija 21 jum imbegħda minn xulxin, sabiex iqanqlu l-produzzjoni ta' antikorpi (“immunoġeniċiti”).
English: Although levels of antibodies slowly fell over the year after vaccination, a booster dose after 12 months resulted in protective levels of antibodies in 93 to 100% of children who received it.
Maltese: Minkejja li l-livelli ta' antikorpi bdew neżlin bil-mod fl-ewwel sena wara l-vaċċinazzjoni, doża ta' buster wara 12-il xahar wasslet għal-livelli protettivi ta' antikorpi fi 93 sa 100% tat-tfal li ħaduha.
English: It contains influenza (flu) viruses that have been inactivated (killed).
Maltese: Fih virusis tal-influwenza li ġew diżattivati (maqtula).
English: According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of adults for it to be considered suitable.
Maltese: Skont il-kriterji stabbiliti mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), vaċċin finta huwa meħtieġ joħloq livelli ta' protezzjoni ta' antikorpi f'mhux inqas minn 70 % tal-adulti biex jitqies xieraq.
English: When the company that makes Pandemic Influenza Vaccine H5N1 Baxter AG includes the flu strain responsible for a pandemic in the vaccine, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Maltese: Meta l-kumpanija li tagħmel il-vaċċin tal-Influwenza Pandemika H5N1 Baxter AG tinkludi r-razza talinfluwenza responsabbli għal pandemija fil-vaċċin, se tiġbor informazzjoni dwar is-sigurtà u l-effettività tal-vaċċin pandemiku finali, u jissottomettu dan is-CHMP għal evalwazzjoni.
English: Pandemic Influenza Vaccine H5N1 Baxter AG is a vaccine to prevent ‘pandemic' flu.
Maltese: Il-Vaċċin tal-Influwenza Pandemika H5N1 Baxter AG huwa vaċċin biex jipprevjeni l-influwenza “pandemika”.
English: Pandemic Influenza Vaccine H5N1 Baxter AG is a ‘mock-up' vaccine.
Maltese: Il-vaċċin tal-Influwenza Pandemika H5N1 Baxter AG huwa vaċċin “finta”.
English: This is a summary of the European public assessment report (EPAR) for Pandemic Influenza Vaccine H5N1 Baxter AG.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal vaċċin għall-influwenza prepandemika H5N1 Baxter AG.
English: This summary was last updated in 11-2013.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fil-11-2013.
English: The company that made the Celvapan H5N1 mock-up vaccine has agreed that its scientific data can be used for Pandemic Influenza Vaccine H5N1 Baxter AG (‘informed consent').
Maltese: Il-kumpanija li pproduċiet il-vaċċin finta Celvapan H5N1 qablet li l-informazzjoni xjentifika tagħha tista' tintuża għal Vaċċin tal-Influwenza Pandemika H5N1 Baxter AG (“b'kunsense infurmat”).
English: What is the risk associated with Pandemic Influenza Vaccine H5N1 Baxter AG?
Maltese: X'inhu r-riskju tal-Vaċċin tal-Influwenza Pandemika H5N1 Baxter AG?
English: This vaccine is the same as the Celvapan H5N1 mock-up vaccine, which was previously authorised in the European Union (EU).
Maltese: Dan il-vaċċin huwa l-istess bħall-vaċċin finta Celvapan H5N1, li diġà kien awtorizzat fl-Unjoni Europea (UE).
English: The vaccine must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as formaldehyde, benzonase or sucrose.
Maltese: Il-vaċċin ma għandux jingħata lil nies li fil-passat kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill-komponenti tal-vaċċin, jew għal kwalunkwe sustanza li tinsab f'livelli ta' traċċi (ftit ħafna) fil-vaċċin, formalididrid, il-benzonase jew iz-zokkor tal-kannamieli.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pandemic Influenza Vaccine H5N1 Baxter AG on 16 October 2009.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għall-vaċċin tal-Influwenza Pandemika H5N1 Baxter AG lil Baxter AG fis-16 ta' Ottubru 2009.
English: The most common side effects with Pandemic Influenza Vaccine H5N1 Baxter AG in adults (seen in more than 1 person in 10) are headache, fatigue (tiredness) and pain at the site of the injection.
Maltese: L-effetti sekondarji l-aktar komuni bil-Vaċċin tal-Influwenza Pandemika H5N1 Baxter AG (li dehru f'aktar minn pazjent 1 minn 10) huma wġigħ ta' ras, għeja u wġigħ fil-post fejn saret l-injezzjoni .
English: Other information about Pandemic Influenza Vaccine H5N1 Baxter AG
Maltese: Informazzjoni oħra dwar il-Vaċċin tal-Influwenza Pandemika H5N1 Baxter AG:
English: Pandemic Influenza Vaccine H5N1 Baxter AG is given by injection into the shoulder muscle or thigh in two doses, at least three weeks apart.
Maltese: Il-vaċċin tal-Influwenza Pandemika H5N1 Baxter AG jingħata b'injezzjoni fil-muskolu tal-parti ta' fuq tad-driegħ jew fil-koxxa f'żewġ dożi, mill-anqas bi tliet ġimgħat bejniethom.
English: The CHMP decided that Pandemic Influenza Vaccine H5N1 Baxter AG's benefits are greater than its risks in all age groups investigated and recommended that it be given marketing authorisation.
Maltese: Is-CHMP ddeċieda li l-benefiċċji tal-vaċċin kontra l-influwenza pandemika H5N1 Baxter AG huma akbar mir-riskji tiegħu fil-gruppi ta' etajiet kollha investigati u rrakkomanda li jingħata l-awtorizzazzjoni għattqegħid fis-suq.
English: What information is still awaited for Pandemic Influenza Vaccine H5N1 Baxter AG?
Maltese: Liema informazzjoni għadha mistennija għall-Vaċċin tal-Influwenza Pandemika H5N1 Baxter AG ?
English: What is Pandemic Influenza Vaccine H5N1 Baxter AG?
Maltese: Kif jaħdem il-vaċċin tal-Influwenza Pandemika H5N1 Baxter AG?
English: A risk management plan has been developed to ensure that Pandemic Influenza Vaccine H5N1 Baxter AG is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li l-vaċċin tal-Influwenza Pandemika H5N1 Baxter AG jintuża bl-aktar mod sikur possibbli.
English: The viruses used in Pandemic Influenza Vaccine H5N1 Baxter AG are grown in mammal cells (‘vero cells'), unlike those in some other flu vaccines, which are grown in hen's eggs.
Maltese: Il-virusis użati fil-vaċċin tal-Influwenza Pandemika H5N1 Baxter AG jitkabbru f'ċelloli tal-mammiferi (“ċelloli vero”), kuntrarjament għal dawk użati f'vaċċini oħra tal-influwenza, li jitkabbru fil-bajd tattiġieġ.
English: For more information about treatment with Pandemic Influenza Vaccine H5N1 Baxter AG, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Maltese: Għal aktar informazzjoni rigward it-trattament bil-vaċċin tal-influwenza Pandemika (H5N1) Baxter AG, aqra l-fuljett tat-tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: Fatro Polska Sp. z o.o.
Maltese: Fatro Polska Sp. z o.o. ul.
English: B-2321 Hoogstraten Belgium
Maltese: B-2321 Hoogstraten
English: 5 days.
Maltese: 5 ijiem.
English: Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Maltese: Meloxicam huwa metabolizzat għal alkoħol, derivattiv tal-aċidu u għal diversi metaboliti polari.
English: GR-190 02 ΠΑΙΑΝΙΑ Τηλ: + 30 210 6644331
Maltese: Τηλ: + 30 210 6644331
English: I-40064 Ozzano dell'Emilia - Bologna Tel: +39 051 6512711
Maltese: Ozzano dell'Emilia - Bologna Tel: +39 051 6512711
English: Matije Gupca 42
Maltese: Vet Consulting d.o.o. Matije Gupca 42
English: Date of first authorisation: 18.08.2011 Date of last renewal: 21.06.2016
Maltese: Data tal-ewwel awtorizzazzjoni: 18.08.2011 Data tal-aħħar tiġdid: 21.06.2016
English: SC Altius SRL Str Iancu Capitanu nr 38 Ap 1 Sector 2, Bucuresti - RO Tel: + 40 021 310 88 80
Maltese: Str Iancu Capitanu nr 38 Ap 1 Sector 2, Bucuresti - RO Tel: + 40 021 310 88 80
English: - The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: ChemVet dk A/S A.C. Illums Vej 6
Maltese: ChemVet dk A/S A.C.
English: Cattle: S.C., I.V.
Maltese: S.C., I.V.
English: CZ-254 49 Jílové u Prahy Tel: +420 241 950 383
Maltese: 49 Jílové u Prahy Tel: +420 241 950 383
English: Manufacturer responsible for batch release: Produlab Pharma bv
Maltese: Manifattur responsabbli għall-ħrug tal-lott: Produlab Pharma bv
English: 15 days;
Maltese: 15-il jum;
English: Azienda Terapeutica Italiana A.T.I.
Maltese: Azienda Terapeutica Italiana A.T.I. s.r.l. Via Emilia 285
English: DD.MM.YYYY
Maltese: JJ.MM.SSSS
English: Richter Pharma AG Feldgasse 19, A A-4600 Wels Tel: +43 7242 490 0
Maltese: Richter Pharma AG Feldgasse 19, A A-4600
English: Ethanol (96%) Poloxamer 188
Maltese: Ethanol (96%) 150 mg
English: Bovine, caprine
Maltese: mogħoż, qżieżeż,
English: 150 mg For the full list of excipients, see section 6.1.
Maltese: 150 mg Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Emdoka bvba J. Lijsenstraat 16 B-2321 Hoogstraten Belgium
Maltese: Emdoka bvba J. Lijsenstraat 16
English: Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.
Maltese: Meloxicam jiġi eliminat b'half-life ta' 26 siegħa u 17.5 sigħat wara li jingħata b'injezzjoni taħt il-ġilda f'baqar żgħar u f'baqar li jkunu li qed ireddgħu, rispettivament.
English: For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Maltese: Għal terapija addizzjonali fit-trattament ta' settiċemija puwerperali u tossemija (sindrome mastite metrite-agalaktja) flimkien ma' terapija antibijotika adattata.
English: IM
Maltese: U
English: I.M.
Maltese: Majjali: I.M.
English: QUANITITY OF THE ACTIVE SUBSTANCE(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Pack size of 1 colourless Type I glass vial containing 50 ml, 100 ml or 250 ml.
Maltese: Daqs tal-pakkett tal-kunjett tal-ħġieġ ta' Tip I bla kulur li fih 50 ml, 100 ml jew 250 ml.
English: Horses: IV
Maltese: SC, IV
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 µg/ml and 2.7 µg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Maltese: Wara l-għoti ta' doża waħda taħt il-ġilda ta' 0.5 mg ta' meloxicam/kg, intlaħqu valuri Cmax ta' 2.1 µg/ml u 2.7 µg/ml wara 7.7 sigħat u 4 sigħat f'baqar żgħar u f'baqar li jkunu qed ireddgħu,
English: Single intravenous injection at a dose of 0.6 mg meloxicam/kg body weight (i.e. 3 ml/100 kg body weight).
Maltese: Injezzjoni waħda ġol-vina b'doża ta' 0.6 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e. 3 ml/ 100 kg ta' piż tal-ġisem).
English: PACKAGE SIZE(S)
Maltese: DAQS TAL-PAKKETT(I)
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, anti-exudative, analgesic and antipyretic effects.
Maltese: 5.1 Tagħrif farmakodinamiku Meloxicam hu Mediċina Mhux Sterojdi Kontra l-Infjammazzjoni (NSAID) tal-klassi oxicam li taġixxi bl-inibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita effetti anti-infjammatorji, kontra t tnixxija, analġesiċi u antipiretiċi.
English: People with known hypersensitivity to Non-Steroidal AntiInflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Maltese: Nies li huma sensittivi għal Mediċini Mhux Sterojdi Kontra l-Infjammazzjoni (NSAIDs) għandhom jevitaw li jmissu mal-prodott mediċinali veterinarju.
English: If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Maltese: Jekk ikun hemm reazzjonijiet mhux mixtieqa, it-trattament għandu jitwaqqaf u għandu jittieħed il parir ta' veterinarju.
English: Pharmacologically active substance
Maltese: Sustanza farmakoloġikamen t attiva
English: Cattle: meat and offal: 15 days; milk: 5 days
Maltese: laħam u ġewwieni tal-annimali: 15-il jum; ħalib: 5 ijiem
English: Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant medicinal products.
Maltese: M'għandux jingħata flimkien ma' glukokortikosterojdi, sustanzi anti-infjammatorji oħrajn mhux sterojdiċi u jew ma' prodotti mediċinali antikoagulanti.
English: Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.
Maltese: thromboxane B2 ikkaġunata mill-għoti ta' E. coli endotoxin fl-għoġġiela, baqar li jkunu qed ireddgħu u majjali.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06
Maltese: Prodotti anti-infjammatorji u antirewmatiċi, mhux sterojdiċi
English: Interactions with other medicinal products and other forms of interaction:
Maltese: Interazzjoni ma' prodotti mediċinali oħrajn u forom oħrajn ta' interazzjoni:
English: Excipient:
Maltese: Żwiemel:
English: Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.
Maltese: Evita l-użu f'annimali li huma deidratati, ipovolemiċi jew ipotensivi severament, li jkunu jeħtieġu idratazzjoni mill-ġdid permezz ta' injezzjoni, għax jista' jkun hemm riskju potenzjali ta' tossiċità tal kliewi.
English: Metabolism
Maltese: meloxicam
English: Withdrawal periods: Cattle: meat and offal: 15 days; milk: 5 days.
Maltese: laħam u ġewwieni tal-annimali: 15-il jum; ħalib: 5 ijiem.
English: meat and offal: 5 days
Maltese: laħam u ġewwieni tal-annimali: 5 ijiem
English: Emdocam 20 mg/ml solution for injection for cattle, pigs and horses meloxicam
Maltese: VETERINARJU Emdocam 20 mg/ml soluzzjoni għall-injezzjoni għal baqar, majjali u żwiemel.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON - 50, 100 or 250 ml vials
Maltese: KARTUNA TA' BARRA - 50, 100 jew 250 ml kunjetti
English: Sodium hydroxide Hydrochloric acid Meglumine Water for injections
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni