FrancophonIA/ELRC3.0 huggingface dataset:
English: The other study, which compared RoActemra injected under the skin with RoActemra given by infusion, showed that RoActemra injected under the skin was no less effective in achieving a response after 6 months.
Maltese: L-istudju l-ieħor, li qabbel RoActemra injettat taħt il-ġilda ma' RoActemra mogħti b'infużjoni, wera li RoActemra injettat taħt il-ġilda ma kienx inqas effettiv fil-kisba ta' rispons wara 6 xhur.
English: This summary was last updated in 12/2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 12/2012.
English: In patients receiving NexoBrid, in around 15% (16 out of 106) of the wounds the eschar needed to be removed by surgery and around 18% (19 out of 106) required a skin graft, compared with around 63% (55 out of 88) and around 34% (30 out of 88) respectively in patients receiving standard debridement treatment.
Maltese: Filpazjenti li ngħataw NexoBrid, f'madwar 15% (16 minn 106) tal-feriti l-eskar kellu jitneħħa permezz ta' intervent kirurġiku u madwar 18% (19 minn 106) kienu jeħtieġu trapjant tal-ġilda, meta mqabbla ma' madwar 63% (55 minn 88) u madwar 34% (30 minn 88) rispettivament fil-pazjenti li ngħataw trattament ta' tindif standard.
English: The full EPAR for NexoBrid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for NexoBrid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal NexoBrid jista' jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: NexoBrid concentrate of proteolytic enzymes enriched in bromelain
Maltese: NexoBrid konċentrat ta' enzimi proteolitiċi arrikkiti bi bromelain
English: This is a summary of the European public assessment report (EPAR) for NexoBrid.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal NexoBrid.
English: For a burn wound area of 250 cm2, NexoBrid 5 g/50 g gel is used.
Maltese: Għal ħarqa ta' 250 cm2, għandu jintuża l-ġell NexoBrid 5 g/50 g.
English: NexoBrid is a medicine that contains the active substance ‘concentrate of proteolytic enzymes enriched in bromelain'.
Maltese: NexoBrid huwa mediċina li fiha s-sustanza attiva ‘konċentrat ta' enzimi proteolitiċi arrikkiti bi bromelain'.
English: For a burn wound area of 100 cm2, NexoBrid 2 g/20 g gel is used.
Maltese: Għal ħarqa ta' 100 cm2, għandu jintuża l-ġell NexoBrid 2 g/20 g.
English: Why has NexoBrid been approved?
Maltese: Għaliex ġie approvat NexoBrid?
English: The most commonly reported side effects with NexoBrid are local pain, and pyrexia (fever) or hyperthermia (high body temperature).
Maltese: L-effetti sekondarji l-aktar komuni rrappurtati b'NexoBrid huma uġigħ lokali, u piressija (deni) jew ipertermija (temperatura għolja tal-ġisem).
English: What is NexoBrid?
Maltese: X'inhu NexoBrid?
English: The European Commission granted a marketing authorisation valid throughout the European Union for NexoBrid on 18 December 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea kollha għal NexoBrid fit-18 ta' Diċembru 2012.
English: NexoBrid must not be used in people who are hypersensitive (allergic) to the active substance, pineapples, papain (an enzyme found in papaya fruit) or any of the other ingredients.
Maltese: NexoBrid ma għandux jintuża f'persuni li jistgħu ikunu ipersensittivi (allerġiċi) għas-sustanza attiva, ananas, papain (enzima li tinsab fil-frotta tal-papaya) jew għal xi sustanza oħra.
English: Other information about NexoBrid
Maltese: Kif jintuża NexoBrid?
English: The Committee considered that NexoBrid was shown to be an effective debridement treatment with an acceptable safety profile which complements available surgical techniques.
Maltese: Il-Kumitat ikkunsidra li NexoBrid intwera li huwa trattament ta' tindif effettiv bi profil ta' sigurtà aċċettabbli li jikkumplimenta t-tekniki kirurġiċi disponibbli.
English: Because the number of patients with deep partial thickness and full thickness thermal burn wounds is low, the disease is considered ‘rare', and NexoBrid was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 July 2002.
Maltese: Minħabba li l-għadd ta' pazjenti bi ħruq termali fil-fond ta' ħxuna parzjali u ta' ħxuna sħiħa huwa żgħir, il-marda hija kkunsidrata ‘rari', u NexoBrid ġie kklassifikat bħala ‘mediċina orfni' (mediċina użata f'mard rari) fit-30 ta' Lulju 2002.
English: The active substance in NexoBrid is a mixture of enzymes extracted from the stem of the pineapple plant.
Maltese: Is-sustanza attiva f'NexoBrid hija taħlita ta' enzimi estratti miz-zokk tal-pjanta tal-ananas.
English: It is available as a powder and gel, which are mixed together to make a gel (2 g/22 g or 5 g/55 g).
Maltese: Jiġi bħala trab u ġel, li jitħalltu flimkien sabiex jifformaw ġell (2 g/22 g jew 5 g/55 g).
English: The effects of NexoBrid were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' NexoBrid ġew l-ewwel analizzati fuq mudelli sperimentali qabel ma ġew studjati filbniedem.
English: NexoBrid was also seen to be an effective debridement treatment for burn wounds of all thicknesses, including full thickness wounds.
Maltese: NexoBrid deher ukoll li huwa trattament ta' tindif effettiv għall-feriti ta' ħruq ta' kull ħxuna, inklużi l-feriti ta' ħxuna sħiħa.
English: What is the risk associated with NexoBrid?
Maltese: X'inhu r-riskju assoċjat ma' NexoBrid?
English: How has NexoBrid been studied?
Maltese: Kif ġie studjat NexoBrid?
English: The company that markets NexoBrid must ensure that healthcare professionals in specialised burns centres who are expected to use NexoBrid receive appropriate training and an educational pack including a step-by-step guide to NexoBrid treatment, covering important safety considerations before and after using NexoBrid.
Maltese: Il-kumpanija li tbiegħ NexoBrid għandha tiżgura li t-tobba fiċ-ċentri speċjalizzati fil-ħruq li huma mistennija li jużaw NexoBrid jingħataw taħriġ xieraq u pakkett edukattiv inkluża gwida pass pass dwar il-kura b'NexoBrid, li tkopri l-kunsiderazzjonijiet ta' sigurtà qabel u wara l-użu ta' NexoBrid.
English: What measures are being taken to ensure the safe use of NexoBrid?
Maltese: Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur ta' NexoBrid?
English: The CHMP concluded that NexoBrid effectively removes eschar from deep partial thickness and full thickness wounds and reduces the need for surgery to remove further skin tissue in deep partial thickness wounds.
Maltese: Is-CHMP ikkonkluda li NexoBrid huwa effettiv fit-tneħħija tal-eskar minn feriti fil-fond ta' ħxuna parzjali u ta' ħxuna sħiħa u jnaqqas il-ħtieġa ta' interventi kirurġiċi għat-tneħħija ta' aktar tessut tal-ġilda f'feriti fil-fond ta' ħxuna parzjali.
English: The CHMP noted the importance of prompt skin grafting of areas of full thickness and deep burn directly after debridement with NexoBrid, in line with the standard of care in European burns centres.
Maltese: Is-CHMP innota l-importanza ta' trapjant fil-pront tal-ġilda f'żoni ta' ħxuna sħiħa u ta' ħruq fil-fond direttament wara t-tindif b'NexoBrid, skont l-istandard tal-kura fiċ-ċentri tal-ħruq Ewropej.
English: NexoBrid was studied in one main study involving 156 patients, who were hospitalised with deep partial thickness or full thickness burn wounds.
Maltese: NexoBrid ġie studjat fi studju ewlieni li kien jinvolvi 156 pazjent, li ddaħħlu l-isptar b'feriti ta' ħruq ta' ħxuna parzjali jew sħiħa.
English: The study showed that NexoBrid was more effective than standard of care treatment (surgical and non-surgical) at reducing the proportion of the deep partial thickness burn wounds that needed surgery to remove skin tissue or required a skin graft.
Maltese: L-istudju wera li NexoBrid kien aktar effettiv mit-trattament standard ta' kura (kirurġiku jew mhux kirurġiku) fit-tnaqqis tal-proporzjon tal-feriti ta' ħruq fil-fond ta' ħxuna parzjali li kienu jeħtieġu intervent kirurġiku sabiex jitneħħielhom it-tessut tal-ġilda jew li kienu jeħtieġu trapjant tal-ġilda.
English: How does NexoBrid work?
Maltese: Għal xiex jintuża NexoBrid?
English: In addition, it was found that NexoBrid removed eschar from wounds faster than standard treatments.
Maltese: Barra minn hekk, instab li NexoBrid ineħħi l-eskar mill-feriti aktar malajr mit-trattamenti standard.
English: Cattle (calves and young cattle) and pigs.
Maltese: Baqar (għoġġiela u erieħ) u majjali
English: 20 μg/kg 65 μg/kg 65 μg/kg
Maltese: 20 μg/kg 65 μg/kg
English: Hydrochloric acid/sodium hydroxide Macrogol 300
Maltese: Hydrochloric acid/ idrossidutas-sodju Macrogol 300
English: The active substance in Melovem is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'Melovem hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tarRegolament tal-Kummissjoni (UE) Nru 37/2010:
English: Hydrochloric acid/sodium hydroxide Macrogol 1500
Maltese: Hydrochloric acid/idrossidu tas-sodju Macrogol 1500
English: Benzyl alcohol
Maltese: Alkoħol benzyl
English: The maximum number of broachings should be limited to 20.
Maltese: In-numru massimu ta' titqib għandu jkun limitat għal 20.
English: N-Methylpyrrolidone Water for injection
Maltese: N-methylpyrrolidone Ilma għall-injezzjoni
English: For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritisagalactia 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: Cattle: SC or IV
Maltese: SC jew IV
English: EXPIRY DATE EXP: {month/year} Once broached use by…
Maltese: DATA TA' SKADENZA EXP: {xahar/sena}
English: Benzyl alcohol 20 mg
Maltese: Alkoħol benżiliku 20 mg
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07-07-2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 07-07-2009
English: 15 μg/kg Milk
Maltese: 65 μg/kg
English: MANUFACTURER'S BATCH NUMBER Lot: {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR Lott:{numru}
English: To obtain the best possible pain relieving effect post surgery Melovem should be administered 30 minutes before surgical intervention.
Maltese: Biex tikseb l-aħjar effett possibbli biex jittaffa l-uġigħ wara operazzjoni, Melovem għandu jingħata 30 minuta qabel intervent kirurġiku.
English: Transient swelling at the injection site was observed in clinical studies following intramuscular administration in pigs.
Maltese: Ġiet osservata nefħa għal żmien qasir fi studji kliniċi wara amministrazzjoni intramuskolari fil-majjali.
English: INDICATIONS Read the package leaflet before use.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: Elimination Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
Maltese: Meloxicam jiġi eliminat b'half-life ta' 26 siegħa wara li jingħata b'injezzjoni taħt il-ġilda f'baqar żgħar.
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code: QM01AC06.
Maltese: Prodotti anti-infjammatorji u anti-rewmatiċi, mhux sterojdi (oxicams)
English: 150 mg For the full list of excipients, see section 6.1.
Maltese: 50 mg Għal-lista sħiħa tal-ingredjenti mhux attivi, ara s-sezzjoni 6.1.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
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: 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 ttnixxija, analġesiċi u antipiretiċi.
English: Cattle: meat and offal: 15 days; milk: 5 days Pigs, horses: meat and offal: 5 days
Maltese: Baqar: laħam u ġewwieni tal-annimal: 15-il jum; ħalib: 5 ijiem Majjali, żwiemel: laħam u ġewwieni tal-annimal: 5 ijiem.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 30 mg/ml
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Meloxicam 30 mg/ml
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 and pigs.
Maltese: Meloxicam għandu wkoll proprjetajiet anti-endotossiċi għax intwera li jinibixxi l-produzzjoni ta' thromboxane B2 ikkaġunata mill-għoti ta' E. coli endotoxin fl-għoġġiela u fil-majjali.
English: Manufacturer responsible for batch release: Dopharma B.V.
Maltese: Manifattur responsabbli mill-ħruġ tal-lott: Dopharma Research B.V.
English: Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight).
Maltese: Injezzjoni waħda ġol-vina b'dożaġġ ta' 0.6 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e. 3.0 ml/ 100 kg ta' piż tal-ġisem).
English: Cattle: meat and offal: 15 days; milk: 5 days.
Maltese: Baqar: laħam u ġewwieni tal-annimal: 15-il jum; ħalib: 5 ijiem
English: For the relief of post operative pain associated with minor soft tissue surgery such as castration.
Maltese: Għas-solliev ta' uġigħ ta' wara l-operazzjoni assoċjat ma' kirurġija minuri fuq tessut artab bħal kastrazzjoni.
English: 4941 VX Raamsdonksveer THE NETHERLANDS
Maltese: 4941 VX Raamsdonksveer L-OLANDA
English: 4941 VX Raamsdonksveer The Netherlands
Maltese: 4941 VX Raamsdonksveer L-Olanda
English: Sodium citrate
Maltese: Ċitrat tas-sodju
English: Cardboard box with 1 colourless glass injection vial of 50 ml, 100 ml or 250 ml.
Maltese: Kaxxa tal-kartun b'kunjett wieħed bla kulur, tat-tip I tal-ħġieġ għall-injezzjoni, ta' 50 ml, 100 ml u
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values 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 intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body weight).
Maltese: Injezzjoni waħda ġol-muskoli b'dożaġġ ta' 0.4 mg ta' meloxicam/kilogramm ta' piż tal-ġisem (i.e. 0.4 ml/5 kg ta' piż tal-ġisem).
English: Milk:
Maltese: Majjali:
English: Manufacturer responsible for the batch release Dopharma B.V.
Maltese: Manifattur responsabbli għall-ħrug tal-lott Dopharma B.V.
English: Cardboard box with 1 colourless, type I glass injection vial of 50 ml, 100 ml and 250 ml closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
Maltese: Kaxxa tal-kartun b'kunjett wieħed bla kulur, tat-tip I tal-ħġieġ għall-injezzjoni, ta' 100 ml, mingħajr kulur, li huwa magħluq bil-lastku bromobutil u ssiġillat b'għatu tal-aluminju.
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: 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: STATEMENT OF ACTIVE SUBSTANCE Meloxicam 5 mg/ml
Maltese: Meloxicam 5 mg/ml
English: For lactating animals see section 4.11.
Maltese: 4.3 Kontra indikazzjonijiet Ara wkoll sezzjoni 4.7.
English: Meglumine Water for injection
Maltese: Meglumine Ilma għall-injezzjoni
English: Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 μg/ml was reached within 1 hour in pigs.
Maltese: Wara l-għoti ta' dożi waħidhom fil-muskoli ta' 0.4 mg ta' meloxicam/kg, intlaħaq valur Cmax ta' 1.1 sa 1.5 µg/ml fi żmien siegħa fil-majjali.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: Fl-assenza ta' studji dwar il-kumpatibilità, dan il-prodott ta' mediċina veterinarja ma għandux jitħallat ma' prodotti mediċinali oħra.
English: Pigs: Meat and offal: 5 days
Maltese: Majjali: laħam u ġewwieni tal-annimali: 5 ijiem
English: In pigs, after intramuscular administration, the mean plasma biological elimination half-life is approximately 2.5 hours.
Maltese: Fil-majjali, wara li jingħata b'injezzjoni ġol-muskoli, il-medja tal-half-life tal-eliminazzjoni tal-plażma hi ta' madwar 2.5 sigħat.
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 properties.
Maltese: 5.1 Kwalitajiet farmakodinamiċi Meloxicam hu mediċina anti-infjammatorja mhux sterojdika (NSAID) tal-klassi oxicam li taġixxi bl inibizzjoni tas-sintesi ta' prostaglandin, u b'hekk teżerċita proprjetajiet anti-infjammatorji, kontra t tnixxija, analġesiċi u antipiretiċi.
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml were reached after 7.7 hours in young cattle.
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 wara 7.7 sigħat f'baqar żgħar.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 20 mg/ml solution for injection for cattle, pigs and horses Meloxicam
Maltese: VETERINARJU Melovem 20 mg/ml soluzzjoni għal injezzjoni għal baqar, majjali u żwiemel
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) 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 effett(i) mhux mixtieq(a) 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: In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Maltese: EFFETTI MHUX MIXTIEQA Fil-baqar u fil-majjali, l-għoti taħt l-ġilda, fil-muskolu, kif ukoll ġol-vina hu ttollerat tajjeb; kienet osservata biss nefħa ħafifa li tgħaddi malajr fis-sit tal-injezzjoni wara l-għoti taħt il-ġilda, f'inqas minn 10% tal-baqar li kienu ttrattati fi studji kliniċi.
English: Overdose (symptoms, emergency procedures, antidotes) In the case of overdose, symptomatic treatment should be initiated.
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti) F'każ ta' doża eċċessiva, għandu jinbeda trattament sintomatiku.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 30 mg/ml solution for injection for cattle and pigs Meloxicam
Maltese: VETERINARJU Melovem 30 mg/ml soluzzjoni għal injezzjoni għalbaqar u majjali
English: WITHDRAWAL PERIOD Cattle:
Maltese: Kodici ATC veterinarja:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Glass vial
Maltese: Prekawzjonijiet Speċjali għall-Użu
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/001
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/09/098/001
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 5 mg/ml solution for injection for cattle and pigs.
Maltese: VETERINARJU Melovem 5 mg/ml soluzzjoni għall-injezzjoni għall-baqar u l-majjali.
English: Pigs:
Maltese: Żwiemel:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 30 mg/ml solution for injection for cattle and pigs
Maltese: VETERINARJU Melovem 30 mg/ml soluzzjoni għal injezzjoni għal baqar u majjali
English: Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/150 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Maltese: Injezzjoni waħda taħt il-ġilda, b'dożaġġ ta' 0.5 mg ta' meloxicam / kg ta' piż tal-ġisem (i.e. 2.5 ml / 150 kg ta' piż tal-ġisem) flimkien ma' terapija antibijotika, jew ma' terapija orali ta' idratazzjoni millġdid, skont kif ikun xieraq.
English: Locomotor disorders:
Maltese: Mhux applikabbli.
English: ROUTE(S) OF ADMINISTRATION Cattle: SC
Maltese: MOD(I) TA' AMMINISTRAZZJONI Baqar:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 20 mg/ml solution for injection for cattle, pigs and horses
Maltese: VETERINARJU Melovem 20 mg/ml soluzzjoni għall-injezzjoni għal baqar, majjali u żwiemel
English: 20 mg For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains:
Maltese: 5 mg Sustanza(i) mhux attiva(i):
English: Interactions with other medicinal products and other forms of interaction Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Maltese: Interazzjoni ma' prodotti mediċinal oħrajn u forom oħrajn ta' interazzjoni M'għandux jingħata flimkien ma' glukokortikosterojdi, sustanzi oħrajn anti-infjammatorji mhux sterojdiċi u jew ma' antikoagulanti.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: SC
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Baqar:
English: For animal treatment only.To be supplied only on veterinary prescription.
Maltese: Jekk ikun hemm reazzjonijiet mhux mixtieqa, it-trattament għandu jitwaqqaf u għandu jittieħed ilparir ta' veterinarju.
English: EXPIRY DATE EXP {month/year} Once broached use by…
Maltese: DATA TA' SKADENZA EXP {xahar/sena}
English: Treatment of calves with Melovem 20 minutes before dehorning reduces post-operative pain.
Maltese: Trattament ta' għoġġiela b'Melovem 20 minuta qabel it-tneħħija tal-qrun tnaqqas l-uġigħ ta' wara loperazzjoni.
English: In pigs, bile and urine contain only traces of the parent compound.
Maltese: Fil-majjali, il-bili u l-awrina biss fihom traċċi tal-kompost prinċipali.
English: Comparatively low concentrations are detectable in skeletal muscle and fat.
Maltese: Majjali: injezzjoni ġol-muskoli.