qanastek/EMEA-V3 huggingface dataset:
In horses, Metacam is also used for the relief of pain associated with colic.
Fiż- żwiemel, Metacam jintuża wkoll għat- taffija tal- uġigħ assoċjat mal- kolika.
In dogs Metacam is also used to reduce post-operative pain and inflammation following orthopaedic and soft tissue surgery.
Fil- klieb, Metacam jintuża għat- tnaqqis ta ’ uġigħ postoperatorju u tal- infjammazzjoni wara li tkun saret kirurġija ortopedika u tat- tessut artab.
The indication in cats is reduction of post-operative pain after a spay operation and minor soft tissue surgery.
L- indikazzjoni fil- qtates hija t- tnaqqis ta ’ uġigħ postoperatorju wara kirurġija fejn jitneħħa l - ovarju (spay) u ssir kirurġija minuri tat- tessut artab.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How does Metacam work?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif jaħdem Metacam?
Metacam contains meloxicam, which belongs to a class of medicines called non-steroidal anti- inflammatory drugs (NSAIDs).
Metacam fih meloxicam li jappartjeni għal klassi ta ’ mediċini msejħin mediċini antinfjammatorji mhux sterojdali (NSAIDs).
How has the effectiveness of Metacam been studied?
Kif ġiet studjata l- effikaċja ta ’ Metacam?
Appropriate studies have been made to show the effectiveness in the various target animals.
Twettqu studji xierqa biex juru l- effikaċja fid- diversi annimali fil- mira.
What are the side effects of Metacam?
X’ inhuma l- effetti sekondarji ta ’ Metacam?
In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
L- għoti minn taħt il- ġilda, dak intramuskolari kif ukoll fil- vina huwa tollerat sew fil- bhejjem tal- ifrat u fil- ħnieżer; ġiet osservata biss nefħa provviżorja fis- sit tal- injezzjoni wara l- għoti minn taħt il- ġilda f' inqas minn 10% tal- bhejjem tal- ifrat ittrattati fi studji kliniċi.
In horses, anaphylactoid (hypersentivity) reactions can occur and should be treated symptomatically.
Fiż- żwiemel, jistgħu jseħħu reazzjonijiet anafilatojdi (ipersensittività) u għandhom jiġu ttrattati b’ mod sintomatiku.
A temporary swelling at the injection site can occur but resolves without intervention.
Jista ’ jkun li tiżviluppa nefħa provviżorja fis- sit tal- injezzjoni iżda din tiġi riżolta mingħajr l- ebda intervent.
In dogs and cats, occasional side effects of Metacam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Fil- klieb u l- qtates, effetti sekondarji osservati okkażjonalment bi Metacam huma dawk tipiċi tal- NSAIDs, bħal telf tal- aptit, remettar, dijarrea, demm fil- feċi u apatija (nuqqas ta ’ vitalità).
In dogs, these side effects occur usually within the first week of treatment and are generally transient (temporary).
Fil- klieb, dawn l- effetti sekondarji jidhru normalment matul l- ewwel ġimgħa tat- trattament u huma ġeneralment temporanji.
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Metacam.
Il- persuni ipersensittivi (allerġiċi) għall- NSAIDs għandhom jevitaw il- kuntatt ma 'Metacam.
If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
F’ każ li l- prodott jinbela ’ minn persuna, din għandha tkellem minnufih lil tabib.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Kemm irid jgħaddi żmien qabel ma l- annimal ikun jista 'jinqatel u l- laħam tiegħu jintuża għall - konsum mill- bniedem (perjodu ta' rtirar)?
After the last administration of Metacam cattle should not be slaughtered for 15 days and the milk not used for 5 days.
Wara li Metacam jingħata għall- aħħar darba, il- bhejjem tal- ifrat ma jistgħux jinqatlu qabel ma jgħaddu 15- il jum u l- ħalib m’ għandux jintuża għal 5 ijiem.
Pigs and horses should not be slaughtered for 5 days.
Il- ħnieżer u ż- żwiemel m’ għandhomx jinqatlu għal 5 ijiem.
Why has Metacam been approved?
Għaliex ġie approvat Metacam?
The Committee for Medicinal Products for Veterinary Use (CVMP) decided that the benefits of Metacam are greater than any risks of treatment and they recommended that Metacam should be given a marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) iddeċieda li l- benefiċċji ta 'Metacam huma ikbar minn kwalunkwe riskju tat- trattament u rrakkomanda li tinħareġ awtorizzazzjoni għat- tqegħid fis- suq għal din il- mediċina.
Other information about Metacam:
Informazzjoni oħra dwar Metacam:
The European Commission granted a marketing authorisation valid throughout the European Union, for Metacam to Boehringer Ingelheim Vetmedica, Germany on 7 January 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Metacam lil Boehringer Ingelheim Vetmedica, il- Ġermanja fis- 7 ta 'Jannar 1998.
Information on the prescription status of this product may be found on the label of the carton.
L- informazzjoni dwar l- istat tal- preskrizzjoni ta 'dan il- prodott jinstab fuq it- tikketta ta' dan il - pakkett.
This summary was last updated in May 2006.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Page 2/ 2 ©EMEA 2006
Paġna 2/ 2 ©EMEA 2006
EU/ 2/ /97/ 004/ 00
Laħam u l -
Cattle, Pigs
Baqar,
Subcutaneous or intravenous injection; Intramuscular injection
Injezzjoni taħt il -
Injection vial (glass)
Kunjett ta ’ l -
Meat and offal:
15- il
15 days (cattle), 5 days (pigs)
jum (baqar), 5 ijiem (majjali)
Dogs Oral
Orali
Polyethylene bottle
Flixkun tal - poli- etilin
EU/ 2/ 97/ 004/ 005
Orali EU/ 2/ 97/ 004/ 005
Oral
Klieb
Subcutaneous or intravenous injection
Injezzjoni taħt il - ġilda jew ġol- vini
Injection vial (glass)
Kunjett ta ’ l - injezzjoni (ħġieġ)
Cattle, pigs and horses
Baqar, majjali u żwiemel
Subcutaneous, intramuscular, intravenous injection
Injezzjoni taħt il - ġilda, ġol - muskolu, ġol - vina
Meat and offal:
Laħam u l - ġewwieni ta ’ l - annimali:
15 days (cattle), 5 days (pigs/ horses) Milk:
15- il jum (baqar), 5 ijiem (majjali/ żwiemel) Ħalib:
5 days
5 ijiem
3 days
3 ijiem
Cattle & Pigs
Baqar u
12
Mhux
Oral suspension
Suspensjoni
Polyethylene bottle
Flixkun tal -
Not applicable
applikabbli.
EU/ 2/ 97/ 004/ 0
EU/ 2/ 97/ 004/ 013
13
Mhux
Chewable tablets
Pillola li tomogħdha
PVDC/ PE/ P VC/ AL blisters
Folji PVDC/ PE/ P VC/ AL
20 tablets 1
20 pillola 1
100 tablets 1
100 pillola 1
500 tablets 1
500 pillola 1
1
100 pillola 1
EU/ 2/ 97/ 004/ 023
3/ 5 EU/ 2/ 97/ 004/ 023
EU/ 2/ 97/ 004/ 030
4/ 5 EU/ 2/ 97/ 004/ 030
15 days (cattle), 5 days (pigs/ horses) Milk:
5 ijiem
5 days
5/ 5
Metacam 5 mg/ ml solution for injection for cattle and pigs
Metacam 5 mg/ ml soluzzjoni għall- injezzjoni għall- baqar u l- majjali.
Each ml of Metacam 5 mg/ ml solution for injection contains:
Kull ml ta ’ Metacam 5 mg/ ml soluzzjoni għall- injezzjoni fih:
Clear yellow solution for injection.
Soluzzjoni safra ċara għall- injezzjoni.
Cattle (calves and young cattle) and pigs
Baqar (għoġġiela u baqar żgħar) u majjali
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
Għall- użu fi żmien ta ’ infezzjoni akuta fis- sistema tan- nifs, flimkien ma ’ terapija antibijotika adattata biex ittaffi s- sintomi kliniċi tal- marda fil- baqar.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.
Għall- użu fit- trattament ta ’ dijarea flimkien ma ’ terapija orali ta ’ idratazzjoni mill- ġdid, biex jitnaqqsu s- sintomi kliniċi f’ għoġġiela li għandhom aktar minn ġimgħa jew frieħ baqar ta ’ età żgħira.
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
Għall- użu waqt mard mhux infettiv tal- mixi biex jitnaqqsu s- sintomi ta ’ meta l- annimal ikun qed izappap u dawk ta ’ l- infjammazzjoni.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Tużax f’ annimali li għandhom indeboliment fil- funzjoni tal- fwied, tal- qalb jew tal- kliewi, u mard emorraġiku, jew fejn ikun hemm evidenza ta ’ leżjonijiet gastrointestinali ulċeroġeniċi.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Għat- trattament tad- dijarea fil- baqar, tużax f’ annimali li għandhom inqas minn ġimgħa.
2/ 125 4.5 Special precautions for use
2/ 125 4. 5 Prekawzjonijiet speċjali għall- użu
Special precautions for use in animals If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Prekawzjonijiet speċjali għall- użu fl- annimali Jekk ikun hemm reazzjonijiet mhux mixtieqa, it- trattament għandu jitwaqqaf u għandu jittieħed il - parir ta ’ veterinarju.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.
Evita l- użu f’ annimali li huma deidratati, ipovolaemiċi jew ipotensivi severament, li jkunu jeħtieġu idratazzjoni mill- ġdid permezz ta ’ injezzjoni, għax jista ’ jkun hemm riskju potenzjali ta ’ tossiċità tal - kliewi.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Accidental self-injection may give rise to pain.
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Injezzjoni aċċidentali tiegħek nnifsek tista ’ tikkaġuna wġigħ.
People with known hypersensitivity to NSAID should avoid contact with the veterinary medicinal product.
Persuni li jafu li għandhom sensittività eċċessiva għal NSAID għandhom jevitaw li jmissu mal- prodott mediċinali veterinarju.
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.
L- għoti taħt l- ġilda, fil- muskolu, kif ukoll ġol- vina hu tollerat tajjeb; kienet osservata biss nefħa ħafifa li tgħaddi malajr fis- sit ta ’ l- injezzjoni wara l- għoti taħt il- ġilda, f’ inqas minn 10% tal- baqar li kienu ttrattati fi studji kliniċi.
Can be used during pregnancy and lactation.
Jista ’ jintuża waqt it- tqala u t- treddigħ.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
M’ għandux jingħata flimkien ma ’ glukokortikosterojdi, sustanzi anti- infjammatorji oħrajn mhux sterojdi jew ma ’ antikoagulanti.
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/ kg body weight (i. e.
Injezzjoni waħda taħt il- ġilda jew ġol- vina, b’ dożaġġ ta ’ 0. 5 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem (i. e.
10.0 ml/ 100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
10. 0 ml / 100 kg ta ’ piż tal- ġisem) flimkien ma ’ terapija antibijotika, jew ma ’ terapija orali ta ’ idratazzjoni mill- ġdid, skond kif ikun xieraq.
Single intramuscular injection at a dosage of 0.4 mg meloxicam/ kg body weight (i. e.
Injezzjoni waħda ġol- vina b’ dożaġġ ta ’ 0. 4 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem (i. e.
2.0 ml/ 25 kg body weight).
2. 0 ml / 25 kg ta ’ piż tal- ġisem).
If required, a second administration of meloxicam can be given after 24 hours.
Jekk ikun meħtieġ, it- tieni doża ta ’ meloxicam tista ’ tingħata wara 24 siegħa.
3/ 125 4.11 Withdrawal periods
3/ 125 4. 11 Perjodu ta ’ tiżmim
Meat and offal:
Laħam u ġewwieni ta ’ l- annimali:
15 days
15- il jum
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.
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.
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.
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.
Absorption 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.
Assorbiment 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.
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.
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.
Distribution More than 98% of meloxicam is bound to plasma proteins.
Distribuzzjoni Iktar minn 98% ta ’ meloxicam jeħel mal- proteini tal- plażma.
The highest meloxicam concentrations are to be found in liver and kidney.
L- ogħla konċentrazzjonijiet ta ’ Meloxicam jinsabu fil- fwied u fil- kliewi.
Comparatively low concentrations are detectable in skeletal muscle and fat.
Konċentrazzjonijiet iktar baxxi, meta mqabbla ma ’ dawk fil - fwied u fil- kliewi, jinsabu fil- muskoli skeletriċi u fix- xaħam.
Metabolism Meloxicam is predominantly found in plasma.
Metaboliżmu Il- biċċa l- kbira ta ’ meloxicam jinsab fil- plażma.
In cattle, meloxicam is also a major excretion product in milk and bile whereas urine contains only traces of the parent compound.
Fil- baqar, meloxicam jitneħħa l- iktar fil- ħalib u fil - bili, filwaqt li l- awrina fiha biss traċċi tal- kompost prinċipali.
In pigs, bile and urine contain only traces of the parent compound.
Fil- majjali, il- bili u l- awrina fihom biss traċċi tal- kompost prinċipali.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites.
Meloxicam huwa metabolat għal alkoħol, derivattiv ta ’ l- aċidu u għal diversi metaboliti polari.
Elimination Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
Eliminazzjoni Meloxicam jiġi eliminat b’ half- life ta ’ 26 siegħa wara li jingħata b’ injezzjoni taħt il- ġilda f’ baqar żgħar.
In pigs, after intramuscular administration, the mean plasma elimination half-life is approximately 2.5 hours.
Fil- majjali, wara li jingħata b’ injezzjoni ġol- muskoli, il- medja tal- half- life ta ’ l- eliminazzjoni tal - plażma hi ta ’ madwar 2. 5 sigħat.
Approximately 50% of the administered dose is eliminated via urine and the remainder via faeces.
Madwar 50% tad- doża li tingħata titneħħa fl- awrina, u l- bqija fl- ippurgar.
4/ 125 6.
4/ 125
- Water for injection
- Ilma għall- injezzjoni
Shelf-life of the veterinary medicinal product as packaged for sales:
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ:
3 years Shelf-life after first opening the immediate packaging:
3 snin Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
28 days
28 jum
Cardboard box with 1 or 12 colourless glass injection vial(s) of 100 ml, which are closed with a rubber stopper and sealed with an aluminium cap.
Kaxxa tal- kartun b’ kunjett wieħed jew 12- il kunjett tal- ħġieġ għall- injezzjoni, ta ’ 100 ml, mingħajr kulur, li huma magħluqa b’ tapp tal- lastku u ssiġillati b’ għatu ta ’ l- aluminju.
Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein Germany
Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein Ġermanja
MARKETING AUTHORISATION NUMBERS
NUMRU( I) TA ’ L- AWTORIZZAZZJONI TAL- KUMMERC
07.01.1998 Date of last renewal:
07. 01. 1998 Data ta ’ l- aħħar tiġdid:
5/ 125 10.
5/ 125 10.
Metacam 1.5 mg/ ml oral suspension for dogs
Metacam 1. 5 mg/ ml Suspensjoni orali għall- klieb
Each ml of Metacam 1.5 mg/ ml oral suspension contains:
Kull ml ta ’ Metacam 1. 5 mg/ ml suspensjoni orali fih:
Meloxicam 1.5 mg (equivalent to 0.05 mg per drop)
Meloxicam 1. 5 mg (ekwivalenti għal 0. 05 mg kull qatra)
Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)
Sodium benzoate 1. 5 mg (ekwivalenti għal 0. 05 mg kull qatra)
Honey flavoured, yellowish viscous oral suspension with a green tinge.
Suspensjoni orali magħquda, b’ togħma ta ’ l- għasel, safra u bi sfumatura ħadranija.
7/ 125 Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
7/ 125 Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
In cats, Metacam 0.5 mg/ ml oral suspension for cats should be used.
Fil- qtates, Metacam 0. 5 mg/ ml suspensjoni orali għall- qtates għandha tintuża.
Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Persuni li jafu li għandhom sensittività eċċessiva għal NSAIDs għandhom jevitaw li jmissu mal - prodott mediċinali veterinarju.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ li tibla ’ l- prodott b’ mod aċċidentali, fittex parir mediku minnufih u uri l- fuljett tal- pakkett jew it- tikketta lit- tabib.
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Reazzjonijiet avversi tipiċi tal- mediċini NSAIDs bħal nuqqas t’ aptit, rimettar, dijarea, demm moħbi fl - ippurgar, apatija u insuffiċjenza renali kienu rrappurtati xi kultant.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (See 4.3).
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita waqt it- tqala u fi żmien il- ħalib (Ara 4. 3).
Metacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Metacam m’ għandux jingħata flimkien ma ’ NSAIDs oħrajn jew ma ’ glukokortikosterojdi.
The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Il- perjodu mingħajr trattament, madankollu, irid jikkunsidra l - karatteristiċi farmakoloġiċi tal- prodotti użati qabel.
Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/ kg body weight.
It- trattament għandu jitkompla darba kuljum bl- għoti orali (f’ intervalli ta ’ 24 siegħa) bid - doża tal- manteniment ta ’ 0. 1 mg meloxicam / kg ta ’ piż tal- ġisem.
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of Metacam can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
Għal trattament iktar fit- tul, ġaladarba r- rispons kliniku jkun ġie osservat (wara ≥ 4 ijiem), id- doża ta ’ Metacam tista ’ tiġi aġġustata għall- inqas doża effettiva individwali, li tirrifletti li l- grad ta ’ uġigħ u ta ’ infjammazzjoni marbuta ma ’ mard kroniku muskolu- skeletriku, jista ’ jvarja matul iż- żmien.
To be administered orally either mixed with food or directly into the mouth.
Biex jingħata mill- ħalq jew imħallat ma ’ l- ikel jew direttamemt fil- ħalq.
The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the Metacam measuring syringe provided in the package.
Is- suspensjoni tista ’ tingħata jew permezz tal- qattara tal- flixkun (għal razez ta ’ klieb żgħar ħafna) jew bis- siringa tal- kejl ta ’ Metacam ipprovduta fil- pakkett.
Dosing procedure using the drop dispenser of the bottle:
Il- proċedura tad- dożaġġ bl- użu tal- qattara tal- flixkun:
Initial dose:
Doża tal- bidu:
4 drops / kg body weight Maintenance dose:
4 qtar / kg ta ’ piż tal- ġisem Doża tal- manteniment:
2 drops / kg body weight
2 qatriet / kg ta ’ piż tal- ġisem
8/ 125 Dosing procedure using the measuring syringe:
8/ 125 Il- proċedura tad- dożaġġ bl- użu tas- siringa tal- kejl:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose.
Is- siringa teħel mal- qattara tal- flixkun u għandha skala ta ’ kilogramm- piż tal- ġisem li tikkorrispondi mad- doża tal- manteniment.
Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
Għalhekk, għall- bidu tat- terapija fl- ewwel jum, id- doppju tal- volum tal - manteniment ser ikun meħtieġ.
Alternatively therapy may be initiated with Metacam 5 mg/ ml solution for injection.
Alternattivament, it- terapija tista ’ tinbeda b’ 5 mg/ ml soluzzjoni għal injezzjoni.
Absorption Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 4.5 hours.
Assorbiment Meloxicam huwa kompletament assorbit wara l- għoti mill- ħalq u l- ogħla konċentrazzjonijiet fil - plażma jinkisbu wara madwar 4. 5 sigħat.
When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.
Meta l- prodott jintuża skond il- kors rakkomandat tad - dożaġġ, il- konċentrazzjonijiet fl- istat fiss ta ’ meloxicam fil- plażma jintlaħqu fit- tieni jum tat - trattament.
Distribution There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range.
Distribuzzjoni Hemm relazzjoni lineari bejn id- doża mogħtija u l- konċentrazzjoni fil- plażma osservata fil- firxa tad - doża terapewtika.
The volume of distribution is 0.3 l/ kg.
Il- volum tad - distribuzzjoni hu ta ’ 0. 3 l/ kg.
Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.
Madwar 75% tad- doża li tingħata titneħħa fl - ippurgar, u l- bqija fl- awrina.
- Water, purified
- Ilma, purifikat
Polyethylene bottle containing 10, 32, 100 or 180 ml with a polyethylene dropper, a tamper proof child resistant closure and a polypropylene measuring syringe.
Flixkun tal- polyethylene li fih 10, 32, 100 jew 180 ml b’ qattara tal- polyethylene, tapp li jirreżisti l- ftuħ mit- tfal żgħar u siringa tal- kejl tal- polypropylene.
EU/ 2/ 97/ 004/ 003 10 ml EU/ 2/ 97/ 004/ 004 32 ml
EU/ 2/ 97/ 004/ 003 10 ml EU/ 2/ 97/ 004/ 004 32 ml
10/ 125 EU/ 2/ 97/ 004/ 005 100 ml EU/ 2/ 97/ 004/ 029 180 ml
10/ 125 EU/ 2/ 97/ 004/ 005 100 ml EU/ 2/ 97/ 004/ 029 180 ml
24.03.2000 Date of last renewal:
24. 03. 2000 Data ta ’ l- aħħar tiġdid:
Metacam 5 mg/ ml solution for injection for dogs and cats
Metacam 5 mg/ ml soluzzjoni għall- injezzjoni għall- klieb u l- qtates.
12/ 125 4.5 Special precautions for use
12/ 125 4. 5 Prekawzjonijiet speċjali għall- użu
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
Any oral follow-up therapy using meloxicam or other NSAIDs should not be administered in cats, as appropriate dosage regimens for such follow-up treatments have not been established.
Kwalunkwe follow- up orali li bl- użu ta ’ meloxicam jew NSAIDs oħrajn m’ għandhomx jingħataw lill - qtates, minħabba li korsijiet adattati tad- dożaġġ għal dawn il- kuri follow- up ma kinux stabbiliti.
The treatment-free period, however, should take into account the pharmacological properties of the products used previously.
Il- perjodu mingħajr trattament, madankollu, irid jikkunsidra l - karatteristiċi farmakoloġiċi tal - prodotti użati qabel.
Metacam 1.5 mg/ ml oral suspension for dogs or Metacam 1 mg and 2.5 mg chewable tablets for dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/ kg body weight, 24 hours after administration of the injection.
Metacam 1. 5 mg/ ml suspensjoni orali għall- klieb jew Metacam 1 mg u 2. 5 mg pilloli li tomgħodhom għall- klieb jista ’ jintuża għat- tkomplija tat- trattament f’ dożaġġ ta ’ 0. 1 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem, 24 siegħa wara l- għoti ta ’ l- injezzjoni.
13/ 125 Reduction of post-operative pain (over a period of 24 hours):
13/ 125 Tnaqqis ta ’ l- uġigħ ta ’ wara l- operazzjoni (matul perjodu ta ’ 24 siegħa):
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.
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.
14/ 125 Meloxicam is eliminated with a half-life of 24 hours in dogs and 15 hours in cats.
14/ 125 Eliminazzjoni Meloxicam jiġi eliminat b’ half- life ta ’ 24 siegħa fil- klieb u 15- il siegħa fil- qtates.
Colourless glass injection vial of 10 or 20 ml, closed with a rubber stopper and sealed with an aluminium cap.
Kunjett tal- ħġieġ għall- injezzjoni, ta ’ 10 jew 20 ml, mingħajr kulur, magħluq b’ tapp tal- lastku u ssiġillat b’ għatu ta ’ l- aluminju.
15/ 125 9.
15/ 125 9.
Metacam 20 mg/ ml solution for injection for cattle, pigs and horses
Metacam 20 mg/ ml soluzzjoni għall- injezzjoni għall- baqar, majjali u żwiemel.
Each ml of Metacam 20 mg/ ml solution for injection contains:
Kull ml ta ’ Metacam 20 mg/ ml soluzzjoni għall- injezzjoni fih:
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
Għall- użu fit- trattament ta ’ dijarea flimkien ma ’ terapija orali ta ’ idratazzjoni mill- ġdid, biex jitnaqqsu s- sintomi kliniċi f’ għoġġiela li għandhom aktar minn ġimgħa jew frieħ baqar ta ’ età żgħira li mhumiex qed jerdgħu Għal terapija addizzjonali fit- trattament ta ’ mastite akuta, flimkien ma ’ terapija antibijotika.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis- agalactia syndrome) with appropriate antibiotic therapy.
Għal terapija addizzjonali fit- trattament ta ’ settiċemija puwerperali u tossemija (sindrome mastite - metrite- agalaktja) flimkien ma ’ terapija antibijotika adattata.
Horses:
Żwiemel:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.
Għall- użu sabiex tittaffa l- infjammazzjoni u għas- solliev ta ’ l- uġigħ f’ mard muskolu- skeletriku li jkun kemm akut kif ukoll kroniku.
For the relief of pain associated with equine colic.
Għas- solliev ta ’ l- uġigħ marbut ma ’ kolika ekwina.
See also section 4.7.
Ara wkoll sezzjoni 4. 7.
Do not use in horses less than 6 weeks of age.
17/ 125 Tużax fuq żwiemel li għandhom inqas minn 6 ġimgħat.
17/ 125 Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Tużax f’ annimali li għandhom indeboliment fil- funzjoni tal- fwied, tal- qalb jew tal- kliewi, u mard emorraġiku, jew fejn ikun hemm evidenza ta ’ leżjonijiet gastrointestinali ulċeroġeniċi.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Jekk ikun hemm reazzjonijiet mhux mixtieqa, it- trattament għandu jitwaqqaf u għandu jittieħed il - parir ta ’ veterinarju.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.
F’ każ ta ’ solliev mhux adegwat ta ’ l- uġigħ meta użat fit- trattament ta ’ kolika ekwina, għandha ssir evalwazzjoni mill- ġdid bir- reqqa tad- dijanjosi, għax din tista ’ tindika l- ħtieġa ta ’ intervent kirurġiku.
Accidental self-injection may give rise to pain.
Injezzjoni aċċidentali tiegħek nnifsek tista ’ tikkaġuna wġigħ.
People with known hypersensitivity to NSAID should avoid contact with the veterinary medicinal product.
Persuni li jafu li għandhom sensittività eċċessiva għal NSAIDs għandhom jevitaw li jmissu mal- prodott mediċinali veterinarju.
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.
Fil- baqar u fil- majjali, l- għoti taħt l- ġilda, fil- muskolu, kif ukoll ġol- vina hu ittollerat tajjeb; kienet osservata biss nefħa ħafifa li tgħaddi malajr fis- sit ta ’ l- injezzjoni wara l- għoti taħt il- ġilda, f’ inqas minn 10% tal- baqar li kienu ttrattati fi studji kliniċi.
In horses, a transient swelling at the injection site can occur but resolves without intervention.
Fiż- żwiemel, nefħa ħafifa li tgħaddi malajr fis- sit ta ’ l- injezzjoni tista ’ sseħħ, iżda tfieq mingħajr ma jkun hemm l- ebda intervent.
Cattle and pigs:
Baqar u majjali:
Do not use in pregnant or lactating mares.
Tużax fuq debbijiet tqal jew li qed ireddgħu.
Do not use in horses producing milk for human consumption.
Tużax fuq żwiemel li jkunu jipproduċu ħalib għall- konsum uman.
See also section 4.3.
Ara wkoll sezzjoni 4. 3.
4.8 Interaction with other medicinal products and other forms of interaction
18/ 125 4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
M’ għandux jingħata flimkien ma ’ glukokortikosterojdi, sustanzi oħrajn mhux sterojdiċi u anti - infjammatorji jew ma ’ mediċini antikoagulanti.
18/ 125 4.9 Amounts to be administered and administration route
4. 9 Doża rakkomandata u l- metodu ta ’ amministrazzjoni
2.5 ml/ 100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
2. 5 ml / 100 kg ta ’ piż tal- ġisem) flimkien ma ’ terapija antibijotika, jew ma ’ terapija orali ta ’ idratazzjoni mill- ġdid, skond kif ikun xieraq.
Single intramuscular injection at a dosage of 0.4 mg meloxicam/ kg body weight (i. e.
Injezzjoni waħda fil- muskolu b’ dożaġġ ta ’ 0. 4 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem (i. e.
2.0 ml/ 100 kg body weight) in combination with antibiotic therapy, as appropriate.
2. 0 ml/ 100 / kg ta ’ piż tal- ġisem) flimkien ma ’ terapija antibijotika, kif ikun xieraq.
Single intravenous injection at a dosage of 0.6 mg meloxicam/ kg body weight (i. e.
Injezzjoni waħda ġol- vina b’ dożaġġ ta ’ 0. 6 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem (i. e.
3.0 ml/ 100 kg body weight).
3. 0 ml / 100 kg ta ’ piż tal- ġisem).
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo – skeletal disorders, Metacam 15 mg/ ml oral suspension may be used for continuation of treatment at a dosage of 0.6 mg meloxicam/ kg body weight, 24 hours after administration of the injection.
Għall- użu sabiex tittaffa l- infjammazzjoni u għas- solliev ta ’ l- uġigħ f’ mard muskolu- skeletriku li jkun kemm akut kif ukoll kroniku, Metacam 15 mg/ ml suspensjoni orali jista ’ jintuża għat- tkomplija tat- trattament f’ dożaġġ ta ’ 0. 6 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem, 24 siegħa wara l- għoti ta ’ l - injezzjoni.
In the case of overdosage, symptomatic treatment should be initiated.
F’ każ ta ’ doża eċċessiva, għandu jinbeda trattament sintomatiku.
4.11 Withdrawal periods
4. 11 Perjodi ta ’ tiżmim
15 days Milk:
15- il jum Ħalib:
5 days.
5 ijiem.
Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATCvet code:
Prodotti anti- infjammatorji u anti- rewmatiċi, mhux sterojdiċi (oxicams) Kodici ATĊ veterinarja:
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.
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, kontra t- tnixxija, analġesiċi u antipiretiċi.
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.
Meloxicam għandu
19/ 125 5.2 Pharmacokinetic particulars
19/ 125 wkoll proprjetajiet anti- endotossiċi għax intwera li jinibixxi l- produzzjoni ta ’ thromboxane B2 ikkaġunata mill- għoti ta ’ E. coli endotoxin fl- għoġġiela, baqar li jkunu qed ireddgħu u majjali.
Absorption 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.
Assorbiment 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, rispettivament.
After two intramuscular doses of 0.4 mg meloxicam/ kg, a Cmax value of 1.9 µg/ ml was reached after 1 hour in pigs.
Wara l- għoti ta ’ żewġ dożi fil- muskoli ta ’ 0. 4 mg ta ’ meloxicam/ kg, intlaħaq valur Cmax ta ’ 1. 9 µg/ ml fi żmien siegħa fil- majjali.
The metabolism in horses has not been investigated.
Il - metaboliżmu fiż- żwiemel ma kienx investigat.
Elimination Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.
Eliminazzjoni 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 jerdgħu, rispettivament.
In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.
Fil- majjali, wara li jingħata b’ injezzjoni ġol- muskoli, il- medja tal- half- life ta ’ l- eliminazzjoni tal - plażma hi ta ’ madwar 2. 5 sigħat.
In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.
Fiż- żwiemel, wara li jingħata b’ injezzjoni ġol- vina, meloxicam jiġi eliminat b’ half- life terminali ta ’ 8. 5 sigħat.
6.3 Shelf life
20/ 125 6. 3 Żmien ta 'kemm il- prodott idum tajjeb
Shelf-life of the veterinary medicinal product as packaged for sale(20, 50 or 100 ml vials):
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ (kunjetti ta ’ 20, 50 jew 100 ml):
2 years
3 snin Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ (kunjetti ta ’ 250 ml): sentejn Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
Cardboard box with either 1 or 12 colourless glass injection vial(s) each containing 20, 50 or 100 ml.
Kaxxa tal- kartun b’ kunjett wieħed jew 12- il kunjett tal- ħġieġ għall- injezzjoni, li kull wieħed ikun fih 20, 50 jew 100 ml, mingħajr kulur.
Cardboard box with either 1 or 6 colourless glass injection vial(s) each containing 250 ml.
Kaxxa tal- kartun b’ kunjett wieħed jew 6- il kunjett tal- ħġieġ għall- injezzjoni, li kull wieħed ikun fih 250 ml, mingħajr kulur.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Kull kunjett hu magħluq b’ tapp tal- lastku u ssiġillat b’ għatu ta ’ l- aluminju.
23.04.2001 Date of last renewal:
23. 04. 2001 Data ta ’ l- aħħar tiġdid:
06.12.2007
06. 12. 207
10.
21/ 125 10.
21/ 125 1.
22/ 125 1.
Metacam 15 mg/ ml oral suspension for horses
Metacam 15 mg/ ml suspensjoni orali għaż- żwiemel
Each ml of Metacam 15 mg/ ml oral suspension contains:
Kull ml ta ’ Metacam 15 mg/ ml suspensjoni orali fih:
Oral suspension Honey flavoured, yellowish viscous oral suspension with a green tinge.
Suspensjoni orali Suspensjoni orali magħquda, b’ togħma ta ’ l- għasel, safra u bi sfumatura ħadranija.
Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.
Għas- serħan mill- infjammazzjoni u uġigħ f’ mard muskolu- skeletriku li jkun kemm akut kif ukoll kroniku.
Do not use in horses less than 6 weeks of age.
Tużax fuq żwiemel li għandhom inqas minn 6 ġimgħat.
22/ 125 Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
23/ 125 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali Persuni li jafu li għandhom sensittività eċċessiva għal NSAIDs għandhom jevitaw li jmissu mal - prodott mediċinali veterinarju.
Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea).
Każijiet iżolati ta ’ reazzjonijiet avversi li ġeneralment huma assoċjati mal- NSAIDs kienu osservati fi provi kliniċi (urtikarja ħafifa, dijarea).
Symptoms were reversible.
Is- sintomi kienu riversibbli.
Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects.
Studji fil- laboratorju fil- baqar ma pprovdew l- ebda evidenza ta ’ effetti teratoġeniċi, fetotossiċi jew maternotossiċi.
However, no data have been generated in horses.
Madankollu, m’ hemm l- ebda informazzjoni dwar dan fiż- żwiemel.
Therefore the use in this species is not recommended during pregnancy and lactation.
Għalhekk, l- użu tiegħu f’ din l- ispeċi mhux rakkomandat waqt it- tqala jew fi żmien il- ħalib.
Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Tagħtix flimkien ma ’ glukokortikosterojdi, sustanzi oħrajn mhux sterojdiċi u anti- infjammatorji jew ma ’ aġenti antikoagulanti.
To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/ kg body weight, once daily, up to 14 days.
Biex jingħata jew imħallat ma ’ l- ikel jew direttament ġol- ħalq f’ dożaġġ ta ’ 0. 6 mg / kg ta ’ piż tal - ġisem, darba kuljum, sa 14- il jum.
In case the product is mixed with food, it should be added to a small quantity of food, prior to feeding.
F’ każ li l- prodott jitħallat ma ’ l- ikel, dan għandu jiżdied ma ’ kwantità żgħira ta ’ l- ikel, qabel ma jiġi mitmugħ.
The suspension should be given using the Metacam measuring syringe provided in the package.
Is- suspensjoni għandha tingħata permezz tas- siringa tal- kejl ta ’ Metacam ipprovduta fil- pakkett.
The syringe fits onto the bottle and has a kg-body weight scale.
Is - siringa teħel fuq il- flixkun u għandha skala ta ’ kilogramm- piż tal- ġisem.
3 days.
3 ijiem.
It reduces leukocyte infiltration into the inflamed tissue.
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.
To a minor extent it also inhibits collagen-induced thrombocyte aggregation.
Sa ċertu
Meloxicam also has anti-endotoxic properties 23/ 125 because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.
Meloxicam għandu wkoll proprjetajiet anti- endotossiċi għax intwera li jinibixxi l- produzzjoni ta ’ thromboxane B2 ikkaġunata mill- għoti ġol- vina ta ’ E. coli endotoxin fl- għoġġiela u fil- majjali.
Absorption When the product is used according to the recommended dosage regime the oral bioavailability is approximately 98%.
Assorbiment Meta l- prodott jintuża skond il- kors tad- dożaġġ rakkomandat, il- bijodisponibilità orali hi ta ’ madwar 98%.
Maximal plasma concentrations are obtained after approximately 2 - 3 hours.
L- ogħla konċentrazzjonijiet fil- plażma jinkisbu wara madwar 2 sa 3 sigħat.
The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.
Il- fattur ta ’ l - akkumulazzjoni ta ’ 1. 08 jindika li meloxicam ma jakkumulax meta jingħata kuljum.
Distribution Approximately 98% of meloxicam is bound to plasma proteins.
Distribuzzjoni Madwar 98% ta ’ meloxicam jeħel mal- proteini tal- plażma.
The volume of distribution is 0.12 l/ kg.
Il- volum tad- distribuzzjoni hu ta ’ 0. 12 l/ kg.
Metabolism The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively there are differences.
Metaboliżmu Il- metaboliżmu huwa kwalitattivament simili fil- firien, majjali żgħar, fil- bniedem, baqar u majjali, għalkemm jeżistu xi differenzi kwantitattivi.
The major metabolites found in all species were the 5-hydroxy- and 5-carboxy-metabolites and the oxalyl-metabolite.
Il- metaboliti ewlenin li jinsabu f’ kull speċi kienu l - metaboliti 5- hydroxy - u 5- carboxy u l- metabolit oxalyl.
The metabolism in horses was not investigated.
Il- metaboliżmu fiż- żwiemel ma kienx investigat.
Elimination Meloxicam is eliminated with a terminal half-life of 7.7 hours.
Eliminazzjoni Meloxicam jiġi eliminat b’ half- life terminali ta ’ 7. 7 sigħat.
- Water, purified
- Ilma purifikat
3 years Shelf-life after first opening of the immediate packaging:
3 snin Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
After administration of the drug, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.
Wara li tagħti l- mediċina, agħlaq il- flixkun billi terġa ’ tpoġġi t- tapp f’ postu, aħsel is- siringa tal- kejl b’ ilma sħun u ħalliha tinxef.
24/ 125 6.5 Nature and composition of immediate packaging
25/ 125 6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
Polyethylene bottle containing 100 or 250 ml with a polyethylene tip adapter, a tamper proof child resistant closure and a polypropylene measuring syringe.
Flixkun tal- polyethylene li fih 100 jew 250 ml b’ tip adapter tal- polyethylene, tapp li jirreżisti l- ftuħ mit- tfal żgħar u siringa tal- kejl tal- polypropylene.
08.10.2003 Date of last renewal:
08. 10. 2003 Data ta ’ l- aħħar tiġdid:
25/ 125 1.
26/ 125 1.
Metacam 0.5 mg/ ml oral suspension for dogs
Metacam 0. 5 mg/ ml suspensjoni orali għall- klieb
Each ml of Metacam 0.5 mg/ ml oral suspension contains:
Kull ml ta ’ Metacam 0. 5 mg/ ml suspensjoni orali fih:
Meloxicam 0.5 mg (equivalent to 0.02 mg per drop)
Meloxicam 0. 5 mg (ekwivalenti għal 0. 02 mg kull qatra)
Sodium benzoate 1.5 mg (equivalent to 0.06 mg per drop)
Sodium benzoate 1. 5 mg (ekwivalenti għal 0. 06 mg kull qatra)
26/ 125 Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
27/ 125 Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
This product for dogs should not be used in cats due to the different dosing devices.
Dan il- prodott għall- klieb m’ għandux jintuża għall- qtates minħabba l- istrumenti differenti li jintużaw biex jingħata d- dożaġġ.
These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Fil- klieb, dawn l- effetti sekondarji ġeneralment iseħħu fi żmien l- ewwel ġimgħa tat- trattament, u f’ ħafna każijiet jgħaddu malajr u jisparixxu wara t- tmiem tat- trattament, iżda f’ każijiet rari ħafna, jistgħu jkunu serji jew fatali.
10 drops / kg body weight Maintenance dose:
10 qatriet / kg ta ’ piż tal- ġisem Doża tal- manteniment:
5 drops / kg body weight
5 qatriet / kg ta ’ piż tal- ġisem
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose.
28/ 125 Is- siringa teħel mal- qattara tal- flixkun u għandha skala ta ’ kilogramm- piż tal- ġisem li tikkorrispondi mad- doża tal- manteniment.
Alternatively therapy may be initiated with Metacam 5 mg/ ml solution for injection.
Alternattivament, it- terapija tista ’ tinbeda b’ 5 mg/ ml soluzzjoni għal injezzjoni ta ’ Metacam
Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Rispons kliniku ġeneralment ikun osservat wara 3- 4 ijiem It- trattament għandu jitwaqqaf jekk wara perjodu massimu ta ’ 10 t’ ijiem, l- ebda titjib kliniku ma jkun evidenti.
28/ 125 6.
29/ 125 6.
5 years Shelf-life after first opening the immediate packaging:
5 snin Żmien li l- prodott jibqa ’ tajjeb wara li jkun tneħħa mill- ewwel ippakkjar:
Polyethylene bottle containing 15 or 30 ml with a polyethylene dropper, a tamper proof child resistant closure and a polypropylene measuring syringe.
Flixkun tal- polyethylene li fih 15, 30 ml b’ qattara tal- polyethylene, tapp li jirreżisti l- ftuħ mit- tfal żgħar u siringa tal- kejl tal- polypropylene.
29/ 125 9.
30/ 125 9.
01.08.2005 Date of last renewal:
01. 08. 2005 Data ta ’ l- aħħar tiġdid:
30/ 125 1.
31/ 125 1.
Metacam 1 mg chewable tablets for dogs Metacam 2.5 mg chewable tablets for dogs
Metacam 1 mg pilloli li tomgħodhom għall- klieb Metacam 2. 5 mg pilloli li tomgħodhom għall- klieb
Each chewable tablet contains:
Kull pillola li tomgħodha fiha:
1 mg / chewable tablet 2.5 mg / chewable tablet
1 mg / pillola li tomgħodha 2. 5 mg / pillola li tomgħodha
Chewable tablets Honey flavoured, pale-yellow, single-scored, oval chewable tablets with embedded code M01 (1 mg) and M02 (2.5 mg) on one side of the tablet.
Pilloli li tomgħodhom Pilloli li tomgħodhom b’ togħma ta ’ l- għasel, ta ’ lewn isfar ċar, b’ linja waħda, ovali, bil- kodiċi M01 (1 mg) u M02 (2. 5 mg) imnaqqxa fuq naħa waħda tal- pillola.
Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.
Tużax fuq klieb li għandhom inqas minn 6 ġimgħat jew li għandhom piż tal- ġisem ta ’ inqas minn 4 kg.
31/ 125 toxicity.
32/ 125 Evita l- użu fi kwalunkwe annimal li jkun deidratat, ipovolaemiku jew ipotensiv, għax hemm riskju potenzjali ta ’ tossiċità tal- kliewi.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Persuni li jafu li għandhom sensittività eċċessiva għal NSAIDs għandhom jevitaw li jmissu mal - prodott mediċinali veterinarju.
Initial treatment is a single dose of 0.2 mg meloxicam/ kg body weight on the first day, which can be given orally or alternatively using Metacam 5 mg/ ml solution for injection.
It- trattament tal- bidu jikkonsisti minn doża waħda ta ’ 0. 2 mg ta ’ meloxicam / kg ta ’ piż tal- ġisem fl - ewwel jum, li tista ’ tingħata mill- ħalq jew, alternattivament, billi tuża Metacam soluzzjoni għall - injezzjoni ta ’ 5 mg/ ml.
Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/ kg body weight.
It- trattament għandu jitkompla darba kuljum bl- għoti orali (f’ intervalli ta ’ 24 siegħa) bid- doża tal - manteniment ta ’ 0. 1 mg meloxicam / kg ta ’ piż tal- ġisem.
Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively.
Kull pillola li tomgħodha fiha jew 1 mg jew 2. 5 mg ta ’ meloxicam, li jikkorrispondu għad- doża tal - manteniment ta ’ kuljum għal kelb li għandu piż tal- ġisem ta ’ 10 kg, jew kelb li għandu piż tal- ġisem ta ’ 25 kg rispettivament.
Each chewable tablet can be halved for accurate dosing according to the individual body weight of the animal.
Kull pillola li tomgħodha tista ’ tinqasam għall- dożaġġ preċiż skond il- piż tal- ġisem individwali ta ’ l - annimali.