natgillin/translations-raw huggingface dataset:
(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 Kako zdravilo Metacam deluje?
Metacam contains meloxicam, which belongs to a class of medicines called non-steroidal anti- inflammatory drugs (NSAIDs).
Zdravilo Metacam vsebuje meloksikam, ki spada v skupino zdravil, ki jim pravimo nesteroidna protivnetna zdravila (NSPVZ).
Meloxicam acts by inhibition of prostaglandin synthesis.
Meloksikam deluje z zaviranjem sinteze prostaglandinov.
How has the effectiveness of Metacam been studied?
Kako je bilo raziskana učinkovitost zdravila Metacam?
Appropriate studies have been made to show the effectiveness in the various target animals.
V ustreznih raziskavah so dokazali učinkovitost zdravila pri različnih ciljnih živalih.
What are the side effects of Metacam?
Kakšni so neželeni učinki zdravila 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.
Pri manj kot 10% goveda, zdravljenega v kliničnih raziskavah, so opazili rahlo začasno oteklino na mestu injiciranja po podkožni uporabi.
In horses, anaphylactoid (hypersentivity) reactions can occur and should be treated symptomatically.
Pri konjih se lahko pojavijo anafilaktoidne (preobčutljivostne) reakcije, ki jih je treba zdraviti simptomatsko.
A temporary swelling at the injection site can occur but resolves without intervention.
Lahko se pojavi začasna oteklina na mestu injiciranja, vendar izzveni brez ukrepanja.
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).
Pri psih in mačkah so občasni neželeni učinki zdravila Metacam so enaki kot pri drugih nesteroidnih protivnetnih zdravilih (NSPVZ), ki so zmanjšan apetit, bruhanje, driska, kri v blatu, in apatija (pomanjkanje vitalnosti).
In dogs, these side effects occur usually within the first week of treatment and are generally transient (temporary).
Pri psih se ti neželeni učinki običajno pojavijo v prvem tednu zdravljenja in so ponavadi prehodni (začasni).
In very rare cases, they may be serious or fatal.
V redkih primerih so lahko resni ali povzročijo smrtni izid.
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Metacam.
Osebe, ki so preobčutljive za (alergične na) nesteroidna protivnetna zdravila (NSPVZ), se morajo izogibati stiku z zdravilom Metacam.
After the last administration of Metacam cattle should not be slaughtered for 15 days and the milk not used for 5 days.
Goveda, ki je prejelo zdravilo Metacam, se ne sme zaklati 15 dni, mleka goveda pa ne uporabljati 5 dni po zadnjem odmerku.
Pigs and horses should not be slaughtered for 5 days.
Prašičev in konjev se ne sme zaklati 5 dni.
Why has Metacam been approved?
Zakaj je bilo zdravilo Metacam odobreno?
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.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristi zdravila Metacam večje od vseh tveganj zdravljenja, in priporoča odobritev dovoljenja za promet z zdravilom Metacam.
The benefit-risk balance may be found in module 6 of this EPAR.
Razmerje med koristmi in tveganji je najti v modulu 6 tega Evropskega javnega poročila o oceni zdravila (EPAR).
Other information about Metacam:
Druge informacije o zdravilu Metacam:
The European Commission granted a marketing authorisation valid throughout the European Union, for Metacam to Boehringer Ingelheim Vetmedica, Germany on 7 January 1998.
Evropska Komisija je dovoljenje za promet z zdravilom Metacam, veljavno po vsej Evropski uniji, odobrila družbi Boehringer Ingelheim Vetmedica dne 7. januarja 1998.
This summary was last updated in May 2006.
Ta povzetek je bil nazadnje posodobljen 05- 2006.
Withdrawal period
Karenca( e)
EU/ 2/ /97/ 004/ 00
EU/ 2 // 97/ 004/ 00
Cattle, Pigs
goveda in prašiči
Subcutaneous or intravenous injection; Intramuscular injection
podkožno ali intravensko; intramuskularno
Meat and offal:
meso in organi:
15 days (cattle), 5 days (pigs)
15 dni (goveda), 5 dni (prašiči)
Dogs Oral
peroralno
Not applicable
navedba smiselno ni potrebna
Dogs and Cats
psi in mačke
Cattle, pigs and horses
goveda, prašiči in konji
Subcutaneous, intramuscular, intravenous injection
podkožno, intramuskularno, intravensko
15 days (cattle), 5 days (pigs/ horses) Milk:
15 dni (goveda), 5 dni (prašiči / konji) mleko:
Cattle & Pigs
goveda in prašiči
2/ 4 EU/ 2/ 97/ 004/ 0
2/ 4 EU/ 2/ 97/ 004/ 0
20 tablets 1
pretisni omoti 20 tablet 1 iz PVDC/ PE / PVC/ AL
100 tablets 1
pretisni omoti 100 1 iz PVDC/ PE / tablet PVC/ AL
PVDC/ PE/ P VC/ AL blisters
pretisni omoti iz PVDC/ PE / PVC/ AL
500 tablets 1
500 1 tablet
100 tablets 1
100 1 tablet
EU/ 2/ 97/ 004/ 021
EU/ 2/ 97/ 004/ 02
10 tablets 1
10 tablet 1
EU/ 2/ 97/ 004/ 027
3/ 4 EU/ 2/ 97/ 004/ 027
15 days (cattle), 5 days (pigs/ horses) Milk:
15 dni (goveda), 5 dni (prašiči/ konji) mleko:
Metacam 5 mg/ ml solution for injection for cattle and pigs
Metacam 5 mg/ ml, raztopina za injiciranje za goveda in prašiče
Each ml of Metacam 5 mg/ ml solution for injection contains:
1 ml raztopine za injiciranje Metacam 5 mg/ ml vsebuje:
5 mg
Meloksikam 5 mg
Clear yellow solution for injection.
Prozorna rumena raztopina za injiciranje
2/ 125 4.5 Special precautions for use
Posebni previdnostni ukrepi za uporabo pri živalih
Special precautions for use in animals If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
2/ 122 Če se pojavijo neželeni učinki, je treba zdravljenje prekiniti in se posvetovati z veterinarjem.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Accidental self-injection may give rise to pain.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Nenamerno samoinjiciranje lahko povzroči bolečino.
People with known hypersensitivity to NSAID should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila naj se izogibajo stiku z zdravilom.
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.
Živali podkožno, intramuskularno in intravensko dajanje dobro prenašajo; v kliničnih raziskavah so zasledili samo blago in prehodno oteklino na mestu podkožne injekcije, in sicer pri manj kot 10% goved.
10.0 ml/ 100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Enkratna podkožna ali intravenska injekcija odmerka po 0, 5 mg meloksikama na kilogram telesne mase (to je 10, 0 ml/ 100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
2.0 ml/ 25 kg body weight).
Enkratna intramuskularna injekcija odmerka po 0, 4 mg meloksikama na kilogram telesne mase (to je 2, 0 ml/ 25 kg telesne mase).
3/ 125 4.11 Withdrawal periods
4. 11 Karenca( e)
5.
5 dni
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.
Deluje protivnetno, antieksudativno, analgetično in antipiretično.
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.
Coli pri teletih in prašičih.
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.
Absorpcija Po enkratnem podkožnem odmerku meloksikama po 0, 5 mg/ kg je znašala Cmax pri mladih govedih 2, 1 µg/ ml po 7, 7 ure.
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.
Po enkratnih intramuskularnih odmerkih meloksikama po 0, 4 mg/ kg je znašala Cmax pri prašičih po 1 uri 1, 1 do 1, 5 µg/ ml.
Distribution More than 98% of meloxicam is bound to plasma proteins.
Porazdelitev Več kot 98% meloksikama se veže na beljakovine v plazmi.
Metabolism Meloxicam is predominantly found in plasma.
Presnavljanje Meloksikam se pretežno nahaja v plazmi.
Elimination Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
Izločanje Razpolovna doba izločanja meloksikama je po podkožni injekciji pri mladih govedih 26 ur.
In pigs, after intramuscular administration, the mean plasma elimination half-life is approximately 2.5 hours.
Pri prašičih je srednja razpolovna doba izločanja po intramuskularnem dajanju približno 2, 5 ure.
Approximately 50% of the administered dose is eliminated via urine and the remainder via faeces.
Približno 50% vnesenega odmerka se izloči s sečem, preostanek pa z blatom.
- Poloxamer 188
- poloksamer 188
- Sodium chloride
- natrijev klorid
- Glycine
- glicin
- Sodium hydroxide
- natrijev hidroksid
- Glycofurol
- glikofurol
- Meglumine
- meglumin
- Water for injection
- voda za injekcije
6.3 Shelf life
4/ 122 6. 3 Rok uporabnosti
Shelf-life of the veterinary medicinal product as packaged for sales:
Rok uporabnosti zdravila v pakiranju za prodajo:
3 years Shelf-life after first opening the immediate packaging:
3 leta Rok uporabnosti po prvem odpiranju stične ovojnine:
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.
Kartonska škatla z 1 ali 12 brezbarvnimi steklenimi vialami po 100 ml, zaprtimi z gumijastim zamaškom in aluminijasto zaporko.
Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein Germany
Boehringer Ingelheim Vetmetica GmbH 55216 Ingelheim/ Rhein Nemčija
07.01.1998 Date of last renewal:
07. 01. 1998 Datum podaljšanja dovoljenja za promet:
Metacam 1.5 mg/ ml oral suspension for dogs
Metacam 1, 5 mg/ ml, peroralna suspenzija za pse
Each ml of Metacam 1.5 mg/ ml oral suspension contains:
1 ml peroralne suspenzije Metacam 1, 5 mg/ ml vsebuje:
Meloxicam 1.5 mg (equivalent to 0.05 mg per drop)
Meloksikam 1, 5 mg (kar ustreza 0, 05 mg v 1 kapljici)
Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)
Natrijev benzoat 1, 5 mg (kar ustreza 0, 05 mg v 1 kapljici)
Honey flavoured, yellowish viscous oral suspension with a green tinge.
Peroralna suspenzija Rumenkasta, viskozna peroralna suspenzija z nadihom zelene in aromo medu
None.
Ni posebnih opozoril.
Special precautions for use in animals If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Posebni previdnostni ukrepi za uporabo pri živalih Če se pojavijo neželeni učinki, je treba zdravljenje prekiniti in se posvetovati z veterinarjem.
7/ 125 Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
6/ 122 Tega zdravila za pse ne smemo uporabljati pri mačkah, ker za to živalsko vrsto ni primerno.
This product for dogs should not be used in cats as it is not suitable for use in this species.
Pri mačkah uporabljamo Metacam 0, 5 mg/ ml, peroralno suspenzijo za mačke.
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.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila naj se izogibajo stiku z zdravilom.
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Občasno so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil, kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev), apatija in ledvična odpoved.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (See 4.3).
Varnost veterinarskega zdravila med brejostjo in laktacijo ni raziskana (glejte poglavje 4. 3).
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.
Zdravljenje nadaljujemo z enim peroralnim, vzdrževalnim odmerkom po 0, 1 mg meloksikama na kilogram telesne mase na dan (v 24- urnih presledkih).
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.
Za dolgotrajnejše zdravljenje lahko, ko se pokaže klinični odziv (po ≥ 4 dneh), odmerek Metacama prilagodimo, tako da določimo najmanjši učinkoviti individualni odmerek ob upoštevanju, da se lahko jakost bolečine in vnetja pri kroničnih mišično- skeletnih obolenjih s časom spreminjata.
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.
Suspenzijo lahko dajemo s kapalko plastenke (zelo majhnim pasmam) ali s priloženo merilno brizgo za Metacam.
Dosing procedure using the drop dispenser of the bottle:
Odmerjanje s kapalko plastenke:
4 drops / kg body weight Maintenance dose:
4 kapljice na kilogram telesne mase Vzdrževalni odmerek:
2 drops / kg body weight
2 kapljici na kilogram telesne mase
8/ 125 Dosing procedure using the measuring syringe:
Odmerjanje z merilno brizgo:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose.
Brizga je oblikovana tako, da se prilega kapalki plastenke in ima merilno skalo z oznakami telesne mase v kilogramih, ki ustrezajo vzdrževalnemu odmerku.
Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
Za začetek zdravljenja je prvi dan torej potreben dvakratni volumen vzdrževalnega odmerka.
Alternatively therapy may be initiated with Metacam 5 mg/ ml solution for injection.
Zdravljenje lahko začnemo tudi z raztopino za injiciranje Metacam 5 mg/ ml.
A clinical response is normally seen within 3 - 4 days.
7/ 122 Klinični odziv na zdravljenje je običajno opazen po 3 do 4 dneh.
Distribution There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range.
Porazdelitev Pri terapevtskem razponu odmerkov je med vnesenim odmerkom in koncentracijo v plazmi linearno razmerje.
- Sodium benzoate
- natrijev benzoat
- Sorbitol, liquid
- sorbitol, tekoči
- Glycerol
- glicerol
- Saccharin sodium
- natrijev saharinat
- Xylitol
- ksilitol
- Sodium dihydrogen phosphate dihydrate
- natrijev dihidrogenfosfat dihidrat
- Silica, colloidal anhydrous
- silicijev dioksid, koloidni, brezvodni
- Hydroxyethylcellulose
- hidroksietilceluloza
- Citric acid
- citronska kislina
- Honey aroma
- aroma medu
- Water, purified
- prečiščena voda
3 years Shelf-life after first opening the immediate packaging:
3 leta Rok uporabnosti po prvem odpiranju neposredne ovojnine:
Polyethylene bottle containing 10, 32, 100 or 180 ml with a polyethylene dropper, a tamper proof child resistant closure and a polypropylene measuring syringe.
Polietilenska plastenka po 10, 32, 100 ali 180 ml s polietilensko kapalko in varnostnim, za otroke varnim zapiralom ter polipropilenska merilna brizga.
24.03.2000 Date of last renewal:
24. 03. 2000 Datum podaljšanja dovoljenja za promet:
Metacam 5 mg/ ml solution for injection for dogs and cats
Metacam 5 mg/ ml, raztopina za injiciranje za pse in mačke
12/ 125 4.5 Special precautions for use
4. 5 Posebni previdnostni ukrepi
Special precautions for use in animals If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Posebni previdnostni ukrepi za uporabo pri živalih Če se pojavijo neželeni učinki, moramo zdravljenje prekiniti in se posvetovati z veterinarjem.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
11/ 122 Zaradi nevarnosti toksičnih učinkov na ledvice se dajanju zdravila izogibamo pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih.
Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
Občasno so poročali o značilnih neželenih škodljivih učinkih nesteroidnih protivnetnih zdravil, kot so izguba teka, bljuvanje, driska, okultna kri v blatu, apatija in ledvična odpoved.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (See 4.3).
Varnost veterinarskega zdravila v obdobju brejosti in laktacije še ni raziskana (glejte poglavje 4. 3).
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.
Zdravljenje lahko nadaljujemo s peroralno suspenzijo Metacam 1, 5 mg/ ml za pse ali z žvečljivimi tabletami Metacam 1 mg in 2, 5 mg za pse, ki jih damo v odmerku po 0, 1 mg meloksikama na kilogram telesne mase 24 ur po injekciji.
13/ 125 Reduction of post-operative pain (over a period of 24 hours):
Lajšanje pooperativne bolečine (v 24- urnem obdobju):
Particular care should be taken with regard to the accuracy of dosing.
12/ 122 Posebno pozornost je treba nameniti natančnemu odmerjanju.
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.
Deluje protivnetno, analgetično, antieksudativno in antipiretično.
Absorption Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 µg/ ml in dogs and 1.1 µg/ ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.
Absorpcija Meloksikam je po podkožnem dajanju v celoti biološko uporaben in doseže največjo srednjo koncentracijo v plazmi, ki je 0, 73 µg/ ml pri psih in 1, 1 µg/ ml pri mačkah, približno 2, 5 ure oz.
Distribution There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs.
1, 5 ure po dajanju.
14/ 125 Meloxicam is eliminated with a half-life of 24 hours in dogs and 15 hours in cats.
Izločanje Razpolovna doba izločanja meloksikama je pri psih 24 ur, pri mačkah pa 15 ur.
Colourless glass injection vial of 10 or 20 ml, closed with a rubber stopper and sealed with an aluminium cap.
Brezbarvne steklene injekcijske viale po 10 ali 20 ml, zaprte z gumijastim zamaškom in aluminijasto zaporko.
Metacam 20 mg/ ml solution for injection for cattle, pigs and horses
Metacam 20 mg/ ml, raztopina za injiciranje za goveda, prašiče in konje
Each ml of Metacam 20 mg/ ml solution for injection contains:
1 ml raztopine za injiciranje Metacam 20 mg/ ml vsebuje:
20 mg
Meloksikam 20 mg
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.
Za umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih mišično- skeletnih obolenjih.
See also section 4.7.
Glejte tudi poglavje 4. 7.
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.
15/ 122 Ne uporabite pri živalih z motnjami jetrne, srčne ali ledvične funkcije in s hemoragičnimi motnjami ter pri dokazanih ulkusnih lezijah v prebavilih.
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.
Goveda in prašiči podkožno, intramuskularno in intravensko dajanje dobro prenašajo; v kliničnih raziskavah so zasledili samo blago in prehodno oteklino na mestu podkožne injekcije, in sicer pri manj kot 10% goved.
Cattle and pigs:
Goveda in prašiči:
Do not use in horses producing milk for human consumption.
Ne uporabite pri konjih, katerih mleko se uporablja za prehrano ljudi.
See also section 4.3.
Glejte tudi poglavje 4. 3.
18/ 125 4.9 Amounts to be administered and administration route
16/ 122 4. 9 Odmerjanje in pot uporabe
2.5 ml/ 100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Enkratna podkožna ali intravenska injekcija odmerka po 0, 5 mg meloksikama na kilogram telesne mase (to je 2, 5 ml/ 100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
2.0 ml/ 100 kg body weight) in combination with antibiotic therapy, as appropriate.
Enkratna intramuskularna injekcija odmerka po 0, 4 mg meloksikama na kilogram telesne mase (to je 2, 0 ml/ 100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem.
3.0 ml/ 100 kg body weight).
Enkratna intravenska injekcija odmerka po 0, 6 mg meloksikama na kilogram telesne mase (to je 3, 0 ml/ 100 kg telesne mase).
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.
Pri umirjanju vnetja in lajšanju bolečine pri akutnih in kroničnih mišično- skeletnih obolenjih lahko uporabimo peroralno suspenzijo Metacam 15 mg/ ml v odmerku po 0, 6 mg meloksikama na kilogram telesne mase za nadaljevanje zdravljenja 24 ur po injekciji.
4.11 Withdrawal periods
4. 11 Karenca( e)
15 days Milk:
15 dni Mleko:
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.
Deluje protivnetno, antieksudativno, analgetično in antipiretično.
19/ 125 5.2 Pharmacokinetic particulars
5. 2 Farmakokinetični podatki
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.
Absorpcija Po enkratnem podkožnem odmerku meloksikama po 0, 5 mg/ kg je znašala Cmax pri mladih govedih in kravah v obdobju laktacije 2, 1 µg/ ml in 2, 7 µg/ ml po 7, 7 ure in 4 urah.
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.
17/ 122 Po dveh intramuskularnih odmerkih meloksikama po 0, 4 mg/ kg je znašala Cmax pri prašičih po 1 uri 1, 9 µg/ ml.
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.
Izločanje Razpolovna doba izločanja meloksikama je po podkožni injekciji pri mladih govedih in kravah v obdobju laktacije 26 in 17, 5 ure.
In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.
Pri prašičih je srednja razpolovna doba izločanja po intramuskularnem dajanju približno 2, 5 ure.