natgillin/translations-raw huggingface dataset:
In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.
Pri konjih je končna razpolovna doba izločanja meloksikama po intravenskem dajanju 8, 5 ure.
- Disodium edetate
- dinatrijev edetat
- Hydrochloric acid
- klorovodikova kislina
Shelf-life of the veterinary medicinal product as packaged for sale(20, 50 or 100 ml vials):
Rok uporabnosti zdravila v pakiranju za prodajo (viale po 20, 50 ali 100 ml):
3 years Shelf-life of the veterinary medicinal product as packaged for sale (250 ml vials):
3 leta Rok uporabnosti zdravila v pakiranju za prodajo (viale po 250 ml):
2 years
2 leti Rok uporabnosti po prvem odpiranju neposredne ovojnine:
Cardboard box with either 1 or 12 colourless glass injection vial(s) each containing 20, 50 or 100 ml.
Kartonska škatla z 1 ali 12 brezbarvnimi steklenimi injekcijskimi vialami po 20, 50 ali 100 ml.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
18/ 122 Viale so zaprte z gumijastimi zamaški in aluminijastimi zaporkami.
23.04.2001 Date of last renewal:
23. 04. 2001 Datum podaljšanja dovoljenja za promet:
Metacam 15 mg/ ml oral suspension for horses
Metacam 15 mg/ ml, peroralna suspenzija za konje
Each ml of Metacam 15 mg/ ml oral suspension contains:
1 ml peroralne suspenzije Metacam 15 mg/ ml vsebuje:
1.5 mg
15 mg
Oral suspension Honey flavoured, yellowish viscous oral suspension with a green tinge.
Peroralna suspenzija Rumenkasta, viskozna peroralna suspenzija z nadihom zelene in aromo medu
Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.
Umirjanje vnetja in lajšanje bolečine pri akutnih in kroničnih mišično- skeletnih obolenjih.
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.
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.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
20/ 122 V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects.
Laboratorijske raziskave pri govedih niso pokazale teratogenih učinkov niti toksičnih učinkov na plod ali samico.
Therefore the use in this species is not recommended during pregnancy and lactation.
Zato uporabe zdravila v obdobju brejosti in laktacije pri tej živalski vrsti ne priporočamo.
Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Zdravila ne uporabljajte hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali z antikoagulansi.
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.
Zdravilo dajemo pomešano s hrano ali v gobec v odmerkih po 0, 6 mg/ kg telesne mase, enkrat na dan, do 14 dni.
The suspension should be given using the Metacam measuring syringe provided in the package.
Suspenzijo je treba dajati s priloženo merilno brizgo Metacam.
3 days.
3 dni
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.
Coli pri teletih in prašičih.
5.2 Pharmacokinetic particulars
21/ 122 5. 2 Farmakokinetični podatki
Absorption When the product is used according to the recommended dosage regime the oral bioavailability is approximately 98%.
Absorpcija Če dajemo zdravilo po priporočeni shemi odmerjanja, je njegova peroralna biološka uporabnost približno 98- odstotna.
Maximal plasma concentrations are obtained after approximately 2 - 3 hours.
Največjo koncentracijo v plazmi doseže približno po 2 do 3 urah.
The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.
Faktor kopičenja 1, 08 kaže, da se meloksikam pri vsakodnevnem dajanju ne kopiči.
Distribution Approximately 98% of meloxicam is bound to plasma proteins.
Porazdelitev Približno 98% meloksikama se veže na beljakovine v plazmi.
The volume of distribution is 0.12 l/ kg.
Porazdelitveni volumen je 0, 12 l/ kg.
Metabolism The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively there are differences.
Presnavljanje Presnavljanje je kakovostno pri podganah, mini prašičih, ljudeh, govedih in prašičih podobno, količinsko pa se razlikuje.
The major metabolites found in all species were the 5-hydroxy- and 5-carboxy-metabolites and the oxalyl-metabolite.
Poglavitni presnovki, ki so jih odkrili pri vseh vrstah, so 5- hidroksi - in 5 - karboksi- presnovki ter oksalil- presnovek.
Elimination Meloxicam is eliminated with a terminal half-life of 7.7 hours.
Izločanje Končna razpolovna doba izločanja meloksikama je 7, 7 ure.
- Saccharin sodium
- natrivej saharinat
3 years Shelf-life after first opening of the immediate packaging:
3 leti Rok uporabnosti po prvem odpiranju neposredne ovojnine:
24/ 125 6.5 Nature and composition of immediate packaging
6. 5 Vrsta ovojnine in vsebina
Polyethylene bottle containing 100 or 250 ml with a polyethylene tip adapter, a tamper proof child resistant closure and a polypropylene measuring syringe.
Polietilenska plastenka po 100 ali 250 ml s polietilenskim nastavkom in varnostnim, za otroke varnim zapiralom ter polipropilenska merilna brizga.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
22/ 122 6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
08.10.2003 Date of last renewal:
08. 10. 2003 Datum podaljšanja dovoljenja za promet:
Metacam 0.5 mg/ ml oral suspension for dogs
Metacam 0, 5 mg/ ml, peroralna suspenzija za pse
Each ml of Metacam 0.5 mg/ ml oral suspension contains:
1 ml peroralne suspenzije Metacam 0, 5 mg/ ml vsebuje:
Meloxicam 0.5 mg (equivalent to 0.02 mg per drop)
Meloksikam 0, 5 mg (kar ustreza 0, 02 mg v 1 kapljici)
Sodium benzoate 1.5 mg (equivalent to 0.06 mg per drop)
Natrijev benzoat 1, 5 mg (kar ustreza 0, 06 mg v 1 kapljici)
26/ 125 Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
24/ 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 due to the different dosing devices.
Pri mačkah uporabljamo Metacam 0, 5 mg/ ml, peroralno suspenzijo za mačke.
10 drops / kg body weight Maintenance dose:
10 kapljic na kilogram telesne mase Vzdrževalni odmerek:
5 drops / kg body weight
5 kapljic na kilogram telesne mase
27/ 125 Dosing procedure using the measuring syringe:
Odmerjanje z merilno brizgo:
A clinical response is normally seen within 3 - 4 days.
25/ 122 Klinični odziv na zdravljenje je običajno opazen po 3 do 4 dneh.
5 years Shelf-life after first opening the immediate packaging:
5 leta Rok uporabnosti po prvem odpiranju neposredne ovojnine:
Polyethylene bottle containing 15 or 30 ml with a polyethylene dropper, a tamper proof child resistant closure and a polypropylene measuring syringe.
Polietilenska plastenka po 15, ali 30 ml s polietilensko kapalko in varnostnim, za otroke varnim zapiralom ter polipropilenska merilna brizga.
01.08.2005 Date of last renewal:
01. 08. 2005 Datum podaljšanja dovoljenja za promet:
10.
27/ 122 10.
Metacam 1 mg chewable tablets for dogs Metacam 2.5 mg chewable tablets for dogs
Metacam 1 mg, žvečljive tablete za pse Metacam 2, 5 mg, žvečljive tablete za pse
1 mg / chewable tablet 2.5 mg / chewable tablet
1 mg v 1 žvečljivi tableti 2, 5 mg v 1 žvečljivi tableti
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.
Žvečljive tablete Svetlo rumene, ovalne žvečljive tablete z zarezo na eni strani in aromo medu, ki imajo na ene strani vtisnjeno oznako M01 (1 mg) ali M02 (2, 5 mg)
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.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
Zaradi nevarnosti toksičnih učinkov na ledvice se dajanju zdravila izogibamo pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih.
31/ 125 toxicity.
29/ 122 Tega zdravila za pse ne smemo uporabljati pri mačkah, ker za to živalsko vrsto ni primerno.
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.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).
Varnost zdravila za uporabo v veterinarski medicini med brejostjo in laktacijo ni raziskana (glejte poglavje 4. 3).
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.
Damo ga lahko peroralno ali uporabimo raztopino za injiciranje Metacam 5 mg/ ml.
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.
Ena žvečljiva tableta vsebuje 1 mg ali 2, 5 mg meloksikama, kar ustreza dnevnemu vzdrževalnemu odmerku za psa s telesno maso 10 kg oziroma 25 kg.
Number of chewable tablets 1 mg 2.5 mg
Število žvečljivih tablet 2, 5 mg 1 mg
4.0 – 7.0 7.1 – 10.0 10.1– 15.0 15.1 – 20.0
4, 0 – 7, 0 7, 1 – 10, 0 10, 1 – 15, 0 15, 1 – 20, 0 20, 1 – 25, 0 25, 1 – 35, 0 35, 1 – 50, 0
½ 1 1½ 2
½ 1 1½ 2 1 1½ 2
32/ 125 20.
30/ 122 Za še natančnejše odmerjanje presodimo o uporabi peroralne suspenzije za pse Metacam.
A clinical response is normally seen within 3 - 4 days.
Klinični odziv na zdravljenje je običajno opazen po 3 do 4 dneh.
In case of overdosage symptomatic treatment should be initiated.
Pri vnosu prevelikega odmerka uvedemo simptomatsko zdravljenje.
Antiinflammatory and antirheumatic products, non-steroids (oxicams) ATC vet code:
Farmakoterapevtska skupina: protivnetna in protirevmatična zdravila, nesteroidna (oksikami) Oznaka ATCvet:
33/ 125 6.
31/ 122
- Povidone
- povidon
- Silica, colloidal anhydrous
- silicijev dioksid, koloidni brezvodni
- Crospovidone
- krospovidon
- Solid honey flavour
- trdna aroma medu
3 years in blisters:
6. 3 Rok uporabnosti
3 years Metacam 2.5 mg chewable tablets: in bottles:
Rok uporabnosti zdravila v pakiranju za prodajo:
2 years in blisters:
Žvečljive tablete Metacam 1 mg: v plastenkah: v pretisnih omotih:
2 years
2 leti 2 leti
6.4 Special precautions for storage
6. 4 Posebna navodila
1 mg chewable tablets:
Žvečljive tablete po 1 mg:
2.5 mg chewable tablets:
Žvečljive tablete po 2, 5 mg:
Metacam chewable tablets are supplied in:
6. 5 Vrsta ovojnine in vsebina
- Polyethylene bottles containing 100 chewable tablets together with a desiccant and a child-resistant
Žvečljive tablete Metacam so na voljo v:
closure.
- polietilenskih plastenkah s 100 žvečljivimi tabletami, sikativom in z za otroke varno zaporko.
- PVDC/ PE/ PVC/ AL child-resistant blisters with 10, 20, 100 or 500 tablets packed in cardboard
- za otroke varnih pretisnih omotih iz PVDC/ PE/ PVC/ AL z 10, 20, s 100 ali 500 tabletami v zloženkah.
Metacam 1 mg chewable tablets for dogs:
Metacam 1 mg, žvečljive tablete za pse:
EU/ 2/ 97/ 004/ 016 100 tablets Blisters:
EU/ 2/ 97/ 004/ 016 100 tablet Pretisni omoti:
EU/ 2/ 97/ 004/ 024 10 tablets EU/ 2/ 97/ 004/ 017 20 tablets EU/ 2/ 97/ 004/ 018 100 tablets EU/ 2/ 97/ 004/ 019 500 tablets
32/ 122 EU/ 2/ 97/ 004/ 024 10 tablet EU/ 2/ 97/ 004/ 017 20 tablet EU/ 2/ 97/ 004/ 018 100 tablet EU/ 2/ 97/ 004/ 019 500 tablet
Metacam 2.5 mg chewable tablets for dogs:
Metacam 2, 5 mg, žvečljive tablete za pse:
EU/ 2/ 97/ 004/ 020 100 tablets Blisters:
EU/ 2/ 97/ 004/ 020 100 tablet Pretisni omoti:
EU/ 2/ 97/ 004/ 025 10 tablets EU/ 2/ 97/ 004/ 021 20 tablets EU/ 2/ 97/ 004/ 022 100 tablets EU/ 2/ 97/ 004/ 023 500 tablets
EU/ 2/ 97/ 004/ 025 10 tablet EU/ 2/ 97/ 004/ 021 20 tablet EU/ 2/ 97/ 004/ 022 100 tablet EU/ 2/ 97/ 004/ 023 500 tablet
23.03.2006 Date of last renewal:
23. 03. 2006 Datum podaljašanja dovoljenja za promet:
Metacam 0.5 mg/ ml oral suspension for cats
Metacam 0, 5 mg/ ml, peroralna suspenzija za mačke
Excipient(s):
Pomožna( pomožne) snov( i):
Honey flavoured, yellowish viscous oral suspension with a green tinge.
Peroralna suspenzija Rumenkasta viskozna peroralna suspenzija z nadihom zelene in aromo medu
Alleviation of inflammation and pain in chronic musculo-skeletal disorders.
Umirjanje vnetja in lajšanje bolečine pri kroničnih mišično- skeletnih obolenjih.
Special precautions for use in animals If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Če se pojavijo neželeni učinki, je treba zdravljenje prekiniti in se posvetovati z veterinarjem.
36/ 125 toxicity.
34/ 122 Odzivanje na dolgotrajno zdravljenje mora v rednih razmikih spremljati veterinar.
Metacam 0.5 mg/ ml oral suspension for cats should not be used following parenteral injection of meloxicam or any other NSAID as appropriate dosage regimens for such follow-up treatments have not been established in cats.
Peroralne suspenzije Metacam 0, 5 mg/ ml za mačke ne smemo uporabiti po parenteralnem injiciranju meloksikama ali katerega koli drugega NSAID, ker ustrezen režim odmerjanja za takšno nadaljevalno zdravljenje pri mačkah ni določen.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (See 4.3).
(glejte poglavje 4. 3).
Initial treatment is a single oral dose of 0.1 mg meloxicam/ kg body weight on the first day.
Začetni odmerek prvi dan zdravljenja je 0, 1 mg meloksikama na kilogram telesne mase peroralno.
Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg meloxicam/ kg body weight.
Zdravljenje nadaljujemo z enim peroralnim, vzdrževalnim odmerkom po 0, 05 mg meloksikama na kilogram telesne mase na dan (v 24- urnih presledkih).
Alternatively and for cats with a body weight of at least 2 kg, the Metacam measuring syringe (provided in the package) can be used.
Mačkam s telesno maso najmanj 2 kg ga lahko dajemo tudi z brizgo za Metacam (ki je priložena).
6 drops / kg body weight
6 kapljic/ kg telesne mase Vzdrževalni odmerek:
3 drops / kg body weight
3 kapljice/ kg telesne mase
A clinical response is normally seen within 7 days.
35/ 122 Klinični odziv na zdravljenje je običajno opazen po 7 dneh.
In case of overdose, adverse reactions, as listed in Section 4.6, are expected to be more severe and more frequent.
Pri prevelikem odmerjanju lahko pričakujemo resnejše in pogostejše neželene reakcije, opisane v poglavju 4. 6.
5.2 Pharmacokinetic particulars Absorption If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately 3 hours.
Absorpcija Če prejme žival odmerek na tešče, doseže meloksikam največje koncentracije v plazmi po približno 3 urah.
Approximately 75% of the administered dose is
Približno 75% vnesenega odmerka se izloči z blatom, preostanek pa z urinom.
Due to the loading dose, steady state is reached after 2 days (48h).
Zaradi udarnega odmerka se ravnotežno stanje vzpostavi po 2 dneh (48 urah).
PHARMACEUTICAL PARTICULARS
FARMACEVTSKI PODATKI 6. 1 Seznam pomožnih snovi
6.1 List of excipients
- sorbitol, tekoči
- - - - - - - - - - -
- ksilitol
Sodium benzoate Sorbitol, liquid Glycerol Saccharin sodium Xylitol Sodium dihydrogen phosphate dihydrate Silica, colloidal anhydrous Hydroxyethylcellulose Citric acid Honey aroma Water, purified
- silicijev dioksid, koloidni, brezvodni
5 years Shelf-life after first opening the immediate packaging:
5 let Rok uporabnosti po prvem odpiranju stične ovojnine:
Polyethylene bottle containing 15 ml with a polyethylene dropper, a tamper proof child resistant closure and a polypropylene measuring syringe.
Polietilenska plastenka po 15 ml s polietilensko kapalko in varnostnim, za otroke varnim zapiralom ter polipropilenska merilna brizga.
The 1 ml measuring syringe has a kg-body weight scale for cats (2 to 10 kg) and has a pictogram showing a cat.
1- mililitrska merilna brizga ima skalo z oznakami telesne mase v kilogramih za mačke (2 do 10 kg) in piktogram mačke.
MARKETING AUTHORISATION NUMBERS
ŠTEVILKE DOVOLJENJ( A) ZA PROMET
20.04.2007 Date of last renewal:
20. 04. 2007 Datum podaljšanja dovoljenja za promet:
40/ 125 ANNEX II
38/ 122 DODATEK II
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
POGOJI TER DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE
41/ 125 Metacam 5 mg/ ml solution for injection for cattle and pigs
39/ 122 Metacam 5 mg/ ml, raztopina za injiciranje za goveda in prašiče
Venus, 26 Can Parellada Industrial 08228 Terrassa Spain
Venus, 26 Can Parellada Industrial 08228 Terrassa Španija
The Committee for Veterinary Medicinal Products has recommended the inclusion of meloxicam in Annex I of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
2377/ 90 v skladu z naslednjo tabelo:
Other
aktivna snov
active substance(s)
zaostanek
Meloxicam Meloxicam
meloksikam meloksikam
Muscle Liver Kidney Milk
mišice jetra ledvice mleko
Pharmacologically
Farmakološko aktivna snov
Animal
Živalska vrsta
active substance(s)
Druge določbe
species
etanol1
provisions
vse živalske vrste za proizvodnjo živil
Ethanol1 Poloxamer 1882 Sodium Chloride3 Glycine4 Sodium Hydroxide5 Water for injection6 Nitrogen7
poloksamer 1882
All food producing species All food producing species All food producing species All food producing species All food producing species All food producing species All food producing species
vse živalske vrste za proizvodnjo živil
The Committee considered that at the concentration of the dose in the product to be administered to the target species, the excipient glycofurol was not pharmacologically active.
Po mnenju Odbora pomožna snov glikofurol ni farmakološko aktivna v koncentraciji, v kateri jo vsebuje odmerek izdelka, namenjen za uporabo pri ciljni živalski vrsti.
It therefore concluded, in accordance with its recent position paper on pharmacologically active excipients, that an MRL was not required to be established for this substance.
Zato je v skladu s svojim nedavnim dokumentom o stališču o farmakološko aktivnih pomožnih snoveh mnenja, da zanj ni treba določiti najvišje dovoljene meje zaostankov.
Meglumine was not considered within the scope of Council Regulation 2377/ 90 at concentrations up to 1.5 mg/ kg bw (concentrations up to 34.75 mg/ ml).
Meglumin v koncentraciji do 1, 5 mg/ kg telesne mase (koncentracije do 34, 75 mg/ ml) ni bil vključen v Uredbo Sveta 2377/ 90.
1 OJ No.
1 UL št.
L 143 of 27.06.95 2 OJ No.
L 143 z dne 27. 06. 95 2 UL št.
L 290 of 5.12.95 3 OJ No.
L 290 z dne 5. 12. 95 3 UL št.
L 290 of 5.12.95 4 OJ No.
L 290 z dne 5. 12. 95 4 UL št.
L 272 of 25.10.96 5 OJ No.
L 272 z dne 25. 10. 96 5 UL št.
L 272 of 25.10.96 6 OJ No.
L 272 z dne 25. 10. 96 6 UL št.
L 143 of 27.06.95 7 OJ No.
L 143 z dne 27. 06. 95 7 UL št.
L 272 of 25.10.96
L 272 z dne 25. 10. 96
43/ 125 Metacam 1.5 mg/ ml oral suspension for dogs
41/ 122 Metacam 1, 5 mg/ ml, peroralna suspenzija za pse
To be supplied only on veterinary prescription.
Izdaja zdravila za uporabo v veterinarski medicini je le na recept
44/ 125 Metacam 5 mg/ ml solution for injection for dogs and cats
42/ 122 Metacam 5 mg/ ml, raztopina za injiciranje za pse in mačke
Labiana Life Sciences S. A Venus, 26 Can Parellada Industrial 08228 Terrassa Spain
Venus, 26 Can Parellada Industrial 08228 Terrassa Španija
45/ 125 Metacam 20 mg/ ml solution for injection for cattle, pigs and horses
43/ 122 Metacam 20 mg/ ml, raztopina za injiciranje za goveda, prašiče in konje
Other
Druge določbe
active substance(s)
aktivna snov( i)
species
zaostanek
Equidae
konji
Pharmacologically
Farmakološko aktivna snov( i)
Other
etanol8
active substance(s)
poloksamer 1889
species
glicin 10
provisions
dinatrijev edetat
Ethanol8 Poloxamer 1889 Macrogol 300 Glycine10 Disodium edetate Sodium Hydroxide11 Hydrochloric acid Water for injection12 Nitrogen13
vse živalske vrste za proizvodnjo živil
All food producing species All food producing species All food producing species.
vse živalske vrste za proizvodnjo živil
All food producing species All food producing species All food producing species All food producing species All food producing species All food producing species
vse živalske vrste za proizvodnjo živil
N. B.
voda za injekcije 12
Meglumine was not considered
vse živalske vrste za proizvodnjo živil
within the scope of Council Regulation 2377/ 90 at concentrations
vse živalske vrste za proizvodnjo živil
up to 1.5 mg/ kg bw (concentrations up to 34.75 mg/ ml)
Meglumin v koncentraciji do 1, 5 mg/ kg telesne mase (koncentracije do 34, 75 mg/ ml) ni bil vključen v Uredbo Sveta 2377/ 90.
8 OJ No.
8 UL št.
L 143 of 27.06.95 9 OJ No.
L 143 z dne 27. 06. 95 9 UL št.
L 290 of 5.12.95 10 OJ No.
L 290 z dne 5. 12. 95 10 UL št.
L 272 of 25.10.96 11 OJ No.
L 272 z dne 25. 10. 96 11 UL št.
L 272 of 25.10.96 12 OJ No.
L 272 z dne 25. 10. 96 12 UL št.
L 143 of 27.06.95 13 OJ No.
L 143 z dne 27. 06. 95 13 UL št.
47/ 125 Metacam 15 mg/ ml oral suspension for horses
45/ 122 Metacam 15 mg/ ml, peroralna suspenzija za konje
The Committee for Veterinary Medicinal Products has recommended the inclusion of Meloxicam in Annex I of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
2377/ 90 v skladu z naslednjo tabelo:
Animal species MRLs
Živalska vrsta
Meloxicam
kopitarji
Pharmacologically active substance Sorbitol
Farmakološko aktivna snov
Animal Species Annex II (E420): producing species
Živalska vrsta
Glycerol
sorbitol
Annex II (E422): producing species
Dodatek II (E420): vse živalske vrste za proizvodnjo živil
Saccharin
glicerol
Annex II (E954): producing species
Dodatek II (E422): vse živalske vrste za proizvodnjo živil
Xylitol
saharin
Annex II (E967): producing species
Dodatek II (E954): vse živalske vrste za proizvodnjo živil
All food
ksilitol
Annex II (E339): producing species
Dodatek II (E967): vse živalske vrste za proizvodnjo živil
Silica, colloidal anhydrous
natrijev dihidrogenfosfat dihidrat brezvodni koloidni silikagel
Annex II (E551): producing species
Dodatek II (E339): vse živalske vrste za proizvodnjo živil Dodatek II (E551): vse živalske vrste za proizvodnjo živil
Annex II (E211): producing species
Dodatek II (E211): vse živalske vrste za proizvodnjo živil
All food
2377/ 90.
48/ 125 Metacam 0.5 mg/ ml oral suspension for dogs
47/ 122 Metacam 0, 5 mg/ ml, peroralna suspenzija za pse
49/ 125 Metacam 1 mg chewable tablets for dogs Metacam 2.5 mg chewable tablets for dogs
48/ 122 Metacam 1 mg, žvečljive tablete za pse Metacam 2, 5 mg, žvečljive tablete za pse
50/ 125 Metacam 0.5 mg/ ml oral suspension for cats
49/ 122 Metacam 0, 5 mg/ ml, peroralna suspenzija za mačke
51/ 125 ANNEX III
50/ 122 DODATEK III
52/ 125 A.
51/ 122 A.
53/ 125 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
52/ 122 PODATKI NA ZUNANJI OVOJNINI
Metacam 5 mg/ ml solution for injection for cattle and pigs Meloxicam
Metacam 5 mg/ ml, raztopina za injiciranje za goveda in prašiče Meloksikam
Diarrhoea in calves of over one week of age and young, non-lactating cattle.
Akutna okužba dihal Driska pri teletih, starejših od enega tedna, in mladih govedih, ki niso v obdobju laktacije