Contacera
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
16-04-2020
Produktets egenskaber
(SPC)
16-04-2020
Offentlige vurderingsrapport
(PAR)
25-03-2014
Aktiv bestanddel:
meloxicam
Tilgængelig fra:
Zoetis Belgium SA
ATC-kode:
QM01AC06
INN (International Name):
meloxicam
Terapeutisk gruppe:
Horses; Pigs; Cattle
Terapeutisk område:
Anti-inflammatory and anti-rheumatic products, non-steroids
Terapeutiske indikationer:
CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs. 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. For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy. For the relief of post-operative pain following dehorning in calves.PigsFor the reduction of symptoms of lameness and inflammation in non-infectious locomotor disorders and for adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.HorsesFor use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders. For the relief of pain associated with equine colic.
Produkt oversigt:
Revision: 7
Autorisation status:
Authorised
Autorisation dato:
2012-12-06
Indlægsseddel
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET:
CONTACERA 20 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND HORSES
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
Manufacturer responsible for batch release:
Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
IRELAND
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Contacera 20 mg/ml solution for injection for cattle, pigs and horses
meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
One ml contains:
Meloxicam 20 mg
Ethanol (96%) 159.8 mg
Clear, yellow solution.
4.
INDICATION(S)
CATTLE:
For use in acute respiratory infection with appropriate antibiotic
therapy to reduce clinical signs in
cattle.
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.
For adjunctive therapy in the treatment of acute mastitis, in
combination with antibiotic therapy.
For the relief of post-operative pain following dehorning in calves.
PIGS:
For use in non-infectious locomotor disorders to reduce the symptoms
of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and
toxaemia (mastitis-metritis-
agalactia syndrome) with appropriate antibiotic therapy.
HORSES:
For use in the alleviation of inflammation and relief of pain in both
acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.
30
5.
CONTRAINDICATIONS
Do not use in horses less than 6 weeks of age.
Do not use in pregnant or lactating mares.
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.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
For the treatment of dia
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Contacera 20 mg/ml solution for injection for cattle, pigs and horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Meloxicam
20 mg
EXCIPIENT:
Ethanol (96%)
159.8 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, pigs and horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE:
For use in acute respiratory infection with appropriate antibiotic
therapy to reduce clinical signs in
cattle.
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.
For adjunctive therapy in the treatment of acute mastitis, in
combination with antibiotic therapy.
For the relief of post-operative pain following dehorning in calves.
PIGS:
For use in non-infectious locomotor disorders to reduce the symptoms
of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and
toxaemia (mastitis-metritis-
agalactia syndrome) with appropriate antibiotic therapy.
HORSES:
For use in the alleviation of inflammation and relief of pain in both
acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.
3
4.3
CONTRAINDICATIONS
See also section 4.7.
Do not use in horses less than 6 weeks of age.
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.
Do not use in case of hypersensitivity to the active substance(s) or
to any of the excipient(s).
For the treatment of diarrhoea in cattle, do not use in animals of
less than one week of age.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of calves with Contacera 20 minutes before dehorning reduces
post-operative pain.
Contacera alone will not provide ad
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