Recocam
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
24-06-2019
Summary of Product characteristics
(SPC)
24-06-2019
Public Assessment Report
(PAR)
21-07-2013
Active ingredient:
meloxicam
Available from:
Bimeda Animal Health Limited
ATC code:
QM01AC06
INN (International Name):
meloxicam
Therapeutic group:
Horses; Pigs; Cattle
Therapeutic area:
Oxicams
Therapeutic indications:
CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.For use in diarrhoea in combination with oral rehydration 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.PigsFor use in noninfectious 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.HorsesFor use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders.For the relief of pain associated with equine colic.
Product summary:
Revision: 5
Authorization status:
Authorised
Authorization date:
2011-09-13
Patient Information leaflet
17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET
RECOCAM 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 and manufacturer responsible for batch
release:
Bimeda Animal Health Limited,
2, 3 & 4 Airton Close,
Tallaght, Dublin 24,
Ireland.
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Recocam 20 mg/ml solution for injection for cattle, pigs and horses
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One ml contains:
ACTIVE SUBSTANCE:
Meloxicam
20 mg
EXCIPIENT:
Ethanol 99.9%
150 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.
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.
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 horses producing milk for human consumption.
19
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 diarrhoea in cattle, do not use in animals of
l
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Summary of Product characteristics
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Recocam 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
150 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.
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.
4.3
CONTRAINDICATIONS
See also section 4.7.
3
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 cases of hypersensitivity to the active substance 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
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the
advice of a veterinarian should be
sought.
Avoid use in very severe
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