MELOSOLUTE 40 MG/ML SOLUTION FOR INJECTION FOR CAT

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MELOXICAM

Available from:

CP-Pharma Handelsgesellschaft mbH

ATC code:

QM01AC06

INN (International Name):

MELOXICAM

Dosage:

40 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Equine - Food

Therapeutic area:

Meloxicam

Therapeutic indications:

N.S.A.I.D

Authorization status:

Authorised

Authorization date:

2013-06-14

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Melosolute 40 mg/ml solution for injection for cattle and horses.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance:
Meloxicam
40 mg
Excipient:
Ethanol
150 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle 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.
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.
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 or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
IRISH MEDICINES BOARD
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_Date Printed 14/06/2013_
_CRN 7012679_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN A