Metacam 20 mg/ml Solution for Injection for Cattle, Pigs and Horses

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Meloxicam

Διαθέσιμο από:

Boehringer Ingelheim Vetmedica Gmbh

Φαρμακολογική κατηγορία (ATC):

QM01AC06

INN (Διεθνής Όνομα):

Meloxicam

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Cattle, Horses, Pigs

Θεραπευτική περιοχή:

Anti Inflammatory NSAID

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2001-04-23

Αρχείο Π.Χ.Π.

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EMA Version
October 2021 – AN: 01355/2021
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metacam 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.
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.
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.
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Do not use in cases 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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatmen