Metacam 40 mg/ml Solution for Injection for Cattle and Horses

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Αγόρασέ το τώρα

Κατεβάστε Αρχείο Π.Χ.Π. (SPC)
17-04-2023

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

Θεραπευτική περιοχή:

Anti Inflammatory NSAID

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2015-04-09

Αρχείο Π.Χ.Π.

                                51
EMA Version
October 2021 – AN: 01355/2021
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metacam 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 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 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.
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
Do not use in pregnant or lactating mares (see 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 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
Treatment of calves with Metacam 20 minutes before dehorning reduces
post-operative pain. Metacam
52
EMA Version
October 2021 – AN: 01355/2021
alone will not provide adequate pain relief during the dehorning
procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions fo
                                
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