Metacam 15 mg/ml Oral Suspension for 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:

Oral suspension

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Horses

Θεραπευτική περιοχή:

Anti Inflammatory NSAID

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2003-10-08

Αρχείο Π.Χ.Π.

EMA Version
September 2021- AN: 01220/2021
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metacam 15 mg/ml oral suspension for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Meloxicam
15 mg
EXCIPIENT:
Sodium benzoate 1.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
Yellowish viscous oral suspension with a green tinge.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alleviation of inflammation and relief of pain in both acute and
chronic
musculo-skeletal disorders in horses.
4.3
CONTRAINDICATIONS
Do not use in pregnant or lactating mares.
Do not use in horses suffering from gastrointestinal disorders such as
irritation and haemorrhage, impaired hepatic, cardiac or renal
function
and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or
to any of the excipients. Do not use in horses less than 6 weeks
of age.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
EMA Version
September 2021- AN: 01220/2021
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4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animals as
there
is a potential risk of renal toxicity.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals People with known hypersensitivity to
non-
steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with
the
veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and
show the
package leaflet or the label to the physician.
This product can cause eye irritation. In case of contact with the
eyes,
immediately rinse thoroughly with water.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Diarrhoea, typically associated with NSAIDs, was very rarely observed
in
clinical trials. The clinical sign was reversible.
Loss of appetite, lethargy, abdominal pain, colitis a