Metacam 15 mg/ml Oral Suspension for Pigs

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:

Pigs

Θεραπευτική περιοχή:

Anti Inflammatory NSAID

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2010-07-05

Αρχείο Π.Χ.Π.

EMA Version
September 2021- AN: 01220/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metacam 15 mg/ml oral suspension for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE(S):
Meloxicam
15 mg
EXCIPIENT(S):
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
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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
MMA) with appropriate antibiotic therapy.
4.3
CONTRAINDICATIONS
Do not use in pigs 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.
EMA Version
September 2021- AN: 01220/2021
Page 2 of 5
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 severely dehydrated, hypovolaemic or hypotensive
pigs
which require parenteral rehydration, as there may be 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