Metacam 1.5 mg/ml Oral Suspension for Dogs

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:

Dogs

Θεραπευτική περιοχή:

Anti Inflammatory NSAID

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2000-03-24

Αρχείο Π.Χ.Π.

EMA Version
September 2021- AN: 01220/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metacam 1.5 mg/ml oral suspension for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Meloxicam
1.5 mg (equivalent to 0.05 mg per drop)
EXCIPIENT:
Sodium benzoate 1.5 mg (equivalent to
0.05 mg per drop) 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
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Alleviation of inflammation and pain in both acute and chronic
musculo-skeletal
disorders in dogs.
4.3
CONTRAINDICATIONS
Do not use in pregnant or lactating animals.
Do not use in dogs 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 dogs less than 6 weeks of
age.
EMA Version
September 2021- AN: 01220/2021
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there
is a potential risk of renal toxicity.
This product for dogs should not be used in cats as it is not suitable
for
use in this species. In cats, Metacam 0.5 mg/ml oral suspension for
cats
should be used.
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