METACAM 0.5% INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

MELOXICAM

Διαθέσιμο από:

BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

MELOXICAM 5MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική ομάδα:

CATS; DOGS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0131676002

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2021-03-01

Φύλλο οδηγιών χρήσης

BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.
METACAM
® 5 MG/ML (MELOXICAM) INJECTION /PROPOSED LABELING COMPONENTS
BIAH Version 22Feb2023
Page 1 of 15
PACKAGE INSERT (ENGLISH)
DIN 02240463
PR
METACAM
®
0.5%
INJECTION
Meloxicam 5 mg/mL
VETERINARY USE ONLY
Sterile
For Dogs and Cats
DESCRIPTION: A clear, yellow solution containing 5 mg meloxicam per mL
Ethanol (dehydrated)
Ph.Eur. 150 mg/mL is the preservative.
CLINICAL PHARMACOLOGY:
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) of the
oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting
anti-inflammatory, analgesic and
antipyretic effects. Maximum plasma concentrations are obtained after
approximately 1.5 hours
(cats) to 2.5 hours (dogs) post subcutaneous injection. There is a
linear relationship between the
dose administered and plasma concentration observed in the therapeutic
dose range.
Approximately 97% of meloxicam is bound to plasma proteins. The volume
of distribution is 0.3
L/kg. Meloxicam is predominantly found in plasma and is also a major
biliary excretion product
whereas urine contains only traces of the parent compound. Meloxicam
is metabolized to an
alcohol, an acid derivative and to several polar metabolites. All
major metabolites have been
shown to be pharmacologically inactive. Meloxicam is eliminated with a
half-life of 15 hours
(cat) and 24 hours (dog). Approximately 75% of the administered dose
is eliminated via faeces
and the remainder via urine.
INDICATIONS: Metacam
®
0.5% Injection is a nonsteroidal anti-inflammatory drug (NSAID) for
use in dogs and cats. It is indicated for the alleviation of
inflammation and pain in both acute and
chronic musculoskeletal disorders in dogs and also for the control of
perioperative pain
following orthopedic and soft tissue surgery in dogs and cats.
DOSAGE: MUSCULOSKELETAL DISORDERS: DOGS: Metacam
®
0.5% Injection
should be given as a single subcutaneous injection at a dosage of 0.2
mg meloxicam/kg body
weight (0.4 mL per 10 kg body weight). The product Metacam