TOLFEDINE 4% WV SOLUTION FOR INJECTION FOR DOGS AND CATS

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

TOLFENAMIC ACID

Available from:

Gladron Chemicals Sdn Bhd

INN (International Name):

TOLFENAMIC ACID

Units in package:

10.00 mcg/mL

Manufactured by:

Vetoquinol

Summary of Product characteristics

TOLFEDINE
®
4% W/V SOLUTION FOR INJECTION
FOR USE IN DOGS AND CATS
_DIMENSIONS : 160x120 mm _
_RÉFÉRENCE ARTICLE : XXXXXX 0611 B_
_NOM DU PRODUIT :_
_Notice Tolfédine 4% Malaysie_
_1 COULEUR_
_281 U_
_CRÉÉ PAR : A.Milleret_
_LE : _
_VISA :_
_REV B_
_VÉTOQUINOL _
NON STEROIDAL ANTI-INFLAMMATORY - ANALGESIC - ANTIPYRETIC
Each ml contains tolfenamic acid 40mg as active ingredient with benzyl
alcohol
10.4mg and sodium formaldehyde sulphoxylate dihydrate 5mg as
preservative.
USES
Cats:
Adjuvant treatment of upper respiratory disease in association with
anti-
microbial therapy
Dogs: Inflammatory and painful post-operative syndromes
PHARMACODYNAMIC PROPERTIES
Tolfenamic acid (N-52-methyl-3-chloropentyl) anthranilic acid) is
belonging to the
fenamate group. Substances of this group exert antiinflammatory,
analgesic and
antipyretic activities. Fenamates are classified as non steroidal
antiinflammatory
drug (NSAID). the antiinflammatory activity of tolfenamic acid is
mainly due to an
inhibition
of
cyclooxygenase
and
thus
a
reduction
of
the
synthesis
of
prostaglandins, important inflammatory mediator.
PHARMACOKINETIC PARTICULARS
The pharmacokinetics of tolfenamic acid have been investigated in
laboratory
animals, in man and in the target species, dogs and cats.
ABSORPTION
In the dogs, tolfenamic acid is readily absorbed either by oral or by
injectable
administration. By oral route, Cmax of about 4 μg / ml is attained
after about 1 hour
at the single dose of 4 mg / kg. When administering at the same dose
during the
meal tolfenamic acid Cmax is of 2 ± 3 μg /ml. These variation can be
accounted for a
greater enterohepatic recycling when administered with food. By
injectable route,
the maximum plasma concentration of about 4 μg / ml (s.c.) and about
3 μg / ml
(i.m.) are obtained 2 hours after administration of 4 mg / kg i.m. as
well as s.c.
In the cats, the absorption is quite rapid. By oral route, after a
dose of 4 mg/ kg a
mean maximum concentration of about 5.6 μg / ml is attained . The
mean Tmax
is observed aft