Tolfine Solution for Injection 4.0% WV

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:

100.00 mcg/mL

Manufactured by:

Vetoquinol

Summary of Product characteristics

ADVERSE EFFECTS
Transient swelling and inflammation may occur at the injection
point.
OVERDOSE AND TREATMENT
None
FURTHER INFORMATION
Keep out of the reach of children.
Following withdrawal of the first dose, the product should be used
within 28 days.
Dispose of any unused product and empty containers in accor-
dance with guidance from your local waste regulation authority.
STORAGE CONDITIONS
Do not store above 25°C. Protect from light.
Keep the container in the outer carton.
DOSAGE FORMS AND PACKAGING
Amber type II glass vials of 50 or 100 ml closed with a type I
chlorobutyl rubber stopper.
REG NUMBER : MALXXXX
FOR ANIMAL TREATMENT ONLY
CONTROLLED MEDICINE - UBAT TERKAWAL
NAME AND ADRESS OF MANUFACTURER
VETOQUINOL S.A
Magny-Vernois, 70204 Lure, France
NAME AND ADRESS OF REGISTRATION HOLDER
AGE D'OR SDN BHD
15, Jalan 31/54, Section 31, Kota Kemuning 40460, Shah Alam,
Selangor D.E., Malaysia
DATE OF REVISION: March 2014
0414 C
_TOLFINE_
_®_
COMPOSITION
Tolfenamic acid ..................................................4.0%
w/v
Benzyl alcohol..................................................1.04 %
w/v
Sodium formaldehyde sulphoxylate ................0.05 % w/v
PRODUCT DESCRIPTION
Solution for injection, vials of 50ml or 100 ml of clear, colourless
to
slighty yellow, slighty viscous solution.
PHARMACOLOGICAL PROPERTIES
TOLFENAMIC ACID (N-(2-methyl-3-chlorophenyl) anthranilic acid) is a
non-steroidal anti-inflammatory drug (NSAID) belonging to the
fenamate group. Tolfenamic acid exerts anti-inflammatory, analgesic
and
antipyretic
activities.
The
anti-inflammatory
activity
of
tolfenamic acid is mainly due to an inhibition of cyclo-oxygenase
and thus to a reduction in the synthesis of prostaglandins and
thromboxanes, which are important inflammatory mediators.
PHARMACOKINETIC PROPERTIES
PIGS
In pigs, tolfenamic acid injected by IM route at a dose of 2mg/kg is
rapidly absorbed from the injection site with a mean maximum
plasma concentration of about 2.3ug/ml obtained at about 1 hour.
The volume of distribution is appro