TOLFEDINE INJECTABLE Injection

Kraj: Republika Południowej Afryki

Język: angielski

Źródło: South African Health Products Regulatory Authority (SAHPRA)

Dostępny od:

Afrivet Business Management (Pty) Ltd

Dawkowanie:

See ingredients

Forma farmaceutyczna:

Injection

Skład:

Each 1.0 ml Solution contains TOLFENAMIC ACID A 40.0 mg

Dziedzina terapeutyczna:

C 0301. ANTI-INFLAMMATORY

Status autoryzacji:

Registered

Data autoryzacji:

2016-09-06

Charakterystyka produktu

Afrivet Business Management (Pty) Ltd TOLFEDINE Injectable
Each ml contains 40 mg tolfenamic acid
Page 1 of 4
VETERINARY MEDICINE
SCHEDULING STATUS
S3
PROPRIETARY NAME AND DOSAGE FORM
TOLFEDINE Injectable (Solution for injection)
COMPOSITION
Each 100 mℓ injectable solution contains 4,0 g Tolfenamic acid with
1,04 g Benzyl alcohol as
a preservative.
PHARMACOLOGICAL CLASSIFICATION
C 3.1 Anti-rheumatics (anti-inflammatory agents)
PHARMACOLOGICAL ACTION:
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 of the synthesis
of prostaglandins and thromboxanes, which are important inflammatory
mediators.
PHARMACOKINETICS
ABSORPTION:
Following the intramuscular route at a dose of 2 mg/kg is rapidly
absorbed from the injection
site with mean maximum plasma concentration of about 1.4 µg/ml
obtained at about 1 hour.
The volume of distribution is about 1.3 l/kg. Tolfenamic acid is
extensively plasma albumin
bound (>99.5 % in cattle). The bioavailability is about 90%.
DISTRIBUTION, METABOLISM, EXCRETION:
Tolfenamic acid is distributed in all the organs with a higher
concentration in the plasma,
digestive tract, liver, lungs and kidneys on the contrary; the
concentration in the brain is weak.
Tolfenamic acid and its metabolites cross the placenta poorly.
Tolfenamic acid distribution involves extracellular fluids where
concentrations similar to
plasma are achieved both in healthy and inflamed peripheral tissues.
It also appears in milk
in the active form.
Tolfenamic acid undergoes extensive entero-hepatic recirculation and,
as a result, prolonged
concentrations are found in plasma.
Afrivet Business Management (Pty) Ltd TOLFEDINE Injectable
Each ml contains 40 mg tolfenamic acid
Page 2 of 4
The elimination half-life varies from 8-1