Valsts: Dienvidāfrikas Republika
Valoda: angļu
Klimata pārmaiņas: South African Health Products Regulatory Authority (SAHPRA)
Afrivet Business Management (Pty) Ltd
See ingredients
Injection
Each 1.0 ml Solution contains TOLFENAMIC ACID A 40.0 mg
C 0301. ANTI-INFLAMMATORY
Registered
2016-09-06
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 Izlasiet visu dokumentu