देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Flurbiprofen sodium dihydrate 0.03%
Allergan New Zealand Ltd
Flurbiprofen sodium dihydrate 0.03%
0.03% w/v
Eye drops, solution
Active: Flurbiprofen sodium dihydrate 0.03% Excipient: Citric acid monohydrate Hydrochloric acid Polyvinyl alcohol Potassium chloride Sodium chloride Sodium citrate dihydrate Sodium hydroxide Water
Ampoule, plastic, Purell PE 1840H resin ampoule 0.4 mL, 5 dose units
Prescription
Prescription
Aesica Pharmaceuticals Limited
Package - Contents - Shelf Life: Ampoule, plastic, Purell PE 1840H resin ampoule 0.4 mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C - Ampoule, plastic, 0.4 mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C - Ampoule, plastic, (4 x 5) x 0.4 mL - 20 dose units - 24 months from date of manufacture stored at or below 25°C - Ampoule, plastic, (8 x 5) x 0.4 mL - 40 dose units - 24 months from date of manufacture stored at or below 25°C - Ampoule, plastic, (10 x 5) x 0.4 mL - 50 dose units - 24 months from date of manufacture stored at or below 25°C
1996-05-01
OCUFEN ® flurbiprofen sodium Datasheet Version 3.0 Page 1 of 4 NEW ZEALAND DATA SHEET NAME OF MEDICINE: OCUFEN ® flurbiprofen sodium 0.03% PRESENTATION: OCUFEN ® eye drops: each mL contains flurbiprofen sodium 0.3mg with Liquifilm ® (polyvinyl alcohol) 14mg, potassium chloride, sodium chloride, sodium citrate, citric acid, purified water and sodium hydroxide or hydrochloric acid if needed for pH adjustment. USES: ACTIONS CLINICAL PHARMACOLOGY Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic and anti-inflammatory activity in anti-inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure. Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, OCUFEN ® has been shown to inhibit the miosis induced during the course of cataract surgery. Results from clinical studies indicate that flurbiprofen sodium has no significant effect upon intraocular pressure. PHARMACOKINETICS An orally administered dose of flurbiprofen is rapidly absorbed, metabolised in the liver and quickly and evenly distributed to most tissues other than those of the central nervous system. The mean half-life of elimination was seen with three times daily dosing of 50 mg for 10 days. Urinary excretion of unchanged drug (23.2%) and metabolites in humans accounts for 100% of the dose administer पूरा दस्तावेज़ पढ़ें