Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Optilast.
0.5 mg/ml, Eye Drops, solution.
| Pharmaceutical Form |
|---|
|
Eye drops, solution. Clear, colourless solution. |
Azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg azelastine hydrochloride.
Excipient with known effect: 1 ml contains 0.125 mg benzalkonium chloride.
For the full list of excipients see section 6.1.
| Active Ingredient |
|---|
|
Azelastine, a phthalazinone derivative is classified as a potent long-acting anti-allergic compound with selective H1 antagonist properties. An additional anti-inflammatory effect could be detected after topical ocular administration. Data from in vivo (pre-clinical) and in vitro studies show that azelastine inhibits the synthesis or release of the chemical mediators known to be involved in early and late stage allergic reactions e.g. leukotriene, histamine, PAF and serotonin. |
| List of Excipients |
|---|
|
Benzalkonium chloride (preservative) |
10 ml opaque HDPE bottle and LDPE dropper with white HDPE screw cap. One bottle contains either 6 ml, 8 ml or 10 ml solution. Not all volume fill sizes are marketed in all Member States.
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
PL 46302/0136
1st August 2009
| Drug | Countries | |
|---|---|---|
| OPTILAST | Ireland, Israel, United Kingdom, South Africa |
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