When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
1. TRADE NAME OF THE MEDICINAL PRODUCT
Otosporin Ear Drops Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Polymyxin B sulphate 10,000 units Neomycin sulphate 3,400 units Hydrocortisone l% w/v Excipients: Each ml contains 0.005g of cetostearyl alcohol and 0.001g of methyl parahydroxybenzoate (E218). For a full list of excipients, see section 6.1 6.1 List of Excipients Cetostearyl alcohol. Sorbitan monolaurate. Polysorbate 20 Methyl parahydroxybenzoate (E218). Dilute Sulphuric acid Purified water. 6.3 Shelf Life Unopened: 3 years. Discard within one month of first opening the container. 6.5 Nature and Contents of Container Polypropylene dropper bottles with screw caps containing a creamy-white aqueous suspension. Pack sizes: Bottles of 5ml & 10ml. Not all pack sizes may be marketed.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
Polymyxin B sulphate 10,000 units
Neomycin sulphate 3,400 units
Hydrocortisone l% w/v
Excipients: Each ml contains 0.005g of cetostearyl alcohol and 0.001g of methyl parahydroxybenzoate (E218).
For a full list of excipients, see section 6.1
6.1 List of Excipients
Cetostearyl alcohol.
Sorbitan monolaurate.
Polysorbate 20
Methyl parahydroxybenzoate (E218).
Dilute Sulphuric acid
Purified water.
6.3 Shelf Life
Unopened: 3 years.
Discard within one month of first opening the container.
6.5 Nature and Contents of Container
Polypropylene dropper bottles with screw caps containing a creamy-white aqueous suspension.
Pack sizes: Bottles of 5ml & 10ml.
Not all pack sizes may be marketed.