Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1.   List of the Other Excipients
Isopropyl myristate, n-pentane, gas propellant (mixture of propane, butane and isobutane).

6.2.   Incompatibilities
Povidone-iodine is incompatible with reducing agents, alkaloid salts, tannic acid, salicylic acid, silver, mercury and bismuth salts, taurolidine, hydrogen peroxide, and octenidine (see also section 4.5 Interactions with other medicinal products and other forms of interaction).

6.3.   Shelf Life
The expiry date of the product is indicated on the packaging materials.

6.4.   Special Precautions for Storage
Easily flammable. Store below 25ºC.
Do not expose to temperatures above 50°C.
Keep away from potential sources of inflammation.
6.5.   Nature and Contents of The Container
Pressurized aerosol aluminium can with inside lacquer, spray valve and spray head, weighing 30 g or 80 g.
Not all pack sizes may be marketed.

6.6.    Special Precautions for Disposal and Other Advice on Handling Shake the spray can well before use, hold upright and spray from a distance of 15 cm on the area to be treated. (See 4.2 Posology and route of administration).

Due to the oxidative effect of the povidone-iodine, metals may become corroded; plastics are generally resistant to povidone-iodine. In some cases, mostly reversible discolouration may occur.

Betadine Topical Spray can be easily removed from textiles and other materials with warm water and soap, and, in stubborn cases, by using ammonia (ammonia solution) or sodium thiosulphate (fixing salt).

Unused medicinal product or waste material must be disposed of in accordance with national requirements.


7.     REGISTRATION HOLDER
Rafa Laboratories Ltd., P.O.Box 405, Jerusalem 9100301.