Pharmaceutical particulars : מידע רוקחי

6       PHARMACEUTICAL PARTICULARS
6.1     List of excipients
Propylene glycol
Ethanol anhydrous (11 % v/v)
Water for Injections

6.2      Incompatibilities

In the absence of compatability studies, this medicinal product must not be mixed with other medicinal products.

Propylene glycol interacts with heparin and neutralises its effect. Rextol solution for injection contains propylene glycol as an excipient and should be administered through a different injection port than heparin.


6.3     Shelf life
The expiry date of the product is indicated on the packaging materials.
After opening, use immediately.


6.4     Special precautions for storage
Store below 25ºC in the original package.


6.5     Nature and contents of container
Each Type 1 glass ampoule contains 1mL or 2mL of solution for injection.
The presentations of Rextol 5mcg/ml are:
Pack containing 5 ampoules of 1mL of solution for injection
Pack containing 5 ampoules of 2mL of solution for injection
Not all pack sizes may be marketed.


6.6     Special precautions for disposal
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration. The solution is clear and colourless.
For single use only.
Any unused medicinal product or waste should be disposed of in accordance with local requirements.


7       MARKETING AUTHORISATION HOLDER
Lapidot Medical Import and Marketing Ltd.
8 Hashita st., Caesarea Industrial Park 3088900, Israel