Pharmaceutical particulars : מידע רוקחי

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Ethanol anhydrous.

6.2 Incompatibilities

Diluted solutions of Prostin VR should be infused from glass or hard plastic containers, or PVC infusion bags. If undiluted Prostin VR comes in direct contact with a plastic container, plasticisers are leached from the side walls. This appears to be a concentration- dependent phenomenon. See section 6.6
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials. Diluted solutions should be used within 24 hours.

6.4 Special precautions for storage

Store in a refrigerator (2-8°C).
6.5 Nature and contents of container
1ml Type I clear glass ampoule

6.6 Special precautions for disposal and other handling

Dilution Instructions
To prepare infusion solutions, dilute 1 ml of Prostin VR Sterile Solution with sterile 0.9% Sodium Chloride Intravenous Infusion or sterile 5% Dextrose Intravenous Infusion.

If undiluted Prostin VR Sterile Solution comes in direct contact with a plastic container, plasticisers are leached from the side walls. The solution may turn hazy and the appearance of the container may change. Should this occur, the solution should be 
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 discarded and the plastic container should be replaced. This appears to be a concentration-dependent phenomenon.
To minimise the possibility of haze formation, Prostin VR Sterile Solution should be added directly to the intravenous infusion solution, avoiding contact with the walls of plastic containers. Dilute to volumes appropriate for the delivery system available.
Prepare fresh infusion solutions every 24 hours. Discard any solution more than 24 hours old.

PARTICULAR CARE SHOULD BE TAKEN IN CALCULATING AND PREPARING
DILUTIONS OF PROSTIN VR.