Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Hydrochloric acid (for pH adjustment).
Sodium hydroxide (for pH adjustment.)
Water for injections

6.2 Incompatibilities
Phenylephrine Altan 10 mg/ml is incompatible with alkalis, ferric salts, sodium phenytoin and oxidizing agents.

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

After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (20-25°C).
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage
Store below 25°C. Store in the outer package in order to protect from light.
This product is only for a single use.

6.5 Nature and contents of container
Amber-coloured type I glass ampoules.
Each pack contains 10 ampoules of 1 ml .

6.6 Special precautions for disposal and other handling

Phenylephrine Altan 10 mg/ml solution for injection/infusion can be diluted with the following solutions:
Glucose 5%, sodium chloride 0.9%.
Any unused medicinal product or material that had been in contact with it, should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Propharm Ltd.
P.O.Box 4046, Ben-Gurion 23,
Zichron Yaacov, 30900

8. MARKETING AUTHORIZATION NUMBER
162-16-35141-00