Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injections

6.2 Incompatibilities

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

6.3 Shelf life

The expiry date is indicated on the package materials.
After opening: the product must be used immediately.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light. Do not refrigerate or freeze.

6.5 Nature and contents of container

Type I, 2 ml one point cut brown glass ampoules.
Box of 10 ampoules containing 1 ml of solution.
6.6 Special precautions for disposal and other handling

Instructions for use: The ampoule is for single use only. The solution should be used immediately after the opening of the container.
After dilution:
The product is chemically stable for 24 hours.
However, 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.

Any unused product or waste material should be disposed of in accordance with local requirements.
Discard ampoule after use. DO NOT REUSE.
The content of un-opened and un-damaged ampoule is sterile, and must not be opened until use.
The product should be inspected visually for particles and discoloration prior to administration. Only clear colourless solution free from particles or precipitates should be used.

Ephedrin Sintetica 50 mg/ml can be diluted with 0.9% NaCl solution.