Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars

6.1     List of excipients
Water for injections
Disodium edetate
6.2     Incompatibilities
Orfiril injection solution for injection should not be administered via the same intravenous line as other IV additives.
6.3     Shelf life
The expiry date of the product is indicated on the packaging materials.
Shelf life after dilution or reconstitution according to the directions: Chemical and physical in-use stability has been demonstrated for 3 days at 20 - 22°C. From a microbiological point of view, the product should be used immediately after opening. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally be not longer than 24 hours at 2 to 8°C, unless dilution has taken place in and validated aseptic conditions.
6.4     Special precautions for storage
Store below 25 0C.
Do not freeze.
6.5     Nature and contents of container
Glass (type I) ampoule containing 3 ml or 10 ml solution for injection.
Not all pack sizes may be marketed.
6.6     Special precautions for disposal and other handling
For infusion of Orfiril injection solution for injection it may be diluted in 0.9% saline or 5% dextrose.
Prior to use Orfiril injection solution for injection and the diluted solution should be visually inspected. Only clear solutions without particles should be used.
The contents of the vial are for single use only