Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Powder: Mannitol, trometamol, disodium edetate
Solvent: Water for injection
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 
6.3. Shelf life
The expiry date of the product is indicated on the packaging materials.
Single use only.
Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 21 °C (±2 °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 is the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

6.4. Special precautions for storage
Do not store above 25°C. Keep vial in the outer carton. Protect from light.
For storage conditions of the reconstituted medicinal product, see section 6.3 
6.5. Nature and contents of container
Immediate packaging:
1 set contains:
Powder for injection: Amber glass vial with rubber stopper, sealed with aluminium snap-off closure Water for injection: 2 ml clear glass ampoule
Pack Sizes: 1,5, 6 or 10 sets
Not all pack sizes may be marketed

6.6. Special precautions for disposal and other handling
The solution for injection is prepared by dissolving the content of one vial in water for injection from the accompanying ampoule, immediately prior to use. The appearance of the product after reconstitution is a yellow, clear liquid.

If visible signs of deterioration are seen in the medicinal product, the product must be disposed of in accordance with local requirements

Lornoxicam has shown compatibility with 0.9% NaCl, 5% dextrose (glucose) and Ringer’s solution.