Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients

Sodium chloride
Hydrochloric acid, concentrated
Sodium hydroxide
Water for injections

6.2. Incompatibilities
Levofloxacin Fresenius 5mg/ml solution for infusion should not be mixed with heparin or alkaline solutions (e.g. sodium hydrogen carbonate).
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.


Diluted solution:
Dilution is not necessary prior to administration.
For the diluted product chemical and physical in use stability has been demonstrated for 3 hours at 25 °C.

After first opening:

From the microbiological point of view, the product should be used immediately (within 3 hours). If not used immediately (within 3 hours), in-use storage times and conditions prior to use are the responsibility of the user, unless reconstitution/dilution has been taken place in controlled and validated conditions.

No protection from light is necessary during infusion.

6.4. Special precautions for storage
Freeflex® bags:
Do not store above 25°C.
Keep container in the outer carton in order to protect from light.
Do not refrigerate or freeze.

For storage conditions of the diluted product see section 6.3

6.5. Nature and contents of container
50 ml filled in 100 ml bag: 100 ml polyolefine Freeflex bag system
Pack size: 10 and 20 bags

100 ml filled in 100 ml bag: 100 ml polyolefine Freeflex bag system
Pack size: 10 and 20 bags

Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Mixture with other solutions for infusion:
Levofloxacin Fresenius 5mg/ml solution for infusion is compatible with the following solutions for infusion:

- Glucose 50 mg/ml (5%).
- Glucose-Ringer 25 mg/ml (2.5%).
- Sodium chloride 9 mg/ml (0.9%).
- Amino acid solution

See section 6.2 for incompatibilities.


   7. MARKETING AUTHORISATION HOLDER
Neopharm (Israel) 1996 LTD, Hashiloach 6,
POB 7063 Petach Tiqva 4917001


8. MARKETING AUTHORISATION NUMBER(S)
156-84-34212