Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium chloride
Hydrochloric acid 3.6% w/v (E507)
Sodium hydroxide (E524) (for pH-adjustment)
Water for injection
6.2 Incompatibilities
Studies carried out on alkaline solutions, showed that ropivacaine has poor solubility at pH> 6.0 and therefore precipitation may occur.

6.3 Shelf-life
The expiry date of the product is indicated on the packaging materials 
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.

6.5 Nature and contents of container
Ropivacaine BioAvenir 2 mg/ml solution for infusion:
- 100 ml transparent polypropylene bags in sterile plastic cover, pack of 5 - 200 ml transparent polypropylene bags in sterile plastic cover, pack of 5 

Ropivacaine Bioavenir 2 mg/ml solution for injection:
- 10 ml transparent polypropylene ampoules in sterile plastic cover, pack of 5 - 20 ml transparent polypropylene ampoules in sterile plastic cover, pack of 5 Ropivacaine Bioavenir 7.5 mg/ml solution for injection:
- 10 ml transparent polypropylene ampoules in sterile plastic cover, pack of 5 - 20 ml transparent polypropylene ampoules in sterile plastic cover, pack of 5 Ropivacaine Bioavenir 10 mg/ml solution for injection:
- 10 ml transparent polypropylene ampoules in sterile plastic cover, pack of 5 - 20 ml transparent polypropylene ampoules in sterile plastic cover, pack of 5 
Not all pack-sizes may be marketed.

6.6 Special precautions for disposal and other handling
Ropivacaine Bioavenir 2 mg/ml; 7.5 mg/ml; 10 mg/ml solution for injection The solution for injection is preservative free and is intended for single use only. Discard any unused solution.
The medicinal product is to be visually inspected prior to use: only clear solutions practically free from particles should be used.
Do not re-autoclaved the container: when a sterile outside is required, the intact covered container should be used.
The polypropylene ampoules are especially designed to fit Luer Lock and Luer fit syringes.
Ropivacaine BioAvenir 2 mg/ml solution for infusion
The solution for infusion is preservative free and is intended for single use only. Discard any unused solution.
Physical and chemical stability of the solution after opening was demonstrated for 24 hours at 2-80 C.
From microbiological point of view the product should be used immediately.
The medicinal product is to be visually inspected prior to use. only clear solutions practically free from particles should be used.
On the bag there are the insertion port for the infusion device and the injection port to inject other pharmaceutical products into the solution.

7. LICENSES' REGISTRATION NUMBERS
2mg/ml infusion bags - 153-67-33924-00, 153-67-33924-01, 153-67-33924-02
2mg/ml ampoules -     153-22-33926-00, 153-22-33926-01
7.5mg/ml ampoules - 153-23-33927-00, 153-23-33927-01
10mg/ml ampoules - 153-24-33928-00, 153-24-33928-01