Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium chloride
Hydrochloric acid
Sodium hydroxide
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
Ropivacaine Fresenius2 mg/ml solution for infusion/injection
The expiry date of the product is indicated on the packaging materials.


Shelf life after first opening:
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 and would normally not be longer than 24 hours at 2 to 8°C.

6.4 Special precautions for storage

Ropivacaine Fresenius2 mg/ml solution for infusion
Store below 25 °C.
Ropivacaine Fresenius2 mg/ml solution for injection
Store below 25 °C.

6.5 Nature and contents of container
Ropivacaine Fresenius 2 mg/ml solution for infusion:
- 100 ml transparent polyolefine bags in sterile plastic cover, pack of 1,5,10 - 200 ml transparent polyolefine bags in sterile plastic cover, pack of 1,5,10 
Ropivacaine Fresenius2 mg/ml solution for injection:
- 10 ml transparent polypropylene ampoules in sterile plastic cover, pack of 1,5 , 10 - 20 ml transparent polypropylene ampoules in sterile plastic cover, pack of 1, 5, 10 Not all pack-sizes may be marketed.

6.6 Special precautions and other handling

Ropivacaine Fresenius 2 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 Fresenius 2 mg/ml solution for infusion
The solution for infusion is preservative free and is intended for single use only. Discard any unused solution.
Ropivacaine solution for infusion in plastic infusion bag is chemically and physically compatible with the following drugs:

Concentration of Ropivacaine Fresenius: 1-2 mg/ml
Additive                         Concentration*
Fentanyl citrate                 1.0 - 10.0 microgram/ml
Sufentanil citrate               0.4 - 4.0 microgram/ml
Morphine sulfate                 20.0 - 100 microgram/ml
Clonidine hydrochloride          5.0 - 50 microgram/ml
* The concentration ranges stated in the table are wider than those used in clinical practice. Epidural infusions of Ropivacaine Fresenius/sufentanil citrate, Ropivacaine Fresenius/morphine sulphate and Ropivacaine Fresenius/clonidine hydrochloride have not been evaluated in clinical studies.

The mixtures are chemically and physically stable for 30 days at 20-30 ° C. From a microbiological point of view, the mixtures should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C.

The medicinal product is to be visually inspected prior to use. only clear solutions practically free from particles should be used.
The intact container must not be re -autoclaved.
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
Ropivacaine Fresenius 2 mg /ml solution for infusion- 158-69-34446
Ropivacaine Fresenius 2 mg /ml solution for injection - 158-68-34445