Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium chloride, sodium citrate, citric acid monohydrate, sodium hydroxide (for pH adjustment), water for injection.

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4   Special precautions for storage

Store below 30°C.

Store the pre-filled syringes in their unopened blister until use. Store the blister in the outer carton in order to protect from light.
6.5       Nature and contents of container

10-ml polypropylene pre-filled syringe in blister pack. Box of 10 syringes.

6.6 Special precautions for disposal and other handling
Instructions for use:
Please prepare the syringe carefully as follows
The pre-filled syringe is for single patient only. Discard syringe after use.

The content of un-opened and un-damaged blister is sterile, and must not be opened until use.

When handled using an aseptic method, Phenylephrine Aguettant 50 mcg/ml in pre-filled syringe can be placed on a sterile field.

1) Withdraw the pre-filled syringe from the sterile blister.

2


2) Push on the plunger to free the bung. The sterilisation process may have caused adhesion of the bung to the body of the pre-filled syringe.



3

3) Twist off the end cap to break the seal. Do not touch the exposed luer connection in order to avoid contamination.



4

4) Check the pre-filled syringe seal tip has been completely removed.
If not, replace the cap and twist again



5

5) Expel the air by gently pushing the plunger.
6) Connect the pre-filled syringe to the IV access. Push the plunger slowly to inject the required volume.

7) After use, dispose of the pre-filled syringe according to the practices in force in your facility.

7.    MARKETING AUTHORISATION HOLDER
MBI Pharma Ltd., P.O.B. 5061, Kadima, Israel