Pharmaceutical particulars : מידע רוקחי

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium chloride
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this 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 25°C. Do not freeze.
Store in the aluminium pouch in order to protect from light and oxygen.

6.5 Nature and contents of container

10 ml solution in a polypropylene pre-filled syringe without a needle, individually packaged in a transparent blister and overwrapped in an aluminium pouch containing an oxygen absorbing sachet. Available in a box of 10.
6.6 Instructions for Use, Handling and Disposal

The aluminium pouch and syringe blister should only be opened immediately prior administration.
After opening the pouch the product must be used immediately.

The external surface of the syringe and its content are sterile if the blister is unopened and undamaged.

Strictly respect the protocol below

The pre-filled syringe is for single patient use only. Discard the syringe after use. Do not reuse.

The product should be inspected visually for particles and discolouration prior to administration. Only clear colourless solution free from particles or precipitates should be used.

The product should not be used if the pouch or the blister has been opened or if the tamper evident seal on the syringe (plastic film at the basis of the end cap) is broken.
1) Tear open the aluminium pouch by hand only using the indent(s) Do not use sharp instruments to open the pouch.
2) Withdraw the pre-filled syringe from the sterile blister.
3) Push on the plunger to free the bung. The sterilisation process may have caused adhesion of the bung to the body of the syringe.


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



5) Check the syringe seal tip has been completely removed.
If not, replace the cap and twist again.



6) Expel the air by gently pushing the plunger.


7)      Connect syringe to vascular access device or to needle. Push the plunger to inject the required volume.
Any unused product or waste material should be disposed of in accordance with local requirements.


7 MARKETING AUTHORISATION HOLDER
MBI Pharma Ltd., POB 5061, Kadima, Israel