Pharmaceutical particulars : מידע רוקחי

6. Pharmaceutical particulars
6.1 List of excipients

Powder:
None

Solvent:
Water for injections, Sodium chloride, Disodium phosphate dihydrate,
Potassium dihydrogen phosphate, Hydrochloric acid 1 M, Sodium hydroxide.
6.2 Incompatibilities

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 
From a microbiological point of view, the reconstituted 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 2 hours at 2°C - 8°C.


6.4 Special precautions for storage
Do not store above 30°C.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Pack of one 10 ml Type I colourless glass vial with butyl rubber stopper containing powder, and one 50 ml cyclic olefin copolymer syringe with plunger stopper (bromobutyl rubber) and plunger rod, containing solvent.


The pack contains 1 vial with powder and 1 prefilled syringe with solvent.


6.6 Special precautions for disposal and other handling

No special requirements for disposal.
Hexaminolevulinate may cause sensitisation by skin contact.

Handling instructions for the pharmacist or other healthcare professionals: All steps should be performed with sterile equipment and under aseptic conditions. A brief description of the reconstitution procedure is provided below.

1. Fasten the plunger rod into the rubber stopper of the syringe by turning the plunger rod clockwise until it stops.

2. Remove the cap from the syringe and keep it for later use. Connect a needle suitable for reconstitution to the syringe. Hold the syringe upright and carefully press the plunger rod upward to remove air.
3. Using the prefilled syringe, inject about 10 ml of the solvent into the vial of Hexvix powder. The vial should be about ¾ full.


4. Without withdrawing the needle from the vial, hold the powder vial and the syringe in a firm grip and shake gently to ensure complete dissolution.


5. Withdraw all of the dissolved solution from the powder vial into the syringe.


6. Disconnect the empty vial from the syringe and discard it.
Disconnect the needle from the syringe tip and discard it.
Plug the syringe with the syringe cap.
Gently mix the contents of the syringe.


Hexvix is now reconstituted and ready for use. The appearance of the reconstituted solution is clear to slightly opalescent, and colourless to pale yellow.

Add two hours to the present time and write the resulting expiration time and date on the syringe label.

The product is for single use only. Any unused product should be discarded.