Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Hydrochloric acid 1M
Carmellose sodium (Blanose 12M31P)
Citric acid monohydrate
Sodium hydroxide
Disodium edetate
Benzalkonium chloride 50% solution
Sodium hydroxide 1M
Water for injections
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.
After first opening: 7 days. Store below 25°C. Do not refrigerate. Keep the dropper bottle tightly closed in the outer carton in order to protect from light.

6.4       Special precautions for storage

Before first opening:
Store in a refrigerator (2°C - 8°C).
Keep the vial in the outer carton in order to protect from light.
For storage conditions after first opening of the medicinal product, see section 6.3.

6.5       Nature and contents of container

5 mL solution in a 10 mL amber glass vial closed by a bromobutyl stopper and sealed with an aluminium tear-off cap. A PVC dropper applicator with HDPE closure is packed separately and included in each carton box.

Each carton box contains 1 vial and 1 dropper applicator.

6.6       Special precautions for disposal and other handling
The patient should be advised to follow the instructions below for opening of the vial and attachement of the dropper applicator:

•     Wash your hands carefully in order to avoid microbiological contamination of the content in the vial.
•     Remove the green protective cap (picture 1).
•     Remove the metal seal (picture 2).
•     Remove the grey stopper (picture 3) from the vial.
•     Do not touch the opening of the vial after removing the grey stopper.

 remove remove                                    remove green protective cap                                      grey metal seal stopper
 vial



•     Take the dropper out of its sachet, without touching the end intended to be attached to the vial, attach it (picture 4) to the vial and do not remove it.



small white cap
 turn and push         small white cap to attach                                     dropper
 dropper vial vial



•    Make sure that you do not lose the small white cap (picture 5) that comes on the top of the dropper.