Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Each vial contains disodium edetate 1.5 mg and sodium hydroxide q.s. for pH adjustment.


6.2 Incompatibilities
This medicinal product must not be used with other medicinal products except those mentioned in section 6.6.


6.3 Shelf-life
The expiry date of the product is indicated on the packaging materials.

Shelf-life reconstitution
Chemical and physical in-use stability has been demonstrated for 12 hours at 30ºC.
From a microbiological point of view, the product should be used immediately.

6.4 Special precautions for storage
Store in the original package, in order to protect from light. Vials can however be stored exposed to normal in-door light outside the box for up to 24 hours.

Store below 30ºC.

6.5 Nature and contents of container
5 mL vial made of colourless type 1 glass. Stopper made of bromobutyl rubber, cap made of aluminium and a plastic flip-off seal.
Pack sizes: 1 vial


6.6 Instructions for use, handling and disposal
The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration. Only clear solution should be used. For single use only.
If the entire reconstituted content of the vial is not required, any unused solution should be discarded in accordance with local requirements.


Injection 40 mg
A solution for injection (8 mg/ml) is prepared by adding 5 mL of 0.9% sodium chloride for intravenous use to the esomeprazole 40 mg vial. The reconstituted solution for injection is clear and colourless to very slightly yellow.


Infusion 40 mg
A solution for infusion is prepared by dissolving the content of one vial with esomeprazole 40 mg in up to 100 mL 0.9% sodium chloride for intravenous use.


Infusion 80 mg
A solution for infusion is prepared by dissolving the content of two vials of esomeprazole 40 mg in up to 100 ml of 0.9% sodium chloride for intravenous use.

The reconstituted solution for infusion is clear and colourless to very slightly yellow.


7. MANUFACTURER:

Anfarm Hellas S.A.
4 ACHAIAS STR. & TRIZINIAS, 14564 KIFISSIA, ATTIKI, GREECE