Pharmaceutical particulars : מידע רוקחי

6.   PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Capsule content
Starch, Pregelatinised
Capsule shell
Gelatin
Titanium dioxide
Imprint
Black iron oxide (E 172),
6.2 Incompatibilities
Not applicable.

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

6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Orfadin 2 mg hard capsules:
• The capsules can be kept out of the refrigerator in a temperature that does not exceed 25°C for up to 2 months. After this period, the packaging should be destroyed.
• After first opening it can be used for 2 months.
Orfadin 5 mg hard capsules:
• The capsules can be kept out of the refrigerator in a temperature that does not exceed 25°C for up to 3 months. After this period, the packaging should be destroyed.
• After first opening you can use for 2 months.
Orfadin 10 mg hard capsules:
• The capsules can be kept out of the refrigerator in a temperature that does not exceed 25°C for up to 3 months. After this period, the packaging should be destroyed.
• After first opening you can use for 2 months.


6.5 Nature and contents of container
High density polyethylene bottle with a tamper proof low density polyethylene snap –on caps, childproof cap, containing 60 capsules.

6.6 Special precautions for disposal
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.