Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Capsule shell

Gelatin
Noncrystallizing Sorbitol Liquid
Glycerol
Purified water
Maltitol liquid

Capsule fill all-rac-alpha-tocopherol
Printing ink

Opacode WB White, NS-78-18011

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 below 30 °C.
Bottle: keep the bottle tightly closed in order to protect from moisture.
Blister: store in the original package in order to protect from moisture.
6.5   Nature and contents of container

High density polyethylene (HDPE) bottles with a child-resistant polypropylene heat induction sealed closure containing 120 soft capsules.
Pack size of one bottle or three bottles per carton.

PVC/PCTFE/Al perforated unit dose blisters containing 8 soft capsules. Not  all pack sizes may be marketed.

6.6   Special precautions for disposal
No special requirements for disposal.


Manufacturer: Amarin Pharmaceuticals Ireland Limited, 88 Harcourt Street, Dublin 2, D02DK18, Ireland

Registration Holder: Neopharm Israel 1996 Ltd., HaShiloach 6, Petach Tikva, Israel.