Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Capsule content
Microcrystalline cellulose
Anhydrous dibasic calcium phosphate
Sodium starch glycolate
Magnesium stearate
Colloidal silicon dioxide
Pink opaque capsule shell
Gelatin
Titanium dioxide
Red iron oxide
White opaque capsule shell
Gelatin
Titanium dioxide

Printing ink
Shellac
Propylene glycol
Strong ammonia solution
Potassium hydroxide
Black iron oxide.

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 25°C
Bottle: after first opening, use within one month.

6.5   Nature and contents of container
XALKORI 200 mg capsules
HDPE bottles with a polypropylene closure containing 60 capsules.
PVC-foil blisters containing 10 capsules. The capsules contain a white to pale yellow powder.
The capsules should be swallowed whole and shouldn’t be crushed, dissolved, or opened since this method of administration hasn't been checked.

Each carton contains 60 hard capsules.

XALKORI 250 mg capsules
HDPE bottles with a polypropylene closure containing 60 capsules.

PVC-foil blisters containing 10 capsules. The capsules contain a white to pale yellow powder.
The capsules should be swallowed whole and shouldn’t be crushed, dissolved, or opened since this method of administration hasn't been checked.

Each carton contains 60 hard capsules.

Not all pack sizes may be marketed.
6.6   Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements.