Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Ferriprox Tablets 500 mg
Tablet core
Microcrystalline cellulose
Magnesium stearate
Colloidal silicon dioxide

Coating
Hydroxypropyl methylcellulose
Polyethylene glycol
Titanium dioxide
Purified water
Ferriprox Tablets 1000 mg
Tablet core
Methylcellulose A15LV
Crospovidone
Magnesium stearate vegetable sourrce

Coating
Hydroxyproyl methylcellulose 2910E5
Hydroxypropyl cellulose (LF)
Polyethylene Glycol 8000
Titanium Dioxide
Purified water

6.2   Incompatibilities
Not applicable.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
Ferriprox Tablets 500 mg
After first opening use within 100 days.

Ferriprox Tablets 1000 mg
After first opening use within 50 days.

6.4   Special precautions for storage
Ferriprox Tablets 500 mg
Do not store above 30ºC.

Ferriprox Tablets 1000 mg
Do not store above 30ºC.
Keep the bottle tightly closed in order to protect from moisture.

6.5   Nature and contents of container
Ferriprox Tablets 500 mg
High density polyethylene (HDPE) bottle with a child resistant polypropylene cap.
Pack size of 100 tablets.

Ferriprox Tablets 1000 mg
High density polyethylene (HDPE) bottle with a child resistant polypropylene cap and a desiccant.
Pack size of 50 tablets.

6.6   Special precautions for disposa

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

7.    MANUFACTURER:

Apotex Inc., Canada
50 Steinway Boulevard, Etobicoke, Ontario M9W 6Y3,
Canada