Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Onureg 200 mg:
Mannitol (E421)
Silicified microcrystalline cellulose (E460, E551)
Croscarmellose sodium (E468)
Magnesium stearate (E570)
Opadry II pink film coating

Opadry II pink containing:
Hypromellose (E464)
Titanium dioxide (E171)
Lactose monohydrate
Polyethylene glycol/macrogols (E1521)
Triacetin (E1518)
Ferric oxide red (E172)
Onureg 300 mg:
Mannitol (E421)
Silicified microcrystalline cellulose (E460, E551)
Croscarmellose sodium (E468)
Magnesium stearate (E570)
Opadry II brown film coating

Opadry II brown containing:
Hypromellose (E464)
Titanium dioxide (E171)
Lactose monohydrate
Polyethylene glycol/macrogols (E1521)
Triacetin (E1518)
Ferric oxide yellow (E172)
Ferric oxide red (E172)

Ferrosoferric oxide / black ferric oxide (E172)
6.2   Incompatibilities

Not applicable.

Onureg_API_June2022_clean
6.3   Shelf life
The expiry date of the product is indicated on the packaging materials 
6.4   Special precautions for storage

This medicinal product does not require any special storage conditions.
6.5   Nature and contents of container

The film-coated tablets are packaged in nylon (OPA) / polyvinyl chloride (PVC) aluminium blisters with push through aluminium foil.

Pack size of 7 film-coated tablets.


6.6   Special precautions for disposal and other handling
Onureg is a cytotoxic medicinal product. If powder from the film-coated tablets makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water. If the powder comes in contact with mucous membranes, the area should be thoroughly flushed with water.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.