Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1.    List of excipients
Meglumine, water for injections.
6.2.     Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


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


6.4.     Special precautions for storage
Pre-filled syringe: Store below 25°C, Do not freeze.
Vial: No specific storage conditions.

6.5.     Nature and contents of container
10, 15 and 20 mL type I glass prefilled syringes, and latex-free elastomeric seals.
5, 10, 15 and 20 mL type II glass vials, closed by an elastomer stopper.
Not all pack sizes may be marketed.


6.6.     Special precautions for disposal and other handling
Pre-filled Syringe: Screw the piston onto the syringe, and intravenously inject the quantity of product required for the examination.
The peel-off tracking label on the syringes should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.
Any unused product or waste material should be disposed of in accordance with local requirements Vials: The peel-off tracking label on the vials should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.
Prepare a syringe with a needle. Remove the plastic disk. After cleaning the stopper with a pad soaked in alcohol, puncture the stopper with the needle.
Withdraw the quantity of product required for the examination and inject it intravenously.
Any unused product or waste material should be disposed of in accordance with local requirements