Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1.    List of excipients
Meglumine
DOTA
Water for injection

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.

Shelf life after opening, for Bottles
Chemical and physical in-use stability has been demonstrated for 48 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8° C, unless opening has taken place in controlled and validated aseptic conditions.

6.4.    Special precautions for storage
Pre-filled syringe: Store below 30°C. Protect from freezing.
Vial: Store below 30°C
Bottles: Store below 30°C
Poly-propylene bottles: Store below 30°C

6.5.    Nature and contents of container
Clariscan is filled in the following containers:
Vials
Glass vials (type I, colourless) of 10 mL (filled to 5 or 10 mL) and 20 mL (filled to 15 or 20 mL), closed with halo-butyl rubber stopper sealed with caps of aluminium with coloured plastic top. Packed in outer box of 1 and 10 units.

Pre-filled syringes
Polymer syringe: Poly-cycloolefin, Crystal Clear Polymer (CCP) syringe of 20 mL (filled to 10, 15, and 20 mL), label graduated per mL with tip cap and halo-butyl plunger stopper attached to a plunger rod.
Packed in outer box of 1 and 10 units.

Bottles
Glass bottles (type I, colourless) of 50 mL (filled to 50 mL) and 100 mL (filled to 100 mL), closed with halo-butyl rubber stopper sealed with caps of aluminium with coloured plastic top.
Packed in outer box of 1 and 10 units.

Poly-propylene bottles
Polypropylene bottles of 50 ml (filled to 50 ml) or 100 ml (filled with 100 ml), closed with rubber stopper and a screw cap.
Packed in outer box of 1 and 10 units.

Not all pack sizes may be marketed.

6.6.    Special precautions for disposal and other handling
For single use
The solution for injection should be inspected visually prior to use. Only clear solutions free of visible particles should be used.

Vials and bottles: Prepare a syringe with a needle. For vials, 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.
For Poly-propylene bottles, remove the plastic screw cap or top plastic lid by pulling the top ring.

Pre-filled syringes: Inject intravenously the quantity of product required for the examination.

The remaining contrast medium in the vial/bottle, the connecting lines and all disposable components in the injector system must be discarded after the examination.

The peel-off tracking label on the syringes/vials/bottles 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 medicinal product or waste material should be disposed of in accordance with local requirements.