Pharmaceutical particulars : מידע רוקחי

6      PHARMACEUTICAL PARTICULARS

6.1    List of excipients
The following excipients are included: Trometamol, sodium chloride, sodium calcium edetate calcium chloride dihydrate, , hydrochloric acid (pH adjustment) and water for injections.
The pH of the product is 6.8 - 7.6.

6.2    Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. A separate syringe should be used.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4    Special precautions for storage

VISIPAQUE should be stored at or below 30°C, protected from light.

6.5    Nature and content of container
Glass vials and bottles:
The product is filled in injection vials (20 ml) and infusion bottles (50, 100 and 200 ml). Both containers are made of colourless highly resistant borosilicate glass (Ph.Eur. Type I), closed with halobutyl rubber stoppers (Ph.Eur. Type I), and sealed with complete tear off aluminium caps with coloured plastic “flip-off” tops (polypropylene lid).
Polypropylene bottles:
The product is filled in polypropylene bottles. The bottles of 50,100, 200 and 500 ml are closed with halobutyl rubber stoppers (Ph.Eur. Type I), supplied with a plastic (polypropylene) screw cap which is provided with a tamper proof ring.

The product is supplied as:

Glass vials/bottles:
270 mg I/ml:           10 vials of 20 ml
10 bottles of 50 ml
10 bottles of 100 ml
6 bottles of 200 ml
320 mg I/ml:           10 vials of 20 ml
10 bottles of 50 ml
10 bottles of 100 ml
6 bottles of 200 ml

Polypropylene bottles:
270 mg I/ml         10 x 50 ml
10 x 100 ml
10 x 200 ml
6 x 500 ml

320 mg I/ml            10 x 50 ml
10 x 100 ml
10 x 200 ml
6 x 500 ml
Not all pack sizes may be marketed.

6.6    Special precautions for disposal

Like all parenteral products, VISIPAQUE should be inspected visually for particulate matter, discolouration and the integrity of the container prior to use.

VISIPAQUE may be warmed to body temperature (37°C) before administration. Any unused product or waste material should be disposed of in accordance with local requirements.

Glass vials/bottles and polypropylene bottles up to 200 ml
The product should be drawn into the syringe immediately before use. For single use only, any unused portions must be discarded.
Polypropylene bottles of 500 ml

 The 500 ml contrast medium bottles should only be used in connection with auto injectors/pumps approved for this volume.
 A single piercing procedure should be used.
 Remove the plastic screw cap by tearing off the pull ring.
 After cleaning the stopper with a pad soaked in sporicidal solution followed by a pad soaked in alcohol, puncture the stopper with the needle.
 The line running from the auto injector/pump to the patient must be exchanged after each patient. Any unused portions of the contrast medium remaining in the bottle and all connecting tubes must be discarded after 24 hours.

Instructions from the manufacturer of the auto injector/pump must be followed.