Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1.    List of Excipients
The following excipients are included:
Trometamol,
Sodium calcium edetate,
Hydrochloric acid (pH adjustment),
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
OMNIPAQUE should be stored up to 30ºC protected from light.
Vials are intended for single use any unused portions must be discarded.


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, 200 ml).
Both containers are made of colourless highly resistant borosilicate glass (Ph. Eur.
Type I), closed with chlorobutyl rubber or bromobutyl stoppers (Ph. Eur. Type I), and sealed with combined "flip off seal/tear off seal - flat plast disc".

Polypropylene bottles:
The product is filled in polypropylene bottles. The bottles of 50, 100, 200 and 500 ml are closed with chlorobutyl or bromobutyl stoppers (Ph.Eur.Type I), and supplied with a plastic screw cap, which is provided with a tamper proof ring.
OMNIPAQUE    Injection X-ray contrast medium

Presentations:

Glass vials/bottles:
240 mg I/ml: 6 vials of 20 ml
25 vials of 20 ml
10 bottles of 50 ml
10 bottles of 100 ml
6 bottles of 200 ml
300 mg I/ml: 6 vials of 20 ml
25 vials of 20 ml
10 bottles of 50 ml
10 bottles of 100 ml
6 bottles of 200 ml

350 mg I/ml: 6 vials of 20 ml
25 vials of 20 ml
10 bottles of 50 ml
10 bottles of 100 ml
6 bottles of 200 ml

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

6.6       Special precautions for disposal and other handling

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

Omnipaque 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. Vials are intended 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.
OMNIPAQUE    Injection X-ray contrast medium
•   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 at the end of the day.

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

7.       MARKETING AUTHORISATION HOLDER

Eldan Electronic Instrument Co. Ltd.
Hashiloach 6
P.O.B 7641
Petach Tiqva 49170
Israel