Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Trometamol, hydrochloric acid 32%, water for injection.
6.2 Incompatibilities
No other drug should be mixed with the contrast medium.

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

6.4 Special precautions for storage
Protect from light.
6.5 Nature and contents of container
Colourless Type I glass vials or bottles.
Pack sizes:
Iomeron 300: 50, 75, 100, 200 or 500 ml of solution.
Iomeron 350: 100, 250 or 500 ml of solution.
Iomeron 400: 50, 75, 100 or 200 ml of solution.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling

Bottles containing contrast media solution are not intended for the withdrawal of multiple doses. The rubber stopper should never be pierced more than once. The use of proper withdrawal cannulae for piercing the stopper and drawing up the contrast medium is recommended.

Before use, examine the product to assure that the container and closure have not been damaged. Do not use the solution if it is discoloured or particulate matter is present.

The contrast medium should not be drawn into the syringe until immediately before use. Withdrawal of contrast agents from their containers should be accomplished under aseptic conditions with sterile syringes.
Sterile techniques must be used with any intravascular injection, and with catheters and guidewires. If non- disposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

It is desirable that solutions of contrast media for intravascular use should be at body temperature when injected.

Any residue of contrast medium in the syringe must be discarded. Solutions not used in one examination session or waste material, such as the connecting tubes, should be disposed in accordance with local requirements.

Bottles of 500 ml should be used in conjunction with an injector system. After each patient examination, the connecting tubes (to the patient) and relevant disposable parts should be disposed because they could be contaminated with blood.
At the end of the sessions, the left over solution in the bottle and in the connecting tubes as well as any disposable parts of the injector system should be discarded. Any additional instructions from the respective equipment manufacturer must also be adhered to.