VISIPAQUE Solution for injection Ref.[8843] Active ingredients: Iodixanol

Diagnostic procedures that involve the use of radiopaque imaging agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed.

Preparation of the patient will vary with the particular agent used, preference of the radiologist and the type of radiologic procedure performed. Specific radiographic procedures used will depend on the state of the patient and the diagnostic indications.

The combination of volume and concentration of VISIPAQUE to be used should be carefully individualised, accounting for factors such as age, body weight, size of the vessel, rate of blood flow within the vessel, cardiac output, indication for examination, and timing of the X-ray or CT scan. Other factors to be considered are anticipated pathology, degree and extent of opacification required, structure or area to be examined, disease processes affecting the patient, and equipment and technique used.

Usually approximately the same iodine concentration and volume is used as with other iodinated X-ray contrast media in current use, but adequate diagnostic information has also been obtained in some studies with iodixanol injection with somewhat lower iodine concentration.

Generally recommended doses are contained in the following tables. The doses given for intraarterial use are for single injections that may be repeated:

Adult Dosages

Paediatric Dosages

Elderly

As for other adults.

VISIPAQUE may be warmed to body temperature (37°C) before administration.

Overdosage is unlikely in patients with a normal renal function. The duration of the procedure is important for the renal tolerability of high doses of contrast media (t_1/2 ~ 2 hours). In the event of accidental overdosing, the water and electrolyte losses must be compensated by infusion. Renal function should be monitored for at least the next 3 days. If needed, haemodialysis may be used to remove iodixanol from the patient’s system. There is no specific antidote.

In case of overdose, immediately contact the Poisons Information Centre for advice, in New Zealand, call 0800 764 766.

36 months.

Protect vials, bottles and flexible containers of VISIPAQUE from strong daylight and direct exposure to sunlight. Store at controlled room temperature, 15°C to 30ºC. Do not remove foil overwrap, which serves as a moisture and light barrier, from flexible containers until ready to use. VISIPAQUE in glass containers and in polypropylene bottles 50 ml and over in size may be stored at 37°C for up to one month prior to use. 10 ml and 20 ml polypropylene bottles may be stored at 37°C for up to one week prior to use.

Do not freeze. Freezing may compromise the closure integrity of these packages. Do not use if the product is inadvertently frozen.

VISIPAQUE (iodixanol) injection 270 mg l/ml:

20 ml glass vial, boxes of 10
50 ml glass or polypropylene bottles, boxes of 10
75 ml polypropylene bottles, boxes of 10
100 ml glass or polypropylene bottles, boxes of 10
150 ml polypropylene bottles, boxes of 10
200 ml glass or polypropylene bottles, boxes of 6 or 10
500 ml glass or polypropylene bottles, boxes of 6

VISIPAQUE (iodixanol) injection 320 mg l/ml:

20 ml glass vial, boxes of 10
50 ml glass or polypropylene bottles, boxes of 10
75 ml polypropylene bottles, boxes of 10
100 ml glass or polypropylene bottles, boxes of 10
150 ml polypropylene bottles, boxes of 10
200 ml glass or polypropylene bottles, boxes of 6 or 10
500 ml glass or polypropylene bottles, boxes of 6

Not all presentations are marketed.

Instructions for Use / Handling

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

The product should be drawn into the syringe immediately before use. Vials are intended for single use only, any unused portions must be discarded. VISIPAQUE may be warmed to body temperature (37°C) before administration.

Additional Instruction for Auto Injector / pump

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.

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. When convenient, smaller bottles can also be used. Instructions from the manufacturer of the auto injector/pump must be followed.