IOMERON Solution for injection Ref.[9477] Active ingredients: Iomeprol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Bracco U.K. Ltd, Unit 15, Valley Business Centre, Gordon Road, High Wycombe, Buckinghamshire HP13 6EQ, United Kingdom

Therapeutic indications

X-ray contrast medium used for:

  • venography
  • cerebral arteriography
  • digital subtraction angiography
  • computed tomography enhancement
  • urography
  • cavernosography
  • myelography

Posology and method of administration

venography
adults10-100ml*
max 250ml
10-50ml upper extremity
50-100 lower extremity
cerebral arteriography
adults5-12ml*
children3-7ml or**
digital subtraction angiography
Intra arterial
visceral
adults2-20ml per artery*
aorta 25-50ml*
both 250ml max
peripheral
adults5-10ml per artery*
max 250ml
intravenous
adults30-60ml*
max 250ml
computed tomography
brainadults50-150
children**
bodyadults40-150ml
max 250ml
children**
urography intravenousadults50-150ml
neonates3-4.8ml/kg
babies2.5-4ml/kg
children1-2.5ml/kg or *
cavernosographyadults40-250ml
myelographyadults12-18ml
by lumbar injection

* Repeat as necessary
** According to body size and age

In elderly patients the lowest effective dose should be used.

Unless otherwise instructed by the doctor, a normal diet may be maintained on the day of the examination.

In myelography, lower doses may be used for lumbar or thoracic studies and higher doses for cervical or total columnar studies. Regardless of the nature of the myelographic study, Iomeron should be injected slowly over 1-2 minutes.

The X ray can be taken up to 60 minutes following injection. Post myelographic CT of the spinal column should be delayed for approximately four hours to allow dilution and clearance of excessive contrast.

Overdose

The effects of overdose on the pulmonary and cardiovascular systems may become life-threatening. Treatment consists of support of the vital functions and prompt use of symptomatic therapy. Iomeprol does not bind to plasma or serum proteins and is therefore dialyzable.

Shelf life

Five years.

Special precautions for storage

Store below 30°C.

Protect from light.

Nature and contents of container

Colourless Type I or Type II glass bottles with rubber/aluminium cap.

Quantities of 20, 30, 50, 75, 100, 150, 200 or 250 ml of solution.

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 cannulas 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 discolored 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 spinal puncture or 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 and intrathecal 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.

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