Omnipaque contains the active substance iohexol. This medicine is for diagnostic purposes only.
It is used only to help identify a disease and not in connection with treatment.

Omnipaque is a ‘contrast agent’. It is given before an X-ray to make
the clearer the image your doctor gets.
• Once injected, it helps the doctor visualize the normal or abnormal appearance and shape of organs in your body.
• Can be used for X-ray examinations of: the urinary system, spine, or blood vessels, including the blood vessels of the heart.
• You may be given this medicine before or during a scan of your head or body using a ‘computed tomography scan’ (also called a CT scan). This type of scan uses X-rays.
• It can also be used for investigating the salivary glands, stomach and intestine, or for visualizing body cavities such as joints, uterus and fallopian tubes.

The doctor will explain which part of your body will be examined.

Do not use Omnipaque:
• If you suffer from severe thyroid conditions.
• If you are allergic (hypersensitive) to iohexol or any of the other ingredients of Omnipaque.

A history of allergy, asthma or adverse reactions to iodinated contrast media indicates the need for special precautions. In these cases, preparation with glucocorticoids or H1 and H2 blocking antihistamines should be considered.

Pregnancy, lactation and fertility:
The safety of Omnipaque during pregnancy has not been established in humans. Preclinical studies in animals do not indicate direct or indirect harmful effects with respect to reproduction, embryonal or foetal development, gestation and peri- and postnatal development.
Since radiation exposure should be avoided as much as possible during pregnancy, the benefits of radiological examination, with or without contrast medium, should be carefully weighed against the possible risks. Omnipaque should not be used during pregnancy unless the benefits outweigh the risks and the doctor considers the radiological examination essential.
Breastfeeding can continue normally when iodinated contrast medium is administered to the mother.
The level of iohexol excreted in breast milk 24 hours after its injection was 0.5% of the weight-adjusted dose used in the study. The blood level of iohexol in children in the first 24 hours after injection corresponds to only 0.2% of the dose used in children.

Driving and using machines:
There is no known effect on the ability to drive or use machines. However, due to the risk of delayed adverse reactions, it is not recommended that the patient drive or use machines for the first 24 hours, especially after intrathecal administration of Omnipaque.
If post-myelography symptoms persist, each case must be judged individually.

The dose administered varies depending on the nature of the examination, age, weight, cardiac output, clinical situation and technique used. As a rule, the volume and concentration of iodine required are the same as for other iodinated contrast agents commonly used in radiology. As with other contrast agents, the patient should be adequately hydrated before and after the administration of Omnipaque.
The product is usually administered intravascularly or intrathecally.

If you have any further questions on this medicine, ask your doctor or pharmacist.

- The active substance is iohexol.
Omnipaque 240 mg I/ml contains 518 mg iohexol per ml (equivalent to 240 mg iodine per ml).
Omnipaque 300 mg I/ml contains 647 mg iohexol per ml (equivalent to 300 mg iodine per ml).
Omnipaque 350 mg I/ml contains iohexol 755 mg per ml (equivalent to 350 mg iodine per ml).
- The other ingredients are small amounts of trometamol, monocalcium disodium edetate, 5M hydrochloric acid
(for pH adjustment) and water for injections.

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

10 bottles x 200 ml