PACKAGE LEAFLET: INFORMATION FOR THE USER

HEXABRIX 320 (320 mgl/ml)

Solution for injection

Meglumine ioxaglate, Sodium ioxaglate

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. WHAT HEXABRIX 320 IS AND WHAT IT IS USED FOR

HEXABRIX 320 is a diagnostic agent. It belongs to the group of contrast agents used for radiological examinations.

HEXABRIX 320 is used to enhance the contrast of the images obtained during radiological examinations.

This contrast enhancement improves the visualisation and delineation of certain body parts.

This medicine is for diagnostic use only.

2. BEFORE YOU ARE GIVEN HEXABRIX 320

You should read the information in this section carefully.

You and your doctor should consider this information before you are given HEXA-BRIX 320.

You should NOT be given HEXABRIX 320 if:

•    you are allergic to ioxaglic acid or iodine or any of the other ingredient of HEXABRIX 320.

When special care is needed with Hexabrix 320

Inform your doctor if the following applies to you:

•    you have already experienced an allergic reaction after previous iodinated contrast injection.

•    you have allergies or asthma.

•    you have kidney or liver disease

•    you have diabetes (metabolic disease characterized by high blood sugar levels).

•    you have multiple myeloma.

•    you have heart disease

•    you have thyroid disorders or a history of thyroid disease

•    you are due to undergo a thyroid examination in the near future or treatment with radioactive iodine

In all these cases, your doctor will only give you HEXABRIX 320 if the benefits outweigh the risks. If you are given HEXABRIX 320, your doctor will take the precautions necessary and the administration of HEXABRIX 320 will be carefully monitored.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, please inform your doctor or pharmacist if:

•    you are taking or have recently taken medicines for:

-    heart and blood disorders such as beta-blockers, diuretics or drugs containing verapamil (calcium ion antagonist)

-    diabetes (metformine)

•    you have recently received interleukin-2.

Taking HEXABRIX 320 with food and drink

There are no known interactions between HEXABRIX 320 and food and drinks. However, please check with your doctor or health professional if it is required not to eat or drink before the examination.

Pregnancy and breast-feeding

Inform your doctor if you are pregnant, might be pregnant, or if your period is late.

Stop breast-feeding for at least 24 hours after the administration of HEXABRIX 320. HEXABRIX 320 may pass into your breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

There is no know effect on your ability to drive. However, because of the risk of early reactions driving is not advisable for 1 hour following the time of injection.

Important information about some of the ingredients of HEXABRIX 320

Sodium diet

This medicinal product contains 352 mg of sodium (salt) per 100 mL. Take this into account in case you are on a low sodium diet.

3. HOW TO USE HEXABRIX 320

HEXABRIX 320 will be administered to you by injection.

Your doctor will determine the dose you will receive and supervise the injection.

Your doctor or health professional will make a decision as to how you will be given Hexabrix 320, and how much you will need for your examination. This will be based on the type of of X-ray examination that you need and may also depend on how much you weigh. You will be given Hexabrix 320 by injection into either a blood vessel or a joint, or through the neck of your womb, depending upon the X-ray examination.

You will be supervised for at least 30 minutes following injection of Hexabrix 320.

If too much HEXABRIX 320 has been administered to you

You will be given Hexabrix 320 in a medical setting by a trained person. It is highly unlikely that you will be given an overdose. If you think a child or anyone else has accidentally taken any of this treatment, let the hospital casualty department or hospital staff know immediately.

4. POSSIBLE SIDE EFFECTS

Like all medicines, HEXABRIX 320 can cause side effects, although not everybody gets them.

These effects usually disapear quite rapidly, however you should inform your doctor as soon as you develop any such effects.

The most frequently reported side effects are:

•    a feeling of warmth,

•    a feeling or being sick

•    headache

•    a feeling of dizziness or faintness

•    hives

The less frequently reported side effects are:

•    fever

•    shivering

•    moderate pain and/or swelling in the joints

There is a small risk (very rare) that you may have an allergic reaction to Hexabrix 320. Let your doctor or health professional know immediately is you feel any of the following during or after you have been given Hexabrix 320:

•    difficulty breathing

•    feeling of dizziness or faintness

•    pain or tightness in your chest

•    flushing of your skin

•    skin reaction

•    hives or hitching of your skin

Rare cases of dysfunction of the thyroid have been reported when given to new born babies, especially premature babies.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE HEXABRIX 320

Keep out of the reach and sight of children.

This medicinal product should be stored in its outer packaging.

Do not use HEXABRIX 320 after the expiry date which is stated on the vial and on the carton, after the abbreviation "Exp".

The expiry date refers to the last day of that month.

It is unlikely that you will be asked to dispose of any left over HEXABRIX 320. If this happens ask your pharmacist what you should do. These measures will help to protect the environment.

What HEXABRIX 320 contains

•    The active substances is ioxaglic acid. 100 millilitres of solution for injection of: Hexabrix 320 contains ioxaglic acid under the form of meglumine ioxaglate (39.30 g) and sodium ioxaglate (19.65 g), corresponding to a quantity of 32 g of iodine.

•    The other ingredients are: meglumine, sodium calcium edetate, water for injection, sodium hydroxide (for pH adjustement

What HEXABRIX 320 looks like and contents of the pack

Hexabrix 320, solution for injection, is packaged in a glass vials closed with a rubber stopper and is presented in the following containers sizes: 20 mL filled in a 20 mL or 30 mL vial, 50 mL filled in a 60 mL vial and 100 mL filled in a 100 mL or 125 mL vial,

Pack size: 10

Not all pack sizes may be marketed

Marketing Authorisation Holder:

Guerbet

BP 57400 - 95943 Roissy CdG cedex - FRANCE

Manufacturer:

Guerbet

16-24, rue Jean Chaptal - 93600 AULNAY-SOUS-BOIS - FRANCE

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Guerbet Laboratories

Avon House - 435 Stratford road — Shirley - Solihull B90 4AA - UK Phone: + 44 1217 338 542

This leaflet was last approved in October 2012

The following information is intended for medical or healthcare professionals only. For full prescribing information please consult the Summary of Product Characteristics.

POSOLOGY AND METHOD OF ADMINISTRATION

Procedure	Product	Dosage and Administration
Femoral and other peripheral arteriographies	Hexabrix 320	15-20 ml. A similar or smaller dose is indicated for smaller arteries
Cerebral angiography (carotid and vertebral)	Hexabrix 320	Average adult dose: 6 - 8 ml for each injection. Up to 10 injections may be required.
Angiocardiography	Hexabrix 320	Multiple small test injections may be used for positioning catheter tip. Adults: 30-50 ml per injection Children and infants: 1-1,5 ml per kg body weight. Multiple injections may be required, although total dosage should not normally exceed 4 ml per kg body weight.
Abdominal aortography (direct puncture or catheterization)	Hexabrix 320	Adults: 20-30 ml. Up to 50 ml may be used.
Thoracic aortography (including arch aortography)	Hexabrix 320	0.5 ml - 1.0 per body weight, up to 40 ml per injection. This may be repeated if necessary. Total dosage should not normally exceed 4 ml per kg body weight.

Action to be taken in the event of overdose

In laboratory animals the main signs of toxicity are convulsions, pulmonary congestion and oedema, respiratory depression, prostration, darkening of the eyes and hypersalivation. It is most unlikely that such toxic signs would occur in man, as it would be necessary to inject far greater doses than the minimum recommended. In man, overdose as such should not arise but, since the causes of severe reactions to iodinated water-soluble contrast media are unknown, the information detailed under special warnings and precautions should be carefully studied.

CONTRA-INDICATIONS

1.    Use by subarachnoid or epidural route.

2.    Use in myelography.

3.    Use for hysterosalpingography during pregnancy or suspected pregnancy or in the presence of acute gynaecological or abdominal infection.

Special warnings and precautions for use

This product may provoke anaphylaxis or other manifestations of allergy e.g. nausea, vomiting, dyspnoea, widespread reddening of the skin and hypotension. Appropriate resuscitative measures should be immediately available.

A positive history of allergy, asthma or untoward indicates a need for extra caution, fix a sensitivity test dose and for steroid cover. The benefit should be carefully weighed against any possible risk to the patient.

Particular care should be exercised in patients with severe systemic disease, in allergic subjects and in myelomatosis. Patients with the latter condition should not be exposed to dehydration.

Prior to use of this product, any abnormalities of fluid or electrolyte balance should be corrected.

In patients with moderate to severe impairment of renal function (as reflected by the raised blood urea) or in diabetes, particular care should be exercised. Substantial deterioration in renal function is minimized if the patient is well hydrated. Renal function parameters especially urinary output should be monitored after the procedure in these patients.

Patients with hepato-renal insufficiency should not be examined unless benefit clearly outweighs risk. Re-examination should be delayed for 5-7 days.

Special care should be exercised when this product is injected into the right heart or pulmonary hypertension. Right heart angiography should be avoided where possible in patients with pulmonary arterial hypertension.

This product may interfere with tests of thyroid.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Apart from water for injection and dextrose solve Hexabrix should not be mixed with any other solutions.    ^

O

STORING HEXABRIX 3 years.

Once opened, use immediately. Keep container in the outer carton.

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