HEXVIX Powder and solvent for intravesical solution Ref.[9504] Active ingredients: Hexaminolevulinate

Hexvix cystoscopy should only be performed by health care professionals trained specifically in Hexvix cystoscopy. The bladder should be drained before the instillation.

Posology

Adults (including the elderly)

50 ml of 8 mmol/l reconstituted solution (see section 6.6) is instilled into the bladder through a catheter. The patient should retain the fluid for approximately 60 minutes.

Following evacuation of the bladder, the cystoscopic examination in blue light should start within approximately 60 minutes. The cystoscopic examination should not be performed more than 3 hours after Hexvix is instilled in the bladder.

Also if the retention time in the bladder is considerably shorter than one hour, examination should start no earlier than after 60 minutes. No minimum retention time has been identified making examination non-informative.

For optimal visualisation it is recommended to examine and map the entire bladder under both white and blue light before any surgical measures are initiated. Biopsies of all mapped lesions should normally be taken under white light and complete resection should be verified by switching to blue light.

Only CE marked cystoscopic equipment should be used, equipped with necessary filters to allow both standard white light cystoscopy and blue light (wavelength 380–450 nm) fluorescence cystoscopy.

The light doses given during cystoscopy will vary. Typical total light doses (white light and blue light) range between 180 and 360 J at an intensity of 0.25 mW/cm².

Children and adolescents

There is no experience of treating patients below the age of 18 years.

Method of administration

Precaution to be taken before handling or administrating the medicinal product.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

No case of overdose has been reported.

No adverse events have been reported with prolonged instillation times exceeding 180 minutes (3 times the recommended instillation time), in one case 343 minutes. No adverse events have been reported in the dose-finding studies using twice the recommended concentration of hexaminolevulinate.

There is no experience of higher light intensity than recommended or prolonged light exposure.

4 years.

After dilution with the solvent: Chemical and physical stability of the solution has been demonstrated for 2 hours at 2°C-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 2 hours at 2°C-8°C.

This medicinal product does not require any special storage conditions.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

Pack of one 10 ml Type I colourless glass vial with butyl rubber stopper containing powder, and , one 50 ml cyclic olefin copolymer syringe with plunger stopper (bromobutyl rubber) and plunger rod, containing solvent.

Pack sizes: Pack containing 1 vial with powder and 1 prefilled syringe with solvent, with or without a Mini-Spike transfer device.

Not all pack sizes may be marketed.

No special requirements for disposal.

Hexaminolevulinate may cause sensitisation by skin contact.

Handling instructions for the pharmacist or other healthcare professionals

All steps should be performed with sterile equipment and under aseptic conditions. A brief description of the reconstitution procedure is provided below. For detailed description, see package leaflet section Instruction for handling.

1. Using the pre-filled syringe, inject about 10 ml of the solvent into the vial of Hexvix powder. The vial should be about ¾ full.

2. Without withdrawing the syringe from the vial, hold the powder vial and the syringe in a firm grip and shake gently to ensure complete dissolution.

3. Withdraw all of the dissolved solution from the powder vial into the syringe.

4. Disconnect the empty vial from the syringe and discard the vial.

5. Gently mix the contents of the syringe.

6. Hexvix is now reconstituted and ready for use. The appearance of the reconstituted solution is clear to slightly opalescent, and colourless to pale yellow.

For single use only. Any unused product should be discarded.