Hexvix
From Kidney Cancer Resource
Contents |
Overview
A drug produced by Photocure of Norway and used to act as an attractant to light in the treatment of Bladder Cancer using Blue-Light Flourescence (Fluorescence Cystoscopy) further data can be found at Photocure
UK Agent:
GE Healthcare Limited
Amersham Place
Little Chalfont
HP7 9NA - UK
Tel: 01494 - 54 40 00
Health Care Professionals with an interest in Urology are advised to find out more and may well wish to do so with a Click Here
Details
HEXVIX® 85 MG POWDER AND SOLVENT FOR SOLUTION FOR INTRAVESICAL USE
Read all of this page carefully before you start using this medicine.
- Bookmark this page. You may need to read it again. - If you have further questions, please ask your healthcare professional.
On this page: 1. What Hexvix is and what it is used for 2. Before you use Hexvix 3. How to use Hexvix 4. Possible side effects 5. Storing Hexvix 6. Further information
HEXVIX® 85 MG POWDER AND SOLVENT FOR SOLUTION FOR INTRAVESICAL USE hexaminolevulinate
Each pack consists of a vial of powder containing 85 mg of the active substance, hexaminolevulinate (as hydrochloride), and a vial containing 50 ml liquid to dissolve the powder. A healthcare professional will have made up the solution before it is given to you.
Marketing Authorisation Holder: GE Healthcare AS Nycoveien 1-2 P.O.Box 4220 Nydalen NO-0401 Oslo Norway
Manufacturer: Photocure ASA Hoffsveien 48 NO-0377 Oslo Norway
1. WHAT HEXVIX IS AND WHAT IT IS USED FOR Hexvix powder is dissolved in the 50 ml solution of disodium phosphate, potassium dihydrogen phosphate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections provided in the pack. Once the powder and the solvent are mixed, a solution is made containing 1.7 mg/ml hexaminolevulinate, which corresponds to a 8 mmol/l solution of hexaminolevulinate.
This product is not a treatment. It is given to help the doctor to see inside the bladder.
Hexvix solution is used to look for bladder cancers as part of a test that uses a thin, lighted tube to see inside the bladder, this is called cystoscopy.
2. BEFORE YOU USE HEXVIX The product should only be used by a healthcare professional who is trained to use Hexvix cystoscopy.
Do not use Hexvix: - if you are hypersensitive (allergic) to hexaminolevulinate or any of the ingredients in the liquid used to dissolve Hexvix powder - if you have porphyria (a rare inherited blood disease) - if you are a woman of child-bearing potential.
Tell your doctor: - if you have water infection (urinary infection) or notice burning or urgency when you pass water.
Pregnancy: Tell your doctor if you are pregnant or think you might be pregnant. Hexvix must not be used during pregnancy.
Breast Feeding: Hexvix must not be used when you are breast feeding.
Driving and using machines: No effects on the ability to drive and use machines are known.
Using other medicines: Please tell your healthcare professional if you are taking or have recently taken any other medicines, even those not prescribed.
3. HOW TO USE HEXVIX Hexvix is usually given in hospitals. Healthcare professionals will use Hexvix when carrying out cystoscopy tests to look inside your bladder.
Before Hexvix is given, your bladder will be emptied. The Hexvix solution will be put into the bladder, using a small tube placed into the bladder (catheter). The solution will be kept inside the bladder for 60 minutes. After this time the bladder will be emptied using the catheter and the examination of the bladder will take place.
If more Hexvix is used than should be: No side effects are expected if too much Hexvix is used or if the time that Hexvix stays in the bladder is more than 60 minutes. If you are worried about this please speak to your healthcare professional.
4. POSSIBLE SIDE EFFECTS Like all medicines, Hexvix can have side effects.
If side effects do occur, these are likely to be mild to moderate and temporary.
Common side effects reported (reported by more than 1 in 100 but less than 1 in 10 patients) during the clinical trials were: feeling sick (nausea), vomiting, constipation, bladder spasm/bladder pain (this will feel like muscle cramp or pain in your lower abdomen), pain and difficulties when passing water, frequent need to pass water, unable to empty the bladder (urinary retention), blood in the urine, fever and headache.
Uncommon side effects reported (reported by more than 1 in 1000 but less than 1 in 100 patients) include: inflammation of the bladder, blood poisoning (septicaemia), burning or urgency when you pass water (urinary tract infection), an increase in white blood cell counts, increased levels of bilirubin (yellowish pigment in the bile) or liver enzymes, pain after the procedure, pain in the urethra, incontinence (bladder weakness), not being able to sleep or difficulty going to sleep (insomnia), decrease in number of red blood cells in the blood (anaemia), gout and rash.
If you notice any side effects mentioned above or any side effects not mentioned in this leaflet, please tell your healthcare professional.
5. STORING HEXVIX Keep out of the reach and sight of children.
Powder and solvent: The product does not require any special storage conditions. Solution (after mixing): Store at 2°C – 8°C (in a refrigerator) for not longer than 2 hours.
Do not use after the expiry date which is stated on the label.
6. FURTHER INFORMATION For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
UK: GE Healthcare Limited Amersham Place Little Chalfont HP7 9NA - UK Tel: +44 (0) 1494 54 40 00
This information was last approved on 7 August 2006
Licensed from Photocure ASA. Hexvix is a trademark of Photocure ASA.
GE and the GE Monogram are trademarks of General Electric Company.
To view the original of this product leaflet Click Here
Articles
16-Oct-2007 - A review of the role of Hexvix® fluorescence cystoscopy in bladder cancer
To view this article Click Here
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