ImmuCyst 81 mg
BCG Immunotherapy
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.
In this leaflet:
- 1. What ImmuCyst 81 mg is and what it is used for
- 2. Before you are given ImmuCyst 81 mg
- 3. How ImmuCyst 81 mg is administered
- 4. Possible side effects
- 5. How to store ImmuCyst 81 mg
- 6. Further information
WHAT IMMUCYST 81 mg IS AND WHAT IT IS USED FOR
ImmuCyst 81 mg is used for the treatment and prevention of early forms of bladder cancer.
When ImmuCyst 81 mg is injected into the bladder it sets off a reaction in which cells of the immune (defensive) system in the bladder wall start to destroy surrounding cells including cancerous cells.
ImmuCyst 81 mg is a specially prepared form of the tubercle bacillus, which is the bacterium that is used in the BCG injection that is given to people to protect them against tuberculosis (TB). However, the use of ImmuCyst 81 mg has nothing to do with the treatment of TB.
BEFORE YOU ARE GIVEN IMMUCYST 81 mg
You should not be given ImmuCyst 81 mg if:
- You have had surgery on your prostate gland (men only) or a catheter (tube) inserted in your bladder which caused bleeding within the past 10 days
- You have any problem with your immune system including HIV infection.
- You have active TB infection or evidence of previous TB infection
- You have a high temperature of unknown cause
- You have a urinary tract infection
If you know any of the above apply to you tell your doctor.
Take special care
Tell your doctor if you have any artificial joints or surgical implants, or if you know you have an aneurysm, which is a swelling of the wall of an artery.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines obtained without a prescription.
In particular, tell your doctor if you are having any treatments that affect your immune system as they may affect the effectiveness of ImmuCyst 81 mg. These include:
- Anti-cancer medicines, e.g., methotrexate, ciclophosphamide, doxorubicin
- Medicines used to suppress rejection of transplants, e.g., ciclosporin
- Radiation treatment
- Any antibiotics
Pregnancy and Breast feeding
You should not be given ImmuCyst 81 mg if you are pregnant (or think you may be), or breast feeding unless your doctor has decided that it is in your best interests.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
ImmuCyst 81 mg should not affect your ability to drive or use machinery.
HOW IMMUCYST 81 mg IS ADMINISTERED
ImmuCyst 81 mg is administered by a doctor or nurse.
It comes as a dry powder which is diluted with sterile saline (salt water). 53 ml of fluid is introduced into the bladder through a catheter (tube) which is threaded into the bladder via the urethra (the passage through which you pass water).
After instillation you will be asked to retain the fluid for as long as possible for up to 2 hours. For the first 15 minutes you will be asked to lie on your front. After that you will be allowed to get up and encouraged to drink. After 2 hours you will be asked to empty your bladder if you have not already done so.
Your doctor will decide the dose. Your first set of treatments will usually be given once a week for 6 weeks, followed by a 6 week break, and then once a week for 1-3 weeks.
You will then need maintenance treatment which is usually once a week for 1-3 weeks every six months up to 36 months from the start.
ImmuCyst 81 mg is not suitable for children.
If you think you have been given more ImmuCyst 81 mg than you should
As ImmuCyst 81 mg is administered by a health-care professional it is most unlikely that you will be given the wrong dose. If you have any concerns about your dose or the use of this product speak to your doctor.
ImmuCyst 81mg Side Effects
Like all medicines ImmuCyst 81 mg can sometimes cause side-effects, although not everybody gets them.
ImmuCyst 81 mg commonly causes an inflammation of the bladder which may result in a high temperature, blood in the urine and pain and frequency of passing water.
Rare side effects are urinary tract infection, shrinkage of the bladder, infection of the prostate gland and /or testicles, obstruction of the urethra, infection of the kidneys, eye infections causing altered vision and redness and widespread BCG infection which may affect the lungs, liver or blood cells. Allergic reactions may cause skin rash and joint pains.
After receiving ImmuCyst 81 mg your doctor will monitor you carefully. You will be asked to report any fever (high temperature) lasting longer than 24 hours and any problems not involving your waterworks.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor (GP or hospital doctor).
HOW TO STORE IMMUCYST 81 mg
The information in section 5 and 6 is primarily for health-care professionals.
ImmuCyst 81 mg should be kept in a refrigerator at a temperature between 2º and 8ºC.
Do not use after the expiry date marked on the vial.
At no time should the freeze-dried or reconstituted ImmuCyst 81 mg be exposed to sunlight, direct or indirect. Exposure to artificial light should be kept to a minimum.
Further Information
The active substance is a freeze-dried preparation made from a culture of the Connaught strain of Bacillus of Calmette and Guérin (BCG), which is an attenuated strain of living bovine tubercle bacillus, Mycobacterium bovis. The bacilli are lyophilised (freeze-dried) and are viable upon reconstitution. The product contains no preservative.
The other ingredient is monosodium glutamate.
For instructions on the handling and the preparation of ImmuCyst 81 mg see the Summary of Product Characteristics.
What ImmuCyst 81 mg looks like and contents of pack
ImmuCyst 81 mg is a white powder in a 5 ml glass container.
Marketing Authorisation Holder
Tyne & Wear
Manufacturer
This leaflet was last approved in:
November 2008
CL/0024/01/01
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