VESICULTURE SUSPENSION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

KAHMA BIOTECH (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

SUSPENSION

Composition:

EACH VIAL CONTAINS MYCOBACTERIUM BOVIS 30,0 mg

Authorization status:

Registered

Authorization date:

2003-07-11

Patient Information leaflet

Kahma Biotech (Pty) Ltd
VESICULTURE
Freeze dried powder for reconstitution
30 mg
08 June 2020
Page 1 of 8
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S2
VESICULTURE FREEZE-DRIED POWDER FOR RECONSTITUTION
_MYCOBACTERIUM BOVIS_ BCG
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE VESICULTURE
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
VesiCulture has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours._ _
_ _
WHAT IS IN THIS LEAFLET
1. What VesiCulture is and what it is used for
2. What you need to know before you receive VesiCulture
3. How to receive VesiCulture
4. Possible side effects
5. How to store VesiCulture
6. Contents of the pack and other information
1.
WHAT VESICULTURE IS AND WHAT IT IS USED FOR
VesiCulture contains _Mycobacterium bovis_ BCG. This is a bacteria
which has been specially
altered, so that it can be used as a medicine.
Kahma Biotech (Pty) Ltd
VESICULTURE
Freeze dried powder for reconstitution
30 mg
08 June 2020
Page 2 of 8
VesiCulture is used to treat bladder cancer or to prevent bladder
cancer from coming back
after bladder surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE VESICULTURE
VESICULTURE SHOULD NOT BE ADMINISTERED TO YOU IF:
•
you are allergic (hypersensitive) to _ Mycobacterium bovis_ BCG or any
of the other
ingredients of VesiCulture (listed in section 6).
•
you have problems with your immune system. This could be something
which runs in the
family or is caused by an illness or other medicines you are taking.
•
you have TB (tuberculosis). Before you receive VesiCulture, your
doctor may do a skin
reaction test, to see if you have TB.
•
you are receiving medical treatment against TB.
•
you are HIV-positive. You may need to have a blood test for HIV.
•
you are pregnant or breastfeeding your baby.
•
you have had radiation thera

Summary of Product characteristics

Kahma Biotech (Pty) Ltd
VESICULTURE
Freeze dried powder for reconstitution
30 mg
08 June 2020
Page 1 of 12
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S2
1
NAME OF THE MEDICINE
VESICULTURE freeze-dried powder for reconstitution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of live VesiCulture contains a semi-dry mass of 30 mg
_Mycobacterium bovis_ BCG,
Danish strain 1331 with approximately 2,5 x 10
8
CFU. It also contains 40 mg sodium glutamate.
There is no bactericidal or bacteriostatic agent present.
Sugar free.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Freeze-dried powder for reconstitution.
Brown glass vials containing a white to off-white freeze-dried powder.
Reconstituted product: slightly opaque and colourless suspension.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VesiCulture is intended for instillation in the urinary tract after
transurethral resection, as
immunoprophylaxis in primary or recurrent grade Ta or T1 superficial
bladder cancer, or for
immunotherapy treatment of non-invasive carcinoma _in-situ_ of the
bladder.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The
recommended
dose
for
immunotherapy
or
immunoprophylaxis
is
120
mg,
or
Kahma Biotech (Pty) Ltd
VESICULTURE
Freeze dried powder for reconstitution
30 mg
08 June 2020
Page 2 of 12
approximately 1 x 10
9
CFU. This dose should not be exceeded.
Seven to fourteen days should elapse after a transurethral section,
bladder biopsy, or
traumatic catheterisation before initiating treatment with
VesiCulture.
The standard schedule of treatment consists of 6 installations, with
an interval of one week
between each instillation. This treatment schedule may be repeated
once if insufficient or no
response is achieved after the first immunotherapy treatment.
Maintenance treatment may be
recommended for certain high risk patients.
_INTRAVESICAL DOSAGE:_ The required dosage of VesiCulture, (normal
dose = 120 mg = 4
reconstituted vials) is resuspended in 50 ml sterile saline
(preservative free 0,9 % sodium
chlori