BCG medac, powder and solvent for intravesical suspension

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Bacillus Calmette Guérin (BCG)

Доступна з:

medac Gesellschaft für klinische Spezialpräparate mbH

Код атс:

L03AX; L03AX03

ІПН (Міжнародна Ім'я):

Bacillus Calmette Guérin (BCG)

Дозування:

Unknown

Фармацевтична форма:

Powder and solvent for intravesical suspension

Тип рецепту:

Product subject to prescription which may not be renewed (A)

Терапевтична области:

Other immunostimulants; BCG vaccine

Статус Авторизація:

Marketed

Дата Авторизація:

2002-04-05

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
BCG-MEDAC, POWDER AND SOLVENT FOR INTRAVESICAL SUSPENSION
Bacillus Calmette-Guérin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
If you get any side effects, talk your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What BCG-medac is and what it is used for
2.
What you need to know before you use BCG-medac
3.
How to use BCG-medac
4.
Possible side effects
5.
How to store BCG-medac
6.
Contents of the pack and other information
1.
WHAT BCG-MEDAC IS AND WHAT IT IS USED FOR
The full name of this medicine is BCG-medac, powder and solvent for
intravesical suspension. It will
be referred to as BCG-medac in the rest of this leaflet.
BCG-medac contains weakened (attenuated)
_Mycobacterium bovis_
bacteria with low infectious
potential.
BCG-medac stimulates the immune system and is used to treat several
types of cancer in the urinary
bladder. It is effective if the cancer is limited to the cells lining
the inside of the bladder (urothelium)
and has not invaded the inner tissues of the bladder.
BCG-medac is administered directly into the bladder by instillation.
For the flat lesion form of bladder cancer (carcinoma
_in situ_
) BCG-medac is used to cure the disease
confined to the bladder lining. There are different grades of cancer
that can affect the lining of the
bladder and the layer of cells next to the lining (lamina propria).
BCG-medac is also used to prevent the cancer coming back (prophylactic
treatment).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BCG-MEDAC
DO NOT USE BCG-MEDAC
•
if you are allergic to viable BCG (Bacillus Calmette-Guérin) bacteria
or any of the other
ingredients of this medicine (listed in section 6.).
•
if the activity of your immune system is reduced or you suffer from
i

Характеристики продукта

Health Products Regulatory Authority
01 March 2024
CRN00F5DP
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BCG medac, powder and solvent for intravesical suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one vial contains:
BCG (Bacillus Calmette‑Guérin) bacteria derived from Mycobacterium
bovis, seed RIVM derived from seed
1173‑P2………………………………………………………………………2
x 10
8
to 3 x 10
9
viable units
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for intravesical suspension
Powder:
White or almost white powder or porous cake with shades of yellow and
grey
Solvent:
Colourless, clear solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of non‑invasive urothelial bladder carcinoma:

curative treatment of carcinoma in situ

prophylactic treatment of recurrence of:
o
urothelial carcinoma limited to mucosa:

Ta G1‑G2 if multifocal and/or recurrent tumour

Ta G3
o
urothelial carcinoma in lamina propria but not the muscular of the
bladder (T1)
o
carcinoma in situ
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
BCG‑medac must be administered by physicians experienced in this
therapy.
BCG‑medac is intended for intravesical use following reconstitution.
For instructions on reconstitution of the BCG-medac suspension before
administration, see section 6.6.
Posology
_Adults and the elderly_
The content of one vial, reconstituted and diluted as indicated, is
required for one instillation into the urinary bladder.
_Induction therapy _
BCG‑therapy should begin about 2 – 3 weeks after transurethral
resection (TUR) or bladder biopsy, and without traumatic
catheterisation, and be repeated at weekly intervals for 6 weeks. In
intermediate- and high-risk tumours this should be
followed by maintenance therapy. Maintenance treatment schemes are
described below.
Health Products Regulatory Authority
01 March 2024
CRN00F5DP
Page 2 of 14
_Maintenance therapy