ImmuCyst 81mg powder for reconstitution for instillation vials

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Connaught strain Bacillus of Calmette-Guerin

可用日期:

Alliance Pharmaceuticals Ltd

ATC代码:

L03AX03

INN（国际名称）:

Connaught strain Bacillus of Calmette-Guerin

剂量:

81mg

药物剂型:

Powder for reconstitution for instillation

给药途径:

Intravesical

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 08020400; GTIN: 5024403000882

资料单张

Immucyst 81 mg PIL UK 005
PATIENT INFORMATION LEAFLET
IMMUCYST
 81 MG
POWDER FOR INTRAVESICAL SUSPENSION
BCG IMMUNOTHERAPY
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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 nurse.
If any of the side effects gets serious tell your doctor or nurse.
This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What ImmuCyst 81 mg is and what it is used for
2.
What you need to know before you are given ImmuCyst 81 mg
3.
How ImmuCyst 81 mg is given
4.
Possible side effects
5.
How to store ImmuCyst 81 mg
6.
Contents of the pack and other information
1. WHAT IMMUCYST 81 MG IS AND WHAT IT IS USED FOR
ImmuCyst 81 mg is a specially prepared form of the bacterium that is
used in the BCG
(Bacillus Calmette-Guérin) 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
prevention of TB.
ImmuCyst 81 mg is a medication used for the treatment of certain
cancers that are found
on the surface of the urinary bladder wall. ImmuCyst 81 mg is also
used in the
prevention of recurrence of some of these cancers.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IMMUCYST 81
MG
YOU SHOULD NOT BE GIVEN IMMUCYST 81 MG IF:
•
you are allergic to BCG or any of the ingredients of this medicine
(listed in
section 6);
Immucyst 81 mg PIL UK 005
•
you have had bladder surgery or a catheter (tube) inserted in your
bladder
which caused bleeding within the past 14 days;
•
you have a weakened immune system, from treatment (chemotherapy,
radiation therapy or other), or from disease, including HIV infection;
•
you have active TB infection;
•
you have any

产品特点

OBJECT 1
IMMUCYST 81MG
Summary of Product Characteristics Updated 12-Oct-2016 | Alliance
Pharmaceuticals
1. Name of the medicinal product
ImmuCyst
®
81 mg powder for intravesical suspension
2. Qualitative and quantitative composition
ImmuCyst
®
81 mg is freeze-dried preparation made from the Connaught substrain of
Bacillus Calmette-
Guérin (BCG), which is an attenuated strain of _Mycobacterium bovis_.
The bacilli are lyophilised (freeze-
dried) and are viable upon reconstitution. The product contains no
preservative.
Lyophilisate
BCG Immunotherapy
(Connaught substrain of BacillusCalmette-Guérin)
Content per Vial
81 mg (dry weight)
Approximately 1.8 to 15.9 x 10
8
Colony Form Units
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for intravesical suspension.
ImmuCyst
®
81 mg is a freeze-dried white powder which is free from preservatives.
4. Clinical particulars
4.1 Therapeutic indications
ImmuCyst
®
81 mg is indicated for intravesical use in the treatment of primary or
recurrent carcinoma _in _
_situ_ (CIS) of the urinary bladder, for the prophylaxis of recurrence
of CIS of the urinary bladder and for
the prophylaxis following transurethral resection (TUR) of primary or
recurrent stage Ta and/or T1
papillary tumours, or any combination thereof, regardless of
antecedent intravesical treatment.
4.2 Posology and method of administration
POSOLOGY
Adults
One dose of ImmuCyst
®
81 mg consists of the intravesical instillation of 81 mg BCG.
Intravesical treatment of the urinary bladder should begin a minimum
of 14 days after biopsy or TUR (see
section 4.3) and consists of induction and maintenance therapy.
• The induction therapy schedule consists of one intravesical
instillation of ImmuCyst
®
81mg each week
for 6 weeks for a total of 6 doses.
• After a 6 week pause, one intravesical dose should be given each
week for 1 to 3 weeks. Clinical studies
have demonstrated that 3 weekly instillations significantly increase
the complete response rate from 73%
to 87% at 6 months, compared