OncoTICE

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Bacillus Calmette-Guerin 500 MCFU (Range: 2-8x10e8 CFU)

Disponibbli minn:

Merck Sharp & Dohme (New Zealand) Limited

INN (Isem Internazzjonali):

BCG vaccine 500 MCFU (Range: 2-8x10e8 CFU)

Dożaġġ:

500 MCFU

Għamla farmaċewtika:

Powder for injection

Kompożizzjoni:

Active: Bacillus Calmette-Guerin 500 MCFU (Range: 2-8x10e8 CFU) Excipient: Ammonia solution Asparagine Citric acid monohydrate Dibasic potassium phosphate Ferric ammonium citrate Glycerol Zinc formate Lactose Magnesium sulfate

Unitajiet fil-pakkett:

Vial, glass, 2 mL

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Organon Teknika Corporation

Indikazzjonijiet terapewtiċi:

ONCOTICE is used as a treatment of flat urothelial cell carcinoma in situ (CIS) of the bladder, and as an adjuvant therapy after transurethral resection (TUR) of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder stage TA (grade 2 or 3) or T1 (grade 1, 2 or 3). ONCOTICE is only recommended for stage TA grade 1 papillary tumours when there is judged to be a high risk of tumour recurrence.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Vial, glass, 1 x 2 mL vial - 1 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, 3 x 2mL vials - 3 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, 6 x 2mL vials - 6 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Data ta 'l-awtorizzazzjoni:

1990-06-11

Fuljett ta 'informazzjoni

ONCOTICE
®
1
ONCOTICE
®
_Mycobacterium bovis (Bacillus Calmette and Guerin [BCG, strain
Tice™]) _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
BEFORE ADMINISTRATION OF THIS MEDICINE PLEASE READ THIS LEAFLET
CAREFULLY. IN THIS LEAFLET YOU WILL FIND
INFORMATION ABOUT ONCOTICE AS WELL AS SOME GENERAL ADVICE ON USING
MEDICINES. IF YOU HAVE ANY
QUESTIONS OR WORRIES, ASK YOUR DOCTOR OR PHARMACIST.
WHAT IS IN THIS LEAFLET
This information has been provided
to help understand how this product
works and to answer some common
questions about OncoTICE. If you
need more information please ask
your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
OncoTICE against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ONCOTICE IS
USED FOR
OncoTICE belongs to the group of
medicines called immunostimulants.
These medicines stimulate certain
parts of the immune system.
OncoTICE is used for the treatment
of superficial bladder cancer by
stimulating the body's natural ability
to fight disease. It is also used to
prevent the disease from recurring
after bladder surgery.
Ask your doctor if you have any
questions about why OncoTICE has
been prescribed for you.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
ONCOTICE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ONCOTICE IF:
•
you have a urinary tract infection.
If you have cystitis (inflammation
of the bladder), you will receive a
course of antibiotics before
treatment with OncoTICE starts.
The treatment with antibiotics
needs to be finished before
treatment with OncoTICE is
commenced.
•
you have blood in your urine
•
you have active tuberculosis.
Your doctor will probably do a
skin reaction test (Mantoux) to
assist in making this diagnosis.
•
you are being treated with anti-
tuberculosis drugs.
•
you suffer from an impaired
immune system (reduced
immunity against infectious

Karatteristiċi tal-prodott

Page 1 of 10
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
OncoTICE
®
powder for instillation fluid for intravesical use containing 2-8 ×
10
8
colony
forming units (CFU), Tice
™
BCG.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OncoTICE is a freeze-dried preparation containing attenuated bacilli
of _ Mycobacterium _
_bovis_, prepared from a culture of Bacillus Calmette-Guérin (BCG).
The freeze-dried OncoTICE is delivered in sealed glass vials, each
containing 2-8 × 10
8
CFU. After reconstitution in 50 ml saline the suspension contains
0.4-1.6 × 10
7
CFU/mL.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Vial: a white to off-white cake or powder (for instillation fluid for
intravesical use) containing
2-8 × 10
8
CFU Tice BCG.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OncoTICE is used as a treatment of flat urothelial cell carcinoma in
situ (CIS) of the bladder,
and as an adjuvant therapy after transurethral resection (TUR) of a
primary or relapsing
superficial papillary urothelial cell carcinoma of the bladder stage
TA (grade 2 or 3) or T1
(grade 1, 2 or 3). OncoTICE is only recommended for stage TA grade 1
papillary tumours
when there is judged to be a high risk of tumour recurrence.
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSE _
Per instillation, the contents of one reconstituted and diluted vial
of OncoTICE, are instilled
into the urinary bladder.
_Induction Treatment _
Weekly instillation with OncoTICE during the first 6 weeks.
When used as an adjuvant therapy after TUR of a superficial urothelial
cell carcinoma of the
bladder (see SECTION 4.1 THERAPEUTIC INDICATIONS), treatment with
OncoTICE should be
started between 10 and 15 days after performing the TUR. Treatment
should not be started
until mucosal lesions after TUR have healed.
_Maintenance Treatment _
Maintenance treatment is indicated for all patients and consists of
weekly instillation with
OncoTICE during 3 consecutive weeks at months 3, 6, and 12 after
initiation of the
treatment. The need for maintenance treatment eve