ONCOTICE 5 hundred million CFU powder for injection vial

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain), Quantity: 200000000 CFU

Tillgänglig från:

Merck Sharp & Dohme (Australia) Pty Ltd

Läkemedelsform:

Injection, powder for

Sammansättning:

Excipient Ingredients: citric acid monohydrate; ferric ammonium citrate; strong ammonia solution; purified water; asparagine; magnesium sulfate heptahydrate; zinc formate dihydrate; lactose monohydrate; dibasic potassium phosphate; glycerol

Administreringssätt:

Intravesical

Enheter i paketet:

6 vials, 3 vials, 1 vial - 2-8 hundred million CFU

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

Onco TICE is used as a treatment of primary or recurrent carcinomain situ of the urinary bladder. Onco TICE is also used after transurethral resection for the prevention or recurrence of high grade and/or relapsing superficial papillary transitional cell carcinoma of the urinary bladder (viz papillary carcinoma stage TA or T1 - grades 1, 2, or 3) INDICATIONS AS AT 3 OCTOBER 2001: OncoTICE is used as a treatment ofthe urinary bladder. OncoTICE is also used after transurethral resection for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional cell carinoma of the urinary bladder (viz papillary carcinoma stage TA (grade 2 or 3) or T1 (grade 1, 2, or 3). OncoTICE is only recommended for stage TA grade 1 tumours, when there is judged to be a high risk of tumour recurrence is considered likely. INIDICATIONS AS AT 24 APRIL 2002: OncoTICE is used as a treatment of primary of recurrent carcinoma in situ (CID) of the urinary bladder. OncoTICE is also used after transurethral resection for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional cell carcinoma of the urinary bladder (viz papillary carcinoma stage Ta (grade 2 or 3) or T1 (grade 1, 2, or 3). OncoTICE is only reccommended for stage Ta grade 1 tumours, when there is judged to be a high risk of tumour recurrence.

Produktsammanfattning:

Visual Identification: Off-white to beige coloured freeze dried substance.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 1 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Bemyndigande status:

Registered

Tillstånd datum:

1997-05-27

Bipacksedel

ONCOTICE
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ONCOTICE?
OncoTICE contains the active ingredient Mycobacterium bovis (Bacillus
Calmette and Guerin (BCG) strain). 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.
For more information, see Section 1. Why am I using OncoTICE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ONCOTICE?
Do not use if you have ever had an allergic reaction to OncoTICE or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
OncoTICE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with OncoTICE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW AM I GIVEN ONCOTICE?
•
OncoTICE will be instilled into the bladder via a sterile tube
(catheter) by a doctor or nurse.
•
Your doctor will decide on the duration and frequency of treatment for
you.
More instructions can be found in Section 4. How am I given OncoTICE?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ONCOTICE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
OncoTICE.
•
Refrain from drinking any fluid in the four hours before receiving
this product and during the two hours the
OncoTICE remains in the bladder.
•
It is important you move around while OncoTICE is in the bladder. The
solution must remain in the
bladder for two hours and you should not empty your bladder during
this period. After two hours the
bladder should be

Produktens egenskaper

Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
ONCOTICE
®
MYCOBACTERIUM BOVIS (BACILLUS CALMETTE AND GUERIN (BCG) STRAIN)
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OncoTICE
®
is a freeze-dried preparation of live, attenuated Mycobacterium bovis_
_(Bacillus
Calmette and Guerin (BCG) strain) (Tice™ BCG).
The freeze-dried BCG preparation contains 2-8 × 10
8
colony forming units (CFU) of Tice BCG.
After reconstitution in 50 mL saline (0.9% sodium chloride solution)
the suspension contains
0.4-1.6 × 10
7
CFU/mL.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
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 primary or recurrent carcinoma in
situ (CIS) of the urinary
bladder. OncoTICE is also used after transurethral resection for the
prevention of recurrence
of high grade and/or relapsing superficial papillary transitional cell
carcinoma of the urinary
bladder (viz papillary carcinoma stage T
A
[grade 2 or 3] or T
1
[grade 1, 2, or 3]). OncoTICE is
only recommended for stage T
A
grade 1 tumours, when there is judged to be a high risk of
tumour recurrence.
4.2
DOSE AND METHOD OF ADMINISTRATION
RECONSTITUTION, PREPARATION AND ADMINISTRATION OF ONCOTICE SUSPENSION
FOR BLADDER
INSTILLATION
OncoTICE is incompatible with hypotonic and hypertonic solutions.
OncoTICE
contains
live,
attenuated
mycobacteria.
Because
of
the
potential
risk
for
transmission, it should be prepared, handled and disposed of as a
biohazard material. The
use
of
needleless
closed-system
transfer
device
products
may
be
considered
when
transferring OncoTICE from primary packaging to instillation
equipment.
Page 2 of 12
PERFORM THE FOLLOWING PROCEDURES UNDER ASEPTIC CONDITIONS:
RECONSTITUTION
Add 1 mL of preservative-free sterile physiological saline (0