Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain), Quantity: 200000000 CFU
Merck Sharp & Dohme (Australia) Pty Ltd
Injection, powder for
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
Intravesical
6 vials, 3 vials, 1 vial - 2-8 hundred million CFU
(S4) Prescription Only Medicine
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.
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
Registered
1997-05-27
ONCOTICE ® O n c o T I C E ® 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 Leggi il documento completo
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 Leggi il documento completo