Country: Ísrael
Tungumál: enska
Heimild: Ministry of Health
BCG STRAIN
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
L03AX03
POWDER FOR SOLUTION FOR INSTILLATION
BCG STRAIN 200 - 800 MIU
INTRA-VESICALLY
Required
ORGANON N.V., THE NETHERLANDS
BCG VACCINE
BCG VACCINE
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 tumors when there is judged to be a high risk of tumor recurrence.
2021-10-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine is marketed upon physician’s prescription only OncoTICE ® Powder for solution for instillation Each vial contains: 2-8 x 10 8 CFU Tice BCG. For a list of inactive ingredients see section 6.1 “What OncoTICE contains?”. See also section 2.7 “Important information about some of the ingredients of OncoTICE”. Read all of this leaflet carefully before you start using this medicine. • This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. 1. WHAT ONCOTICE IS INTENDED FOR? OncoTICE is used to: • treat bladder cancer • prevent bladder cancer from coming back after bladder surgery . Therapeutic group: immunostimulating agent 2. BEFORE USING OncoTICE 2.1 Do not use OncoTICE if: • You are sensitive (allergic) to the active substance (Tice BCG) or any of the other ingredients that this medicine contains. For a list of inactive ingredients, see section 6.1 “What OncoTICE contains?” . • You have a urinary tract infection (UTI) or cystitis (inflammation of the bladder). This must be treated first. • You have blood in your urine. • You have or think you have tuberculosis. Before you have OncoTICE, your doctor may do a skin reaction test, to see if you have tuberculosis. This is called a Tuberculin Test. If you have had OncoTICE before, this may give you a positive result in this test. • You are HIV-positive. You may need to have a blood test for HIV. • Are pregnant or breast-feeding. Tell your doctor if any of the following apply to you: • you have been a drug user and have shared a needle. • you have had unsafe sex. • you have had a blood transfusion. • you have problems with your immune system. This could be something which runs in the family, or is caused by an Lestu allt skjalið
OncoTICE ® Powder for solution for instillation 1. NAME OF THE MEDICINAL PRODUCT OncoTICE ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION OncoTICE BCG containing 2-8 x 10 8 CFU Tice BCG per vial. After reconstitution in 50 ml saline the suspension contains 0.4-1.6 x 10 7 CFU/ml. OncoTICE is a freeze-dried preparation containing attenuated bacilli of Mycobacterium bovis, prepared from a culture of Bacillus Calmette-Guérin (BCG). For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for instillation 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 tumors when there is judged to be a high risk of tumor recurrence. 4.2 Posology and method of administration For preparation of the OncoTICE suspension see section 6.6. Posology The contents of one vial of OncoTICE, reconstituted and diluted as indicated, 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 “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. Treatment should also be delayed in cases of gross haematuria. Delay in treatment should be considered in cases of major bladder irritability. Maintenance treatment Maintenance 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 every 6 months beyond the first year of treatment should be evaluated on the basis of tumo Lestu allt skjalið