ONCOTICE

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

BCG STRAIN

Saatavilla:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC-koodi:

L03AX03

Lääkemuoto:

POWDER FOR SOLUTION FOR INSTILLATION

Koostumus:

BCG STRAIN 200 - 800 MIU

Antoreitti:

INTRA-VESICALLY

Prescription tyyppi:

Required

Valmistaja:

ORGANON N.V., THE NETHERLANDS

Terapeuttinen ryhmä:

BCG VACCINE

Terapeuttinen alue:

BCG VACCINE

Käyttöaiheet:

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.

Valtuutus päivämäärä:

2021-10-31

Pakkausseloste

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

Valmisteyhteenveto

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