OncoTICE 12.5mg powder for reconstitution for instillation vials

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

TICE strain Bacillus of Calmette-Guerin

Tillgänglig från:

Merck Sharp & Dohme (UK) Ltd

ATC-kod:

L03AX03

INN (International namn):

TICE strain Bacillus of Calmette-Guerin

Dos:

12.5mg

Läkemedelsform:

Powder for reconstitution for instillation

Administreringssätt:

Intravesical

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 08020400; GTIN: 5013945300642

Bipacksedel

ONCOTICE® POWDER FOR SUSPENSION
2-8 X 10
8 CFU TICE® BCG
INFORMATION FOR THE PATIENT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or
pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effect not listed in this
leaflet, please tell your doctor or pharmacist.
_ _
_In this leaflet: _
1. WHAT ONCOTICE IS AND WHAT IT IS USED FOR
2. BEFORE YOU ARE GIVEN ONCOTICE
3. HOW ONCOTICE IS GIVEN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ONCOTICE
6. FURTHER INFORMATION
1. WHAT ONCOTICE IS AND WHAT IT IS USED FOR
Oncotice contains something called ‘BCG’ (‘Bacillus
Calmette-Guérin’). This is a
bacteria which has been specially altered, so that it can be used as a
medicine.
Oncotice is used to:
•
treat bladder cancer
•
prevent bladder cancer from coming back after bladder surgery.
It comes as a powder which is mixed with saline (salt water). It is
then run into your
bladder through a tube. BCG is also used as a vaccine for TB
(tuberculosis). Oncotice is a
much stronger sort of BCG that can’t be used as a vaccine.
2. BEFORE YOU ARE GIVEN ONCOTICE
ONCOTICE SHOULD NOT BE GIVEN IF:
•
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 TB (tuberculosis). Before you have
Oncotice, your
doctor may do a skin reaction test, to see if you have TB. 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.
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 t

Produktens egenskaper

OBJECT 1
ONCOTICE
Summary of Product Characteristics Updated 10-Apr-2018 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
OncoTICE
®
powder for instillation fluid for intravesical use containing 2-8 x 10
8
CFU Tice BCG.
2. Qualitative and quantitative composition
OncoTICE BCG 12.5mg per vial containing 2-8 x 10
8
CFU Tice BCG.
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 instillation fluid for intravesical use.
4. Clinical particulars
4.1 Therapeutic indications
OncoTICE is indicated for treatment of primary or concurrent
carcinoma-in-situ of the urinary bladder
and for the prevention of recurrence of high grade and/or relapsing
superficial papillary transitional cell
carcinoma of the urinary bladder (Stage Ta (grade 2 or 3) or T1 (grade
1, 2 or 3)) after transurethral
resection.
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 Posology and method of administration
For preparation of the OncoTICE suspension see section 6.6.
POSOLOGY
_Adults and the elderly_
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 or major
bladder irritability.
MAINTENANCE TREATMENT
Maintenance treatment consists of weekly instillation with OncoTICE
during 3 consecutive weeks at