SUPREFACT DEPOT 3-MONTHS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BUSERELIN ACETATE

Available from:

SANOFI - AVENTIS ISRAEL LTD

ATC code:

L02AE01

Pharmaceutical form:

RODS FOR IMPLANT

Composition:

BUSERELIN ACETATE 9.9 MG

Administration route:

S.C

Prescription type:

Required

Manufactured by:

SANOFI - AVENTIS DEUTSCHLAND GMBH, GERMANY

Therapeutic group:

BUSERELIN

Therapeutic area:

BUSERELIN

Therapeutic indications:

Treatment of advanced hormone dependent prostatic carcinoma. However not after bilateral orchiectomy ( no further reduction of testosterone level by buserelin to be expected).

Authorization date:

2014-10-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
SUPREFACT DEPOT 3 MONTHS
Implant for subcutaneous injection
ACTIVE INGREDIENT
Each syringe, which contains three implant strips,
includes:
Buserelin acetate 9.9 mg )equivalent to 9.45 mg buserelin(
Inactive ingredients: see section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE.
Keep this leaflet; you may need to read it again.
This leaflet contains concise information about the
medicine.
If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may harm them even
if it seems to you that their medical condition is similar.
This medicine is intended for men only.
1. WHAT IS THE MEDICINE INTENDED FOR?
To treat prostate cancer.
The medicine acts by lowering testosterone hormone
levels.
Therapeutic group: GnRH – Gonadotropin releasing
hormone analog.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE:
∙ If you are sensitive to buserelin, to other GnRH analogs,
to LHRH analogs or to any of the other ingredients of
the medicine )see section 6(. Signs of an allergic reaction
include: rash, swallowing or breathing problems,
swelling of the lips, face, throat or tongue.
∙ If the tumor is resistant to hormonal treatment.
∙ After surgical removal of the testicles.
∙ This medicine is intended for men only. Use in women
is prohibited.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH THE MEDICINE, TELL THE DOCTOR
IF:
∙ you are suffering, or have suffered in the past, from:
depression, hypertension, diabetes )see Tests and follow-
up section(.
∙ you are sensitive to any food or medicine.
∙ you are suffering from problems in the nervous system.
∙ you have difficulties passing urine.
∙ you have a drop in red blood cell counts )anemia( or are
suffering from increased fatigue.
There are reports of depres

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Suprefact Depot 3 Months, implant for subcutaneous route
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe of Suprefact Depot with three identical rod–
shaped implants contains,
as active ingredient, 9.9mg buserelin acetate, equivalent to 9.45mg
buserelin.
Excipients:
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Implant
Each implant consists of three creamy-coloured rod– shaped implants
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Suprefact Depot 3 Months is used for the treatment of advanced
hormone-dependent prostatic
carcinoma.
However, Suprefact Depot 3 Months is not indicated after bilateral
orchiectomy as there
would be no further reduction in testosterone levels.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Suprefact Depot 3 Months is intended for the long-term treatment of
advanced prostatic
carcinoma.
Method of administration
It is recommended that administration of an anti-androgen is started
as adjunctive therapy
about 5 days before starting Suprefact Depot 3 Months (see also
section 4.4).
Before injection, a local anaesthetic may be given.
The contents of the syringe (three implant rods, equivalent to 9.45mg
buserelin) are injected
subcutaneously into the abdominal wall every three months (see section
6.4).
The three-month interval between injections may, however, occasionally
be extended by up to
three weeks.
4.3
CONTRAINDICATIONS
Suprefact Depot 3 Months must not be administered to patients with
hypersensitivity to
buserelin, LHRH analogues or to any of the ingredients of Suprefact
Depot 3 Months.
After surgical removal of the testes, no further reduction of
testosterone levels by Suprefact
Depot can be expected.
2
Suprefact should not be used if the tumour is found to be insensitive
to hormone manipulation
or after surgical removal of the testes.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
It is recommended that administration of an anti-androgen is started
as adjun