Suprefact 1 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Buserelin

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

L02AE; L02AE01

INN (International Name):

Buserelin

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Gonadotropin releasing hormone analogues; buserelin

Authorization status:

Marketed

Authorization date:

1986-08-28

Patient Information leaflet

529108
529108
SAP-NR. (DMC): 529108
SRZ-NR.: 190631
SCHRIFTGRÖSSE: 8,5 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE FORMAT: 420 X 296 MM
ERSTELLT AM: 07. JULI 2015 / VERSION: 3 / MAC
529108
SUPREFACT
®
1 MG/ML
SOLUTION FOR INJECTION
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
SUPREFACT 1mg/ml Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection contains as active
ingredient, 1.05mg buserelin acetate, equivalent to
1mg buserelin.
Each multidose vial of Suprefact Injection contains
5.5mg buserelin (equivalent to 5.78mg buserelin
acetate) in 5.5ml solution for injection.
Excipients: Also contains 10.000mg benzyl alcohol
per ml and 2.255mg sodium per ml.
For a full list of excipents, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, sterile solution for injection.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
(1) For the treatment of advanced prostatic carci-
noma.
(2) Pituitary desensitisation prior to ovulation in-
duction regimens using gonadotrophins
(subcutaneous administration).
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
To ensure that the desired effect it is very important
that the individual doses be administered at ap-
proximately equal intervals. Patients must adhere to
these intervals conscientiously.
Dosage is generally based on the following guide-
lines.
for monitoring the response to treatment. There is
an increased risk of incident depression (which may
be severe) in patients undergoing treatment with
GnRH agonists, such as buserelin. Patients should be
informed accordingly and treated as appropriate if
symptoms occur. Patients with a history of depres-
sion must be monitored carefully and treated if nec-
essary (risk of recurrence or worsening of depression).
In patients with hypertension, blood pressure must
be monitored regularly (risk of deterioration of
blood pressure levels).
In some patients treated with GnRH-agonists,
change in glucose tolerance is observed (see sec-
tion 4.8)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Suprefact 1 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection contains as active ingredient, 1.05
mg buserelin acetate, equivalent to 1 mg buserelin.
Each multidose vial of Suprefact Injection contains 5.5mg buserelin
(equivalent to 5.78mg buserelin acetate) in 5.5ml
solution for injection.
Excipients: Also contains 10.000mg benzyl alcohol and 2.255mg sodium
per ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless, sterile solution for injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(1)
For the treatment of advanced prostatic carcinoma.
(2)
Pituitary desensitisation prior to ovulation induction regimens using
gonadotrophins (subcutaneous
administration).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To ensure that the desired effect it is very important that the
individual doses be administered at approximately equal
intervals. Patients must adhere to these intervals conscientiously.
Dosage is generally based on the following guidelines.
(1)
Prostatic carcinoma
_Initiation of therapy:_
is most conveniently carried out in hospital; 0.5 ml Suprefact
injection should be injected
subcutaneously at 8 hourly intervals for 7 days.
_Maintenance therapy:_
on the 8th day of treatment the patient is changed to intranasal
administration of Suprefact. (See
manufacturer's instructions).
(2)
For adjunctive use in ovulation induction (subcutaneous use only).
The total daily subcutaneous dose for this indication is 0.5 mg
buserelin, given in one injection. Treatment should start
in the early follicular phase (day 1 or 2) or, provided the existence
of an early pregnancy has been excluded, in the mid-
luteal phase (approx. day 21).
It should continue at least until down-regulation is achieved (serum
oestradiol < 50 ng/l and serum progesterone < 1
micrograms/l). This will usually take about 2-3 weeks.
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