SUPREFACT 3-MONTH DEPOT IMPLANT

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharmaco Distribution (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

IMPLANT

Composition:

EACH IMPLANT CONTAINS BUSERELIN ACETATE EQUIVALENT TO BUSERELIN 9,45 mg

Authorization status:

Registered

Authorization date:

1999-03-06

Patient Information leaflet

SUPREFACT
®
3-MONTH DEPOT
PHARMACO DISTRIBUTION (PTY) LTD
1.3.2
32/21.10/0345
Each implant contains buserelin acetate equiv. to buserelin 9,45 mg
Amended: 15 Jan 2020
_ _
_ _
Page 1 of 8
1.3.2
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
SUPREFACT
® 3-MONTH DEPOT implant
(buserelin acetate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING SUPREFACT

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or pharmacist.

SUPREFACT has been prescribed for you personally and you should not
share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT SUPREFACT CONTAINS
The active ingredient of SUPREFACT is called buserelin. Each
pre-filled syringe (one implant)
contains three identical rods each containing 3,3 mg buserelin acetate
(9,9 mg), equivalent to 9,45 mg
buserelin base. The total dose is gradually released over a 3-month
period. The ingredient that
controls the gradual release of buserelin from the rods is
poly(D,L-lactide-co-glycolide) with a 75:25
ratio of lactide:glycolide.
Sugar free.
WHAT SUPREFACT IS USED FOR
SUPREFACT contains a medicine called buserelin. Buserelin is similar
to a natural hormone released
by the brain. It belongs to a group of medicines called
gonadotropin-releasing hormone (GnRH)
analogues or luteinising hormone-releasing hormone (LHRH) analogues.
SUPREFACT
®
3-MONTH DEPOT
PHARMACO DISTRIBUTION (PTY) LTD
1.3.2
32/21.10/0345
Each implant contains buserelin acetate equiv. to buserelin 9,45 mg
Amended: 15 Jan 2020
_ _
_ _
Page 2 of 8
SUPREFACT works by lowering the amount of hormones which promote
prostate tumour growth. The
prostate is a gland that lies underneath the bladder of men. The
suppressive effect is fully reversible.
SUPREFACT is used to treat advanced prostate cancer.
BEFORE YOU RECEIVE SUPREFACT
YOU SHOULD NOT BE GIVEN SUPREFACT:

If you are allergic to buserelin or any of the other ingredients of
SUPR

Summary of Product characteristics

SUPREFACT
®
3-MONTH DEPOT
PHARMACO DISTRIBUTION (PTY) LTD
1.3.1.1
32/21.10/0345
Each implant contains buserelin acetate equiv. to buserelin 9,45 mg
Amended: 15 Jan 2020
_ _
_ _
Page 1 of
9
1.3.1.1
PACKAGE INSERT
SCHEDULING STATUS
S4
PROPRIETARY NAME AND DOSAGE FORM
SUPREFACT
® 3-MONTH DEPOT implant
COMPOSITION
One implant consisting of three identical rods each containing 3,3 mg
buserelin acetate (9,9 mg),
equivalent to 9,45 mg buserelin base.
Excipient: Poly(D,L-lactide-co-glycolide) with a 75:25 ratio of
lactide:glycolide.
Sugar free.
PHARMACOLOGICAL CLASSIFICATION
A 21.10 Trophic hormones
PHARMACOLOGICAL ACTION
SUPREFACT contains buserelin, an analogue of the natural
gonadotropin-releasing hormone (GnRH,
LH-RH) with a long duration of action. GnRH stimulates both synthesis
and release of the gonadotropins
LH and FSH. The latter then stimulates steroid biosynthesis in the
gonads. Studies of the behaviour of
the receptor sites both of gonadal LH-receptors and pituitary
GnRH-receptors have shown that long-term
stimulation leads at first to an increase but then to a reduction in
the stimulability of both gonadotropins
and sex-steroid levels. The dose-level and time interval between
individual doses of GnRH are
determinant factors for the receptor loss as indicated in animal
studies. The suppressive effect is fully
reversible.
Natural gonadorelin is bound to receptors for only a short time. It is
degraded within 30 to 60 minutes by
arylamidase and its activity thus abolished. The long-acting analogue,
buserelin, has been developed for
therapeutic use. Enzymatic degradation is inhibited by substitution of
the amino acid, glycine, at two sites
in the molecule. SUPREFACT is capable of inhibiting both gonadotropin
release from the pituitary and
SUPREFACT
®
3-MONTH DEPOT
PHARMACO DISTRIBUTION (PTY) LTD
1.3.1.1
32/21.10/0345
Each implant contains buserelin acetate equiv. to buserelin 9,45 mg
Amended: 15 Jan 2020
_ _
_ _
Page 2 of
9
gonadal steroid biosynthesis. The suppressive effect is reversible.
The secretion of te