Suprefact Depot 9,45 mg Implantat

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

buserelinacetat

Available from:

Orifarm AB

ATC code:

L02AE01

INN (International Name):

buserelin acetate

Dosage:

9,45 mg

Pharmaceutical form:

Implantat

Composition:

buserelinacetat 9,9 mg Aktiv substans

Class:

Apotek

Prescription type:

Receptbelagt

Therapeutic area:

Buserelin

Authorization status:

Avregistrerad

Authorization date:

2014-01-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUPREFACT DEPOT 9.45 MG IMPLANT
BUSERELIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Suprefact Depot is and what it is used for
2.
What you need to know before you use Suprefact Depot
3.
How to use Suprefact Depot
4.
Possible side effects
5.
How to store Suprefact Depot
6.
Contents of the pack and other information
1.
WHAT SUPREFACT DEPOT IS AND WHAT IT IS USED FOR
WHAT SUPREFACT DEPOT IS
Suprefact Depot contains a medicine called buserelin. Buserelin is
similar to a natural hormone released
by the brain. It belongs to a group of medicines called
‘luteinizing-hormone-releasing hormones
analogues’ (
LHRH analogues)
.
HOW SUPREFACT DEPOT WORKS
It works by lowering the amount of hormones which promote prostate
tumour growth. Prostate is a gland
that lies underneath the bladder of men.
WHAT SUPREFACT DEPOT IS USED FOR
Suprefact Depot is used to treat advanced prostate cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SUPREFACT DEPOT
DO NOT USE SUPREFACT DEPOT :

If you are allergic to buserelin, to other LHRH analogues (e.g.
leuprolide, goserelin, triptorelin) or any
of the other ingredients of this medicine (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips,
face, throat or tongue.
Do not have this medicine if any of the above apply to you. If you are
not sure, talk to your doctor or
pharmacist before starting treatment with Suprefact Depot.
1
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING
SUPREFACT DEPOT :

If you have had your testicles removed.

If your cancer has spread (metastatic

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Suprefact Depot 9.45 mg implant
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe with three identical rod-shaped implants
contains, as active ingredient,
9.9 mg buserelin acetate, equivalent to 9.45 mg buserelin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Implants
Each implant consists of three creamy-coloured rod-shaped implant.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Suprefact Depot is indicated in adults for the treatment of advanced
hormone-dependent
prostatic carcinoma. However, Suprefact Depot 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 is intended for the long-term treatment of advanced
prostatic carcinoma.
_Paediatric population_
Suprefact Depot should not be used in children. The safety and
efficacy of Suprefact Depot in
children has not been established.
Method of administration
The contents of the syringe (three implant rods, equivalent to 9.45 mg
buserelin) are injected
subcutaneously into the abdominal wall every three months (see section
6.6). The three month
interval between injections may, however, occasionally be extended by
up to three weeks.
Before injection, a local anaesthetic may be given.
It is recommended that administration of an anti-androgen is started
as adjunctive therapy
about 5 days before starting Suprefact Depot (see also section 4.4).
4.3
CONTRAINDICATIONS
Hypersensitivity to
the active substance
, LHRH analogues or to any of the excipients listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
It is recommended that administration of an anti-androgen is started
as adjunctive therapy
about 5 days before starting Suprefact Depot. This supplementary
treatment must be
continued in parallel with buserelin therapy for 3 – 4 weeks. After
this time testosterone levels
have usually fallen into the desired range in response to buserelin.
In patients with kn