SUPREFACT 100 Mcg/Dose Nasal Spray Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BUSERELIN ACETATE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

L02AE01

INN (International Name):

BUSERELIN ACETATE

Dosage:

100 Mcg/Dose

Pharmaceutical form:

Nasal Spray Solution

Prescription type:

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

Therapeutic area:

Gonadotropin releasing hormone analogues

Authorization status:

Authorised

Authorization date:

2001-08-28

Patient Information leaflet

529150
529150
AP-NR. (DMC): 529150
SRZ-NR.: 503338
CODE: 937
SCHRIFTGRÖSSE: 9,5 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 148 MM
ERSTELLT AM: 07. JULI 2015 / VERSION: 3 / MAC
529150
• 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 effects not listed in this
leaflet, please tell your doctor or pharma-
cist.
WHAT IS IN THIS LEAFLET
1. What Suprefact Nasal Spray is and what it is
used for
2. What you need to know before you use
Suprefact Nasal Spray
3. How to use Suprefact Nasal Spray
4. Possible side effects
5. How to store Suprefact Nasal Spray
6. Contents of the pack and other information
1. WHAT SUPREFACT NASAL SPRAY IS AND WHAT
IT IS USED FOR
Suprefact Nasal Spray contains a medicine
called buserelin acetate. This belongs to a
group of medicines called gonadotropin re-
leasing hormone analogues. This is a synthetic
version of a hormone that occurs naturally in
the body. It works by lowering the production
of sex hormones. It is used to treat prostate
cancer by lowering the amount of the hor-
mone ‘testosterone’.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
SUPREFACT NASAL SPRAY
Do not use this medicine and tell your doctor
if:
× You are allergic (hypersensitive) to:
– buserelin
– other similar medicines such as goserelin
– any of the other ingredients of Suprefact
Nasal Spray (listed in Section 6 below)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling
of your lips, face, throat or tongue
× You have a tumour that is not affected by
changes in hormone levels
× You have had an operation to remove your
testicles
Do not use if any of the above apply to you. If
you are not sure, talk to your doctor or phar-
macist before using Suprefact Nasal Spray.
WARNINGS AND PRECAUTIONS
CHECK WITH YOUR DOCTOR OR PHARMACIST BE-
FORE USING YOUR MEDICINE IF:
• You have depres

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Suprefact 100 micrograms/metered dose Nasal Spray, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (100mg) contains 100 micrograms buserelin as buserelin acetate.
100 micrograms buserelin is equivalent to 105 micrograms buserelin acetate.
Excipients: Suprefact nasal spray contains 10 micrograms of Benzalkonium chloride per metered dose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray
Clear colourless to faintly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of advanced hormone-dependent prostatic carcinoma; however, not after bilateral orchiectomy (no
further reduction of testosterone level by buserelin to be expected)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To ensure the desired effect it is very important the individual doses be administered at approximately equal intervals.
Patients must adhere to these intervals conscientiously.
_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. One
spray dose is introduced into each nostril 6 times a day.
4.3 CONTRAINDICATIONS
Suprefact should not be used if the tumour is found to be insensitive to hormone manipulation or after surgical removal
of the testes.
Suprefact must not be administered in patients with hypersensitivity to buserelin or, if applicable, to any of the
excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH
agonists,such as