Suprefact 5.5mg/5.5ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Buserelin acetate

Available from:

Neon Healthcare Ltd

ATC code:

L02AE01

INN (International Name):

Buserelin acetate

Dosage:

1mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030402; GTIN: 5013011006164

Patient Information leaflet

528235
528235
SAP-NR. (DMC): 528235
SRZ-NR.: 508940
SCHRIFTGRÖSSE: 9 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 148 MM
ERSTELLT AM: 10. JANUAR 2015 / VERSION: 2 / MAC
528235
5. HOW TO STORE SUPREFACT INJECTION
Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Suprefact Injection after the expiry
date which is stated on the label and carton.
The expiry date refers to the last day of that
month. Once opened use within 15 days.
Do not store above 25°C. Do not freeze.
Keep the vials in the outer carton in order to
protect from light.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT SUPREFACT INJECTION CONTAINS
• Each 1 ml contains 1 milligram of the active
substance, buserelin as buserelin acetate
• The other ingredients are, sodium chloride,
sodium dihydrogen phosphate, sodium
hydroxide, benzyl alcohol and water for
injections
WHAT SUPREFACT INJECTION LOOKS LIKE AND
CONTENTS OF THE PACK
Suprefact Injection is available in boxes
containing two multidose vials. Each vial
contains 5.5 milligrams of solution.
MARKETING AUTHORISATION HOLDER AND
MANUFACTURER
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Tel: [phone]
email: [e-mail]
Manufacturer
Sanofi-Aventis Deutschland GmbH,
Industriepark Höchst,
65926 Frankfurt am Main,
Germany
This leaflet does not contain all the
information about your medicine. If you have
any questions or are not sure about anything,
ask your doctor or pharmacist.
THIS LEAFLET WAS LAST REVISED IN
NOVEMBER 2014.
© _SANOFI, 1986 – 2014_
IS THIS LEAFLET HARD
TO SEE OR READ?
PHONE [phone]
FOR HELP
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.

Summary of Product characteristics

OBJECT 1
SUPREFACT INJECTION
Summary of Product Characteristics Updated 26-Feb-2015 | SANOFI
1. Name of the medicinal product
Suprefact® Injection
2. Qualitative and quantitative composition
Suprefact Injection contains 1.00mg buserelin as buserelin acetate in
1ml aqueous solution.
1.00mg buserelin is equivalent to 1.05mg buserelin acetate.
Suprefact Injection also contains 10mg benzyl alcohol in 1ml aqueous
solution.
For full list of excipients, see section 6.1
3. Pharmaceutical form
Injection
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of advanced hormone dependent prostatic carcinoma
(stage C or stage D according to
the classification of Murphy _et al,_ in Cancer 45, p1889-95, 1980) in
which suppression of testosterone is
indicated; however, not after bilateral orchiectomy (no further
reduction of testosterone level by buserelin
to be expected).
Buserelin acts by blockade and subsequent down-regulation of pituitary
LHRH receptor synthesis.
Gonadotropin release is consequently inhibited. As a result of this
inhibition there is reduced stimulation
of testosterone secretion and serum testosterone levels fall to
castration range. Before inhibition occurs
there is a brief stimulatory phase during which testosterone levels
may rise.
4.2 Posology and method of administration
Initiation of therapy: is most conveniently carried out in hospital;
0.5ml Suprefact injection should be
injected subcutaneously at 8 hourly intervals for 7 days.
Maintenance therapy: on the 8
th
day of treatment the patient is changed to intranasal administration
of
Suprefact. (see literature for dosage).
4.3 Contraindications
Buserelin should not be used if the tumour is found to be insensitive
to hormone manipulation or after
surgical removal of the testes. It is contraindicated in cases of
known hypersensitivity to LHRH, buserelin
or any of the excipients. It should not be used during pregnancy or
lactation (see section 4.6 Pregnancy
and lactation).
Because of the content of benzyl alcohol Suprefact Injection must n