Suprecur 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: 5013011006140

Patient Information leaflet

528234
528234
SAP-NR. (DMC): 528234
SRZ-NR.: 508940
SCHRIFTGRÖSSE: 8,5 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 148 MM
ERSTELLT AM: 27. JANUAR 2015 / VERSION: 2 / MAC
528234
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE SUPRECUR INJECTION
This medicine should be kept in a safe place
where children cannot see or reach it.
Do not use Suprecur Injection after the expiry date
which is stated on the carton and label. 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.
Discoloured or cloudy solution should not be
used.
Each vial contains enough solution for ten doses.
After finishing a course of treatment the vial
should be disposed of and a new vial started for
the next treatment.
Medicines should not be disposed of via
wastewater or household waste. If you are using
this medicine at home you will be given a
container (a sharps bin) to use for disposal. Return
the sharps bin or any used or unused syringes to
your doctor or nurse or pharmacist for disposal.
These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT SUPRECUR INJECTION CONTAINS
• Each 1ml of solution 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 SUPRECUR INJECTION LOOKS LIKE AND
CONTENTS OF THE PACK
Suprecur Injection is available in boxes
containing two multidose vials. Each vial contains
5.5 millilitres of solution.
MARKETING AUTHORISATION HOLDER AND
MA

Summary of Product characteristics

OBJECT 1
SUPRECUR INJECTION
Summary of Product Characteristics Updated 26-Feb-2015 | SANOFI
1. Name of the medicinal product
Suprecur Injection
2. Qualitative and quantitative composition
Suprecur Injection contains 1.00mg buserelin as buserelin acetate in
1ml aqueous solution.
1.00mg buserelin is equivalent to 1.05mg buserelin acetate.
Suprecur Injection also contains 10mg benzyl alcohol in 1ml aqueous
solution.
For full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for Injection.
4. Clinical particulars
4.1 Therapeutic indications
Pituitary desensitisation in preparation for ovulation induction
regimens using gonadotrophins
4.2 Posology and method of administration
The total daily dose is usually in the range 200 - 500 microgram (μg)
given as a single injection by the
subcutaneous route. Treatment should start in the early follicular
phase (day 1) or, provided the existence
of an early pregnancy has been excluded, in the midluteal phase (day
21). It should continue at least until
down-regulation is achieved e.g. serum estradiol <180pmol/l and serum
progesterone <3nmol/l. This will
usually take about 1 - 3 weeks. Doses may have to be adjusted for
individuals. Occasionally, patients may
require up to 500 μg twice daily in order to achieve down-regulation.
When down-regulation is achieved,
stimulation with gonadotropin is commenced while the dosage of
buserelin is maintained. At the
appropriate stage of follicular development, gonadotropin and
buserelin are stopped and hCG is given to
induce ovulation.
Treatment monitoring, oocyte transfer and fertilisation techniques are
performed according to the normal
practice of the individual clinic.
Luteal support with hCG or progesterone should be given as
appropriate.
4.3 Contraindications
Buserelin should not be used if the tumour is found to be insensitive
to hormone manipulation or in cases
of undiagnosed vaginal bleeding. It is contraindicated in cases of
known hypersensitivity to LHRH,
buserelin or any of the excipients. It should not be used