Suprecur 150micrograms/dose nasal spray

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:

150microgram/1dose

Pharmaceutical form:

Spray

Administration route:

Nasal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06070200; GTIN: 5013011006157

Patient Information leaflet

528237
528237
SAP-NR. (DMC): 528237
SRZ-NR.: 503338
CODE: 1316
SCHRIFTGRÖSSE: 8,5 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 148 MM
ERSTELLT AM: 10. FEBRUAR 2015 / VERSION: 2 / MAC
528237
• 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 pharmacist.
WHAT IS IN THIS LEAFLET
1. What Suprecur Nasal Spray is and what it is
used for
2. What you need to know before you use
Suprecur Nasal Spray
3. How to use Suprecur Nasal Spray
4. Possible side effects
5. How to store Suprecur Nasal Spray
6. Contents of the pack and other information
1. WHAT SUPRECUR NASAL SPRAY
IS AND WHAT IT IS USED FOR
The name of your medicine is Suprecur 150
micrograms Nasal Spray Solution (called Suprecur
Nasal Spray throughout this leaflet). It contains a
medicine called buserelin acetate. This belongs to
a group of medicines called gonadotropin
releasing 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 can be used for the following:
• Treatment of endometriosis – an illness where
some of the tissues that line the womb are
found elsewhere in the body
• As part of a treatment for infertility – it works
by stopping the natural production of
hormones that control ovulation. Synthetic
hormones are then used to artificially stimulate
ovulation. Your doctor should give you more
information about how your treatment works
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE SUPRECUR NASAL SPRAY
DO NOT USE THIS MEDICINE AND TELL YOUR
DOCTOR IF:
× You are allergic (hypersensitive) to buserelin or
other similar medicines such as goserelin,
benzalkonium chloride or any of the other
ingredients of Suprecur 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 abnormal menstrual bleeding where
the cause is not endometriosis
× You have a

Summary of Product characteristics

OBJECT 1
SUPRECUR 150 MCG NASAL SPRAY SOLUTION
Summary of Product Characteristics Updated 26-Feb-2015 | SANOFI
1. Name of the medicinal product
Suprecur 150 micrograms Nasal Spray Solution
2. Qualitative and quantitative composition
Suprecur nasal spray contains 150 micrograms buserelin, as buserelin
acetate, in one spray dose.
150 micrograms buserelin is equivalent to 157.5 micrograms buserelin
acetate.
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Nasal Spray Solution
The preparation is a clear solution.
4. Clinical particulars
4.1 Therapeutic indications
The treatment of endometriosis in cases that do not require surgery as
primary therapy.
Pituitary desensitisation in preparation for ovulation induction
regimens using gonadotrophins.
4.2 Posology and method of administration
_Endometriosis:_ The total daily dose is 900 micrograms buserelin,
administered as one spray dose in each
nostril in the morning, at mid-day and in the evening. The product may
be used before or after meals or at
other times, provided that uniform intervals are maintained between
doses.
The usual duration of treatment is six months and this should not be
exceeded. Only a single course of
treatment is recommended.
Repeated courses of treatment must only be administered after a
careful review of the risk/benefit ratio by
the attending physician since the possibility of additive effects on
bone mass (reduction in bone mass)
cannot be excluded (see also section 4.4).
_Pituitary desensitisation prior to ovulation induction: _The total
daily intranasal dose for this indication is
600 micrograms buserelin, given in four divided dosages of 150
micrograms (one application in one
nostril) spread over the waking hours. 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 <50 ng/l and serum progesterone
<1 microgram/l. This will usually tak