Suprefact 100micrograms/dose nasal spray

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Buserelin acetate

Inapatikana kutoka:

Neon Healthcare Ltd

ATC kanuni:

L02AE01

INN (Jina la Kimataifa):

Buserelin acetate

Kipimo:

100microgram/1dose

Dawa fomu:

Spray

Njia ya uendeshaji:

Nasal

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 08030402; GTIN: 5013011006171

Taarifa za kipeperushi

528236
528236
SAP-NR. (DMC): 528236
SRZ-NR.: 503338
CODE: 1326
SCHRIFTGRÖSSE: 9 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 148 MM
ERSTELLT AM: 10. FEBRUAR 2015 / VERSION: 3 / MAC
528236
• 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 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 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 is used to treat prostate cancer by lowering the
amount of the hormone “testosterone”.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE SUPREFACT NASAL SPRAY
Before using Suprefact, your doctor should
assess your risk of developing diseases of heart
and blood vessels (cardiovascular disease),
diabetes mellitus and anaemia. If you develop
any of the above, you should be monitored and
treated accordingly.
DO NOT TAKE 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 pharmacist
before using Suprefact Nasal Spray.
TAKE SPECIAL CARE WITH SUPREFACT

Tabia za bidhaa

OBJECT 1
SUPREFACT NASAL SPRAY
Summary of Product Characteristics Updated 26-Feb-2015 | SANOFI
1. Name of the medicinal product
Suprefact Nasal Spray
2. Qualitative and quantitative composition
Suprefact nasal spray contains 100 micrograms buserelin as buserelin
acetate in 1 spray dose of aqueous
solution containing benzalkonium chloride as preservative.
100 micrograms buserelin is equivalent to 105 micrograms buserelin
acetate
3. Pharmaceutical form
Nasal spray
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, p 1889-95, 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 the
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;
0.5 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 according to the following
schedule:
1st dose before breakfast
2nd dose after breakfast
3rd and 4th doses before and after midday meal
5th and 6th doses before and after evening meal.
This dosage regimen is to ensure adequate absorption of the material
and to distribute the dose throughout
the day.
If used correctly, reliable absorption of the active ingredient takes
place via nasal mucous membranes.
Suprefact nasal