SYNAREL NASAL SPRAY nafarelin (as acetate) 2mg/mL

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

nafarelin, Quantity: 2 mg/mL

Tersedia dari:

Pfizer Australia Pty Ltd

Bentuk farmasi:

Spray, solution

Komposisi:

Excipient Ingredients: benzalkonium chloride; sorbitol; glacial acetic acid; hydrochloric acid; purified water; sodium hydroxide

Rute administrasi :

Nasal

Unit dalam paket:

1 x 8mL

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

INDICATIONS AS AT 31 AUGUST 1995. Synarel is indicated for the hormonal management of visually proven endometriosis, including pain relief and reduction of endometriotic lesions and for use in controlled ovarian stimulation programmes prior to in-vitro fertilisation, under the supervision of an infertility specialist.

Ringkasan produk:

Visual Identification: Clear, colourless to slightly yellow solution.; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Registered

Tanggal Otorisasi:

1994-02-25

Selebaran informasi

SYNAREL
® NASAL
SPRAY
_nafarelin acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully.
This leaflet answers some common
questions about Synarel nasal spray.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist. All medicines have risks
and benefits. Your doctor has
weighed the risks of you taking
Synarel nasal spray against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SYNAREL IS USED
FOR
The name of your medicine is
Synarel which contains an active
ingredient called nafarelin acetate.
Synarel belongs to a group of
medicines called pituitary hormone
analogues which work by decreasing
the secretion of sex hormones.
Specifically, Synarel belongs to a
class of drugs known as synthetic
gonadotrophin-releasing hormones.
Synarel is usually prescribed by your
doctor to treat a condition called
endometriosis. The lining of the
uterus or womb is called the
endometrium, and part of it is shed
during menstruation (periods). In
endometriosis, tissue similar to this
lining is found outside the uterus
(e.g. ovaries, intestines or other
organs in the pelvis), and like normal
endometrial tissue, this can bleed
during a menstrual cycle.
Although some women with
endometriosis may not experience
any symptoms, others may have
lower back pain, have painful bowel
movements, painful periods, or
experience pain during intercourse.
Endometrial tissue is affected by the
body's hormones, especially
estrogen, which is made by the
ovaries. When estrogen levels are
low, the endometrial-like tissue
shrinks or may even disappear, and
the symptoms of endometriosis ease.
Synarel will temporarily reduce the
level of estrogen in the body, thereby
temporarily relieving your
endometriosis symptoms.
Synarel can also be prescribed by a
specialist for women as part of in-
vitro fertilisati

Karakteristik produk

Version: pfpsynan10220
Supersedes: pfpsynan11008
Page 1 of 11
AUSTRALIAN
PRODUCT
INFORMATION
–
SYNAREL
®
NASAL
SPRAY
(NAFARELIN
ACETATE)
1.
NAME OF THE MEDICINE
Nafarelin acetate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SYNAREL NASAL SPRAY contains nafarelin acetate equivalent to 2 mg/mL
of nafarelin
base.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
SYNAREL NASAL SPRAY is supplied as a clear, colourless to slightly
yellow solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SYNAREL is indicated for the hormonal management of visually proven
endometriosis,
including pain relief and reduction of endometriotic lesions and for
use in controlled ovarian
stimulation programmes prior to
_in-vitro _
fertilisation, under the supervision of an infertility
specialist.
4.2 DOSE AND METHOD OF ADMINISTRATION
ENDOMETRIOSIS
The recommended daily dose of SYNAREL in endometriosis patients is one
spray (200 µg of
nafarelin free base) to one nostril in the morning and one spray into
the other nostril in the
evening (400 µg/day). Treatment should be started between days 2 and
4 of the menstrual
cycle. The 400 µg daily dose may not produce amenorrhoea in all
endometriosis patients. For
these patients, if the symptoms of endometriosis persist, the dose may
be increased to 800 µg
daily. The 800 µg dose is administered as one spray into each nostril
in the morning (a total of
two sprays) and again in the evening.
The recommended duration of therapy is six months. Retreatment cannot
be recommended
since safety data for retreatment are not available. If the symptoms
of endometriosis recur after
a course of therapy, and further treatment with SYNAREL or another
GnRH agonist is
contemplated, it is recommended that bone density be assessed before
retreatment begins to
ensure that values are within normal limits. Current data suggests
that at least two years are
required between courses of treatment. It is recommended that the
risks and benefits of
treatment with SYNAREL be co