Goserelin

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Goserelin acetate 12.5mg equivalent to 10.8 mg goserelin

から入手可能:

Teva Pharma (New Zealand) Limited

投薬量:

10.8 mg

医薬品形態:

Subcutaneous implant

構図:

Active: Goserelin acetate 12.5mg equivalent to 10.8 mg goserelin Excipient: Poly(lactide) Polyglactin

処方タイプ:

Prescription

適応症:

Prostate cancer suitable for hormonal manipulation. Adjuvant and neoadjuvant therapy in combination with radiotherapy for the management of locally advanced prostate cancer in men suitable for hormonal manipulation.

製品概要:

Package - Contents - Shelf Life: Syringe, with plastic polymer implant holder unit, stainless steel cannula and mandrin - 1 dose units - 48 months from date of manufacture stored at or below 30°C protect from light and moisture

承認日:

2016-04-04

情報リーフレット

NEW ZEALAND CONSUMER MEDICINE INFORMATION
GOSERELIN (TEVA)
Goserelin, 10.8 mg implant, in a prefilled syringe
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Goserelin (Teva) 10.8
mg. 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 will have weighed
the risks
of you receiving Goserelin (Teva) 10.8 mg against the benefits they
expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT GOSERELIN (TEVA) IS USED FOR
Goserelin (Teva) 10.8 mg is a special preparation of goserelin acetate
which is
designed to work in the body for 12 weeks (3 months) after each
injection.
Most
people
will
need
one
injection
for
each
12
weeks
(3
months)
of
treatment. Goserelin (Teva) 10.8 mg is otherwise similar to Goserelin
(Teva)
3.6 mg which you may have received in the past. Goserelin (Teva) 3.6
mg
lasts for only 28 days.
Goserelin
(Teva)
10.8
mg
is
a
member
of
the
anti-hormonal
group
of
medicines. This means that it affects the levels of various hormones
(natural
chemicals produced by the body).
In men it will reduce levels of
the male
hormone, testosterone.
In women it will reduce the levels of the female
hormone, oestrogen.
In women, female hormones make the breasts grow, prepare the womb and
other sex organs for pregnancy, and increase the sex drive.
In men, male hormones make the testicles grow, assist an erection, and
increase
the
sex
drive.
When
Goserelin
(Teva)
10.8
mg
lowers
sex
hormones, all these actions will be reduced. Due to the action of
Goserelin
(Teva) 10.8 mg on hormones, Goserelin (Teva) 10.8 mg can treat very
different illnesses in both men and women.
MEN
Goserelin (Teva) 10.8 mg can treat prostate cancer in some men. It is
not a
cure for prostate cancer and does not work in every patient with
prostate
cancer.
WOMEN
Goserelin (Teva) 10.8 mg may be

製品の特徴

Version 1.3
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Goserelin, 10.8 mg implant, in a prefilled syringe (Teva)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One implant contains 10.8 mg goserelin (as goserelin acetate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Implant, in a pre-filled syringe
White to off-white cylindrical rods (approximate dimensions: diameter
1.5 mm, length 20 mm, mass
44 mg), embedded in biodegradable polymer matrix.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Goserelin (Teva) 10.8 mg is indicated for the management of:
•
Prostate cancer suitable for hormonal manipulation.
•
Adjuvant and neoadjuvant therapy in combination with radiotherapy for
the management of
locally advanced prostate cancer in men suitable for hormonal
manipulation.
•
Endometriosis: Goserelin (Teva) alleviates symptoms including pain,
and reduces the size and
number of endometrial lesions.
•
Uterine fibroids: Goserelin (Teva) shrinks the lesions, reduces
symptoms including pain, and
causes cessation of menses in the majority of patients thereby
improving haematological status
when previous heavy menstrual loss has caused anaemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
_Adults - Males _
One 10.8 mg depot of Goserelin (Teva) injected subcutaneously into the
anterior abdominal wall, every
3 months.
Adjuvant and/or neoadjuvant therapy in combination with radiotherapy
may include short-term use of
an anti-androgen to prevent flare.
_Adults - Females _
One 10.8 mg depot of Goserelin (Teva) injected subcutaneously into the
anterior abdominal wall, every
12 weeks.
_Paediatric population _
Goserelin (Teva) is not indicated in children.
_Special populations _
No dosage adjustment is necessary for patients with renal or hepatic
impairment, or in the elderly.
Method of administration
Goserelin (Teva) is indicated for subcutaneous use. For correct
administration of Goserelin (Teva),
refer to instructions printed on inside of carton.
Use only if pouch is undamaged. Use immediately after o