Lucrin

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Leuprorelin acetate 5 mg/mL

זמין מ:

AbbVie Limited

INN (שם בינלאומי):

Leuprorelin acetate 5 mg/mL

כמות:

5 mg/mL

טופס פרצבטיות:

Solution for injection

הרכב:

Active: Leuprorelin acetate 5 mg/mL Excipient: Benzyl alcohol Glacial acetic acid Sodium chloride Sodium hydroxide Water for injection

יחידות באריזה:

Vial, glass, 2.8 mL

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

Takeda Pharmaceutical Company Limited

סממני תרפויטית:

Lucrin (leuprorelin acetate) is indicated · in metastatic prostate cancer · in locally advanced prostate cancer, as an alternative to surgical castration · as an adjuvant treatment to radiotherapy in patients with high-risk localized or locally advanced prostate cancer · as an adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression

leaflet_short:

Package - Contents - Shelf Life: Vial, glass, - 2.8 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

תאריך אישור:

1985-12-05

מאפייני מוצר

Lucrin 5 mg/mL DS
Version 5
08 February 2018
Page 1 of 12
NEW ZEALAND DATA SHEET
1.
LUCRIN
® 5 MG/ML SOLUTION FOR INJECTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 5 mg of leuprorelin acetate.
EXCIPIENTS WITH KNOWN EFFECT
Benzyl alcohol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection.
Lucrin is a sterile, clear aqueous solution intended for subcutaneous
injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROSTATE CANCER
Lucrin (leuprorelin acetate) is indicated
•
in metastatic prostate cancer,
•
in locally advanced prostate cancer, as an alternative to surgical
castration,
•
as an adjuvant treatment to radiotherapy in patients with high-risk
localised or locally advanced
prostate cancer,
•
as an adjuvant treatment to radical prostatectomy in patients with
locally advanced prostate cancer at
high risk of disease progression.
ASSISTED REPRODUCTIVE TECHNIQUES
Lucrin is also indicated for controlled ovarian hyperstimulation for
_in-vitro_
fertilisation or other assisted
reproductive technique options.
4.2
DOSE AND METHOD OF ADMINISTRATION
Leuprorelin acetate must be administered under the supervision of a
physician.
Parenteral
products
should
be
inspected
visually
for
particulate
matter
and
discolouration
prior
to
administration, whenever solution and container permit.
Lucrin 5 mg/mL DS
Version 5
08 February 2018
Page 2 of 12
PROSTATE CANCER
The recommended dose is 1 mg (0.2 mL) administered as a single daily
subcutaneous injection. As with
other medicines administered chronically by subcutaneous injection,
the injection site should be varied
periodically.
In
patients
treated
with
GnRH
analogues
for
prostate
cancer,
treatment
is
usually
continued
upon
development of castration-resistant prostate cancer. Reference should
be made to relevant guidelines.
ASSISTED REPRODUCTIVE TECHNIQUES
_Long protocol: _
The
maximum
recommended
daily
dose
of
leuprorelin
acetate
is
1
mg
(0.2
mL)
administered
by
subcutaneous injection. The treatment m