DIPHERELINE triptorelin (as embonate) 22.5 mg powder for suspension vial and water for injections ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

triptorelin embonate, Quantity: 31 mg (Equivalent: triptorelin, Qty 22.5 mg)

Available from:

Ipsen Pty Ltd

INN (International Name):

triptorelin embonate,water for injections

Pharmaceutical form:

Suspension, powder for

Composition:

Excipient Ingredients: polyglactin; carmellose sodium; polysorbate 80; mannitol

Administration route:

Intramuscular

Units in package:

1 vial, 1 ampoule

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Diphereline is indicated for the treatment of hormone-dependent locally advanced or metastatic prostate cancer.,Diphereline 22.5mg 6 month formulation only:,Diphereline 22.5 mg is indicated for the treatment of children 2 years and older with central precocious puberty (CPP).

Product summary:

Visual Identification: White to slightly yellow cake; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2010-07-27

Patient Information leaflet

This medicine is subject to additional monitoring in Australia due to
approval of an extension of indications. This will
allow quick identification of new safety information. You can help by
reporting any side effects you may get. You can
report side effects to your doctor, or directly at
www.tga.gov.au/reporting-problems
DIPHERELINE
®
_triptorelin embonate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
Please read this leaflet carefully
before you are given
DIPHERELINE.
This leaflet answers some common
questions about DIPHERELINE. 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. Sometimes new risks are
found even when a medicine has
been used for many years.
Your doctor has weighed the risks of
you being given DIPHERELINE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DIPHERELINE
IS USED FOR
The name of your medicine is
DIPHERELINE. It contains the
active ingredient triptorelin
embonate.
In adult men, DIPHERELINE is used
to treat prostate cancer that has
spread into surrounding tissue and/or
to other parts of the body. It is not a
cure for prostate cancer.
In children, DIPHERELINE 22.5 mg
is used to treat puberty that occurs at
a very young age (Precocious
Puberty). This is called “early
puberty” in the rest of this leaflet.
DIPHERELINE belongs to a group
of medicines called Gonadotrophin
Releasing Hormone agonists
(GnRHa).
In males, DIPHERELINE works by
lowering the production of
testosterone . Testosterone is the
natural male sex hormone.
In some types of prostate cancer,
testosterone may help the cancer
cells to grow. By lowering
testosterone, DIPHERELINE may
slow or stop the growth of cancer.
In females, DIPHERELINE lowers
the levels of the hormone oestrogen.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICI

Summary of Product characteristics

DIPHERELINE Product Information v4, 1 September 2021
1
This medicinal product is subject to additional monitoring in
Australia due to approval of
an extension of indications. This will allow quick identification of
new safety information.
Healthcare professionals are asked to report any suspected adverse
events at
www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
DIPHERELINE
TRIPTORELIN (AS EMBONATE) 3.75 MG, 11.25 MG & 22.5 MG
POWDER FOR SUSPENSION
1
NAME OF THE MEDICINE
Triptorelin embonate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DIPHERELINE 3.75MG 1 MONTH FORMULATION
Each vial contains a triptorelin content which allows the
administration of an effective dose of
3.75 mg triptorelin. After reconstitution in 2 mL of solvent, 1 mL of
reconstituted suspension
contains 1.875 mg of triptorelin.
DIPHERELINE 11.25MG 3 MONTH FORMULATION
Each vial contains a triptorelin content which allows the
administration of an effective dose of
11.25 mg triptorelin. After reconstitution in 2 mL of solvent, 1 mL of
reconstituted suspension
contains 5.625 mg of triptorelin.
DIPHERELINE 22.5MG 6 MONTH FORMULATION
Each vial contains a triptorelin content which allows the
administration of an effective dose of
22.5 mg triptorelin. After reconstitution in 2 mL of solvent, 1 mL of
reconstituted suspension
contains 11.25 mg of triptorelin.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection, prolonged release
granules.
White to off-white powder
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diphereline is indicated for the treatment of hormone-dependent
locally advanced or metastatic
prostate cancer.
▼

DIPHERELINE Product Information v4, 1 September 2021
2
DIPHERELINE 22.5MG 6 MONTH FORMULATION ONLY:
Diphereline 22.5 mg is indicated for the treatment of children 2 years
and older with central
precocious puberty (CPP).
4.2
DOSE AND METHOD OF ADMINISTRATION
DIPHERELINE 3.75MG - 1MONTH FORMULATION
The recommended dose of Diphere