ZYPREXA RELPREVV olanzapine (as pamoate monohydrate) 405mg powder for injection vial with diluent vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olanzapine pamoate monohydrate, Quantity: 931 mg (Equivalent: olanzapine, Qty 405 mg)

Available from:

Eli Lilly Australia Pty Ltd

INN (International Name):

olanzapine pamoate monohydrate

Pharmaceutical form:

Diluent, not applicable

Composition:

Excipient Ingredients: hydrochloric acid; carmellose sodium; sodium hydroxide; mannitol; polysorbate 80; water for injections

Administration route:

Intramuscular

Units in package:

one vial of powder and one vial of diluent per carton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ZYPREXA RELPREVV is a long acting injectable formulation of olanzapine indicated for maintenance treatment of schizophrenia in adult patients sufficiently stabilized during acute treatment with oral olanzapine. The effectiveness of ZYPREXA RELPREVV is consistent with the established effectiveness of orally administered olanzapine for acute or maintenance treatment of schizophrenia.

Product summary:

Visual Identification: Clear, colourless to slightly yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2009-03-24

Patient Information leaflet

ZYPREXA RELPREVV
®
_Olanzapine pamoate monohydrate_
CONSUMER MEDICINE INFORMATION
WARNING:
ZYPREXA RELPREVV should be administered by appropriately qualified
health professionals in a healthcare facility with
access to emergency services for management of olanzapine overdose.
Your healthcare professional who prescribes or ad-
ministers ZYPREXA RELPREVV will need to monitor you for at least two
hours after each injection for signs and symp-
toms of sedation and/or confusion (post injection syndrome). The two
hour period should be extended if you show any
potential signs or symptoms of post injection syndrome event.
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about this medicine. It does
not contain all the available
information and does not take the
place of talking with your doctor.
The information in this leaflet was
last updated on the date shown on the
final page. More recent information
on this medicine may be available.
Make sure you speak to your
pharmacist, nurse or doctor to obtain
the most up to date information on
this medicine. You can also
download the most up to date leaflet
from www.lilly.com.au. The updated
leaflet may contain important
information about ZYPREXA
RELPREVV and its use that you
should be aware of.
All medicines have risks and
benefits.
Your doctor has more information
about this medicine than is contained
in this leaflet. Also, your doctor has
had the benefit of taking a full and
detailed history from you and is in
the best position to make an expert
judgement to meet your individual
needs.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT ZYPREXA
RELPREVV IS USED FOR
ZYPREXA RELPREVV belongs to a
group of medicines called
antipsychotics. It helps to correct
chemical imbalances in the brain,
which may cause mental illness.
ZYPREXA RELPREVV is used to
treat symptoms of schizophrenia.
Schizophrenia is a mental illness

Summary of Product characteristics

vA13_Sept2019
SUPERSEDES: vA12_20Aug2018
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION
ZYPREXA RELPREVV (OLANZAPINE PAMOATE MONOHYDRATE)
POWDER FOR INJECTION
WARNING: The potential for signs and symptoms of sedation and/or
delirium consistent
with olanzapine overdose exists after every injection of ZYPREXA
RELPREVV. ZYPREXA
RELPREVV should be administered by appropriately qualified health
professionals in a
healthcare facility with access to emergency services for management
of olanzapine
overdose. Healthcare professionals who prescribe or administer ZYPREXA
RELPREVV
should be aware of this potential risk and the consequent need to
monitor patients for at
least two hours after each injection. The two hour period should be
extended as clinically
appropriate for patients who exhibit any potential signs or symptoms
of a post-injection
syndrome event. See 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE,
POST-INJECTION
SYNDROME.
1.
NAME OF THE MEDICINE
ZYPREXA RELPREVV
®
(olanzapine pamoate monohydrate – alternatively named olanzapine
embonate monohydrate).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olanzapine pamoate monohydrate, equivalent to olanzapine 210 mg.
Olanzapine pamoate monohydrate, equivalent to olanzapine 300 mg.
Olanzapine pamoate monohydrate, equivalent to olanzapine 405 mg.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
ZYPREXA RELPREVV 210 mg, 300 mg and 405 mg is available in a Type I
cerium oxide vial.
One carton provides a kit containing 1 vial of olanzapine pamoate
monohydrate, one vial of
sterile diluent, one 3 mL syringe with pre-attached 19-gauge 38 mm
Hypodermic Needle-
Pro
®
safety needle, one 19-gauge 38 mm Hypodermic Needle-Pro
®
safety needle and two
19-gauge 50 mm Hypodermic Needle-Pro
®
safety needles.
vA13_Sept2019
SUPERSEDES: vA12_20Aug2018
Page 2 of 26
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZYPREXA RELPREVV is a long-acting injectable formulation of olanzapine
indicated for
maintenance treatment of schizophrenia in adult patients su