ZYPREXA IM olanzapine 10mg powder for injection vial

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

olanzapine, Quantity: 10 mg

זמין מ:

Eli Lilly Australia Pty Ltd

טופס פרצבטיות:

Injection, powder for

הרכב:

Excipient Ingredients: tartaric acid; lactose monohydrate

מסלול נתינה (של תרופות):

Intramuscular

יחידות באריזה:

1 vial, 10 vials

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

ZYPREXA IM is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia and related psychoses and in patients with acute mania associated with Bipolar I Disorder, when oral therapy is not appropriate.

leaflet_short:

Visual Identification: Yellow liophilised powder; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

מצב אישור:

Licence status A

תאריך אישור:

2001-07-12

עלון מידע

ZYPREXA
®
IM
_olanzapine_
CONSUMER MEDICINE INFORMATION
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
about this medicine may be available.
Make sure you speak to your
pharmacist 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 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 IS
USED FOR
ZYPREXA belongs to a group of
medicines called antipsychotics. It
helps to correct chemical imbalances
in the brain, which may cause mental
illness.
ZYPREXA IM injection is used for
the rapid control of agitation and
disturbed behaviours in patients with
schizophrenia and related psychoses
and in patients with acute mania
associated with Bipolar I Disorder.
Schizophrenia is a mental illness
with disturbances in thinking,
feelings and behaviour. Bipolar I
Disorder is a mental illness with
symptoms such as feeling "high",
having excessive amounts of energy,
needing much less sleep than usual,
talking very quickly with racing
ideas and sometimes severe
irritability.
ZYPREXA IM injection is given
when treatment with ZYPREXA
tablets is not appropriate. Your
doctor will change your treatment to
ZYPREXA tablets or ZYPREXA
Zydis wafers

מאפייני מוצר

vA18_Sept19
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AUSTRALIAN PRODUCT INFORMATION
ZYPREXA IM (OLANZAPINE) POWDER FOR INJECTION
1.
NAME OF THE MEDICINE
ZYPREXA IM
®
(olanzapine).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olanzapine 10 mg
The active ingredient in ZYPREXA IM is olanzapine 10 mg. ZYPREXA IM
also contains
excipients: lactose monohydrate and tartaric acid. Hydrochloride acid
and/or sodium
hydroxide may have been added during manufacture to adjust pH.
3.
PHARMACEUTICAL FORM
ZYPREXA IM 10mg is yellow lyophilised powder in a clear glass vial. It
is intended for
intramuscular use only.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZYPREXA IM is indicated for the rapid control of agitation and
disturbed behaviours in
patients with schizophrenia and related psychoses and in patients with
acute mania
associated with Bipolar 1 Disorder, when oral therapy is not
appropriate.
4.2
DOSE AND METHOD OF ADMINISTRATION
ZYPREXA IM is for intramuscular use. Do not administer intravenously
or subcutaneously.
ZYPREXA IM is intended for short-term use only.
AGITATED PATIENTS WITH SCHIZOPHRENIA OR BIPOLAR MANIA
The recommended dose for ZYPREXA IM is 10 mg, administered as a single
intramuscular
injection. In clinical trials, ZYPREXA IM was effective following a
dose of 5 to 10 mg.
Therefore, a lower dose may be given, on the basis of individual
clinical status. A second
injection, up to 10 mg, may be administered as early as 2 hours after
the first injection on the
basis of individual clinical status. A third injection, up to 10 mg
may be administered as early
as 4 hours after the second injection. In clinical trials, 30 mg
olanzapine was the maximum
dose administered intramuscularly in any 24-hour period. There is
limited information on
the safety and efficacy of higher doses of ZYPREXA IM, as less than
10% of agitated clinical
trial patients received doses higher than 20 mg in any 24-hour period.
Vital signs should be
vA18_Sept19
SUPERSEDES: vA17-0_10Oct2018
Page 2 of 24
closely monitored in patient who receiv