Zyprexa IM

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Olanzapine 10mg (There is a 10% overfill of powder)

Available from:

Pharmaco (NZ) Ltd

INN (International Name):

Olanzapine 10 mg (There is a 10% overfill of powder)

Dosage:

10 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Olanzapine 10mg (There is a 10% overfill of powder) Excipient: Lactose monohydrate Tartaric acid Sodium chloride Water for injection

Units in package:

Syringe, glass, (Diluent), 2.1 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Eli Lilly SA

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 I Disorder, when oral therapy is not appropriate.

Product summary:

Package - Contents - Shelf Life: Syringe, glass, (Diluent) - 2.1 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, single dose, (Powder) - 10 mg - 36 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, single dose, (Powder) 10s - 100 mg -  

Authorization date:

2000-06-12

Patient Information leaflet

NZ ZYPREXA
®
IM CMI 001
1
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.co.nz. 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 tablet

Summary of Product characteristics

NEW ZEALAND DATASHEET
ZYPREXAIM001
Page 1 of 22
1.
ZYPREXA
IM
ZYPREXA IM
®
10 mg powder for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olanzapine 10 mg.
The active ingredient in ZYPREXA IM is olanzapine 10mg. ZYPREXA IM
also contains
excipients: lactose monohydrate and tartaric acid. Hydrochloric acid
and/or sodium
hydroxide may have been added during manufacture to adjust pH.
3.
PHARMACEUTICAL FORM
ZYPREXA IM is a 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 Biopolar I 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 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
closely monitored in patients who receive the maximum dose of 30 mg
with the specified
minimum time period of 6 hours in order to detect adverse
cardiovascular effects, such as