HOSPIRA ISOPRENALINE HYDROCHLORIDE INJECTION isoprenaline hydrochloride 200 microgram/1 mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

isoprenaline hydrochloride

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Isoprenaline hydrochloride

Authorization status:

Registered

Patient Information leaflet

Hospira™ Isoprenaline Hydrochloride Injection CMI
1
HOSPIRA™ ISOPRENALINE HYDROCHLORIDE
INJECTION
_isoprenaline hydrochloride _
(i-so-pren’a-len)
CONSUMER MEDICINE INFORMATION_ _
_Date of Dispensing _
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET
_ _
This leaflet answers some common
questions about Hospira™
Isoprenaline Hydrochloride Injection.
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. Your doctor has weighed
the risks of you taking Hospira™
Isoprenaline Hydrochloride Injection
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
HOSPIRA™
ISOPRENALINE
HYDROCHLORIDE
INJECTION IS USED FOR
Hospira™ Isoprenaline
Hydrochloride Injection is used to
treat heart block and cardiac arrest.
Hospira™ Isoprenaline
Hydrochloride Injection is intended
to be used in hospitals only.
It belongs to a group of medicines
called synthetic sympathomimetic
amines.
Hospira™ Isoprenaline
Hydrochloride Injection helps
improve the efficiency with which
your heart pumps blood around your
body.
Hospira™ Isoprenaline
Hydrochloride Injection works by
strengthening your heart muscles and
increasing the heartbeat rate.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
_ _
BEFORE YOU ARE GIVEN
HOSPIRA™
ISOPRENALINE
HYDROCHLORIDE
INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN HOSPIRA™
ISOPRENALINE HYDROCHLORIDE
INJECTION IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
isoprenaline
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness

Summary of Product characteristics

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Supersedes: Version 2.0
Page 1 of 10
AUSTRALIAN
PRODUCT
INFORMATION
–
HOSPIRA™
ISOPRENALINE
HYDROCHLORIDE
INJECTION
(ISOPRENALINE HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Isoprenaline Hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each milliliter of the sterile 1:5000 solution contains 200 µg of
isoprenaline hydrochloride.
The
sterile
1:5000
solution
can
be
administered
by
the
intravenous,
intramuscular,
subcutaneous or intracardiac routes.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Concentrated solution for injection
Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hospira™ Isoprenaline Hydrochloride Injection is indicated for:
Mild or transient episodes of heart block that do not require electric
shock or pacemaker
therapy.
Serious episodes of heart block and Adams-Stokes attacks (except when
caused by ventricular
tachycardia or fibrillation). (See Section 4.3 Contraindications.)
Use in cardiac arrest until electric shock or pacemaker therapy, the
treatments of choice, are
available. (See Section 4.3 Contraindications.)
Bronchospasm occurring during anaesthesia.
As an adjunct to fluid and electrolyte replacement therapy and the use
of other drugs and
procedures
in
the
treatment
of
hypovolaemic
and
septic
shock,
low
cardiac
output
(hypoperfusion) states, congestive heart failure and cardiogenic
shock. (See Section 4.4 Special
warnings and precautions for use.)
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Supersedes: Version 2.0
Page 2 of 10
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Hospira™ Isoprenaline Hydrochloride Injection should generally be
started at the lowest
recommended dose and the rate of administration gradually increased if
necessary while
carefully monitoring the patient.
The usual route of administration is by intravenous infusion or bolus
intravenous injection. In
dire emergencies, the drug may be administered by intracardiac
injection. If time is not of the
utmost importance, initial therapy by