Isuprel 1:5000 1mg/5mL injection

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

isoprenaline hydrochloride

Доступна з:

Pfizer Australia Pty Ltd

ІПН (Міжнародна Ім'я):

Isoprenaline hydrochloride

Клас:

Medicine Registered

Статус Авторизація:

Registered

інформаційний буклет

Isuprel

1
ISUPREL™ 1:5000
_ _
_ _
_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 Isuprel
™
.
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 Isuprel
™
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 ISUPREL
™ IS USED
FOR
Isuprel
™
is used to treat heart block
and cardiac arrest. Isuprel
™
is
intended to be used in hospitals only.
It belongs to a group of medicines
called synthetic sympathomimetic
amines.
Isuprel
_™_
helps improve the efficiency
with which your heart pumps blood
around your body. Isuprel
_™_
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
ISUPREL
™
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN ISUPREL
™ 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 of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
YOU MUST NOT BE GIVEN ISUPREL
™ IF
YOU HAVE ANY OF THE FOLLOWING:
•
fast heart rate
•
fast, slow or irregular heart beat
caused by digitalis toxicity
•
medicines used to treat unusual
heart beat, such as inotropic
therap

Характеристики продукта

Version: pfpisupi11019
Supersedes: Version 6.0
Page 1 of 9
AUSTRALIAN
PRODUCT
INFORMATION
–
ISUPREL™
1:5000
(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.
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
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Isuprel™ is indicated:
For mild or transient episodes of heart block that do not require
electric shock or pacemaker
therapy.
For serious episodes of heart block and Adams-Stokes attacks (except
when caused by
ventricular tachycardia or fibrillation). (See Section 4.3
Contraindications.)
For use in cardiac arrest until electric shock or pacemaker therapy,
the treatments of choice,
are available. (See Section 4.3 Contraindications.)
For 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)
Version: pfpisupi11019
Supersedes: Version 6.0
Page 2 of 9
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Isuprel™ 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 intramuscular or subcutaneous
injection is preferred.
Elderly patients may be more sensitive to the effects of
sympathomimetics and lowe