ASPEN ADRENALINE adrenaline (epinephrine) 1 mg/1 mL injection solution ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

adrenaline (epinephrine), Quantity: 1 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

adrenaline (epinephrine)

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: tartaric acid; sodium metabisulfite; sodium chloride; water for injections

Administration route:

Intramuscular, Subcutaneous

Units in package:

5's, 50's

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

The drug of choice in the emergency treatment of acute severe anaphylactic reactions due to insect bites, drugs and other allergens. It may also be used for the symptomatic relief of respiratory distress due to bronchospasm.

Product summary:

Visual Identification: Clear colourless to slightly yellow solution, free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-05-29

Patient Information leaflet

                                ASPEN ADRENALINE Injection - CMI
Page 1 of 3
ASPEN ADRENALINE INJECTION
_Adrenaline (epinephrine) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ASPEN
ADRENALINE 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 being given ASPEN
ADRENALINE Injection against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET._ _
You may need to read it again.
WHAT ASPEN
ADRENALINE INJECTION
IS USED FOR
ASPEN ADRENALINE Injection is
usually only given in cases of
extreme emergency.
ASPEN ADRENALINE may be
used following a heart attack, or to
make the heart beat if it has
stopped.
ASPEN ADRENALINE is also used
in the emergency treatment of
severe allergic reactions to insect
bites or stings, medicines, foods or
other substances. It may also be
given during acute asthma attacks
for severe breathing difficulties.
In heart conditions it can help to
restart the heart and stimulates it to
bet more strongly.
ASPEN ADRENALINE opens up
the airways making it easier to
breathe.
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 not addictive.
It is available only with a doctor’s
prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN ASPEN
ADRENALINE INJECTION IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
adrenaline (epinephrine)
•
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, itch
                                
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Summary of Product characteristics

                                1
AUSTRALIAN PRODUCT INFORMATION
ASPEN ADRENALINE INJECTION
1
NAME OF THE MEDICINE
Adrenaline (epinephrine)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ASPEN ADRENALINE Injection contains adrenaline (epinephrine) 1:1000
(1mg/mL) or
1:10,000 (1mg/10mL) as the active ingredient.
The excipients are tartaric acid, sodium metabisulfite, sodium
chloride and water for
injections.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ASPEN ADRENALINE 1:10,000.
An adjunct in the management of cardiac arrest.
ASPEN ADRENALINE 1:1,000.
The drug of choice in the emergency treatment of acute
severe anaphylactic reactions due to insect bites, drugs and other
allergens. It may also be
used for the symptomatic relief of respiratory distress due to
bronchospasm.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ASPEN ADRENALINE 1:1,000 injection is preferably administered
subcutaneously. It may
also be administered intramuscularly but not into the buttocks. In
emergency situations,
adrenaline (epinephrine) may be injected very slowly intravenously but
only as the dilute
solution 1:10,000.
ASPEN ADRENALINE Injection is for single use in one patient only.
Discard any residue.
Adrenaline injection should not be used if it is coloured.
CARDIAC ARREST
ADULTS.
The recommended dose is 1 mg intravenously, using 10 mL of the
1:10,000 solution.
This may be repeated every three to five minutes. If given through a
peripheral line, each
dose should be followed by a flush of 20 mL of intravenous fluid to
ensure delivery of the
drug to the central compartment.
Intracardiac administration is no longer recommended.
CHILDREN.
The recommended dose is 10 microgram (0.1 mL of the 1:10,000
solution)/kg
bodyweight administered intravenously. This may be repeated every
three to five minutes.
SEVERE ANAPHYLAXIS OR ASTHMA
ADULTS.
The usual initial dose is 100 to 500 micrograms (0.1 to 0.5 mL of the
1:1,000
2
solution) subcutaneously or intramuscularly. Subc
                                
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