ADRENALINE-LINK 1:10,000 1mg/10mL adrenaline (epinephrine) acid tartrate injection BP pre filled syringe
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
04-09-2020
Summary of Product characteristics
(SPC)
04-09-2020
Public Assessment Report
(PAR)
09-10-2017
Active ingredient:
adrenaline (epinephrine) acid tartrate, Quantity: 182 microgram/mL (Equivalent: adrenaline (epinephrine), Qty 100 microgram/mL)
Available from:
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
INN (International Name):
adrenaline (epinephrine) acid tartrate
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: sodium citrate dihydrate; sodium metabisulfite; dilute hydrochloric acid; water for injections; sodium chloride; citric acid monohydrate
Administration route:
Intravenous, Subcutaneous
Units in package:
10mL x 1
Prescription type:
(S3) Pharmacist Only Medicine
Therapeutic indications:
Adrenaline 1:10,000 is used as an adjunct in the management of cardiac arrest.
Product summary:
Visual Identification: Clear colourless solution free from visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 15 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-11-13
Patient Information leaflet
Adrenaline-Link CMI
1
ADRENALINE-LINK
_adrenaline (epinephrine) acid tartrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Adrenaline-Link. It does not
contain all the information that is
known about Adrenaline-Link.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you using
Adrenaline-Link against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT ADRENALINE-LINK
IS USED FOR
Adrenaline-Link is usually only
given in cases of extreme
emergency.
Adrenaline-Link may be used
following a heart attack, or to make
the heart beat if it has stopped.
Adrenaline-Link 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
beat more strongly. Adrenaline-
Link also 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.
Adrenaline-Link is not addictive.
BEFORE YOU USE
ADRENALINE-LINK
_WHEN YOU MUST NOT USE IT _
Adrenaline-Link is an emergency
life-saving product.
HOWEVER, IT SHOULD BE GIVEN WITH
CARE IF YOU HAVE AN ALLERGY TO:
•
ADRENALINE
•
SODIUM METABISULFITE
•
OR ANY OTHER INGREDIENTS LISTED
AT THE END OF THE 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
DO NOT USE ADRENALINE-LINK IF:
•
YOU ARE PREGNANT UNLESS YOUR
DOCTOR SAYS SO.
Yo
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Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION - ADRENALINE-
LINK (ADRENALINE (EPINEPHRINE) ACID TARTRATE)
1
NAME OF THE MEDICINE
Adrenaline (epinephrine) acid tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Adrenaline-Link 1:1,000 1mg/1mL: Adrenaline (epinephrine) acid
tartrate 1 mg in 1 mL
ampoules.
Adrenaline-Link 1:10,000 1mg/10mL: Adrenaline (epinephrine) acid
tartrate 1 mg in 10 mL
ampoules.
Adrenaline-Link 1:10,000 1mg/10mL: Adrenaline (epinephrine) acid
tartrate 1 mg in 10 mL
Pre-filled syringe.
EXCIPIENTS WITH KNOWN EFFECT
Contains sulfites.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Adrenaline (epinephrine) acid tartrate solution for injection is a
clear, colourless solution and
should not be used if it is coloured.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
ADRENALINE-LINK 1:10,000 1MG/10ML is used as an adjunct in the
management of cardiac
arrest.
ADRENALINE-LINK 1:1,000 1MG/1ML is 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
DOSE
AND
METHOD
OF
ADMINSTRATION
The 1:1,000 (1 mg/1 mL) injection is preferably administered
subcutaneously. It may also be
administered intramuscularly but not in the buttocks.
In emergency situations, adrenaline (epinephrine) acid tartrate may be
injected very slowly
intravenously but ONLY as the dilute solution 1:10,000.
Adrenaline-Link injection contains no antimicrobial agent. It should
be used only once and any
residue discarded. Adrenaline (epinephrine) acid tartrate 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 3-5 minutes. If given through a peripheral line,
each dose should be
followed by a flush of 20 mL of IV fluid to ensure delivery of the
drug to the central
compartment.
Intracardiac administration is no lon
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