Aspen Adrenaline

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Adrenaline 1 mg/mL;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Adrenaline 1 mg/mL

Dosage:

1 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Adrenaline 1 mg/mL   Excipient: Sodium chloride Sodium metabisulfite Tartaric acid Water for injection

Units in package:

Ampoule, glass, Type I, dark glass, 1 mL, serigraphed ampoule marked with break-ring. 5 ampoule pack, 5 dose units

Class:

Restricted

Prescription type:

Restricted

Manufactured by:

Boehringer Ingelheim Pharma GmbH & Co KG

Therapeutic indications:

Latest Regulatory Activity

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type I, dark glass, 1 mL, serigraphed ampoule marked with break-ring. 5 ampoule pack - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, Type I, dark glass, 1 mL, serigraphed ampoule marked with break-ring. 50 ampoule pack - 50 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2007-06-25

Patient Information leaflet

 
ASPEN ADRENALINE Injection CMI - 230310 

Page 1 of 3 

ASPEN ADRENALINE INJECTION  
_adrenaline acid tartrate _

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 is 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. 

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 
•  any of the ingredients listed at 
the end of this leaflet. 

S

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
ASPEN ADRENALINE INJECTION 1MG/ML AND 1MG/10ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Adrenaline acid tartrate equivalent to adrenaline 1:1,000 (1mg/mL) and
adrenaline
1:10,000 (1mg/10mL)
Adrenaline is a white or creamy-white, odourless, crystalline powder
or granule. It
darkens in colour on exposure to air and light. The BP solubilities
are: practically
insoluble in water, in ethanol (96 %) and in methylene chloride. It
dissolves in
hydrochloric acid.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
ASPEN ADRENALINE Injection should be used only once and any residue
discarded. It should not be used if it is coloured.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
ADRENALINE 1:10,000. An adjunct in the management of cardiac arrest.
4.2 DOSE 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 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