ANAPEN 300 adrenaline (epinephrine) 300 micrograms/0.3 mL solution for injection pre-filled syringe (auto-injector)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

adrenaline (epinephrine), Quantity: 300 microgram

Available from:

Allergy Concepts Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intramuscular

Units in package:

1 x syringe, 2 x syringes

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

For the emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings, drugs or other allergens.

Product summary:

Visual Identification: Clear, colourless solution practically free from visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-03-23

Patient Information leaflet

ANAPEN
®
CMI Version 1.3, Mar 2021
1
ANAPEN

CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ANAPEN®?
ANAPEN® contains the active ingredient adrenaline(epinephrine).
ANAPEN® is used for the immediate EMERGENCY
TREATMENT of a SEVERE ALLERGIC REACTION (also known as ANAPHYLAXIS).
For more information, see Section 1. Why am I
using ANAPEN®? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ANAPEN®?
It is important to know how to use an ANAPEN® BEFORE a severe
allergic reaction causes a medical emergency. Ask your
doctor or pharmacist how you can get an ANAPEN® Training Device for
practice.
Do not use if you have ever had an allergic reaction to
adrenaline(epinephrine) or any of the ingredients listed at the end of
the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS,
USE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO
BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see
Section 2. What should I know before I use ANAPEN®?
in
the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ANAPEN® and affect how it works. A
list of these medicines is in Section 3. What if I am
taking other medicines? in the full CMI.
4.
HOW DO I USE ANAPEN®?
For single use only, please ensure you discard safely immediately
after use. Inject into outer part of thigh. If necessary, you can
use ANAPEN
®
through light clothing, such as denim, cotton or polyester. It is
important to know how to use your ANAPEN® in
an emergency.
Read the instructions in the full CMI carefully. Always carry 2 units
of auto-injectors in case the first
administration fails or if one dose is not sufficient. More
instructions can be found in Section 4. How do I use ANAPEN®? in the
full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ANAPEN®?
THINGS YOU
SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are using
adrenaline(epinephrine)
•
Y

Summary of Product characteristics

Version 1.5, Mar 2021
1
AUSTRALIAN PRODUCT INFORMATION – ANAPEN
® (ADRENALINE
(EPINEPHRINE))
1
NAME OF THE MEDICINE
Adrenaline (epinephrine)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ANAPEN Junior 150 micrograms
Each 0.3 mL contains 150 micrograms of adrenaline (epinephrine)
ANAPEN 300 micrograms
Each 0.3 mL contains 300 microgram of adrenaline (epinephrine)
ANAPEN 500 micrograms
Each 0.3 mL contains 500 microgram of adrenaline (epinephrine)
Excipients with known effect: sodium chloride, sodium metabisulfite
FOR FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
3
PHARMACEUTICAL FORM
Solution for injection in a pre-filled syringe (Auto-injector).
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the emergency treatment of anaphylaxis (acute severe allergic
reactions) due to insect
stings, drugs or other allergens.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Product is for single use in one patient only. Discard any residue
The patient should always carry 2 units of auto injectors in case the
first administration fails or
if one dose is not sufficient.
The effective dose is typically in the range 5-10 micrograms per
kilogram of bodyweight but
higher doses may be necessary in some cases.
USE IN ADULTS:
The usual dose is 300 micrograms. The recommended dose is 300
micrograms for individuals
under 60 kg bodyweight. The recommended dose is 300 to 500 micrograms
for individuals
over 60 kg bodyweight, depending on clinical judgement.
Larger adults may require more than one injection to reverse the
effect of an allergic reaction.
Version 1.5, Mar 2021
2
In the absence of clinical improvement or if deterioration occurs, a
second injection with an
additional Anapen may be administered 5-15 minutes after the first
injection. It is
recommended that patients are prescribed two Anapen which they should
carry at all times.
In case of a second injection needed it is recommended to inject in
the opposite thigh.
Patients must be shown how to use the Anapen device at the time a
prescription is written.
USE IN CHILDREN:
ANAPEN 500 MICROG