Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Epinephrine

Available from:

Bioprojet Pharma

ATC code:

C01CA; C01CA24

INN (International Name):

Epinephrine

Dosage:

0.3 milligram(s)

Pharmaceutical form:

Solution for injection in pre-filled syringe

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Adrenergic and dopaminergic agents; epinephrine

Authorization status:

Marketed

Authorization date:

2003-02-21

Patient Information leaflet

1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANAPEN 300 MICROGRAMS IN 0.3ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
ADRENALINE (EPINEPHRINE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Anapen is and what it is used for
2.
What you need to know before you use Anapen
3.
How to use Anapen
4.
Possible side effects
5.
How to store Anapen
6.
Contents of the pack and other information
1.
WHAT ANAPEN IS AND WHAT IT IS USED FOR
•
Anapen consists of a pre-filled syringe of adrenaline contained in an
automatic injection device
(Auto-Injector). This injects a single dose of adrenaline into muscle.
•
This medicine is for
EMERGENCY
only and you should seek immediate medical attention after using
your Auto-Injector.
•
Adrenaline is a natural hormone released in response to stress. In
acute allergic reactions it
improves blood pressure, heart function and breathing, and reduces
swelling. Adrenaline is also
known as epinephrine.
•
Anapen is used for the emergency treatment of serious allergic
reactions or anaphylaxis caused by
peanuts or other foods, drugs, insect bites or stings and other
allergens as well as exercise or an
unknown cause.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ANAPEN
DO NOT USE ANAPEN
There is no known reason why anyone should not use Anapen during an
allergic emergency.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Anapen.
•
Your doctor should have carefully instructed you when to use and the
correct way to use your
Anapen Auto

Summary of Product characteristics

Health Products Regulatory Authority
06 February 2024
CRN008JP5
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled
syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre contains 1 mg of adrenaline (epinephrine)
One dose of 0.3 ml contains 300 micrograms of adrenaline (epinephrine)
Excipients with known effect: sodium metabisulfite (E223), sodium
chloride
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in a pre-filled syringe
Clear colourless solution practically free from particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Emergency treatment for acute allergic reactions (anaphylaxis) caused
by peanuts or other foods, drugs, insect bites or stings,
and other allergensas well as exercise-induced or idiopathic
anaphylaxis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The patient should always carry 2 units of auto injectors in case the
first administration fails or if one dose is not sufficient.
Posology
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 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.
Adults over 60 kg may require more than one injection to reverse the
effect of an allergic reaction, depending on clinical
judgement. 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.
_Paediatric population_
Use in children:
The appropriate dose may be 150 micrograms (Anapen Junior) or 300
micrograms (Anapen) of adrenaline (epinephrine),
depending on the body weight of the child and the discretio