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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

EPINEPHRINE

Available from:

Bioprojet Pharma 9 rue Rameau 75002 Paris, France

ATC code:

C01CA24

INN (International Name):

EPINEPHRINE 300 µg

Pharmaceutical form:

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Composition:

EPINEPHRINE 300 µg

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Authorised

Authorization date:

2011-08-02

Patient Information leaflet

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PACKAGE LEAFLET
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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.
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•
Your doctor should have carefully instructed you when to use and the
correct way to

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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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 allergens as 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 0.005-0.01 mg/kg but
higher doses may be necessary in
some cases.
Use in adults: The usual dose is 300 micrograms. Larger adults may
require more than one injection
to reverse the effect of an allergic reaction. 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.
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 discretion
of the doctor. Children and adolescents over 30 kg in weight should be
prescribed Anapen 300
micrograms. The auto-injector of Anapen Junior is designed to deliver
a single dose of 150
micrograms adrenaline (epinephrine), a dosage below 150 micrograms
cannot be administered in
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sufficient accu