ANAPEN JUNIOR 0.15 Milligram Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

EPINEPHRINE

Available from:

Lincoln Medical Ltd

ATC code:

C01CA24

INN (International Name):

EPINEPHRINE

Dosage:

0.15 Milligram

Pharmaceutical form:

Solution for Injection

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Adrenergic and dopaminergic agents

Authorization status:

Authorised

Authorization date:

2003-02-21

Patient Information leaflet

1
PACKAGE LEAFLET
Common Text - Anapen Junior 150 mcg
PT/H/1189/01-02/IA/040
Change of address of Lincoln Medical Ltd.
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANAPEN JUNIOR 150 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 Junior is and what it is used for
2.
What you need to know before you use Anapen Junior
3.
How to use Anapen Junior
4.
Possible side effects
5.
How to store Anapen Junior
6.
Contents of the pack and other information
1.
WHAT ANAPEN JUNIOR IS AND WHAT IT IS USED FOR

Anapen Junior 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 Junior 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 JUNIOR
DO NOT USE ANAPEN JUNIOR
There is no known reason why anyone should not use Anapen Junior
during an allergic emergency.
WARNINGS A

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anapen Junior 150 micrograms in 0.3ml solution for injection in a pre-
filled syringe.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre contains 0.5 mg of adrenaline (epinephrine)
One dose of 0.3ml contains 150 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 sufficient accuracy in children wei