Anapen Junior 150 micrograms in 0.3ml solution for injection in a pre-filled syringe

Pajjiż: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

EPINEPHRINE

Disponibbli minn:

Bioprojet Pharma 9 rue Rameau 75002 Paris, France

Kodiċi ATC:

C01CA24

INN (Isem Internazzjonali):

EPINEPHRINE 150 µg

Għamla farmaċewtika:

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Kompożizzjoni:

EPINEPHRINE 150 µg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

CARDIAC THERAPY

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2011-08-02

Fuljett ta 'informazzjoni

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PACKAGE LEAFLET
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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
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There is no known reason why anyone should not use Anapen Junior
during an allergic emergency.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Anapen Junior.
•
Y

Karatteristiċi tal-prodott

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SUMMARY OF PRODUCT CHARACTERISTICS
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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 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. Larger children 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 Junior may be administered 5–15 minutes after
the first injection. It is
recommended that patients are prescribed two Anapen Junior which they
should carry at all times.
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 weighing less th