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

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Thành phần hoạt chất:

EPINEPHRINE

Sẵn có từ:

Lincoln Medical Limited

Mã ATC:

C01CA24

INN (Tên quốc tế):

EPINEPHRINE

Dạng dược phẩm:

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Thành phần:

EPINEPHRINE 150 µg

Loại thuốc theo toa:

POM

Khu trị liệu:

CARDIAC THERAPY

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2011-08-02

Tờ rơi thông tin

Page 1 of 8
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.
Page 2 of 8
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 AND PRECAUTIONS
Talk to your doctor or pharmacist before using Anapen Junior.

Your doctor sh

Đặc tính sản phẩm

Page 1 of 9
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 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
than 1