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

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Epinephrine

Pieejams no:

Bioprojet Pharma

ATĶ kods:

C01CA; C01CA24

SNN (starptautisko nepatentēto nosaukumu):

Epinephrine

Deva:

0.15 milligram(s)

Zāļu forma:

Solution for injection in pre-filled syringe

Receptes veids:

Product subject to prescription which may be renewed (B)

Ārstniecības joma:

Adrenergic and dopaminergic agents; epinephrine

Autorizācija statuss:

Marketed

Autorizācija datums:

2003-02-21

Lietošanas instrukcija

1
PACKAGE LEAFLET
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 AND PRECAUTIONS
Talk to your doctor or pharmacist before using Anapen Junior.
•
Your doctor should h

Produkta apraksts

Health Products Regulatory Authority
06 February 2024
CRN008JP5
Page 1 of 8
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)
Each 0.3 ml (150 micrograms) dose contains 0.51 mg of sodium
metabisulfite (E223).
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.
_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 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