Anapen 500 micrograms / 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:

500 microgram(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:

2018-08-10

Lietošanas instrukcija

CONFIDENTIAL – Anapen 500 µg
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANAPEN 500 MICROGRAMS / 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.
CONFIDENTIAL – Anapen 500 µg

Your doctor should have carefully instructed you wh

Produkta apraksts

Health Products Regulatory Authority
14 January 2021
CRN00C3WY
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anapen 500 micrograms / 0.3ml solution for injection in a pre-filled
syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre contains 1.7 mg of adrenaline (epinephrine)
One dose of 0.3 ml contains 500 micrograms of adrenaline (epinephrine)
Excipients with known effect: sodium chloride, sodium metabisulfite
(E223)
Each 0.3 ml (500 micrograms) dose contains 1.8 mg of sodium chloride
and 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.
_Adults_: The recommended dose is 300 micrograms for individuals under
60 kg bodyweight. The recommended dose is 300 to
500 micrograms for individuals over 60 kg bodyweight, depending on
clinical judgement.
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.
In case of a second injection needed it is recommended to inject in
the opposite thigh.
_Paediatric population_
Use in children: ANAPEN 500 MICROGRAMS IS NOT RECOMMENDED FOR USE IN
CHILDREN.
The appropriate dose may be 150 micrograms (Anape