Emerade 300 micrograms solution for injection in pre-filled pen

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Adrenaline

Available from:

PharmaSwiss Ceska republika s.r.o.

ATC code:

C01CA; C01CA24

INN (International Name):

Adrenaline

Dosage:

300 microgram(s)

Pharmaceutical form:

Solution for injection in pre-filled pen

Administration route:

intramuscular injection

Units in package:

Pack sizes: 1 or 2 pre-filled pens.

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Rechon Life Science AB

Therapeutic group:

peutic group: Cardiac stimulants excl. cardiac glycosides - Adrenergic and dopaminergic agents – Adrenaline

Therapeutic area:

Adrenergic and dopaminergic agents; epinephrine

Therapeutic indications:

peutic group: Cardiac stimulants excl. cardiac glycosides - Adrenergic and dopaminergic agents – Adrenaline

Authorization status:

Not marketed

Authorization date:

2015-09-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
EMERADE 150 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN
EMERADE 300 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN
EMERADE 500 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN
adrenaline
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 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 Emerade is and what it is used for
2.
What you need to know before you use Emerade
3.
How to use Emerade
4.
Possible side effects
5.
How to store Emerade
6.
Contents of the pack and other information
1.
WHAT EMERADE IS AND WHAT IT IS USED FOR
Emerade is an auto-injector that contains adrenaline in a solution for
injection into the muscle
(intramuscular).
Adrenaline counteracts the fall of blood pressure in anaphylactic
reactions. It also stimulates the heart
and facilitates breathing.
Emerade is used for emergency treatment of severe allergic reactions
(anaphylaxis) caused by
allergens in foods, medicines, insect stings or bites and other
allergens as well as triggered by exercise
or unknown causes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EMERADE
Your doctor should have explained when and how you should use Emerade.
If you are not completely
sure or you have questions you must contact your doctor.
WARNINGS AND PRECAUTIONS
Emerade can always be used during an allergic emergency. If you are
allergic (hypersensitive) to
sodium metabisulphite or to any of the other ingredients of Emerade,
your doctor will need to instruct
you under which circumstances Emerade should be used.
Talk to your doctor before using Eme

Summary of Product characteristics

Health Products Regulatory Authority
24 February 2022
CRN00CHPH
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emerade 300 micrograms solution for injection in pre-filled pen
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The pre-filled pen contains 0.5 ml of adrenaline solution 1 mg/ml.
Emerade 300 micrograms delivers a single dose of 0.3 ml containing 300
micrograms of adrenaline (as tartrate).
Each 0.3 ml (300 micrograms) dose contains 0.15 mg sodium
meta-bisulphite (E223).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in a pre-filled pen (auto-injector).
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Emerade is indicated for the emergency treatment of severe acute
allergic reactions (anaphylaxis) triggered by allergens in
foods, medicines, insect stings or bites, and other allergens as well
as for exercise-induced or idiopathic anaphylaxis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The effective dose is usually within the range 5- 10 micrograms per kg
bodyweight but higher doses may be necessary in some
cases.
_Paediatric population_
Use in children: Emerade 500 micrograms is not recommended for use in
children.
_Children below 15 kg bodyweight_
A dosage below 150 micrograms cannot be administered with sufficient
accuracy in children weighing less than 15 kg and use
is therefore not recommended unless during a life-threatening
situation and under medical advice.
_ _
_Children between 15 kg and 30 kg bodyweight_
The usual dose is 150 micrograms.
_ _
_Children over 30 kg bodyweight_
The usual dose is 300 micrograms.
_Adolescent patients over 30 kg bodyweight_
The dosage recommendations for adult patients should be followed.
_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.
Health Products Regulatory Authority
24 February 2022
CRN00CHPH
Pag