EpiPen 300 micrograms solution for injection in pre-filled pen

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Adrenaline

Available from:

Mylan IRE Healthcare Limited

ATC code:

C01CA; C01CA24

INN (International Name):

Adrenaline

Dosage:

0.30 milligram(s)/dose

Pharmaceutical form:

Solution for injection in pre-filled pen

Therapeutic area:

Adrenergic and dopaminergic agents; epinephrine

Authorization status:

Marketed

Authorization date:

2013-08-29

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPIPEN 300 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What EpiPen is and what it is used for
2.
What you need to know before you use EpiPen
3.
How to use EpiPen
4.
Possible side effects
5.
How to store EpiPen
6.
Contents of the pack and other information
1.
WHAT EPIPEN IS AND WHAT IT IS USED FOR
EpiPen is a sterile solution in pre-filled pen for emergency injection
into the muscle (intramuscular).
EpiPen is to be used for the emergency treatment of severe allergic
reactions (anaphylaxis) caused by
allergens in e.g.
_ _
foods, drugs, insect stings or bites as well as triggered by exercise
or by unknown
causes.
EpiPen Auto-Injectors are intended for immediate administration in
patients, who are determined to be
at increased risk for anaphylaxis, including individuals with a
history of anaphylactic reactions.
Symptoms that signal the onset of an anaphylactic reaction include:
itching of the skin; raised rash
(like a nettle rash); flushing; swelling of the lips, throat, tongue,
hands and feet; wheezing; hoarseness;
nausea; vomiting; abdominal cramps and in some cases, loss of
consciousness.
The medicine in the Auto-Injector (the pen) is adrenaline which is an
adrenergic drug.
It works directly on the cardiovascular (heart and circulation) system
and respiratory (lung) system,
countering the potentially fatal effects of anaphylaxis by rapidly
constricting the blood ve

Summary of Product characteristics

Health Products Regulatory Authority
01 December 2021
CRN00CJ8P
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
EpiPen 300 micrograms solution for injection in pre-filled pen
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 1 mg adrenaline (epinephrine). A single dose (0.3 ml)
contains 300 micrograms (0.3 mg) adrenaline.
Excipients with known effect: Sodium metabisulfite (E223) 0.5 mg/dose,
sodium chloride 1.8 mg/dose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection in pre-filled pen (Auto-Injector).
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EpiPen (adrenaline) Auto-Injectors are indicated in the emergency
treatment of severe allergic reactions (anaphylaxis) to insect
stings or bites, foods, drugs and other allergens, as well as
idiopathic or exercise induced anaphylaxis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
Usual paediatric dose is 0.01 mg/kg body weight. However, the
prescribing physician has the option of prescribing more or less
than these amounts based on careful assessment of each individual
patient and recognizing the life-threatening nature of
reactions for which this is being described. A dosage below 150
micrograms cannot be administered with EpiPen adrenaline
Auto-Injector. The physician should consider using other forms of
injectable adrenaline if lower doses are felt to be necessary
for small children.
_ _
_Children and adolescents over 30 kg weight_:
The usual dose is 300 micrograms for intramuscular use.
_Children between 15 kg and 30 kg in weight*_:
The usual dose is 150 micrograms for intramuscular use.
* For these patients EpiPen Junior Auto-Injector containing 150
micrograms adrenaline per dose is available.
Children below 15 kg in weight:
The suitability of EpiPen Junior has to be judged individually. The
use in children weighing less than 7.5 kg is not
recommended unless in a life-threatening situation and under medical
advice.
_Adu