Epipen Junior 150 micrograms solution for injection in pre-filled pen

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Adrenaline

Available from:

Meda Health Sales Ireland Limited

ATC code:

C01CA; C01CA24

INN (International Name):

Adrenaline

Dosage:

0.15 milligram(s)/dose

Pharmaceutical form:

Solution for injection in pre-filled pen

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Adrenergic and dopaminergic agents; epinephrine

Authorization status:

Marketed

Authorization date:

2013-08-29

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
EpiPen
®
Junior
150 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 in-
cludes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Epipen Junior is and what it is
used for
2. What you need to know before you
use Epipen Junior
3. How to use Epipen Junior
4. Possible side effects
5. How to store Epipen Junior
6. Contents of the pack and other infor-
mation
1. WHAT EPIPEN JUNIOR IS AND WHAT
IT IS USED FOR
Epipen Junior is a sterile solution in pre-
filled pen for emergency injection into
the muscle (intramuscular).
Epipen
Junior
is
to
be
used
for
the
emergency treatment of severe allergic
reactions (anaphylaxis) caused by aller-
gens in e.g. foods, drugs, insect stings or
bites as well as triggered by exercise or
by unknown causes. Epipen Junior 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 fat

Summary of Product characteristics

Health Products Regulatory Authority
07 November 2018
CRN008L6L
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epipen Junior 150 micrograms solution for injection in pre-filled pen
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 0.5 mg adrenaline (epinephrine). A single dose (0.3 ml)
contains 150
microgram (0.15 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 Junior (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 in weight*:_
The usual dose is 300 micrograms for intramuscular use.
Health Products Regulatory Authority
07 November 2018
CRN008L6L
Page 2 of 10
* For these patients Epipen 300 micrograms, Auto-Injector containing
300
micrograms adrenaline per dose is available.
_Children between 15 kg and 30 kg in weight:_
The usual dose is 150 micrograms for intramuscular use.
_Children below 15 kg in weight:_
The suitability of Epipen Junior has to be judged individually. The
use in children
weighing