Epipen 300 micrograms solution for injection in pre-filled pen

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Adrenaline

Beszerezhető a:

Meda Health Sales Ireland Limited

ATC-kód:

C01CA; C01CA24

INN (nemzetközi neve):

Adrenaline

Adagolás:

0.30 milligram(s)/dose

Gyógyszerészeti forma:

Solution for injection in pre-filled pen

Recept típusa:

Not applicable

Terápiás terület:

Adrenergic and dopaminergic agents; epinephrine

Engedélyezési státusz:

Marketed

Engedély dátuma:

2013-08-29

Betegtájékoztató

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 infor-
mation
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 con-
sciousness.
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
vessels

Termékjellemzők

Health Products Regulatory Authority
07 November 2018
CRN008L6L
Page 1 of 10
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.
Health Products Regulatory Authority
07 November 2018
CRN008L6L
Page 2 of 10
_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 recom