Adrenaline (Epinephrine) Injection 1:1,000 Minijet (1ml)

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Adrenaline

Saatavilla:

DLRC Pharma Services Limited

ATC-koodi:

C01CA; C01CA24

INN (Kansainvälinen yleisnimi):

Adrenaline

Annos:

1 milligram(s)/millilitre

Lääkemuoto:

Solution for injection

Terapeuttinen alue:

Adrenergic and dopaminergic agents; epinephrine

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

1978-01-25

Pakkausseloste

ADRENALINE (EPINEPHRINE)
1:1,000 MINIJET 1MG/ML SOLUTION
FOR INJECTION
FOR ADMINISTRATION BY
HEALTHCARE
PROFESSIONALS ONLY
READ ALL OF THIS LEAFLET CAREFULLY
Please note this medicine is
mainly used in emergency
situations and the doctor will have
decided that you needed it.
It is unlikely therefore, that you
will have read this leaflet before
the medicine was administered
to you.
−
Keep this leaflet. You may need
to read it again.
−
If you have any further
questions, ask the doctor or
nurse.
−
If you get any side effects, talk
to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet.
−
In this leaflet, Adrenaline
1:1,000 Minijet 1mg/ml Solution
for Injection will be called
Adrenaline Minijet.
WHAT IS IN THIS LEAFLET:
1. What Adrenaline Minijet is and
what it is used for
2. What you need to know before
you are given Adrenaline
Minijet
3. How Adrenaline Minijet is used
4. Possible side effects
5. How to store Adrenaline Minijet
6. Further information.
1. WHAT ADRENALINE MINIJET IS
AND WHAT IT IS USED FOR
Adrenaline is a type of drug that
constricts blood vessels, makes
the heart pump more strongly and
opens airways.
It is used in life-threatening
emergencies such as severe
allergic reactions or asthma. It
will have been used to save your
life.
2. WHAT YOU NEED TO KNOW
BEFORE YOU ARE GIVEN
ADRENALINE MINIJET
In emergencies, it may be
impossible for the people looking
after you to get all your details
before they have to treat you. They
will have assessed the situation
and decided it was better to give
you the injection now and ask
questions later.
PLEASE TELL YOUR DOCTOR IF:
•
You are allergic to any of the
ingredients in this medicine
(listed in section 6)
•
You suffer from
hyperthyroidism (overactive
thyroid gland)
•
You suffer from hypertension
(high blood pressure)
•
You suffer from heart disease or
long standing chest disease like
asthma or emphysema
•
You suffer from diabetes
•
You suffer from closed angle
glaucoma (an eye condition that
causes sudden blu

Valmisteyhteenveto

Health Products Regulatory Authority
29 May 2019
CRN008TLL
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adrenaline (Epinephrine) Injection 1:1,000 Minijet (1ml)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Adrenaline (Epinephrine) 1 mg per ml.
Excipients: sodium metabisulfite (E222) 2.5 mg in 1 ml and total
sodium 3 mg in 1 ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
A clear, colourless, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Emergency treatment of anaphylaxis or acute angioneurotic oedema with
airways obstruction, or acute allergic reactions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For the relief of life-threatening angioneurotic oedema and
anaphylactic shock, adrenaline should be administered by
intramuscular injection.
For acute allergic reactions due to insect stings etc.: Intramuscular
or subcutaneous injection.
The presentation with the 1² integral needle is for paramedic use by
subcutaneous or intramuscular injection.
Adults and children over 12 years: 0.5 ml (0.5 mg), administered
slowly. The dose may be repeated every 5 to 15 minutes as
needed.
This presentation may not be suitable for small or prepubertal
patients over 12 years of age who require a smaller dose.
Elderly: as for adults, use with caution.
Children (up to age of 12): Not recommended.
4.3 CONTRAINDICATIONS
Contraindications are relative as this product is intended for use in
life-threatening emergencies.
Other than in the emergency situation, the following contraindications
should be considered: hyperthyroidism, hypertension,
ischaemic heart disease, diabetes mellitus, closed angleglaucoma and
hypersensitivity to sympathomimetic amines.
Health Products Regulatory Authority
29 May 2019
CRN008TLL
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
These special warnings and precautions are relative as this product is
intended for use in life-threatening situations. Administer
slowly with caution to elderly patients and