Adrenaline (Epinephrine) 1:1000 Solution for Injection 1mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

EPINEPHRINE

Available from:

Mercury Pharma International Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland

ATC code:

C01CA24

INN (International Name):

EPINEPHRINE 1 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

EPINEPHRINE 1 mg/ml

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Withdrawn

Authorization date:

2006-12-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ADRENALINE (EPINEPHRINE) 1:1,000
SOLUTION FOR INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nurse.
• If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed
in this leaflet. See section 4.
The name of your medicine is Adrenaline (Epinephrine) 1:1,000 Solution
for Injection.
It will be referred to as Adrenaline Injection for ease hereafter.
WHAT IS IN THIS LEAFLET
1. What Adrenaline Injection is and what it is used for
2. What you need to know before you are given Adrenaline Injection
3. How Adrenaline Injection will be given to you
4. Possible side effects
5. How to store Adrenaline Injection
6. Contents of the pack and other information
1. WHAT ADRENALINE INJECTION IS AND WHAT IT IS USED FOR
Adrenaline belongs to a class of drugs called sympathomimetic agents.
Adrenaline Injection may be used to
rapidly relieve severe allergic reactions to drugs or other substances
causing allergy. It may also be used in
the emergency treatment of shock due to a severe allergic reaction.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ADRENALINE INJECTION
YOU SHOULD NOT BE GIVEN ADRENALINE INJECTION:
•
if you are allergic to adrenaline, or to any of the other ingredients
of this medicine (listed in section 6).
•
when you are in labour
•
if you have severe heart disease particularly if it is associated with
an increased heart rate
•
if you are suffering from any infection, disease or tumour of the
brain
•
if you have atherosclerosis which is a narrowing, and hardening of the
body's blood vessels (your doctor
will advise you).
Adrenaline injection should not be used in areas such as fingers,
toes, ears, nose or penis, as the blood
supply to these areas might become inadequate.
WARNINGS AND PRECAUTION
Talk to your doctor or nurse b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Adrenaline (Epinephrine) 1:1,000 Solution for Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains adrenaline acid tartrate BP equivalent
to 1mg of
adrenaline
Excipient with known effect:
Sodium metabisulphite
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Clear,
colourless,
sterile,
aqueous
solution,
intended
for
parenteral
administration to human beings.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adrenaline is a direct-acting sympathomimetic agent.
Adrenaline may be used to provide rapid relief of severe
hypersensitivity
reaction to drugs and other allergens, and in the emergency treatment
of
anaphylactic shock.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Severe hypersensitivity reactions, anaphylactic shock _
_IM Injection_
:
_ _
_Adults_
: The usual dose is 500 micrograms (0.5ml of adrenaline 1/1000). If
necessary, this dose may be repeated several times at 5-minute
intervals
according to blood pressure, pulse and respiratory function.
Half
doses
of
adrenaline
may
be
safer
for
patients
who
are
taking
amitriptyline, imipramine or a beta blocker.
_PAEDIATRIC POPULATION_
The following doses of adrenaline 1/1,000 are recommended:
AGE
DOSE
Over 12 years
0.5 mg IM (0.5ml 1:1000 solution)
6 - 12 years
0.3 mg IM (0.3ml 1:1000 solution)
6 months - 6 years
0.15 mg IM (0.15ml 1:1000 solution)
Under 6 months
0.01mg/kg IM (0.01ml/kg 1:1000 solution)
If necessary, these doses may be repeated at 5-15 -minute intervals
according
to blood pressure, pulse and respiratory function.
_ELDERLY _
The dosage is the same as for younger adults but particular caution is
required
when administering adrenaline to elderly patients (see section 4.4).
_RENAL IMPAIRMENT _
Adrenaline
should
be
used
with
caution
in
patients
with
severe
renal
impairment (see section 4.4).
METHOD OF ADMINISTRATION
Adrenaline Injection BP. 1/1000 (1mg/ml) may be administered undiluted
by
S.C.
or
IM
injection.
In
the
shocked
pat