Adrenaline (base) 1mg/1ml (1 in 1,000) solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Adrenaline acid tartrate

Available from:

base) 1mg/1ml (1 in 1,000) solution for injection ampoules (Advanz Pharma

ATC code:

C01CA24

INN (International Name):

Adrenaline acid tartrate

Dosage:

1mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular; Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040300; GTIN: 5099602301092

Patient Information leaflet

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.
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 use Adrenaline Injection
3. How to use Adrenaline Injection
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 USE ADRENALINE INJECTION
DO NOT USE 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 PRE

Summary of Product characteristics

OBJECT 1
ADRENALINE INJECTION BP 1/1000 (1MG/1ML)
Summary of Product Characteristics Updated 29-Dec-2015 | Concordia
International - formerly AMCo
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.
METHOD OF ADMINISTRATION
Adrenaline Injection BP. 1/1000 (1mg/ml) may be administered undiluted
by S.C. or IM injection. In the
shocked patient, the intramuscular route is recommended as absorption
from the intramuscular site is
more rapid and reliable than from the subcutaneous site.
A small volume syringe