Adrenaline (base) 10mg/10ml (1 in 1,000) solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Adrenaline

Available from:

base) 10mg/10ml (1 in 1,000) solution for injection ampoules (Martindale Pharmaceuticals Ltd

ATC code:

C01CA24

INN (International Name):

Adrenaline

Dosage:

1mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040300; GTIN: 5014124270053

Patient Information leaflet

IN THIS LEAFLET:
1. What Adrenaline (Epinephrine) Injection (1:1000) is and
what it is used for
2. What you need to know before Adrenaline (Epinephrine)
Injection (1:1000) is given
3. How Adrenaline (Epinephrine) Injection (1:1000) is given
4. Possible side effects
5. How to store Adrenaline (Epinephrine) Injection (1:1000)
6. Contents of the pack and other information
1. WHAT ADRENALINE (EPINEPHRINE) INJECTION
1:1000 IS AND WHAT IT IS USED FOR
Adrenaline (Epinephrine) belongs to a class of drugs called
sympathomimetic agents. Adrenaline injection can be used for
the emergency treatment of severe allergic reactions.
2. WHAT YOU NEED TO KNOW BEFORE ADRENALINE
(EPINEPHRINE) INJECTION 1:1000 IS GIVEN
YOU SHOULD NOT BE GIVEN ADRENALINE (EPINEPHRINE)
INJECTION 1:1000 IF YOU ARE:
• allergic (hypersensitive) to adrenaline, or to any of the other
ingredients of this medicine (listed in section 6)
• Adrenaline injection should not be used in areas such as
fingers, toes, ears, nose, genitalia or buttocks, as the blood
supply to these areas might become inadequate.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before using
Adrenaline (Epinephrine) Injection 1:1000 if:
• you are elderly
• you suffer from any heart problem, particularly if it affects
the heart rate or if you suffer from chest pain
• you have problems with your brain e.g. stroke, brain damage
or blood vessel disease
• you have an overactive thyroid, diabetes or glaucoma (high
pressure in the eye)
• you have phaeochromocytoma (a tumour on the adrenal
gland)
• you have low blood levels of potassium or high blood levels
of calcium
• you have a tumour on your prostate gland or kidney disease
• you are in shock or have lost a lot of blood
• you are going to have a surgery under general anaesthesia
• you are suffering from high blood pressure
• you have atherosclerosis which is a narrowing and
hardening of the body’s blood vessels (your doctor will
advise you).
If any of the above apply to you or your child please te

Summary of Product characteristics

OBJECT 1
ADRENALINE (EPINEPHRINE) 1:1000 SOLUTION FOR
INJECTION (AMPOULE)
Summary of Product Characteristics Updated 16-Apr-2018 | Martindale
Pharma
1. Name of the medicinal product
Adrenaline (Epinephrine) 1:1000 (1 mg/ml) solution for Injection
2. Qualitative and quantitative composition
Each 1ml contains 1mg Adrenaline (Epinephrine) as Adrenaline Acid
Tartrate.
Each 0.5 mL ampoule contains 0.5 mg Adrenaline
Each 1 mL ampoule contains 1 mg Adrenaline
Each 2 mL ampoule contains 2 mg Adrenaline
Each 5 mL ampoule contains 5 mg Adrenaline
Each 10 mL ampoule contains 10 mg Adrenaline
This medicinal product contains less than 1 mmol sodium (23 mg) per
mL, i.e. essentially 'sodium- free'.
Excipient with known effect:
Contains 1mg/ml Sodium metabisulfite.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sterile Solution for Injection (injection)
Clear, colourless sterile solution, free from visible particulates.
pH 2.8 – 3.6
Osmolarity: Approximately 300mOsm/kg
4. Clinical particulars
4.1 Therapeutic indications
Adrenaline Injection 1:1000 may be used in the emergency treatment of
• anaphylaxis
• acute allergic reactions
4.2 Posology and method of administration
The intramuscular (IM) route is recommended by the EU Resuscitation
Council as the most appropriate
for most individuals who have to give adrenaline to treat an
anaphylactic reaction. The patient should be
monitored as soon as possible (pulse, blood pressure, ECG, pulse
oximetry). This will help monitor the
response to adrenaline.
The best site for IM injection is the anterolateral aspect of the
middle third of the thigh.
The needle used for injection needs to be sufficiently long to ensure
that the adrenaline is injected into
muscle.
The subcutaneous route for adrenaline is not recommended for treatment
of an anaphylactic reaction as it
is less effective.
ADULTS:
The usual dose is 0.5 mg (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