Epipen Adrenaline 0.3mg Auto Injector (1)

EpiPen

Pharmaceutical Product

Prescription-only adrenaline (epinephrine) auto-injector for anaphylaxis

Licensed in the UK as a prescription Only medicine (POM) for the emergency treatment of anaphylaxis.
Holds a UK Marketing Authorisation regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).
Manufactured in accordance with Good Manufacturing Practice (GMP) standards for sterile medicinal products.
Supplied with approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).

Licensed in the UK as a prescription Only medicine (POM) for the emergency treatment of anaphylaxis.
Holds a UK Marketing Authorisation regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).
Manufactured in accordance with Good Manufacturing Practice (GMP) standards for sterile medicinal products.
Supplied with approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).

Prescription-only adrenaline (epinephrine) auto-injector for anaphylaxis

Description

Epipen Adrenaline 0.3mg Auto Injector is a single pre-filled, single-use adrenaline (epinephrine) auto-injector indicated for the emergency treatment of severe allergic reactions (anaphylaxis). Each device automatically delivers a fixed 0.3 mg dose of adrenaline intramuscularly into the outer thigh to rapidly treat life-threatening symptoms caused by allergens such as foods, insect stings or bites, medicines and other triggers, as well as idiopathic or exercise-induced anaphylaxis. It is a prescription-only medicine and should only be used by individuals with a history of, or acknowledged risk for, an anaphylactic reaction, as assessed by a healthcare professional.

Bnefits

Provides a rapid, fixed 0.3 mg dose of adrenaline for the emergency treatment of anaphylaxis.
Pre-filled, single-use auto-injector designed for fast intramuscular administration into the outer thigh, including through clothing if necessary.
Enables early treatment of severe allergic reactions outside hospital by patients or caregivers after appropriate training.
Indicated for allergic emergencies caused by foods, insect stings or bites, medicines and other allergens, as well as idiopathic and exercise-induced anaphylaxis.
Helps reverse life-threatening symptoms such as airway swelling, bronchospasm, low blood pressure and shock via alpha- and beta-adrenergic receptor stimulation.
Compact, portable design so patients at risk can carry an injector at all times; many are advised to carry two devices.
Established brand with extensive clinical experience and regulatory oversight.
Available in 0.3 mg strength typically used for adults and children above a defined weight threshold, as specified in prescribing information.

Indications

Emergency treatment of acute allergic reactions (anaphylaxis) to insect stings or bites, foods, medicines and other allergens.
Emergency treatment of anaphylaxis of idiopathic origin.
Emergency treatment of exercise-induced anaphylaxis.
Intended for immediate self-administration or administration by a caregiver in patients with a known history or clear risk of anaphylaxis, as prescribed by a healthcare professional.

Composition

Active ingredient: Adrenaline (epinephrine) 0.3 mg per 0.3 ml dose (1 mg/ml) in a pre-filled auto-injector.
Excipients typically include sodium metabisulfite (E223) as an antioxidant, sodium chloride and water for injections.
The solution is clear and colourless and is contained in a glass cartridge housed within the auto-injector.

Formulation

Solution for injection in a pre-filled auto-injector (pre-filled pen) delivering 0.3 mg adrenaline (epinephrine) in 0.3 ml via intramuscular injection into the outer thigh.

Packaging

Each pack contains 1 Epipen Adrenaline 0.3mg Auto Injector.
Supplied in an individual carton with an Epipen device and patient information leaflet.
Outer packaging clearly marked with strength (0.3 mg), batch number and expiry date.

Usage

EpiPen must be prescribed and patients trained by a healthcare professional in when and how to use the device.
Carry the EpiPen at all times; many patients are advised to carry two auto-injectors in case a second dose is required.
Use immediately at the first signs of anaphylaxis such as widespread hives, swelling of the face or throat, difficulty breathing, wheeze, sudden drop in blood pressure, feeling faint or collapse following exposure to a known or suspected allergen.
Remove the safety cap(s) as described in the instructions for use, hold the device firmly in the fist, and place the orange/needle end against the outer thigh at a right angle.
Press firmly until a click is heard and hold the device in place against the outer thigh for the recommended time (typically around 3 seconds; follow the current patient leaflet) to deliver the full dose.
EpiPen can be injected through clothing if necessary; do not inject into the buttock, hands, feet or other extremities.
After injection, remove the device and gently massage the injection site for a short period if advised.
Immediately call emergency services or have someone call for you, stating that anaphylaxis is suspected and adrenaline has been administered.
If symptoms do not improve or recur before emergency help arrives, a second EpiPen may be administered with a new device after approximately 5–15 minutes, following medical advice.
After use, place the used pen safely in its carrier tube or a sharps container and give it to medical personnel for disposal.
Regularly check the expiry date and the solution through the device window; replace the pen before it expires or if the solution becomes discoloured or contains particles.

Contraindications

In a life-threatening anaphylactic reaction there are no absolute contraindications to adrenaline.
Use with caution in patients with pre-existing cardiovascular disease, hyperthyroidism, diabetes, hypertension or those receiving medicines that may potentiate or interact with adrenaline (such as tricyclic antidepressants or monoamine oxidase inhibitors), as stated in the summary of product characteristics.
Known hypersensitivity to adrenaline or any of the excipients, including sodium metabisulfite, should be considered, although the emergency benefit usually outweighs the risk in anaphylaxis.
Do not inject into the buttock, fingers, toes, hands or feet due to the risk of tissue ischaemia and potential necrosis in these areas.

Adverse Effects

Common adrenergic effects including palpitations, tachycardia, tremor, anxiety, headache and sweating.
Potential increases in blood pressure; in susceptible individuals risk of angina, arrhythmias or myocardial infarction, especially in those with underlying heart disease.
Other possible effects include pallor, dizziness, weakness, nausea and vomiting.
Local injection site reactions such as pain, bruising, bleeding or swelling; rare risk of tissue damage if injected into small extremities or incorrectly.
Very rare serious adverse events such as intracranial haemorrhage or severe arrhythmias, usually in patients with significant predisposing factors or where dosing or administration errors have occurred.
Any suspected adverse reactions should be discussed with a healthcare professional and reported via national pharmacovigilance schemes.

Storage Conditions

Store below 25°C.
Do not refrigerate or freeze.
Keep the auto-injector in its outer carton to protect from light.
Do not use after the expiry date printed on the label and carton.
Periodically inspect the solution through the viewing window; discard and replace if discoloured (e.g. turns brown) or contains particulate matter.
Protect from extreme temperatures and direct sunlight (for example, avoid leaving in a parked car).
Keep out of the sight and reach of children.

Duration

EpiPen is intended for single-dose, emergency use during an acute anaphylactic episode. Individuals at ongoing risk of anaphylaxis should always keep in-date replacement pens as prescribed and use them as necessary for future reactions in accordance with medical advice.

Onset

Adrenaline administered via intramuscular injection into the thigh generally begins to act within minutes, producing rapid increases in blood pressure, bronchodilation and reduction of mucosal oedema. Clinical improvement in anaphylactic symptoms is often observed very quickly after correct use.