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Epi Pen Auto Injector 0.3mg

Epi Pen Auto Injector 0.3mg

EpiPen

Pharmaceutical Product
  • 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 authorised Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).
Prescription-only adrenaline (epinephrine) auto-injector for anaphylaxis

Description

Epi-Pen Auto Injector 0.3mg is a pre-filled, single-use adrenaline (epinephrine) auto-injector indicated for the emergency treatment of severe allergic reactions (anaphylaxis). Each device delivers a fixed 0.3 mg dose of adrenaline intramuscularly into the outer thigh to rapidly control life-threatening symptoms triggered by exposure to allergens such as foods, insect stings or bites, medicines and other causes, as well as idiopathic or exercise-induced anaphylaxis. It is a prescription-only medicine intended for use in patients with a history of, or clear risk for, anaphylactic reactions, 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 injection into the outer thigh, including through clothing if required.
  • Allows early treatment of severe allergic reactions outside hospital by patients or caregivers after appropriate training.
  • Indicated for anaphylaxis 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 through alpha- and beta-adrenergic effects.
  • Compact and portable, so patients at risk can carry the device at all times; many are advised to carry two injectors.
  • Well-established brand with extensive clinical use and regulatory oversight.

Indications

  • Emergency treatment of acute allergic (anaphylactic) reactions 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 at risk of anaphylaxis, as prescribed by a healthcare professional.

Composition

  • Active ingredient: Adrenaline (epinephrine) 0.3 mg in 0.3 ml (1 mg/ml) solution for injection.
  • Excipients typically include sodium metabisulfite (antioxidant), sodium chloride and water for injections.
  • Clear, colourless solution contained in a glass cartridge 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 Epi-Pen Auto Injector 0.3mg.
  • Supplied in an individual carton with the auto-injector and a patient information leaflet.
  • Carton labelled with strength, 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 auto-injector at all times; many patients are advised to carry two devices.
  • Use immediately at the first signs of anaphylaxis, such as widespread hives, swelling of the face or throat, difficulty breathing, wheezing, sudden drop in blood pressure, feeling faint or collapse after exposure to a known or suspected allergen.
  • Remove the safety cap(s) according to the instructions for use, hold the device firmly in your 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 injector in place for the recommended time (usually around 3 seconds; follow the current patient leaflet) to deliver the full dose.
  • The injection can be given 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) stating that anaphylaxis is suspected and adrenaline has been administered.
  • If symptoms do not improve or recur before medical help arrives, a second dose may be given using a new auto-injector after about 5–15 minutes, in line with medical advice.
  • Dispose of the used pen safely in its carrier tube or a sharps container and hand it to medical personnel.
  • Check the expiry date regularly and inspect the solution through the viewing window; replace the pen before expiry or if the solution appears 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 or hypertension, or those taking medicines that may interact with adrenaline (such as tricyclic antidepressants or monoamine oxidase inhibitors), as described in the prescribing information.
  • Known hypersensitivity to adrenaline or any excipient, including sodium metabisulfite, should be considered, although in anaphylaxis the benefits generally outweigh the risks.
  • Do not inject into the buttock, fingers, toes, hands or feet because of the risk of tissue ischaemia and potential necrosis.

Adverse Effects

  • Common adrenergic effects such as palpitations, tachycardia, tremor, anxiety, headache and sweating.
  • Possible increase in blood pressure; in susceptible individuals, risk of angina, arrhythmias or myocardial infarction, particularly in those with underlying heart disease.
  • Other potential effects include pallor, dizziness, weakness, nausea and vomiting.
  • Local injection site reactions including pain, bruising, bleeding or swelling; tissue damage may occur if injected into small extremities or incorrectly.
  • Rare but serious adverse events such as intracranial haemorrhage or severe arrhythmias have been reported, usually in patients with significant risk factors or where dosing/administration errors occur.

Storage Conditions

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

Duration

Intended for single-dose emergency use during an acute anaphylactic episode. Individuals at ongoing risk should keep in-date replacement pens available at all times for future emergencies, as advised by their prescriber.

Onset

Adrenaline injected intramuscularly into the thigh usually begins to act within minutes, rapidly increasing blood pressure, relieving bronchospasm and reducing mucosal swelling; clinical improvement is often seen very quickly after correct administration.

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