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EpiPen 0.3mg Auto Injector

EpiPen 0.3mg Auto Injector

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

Description

EpiPen 0.3mg Auto-Injector 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 0.3mg 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 intended for patients with a history of, or clear risk for, anaphylactic reactions as assessed by a healthcare professional.

Bnefits

  • Provides a rapid, fixed 0.3mg 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.
  • Enables early treatment of severe allergic reactions outside hospital by patients or caregivers after appropriate training.
  • Indicated for anaphylaxis triggered 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, hypotension and shock via alpha- and beta-adrenergic effects.
  • Compact and portable so patients at risk can carry the device at all times; guidelines commonly recommend carrying two devices.
  • Well-established product with extensive clinical experience and regulatory oversight.
  • Available in different strengths (0.3mg and 0.15mg as EpiPen Jr) to allow dosing according to age and weight.

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 at risk of anaphylaxis, as prescribed by a healthcare professional.

Composition

  • Active ingredient: Adrenaline (epinephrine) 0.3mg per 0.3ml dose (1mg/ml) in a pre-filled auto-injector.
  • Each 0.3ml contains 0.3mg adrenaline, approximately 1.8mg sodium chloride, 0.5mg sodium metabisulfite, hydrochloric acid to adjust pH, 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 0.3mg adrenaline (epinephrine) in 0.3ml via intramuscular injection into the outer thigh.

Packaging

  • Single pre-filled EpiPen 0.3mg Auto-Injector supplied in an individual carton with patient information leaflet.
  • In some markets also supplied in twin packs, each containing 2 auto-injectors.
  • Carton clearly marked with strength (0.3mg), 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.
  • Patients at risk of anaphylaxis are usually advised to carry two in-date auto-injectors at all times.
  • 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 after exposure to a known or suspected allergen.
  • Grasp the EpiPen in your fist, remove the safety cap(s) as instructed in the patient leaflet, and place the orange (needle) end firmly against the outer thigh at a right angle.
  • Press firmly until a click is heard and hold the device in place for the recommended time (typically about 3 seconds; follow the current instructions for use) 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 for you, stating that anaphylaxis is suspected and adrenaline has been given.
  • If symptoms do not improve or recur before medical help arrives, a second dose may be given with another EpiPen after approximately 5–15 minutes, in line with medical advice.
  • Dispose of the used device safely (e.g. in its carrier tube or a sharps container) and hand it to medical personnel.
  • Regularly check the expiry date and inspect the solution through the viewing window; replace the pen before expiry or if the solution is discoloured or contains particles.

Contraindications

  • In a life-threatening anaphylactic reaction there are no absolute contraindications to the use of adrenaline.
  • Use with caution in patients with pre-existing cardiovascular disease, hyperthyroidism, hypertension, diabetes 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 of the excipients, 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 in these areas.

Adverse Effects

  • Common adrenergic effects including palpitations, tachycardia, tremor, anxiety, headache and sweating.
  • Potential increase in blood pressure; in susceptible individuals there is a risk of angina, arrhythmias or myocardial infarction, particularly 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; 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 predisposing factors or where dosing or administration errors occurred.

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 particulate matter is visible.
  • Protect from extreme temperatures and direct sunlight, for example do not leave the device 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 continuing risk of anaphylaxis should maintain in-date replacement auto-injectors as prescribed and use them as necessary for future reactions according to medical advice.

Onset

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

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