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Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Meda Pharmaceuticals Ltd.


EpiPen® and EpiPen® Jr adrenaline auto-injector


Presentation: EpiPen delivers a single dose of 0.3mg of adrenaline BP 1:1000 (0.3ml) in a sterile solution. EpiPen Jr. delivers a single dose of 0.15mg adrenaline BP 1:2000 (0.3ml) in a sterile solution. 1.7ml of adrenaline remains in the auto- injector after activation. Indications: For immediate self administration in the emergency treatment of allergic anaphylactic reactions. Anaphylaxis may be caused by insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise-induced anaphylaxis. Dosage: ADULTS: Self administration of 0.3mg adrenaline (EpiPen ) intramuscularly. CHILDREN: The appropriate dosage may be 0.15mg (EpiPen Jr.) for children 15-30kg body weight and 0.3mg (EpiPen) adrenaline for children >30kg body weight, or at the discretion of the physician. EpiPen should only be injected into the anterolateral aspect of the thigh through clothing if necessary. A second injection with an additional EpiPen may be administered after about 5 - 15 minutes if indicated. As EpiPen is designed for emergency treatment, the patient should always seek immediate medical attention even if symptoms have disappeared. Contraindications: There are no absolute contra-indications to the use of adrenaline in a life threatening situation.


Warnings and precautions: Avoid the risk of inadvertent intravascular injection. DO NOT INJECT INTO THE BUTTOCKS. Accidental injection into the hands or feet may result in loss of blood flow to the affected areas. If there is an accidental injection into these areas, advise the patient to go immediately to the nearest emergency room or hospital casualty department for treatment. Patients must be instructed in the proper use of EpiPen. Use with extreme caution in patients with heart disease and those taking digitalis, mercurial diuretic or quinidine. The effects of adrenaline may be potentiated by tricyclic antidepressants and monoamine oxidase inhibitors. Adrenaline should be used in pregnancy only if the potential benefit justifies any potential risk to the foetus. Side effects: May include palpitations, tachycardia, sweating, nausea and vomiting, respiratory difficultly, pallor, dizziness, nervousness and anxiety. Cardiac arrhythmias may follow administration of adrenaline. Overdoses of adrenaline may cause cerebral haemorrhage or arrhythmias. For a complete list of warnings and side effects, you should consult the Summary of Product Characteristics. Legal category: POM Package quantity and basic NHS price: EpiPen and EpiPen Jr. are available as single unit doses at £26.45 each or as a twin pack of 2 Auto-Injectors at £52.90. Product licence number: EpiPen Auto-Injector PL 15142/0245. EpiPen Jr. Auto-Injector PL 15142/0246. Marketing authorisation holder: Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishop’s Stortford, CM22 6PU. Tel: 0845 4600000 Date of preparation of prescribing information: September 2011. UK/EPI/11/0069


NOTHING ELSE IS AN


EPIPEN Partnership for life ®


(ADRENALINE) AUTO-INJECTOR


Reassuringly familiar for you and your patients


UK/EPI/11/0074 October 2011


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