Solution for injection in an auto-injector (prefilled, disposable automatic injection device) for intramuscular use - clear and colourless solution.
Therapeutic indications:
• EpiPen® auto injectors are automatic injection devices containing adrenaline for allergic emergencies. The auto injectors should be used only by a person with a history or an acknowledged risk of an anaphylactic reaction. The auto injectors are indicated in the emergency treatment of allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise induced anaphylaxis. Such reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhoea and abdominal cramps, involuntary voiding, wheezing, dyspnoea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema.
• For these reasons auto injectors should always be carried by such persons in situations of potential risks.
• Adrenaline is considered the first line drug of choice for allergic emergencies. Adrenaline effectively reverses the symptoms of rhinitis, urticaria, bronchospasm and hypotension because it is a pharmacological antagonist to the effects of the chemical mediators on smooth muscles, blood vessels and other tissues. Adrenaline is recommended as the initial and primary therapeutic agent in the treatment of anaphylaxis by every recognised authority in allergy, and its appropriate use in these circumstances is widely documented in medical literature.
Features
Nature and contents of container:
• The immediate container/closure system consists of a glass cartridge sealed by a rubber plunger at one end and by a rubber diaphragm, which has been inserted into an aluminium hub with an attached stainless steel needle, at the other end. The glass cartridge contains the product.
• The auto injector administration device:
• Glass cartridge container:
• Diaphragm - Stopper:
• PH 701/50/Black (butyl rubber plunger) – complies with USP and Ph. Eur.
• Needle – Hub - Sheath:
• Materials compatible with adrenaline injection.
•Needle: Siliconised Type 304 stainless steel. The exposed needle length after activation is approximately 16 mm.
• Hub: Anodized 3003 aluminium alloy
• Sheath: Synthetic polyisoprene
• The EpiPen® auto injector contains 2 ml of adrenaline injection 1 mg/ml in a prefilled disposable automatic injection device which is designed to deliver a single dose (0.3 ml) of 0.3 mg adrenaline when activated. After activation of the auto injector, 1.7 ml remains in the auto injector.
• Pack sizes: 1 auto injector and 2 auto injectors.
Special precautions for storage:
• Adrenaline is sensitive to light. Keep the auto-injector in the outer carton
• Do not store above 25 °C.
• Do not refrigerate or freeze.
Shelf life:
• The expiry date is indicated on the label and EpiPen® auto injector should not be used after this date. Replace the auto injector by expiration date or earlier if the solution is discoloured or contains a precipitate. Check the solution periodically through the viewing window of the unit to make sure the solution is clear and colourless.
• Shelf life after opening: the EpiPen® auto injector must be discarded immediately after use.
