Anapen 150mcg and 300mcg (epinephrine) auto-injectors (Republic of Ireland)
Please note, Anapen is not licensed in the United Kingdom. ?This information is intended for Ireland only.
Anapen (epinephrine) auto-injectors are used in the emergency treatment for acute allergic reactions (anaphylaxis) caused by peanuts or other foods, drugs, insect bites or stings, and other allergens as well as exercise-induced or idiopathic anaphylaxis. ?For intramuscular route only, Anapen consists of a pre-filled syringe of adrenaline (epinephrine) contained in an auto-injection device or 'auto-injector'. ?The patient should always carry 2 units of auto injectors in case the first administration fails or if one dose is not sufficient.
Anapen is a prescription-only medication. ?Further details regarding Anapen can be viewed in the SPC below:
For Medical Information:?Irish Freephone 016869342
Anapen 300 micrograms in 0.3 ml solution for injection in a pre-filled syringe.Anapen Junior 150 micrograms in 0.3 ml solution for injection in a pre-filled syringe.QUALITATIVE AND QUANTITATIVE COMPOSITION:Anapen 300 micrograms in 0.3 ml solution for injection in a pre-filled syringe: One dose of 0.3 ml contains 300 micrograms of adrenaline (epinephrine). Anapen Junior 150 micrograms in 0.3 ml solution for injection in a pre-filled syringe:. One dose of 0.3 ml contains 150 micrograms of adrenaline (epinephrine). EXCIPIENTS: sodium chloride, sodium metabisulphite (E223), hydrochloric acid, water for injections. EXCIPIENTS WITH KNOWN EFFECT: sodium metabisulfite (E223), sodium chloride. PHARMACEUTICAL FORM: Solution for injection. INDICATIONS: Emergency treatment for acute allergic reactions (anaphylaxis) caused by peanuts or other foods, drugs, insect bites or stings, and other allergens as well as exercise-induced or idiopathic anaphylaxis. POSOLOGY AND METHOD OF ADMINISTRATION: The patient should always carry 2 units of auto injectors in case the first administration fails or if one dose is not sufficient. Posology: The effective dose is typically in the range 0.005-0.01 mg/kg but higher doses may be necessary in some cases. Use in adults: The usual dose is 300 micrograms. Larger adults may require more than one injection to reverse the effect of an allergic reaction. In the absence of clinical improvement or if deterioration occurs, a second injection with an additional Anapen may be administered 5–15 minutes after the first injection. It is recommended that patients are prescribed two Anapen which they should carry at all times. Use in children: The appropriate dose may be 150 micrograms (Anapen Junior) or 300 micrograms (Anapen) of adrenaline (epinephrine), depending on the body weight of the child and the discretion of the doctor. Children and adolescents over 30 kg in weight should be prescribed Anapen 300 micrograms. Larger children may require more than one injection to reverse the effect of an allergic reaction. In the absence of clinical improvement or if deterioration occurs, a second injection with an additional Anapen Junior may be administered 5–15 minutes after the first injection. It is recommended that patients are prescribed two Anapen Junior which they should carry at all times. The auto-injector of Anapen Junior is designed to deliver a single dose of 150 micrograms adrenaline (epinephrine). A dosage below 150 micrograms cannot be administered in sufficient accuracy in children weighing less than 15 kg and use is therefore not recommended unless in a life-threatening situation and under medical advice. Method of Administration: For intramuscular route only. Anapen consists of a pre-filled syringe of adrenaline (epinephrine) contained in an auto-injection device. The whole is referred to as an auto-injector. One Anapen injection should be administered intramuscularly immediately on the appearance of the signs and symptoms of anaphylactic shock. These may occur within minutes of exposure to the allergen and are most commonly manifested by urticaria, flushing or angioedema; more severe reactions involve the circulatory and respiratory systems. Inject Anapen or Anapen Junior only into the anterolateral aspect of the thigh, not the buttock. The injected area may be lightly massaged for 10 seconds following injection to accelerate absorption. The auto-injector is designed to inject through clothing or directly through the skin.Anapen junior and Anapen auto-injectors are intended for immediate self administration by a person with a history of anaphylaxis and are designed to deliver respectively a single dose of 150 micrograms (0.3 ml) adrenaline (epinephrine) or 300 micrograms (0.3 ml) adrenaline (epinephrine). For stability reasons 0.75 ml is left in the syringe after use but the unit cannot be used again and should be safely discarded. The patient/carer should be informed that following each use of Anapen:
They should call for immediate medical assistance, ask for an ambulance and state ‘anaphylaxis’ even if symptoms appear to be improving.
Conscious patients should preferably lie flat with feet elevated but sit up if they have breathing difficulties. Unconscious patients should be placed on their side in the recovery position.
The patient should if possible remain with another person until medical assistance arrives.
CONTRA-INDICATIONS: Hypersensitivity to adrenaline (epinephrine) or to any of the excipients. There are no absolute contraindications for use in allergic emergency situations. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Anapen or Anapen Junior contains sodium metabisulfite which can cause allergic-type reactions including anaphylactic symptoms and bronchopasm in susceptible people, especially those with a history of asthma. Patients with these conditions must be carefully instructed in regard to the circumstances under which Anapen or Anapen Junior should be used. All patients who are prescribed Anapen or Anapen Junior should be thoroughly instructed to understand the indications for the use and the correct method of administration. It is strongly advised also to educate the patient’s immediate associates (e.g. parents, caregivers, teachers) for the correct usage of Anapen or Anapen Junior in case support is needed in the emergency situation. Anapen or Anapen Junior are indicated as emergency supportive therapy only and patients should be advised to seek immediate medical attention following administration, in order to have close monitoring of the anaphylactic episode and further treatment as required. The patient/carer should be informed about the possibility of biphasic anaphylaxis which is characterised by initial resolution followed by recurrence of symptoms some hours later. Patients with concomitant asthma may be at increased risk of a severe anaphylactic reaction. Use with caution in patients with heart disease. There is a risk of adverse reactions following adrenaline (epinephrine) administration in patients with hyperthyroidism, cardiovascular disease, phaeochromocytoma, high intraocular pressure, severe renal impairment, prostatic adenoma, hypercalcemia, hypokalemia, diabetes, or in elderly or pregnant patients. Anapen or Anapen Junior contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium free.Patients should be warned regarding related allergens and should be investigated whenever possible so that their specific allergens can be characterised. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION: The effects of adrenaline (epinephrine) may be potentiated by tricyclic antidepressants mixed noradrenargic-serotoninergic antidepressants, monoamine oxidase inhibitors, COMT blocking agent, thyroid hormones, theophylline, oxytocin, parasympatholytics, certain antihistamines (diphenhydramine, chlorpheniramine), levodopa and alcohol. Severe hypertension and bradycardia may occur when adrenaline (epinephrine) is administered with non-selective beta-blocking medicinal products. Concurrent therapy with sympathomimetics may potentiate the effects of adrenaline (epinephrine). Use Anapen or Anapen Junior with caution in patients receiving medicinal products which may sensitise the heart to arrhythmias, e.g. digitalis, quinidine, halogenated anaesthetics. Adrenaline (epinephrine) inhibits insulin secretion and diabetic patients may require upward adjustment of their insulin or other hypoglycaemic therapy. PREGNANCY AND LACTATION: Adrenaline (epinephrine) should only be used in pregnancy if the potential benefit justifies the potential risk to the foetus. Adrenaline (epinephrine) is not orally bioavailable; any adrenaline (epinephrine) excreted in breast milk would not be expected to have any effect on the nursing infant. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: It is not recommended that patients should drive or use machines following administration of adrenaline (epinephrine), since patients will be affected by symptoms of the anaphylactic shock. UNDESIRABLE EFFECTS: Common adverse reactions even at low doses due to adrenaline (epinephrine) include palpitations, tachycardia, sweating, nausea, vomiting, respiratory difficulty, pallor, dizziness, weakness, tremor, headache, apprehension, nervousness, anxiety and coldness of extremities. Less frequently reported effects include hallucinations, syncopes, hyperglycaemia, hypokalaemia, metabolic acidosis, mydriasis, difficulty in micturition with urinary retention, muscle tremor. Adverse reactions which occur at higher doses or in susceptible individuals are cardiac arrhythmias, sudden rise of blood pressure and vasoconstriction. OVERDOSE: Overdose or accidental intravascular injection of adrenaline (epinephrine) may cause cerebral haemorrhage from a sudden rise of blood pressure. Death may result from acute pulmonary oedema arising from peripheral vascular constriction and cardiac stimulation. Adrenaline (epinephrine) overdose may also result in transient bradycardia followed by tachycardia. INCOMPATIBILITIES: This medicinal product must not be mixed with other medicinal products. SHELF LIFE: Anapen 300 micrograms in 0.3 ml solution for injection: 24 months; Anapen Junior 150 micrograms in 0.3 ml solution for injection: 21 months. SPECIAL PRECAUTIONS FOR STORAGE: Do not store above 25°C. Keep the auto-injector in the outer carton in order to protect from light. LEGAL CATEGORY: POM. NATURE AND CONTENTS OF CONTAINER: Anapen or Anapen Junior consists of a pre-filled syringe contained in a single use auto-injection device. The syringe contains adrenaline (epinephrine) solution. In pack sizes of 2. SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING: See SPC for instructions to be conveyed to the patient/carer regarding actions to be taken following each use of Anapen or Anapen Junior. Immediately after using Anapen or Anapen Junior the patient should call the emergency services, ask for an ambulance and say “anaphylaxis”. The patient should explain to the paramedic that he/she has received an injection of adrenaline into his/her thigh muscle and show them the box and these instructions. MARKETING AUTHORISATION HOLDER: Lincoln Medical Ltd, Unit B Stanley Court, Glenmore Business Park, Telford Road, Salisbury SP2 7GH, United Kingdom. MARKETING AUTHORISATION NUMBER: Anapen 300 micrograms in 0.3 ml solution for injection: PA 1072/001/002, Anapen Junior 150 micrograms in 0.3 ml solution for injection: PA 1072/001/001. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION:PA 1072/001/002: Date of first authorisation: 21 March 2003, Date of last renewal: 11 July 2006; PA 1072/001/001: Date of first authorisation: 21 February 2003, Date of last renewal: 11 July 2006. DATE OF (PARTIAL) REVISION OF THE TEXT: March 2017. Please refer to the full SPC texts before prescribing these products.