Emerade

/ Neopharm

The effective dose is usually within the range 5- 10 micrograms per kg bodyweight but higher doses may be necessary in some cases.
Paediatric population:
Use in children: Emerade 500 micrograms is not recommended for use in children.
Children below 15 kg bodyweight: A dosage below 150 micrograms cannot be administered with sufficient accuracy in children weighing less than 15 kg and use is therefore not recommended unless under medical advice.
Children between 15 kg and 30 kg bodyweight: The usual dose is 150 micrograms.
Children over 30 kg bodyweight: The usual dose is 300 micrograms.
Adolescent patients over 30 kg bodyweight: The dosage recommendations for adult patients should be followed.
Use in adults: The recommended dose is 300 micrograms for individuals under 60 kg bodyweight. The recommended dose is 300 to 500 micrograms for individuals over 60 kg bodyweight, depending on clinical judgement.
An initial dose should be administered as soon as symptoms of anaphylaxis are recognised. In the absence of clinical improvement or if deterioration occurs, a second injection with an additional Emerade may be administered 5 – 15 minutes after the first injection. It is recommended that the patients are prescribed two Emerade pens which they should carry at all times.
Method of administration: For intramuscular injection only. For single use.
Emerade is given intramuscularly as soon as the symptoms of anaphylactic shock arise. A poor outcome from anaphylaxis is associated with late administration of adrenaline. Emerade must be injected in the outer side of the thigh. Massaging around the injection area accelerates absorption.
The injection can be administered through clothing.
The patient/carer should be informed that following each use of Emerade:
– 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.

Emerade is indicated in the emergency treatment of severe allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
Emerade is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
Emerade is intended for immediate administration as emergency supportive therapy only and is not a substitute for immediate medical care.

Hypersensitivity to the active substance or to any of the excipients.

Emerade must be administrated only into the anterolateral thigh.
The injection is delivered immediately after the triggering cylinder is pressed against the skin. Patients should be advised not to inject Emerade into the gluteus maximus due to the risk of accidental injection into a vein.
Emerade should be used in emergency situations as life-sustaining treatment.
The patient must urgently seek medical assistance for further treatment after using Emerade.
All patients who are prescribed Emerade 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 Emerade in case support is needed in the emergency situation.
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 diseases including angina pectoris, cardiac arrhythmia, cor pulmonale, obstructive cardiomyopathy and atherosclerosis. There is also a risk for adverse reactions after the administration of adrenaline to patients with hyperthyroidism, hypertension, phaeochromocytoma, glaucoma, severe renal impairment, prostate adenoma, hypercalcaemia, hypokalaemia, diabetes, and in elderly patients and pregnant women.
Emerade contains sodium metabisulphite which can cause allergic reactions including anaphylaxis and bronchospasm in sensitive individuals particularly in those with a history of asthma. All those patients should be carefully instructed in which circumstances Emerade must be used.
Unintentional injection in hands and feet can result in peripheral ischemia that may require treatment.
Patients should be warned regarding related allergens and should be investigated whenever possible so that their specific allergens can be characterised.
Emerade is essentially sodium free (contains less than 1 mmol sodium (23 mg) per dose).

Side-effects of adrenaline in general are associated with the α- and β-receptor activity of adrenaline.
Emerade contains sodium metabisulphite, which may rarely cause severe hypersensitivity reactions.
See prescribing information for full details.

Certain medicines can enhance the effect of adrenaline: Tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, and catechol-O-methyl transferase (COMT) inhibitors. Adrenaline must be used with caution in patients receiving halogenated hydrocarbons and related medicines and drugs that may
sensitize the heart to arrhythmias, e.g. digitalis, quinidine, halogenated anaesthetics.
The administration of fast-acting vasodilators or α-blockers can counteract the effects of adrenaline on blood pressure. β-blockers can inhibit the stimulating effect of adrenaline.
The hyperglycaemic effect of adrenaline may necessitate an increase in insulin or oral hypoglycaemic treatment in diabetic patients.

Pregnancy: There are no adequate or well-controlled studies of adrenaline during pregnancy. Adrenaline should be used in pregnancy only when the potential benefit to the mother outweighs the possible risk to the foetus.
Lactation: Because of its poor oral bioavailability and short half-life, any adrenaline in breast milk is unlikely to affect the nursing infant.

An overdose, or an accidental intravascular injection of adrenaline, can originate a sudden increase in blood pressure that can cause cerebral haemorrhage. Severe pulmonary oedema caused by peripheral vasoconstriction together with cardiac stimulation can result in death. Severe pulmonary oedema with difficulty in breathing can be treated with fast-acting α-blockers. Life-threatening heart arrhythmias can be treated with β-blocking agents.

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 
Storage: The pen must always be kept in the plastic case provided to ensure it is protected. Store below 25°C. Do not freeze.