EMERADE

Posology 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 during a life- threatening situation and 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.

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.

Method of administration Emerade is intended for intramuscular administration of adrenaline. For single use. Emerade should be administered early, at the first signs of anaphylaxis. 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. 4). 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. If the patient still feels unwell after the first injection, a second injection should be administered 5-15 minutes after the first injection.

It is recommended that patients are prescribed two Emerade pens which they should carry at all times. 6.

Side-effects of adrenaline in general are associated with the α- and β-receptor activity of adrenaline. The following table is based upon experience with the use of adrenaline.

The adverse events were classified according to the following frequencies:

Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Any pen that is suspected of not having functioned as intended should be retained for reporting and investigation.

Such pens should eb returned to your/the nearest pharmacy.

Do not remove the cap until ready for use. 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. 6). 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.

2) and a suboptimal effect. 2). 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 contains sodium metabisulphite Sodium metabisulphite may rarely cause severe hypersensitivity 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.

Emerade contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

There are no absolute contraindications to the use of Emerade in an allergic emergency.