EMERADE Solution for injection in a pre-filled pen Ref.[27518] Active ingredients: Epinephrine

Do not remove the needle shield 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.

All patients who are prescribed Emerade should be thoroughly instructed to understand the indications for the use and the correct method of administration (see section 6.6). 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 disease 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.

In patients with a thick sub-cutaneous fat layer, there is a risk of adrenaline being administered in the sub-cutaneous tissue which may result in a slower adrenaline absorption (see section 5.2) and a suboptimal effect. This may increase the need for a second Emerade injection (see section 4.2).

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.

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.

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.

Because of its poor oral bioavailability and short half-life, any adrenaline in breast milk is unlikely to affect the nursing infant.

Emerade has no or negligible influence on the ability to drive and use machines, however, patients are not recommended to drive or use machines following administration of adrenaline, since they will be affected by the anaphylactic reaction.

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).

Emerade contains sodium metabisulphite, which may rarely cause severe hypersensitivity reactions (see section 4.4).

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. Healthcare professionals are asked to report any suspected adverse reactions via theYellow Card Scheme; Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.