Jext 300 micrograms: One pre-filled pen delivers one dose of 0.30ml solution for injection containing 300 micrograms of adrenaline (as tartrate). 1 ml solution contains 1mg adrenaline (as tartrate). Excipients: Sodium metabisulphite (E223) and sodium chloride. Jext contains less than 1 mmol sodium (23 mg) per dose.

Solution for injection in pre-filled pen. Clear and colourless solution.

Jext is indicated in the emergency treatment of severe acute allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise induced anaphylaxis.

Posology:

Use in adults over 30 kg in weight:

The usual dose is 300 micrograms.

Larger adults may require more than one injection to reverse the effect of an allergic reaction.

Patients between 15 kg and 30 kg in weight should be prescribed a Jext 150 micrograms.

An initial dose should be administered as soon as symptoms of anaphylaxis are recognised.

The effective dose is typically in the range of 0.005-0.01 mg/kg but higher doses may be necessary in some cases.

In the absence of clinical improvement or if deterioration occurs, a second injection with an additional Jext may be administered 5 – 15 minutes after the first injection.

Method of administation:

For intramuscular use.

For single use.

Jext is for intramuscular administration into the anterolateral thigh.

It is designed to inject through clothing or directly through the skin.

Massage around the injection area is advised to accelerate absorption.

Please refer to section 6.6 for detailed instructions for use

There are no absolute contraindications to the use of Jext during an allergic emergency.

Do not remove yellow cap until ready for use.

Jext should be administered into the anterolateral thigh. The injection is delivered immediately after the black needle shield of the auto-injector is pressed firmly against the skin or other surface. Patients should be advised not to inject Jext into the gluteus maximus due to the risk of accidental injection into a vein.

The patient should be instructed to seek emergency medical assistance immediately after administering the first dose in order to have close monitoring of the anaphylactic episode and further treatment as required.

Jext contains sodium metabisulphite which may rarely cause severe hypersensitivity reactions including anaphylactic symptoms and bronchospasm 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 Jext should be used.

Due to an increased risk of adverse reactions following administration of adrenaline special caution should be taken in patients with cardiovascular diseases including angina pectoris, obstructive cardiomyopathy, cardiac arrhythmia, cor pulmonale, atherosclerosis and hypertension.

Special caution should also be taken in patients with hyperthyroidism, phaeochromocytoma, narrow angle glaucoma, severe renal impairment, prostatic adenoma leading to residual urine, hypercalcaemia, hypokalaemia and diabetes.

Caution should also be taken in elderly and pregnant patients.

Peripheral ischaemia following accidental injection into hands or feet may cause loss of blood flow to adjacent areas due to vasoconstriction.

All patients who are prescribed Jext should be thoroughly instructed to understand the indications for use and the correct method of administration.

There is often a prolonged period between supply of Jext and an allergic reaction requiring adrenaline. Patients should be advised to regularly check Jext and ensure it is replaced within the expiry period.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium free.

Caution is indicated in patients receiving drugs that may sensitise the heart to arrhythmias, including digitalis and quinidine. The effects of adrenaline may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors (MAO-inhibitors) and catechol-O-methyl transferase inhibitors (COMT inhibitors).

Adrenaline inhibits the secretion of insulin, thus increasing the blood glucose level. It may be necessary for diabetic patients receiving adrenaline to increase their dosage of insulin or oral hypoglycaemic drugs.

The alpha- and beta-stimulating effect can be inhibited by concomitant use of alpha- and beta-blocking drugs as well as parasympathomimetic drugs.

Side effects associated with adrenaline's alpha and beta receptor activity may include cardiovascular effects as well as undesirable effects on the central nervous system.

The following table is based upon post marketing experience with the use of adrenaline. The frequency cannot be estimated from the available data.

Peripheral ischaemia following accidental injection of adrenaline in the hands or feet has been reported.

Jext contains sodium metabisulphite which may rarely cause severe hypersensitivity reactions including anaphylactic symptoms and bronchospasm.

ALK-Abello Ltd

POM-Prescription Only Medicine

17 November 2010