ALK-Abello Ltd

Jext 300 micrograms solution for injection in pre-filled pen

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.

For a full list of excipients, see section 6.1.

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 administration:

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.

Clinical experience in the treatment of anaphylaxis during pregnancy is limited. Adrenaline should only be used during pregnancy if the potential benefit justifies the potential risk for the foetus.

Adrenaline is not orally bioavailable; any adrenaline excreted in breast milk would not be expected to have any effect on the nursing infant.

Jext 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 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 (see section 4.4. Special warning and precautions for use).

Overdose or inadvertent intravascular injection of adrenaline may cause cerebral haemorrhage and ventricular arrhythmias resulting from a sharp rise in blood pressure. Myocardial ischaemias and necroses as well as renal impairment may occur. Fatalities may also result from pulmonary oedema because of peripheral vascular constriction together with cardiac stimulation.

Pulmonary oedema may be treated with alpha-blocking agents such as phentolamine. In case of arrhythmias these may be treated with beta-blocking agents.

Pharmacotherapeutic group: Cardiac stimulants excl. cardiac glycosides,adrenergic and dopaminergic agents.

ATC code: C01CA24.

Adrenaline is a catecholamine which stimulates the sympathetic nervous system (both alpha and beta receptors) by which cardiac rate, cardiac output and coronary circulation is raised. Adrenaline through its action on beta receptors on bronchial smooth muscles causes bronchial smooth muscle relaxation which alleviates wheezing and dyspnoea.

Adrenaline is a naturally occurring substance produced by the adrenal medulla and secreted in response to exertion or stress. It is rapidly inactivated in the body mostly by the enzymes COMT and MAO. The liver is rich in these enzymes and is an important, although not essential, tissue in the degradation process. Much of the dose of adrenaline is accounted for by excretion of metabolites in the urine.

The plasma half-life of adrenaline is about 2.5 min. However local vasoconstriction may retard absorption, so that the effects can last longer than the half-life would predict. Massage around the injection area is advised to accelerate absorption.

Adrenaline has been utilised in the treatment of allergic emergencies for many years. There is no preclinical data of relevance available.

Sodium Chloride

Sodium Metabisulphite (E223)

Hydrochloric Acid (for pH adjustment)

Water for Injections

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

2 years

Do not freeze.

Pre-filled pen (single dose pen) comprising an auto-injector with a cartridge. The cartridge is made of glass (type 1), sealed with a latex free grey rubber plunger and a latex free bromobutyl rubber seal within an anodised aluminium cap. The auto-injector is made of plastic.

Pack-size: 1 pre-filled pen

Jext is a single-use pre-filled pen designed for easy use.

The pre-filled pen is operated by simply pressing the black injector tip against the outer thigh. This will activate a plunger, which pushes a concealed needle through the membrane on the black injector tip into the muscle and injects a dose of adrenaline. This can be done through clothing.

Jext 300 micrograms contains 1.4 ml of adrenaline injection 1 mg/ml which is designed to deliver a single dose (0.30 ml) of 300 micrograms adrenaline when activated. After activation of the auto-injector 1.1 ml remains in the pre-filled pen. Discard any unused solution.

A small air bubble may occur in Jext. It has no influence on either the use or the efficacy of the product.

The prescriber may use a “Jext Simulator” during patient instruction. This is a pen without needle or adrenaline, which is also available for patients or carers who may wish to practise at home.

Note: the yellow cap prevents the device from activating, and should not be removed before injection is required. The black injector tip should be kept away from the hand.

Any expired products should be disposed of in accordance with local requirements.

Check the solution periodically through the viewing window of the unit to make sure the solution is clear and colourless.

The solution darkens in colour upon exposure to air or light.

Replace and discard the pre-filled pen if the solution is discoloured or contains a precipitate, or at the latest before the expiry date.

The expiry date is indicated on the label and Jext should not be used after this date.

ALK-Abelló A/S

Bøge Allé 6-8

DK-2970 Hørsholm

PA 1255/006/002

Date of First Authorisation : 18^th February 2011