JEXT Solution for injection in pre-filled pen Ref.[27656] Active ingredients: Epinephrine

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 dial 999, ask for ambulance, state anaphylaxis 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.

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.

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.

In case of injection performed by a caregiver, the patient should be instructed not to move and immobilisation of the patient’s leg should be ensured during injection to reduce the risk of laceration. The product is for single use only and cannot be reused.

In patients with 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 Jext injection (see section 4.2).

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 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 the Jext in case support is needed in the emergency situation.

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.

Patients should be warned regarding related allergens and should be investigated whenever possible so that their specific allergens can be characterised.

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), thyroid hormones, theophylline, oxytocin, parasympatholytics, certain antihistamines (diphenhydramine, chlorpheniramine), levodopa and alcohol.

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 of adrenaline 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).

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 the MHRA Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.

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