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

Posology

Paediatric population

Patients between 15 kg and 30 kg in weight

The usual dose is 150 micrograms.

A dosage below 150 micrograms cannot be administered in sufficient accuracy in children weighing less than 15 kg and use is therefore not recommended unless life-threatening situation and under medical advice. Children and adolescents over 30 kg in weight should be prescribed a Jext 300 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. It is recommended that patients are prescribed two Jext pens which they should carry at all times.

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.

The patient/carer should be informed that following each use of Jext:

• They should call for immediate medical assistance, ask for an ambulance and state ‘anaphylaxis’ even if symptoms appear to be improving (see section 4.4).
• 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.

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.

22 months.

Store below 25°C.

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.

Exposed needle length:

Jext 150 micrograms: 13 mm.

Jext 300 micrograms: 15 mm.

Pack-size:

Single pack with 1 pre-filled pen. Multipack with 2 pre-filled pens.

Not all pack sizes may be marketed.

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 150 micrograms contains 1.4 ml of adrenaline injection 1 mg/ml which is designed to deliver a single dose (0.15 ml) of 150 micrograms adrenaline when activated. After activation of the auto-injector 1.25 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.

Educational materials regarding the correct use, storage and care of Jext are available to prescribers, patients and caregivers including a Jext Trainer pen without needle or adrenaline for practising or instructing others in the correct use of Jext.

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.

1. Grasp the Jext injector in your dominant hand (the one you use to write with) with your thumb closest to the yellow cap.

2. Pull off the yellow cap with your other hand.

3. Place the black injector tip against your outer thigh, holding the injector at a right angle (approx 90°) to the thigh.

4. Push the black tip firmly into your outer thigh until you hear a ‘click’ confirming the injection has started, then keep it pushed in. Hold the injector firmly in place against the thigh for 10 seconds (a slow count to 10) then remove. The black tip will extend automatically and hide the needle.

5. Massage the injection area for 10 seconds. Seek immediate medical help. Dial 999, ask for ambulance, state anaphylaxis.

See Section 4.2 for instructions to be conveyed to the patient/carer regarding actions to be taken following each use of Jext.

Any unused medicinal product or waste material 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.

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.