JEXT Solution for injection in pre-filled pen (2020)
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Περιεχόμενα
1. Name of the medicinal product
Jext 150 micrograms solution for injection in pre-filled pen.
2. Qualitative and quantitative composition
<u>Jext 150 micrograms:</u> One pre-filled pen delivers one dose of 0.15ml solution for injection containing 150 micrograms of adrenaline (as tartrate). 1 ml solution contains 1mg adrenaline (as tartrate). ...
3. Pharmaceutical form
Solution for injection in pre-filled pen. Clear and colourless solution.
4.1. Therapeutic indications
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. ...
4.2. Posology and method of administration
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 ...
4.3. Contraindications
There are no absolute contraindications to the use of Jext during an allergic emergency.
4.4. Special warnings and precautions for use
Do not remove yellow cap until ready for use. <b>Jext should be administered into the anterolateral thigh. The injection is delivered immediately</b> after the black needle shield of the auto-injector ...
4.5. Interaction with other medicinal products and other forms of interaction
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, ...
4.6. Pregnancy and lactation
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 ...
4.7. Effects on ability to drive and use machines
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 ...
4.8. Undesirable effects
Side effects associated with adrenalines 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 ...
4.9. Overdose
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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Cardiac stimulants excl. cardiac glycosides, adrenergic and dopaminergic agents. <b>ATC code:</b> C01CA24 Adrenaline is a catecholamine which stimulates the sympathetic ...
5.2. Pharmacokinetic properties
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 ...
5.3. Preclinical safety data
Adrenaline has been utilised in the treatment of allergic emergencies for many years. There is no preclinical data of relevance available.
6.1. List of excipients
Sodium chloride Sodium metabisulphite (E223) Hydrochloric acid (for pH adjustment) Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
22 months.
6.4. Special precautions for storage
Store below 25°C. Do not freeze.
6.5. Nature and contents of container
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 ...
6.6. Special precautions for disposal and other handling
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 ...
7. Marketing authorization holder
ALK-Abelló A/S, Bøge Allé 6-8, DK-2970 Hørsholm
8. Marketing authorization number(s)
PL10085/0052
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 12 October 2010 Date of renewal of the authorisation: 12 October 2015
10. Date of revision of the text
28/05/2020
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