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

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: ALK-Abelló A/S, Bøge Allé 6-8, DK-2970 Hørsholm

Product name and form

Jext 150 micrograms solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection in pre-filled pen.

Clear and colourless solution.

Qualitative and quantitative composition

Jext 150 micrograms: 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).

Excipients with known effect: Sodium metabisulphite (E223) and sodium chloride.

Jext contains less than 1 mmol sodium (23 mg) per dose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Epinephrine

Epinephrine is a direct acting sympathomimetic agent, which exerts effects on both α and β adrenoceptors. It has more pronounced effects on β than on α adrenoceptors, although α effects prevail at high doses. The effects of adrenaline include increased rate and force of cardiac contraction, cutaneous vasoconstriction and broncho-dilatation.

List of Excipients

Sodium chloride
Sodium metabisulphite (E223)
Hydrochloric acid (for pH adjustment)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

ALK-Abelló A/S, Bøge Allé 6-8, DK-2970 Hørsholm

Marketing authorization dates and numbers

PL10085/0052

Date of first authorisation: 12 October 2010
Date of renewal of the authorisation: 12 October 2015

Drugs

Drug Countries
JEXT Austria, Spain, Finland, France, Hong Kong, Croatia, Ireland, Malta, Netherlands, Romania, United Kingdom

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