EMERADE Solution for injection in a pre-filled pen Ref.[27518] Active ingredients: Epinephrine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00 Prague 7, Czech Republic

Product name and form

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

Emerade 300 micrograms solution for injection in pre-filled pen.

Emerade 500 micrograms solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection in a pre-filled pen (auto-injector).

Clear and colourless solution.

Qualitative and quantitative composition

The pre-filled pen contains 0.5 ml of adrenaline solution 1 mg/ml.

Emerade 150 micrograms delivers a single dose of 0.15 ml containing 150 micrograms of adrenaline (as tartrate).

Emerade 300 micrograms delivers a single dose of 0.3 ml containing 300 micrograms of adrenaline (as tartrate).

Emerade 500 micrograms delivers a single dose of 0.5 ml containing 500 micrograms of adrenaline (as tartrate).

Each 0.15 ml (150 micrograms) dose contains 0.075 mg sodium meta-bisulphite (E223).

Each 0.3 ml (300 micrograms) dose contains 0.15 mg sodium meta-bisulphite (E223).

Each 0.5 ml (500 micrograms) dose contains 0.25 mg sodium meta-bisulphite (E223).

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 meta-bisulfite (E223)
Disodium edetate
Hydrochloric acid (for adjustment of pH)
Water for injections

Pack sizes and marketing

Emerade consists of a pre-filled syringe made of glass with a polyisoprene rubber needle plunger in an auto-injector. Emerade is latex free.

Exposed needle length

Emerade 150 micrograms: 16 mm

Emerade 300 micrograms and Emerade 500 micrograms: 23 mm

Package

Emerade has an outer carton as well as a plastic box to store the auto-injector in.

Pack sizes: 1 or 2 pre-filled pens.

Not all pack sizes may be marketed.

Marketing authorization holder

PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00 Prague 7, Czech Republic

Marketing authorization dates and numbers

Emerade 150 micrograms: PL 33616/0013
Emerade 300 micrograms: PL 33616/0014
Emerade 500 micrograms: PL 33616/0015

Date of first authorisation: 03 January 2013

Drugs

Drug Countries
EMERADE Austria, Canada, Spain, Finland, France, Ireland, Netherlands, United Kingdom

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