ADRENALINE AGUETTANT Solution for injection in pre-filled syringe Ref.[7553] Active ingredients: Epinephrine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Laboratoire Aguettant, 1 rue Alexander Fleming, 69007 LYON, FRANCE

Product name and form

Adrenaline 1 mg/10 ml (1:10,000), solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection in pre-filled syringe.

Clear and colourless solution in a 10 ml pre-filled syringe.

pH = 3.0 to 3.4

Osmolarity: 270–300 mOsm/l

Qualitative and quantitative composition

Each ml of solution for injection contains 0.1 mg of adrenaline (as adrenaline tartrate).

Each 10 ml pre-filled syringe contains 1 mg adrenaline (as adrenaline tartrate).

Excipient with known effect: sodium.

Each ml of solution for injection contains 3.54 mg equivalent to 0.154 mmol of sodium.

Each 10 ml pre-filled syringe contains 35.4 mg equivalent to 1.54 mmol of sodium.

For a 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
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

10 ml solution in a polypropylene pre-filled syringe without a needle, individually packaged in a transparent blister and overwrapped in an aluminium pouch containing an oxygen absorbing sachet. Available in a box of 1 or 10.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratoire Aguettant, 1 rue Alexander Fleming, 69007 LYON, FRANCE

Marketing authorization dates and numbers

PL 14434/0031

10/12/2015

Drugs

Drug Countries
ADRENALINE Cyprus

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