PHENYLEPHRINE Injection Ref.[7441] Active ingredients: Phenylephrine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Product name and form

Phenylephrine 10 mg/ml Injection.

Pharmaceutical Form

A clear, colourless liquid, free from extraneous visible particles.

Qualitative and quantitative composition

Each 1 ml ampoule contains 10 mg of the active ingredient phenylephrine hydrochloride.

Excipients with known effect: Sodium hydroxide solution (q.s.- quantity per ml)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Phenylephrine

Phenylephrine is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly alpha adrenergic activity and is without stimulating effects on the central nervous system. The sympathomimetic effect of phenylephrine produces vasoconstriction which in turn relieves nasal congestion.

List of Excipients

Sodium hydroxide solution 1N
Hydrochloric acid 36% 1N
Water for injections
Nitrogen, liquefied

Pack sizes and marketing

1 ml neutral glass ampoule with red imprint break ring.

Pack size: 6 × 1ml and 10 × 1ml ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization dates and numbers

PL 20072/0226

Date of first authorisation: 17 November 1999

Date of latest renewal: 18 November 2005

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