APO-go AMPOULES Solution for injection or infusion (2012)

Active ingredients: Apomorphine

Product name and form

APO-go AMPOULES 10 mg/ml Solution for Injection or Infusion.

Solution for Injection or Infusion.

Clear, colourless or almost colourless, practically free from visible particles

pH 3.0-4.0

Qualitative and quantitative composition

1ml contains 10mg apomorphine hydrochloride
2ml contains 20mg apomorphine hydrochloride
5ml contains 50mg apomorphine hydrochloride

Excipient: Sodium metabisulphite (E223) 1mg per ml
For a full list of excipients, see Section 6.1

Apomorphine

Apomorphine is a direct stimulant of dopamine receptors and while possessing both D1 and D₂ receptor agonist properties does not share transport or metabolic pathways with levodopa. Its actions on parkinsonian motor disability are likely to be mediated at post-synaptic receptor sites.

Sodium metabisulphite (E223)
Hydrochloric acid, concentrated (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

Type I glass ampoules containing 2ml Solution for Injection or Infusion, in packs of 5 ampoules.
Type I glass ampoules containing 5ml Solution for Injection or Infusion, in packs of 5 ampoules.

The ampoules are contained in a plastic tray within a cardboard carton.

There are two types of ampoules:

An ampoule with a coloured spot (partially scored)
An ampoule with a ring around the thinnest part of the neck (fully scored).

Bundle packs of 25 and 50 ampoules are available in some territories.

The 25 ampoule bundle pack consists of 5 packs each containing 5 ampoules.
The 50 ampoule bundle pack consists of 10 packs each containing 5 ampoules.

Not all pack sizes are marketed.

Genus Pharmaceuticals Limited
Park View House
65 London Road
Newbury
Berkshire
RG14 1JN
United Kingdom

January 2000 / January 2010

Marketing authorization number:

PL 06831/0245
PA 1496/2/1

Drugs

APO-GO

Austria, Cyprus, Spain, Netherlands, United Kingdom

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