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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.

Pharmaceutical Form

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

Active Ingredient
Description
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.

List of Excipients

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.

Marketing Authorization Holder
Authorization Dates

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

Drug
Countries
APO-GO
Austria, Cyprus, Spain, Netherlands, United Kingdom