DACEPTON Solution for infusion Ref.[27682] Active ingredients: Apomorphine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: EVER Neuro Pharma GmbH, Oberburgau 3, 4866 Unterach, Austria

Product name and form

Dacepton 5 mg/ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear and colourless to slightly yellow solution, free from visible particles.

pH of 3.3–4.0.

Osmolality: 290 mOsm/kg

Qualitative and quantitative composition

1 ml contains 5 mg apomorphine hydrochloride hemihydrate.

20 ml contain 100 mg apomorphine hydrochloride hemihydrate.

Excipient with known effect:

Sodium metabisulphite (E223) 1 mg per ml.

Sodium chloride 8 mg per ml.

For the 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)
Sodium chloride
Hydrochloric acid (for pH-adjustment)
Water for injections

Pack sizes and marketing

Clear glass vials, type I with bromobutyl rubber stopper and a flip-off cap, containing 20 ml solution for infusion, in packs of 1, 5 or 30 vials.

Bundle packs: 5 × 1, 10 × 1, 30 × 1, 2 × 5 and 6 × 5.

Not all pack sizes may be marketed.

Marketing authorization holder

EVER Neuro Pharma GmbH, Oberburgau 3, 4866 Unterach, Austria

Marketing authorization dates and numbers

PL 40369/0003

20/2/2014

Drugs

Drug Countries
DACEPTON Austria, Estonia, Spain, Finland, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom

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