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APO-GO Solution for injection (2018)

Active ingredients: Apomorphine

Product Name and Form

APO-go PEN 10 mg/ml Solution for Injection*

* Abbreviated to APO-go in the text

Pharmaceutical form

Solution for injection.

The solution is clear, practically colourless, odourless and free from visible particles.

pH = 3.0 to 4.0

Qualitative and Quantitative Composition

1 ml contains 10 mg apomorphine hydrochloride.

Each 3 ml PEN contains 30 mg apomorphine hydrochloride.

Excipient(s) with known effect: Sodium bisulphite 0.93 mg per ml.

For a full list of excipients, see Section 6.1.

Chemical substance
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 bisulphite (E222)
Hydrochloric acid (37%), concentrated (to adjust pH to 3.0–4.0)
Water for injections

Pack sizes and Marketing

Cartridge.

APO-go Pen 10 mg/ml is a disposable multiple dose pen injector system incorporating a clear glass (type I) cartridge containing a clear solution for injection. The glass cartridge is sealed at one end with a bromobutyl rubber piston, and at the other end with a bromobutyl rubber/aluminium membrane.

Each pen contains 3 ml of solution for injection.

Packs containing 1, 5, or 10 × 3 ml pens in a moulded plastic tray in an outer cardboard carton.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Britannia Pharmaceuticals Ltd., 200 Longwater Avenue, Green Park, Reading, Berkshire, RG2 6GP, United Kingdom, Tel: +44 1189209500, Email: bplwebmaster@britannia-pharm.com

March 1999 / June 2016

Marketing authorization number:

PL 04483/0073
MA 957/00102