CHOLSTYQ Solution for injection Ref.[115306] Active ingredients: Glycopyrronium Neostigmine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: Umsebe Healthcare, 506 Sunclare Building, 21 Dreyer Street, Claremont, Cape Town, 7708, South Africa Name of Manufacturer: Sintetica SA

Product name and form

Cholstyq.

Pharmaceutical Form

Solution for injection.

Clear, colourless solution, practically free of visible particles.

Qualitative and quantitative composition

Each 1 ml of solution for injection contains 0,5 mg of glycopyrronium bromide and 2,5 mg neostigmine metilsulfate.

Excipient with known effect: Each 1 ml of the solution for injection contains 3 mg (0,13 mmol) sodium.

For a full list of excipients, see section 6.1.

Active Ingredient

Glycopyrronium is an inhaled long-acting muscarinic receptor antagonist (anticholinergic) for once-daily maintenance bronchodilator treatment of COPD. Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways.

Neostigmine inhibits cholinesterase activity and prolongs and intensifies the muscarinic and nicotinic effects of acetylcholine. The anticholinesterase actions of neostigmine are reversible. It is used mainly for its action on skeletal muscle and less frequently to increase the activity of smooth muscle.

List of Excipients

Citric acid
Disodium phosphate dodecahydrate
Sodium hydroxide
Water for injections

Pack sizes and marketing

Cholstyq is presented in 2 ml (filled to 1 ml) Type I clear colourless glass ampoules. Ampoules are packed into outer cardboard cartons in pack sizes of 10.

Marketing authorization holder

Umsebe Healthcare, 506 Sunclare Building, 21 Dreyer Street, Claremont, Cape Town, 7708, South Africa

Name of Manufacturer: Sintetica SA

Marketing authorization dates and numbers

56/5.11/0094

24 May 2022

Drugs

Drug Countries
CHOLSTYQ South Africa

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