ASMANEX TWISTHALER Inhalation powder Ref.[7527] Active ingredients: Mometasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Product name and form

Asmanex Twisthaler 200 micrograms Inhalation Powder.

Pharmaceutical Form

Inhalation powder.

White to off-white powder agglomerates.

Qualitative and quantitative composition

Each delivered dose contains 200 micrograms of mometasone furoate.

Excipients with known effect: The maximum recommended daily dose contains lactose 4.64 mg per day.

For the full list of excipients, see 6.1.

Active Ingredient Description
Mometasone

Mometasone is a topical glucocorticoid with local anti-inflammatory properties. It is likely that much of the mechanism for the effects of mometasone lies in its ability to inhibit the release of mediators of the inflammatory cascade.

List of Excipients

Lactose anhydrous (which contains trace amounts of milk proteins).

Pack sizes and marketing

Multi-dose powder inhaler.

A counter on the device indicates the number of doses remaining.

The 200 microgram powder inhaler is coloured white with a pink base, and is a multi-component device composed of polypropylene copolymer, polybutylene terephthalate, polyester, acrylonitrile-butadiene-styrene, bromo-butyl rubber and stainless steel. It contains a silica gel desiccant cartridge in the white polypropylene cap. The inhaler device is enclosed in an aluminium foil laminate pouch.

Pack sizes:

Pack of 1 pouched inhaler containing 30 delivered doses.

Pack of 1 pouched inhaler containing 60 delivered doses.

Pack of 3 individually packed and pouched inhalers with each inhaler containing 60 delivered doses.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Marketing authorization dates and numbers

PL 00025/0588

30 April 2001 / 9 August 2006

Drugs

Drug Countries
ASMANEX Austria, Canada, Germany, Spain, Finland, France, Hong Kong, Ireland, Japan, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa

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