TILADE Pressurised inhalation suspension Ref.[9324] Active ingredients: Nedocromil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, G6 1PT, UK Trading as: anofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Tilade CFC-Free Inhaler 2mg per actuation pressurised inhalation suspension.

Pharmaceutical Form

Pressurised inhalation suspension.

Tilade CFC-Free Inhaler/Syncroner/Fisonair contains a new propellant, HFA-227, and does not contain any chlorofluorocarbons (CFCs).

Qualitative and quantitative composition

One metered dose (ex-valve) contains 2 mg nedocromil sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nedocromil

Nedocromil is a non-steroidal agent, which has anti-inflammatory properties when administered topically in the lung. In the treatment of bronchial asthma, nedocromil sodium reduces bronchospasm, cough and bronchial hyperreactivity and improves objective measurements of lung function.

List of Excipients

1,1,1,2,3,3,3-heptafluoropropane (HFA227)
Ppovidone K30
Macrogol 600
Levomenthol

Pack sizes and marketing

The aluminium can is fitted with a metering valve which delivers actuations each containing 2 mg of nedocromil sodium. Each canister contains 112 actuations.

Tilade CFC-Free Inhaler: The cartoned pack consists of;

  • an aerosol canister and a plastic adaptor with a dustcap
  • an aerosol canister and two plastic adaptors with dustcaps

Tilade CFC-Free Syncroner: The cartoned pack consists of either one or two aerosol canisters, each with a spacer device and a dustcap.

Tilade CFC-Free Fisonair: The cartoned pack consists of an aerosol canister and a plastic adaptor with a dustcap and a holding chamber.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, G6 1PT, UK

Trading as: anofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0342

11 October 2005

Drugs

Drug Countries
TILADE Austria, Australia

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