INTAL CFC-FREE Pressurised inhalation, suspension Ref.[7203] Active ingredients: Cromoglicic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Intal CFC-free Inhaler 5mg Pressurised Inhalation, Suspension.

Pharmaceutical Form

Intal CFC-free pressurised inhalation suspension is presented as a metered dose inhaler, containing sodium cromoglicate as a suspension in a new non-CFC propellant, apaflurane (HFA-227), for inhalation. The product contains no chlorofluorocarbons (CFCs).

Qualitative and quantitative composition

The active component of Intal CFC-free is sodium cromoglicate 3.521% w/w. Each canister provides at least 112 actuations each containing 5 mg of sodium cromoglicate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Cromoglicic acid

Sodium cromoglicate (Cromoglicic acid) inhibits the activation of many of the cell types involved in the development and progression of asthma. Thus, sodium cromoglicate inhibits the release of inflammatory mediators including cytokines from mast cells and reduces the chemotactic activity of eosinophils and neutrophils.

List of Excipients

Polyvidone K30
Polyethylene glycol (PEG) 600
Apaflurane (HFA 227 – a non ozone depleting propellant)

Pack sizes and marketing

The aluminium can is fitted with a metering valve which delivers 112 actuations each containing 5 mg of sodium cromoglicate.

Intal CFC-free Inhaler: The cartoned pack consists of an aerosol canister and a plastic adaptor with a dust cap.

Intal CFC-free Syncroner: The cartoned pack consists of either one or two aerosol canisters, each with a spacer device and dust cap.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as:

Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0179

Date of first authorisation: 3 November 2000
Date of latest renewal: 1 March 2006

Drugs

Drug Countries
INTAL Australia, Japan, Turkey, United Kingdom

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