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Intal CFC-free Inhaler 5mg Pressurised Inhalation, Suspension (2011)

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.

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 dustcap.

Marketing authorization holder
Authorization dates

Sanofi-aventis
One Onslow Street
Guildford
Surrey
GU1 4YS
UK

Date of first authorisation: 3 November 2000

Date of latest renewal: 1 March 2006

Marketing authorization number:

PL 04425/0179