TILADE Pressurised inhalation suspension (2019)
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Περιεχόμενα
Name of the medicinal product
Tilade CFC-Free Inhaler 2mg per actuation pressurised inhalation suspension.
Qualitative and quantitative composition
One metered dose (ex-valve) contains 2 mg nedocromil sodium. For the full list of excipients, see section 6.1.
Pharmaceutical form
Pressurised inhalation suspension. Tilade CFC-Free Inhaler/Syncroner/Fisonair contains a new propellant, HFA-227, and does not contain any chlorofluorocarbons (CFCs).
Therapeutic indications
Tilade CFC-Free is recommended for the treatment of bronchial asthma where regular preventative anti-inflammatory therapy is indicated and, in particular, in patients whose asthma is not adequately controlled ...
Posology and method of administration
Posology For inhalation use. Adults, including the elderly and children over 6 years of age The initial dose is 4 mg (2 actuations) four times daily. Once control of symptoms has been achieved it may be ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Tilade CFC-Free must not be used for the relief of an acute attack of bronchospasm. Since therapy is prophylactic, it is important that Tilade CFC-Free be used regularly, every day, in those patients who ...
Interaction with other medicinal products and other forms of interaction
Nedocromil sodium has been used in association with numerous other drugs in man, including oral and inhaled β-adrenergic agonists, inhaled and oral corticosteroids, theophylline and other methylxanthines ...
Pregnancy and lactation
Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. Studies in pregnant and lactating animals have failed ...
Effects on ability to drive and use machines
Tilade CFC Free has no or negligible influence on the ability to drive and use machines.
Undesirable effects
The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1% and <10%; Uncommon ≥0.1% and <1%; Rare ≥0.01% and <0.1%; Very rare <0.01%; Unknown (cannot be estimated from ...
Overdose
Animal studies have not shown evidence of significant toxic effects with nedocromil sodium even at high doses, nor have extended human studies with nedocromil sodium revealed any safety hazard with the ...
Pharmacodynamic properties
Tilade CFC-Free contains nedocromil sodium, a non-steroidal agent, which has anti-inflammatory properties when administered topically in the lung. In-vivo, ex-vivo and in-vitro studies have shown that ...
Pharmacokinetic properties
Absorption After inhalation of nedocromil sodium (in common with other drugs inhaled using an MDI) a small fraction (generally 10%) reaches the lungs, while a major portion of the dose is deposited in ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...
List of excipients
1,1,1,2,3,3,3-heptafluoropropane (HFA227) Ppovidone K30 Macrogol 600 Levomenthol
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Do not store in a refrigerator or freezer. Protect from direct sunlight. The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
Not applicable.
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 number(s)
PL 04425/0342
Date of first authorization / renewal of the authorization
11 October 2005
Date of revision of the text
09 August 2019
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