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SPC, UK: CLENIL Pressurised inhalation solution (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Clenil Modulite 50 micrograms per actuation pressurised inhalation solution.

Qualitative and quantitative composition

Beclometasone dipropionate 50 micrograms per metered (ex-valve) dose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Pressurised inhalation solution. Clenil Modulite contains the new propellant HFA-134a and does not contain any chlorofluorocarbons (CFCs). The solution is clear and colourless.

Therapeutic indications

Clenil Modulite is indicated for the prophylactic management of mild, moderate, or severe asthma in adults or children: Mild asthma: Patients requiring intermittent symptomatic bronchodilator asthma medication ...

Posology and method of administration

Posology Clenil Modulite is for inhalation use only. The Volumatic spacer device may be used by patients who have difficulty synchronising aerosol actuation with inspiration of breath. The starting dose ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Patients should be properly instructed on the use of the inhaler to ensure that the drug reaches the target areas within the lungs. Patients should also be informed that Clenil Modulite should be used ...

Interaction with other medicinal products and other forms of interaction

Clenil Modulite contains a small amount of ethanol. There is a theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole. Beclometasone is less dependent ...

Fertility, pregnancy and lactation

There is no experience of the use of this product in pregnancy and lactation in humans. It should not be used in pregnancy or lactation unless the expected benefits to the mother are thought to outweigh ...

Effects on ability to drive and use machines

None reported.

Undesirable effects

Adverse events are listed below by system class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000), ...

Overdose

Acute Inhalation of doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not require emergency action. In these patients treatment should be continued at ...

Pharmacodynamic properties

Pharmacotherapeutic Group: Glucocorticoid ATC Code: R03BA01 Beclometasone dipropionate is a pro-drug with weak glucocorticoid receptor binding affinity. It is extensively hydrolysed via esterase enzymes ...

Pharmacokinetic properties

Absorption when administered via inhalation by a MDI Systemic absorption of unchanged beclometasone dipropionate (BDP) occurs through the lungs. There is negligible oral absorption of the swallowed dose ...

Preclinical safety data

Preclinical safety studies indicate that beclometasone dipropionate shows negligible systemic toxicity when administered by inhalation. The non-CFC propellant HFA-134a has been shown to have no toxic effect ...

List of excipients

HFA-134a Ethanol Glycerol

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C. As with most inhaled medicines in aerosol canisters, the therapeutic effect may decrease when the canister is cold. Protect from frost and direct sunlight. The canister contains ...

Nature and contents of container

Clenil Modulite 50 is supplied in an aluminium canister fitted with a metering valve, actuator and dust cap. Each inhaler delivers 200 actuations.

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom

Marketing authorization number(s)

PL 08829/0133

Date of first authorization / renewal of the authorization

29/06/2006 / 11/10/12

Date of revision of the text

12/2018

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