BECLAZONE 250mg Pressurised inhalation, solution (2011)
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Περιεχόμενα
1. Name of the medicinal product
Beclazone 250 micrograms CFC-Free Inhaler Pressurised Inhalation Solution.
2. Qualitative and quantitative composition
One metered dose contains 250 micrograms Beclometasone Dipropionate Anhydrous. For a full list of excipients, see Section 6.1.
3. Pharmaceutical form
Pressurised Inhalation, Solution. Pressurised container fitted with a metering valve and an actuator. The colour of the actuator is wine with a pink dust cap.
4.1. Therapeutic indications
Beclazone 250 micrograms CFC-Free Inhaler is indicated for those asthmatic patients who have been shown to require high doses of beclometasone dipropionate anhydrous to control their symptoms. It may also ...
4.2. Posology and method of administration
The preparation is intended for oral inhalation only. For optimum results, beclometasone dipropionate anhydrous should be used regularly. The initial dose of inhaled beclometasone dipropionate anhydrous ...
4.3. Contraindications
Hypersensitivity to Beclometasone Dipropionate Anhydrous or to any of the excipients.
4.4. Special warnings and precautions for use
Steroid‑dependent patients: The transfer of steroid‑dependent patients to beclometasone dipropionate anhydrous inhalers and their subsequent management, needs special care mainly because recovery from ...
4.5. Interaction with other medicinal products and other forms of interaction
Concurrent administration of barbiturates, phenytoin or rifampicin may enhance the metabolism and reduce the effects of oral corticosteroids. Response to anti‑coagulants may be reduced and, on some occasions ...
4.6. Pregnancy and lactation
No specific studies have been performed examining the safety in human pregnancy and lactation for BDP HFA. Beclometasone inhalation may be associated with intrauterine growth retardation in humans. Studies ...
4.7. Effects on ability to drive and use machines
Beclazone 250 micrograms CFC-Free Inhaler has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Frequency estimate: very common = 10%, common = 1% to <10%, uncommon = 0.1% to <1%, rare = 0.01% to <0.1%, very rare <0.01% Infections and infestations <u>Common (>1/100 and <1/10):</u> Candidiasis in ...
4.9. Overdose
The acute toxicity of beclometasone dipropionate anhydrous is low. The only harmful effect that follows inhalation of large amounts of the drug over a short period is suppression of hypothalamic‑pituitary‑adrenal ...
5.1. Pharmacodynamic properties
<b>ATC Code:</b> R03BA01 Beclometasone dipropionate anhydrous given by inhalation has a glucocorticoid anti-inflammatory action within the lungs. The exact mechanism responsible for this anti-inflammatory ...
5.2. Pharmacokinetic properties
Beclometasone dipropionate anhydrous is readily absorbed after oral inhalation. About 25% of an inhaled dose reaches the lungs. The drug and its metabolites are excreted chiefly in the faeces via biliary ...
5.3. Preclinical safety data
Preclinical studies in rats and dogs with beclometasone dipropionate anhydrous formulated in HFA-134a propellant have shown dose related typical signs of glucocorticoid excess. Beclometasone Dipropionate ...
6.1. List of excipients
Ethanol anhydrous 99.5% Norflurane (HFA 134a)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister.
6.5. Nature and contents of container
Pressurised container fitted with a metering valve. The can is of 19ml nominal capacity manufactured from aluminium with either a debossed or a plain base. The can opening is configured to accept 20mm ...
6.6. Special precautions for disposal and other handling
The canister is pressurised; it must not be burnt, punctured or broken even when apparently empty. Medicines no longer required should not be disposed of via wastewater or the municipal sewage system. ...
7. Marketing authorization holder
George Petrou Ltd., 50, Areos Str, Latsia 2234, Nicosia, Cyprus
8. Marketing authorization number(s)
14682
9. Date of first authorization / renewal of the authorization
4<sup>th</sup> April 1994 / 5<sup>th</sup> April 2004
10. Date of revision of the text
April 2011
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