Примери за използване на Clenil на Английски и техните преводи на Български
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What is Clenil?
On 15 September 2016, the European Medicines Agency completed a review of Clenil.
Why was Clenil reviewed?
Clenil Compositum Beclometasone Dipropionate 0.8mg/2 Ml, Salbutamol Sulfate 1.928mg/2 Ml.
The committee agreed on a harmonised product information for Clenil and associated names.
Clenil is a medicine used for the maintenance treatment of asthma in adults and children.
The committee considered the divergences identified in the notification for Clenil and associated names, as well as the remaining sections of the product information.
Clenil is marketed in the following EU Member States: France, Germany, Greece, Ireland and Italy.
For the recurrent wheezing indication in young children,the CHMP concluded that if no treatment benefit of is observed within 2-3 months, Clenil should be discontinued.
Clenil Compositum Beclometasone Dipropionate 50µg Actuation, Salbutamol Sulfate 120µg Actuation.
In children with recurrent wheezing the response to treatment should be carefully monitored;if no benefit is observed within 2-3 months, Clenil should be discontinued.
The starting dose of Clenil depends on the frequency and severity of symptoms and it can be adjusted until symptoms are under control.
On 19 June 2015, the Italian medicines regulatory agency referred the matter to the CHMP in order to harmonise the marketing authorisations for Clenil and associated names in the EU.
Questions and answers on Clenil and associated names(beclometasone dipropionate, 400 and 800 microgram nebuliser suspension).
BDP nebuliser(nBDP) suspension products are authorised in five EU member states including France, Germany, Greece, Ireland and Italy under different invented names: Sanasthmax, Becloneb,Beclospin, Clenil.
Clenil contains the active substance beclometasone dipropionate(which belongs to a group of antiinflammatory medicines commonly known as‘corticosteroids').
In children up to 5 years of age, the decision to start Clenil for the treatment of recurrent wheezing should be determined by the severity and frequency of the wheezing episodes.
Clenil is currently indicated for the treatment of other respiratory conditions with the narrowing of the airways in the lungs(bronchostenotic condition) in Italy.
If no treatment benefit is observed within 2-3 months orif a diagnosis of asthma is not likely, Clenil should be discontinued to avoid unnecessary long-term exposure to inhaled corticosteroids and associated risks in children.
The CHMP agreed that Clenil can be used for the maintenance treatment of asthma in adults and children when the use of pressurised or dry powder inhalers is unsatisfactory or inappropriate.
Due to the divergent national decisions taken by Member States concerning the authorisation of nBDPcontaining products, Italy notified the CHMP/European Medicines Agency on 19 June 2015 of a referral under Article 30 of Directive 2001/83/EC for Clenil and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise its divergent product information across the EU.
However, the Committee considered that Clenil can be used to treat recurrent wheezing in children up to 5 years of age because this use is supported by adequate data.
Clenil(and associated names) monodose was first approved through national procedure in Italy in 1991, then was approved through national procedures in France, while in Ireland, Germany and Greece through Mutual Recognition procedure with Ireland as Reference Member State.
The Committee agreed that Clenil should no longer be used to treat common bronchostenotic conditions(narrowing of the airways in the lungs) because of the lack of rigorous evidence from adequately designed clinical studies.
The CHMP also agreed that Clenil should no longer be used to treat allergic rhinitis(inflammation of the nasal passages caused by an allergy, for example hay fever or allergy to dust mites) because the available data do not support this use and other medicines available as nasal sprays may be better tolerated.