Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE
Mercury Pharmaceuticals Ltd
BECLOMETASONE DIPROPIONATE
50 Mcg/Dose
Nasal Spray Suspension
Product subject to prescription which may be renewed (B)
Withdrawn
2009-05-13
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Beclo-Rhino 50 microgram Aqueous Nasal Spray Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Beclomethasone Dipropionate 50 micrograms per spray. For excipients see 6.1. 3 PHARMACEUTICAL FORM Nasal spray suspension A glass vial fitted with a metered pump and nasal tip containing an opaque white nasal spray suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and treatment of perennial and seasonal allergic rhinitis, including hay fever and vasomotor rhinitis. Inflammatory rhinitis, especially eosinophil-induced rhinitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 1 Spray = 50mg beclomethasone dipropionate. For administration by the intra-nasal route. Adults and the elderly: Two sprays into each nostril twice daily = 400 micrograms/day. In some patients, a preferred dosage may be one spray into each nostril three or four times daily. The total daily dose should not exceed eight sprays. For maximum therapeutic benefit regular use is essential. Maximum benefit may not be obtained in the first few doses, and the co-operation of patients is required to ensure compliance with a regular dosage schedule. Children: (over 6 years). As for adults and the elderly. Use by children under 6 years of age is not recommended because of insufficient clinical data. 4.3 CONTRAINDICATIONS Patients with a known hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Beclomethasone Aqueous Nasal Spray is not specifically contra-indicated in the presence of infections of the nasal passages or paranasal sinuses, but these infections should be treated appropriately. When patients are transferred from systemic steroid therapy to Beclomethasone aqueous nasal spray, care সম্পূর্ণ নথি পড়ুন