BECLATE Nasal spray Ref.[50453] Active ingredients: Beclometasone

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: CIPLA MEDPRO (PTY) LTD., Rosen Heights, Pasita Street, Rosen Park, Bellville, 7530. RSA

Product name and form

BECLATE AQUANASE (aqueous nasal spray).

Pharmaceutical Form

Nasal spray.

A white homogenous, redispersable suspension.

Qualitative and quantitative composition

Each metered spray contains 50 ยตg beclomethasone dipropionate.

Preservatives:

Benzalkonium chloride 0,01% v/v
Phenyl ethyl alcohol 0,25% v/v.
Contains sugar (glucose 500,0 mg/10 ml)

For a full list of excipients, see section 6.1.

Active Ingredient Description
Beclometasone

Beclometasone is a pro-drug with weak glucocorticoid receptor binding affinity. It is extensively hydrolysed via esterase enzymes to the active metabolite beclometasone-17-monopropionate (B-17-MP), which has potent topical anti-inflammatory activity.

List of Excipients

Glucose (anhydrous)
Microcrystalline cellulose + carboxy methyl cellulose sodium
Polysorbate 80
Phenyl ethyl alcohol 0,25% v/v.
Benzalkonium chloride 0,01% v/v
Water for injection

Pack sizes and marketing

10 ml amber glass vial fitted with a metering atomising pump and nasal adaptor.

Each vial contains 7,5 ml of nasal spray (150 doses).

Marketing authorization holder

CIPLA MEDPRO (PTY) LTD., Rosen Heights, Pasita Street, Rosen Park, Bellville, 7530. RSA

Marketing authorization dates and numbers

30/21.5.1/0079

06 February 1996

Drugs

Drug Countries
BECLATE Ecuador, Hong Kong, South Africa

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