Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Cipla (EU) limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom
Sereflo 25 microgram/125 microgram per actuation pressurised inhalation, suspension.
| Pharmaceutical Form |
|---|
|
Pressurised inhalation, suspension. The canister contains a white to off-white suspension. The canisters are fitted into white plastic actuators incorporating an atomising orifice and fitted with pink (25 microgram/125 microgram) dust-caps. |
Each metered dose (ex valve) contains:
25 micrograms of salmeterol (as salmeterol xinafoate) and 125 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex actuator) of 21 micrograms of salmeterol and 110 micrograms of fluticasone propionate.
For the full list of excipients see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fluticasone |
Fluticasone has anti-inflammatory and vasoconstrictive features. Fluticasone given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of both symptoms and exacerbations of asthma, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically. |
|
| Salmeterol |
Salmeterol is a selective long-acting (12 hour) β2 adrenoceptor agonist. These pharmacological properties of salmeterol offer more effective protection against histamine-induced bronchoconstriction and produce a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting β2 agonists. |
| List of Excipients |
|---|
|
Propellant: norflurane (HFA 134a) |
Aluminium canister with a suitable metering valve and a polypropylene white actuator with pink or rubine red dust-caps having dose indicator in a sealed pouch containing desiccant. The actuator has a counter attached which shows how many actuations of medicine are left in the canister.
Each container is filled to deliver 120 doses.
Pack sizes:
1, 2 (bundled package 2x1) or 3 (bundled package 3x1) canisters containing 120 doses.
10 (bundled package 10x1) canisters containing 120 doses -hospital/pharmacy use only
Not all pack sizes may be marketed.
Cipla (EU) limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom
PL 36390/0237
Date of first authorisation: 22/12/2016
Date of renewal: 29/10/2021
| Drug | Countries | |
|---|---|---|
| SEREFLO | Ireland, United Kingdom, South Africa |
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