Source: Medicines Authority (MT) Revision Year: 2022 Publisher: Glenmark Pharmaceuticals Nordic AB, Propellergatan 2, SE-211 15 Malmö, Sweden
Salmex 50 microgram/500 microgram/dose inhalation powder, pre-dispensed.
| Pharmaceutical Form |
|---|
|
Inhalation powder, pre-dispensed. Molded plastic inhaler containing a foil strip with 60 regularly placed blisters. |
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 47 micrograms of salmeterol (as salmeterol xinafoate) and 460 micrograms of fluticasone propionate. This corresponds to a pre-dispensed dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms fluticasone propionate.
Excipient(s) with known effect: Each dose contains lactose up to 13.3 milligram.
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 |
|---|
|
Lactose monohydrate (which contains milk proteins) |
Blisters made from polyamide (OPA)/Aluminium/polyvinyl chloride (PVC)/Aluminium/polyethylene terephthalate (PET)/paper contained in a molded plastic inhaler equipped with a mouthpiece and dose counter. The inhaler is packed in a cardboard box.
One inhaler contains 60 inhalations.
The plastic devices are available in cardboard containers, which hold 1 × 60 dose, 2 × 60 dose, 3x 60 dose, 10 × 60 dose Salmex
Not all pack sizes may be marketed.
Glenmark Pharmaceuticals Nordic AB, Propellergatan 2, SE-211 15 Malmö, Sweden
MA1357/00101
05th November 2018
| Drug | Countries | |
|---|---|---|
| SALMEX | Finland, Malta, Poland, Romania |
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