FOSTER NEXTHALER INHALATION POWDER 100 MCG6 MCG PER DOSE

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Beclometasone dipropionate anhydrous (micronized); Formoterol fumarate dihydrate (micronized)

Available from:

ORIENT EUROPHARMA PTE LTD

ATC code:

R03AK08

Pharmaceutical form:

POWDER, METERED

Composition:

Beclometasone dipropionate anhydrous (micronized) 100mcg/dose; Formoterol fumarate dihydrate (micronized) 6mcg/dose

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

Chiesi Farmaceutici SpA

Authorization status:

ACTIVE

Authorization date:

2017-09-19

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Foster NEXThaler 100 micrograms/6 micrograms per dose inhalation
powder.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of 10 mg inhalation powder contains:
100 micrograms of beclometasone dipropionate anhydrous and 6
micrograms of formoterol fumarate
dihydrate.
This is equivalent to a delivered dose (the dose leaving the
mouthpiece) of 81.9 micrograms of
beclometasone dipropionate anhydrous and 5.0 micrograms of formoterol
fumarate dihydrate.
Excipients with known effect:
Each inhalation contains 9.9 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder.
The multidose inhaler contains a white or almost white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASTHMA
Foster NEXThaler is indicated in the regular treatment of asthma where
use of a combination
product (inhaled corticosteroid and long-acting beta
2
-agonist) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and
'as needed' inhaled short-acting
beta
2
-agonist or
- patients already adequately controlled on both inhaled
corticosteroids and long-acting beta
2
-
agonists.
Foster NEXThaler is indicated for adult patients.
COPD
Symptomatic treatment of patients with severe COPD (FEV
1
< 50% predicted normal) and a history
of repeated exacerbations, who have significant symptoms despite
regular therapy with long-acting
bronchodilators.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Foster NEXThaler is for inhalation use.
ASTHMA
Foster NEXThaler is not intended for the initial management of asthma.
The dosage of Foster
NEXThaler is individual and should be adjusted to the severity of the
disease. This should be
considered not only when treatment with combination products is
initiated but also when the dose is
adjusted. If an individual patient should require a combination of
doses other than those available in
the combination inhaler, appropriate doses of beta
2
-agonists and/or cor