Fostair 100micrograms/dose / 6micrograms/dose inhaler

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Formoterol fumarate dihydrate; Beclometasone dipropionate

Fáanlegur frá:

Chiesi Ltd

ATC númer:

R03AK08

INN (Alþjóðlegt nafn):

Formoterol fumarate dihydrate; Beclometasone dipropionate

Skammtar:

6microgram/1dose ; 100microgram/1dose

Lyfjaform:

Pressurised inhalation

Stjórnsýsluleið:

Inhalation

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 03020000; GTIN: 5028613002797

Upplýsingar fylgiseðill

DRAFT
1
(Mac - IDcc)
06/04/2018
CARATTERE/FONT: Arial
CORPO/SIZE: 10pt
(5)
COD. SOST./REPLACES CODE:
0108002474/01
LINEA CONFEZIONAMENTO/
PACKAGING LINE:
SPRAY
CHIESI FARMACEUTICI
S.P.A. - PARMA - ITALIA
VIETATA LA MANOMISSIONE
D.Q.O.C.
UG - AUTORE/ARTWORKS LAB.:
MS
MAIL: [e-mail]
(1) DESCRIZIONE MATERIALE /DESCRIPTION OF MATERIAL
DIMENSIONI/DIMENSIONS
540 x 300 mm
(4) CODICE/ CHIESI FARMACEUTICI ITEM
0108003833/01
(2) F.TO A.A./FORMAT
F065
(3)
N° PHARMACODE 669
(cod. barre)
DATAMATRIX: /
DIMENSIONI PIEGATO/ AFTER FOLDING
180 x 38 mm
COLORI DI STAMPA/COLOURS PRINT: N. 1
FUSTELLA/
DIE
F.E.FOSTAIR 100/6MCG 120D MDI DC CH LTD
(7) RIF. RICH. DI CODIFICA DEL /REFERS TO NEW CODE REQUEST OF
05/04/2018- (6) MOTIVO/REASON:
- Regolatorio/REGULATORY MODIFICATION: TYPE II VARIATION FOR TEXT
HARMONISATION, CHANGE ON PIL
- Tecnico/TECHNICAL MODIFICATION: UPDATED LAETUS AND CHIESI
FARMACEUTICI ITEM
PRODUCTION LINE:
BLOIS SITE AND PARMA SITE
NOTE PER IL FORNITORE/NOTE FOR SUPPLIER:
TOT. PAG. PDF: N.2
LINGUA/LANGUAGE:
ENGLISH
BLACK+ halftones
TECHNICAL INFORMATION / INFORMAZIONI TECNICHE
DEFINITIVO: X PDF per il fornitore e Chiesi Farmaceutici / FINAL
PRINT: X PDF FOR SUPPLIER AND CHIESI FARMACEUTICI
PAG. 1/2
0108003833/01
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, or pharmacist or
nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects talk with your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. WHAT FOSTAIR IS AND WHAT IT IS USED FOR.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FOSTAIR
3. HOW TO USE FOSTAIR
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE FOSTAIR
6. CONTENT OF THE PACK AND OTHER INFORMATION
1. WHAT FOSTAIR IS AND WH

Vara einkenni

OBJECT 1
FOSTAIR 100/6 INHALATION SOLUTION
Summary of Product Characteristics Updated 16-Apr-2018 | Chiesi
Limited
1. Name of the medicinal product
Fostair 100/6 micrograms per actuation pressurised inhalation
solution.
2. Qualitative and quantitative composition
Each metered dose (ex-valve) contains:
100 micrograms of beclometasone dipropionate and 6 micrograms of
formoterol fumarate dihydrate. This
is equivalent to a delivered dose (ex-actuator) of 84.6 micrograms of
beclometasone dipropionate and 5.0
micrograms of formoterol fumarate dihydrate.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Pressurised inhalation, solution.
Colourless to yellowish solution.
4. Clinical particulars
4.1 Therapeutic indications
Asthma
Fostair 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 rapid-acting
beta
2
-agonist or
- patients already adequately controlled on both inhaled
corticosteroids and long-acting beta
2
-agonists.
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
FOSTAIR is for inhalation use.
POSOLOGY
ASTHMA
FOSTAIR is not intended for the initial management of asthma. The
dosage of the components of Fostair
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 corticosteroids by individual inhalers should be
prescribed.
Beclometasone dipropionate in Fostair is characterised by an extrafine
partic