Trimbow 87microgramsdose 5microgramsdose 9microgramsdose inhaler

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Beclometasone dipropionate; Glycopyrronium bromide; Formoterol fumarate dihydrate

Διαθέσιμο από:

Chiesi Ltd

INN (Διεθνής Όνομα):

Beclometasone dipropionate; Glycopyrronium bromide; Formoterol fumarate dihydrate

Δοσολογία:

87microgram/1dose ; 9microgram/1dose ; 5microgram/1dose

Φαρμακοτεχνική μορφή:

Pressurised inhalation

Οδός χορήγησης:

Inhalation

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Never Valid To Prescribe As A VMP

Περίληψη προϊόντος:

BNF: ; GTIN: 5028613003053

Φύλλο οδηγιών χρήσης

PROOF N.
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30/05/17
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(Mac - IDCC) MS
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TECHNICAL WORKING
(5)
COD. SOST./REPLACES CODE: /
RIF./MOCK UP REFERENCE: 00309/RE
LINEA CONFEZIONAMENTO/
PACKAGING LINE:
SPRAY
CHIESI FARMACEUTICI
S.P.A. - PARMA - ITALIA
VIETATA LA MANOMISSIONE
D.Q.O.C.
UG - AUTORE/ARTWORKS LAB.:
MS/SB
MAIL: [e-mail]
(1) DESCRIZIONE MATERIALE /DESCRIPTION OF MATERIAL
DIMENSIONI/DIMENSIONS
180 x 370 mm
(4) CODICE/ CHIESI FARMACEUTICI ITEM
0108003071/01
(2) F.TO A.A./FORMAT
F109
(3)
N° PHARMACODE 56
(cod. barre)
DATAMATRIX: /
DIMENSIONI PIEGATO/ AFTER FOLDING
180 x 38 mm
COLORI DI STAMPA/COLOURS PRINT: N. 1
FUSTELLA/
DIE
F.E. TRIMBOW PMDI 87/5/9 MCG 120 D GB LUGLIO
(7) RIF. RICH. DI CODIFICA DEL /REFERS TO NEW CODE REQUEST OF
25/05/2017 - (6) MOTIVO/REASON:
- Regolatorio/REGULATORY MODIFICATION: TRIMBOW LAUNCH;
- Tecnico/TECHNICAL MODIFICATION: /
NOTE PER IL FORNITORE/NOTE FOR SUPPLIER:
TOT. PAG. PDF: N. 4
LINGUA/LANGUAGE:
English
BLACK+ halft.
TECHNICAL INFORMATION / INFORMAZIONI TECNICHE
DEFINITIVO: X PDF per il fornitore e Chiesi Farmaceutici / FINAL
PRINT: X PDF FOR SUPPLIER AND CHIESI FARMACEUTICI
CARATTERE/FONT: Ubuntu
CORPO/SIZE: 8 pt
INTERLINEA/LINE SPACING: 8,5 pt
180
38
38
180
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ZONE
BAR - CODE
ZONE
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TEXT DIRECTION
LEAFLET 1
LEAFLET 1
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Leaflet 1 Pag. 3/4
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BIANCA/FRONT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING 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.
-
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illnes

Αρχείο Π.Χ.Π.

OBJECT 1
TRIMBOW 87 MICROGRAMS/5 MICROGRAMS/9
MICROGRAMS PRESSURISED INHALATION, SOLUTION
Summary of Product Characteristics Updated 26-Jul-2017 | Chiesi
Limited
1. Name of the medicinal product
Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised
inhalation, solution
2. Qualitative and quantitative composition
Each delivered dose (the dose leaving the mouthpiece) contains 87
micrograms of beclometasone
dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9
micrograms of glycopyrronium (as 11
micrograms glycopyrronium bromide).
Each metered dose (the dose leaving the valve) contains 100 micrograms
of beclometasone dipropionate,
6 micrograms of formoterol fumarate dihydrate and 10 micrograms of
glycopyrronium (as 12.5
micrograms glycopyrronium bromide).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pressurised inhalation, solution (pressurised inhalation).
Colourless to yellowish liquid solution.
4. Clinical particulars
4.1 Therapeutic indications
Maintenance treatment in adult patients with moderate to severe
chronic obstructive pulmonary disease
(COPD) who are not adequately treated by a combination of an inhaled
corticosteroid and a long-acting
beta2-agonist (for effects on symptoms control and prevention of
exacerbations see section 5.1).
4.2 Posology and method of administration
Posology
_Adults_
The recommended dose is two inhalations of Trimbow twice daily.
The maximum dose is two inhalations of Trimbow twice daily.
Special populations
_Elderly _
No dosage adjustment is required in elderly patients (65 years of age
and older).
_Renal impairment_
Trimbow can be used at the recommended dose in patients with mild to
moderate renal impairment. Use
of Trimbow in patients with severe renal impairment or end-stage renal
disease requiring dialysis,
especially if associated with significant body weight reduction,
should be considered only if the expected
benefit outweighs the potential risk (see section 4.4 and section
5.2).
_Hepatic impairment_
There are no relevant data