Beclometasone dipropionate 100 mcg + Formoterol fumarate dihydrate 6 mcg + Glycopyrronium bromide 12
Trimbow®
PHARMACEUTICAL FORM
Pressurized inhalation, solution.
Colourless to yellowish liquid solution.
CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Registration No.: DR-XY47266
Manufactured by:
Chiesi Farmaceutici S.p.A.
Via San Leonardo,96-43122 Parma, Italy
Shelf life: 20 months
Beclometasone Dipropionate 100 mcg + Formoterol Fumarate Dihydrate 6 mcg Pdr for Inhal'n
Foster Nexthaler
PHARMACEUTICAL FORM:
Inhalation powder.
The multidose inhaler contains a white or almost white powder.
INSTRUCTIONS FOR USE OF NEXTHALER INHALER
A. Contents of the Package
For information on the Contents of the Package, see section 6.If the package contents are not the same as described in section 6, return
your inhaler to the person who supplied it and get a new one.
B. General Warnings & Precautions
• Do not remove the inhaler from the pouch if you do not intend to use it immediately.
• Only use your inhaler as indicated.
• Keep the cover closed until you need to take a dose from your inhaler.
• When you are not using your inhaler keep it in a clean and dry place.
• Do not attempt to take your Nexthaler inhaler apart for any reason.
COPD
Dose recommendations for adults 18 years and above:
Two inhalations twice daily
MANUFACTURER: Chiesi Farmaceutici, S.p.A., Italy
FDA REG. NO. DR-XY45648
SHELF-LIFE: 24 months
Beclometasone Dipropionate100 mcg +Formoterol Fumarate Dihydrate 6 mcg MDI
Foster
FORMULATION
Each actuation/metered dose (ex-valve) contains :
Beclometasone dipropionate (corresponding to 84.6 mcg as deliverable dose)100 mcg
Formoterol fumarate dihydrate (corresponding to 5 mcg as deliverable dose)6 mcg
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The drug should be used with caution (which may include monitoring) in patients with cardiac arrhythmias, especially third degree
atrioventricular block and tachyarrhythmias (accelerated and/or irregular heart beat), idiopathic subvalvular aortic stenosis,
hypertrophic obstructive cardiomyopathy, severe heart disease, particularly acute myocardial infarction, ischaemic heart disease,
congestive heart failure, occlusive vascular diseases, particularly arteriosclerosis, arterial hypertension and aneurysm.
Caution should also be observed when treating patients with known or suspected prolongation of the QTc interval, either congenital or
drug induced (QTc > 0.44 seconds). Formoterol itself may induce prolongation of the QTc interval
DOSAGE AND ADMINISTRATION
The drug is for inhalation use
MANUFACTURER: Chiesi Farmaceutici, S.p.A., Italy
FDA REG. NO. DR-XY42146
SHELF-LIFE: 17 months
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