Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, UNITED KINGDOM
Braltus 10 microgram per delivered dose inhalation powder, hard capsule.
| Pharmaceutical Form |
|---|
|
Inhalation powder, hard capsule. Colourless and transparent, size 3 capsules, containing white powder. |
Each capsule contains 16 micrograms of tiotropium bromide, equivalent to 13 micrograms of tiotropium.
The delivered dose (the dose that leaves the mouthpiece of the Zonda inhaler) is 10 micrograms of tiotropium per capsule.
Excipient with known effect:
Each capsule contains 18 milligrams lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tiotropium |
Tiotropium is a long-acting, specific, muscarinic receptor antagonist, in clinical medicine often called an anticholinergic. By binding to the muscarinic receptors in the bronchial smooth musculature, tiotropium inhibits the cholinergic (bronchoconstrictive) effects of acetylcholine, released from parasympathetic nerve endings. |
| List of Excipients |
|---|
|
Lactose monohydrate (which contains milk protein) Capsule composed of hydroxypropylmethylcellulose (HPMC), commonly known as Hypromellose. |
High density polyethylene (HDPE) bottles closed with polypropylene (PP) screw-caps with polyethylene (PE) safety ring and low density polyethylene (LDPE) desiccant capsule containing silica gel. Each bottle contains 15 or 30 capsules, supplied in a carton with a Zonda inhaler.
The Zonda inhaler is a single dose inhalation device with a green body and cap and a white push button, made from acrylonitrile butadiene styrene (ABS) plastic materials and stainless steel.
Single pack containing either 15 or 30 capsules and a Zonda inhaler.
Multipacks containing either 60 capsules (2 packs of 30), and 2 Zonda inhalers or 90 capsules (3 packs of 30), and 3 Zonda inhalers.
Bundle pack: 30 capsules (bottle) in a box bundled with 1 Zonda inhaler packed in a separate box.
Not all pack sizes may be marketed.
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, UNITED KINGDOM
PL 00289/1870
24/06/2016
| Drug | Countries | |
|---|---|---|
| BRALTUS | Austria, Australia, Estonia, Spain, Croatia, Ireland, Lithuania, New Zealand, Poland, United Kingdom |
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