BRALTUS Inhalation powder, hard capsule (2019)
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Περιεχόμενα
1. Name of the medicinal product
Braltus 10 microgram per delivered dose inhalation powder, hard capsule.
2. Qualitative and quantitative composition
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 ...
3. Pharmaceutical form
Inhalation powder, hard capsule. Colourless and transparent, size 3 capsules, containing white powder.
4.1. Therapeutic indications
Braltus is indicated as a maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD). Braltus is indicated for use in adults.
4.2. Posology and method of administration
Posology <u>Route of administration:</u> Inhalation use. Recommended Dose Adults 18 years of age and older Inhalation of the contents of one capsule once daily with the Zonda inhaler. Inhalation should ...
4.3. Contraindications
Hypersensitivity to the active substance tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium, or to any of the excipients listed in section 6.1, including lactose monohydrate ...
4.4. Special warnings and precautions for use
Tiotropium bromide, as a once daily maintenance bronchodilator, should not be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions ...
4.5. Interaction with other medicinal products and other forms of interaction
Although no formal drug interaction studies have been performed, tiotropium bromide inhalation powder has been used concomitantly with other drugs without clinical evidence of drug interactions. These ...
4.6. Fertility, pregnancy and lactation
Fertility Clinical data on fertility are not available for tiotropium. A non-clinical study performed with tiotropium showed no indication of any adverse effect on fertility (see section 5.3). Pregnancy ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. The occurrence of dizziness, blurred vision, or headache may influence the ability to drive and use machinery.
4.8. Undesirable effects
Many of the listed undesirable effects can be assigned to the anticholinergic properties of tiotropium bromide. The frequencies assigned to the undesirable effects listed below are based on crude incidence ...
4.9. Overdose
High doses of tiotropium bromide may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 340 microgram tiotropium ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other drugs for obstructive airway diseases, inhalants, anticholinergics <b>ATC code:</b> R03BB04 Mechanism of action Tiotropium bromide is a long-acting, specific, muscarinic ...
5.2. Pharmacokinetic properties
Tiotropium bromide is a non-chiral quaternary ammonium compound and is sparingly soluble in water. Tiotropium bromide is administered by dry powder inhalation. Generally with the inhaled route of administration, ...
5.3. Preclinical safety data
Many effects observed in conventional studies of safety pharmacology, repeated dose toxicity, and reproductive toxicity could be explained by the anticholinergic properties of tiotropium bromide. Typically ...
6.1. List of excipients
Lactose monohydrate (which contains milk protein) Capsule composed of hydroxypropylmethylcellulose (HPMC), commonly known as Hypromellose.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
24 months. <u>After first opening:</u> 30 days (15 capsule bottle) or 60 days (30 capsule bottle).
6.4. Special precautions for storage
Keep the bottle tightly closed. Store in the original package to protect from moisture. Do not refrigerate or freeze.
6.5. Nature and contents of container
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 ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, UNITED KINGDOM
8. Marketing authorization number(s)
PL 00289/1870
9. Date of first authorization / renewal of the authorization
24/06/2016
10. Date of revision of the text
27/02/2019
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