ZIMBUS BREEZHALER Inhalation powder (hard capsule) (2021)
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Περιεχόμενα
1. Name of the medicinal product
Zimbus Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation powder, hard capsules.
2. Qualitative and quantitative composition
Each capsule contains 150 mcg of indacaterol (as acetate), 63 mcg of glycopyrronium bromide equivalent to 50 mcg of glycopyrronium and 160 mcg of mometasone furoate. Each delivered dose (the dose that ...
3. Pharmaceutical form
Inhalation powder, hard capsule (inhalation powder). Capsules with green transparent cap and uncoloured transparent body containing a white powder, with the product code IGM150-50-160 printed in black ...
4.1. Therapeutic indications
Zimbus Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta<sub>2</sub>-agonist and a high dose ...
4.2. Posology and method of administration
Posology The recommended dose is one capsule to be inhaled once daily. The maximum recommended dose is 114 mcg/46 mcg/136 mcg once daily. Treatment should be administered at the same time of the day each ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Deterioration of disease This medicinal product should not be used to treat acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required. Increasing ...
4.5. Interaction with other medicinal products and other forms of interaction
No specific interaction studies were conducted with indacaterol/glycopyrronium/mometasone furoate. Information on the potential for interactions is based on the potential for each of the monotherapy components. ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are insufficient data from the use of Zimbus Breezhaler or its individual components (indacaterol, glycopyrronium and mometasone furoate) in pregnant women to determine whether there is ...
4.7. Effects on ability to drive and use machines
This medicinal product has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The most common adverse reactions over 52 weeks were asthma (exacerbation) (41.8%), nasopharyngitis (10.9%), upper respiratory tract infection (5.6%) and headache (4.2%). ...
4.9. Overdose
General supportive measures and symptomatic treatment should be initiated in cases of suspected overdose. An overdose will likely produce signs, symptoms or adverse effects associated with the pharmacological ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids. <b>ATC code:</b> R03AL12 Mechanism ...
5.2. Pharmacokinetic properties
Absorption Following inhalation of Zimbus Breezhaler, the median time to reach peak plasma concentrations of indacaterol, glycopyrronium and mometasone furoate was approximately 15 minutes, 5 minutes and ...
5.3. Preclinical safety data
No animal studies were performed with the combination of indacaterol, glycopyrronium and mometasone furoate. The non-clinical assessments of each monotherapy and of indacaterol/mometasone and indacaterol/glycopyrronium ...
6.1. List of excipients
<u>Capsule contents:</u> Lactose monohydrate Magnesium stearate <u>Capsule shell:</u> Hypromellose Printing ink
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
30 months.
6.4. Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from light and moisture.
6.5. Nature and contents of container
Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl metacrylate acrylonitrile butadiene styrene. Needles and springs are made from stainless steel. PA/Alu/PVC ...
6.6. Special precautions for disposal and other handling
The inhaler provided with each new prescription should be used. The inhaler in each pack should be disposed of after all capsules in that pack have been used. Any unused medicinal product or waste material ...
7. Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
8. Marketing authorization number(s)
EU/1/20/1440/001-005
9. Date of first authorization / renewal of the authorization
03 July 2020
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