TIOGIVA Inhalation powder, hard capsule (2021)
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Περιεχόμενα
1. Name of the medicinal product
Tiogiva 18 microgram, inhalation powder, hard capsule.
2. Qualitative and quantitative composition
Each capsule contains 21.7 microgram tiotropium bromide, anhydrous (amorphous) equivalent to 18 microgram tiotropium. The delivered dose (the dose that leaves the mouthpiece) is 12.1 microgram tiotropium ...
3. Pharmaceutical form
Inhalation powder, hard capsule. Transparent colourless hard capsules containing the inhalation powder with T10 printed on the capsule.
4.1. Therapeutic indications
Tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).
4.2. Posology and method of administration
Posology The recommended dosage of tiotropium bromide is inhalation of the contents of one capsule once daily with the dry powder inhaler the same time of day. To get a full daily dose, the patient must ...
4.3. Contraindications
Hypersensitivity to the active substance or to the excipient listed in section 6.1 or to atropine or its derivatives, e.g. ipratropium or oxitropium.
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
Pregnancy There is a very limited amount of data from the use of tiotropium in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at ...
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
Summary of the safety profile Many of the listed undesirable effects can be assigned to the anticholinergic properties of Tiotropium. Tabulated summary of adverse reactions The frequencies assigned to ...
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
General Introduction 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 ...
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 may contain small amounts of milk proteins). Capsule composed of hydroxypropylmethylcellulose (HPMC), commonly known as Hypromellose. Capsule printing ink: Shellac, black iron ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
24 months. Use the capsule directly after opening of the blister pocket.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
Alu/Alu peel-off blister containing 10 capsules. The blisters are supplied in a cardboard box, depending on the pack the box will also contain a dry powder inhaler. The dry powder inhaler is a single dose ...
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
Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom
8. Marketing authorization number(s)
PL 25258/0370
9. Date of first authorization / renewal of the authorization
07/04/2021
10. Date of revision of the text
17/05/2021
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