BETMIGA Prolonged-release tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Betmiga 25 mg prolonged-release tablets. Betmiga 50 mg prolonged-release tablets.
Qualitative and quantitative composition
<u>Betmiga 25 mg prolonged-release tablets:</u> Each tablet contains 25 mg of mirabegron. <u>Betmiga 50 mg prolonged-release tablets:</u> Each tablet contains 50 mg of mirabegron. For the full list of ...
Pharmaceutical form
Prolonged-release tablet. <u>Betmiga 25 mg tablets:</u> Oval, brown tablet, debossed with the company logo and 325 on the same side. <u>Betmiga 50 mg tablets:</u> Oval, yellow tablet, debossed with the ...
Therapeutic indications
Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
Posology and method of administration
Posology Adults (including elderly patients) The recommended dose is 50 mg once daily. Special populations Renal and hepatic impairment Betmiga has not been studied in patients with end stage renal disease ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ...
Special warnings and precautions for use
Renal impairment Betmiga has not been studied in patients with end stage renal disease (GFR <15 mL/min/1.73 m² or patients requiring haemodialysis) and, therefore, it is not recommended for use in this ...
Interaction with other medicinal products and other forms of interaction
<em>In vitro</em> data Mirabegron is transported and metabolised through multiple pathways. Mirabegron is a substrate for cytochrome P450 (CYP) 3A4, CYP2D6, butyrylcholinesterase, uridine diphospho-glucuronosyltransferases ...
Fertility, pregnancy and lactation
Woman of childbearing potential Betmiga is not recommended in women of childbearing potential not using contraception. Pregnancy There are limited amount of data from the use of Betmiga in pregnant women. ...
Effects on ability to drive and use machines
Betmiga has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The safety of Betmiga was evaluated in 8433 patients with OAB, of which 5648 received at least one dose of mirabegron in the phase ⅔ clinical program, and 622 patients received ...
Overdose
Mirabegron has been administered to healthy volunteers at single doses up to 400 mg. At this dose, adverse events reported included palpitations (1 of 6 subjects) and increased pulse rate exceeding 100 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Urologicals, urinary antispasmodics ATC code: G04BD12 Mechanism of action Mirabegron is a potent and selective beta<sub>3</sub>-adrenoceptor agonist. Mirabegron showed relaxation ...
Pharmacokinetic properties
Absorption After oral administration of mirabegron in healthy volunteers mirabegron is absorbed to reach peak plasma concentrations (C<sub>max</sub>) between 3 and 4 hours. The absolute bioavailability ...
Preclinical safety data
Pre-clinical studies have identified target organs of toxicity that are consistent with clinical observations. Transient increases in liver enzymes and hepatocyte changes (necrosis and decrease in glycogen ...
List of excipients
Core tablet: Macrogol 8,000 and 2,000,000 Hydroxypropylcellulose Butylhydroxytoluene Magnesium stearate Film coating: Betmiga 25 mg prolonged-release tablets: Hypromellose 2910, 6 mPa.s Macrogol 8,000 ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years. Shelf life after first opening of the bottle: 6 months.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Alu-Alu blisters in cartons containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets. HDPE bottles with child-resistant closure of polypropylene (PP) and a silica gel desiccant containing 90 tablets. Each ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
Marketing authorization number(s)
EU/1/12/809/001-018
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 December 2012 Date of latest renewal: 18 September 2017
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