AVELOX Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Avelox 400 mg film-coated tablets.
Qualitative and quantitative composition
1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride). Excipient with known effect: The film-coated tablet contains 68mg lactose monohydrate (=66.56 mg lactose) (see section 4.4). For the ...
Pharmaceutical form
Film-coated tablet. Dull red film-coated tablet with an oblong, convex shape with facet, a dimension of 17 7 mm, and marked with M400 on one side and BAYER on the other side.
Therapeutic indications
Avelox 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin (see sections 4.4, ...
Posology and method of administration
Posology (adults) The recommended dose is one 400 mg film-coated tablet once daily. Renal/hepatic impairment No adjustment of dosage is required in patients with mild to severely impaired renal function ...
Contraindications
Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients listed in section 6.1. Pregnancy and lactation (see section 4.6). Patients below 18 years of age. Patients with a history ...
Special warnings and precautions for use
The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions section. Prolongation of QTc ...
Interaction with other medicinal products and other forms of interaction
Interactions with medicinal products An additive effect on QT interval prolongation of moxifloxacin and other medicinal products that may prolong the QTc interval cannot be excluded. This might lead to ...
Fertility, pregnancy and lactation
Pregnancy The safety of moxifloxacin in human pregnancy has not been evaluated.. Animal studies have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Due to the ...
Effects on ability to drive and use machines
No studies on the effects of moxifloxacin on the ability to drive and use machines have been performed. However, fluoroquinolones including moxifloxacin may result in an impairment of the patients ability ...
Undesirable effects
Adverse reactions based on all clinical trials and derived from post-marketing reports with moxifloxacin 400 mg (oral and sequential therapy) sorted by frequencies are listed below: Apart from nausea and ...
Overdose
No specific countermeasures after accidental overdose are recommended. In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility ...
Pharmacodynamic properties
Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones ATC code: J01MA14 Mechanism of action Moxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative pathogens. ...
Pharmacokinetic properties
Absorption and Bioavailability Following oral administration moxifloxacin is rapidly and almost completely absorbed. The absolute bioavailability amounts to approximately 91%. Pharmacokinetics are linear ...
Preclinical safety data
Effects on the haematopoetic system (slight decreases in the number of erythrocytes and platelets) were seen in rats and monkeys. As with other quinolones, hepatotoxicity (elevated liver enzymes and vacuolar ...
List of excipients
Tablet core: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Film-coat: Hypromellose Macrogol 4000 Ferric oxide (E172) Titanium dioxide (E171)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Polypropylene/aluminium and polyvinyl chloride/polyvinylidene chloride/aluminium blisters: Do not store above 25°C. Store in the original package in order to protect from moisture. Aluminium/aluminium ...
Nature and contents of container
Cartons containing colourless transparent or white opaque polypropylene/aluminium blisters or colourless transparent polyvinyl chloride/polyvinylidene chloride/aluminium blisters: The film-coated tablets ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading RG2 6AD
Marketing authorization number(s)
PL 00010/0291
Date of first authorization / renewal of the authorization
13 March 2003/12 February 2010
Date of revision of the text
03/2019
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