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SPC, UK: AVELOX Solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Avelox 400 mg/250 ml solution for infusion.

Qualitative and quantitative composition

1 bottle or 1 bag of 250 ml contains 400 mg moxifloxacin (as hydrochloride). 1 ml contains 1.6 mg moxifloxacin (as hydrochloride). Excipient with known effect: 250 ml of solution for infusion contains ...

Pharmaceutical form

Solution for infusion. Clear, yellow solution.

Therapeutic indications

Avelox is indicated for the treatment of: Community acquired pneumonia (CAP). Complicated skin and skin structure infections (cSSSI). Moxifloxacin should be used only when it is considered inappropriate ...

Posology and method of administration

Posology The recommended dose is 400 mg moxifloxacin, infused once daily. Initial intravenous treatment may be followed by oral treatment with moxifloxacin 400 mg tablets, when clinically indicated. In ...

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 experimental ...

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 observed in clinical trials and derived from post-marketing reports with moxifloxacin 400 mg daily administered by the intravenous or oral route (intravenous only, sequential [IV/oral] ...

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 inhibits bacterial type II topoisomerases (DNA gyrase and topoisomerase IV) that ...

Pharmacokinetic properties

Absorption and Bioavailability After a single 400 mg intravenous 1 hour infusion peak plasma concentrations of approximately 4.1 mg/l were observed at the end of the infusion corresponding to a mean increase ...

Preclinical safety data

In conventional repeated dose studies moxifloxacin revealed haematological and hepatic toxicity in rodents and non- rodents. Toxic effects on the CNS were observed in monkeys. These effects occurred after ...

List of excipients

Sodium chloride Hydrochloric acid 1N (for pH-adjustment) Sodium hydroxide solution 2N (for pH-adjustment) Water for injections

Incompatibilities

The following solutions are incompatible with moxifloxacin solution for infusion: Sodium chloride 10% and 20% solutions Sodium bicarbonate 4.2% and 8.4% solutions This medicinal product must not be mixed ...

Shelf life

Shelf life Polyolefine bag: 3 years. Glass bottle: 5 years. Use immediately after first opening and/or dilution.

Special precautions for storage

Do not store below 15°C.

Nature and contents of container

Polyolefine bags with polypropylene port sealed in aluminium foil overwrap. 250 ml pack available in cartons of 5 and 12 bags. Colourless glass bottles (type 2) with a chlorobutyl or bromobutyl rubber ...

Special precautions for disposal and other handling

This product is for single use only. Any unused solution should be discarded. The following co-infusions were found to be compatible with moxifloxacin 400 mg solution for infusion: Water for injections, ...

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading RG2 6AD

Marketing authorization number(s)

PL 00010/0613

Date of first authorization / renewal of the authorization

First authorisation: 12<sup>th</sup> November 2009

Date of revision of the text

03/2019

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