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METRONIDAZOLE Solution for infusion (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Metronidazole 500 mg/100 ml Intravenous Infusion.

Qualitative and quantitative composition

Metronidazole 5 mg/ml. 100 ml of solution for infusion containing 500 mg of Metronidazole. For excipients see 6.1. Osmolarity: 308 mOsm/l pH: 4.5 to 6.0

Pharmaceutical form

Solution for infusion. A clear, almost colourless to pale yellow solution.

Therapeutic indications

Metronidazole 500mg/100ml Intravenous Infusion is indicated in adults and children when oral medication is not possible for the following indications: The prophylaxis of postoperative infections due to ...

Posology and method of administration

Method of Administration Metronidazole 500mg/100ml Intravenous Infusion should be infused intravenously at an approximate rate of 5 ml/minute (or one bag infused over 20 to 60 minutes). Oral medication ...

Contraindications

Hypersensitivity to the active substance, to other imidazole derivatives or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Liver disease Caution is needed in patients with severe hepatic impairment. The dose of metronidazole should be reduced as necessary. Metronidazole is mainly metabolised by hepatic oxidation. Substantial ...

Interaction with other medicinal products and other forms of interaction

Not recommended concomitant therapy Disulfiram Concurrent use of metronidazole and disulfiram may result in psychotic reactions and confusion. Metronidazole should not be given to patients who have taken ...

Fertility, pregnancy and lactation

Pregnancy Metronidazole crosses the placental barrier. Clinical data on a large number of exposed pregnancies and animal data did not show a teratogenic or foetotoxic effect. However unrestricted administration ...

Effects on ability to drive and use machines

No studies have been performed following intravenous treatment with Metronidazole on the ability to drive and use machines. Some adverse reactions to metronidazole such as seizure, dizziness, optic neuropathy, ...

Undesirable effects

There are no data available on adverse reactions from Baxter-sponsored clinical trials conducted with Metronidazole. The following adverse reactions have been reported with Metronidazole, listed by MedDRA ...

Overdose

Symptoms In cases of overdose in adults, the clinical symptoms are usually limited to nausea, vomiting and neurotoxic effects, including ataxia, slight disorientation, confusion, seizures and peripheral ...

Pharmacodynamic properties

Metronidazole is an anti-infectious drug belonging to the pharmacotherapeutic group of nitroimidazole derivatives, which have effect mainly on strict anaerobes. This effect is probably caused by interaction ...

Pharmacokinetic properties

Distribution After administration of a single 500 mg dose, mean Metronidazole peak plasma concentrations of ca. 14–18 μg/ml are reached at the end of a 20 minute infusion. 2-hydroxy-metabolite peak plasma ...

Preclinical safety data

Metronidazole has been shown to be non-mutagenic in mammalian cells in vitro and in vivo. Metronidazole and a metabolite have been shown to be mutagenic is some tests with non mammalian cells. Although ...

List of excipients

Disodium phosphate dodecahydrate Citric acid monohydrate Sodium chloride Water for injections

Incompatibilities

Do not use equipment containing aluminum (e.g. needles, cannulae) that would come in contact with the drug solution as precipitates may form. Metronidazole is incompatible with (includes but is not limited ...

Shelf life

2 years.

Special precautions for storage

Keep container in the outer carton in order to protect from light.

Nature and contents of container

The bags are composed of polyolefin/polyamide co-extruded plastic (PL 2442) known as Viaflo. The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene, which serves only ...

Special precautions for disposal and other handling

Use only if the solution is clear, without visible particles and if the container is undamaged. Administer immediately following the insertion of infusion set. Do not remove unit from overpouch until ready ...

Marketing authorization holder

Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, UK

Marketing authorization number(s)

PL 00116/0353

Date of first authorization / renewal of the authorization

12/11/2006

Date of revision of the text

Nov 2017

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