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SPC, UK: LEVOFLOXACIN Solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Levofloxacin Ibigen 5 mg/ml solution for infusion.

Qualitative and quantitative composition

Each 50 ml vial (5 mg/ml solution) contains 250 mg of levofloxacin as levofloxacin hemihydrate. Each 100 ml vial (5 mg/ml solution) contains 500 mg of levofloxacin as levofloxacin hemihydrate. Excipients ...

Pharmaceutical form

Solution for infusion. Clear greenish-yellow isotonic solution.

Therapeutic indications

Levofloxacin Ibigen solution for infusion is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): Community-acquired pneumonia. Complicated skin and soft tissue ...

Posology and method of administration

Posology The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Treatment with Levofloxacin Ibigen after initial use of the intravenous ...

Contraindications

Levofloxacin Ibigen solution for infusion must not be used: In patients hypersensitive to levofloxacin or any other quinolone or to any of the excipients listed in section 6.1. In patients with epilepsy. ...

Special warnings and precautions for use

Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin. Therefore levofloxacin is not recommended for the treatment of known or suspected MRSA ...

Interaction with other medicinal products and other forms of interaction

Effect of other medicinal products on Levofloxacin Ibigen Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs No pharmacokinetic interactions of levofloxacin were found with theophylline ...

Fertility, pregnancy and lactation

Pregnancy There are limited amount of data from the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section ...

Effects on ability to drive and use machines

Levofloxacin Ibigen has some undesirable effects (e.g. dizziness/vertigo, drowsiness, visual disturbances) which may impair the patients ability to concentrate and react, and therefore may constitute a ...

Undesirable effects

The information given below is based on data from clinical studies in more than 8300 patients and on extensive post marketing experience. Frequencies are defined as follows: very common (≥1/10) common ...

Overdose

Symptoms According to toxicity studies in animals or clinical pharmacology studies performed with supra-therapeutic doses, the most important signs to be expected following acute overdosage of Levofloxacin ...

Pharmacodynamic properties

Pharmacotherapeutic group: quinolone antibacterials, fluoroquinolones ATC code: J01MA12 Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic ...

Pharmacokinetic properties

Absorption Orally administered levofloxacin is rapidly and almost completely absorbed with peak plasma concentrations being obtained within 1-2 h. The absolute bioavailability is 99-100%. Food has little ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential and toxicity to reproduction and development. ...

List of excipients

Sodium chloride Hydrochloric acid (qs: pH 4.8) Water for injection

Incompatibilities

This medicinal product must not be mixed with heparin or alkaline solutions (e.g. sodium bicarbonate). This medicinal product must not be mixed with other medicinal products except those mentioned in section ...

Shelf life

Shelf life: 3 years. Shelf life after perforation of the rubber stopper: immediate use (see section 6.6). From a microbiological point of view, the solution for infusion should be used immediately. If ...

Special precautions for storage

Keep the vial in the outer carton in order to protect from light. Inspect visually prior to use. Only clear solutions without particles should be used.

Nature and contents of container

50ml, type 1 glass vial with flanged aluminium cap and bromobutyl rubber stopper. Each vial contains 50 ml solution for infusion. Pack sizes of 1 and 10 vials. 100ml, type 1 glass vial with flanged aluminium ...

Special precautions for disposal and other handling

Levofloxacin Ibigen solution for infusion should be used immediately (within 3 hours) after perforation of the rubber stopper in order to prevent any bacterial contamination. No protection from light is ...

Marketing authorization holder

Ibigen S.r.l., Via Fossignano, 2, 04011 Aprilia (LT), Italy

Marketing authorization number(s)

PL 31745/0012

Date of first authorization / renewal of the authorization

20/01/2012

Date of revision of the text

08/04/2019

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