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SPC, UK: LINEZOLID Solution for infusion (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Linezolid 2 mg/ml solution for infusion.

Qualitative and quantitative composition

1 ml solution for infusion contains 2 mg linezolid. 300 ml infusion bags contain 600 mg linezolid. Excipients with known effect: Each 300 ml also contains 13.7 g glucose and 114 mg sodium. For the full ...

Pharmaceutical form

Solution for infusion. Isotonic, clear, colourless to yellow solution with pH range of 4.4-5.2.

Therapeutic indications

Nosocomial pneumonia Community acquired pneumonia Linezolid is indicated in adults for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible ...

Posology and method of administration

Posology Linezolid solution for infusion, film-coated tablets or oral suspension may be used as initial therapy. Patients who commence treatment on the parenteral formulation may be switched to either ...

Contraindications

Hypersensitivity to linezolid or to any of the excipients listed in section 6.1. Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. phenelzine, ...

Special warnings and precautions for use

Myelosuppression Myelosuppression (including anaemia, leucopenia, pancytopenia and thrombocytopenia) has been reported in patients receiving linezolid. In cases where the outcome is known, when linezolid ...

Interaction with other medicinal products and other forms of interaction

Monoamine oxidase inhibitors Linezolid is a reversible, non-selective inhibitor of monoamine oxidase (MAOI). There are very limited data from drug interaction studies and on the safety of linezolid when ...

Fertility, pregnancy and lactation

Pregnancy There are limited data from the use of linezolid in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). A potential risk for humans exists. Linezolid should ...

Effects on ability to drive and use machines

Patients should be warned about the potential for dizziness or symptoms of visual impairment (as described in section 4.4 and 4.8) whilst receiving linezolid and should be advised not to drive or operate ...

Undesirable effects

The table below provides a listing of adverse drug reactions with frequency based on all-causality data from clinical studies that enrolled more than 2,000 adult patients who received the recommended linezolid ...

Overdose

No specific antidote is known. No cases of overdose have been reported. However, the following information may prove useful: Supportive care is advised together with maintenance of glomerular filtration. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other antibacterials ATC code: J01XX08 General properties Linezolid is a synthetic, antibacterial agent that belongs to a new class of antimicrobials, the oxazolidinones. It ...

Pharmacokinetic properties

Linezolid primarily contains (s)-linezolid which is biologically active and is metabolised to form inactive derivatives. Absorption Linezolid is rapidly and extensively absorbed following oral dosing. ...

Preclinical safety data

Linezolid decreased fertility and reproductive performance of male rats at exposure levels approximately equal to those in humans. In sexually mature animals these effects were reversible. However, these ...

List of excipients

Glucose monohydrate Sodium citrate dihydrate (E331) Citric acid anhydrous (E330) Hydrochloric acid (E507) Sodium hydroxide (E524) Water for injections

Incompatibilities

Additives should not be introduced into this solution. If linezolid is to be given concomitantly with other drugs, each drug should be given separately in accordance with its own directions for use. Similarly, ...

Shelf life

Before opening: 3 years. After opening: From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not ...

Special precautions for storage

Store in the original package (overwrap and carton) until ready to use in order to protect from light. For storage conditions after first opening of the medicinal product, see section 6.3.

Nature and contents of container

Single use, ready-to-use, latex-free, multilayered polyolefine film infusion bags (Excel or Freeflex) sealed inside a foil laminate overwrap. The bag holds 300 ml solution and is packaged in a box. Each ...

Special precautions for disposal and other handling

For single use only. Remove overwrap only when ready to use, then check for minute leaks by squeezing the bag firmly. If the bag leaks, do not use as sterility may be impaired. The solution should be visually ...

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization number(s)

PL 00057/1418

Date of first authorization / renewal of the authorization

Date of first authorisation: 23/11/2012 Date of last renewal: 22/02/2018

Date of revision of the text

02/2018

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