LINEZOLID Solution for infusion Ref.[6948] Active ingredients: Linezolid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Product name and form

Linezolid 2 mg/ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

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

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 list of excipients, see section 6.1.

Active Ingredient Description
Linezolid

Linezolid is a synthetic, antibacterial agent that belongs to a new class of antimicrobials, the oxazolidinones. It has in vitro activity against aerobic Gram-positive bacteria and anaerobic micro-organisms. Linezolid selectively inhibits bacterial protein synthesis via a unique mechanism of action.

List of Excipients

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

Pack sizes and marketing

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 box contains 1*, 2**, 5, 10, 20 or 25 infusion bags.

Note:

The above boxes may also be supplied in “hospital” packs of:

* 5, 10 or 20
** 3, 6 or 10

Not all package sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00057/1418

Date of first authorisation: 23/11/2012

Date of last renewal: 22/02/2018

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