Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
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. |
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 |
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.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 00057/1418
Date of first authorisation: 23/11/2012
Date of last renewal: 22/02/2018
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