SODIUM CHLORIDE 0.9% Solution for infusion Ref.[8051] Active ingredients: Sodium chloride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Product name and form

Sodium Chloride 0.9% Intravenous Infusion BP.

Pharmaceutical Form

Solution for infusion.

Clear solution, free from visible particles.

Qualitative and quantitative composition

Sodium chloride: 9.0 g/l

Each ml contains 9 mg sodium chloride.

mmol/l:
Na+: 154
Cl-: 154

pH: 4,5-7

For the full list of excipients: see section 6.1.

Active Ingredient Description
Sodium chloride

Sodium chloride is the principle salt involved in maintaining the osmotic tension of blood and tissues. Changes in osmotic tension influence the movement of fluids and diffusion of salts in cellular tissue.
List of Excipients

Water for Injections

Pack sizes and marketing

Bag sizes: 50, 100, 250, 500 or 1000 mL

The bags known as Viaflo are composed of polyolefin/polyamide co-extruded plastic (PL-2442).

The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene.

Pack sizes:

  • 50 bags of 50 ml per carton
  • 75 bags of 50 ml per carton
  • 1 bag of 50 ml
  • 50 bags of 100 ml per carton
  • 60 bags of 100 ml per carton
  • 1 bag of 100 ml
  • 30 bags of 250 ml per carton
  • 1 bag of 250 ml
  • 20 bags of 500 ml per carton
  • 1 bag of 500 ml
  • 10 bags of 1000 ml per carton
  • 1 bag of 1000 ml

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00116/0334

Date of first authorisation: 10 May 2001
Date of latest renewal: 19 March 2006

 
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