STEROFUNDIN Solution for infusion Ref.[28263] Active ingredients: Calcium chloride Magnesium chloride Malic acid Potassium chloride Sodium acetate Sodium chloride

Source: Heads of Medicines Agencies (EU)  Revision Year: 2018  Publisher: B. Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen, Germany, Phone: +49 5661 71 0, Fax: +49 5661 71 4567

Product name and form

Sterofundin ISO, solution for infusion.

Pharmaceutical Form

Solution for infusion.

A clear, colourless aqueous solution free from visible particles.

pH: 5.1-5.9
Theoretical osmolarity: 309 mosm/l.

Qualitative and quantitative composition

1000 ml Sterofundin ISO solution for infusion contain:

Sodium chloride6.80 g
Potassium chloride0.30 g
Magnesium chloride hexahydrate0.20 g
Calcium chloride dihydrate0.37 g
Sodium acetate trihydrate3.27 g
L-Malic acid0.67 g
Electrolyte concentrations: mmol/l
Sodium145.0
Potassium4.0
Magnesium1.0
Calcium2.5
Chloride127.0
Acetate24.0
Malate5.0

Excipients with known effect: 1000 ml Sterofundin ISO solution contain 0.2 g Sodium hydroxide (0.115 g Sodium).

For the full list of excipients, see section 6.1

Active Ingredient Description
Calcium chloride

Calcium is the most abundant mineral in the body, and is an essential body electrolyte. Homeostasis is mainly regulated by the parathyroid hormone, by calcitonin, and by the activated form of vitamin D. Calcium is a structural component of bones and teeth. It is also required for blood clotting, neurotransmitter release, muscle contraction and normal heartbeat.
Magnesium chloride
Malic acid
Potassium chloride

Potassium plays a vital physiological role in maintenance of normal electrical excitability of nerve and muscle. It is also important in the genesis and correction of imbalances of acid-base metabolism.
Sodium acetate
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
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

The solution for infusion is packed in:

  • type II glass bottles with butyl rubber stoppers containing 250 ml, 500 ml or 1000ml, available in packs of 1 or 10 bottles (250 ml and 500 ml) or of 1 or 6 bottles (1000 ml);
  • polyethylene plastic bottles containing 250 ml, 500 ml or 1000ml, available in packs of 1 or 10 bottles;
  • plastic bags with outer protective bags. The primary bag consists of a three layer plastic laminate with a polypropylene inner layer and a polyamide outer layer. The bags contain 250 ml, 500 ml or 1000 ml and are available in packs of 1 or 20 bags (250 ml and 500 ml) or of 1 or 10 bags (1000 ml).

Not all package sizes may be marketed.

Marketing authorization holder

B. Braun Melsungen AG, Carl-Braun-Straße 1, 34212 Melsungen, Germany, Phone: +49 5661 71 0, Fax: +49 5661 71 4567

Drugs

Drug Countries
STEROFUNDIN Austria, Cyprus, Ecuador, Estonia, Hong Kong, Croatia, Lithuania, Malta, Poland, Romania, Singapore
 
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