MAINTELYTE Solution for infusion Ref.[27872] Active ingredients: Glucose Magnesium chloride Potassium chloride Sodium acetate Sodium chloride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Product name and form

Maintelyte solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear solution, free from visible particles.

pH: 4.5-6.5

Osmolarity: 402 mOsm/l (approx).

Qualitative and quantitative composition

1000 ml of Maintelyte solution for infusion contains:

Glucose (as monohydrate) 50.00 g
Sodium Chloride1.00 g
Sodium Acetate trihydrate3.13 g
Potassium Chloride1.50 g
Magnesium Chloride hexahydrate0.30 g

Content of electrolytes per 1000 ml:

Na+40 mmol
K+20 mmol
Mg2+1.5 mmol
CH3COO-23 mmol
Cl-40 mmol

For the full list of excipients, see section 6.1.

Active Ingredient Description
Glucose

Glucose is frequently used in both adults and children to restore blood glucose concentrations in the treatment of hypoglycaemia resulting from insulin excess or from other causes. The metabolism of glucose is an energy source for the body.

Magnesium chloride
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

Hydrochloric acid, concentrated (for pH adjustment)
Water for injections

Pack sizes and marketing

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.

Bag size: 1000 ml.

Outer carton content: 10 bags of 1000 ml.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL00116/0666

4th March 2019

Drugs

Drug Countries
MAINTELYTE Cyprus, Spain, France, Ireland, Malta, United Kingdom, South Africa

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