DIGOXIN Solution for injection Ref.[6801] Active ingredients: Digoxin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland

Product name and form

Digoxin 250 micrograms/ml Solution for Injection.

Pharmaceutical Form

Solution for Injection.

Clear, colourless, sterile solution, intended for parenteral administration to human beings.

Qualitative and quantitative composition

Each 2ml of solution contains 500 micrograms of Digoxin.

Excipient(s) with known effect: Ethanol 96% 0.250 ml.

Also contains 2.92 mg sodium per 2ml.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Digoxin

Digoxin increases contractility of the myocardium by direct activity. The primary action of digoxin is specifically to inhibit adenosine triphosphatase, and thus sodium-potassium (Na+ - K+) exchange activity, the altered ionic distribution across the membrane resulting in an augmented calcium ion influx and thus an increase in the availability of calcium at the time of excitation-contraction coupling. The potency of digoxin may therefore appear considerably enhanced when the extracellular potassium concentration is low, with hyperkalaemia having the opposite effect.

List of Excipients

Ethanol
Propylene glycol
Citric acid monohydrate
Disodium hydrogen phosphate
Water for injections

Pack sizes and marketing

2ml, clear One point cut (OPC) glass ampoules, glass type 1 Ph.Eur. borosilicate glass, packed in cardboard cartons to contain 10 × 2ml ampoules.

Marketing authorization holder

Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland

Marketing authorization dates and numbers

PL 02848/5934R

24/1/91

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