SODIUM NITRITE Solutions for injection Ref.[9527] Active ingredients: Sodium nitrite

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Hope Pharmaceuticals, Ltd., 120 Baker Street, London W1U 6TU, United Kingdom

Product name and form

Sodium Nitrite 30 mg/mL Solution for Injection.

Pharmaceutical Form

Solutions for injection.

The solution for injection is a clear and colourless sterile solution.

Qualitative and quantitative composition

Each vial contains 300 mg of sodium nitrite (30 mg/mL).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sodium nitrite

Sodium nitrite is indicated for sequential use with sodium thiosulfate for the treatment of acute cyanide poisoning that is judged to be life-threatening. Sodium nitrite is thought to exert its therapeutic effect by reacting with hemoglobin to form methemoglobin, an oxidized form of hemoglobin incapable of oxygen transport but with high affinity for cyanide.

List of Excipients

Water for injections

Pack sizes and marketing

Each carton of Sodium Nitrite Solution for Injection contains one 10 mL glass vial of sodium nitrite 30 mg/mL solution for injection (containing 300 mg of sodium nitrite).

Marketing authorization holder

Hope Pharmaceuticals, Ltd., 120 Baker Street, London W1U 6TU, United Kingdom

Marketing authorization dates and numbers

PL 42589/0001

19/06/2015

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