SODIUM NITRITE Solutions for injection (2015)
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Περιεχόμενα
Name of the medicinal product
Sodium Nitrite 30 mg/mL Solution for Injection.
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.
Pharmaceutical form
Solutions for injection. The solution for injection is a clear and colourless sterile solution.
Therapeutic indications
Sodium nitrite is indicated for sequential use with sodium thiosulfate for the treatment of acute cyanide poisoning that is judged to be life-threatening. When the diagnosis of cyanide poisoning is uncertain, ...
Posology and method of administration
Posology For intravenous use. For single use only. Adults 10 mL of sodium nitrite (rate of 2.5 to 5 mL/minute) should be administered intravenously, immediately followed by 50 mL of sodium thiosulfate ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Sodium nitrite has been associated with severe hypotension, methemoglobinemia, and death at doses less than twice recommended therapeutic doses. When the diagnosis of cyanide poisoning is uncertain and/or ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Possible interaction may occur with hydroxocobalamin. Sodium nitrite should be used with caution in the presence of other drugs that may cause methemoglobinemia ...
Fertility, pregnancy and lactation
Pregnancy Based on human experience sodium nitrite is suspected to cause congenital malformations when administered during pregnancy. Animal studies do not indicate direct or indirect harmful effects with ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
There have been no controlled clinical trials conducted to systematically assess the adverse events profile of sodium nitrite. The medical literature has reported the following adverse events in association ...
Overdose
Large doses of sodium nitrite result in severe hypotension and toxic levels of methemoglobin which may lead to cardiovascular collapse. Sodium nitrite administration has been reported to cause or significantly ...
Pharmacodynamic properties
Pharmacotherapeutic group: antidotes ATC code: V03AB08 (sodium nitrite) Mechanism of action Exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase ...
Pharmacokinetic properties
Absorption Intravenous administration of sodium nitrite is 100% bioavailable. Distribution After a 30 minutes intravenous infusion of 290-370 mg sodium nitrite, the reported half-life was approximately ...
Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use and development.
List of excipients
Water for injections
Incompatibilities
Chemical incompatibility has been reported between sodium nitrite and hydroxocobalamin and these drugs should not be administered simultaneously through the same IV line. No chemical incompatibility has ...
Shelf life
Shelf life: 5 years.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
Nature and contents of container
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).
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Hope Pharmaceuticals, Ltd., 120 Baker Street, London W1U 6TU, United Kingdom
Marketing authorization number(s)
PL 42589/0001
Date of first authorization / renewal of the authorization
19/06/2015
Date of revision of the text
30/10/2015
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