GENEVA, October 13, 2010 /PRNewswire/ --
- New Presentation of Cyanide Antidote Cyanokit(R) in a Single Vial Facilitates Administration
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the new Cyanokit(R) 5 g presentation (hydroxocobalamin) has been approved by the European Commission. Cyanokit(R) is currently available in a kit comprising two 2.5 g vials as the starting dose that totals 5 g hydroxocobalamin. The new presentation contains the starting dose of 5 g hydroxocobalamin in a single vial.
Cyanokit(R) is indicated for the treatment of known or suspected cyanide poisoning. The drug is typically administered by fire and rescue crews at an emergency scene or in a hospital emergency room. It must be administered in conjunction with appropriate decontamination and supportive measures.
"Immediate administration of an emergency treatment on the scene of a fire within the first minutes after rescue is critical for the survival of a smoke inhalation victim," said Dr. Bernhard Kirschbaum, Executive Vice President Research and Development at Merck Serono. "By simplifying the reconstitution and administration processes, we believe that the new Cyanokit 5 g presentation represents a major improvement, allowing for rapid management of cyanide poisoning, a vital asset particularly when treating more than one victim."
Cyanide poisoning commonly results from exposure to smoke produced from burning synthetic substances or natural materials such as cotton or paper in a closed environment. Additional causes may include accidental or intentional ingestion, exposure during industrial accidents, or a terrorist attack involving cyanide.
In Europe, Cyanokit(R) is marketed by Merck Serono, with the exception of the Netherlands, Ireland, the United Kingdom and the Nordic and Baltic countries where it is marketed by its partner Swedish Orphan Biovitrum.
In the US, a Supplemental New Drug Application (sNDA) for the new Cyanokit(R) presentation is currently under review by the Food and Drug Administration (FDA).
About Cyanokit(R)
The active ingredient in Cyanokit(R), hydroxocobalamin, is a precursor of vitamin B12. Hydroxocobalamin works by binding directly to the cyanide ions, creating cyanocobalamin, a natural form of vitamin B12, which is excreted in the urine.
Advantages of this approach are that methemoglobin is not produced and the oxygen-carrying capacity of the victim's blood is not lowered. Therefore, Cyanokit(R) is suitable for use in smoke inhalation victims. The most common adverse reactions seen in clinical trials of hydroxocobalamin with human subjects are transient and include: reddish discoloration of the skin, mucous membranes and urine, rash, increased blood pressure, nausea, vomiting, diarrhea, headache, decreased white blood cell count and injection site reactions. Allergic reactions have been observed. Usage may interfere with some clinical laboratory evaluations.
The starting dose of Cyanokit(R) for adults is 5 g, administered by intravenous infusion. Depending upon the severity of the poisoning and the clinical response, a second dose of 5 g may be administered up to a total dose of 10 g.
About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.
Merck Serono has leading brands serving patients with cancer (Erbitux(R), cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility (Gonal-f(R), follitropin alpha), endocrine and metabolic disorders (Saizen(R) and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage(R), metformin), (Concor(R), bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available in all markets.
With an annual R&D expenditure of more than EUR 1 billion, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.
About Merck
Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 40,000 (including Merck Millipore) employees in 64 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
For more information, please visit http://www.merckserono.com or http://www.merck.de
Merck Serono
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