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April,15 2015 Merck Serono's Saizen Liquid can now be Stored up to one Week at Room Temperature Change of in-use storage for Saizen Liquid, a recombinant human Growth
Hormone Storage for up to seven days at 25°C now possible
Darmstadt, Germany, April 15, 2015 - Merck Serono, the biopharmaceutical business of Merck, today announced a change in the in-use storage condition for Saizen® solution for injection (6mg, 12mg and 20mg). Saizen is a recombinant human Growth Hormone (r-hGH) indicated for the treatment of growth hormone deficiency (GHD) in children and adults, Turner Syndrome, chronic renal failure and children born short for gestational age (SGA).
The label change for in-use storage gives patients the possibility to keep the product for up to seven consecutive days at room temperature (25°C). After first injection the Saizen cartridge has to be used within 28 days, until now it needed to be stored at
2-8°C during this whole period.1 The change has been made to improve patient
convenience, for example making the medicine easier to store when travelling away from home.
The label change has been recently agreed in the European Union and is planned to be rolled out to other territories and countries.
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Merck KGaA www.merckserono.com Merck Serono is a division of Merck. Frankfurter Strasse 250
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Hotline +49 (0) 6151 72-5000 www.merckgroup.com
Tel. +49 (0) 6151 72-4660 bettina.frank@merckgroup.com
Luciano Rossetti, Head of Global Research and Development at Merck Serono said: "At Merck Serono we are committed to advancing the treatment of growth hormone deficiency and always look for new ways to improve the quality of life for patients who take growth hormone treatment. Our collective goal is to improve adherence, enable the best treatment decisions and deliver better outcomes for patients living with growth hormone disorders; this is made easier when patients are able to store their medicine at ambient temperature of up to 25°C, for example if they are away from home."
The full Saizen solution for injection patient information will be available in the revised
Summary of Product Characteristics (SmPC).
References:
1. Store the unused Saizen cartridge in a refrigerator (2°C-8°C). Do not freeze. Store in the original packaging to protect from light.
After the first injection, the Saizen cartridge or the easypod™ auto-injector containing the Saizen cartridge has to be stored in a refrigerator (2C-8C) for a maximum of 28 days of which up to 7 consecutive days can be outside of a refrigerator at or below 25°C. When stored outside of the
refrigerator for up to 7 consecutive days, the Saizen cartridge must be returned to the refrigerator and used within 28 days after first injection.
When using the easypod auto-injector, the cartridge is kept in the device. The cool.click™ needle-free auto-injector should be stored outside of a refrigerator always separately from the Saizen cartridge.
Protect the used cartridge from light.
About Growth Hormone Deficiency (GHD)
Growth hormone deficiency occurs when the pituitary gland in the brain is unable to release or produce adequate amounts of growth hormone. In children, growth hormone deficiency causes slow growth, and without treatment, few will reach their full height potential as an adult.
It is estimated that the incidence of growth hormone deficiency in children is between one in 4,000 and one in 10,000.
Non childhood related adult growth hormone deficiency can also be a significant problem which affects
three in 10,000 each year. It is recognized as a specific clinical syndrome.
About Saizen® [somatropin (rDNA origin) for injection]
Saizen and Saizen Solution for Injection are formulations of recombinant human growth hormone (GH).
Saizen is currently registered in 80 countries (indications vary according to countries) for the treatment of:
GH deficiency in children
GH deficiency in adult patients and adolescents
Children born small for gestational age (not registered for this indication in the US)
Turner syndrome (not registered for this indication the US)
Growth failure in prepubertal children associated with chronic renal failure (not registered for this indication in the US)
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About Merck Serono
Merck Serono is the biopharmaceutical business of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.
Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.
For more information, please visit www.merckserono.com.
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Merck is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses - Merck Serono, Consumer Health, Allergopharma, Biosimilars, Merck Millipore and Performance Materials - and generated sales of around
€ 11.3 billion in 2014. Around 39,000 Merck employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges. Merck is the world's
oldest pharmaceutical and chemical company - since 1668, the company has stood for innovation,
business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany, holds the
global rights to the Merck name and brand. The only exceptions are Canada and the United States, where
the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.
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