You Are Here >> Products >> HGH Products >> Saizen ®
Saizen ®
Saizen ® - (somatropin (rDNA origin) for injection)
Saizen ® for pediatric growth hormone deficiency was approved in the United States in 1996. In 2004, EMD Serono, Inc. received approval from the Food and Drug Administration (FDA) for treatment of adult growth hormone deficiency for Saizen ®.
Saizen ® is a human growth hormone produced by recombinant DNA technology. Saizen ® has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone (GH).
Saizen ® is indicated for the treatment of growth hormone deficiency (GHD) in children and adults, Turner Syndrome, chronic (lasting a long time) renal failure, and children born short for gestational age. Treatment of GH deficient children with Saizen ® leads to accelerated growth. The overall effect of GH therapy in GHD children who respond well is that, as adults, they will be taller than they would have been if left untreated. Saizen ® works by replacing the GH the body normally produces.
Saizen ® is a sterile, non-pyrogenic, white, lyophilized powder intended for subcutaneous or intramuscular injection after reconstitution with Bacteriostatic Water for Injection.
The safety and effectiveness of Saizen ® in patients aged 65 and over has not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of Saizen ®, and may be more prone to develop adverse reactions.
EMD Serono, Inc. is approved for three clearly distinct diseases, including:
- Saizen ® (somatropin (rDNA origin) for injection) for growth hormone deficiency in children and adults
- Serostim ® (somatropin (rDNA origin) for injection) for HIV-associated wasting
- Zorbtive ™ (somatropin (rDNA origin) for injection) for short bowel syndrome
EMD Serono, Inc. offers a needle and needle-free drug delivery device option for both children and adults with growth hormone deficiency and people with HIV-associated wasting.
- easypod ® - The first of its kind device in the growth hormone therapeutic area, is the newest device developed for the administration of Saizen ®. The easypod device was designed in conjunction with patients, caregivers and healthcare professionals to answer the need for a device that provided simple, everyday use while monitoring patient compliance.
- Cool.click ® - A needle-free drug delivery system exclusively for use with Saizen ® lessens the fear and anxiety that people may experience with needle injections. Cool.click ® disperses Saizen ® through the skin in a fine mist in less than a second.
- One.click ® - The first auto-injector pen for growth hormone in the United States which allows the insertion of the needle and injection of medication all in one step, with the simple click of a button.
Saizen ® - somatropin (rDNA origin) for injection - made by EMD Serono, Inc. For more information visit www.emdserono.com
References:
Food and Drug Administration (FDA)
July 26, 2000
www.fda.gov/MedWatch/SAFETY/2007/Mar_PI/Saizen_PI.pdf
This summary does not include everything there is to know about the medicine mentioned above. Do not use this medicine without first talking to your doctor.
|