Jan. 20, 2010Products
Acquisition of an additional indication of MEROPEN, a carbapenem antibiotic preparation
Dainippon Sumitomo Pharma Co., Ltd. (Headquarters: Osaka, Japan; President: Masayo Tada; hereinafter called "DSP") has obtained an approval for an additional indication and new dosing regimen of "MEROPEN®", a carbapenem antibiotic preparation, relating to febrile neutropenia in Japan as of January 20, 2010 from Ministry of Health, Labor and Welfare.
MEROPEN® is DSP's self-developed carbapenem antibiotic preparation for injection.
The manufacturing approval was obtained in June 1995, and in 2004, an approval for the dosing regimen for children and an additional indication for purulent meningitis were acquired. This drug is widely used for various types of moderate to severe infectious diseases caused by gram-positive / gram-negative bacteria. This medicine is sold by DSP and AstraZeneca, DSP's licensee, in more than 100 countries collectively in the world. In more than 90 countries, indication for febrile neutropenia has been obtained and in more than 10 countries, dosage for children has been approved.
Febrile neutropenia is a serious illness of patients with decreased immune competence.
Most of the cases are thought to be due to some bacterial infections, and selection of antimicrobial agents at the initial phase treatment is considered to be critical.
MEROPEN® has a broad antibacterial spectrum and a strong antibacterial activity, showing remarkable efficacy on gram-positive / gram-negative bacteria which are major causative microorganisms of febrile neutropenia, whereby for the purpose of treatment of febrile neutropenia, MEROPEN® is the first carbapenem antibiotic in Japan approved for adults and the first antimicrobial agent in Japan approved for children.
While the maximum daily dose of MEROPEN® for conventional indications is 2g (potency), that is 3g (potency) for febrile neutropenia for adults, which is the same dose as overseas, based on results of newly implemented clinical studies.
DSP expects that as a result of the additional indication MEROPEN® will further contribute to treatment of infectious diseases in Japan.
|[Brand Name]||MEROPEN® for intravenous drip infusion vial 0.25g
MEROPEN® for intravenous drip infusion vial 0.5g
MEROPEN® for intravenous drip infusion kit 0.5g
|[Generic Name]||Meropenem hydrate|
|[Indication] (Addition only)||Febrile neutropenia|
|[Dosage and Administration]
|For adults, usually 3g (potency) of meropenem is intravenously infused for 30 minutes or longer in three divided doses per day.
For children, usually 120mg (potency) of meropenem is intravenously infused for 30 minutes or longer in three divided doses per day. The dosage should not exceed the maximum daily dose of 3g (potency) for adults.
|[Manufacturer and Distributor]||Dainippon Sumitomo Pharma Co., Ltd.|