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October 20, 2006

Takeda Pharmaceutical Company Limited

Product registration Approval in Japan of "Takepron®I.V.
for Injection 30mg"

Osaka, Japan, October 20, 2006 --- Takeda Pharmaceutical Company Limited ("Takeda") today announced the product registration approval in Japan of "Takepron®I.V. for Injection 30mg" (generic name: lansoprazole) which is a treatment for peptic ulcer as an additional dosage formulation of the current oral formulations.

The new injectable formulation was approved for bleeding associated with gastric ulcer, duodenal ulcer, acute stress ulcer and acute gastric mucosal lesion for the patients who are not able to take the drug orally. The approved dosage and admini- stration is 30mg twice a day.

Lansoprazole is a proton pump inhibitor discovered and developed by Takeda, and launched in Europe, the U.S., and Japan in 1991, 1992 and 1995 respectively.
Lansoprazole is now available in more than 90 countries in the world offering administration option such as orally disintegrating tablets that can be taken without water, and also the product in one package with other medications foreradication of H. pylori.

About Takepron® I.V. for Injection 30mg
Brand Name : Takepron® I.V. for Injection 30mg
Indications : The following indications for patients who are unable to take the oral formulations;
gastric ulcer, duodenal ulcer, acute stress ulcer and acute gastric mucosal lesion accompanied with bleeding
Posology : For adults, usually Takepron I.V. for Injection 30mg can be reconsti- tuted into Saline Solution, JP or 5% Dextrose Injection, JP and administered by intravenous drip infusion twice a day. Or Takepron I.V. for Injection 30mg can be reconstituted into 20ml of Saline Solution, JP or 5% Dextrose Injection, JP and be gradually administered by intravenous infusion twice a day.
  • 1.As Takepron I.V. for Injection can show high hemostatic effect with three-days treatment, once the patient is able to take medications orally, therapy should be switched to an oral formulation and this drug should not be administered aimlessly for a long period.
  • 2.There is no clinical experience over 7 days treatment in Japanese clinical trials.

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