News Release
For Immediate Release
April 4, 2018
Sawai Pharmaceutical Co., Ltd.

MHLW approves New Indication for OLANZAPINE formulation*
and New Administration for MEROPENEM formulation**
Osaka, Japan –April 4, 2018 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka,Japan, President: Mitsuo Sawai) today received approvals of partial change application by theMinistry of Health, Labour and Welfare (MHLW) for OLANZAPINE Tablets 2.5mg “SAWAI”, 5mg“SAWAI”, 10mg “SAWAI” and Fine Granules 1% “SAWAI” and MEROPENEM I.V. Drip Infusion
0.25g “SAWAI” and 0.5g “SAWAI”.
This approval expands the indication of OLANZAPINE Tablets 2.5mg “SAWAI”, 5mg “SAWAI”,
10mg “SAWAI”, Fine Granules 1% “SAWAI” to include the same uses as their brand equivalents.
*Brand products: Zyprexa® Tablets 2.5mg, 5mg, 10mg and Fine Granules 1%**Brand products: MEROPEN® For Intravenous Drip Infusion Vial 0.25g, Vial 0.5g and Kit 0.5g

“Indications and Usage” and “Dosage and Administration” after approvals are as below;(1) OLANZAPINE Tablets 2.5mg “SAWAI”, 5mg “SAWAI”, 10mg “SAWAI” and Fine Granules 1%“SAWAI”
Indications and Usage

Schizophrenia(New approval is underlined) Treatment of manic and depressive symptoms in bipolar disorder
Gastrointestinal symptoms (nausea and vomiting) associatedwith chemotherapy medicine (such as cisplatin) for cancer
Dosage and Administration(New approval is underlined)

Schizophrenia：
In general, for adults, start taking 5 to 10mg of olanzapine at atime, once a day. The dosage is maintained on 10mg once aday, it may be adjusted according to your age and symptoms.
However, the daily dosage should not exceed 20mg.
Treatment of manic symptoms in bipolar disorder：
In general, for adults, start taking 10mg of olanzapine at atime, once a day. The maintenance dosage may be adjusted

News Releaseaccording to your age and symptoms. However, the daily
dosage should not exceed 20mg.
Treatment of depressive symptoms in bipolar disorder：
In general, for adults, start taking 5mg of olanzapine at a timeonce a day, and then increase to 10mg once a day. In either
case, take before bedtime. The dosage may be adjusted
according to your age and symptoms. However, the daily
dosage should not exceed 20mg.
Gastrointestinal symptoms (nausea and vomiting) associatedwith chemotherapy medicine (such as cisplatin) for cancer
In general, for adults, take 5mg of olanzapine at a time, once a
day in combination with other antiemetics. The dosage may be
increased according to your condition. However, the daily
dosage should not exceed 10mg.

(2)MEROPENEM I.V. Drip Infusion 0.25g “SAWAI” and 0.5g “SAWAI”
Dosage and Administration(New approval is underlined)

When using this drug, judge whether the further administrationis necessary around the 3rd day after the start of administration,and consider whether to stop administration or switch to other,more appropriate drugs.
1.Conventional infection
・Conventional infection except for purulent meningitis
In general, for adults, divide a daily dose of 0.5 to 1 g (potency)of meropenem into two to three times and intravenously infuse
taking 30 minutes or longer. The dosage should be adjusted
according to the patient’s age and symptoms and can beincreased to 3g (potency) per day with a ceiling of 1g (potency)
per time in patients with severe / refractory infection.
In general, for children, divide a daily dose of 30 to 60 mg(potency)/kg of meropenem into three times and intravenously
infuse taking 30 minutes or longer. The dosage should be
adjusted according to the age and symptoms and can beincreased to 120mg (potency)/kg per day in children withsevere / refractory infection. However, the dosage should notexceed the maximum daily dose of 3g (potency) for adults.
・purulent meningitis
In general, for adults, divide a daily dose of 6g (potency)/kg ofmeropenem into three times and intravenously infuse taking

News Release
30 minutes or longer. The dosage should be adjusted according
to the age and symptoms.
In general, for children, divide a daily dose of 120mg(potency)/kg of meropenem into three times and intravenously
infuse taking 30 minutes or longer. The dosage should beadjusted according to the age and symptoms. The dosage
should not exceed the maximum daily dose of 6g (potency) per
day for adults.
2. Febrile neutropenia
In general, for adults, divide a daily dose of 3g (potency) ofmeropenem into three times and intravenously infuse taking
30 minutes or longer.
In general, for children, divide a daily dose of 120mg(potency)/kg of meropenem into three times and intravenously
infuse taking 30 minutes or longer. The dosage should notexceed the maximum daily dose of 3g (potency) for adults.

◆ Contact information ◆PR / IR Group, Corporate Strategy Department, Sawai Pharmaceutical Co., Ltd
E-mail：koho@sawai.co.jp