Osaka, Japan – June 6 2018 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approval of partial change applications by the Ministry of Health, Labour and Welfare (MHLW) for OSELTAMIVIR Capsules 75mg [SAWAI] and OSELTAMIVIR Dry Syrup 3% [SAWAI]*.
This approval expands the indication of OSELTAMIVIR Capsules 75mg [SAWAI] and OSELTAMIVIR Dry Syrup 3% [SAWAI] to include the same uses as their brand equivalents.
* Brand products: TAMIFLU® Capsules 75mg and Dry Syrup 3%
“Indications and Usage” and “Dosage and Administration” after approvals are as below;
(1) OSELTAMIVIR Capsules 75 mg [SAWAI]
| Indications and Usage (New approval is underlined) |
Treatment or prophylaxis of influenza type A or B virus infection |
| Dosage and Administration (New approval is underlined) |
- When used for treatment
- In general, for adults, start taking 5 to 10mg of olanzapine at a time, once a day. The dosage is maintained on 10mg once a day, it may be adjusted according to your age and symptoms. However, the daily dosage should not exceed 20mg.
- When used for prophylaxis
- (1) Adults
In general, 75 mg as oseltamivir is administered orally once a day for 7 to 10 days.
- (2) Children weighing 37.5 kg or more
In general, 75 mg as oseltamivir is administered orally once a day for 10 days.
|
(2) OSELTAMIVIR Dry Syrup 3%[SAWAI]
| Indications and Usage (New approval is underlined) |
Treatment or prophylaxis of influenza type A or B virus infection |
| Dosage and Administration (New approval is underlined) |
- When used for treatment
- (1) Adults
In general, 75 mg as oseltamivir is suspended before use and administered orally twice a day for 5 days.
- (2) Children
In general, the dosage below is suspended before use and administered orally twice a day for 5 days. However, the maximum dose per administration is 75 mg as oseltamivir.
Children and young children: 2 mg/kg as oseltamivir (66.7 mg/kg as Dry Syrup)
Neonates and infants: 3 mg/kg as oseltamivir (100 mg/kg as Dry Syrup)
- When used for prophylaxis
- (1) Adults
In general, 75 mg as oseltamivir is suspended before use and administered orally once a day for 7 to 10 days.
- (2) Children
In general, the dosage below is suspended before use and administered orally once a day for 10 days. However, the maximum dose per administration is 75 mg as oseltamivir.
Children and young children: 2 mg/kg as oseltamivir (66.7 mg/kg as Dry Syrup)
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