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About Emtriva® Capsules 200mg
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| 1. |
Brand Name: |
Emtriva® Capsules 200mg |
| 2. |
Generic Name: |
emtricitabine |
| 3. |
Indication: |
HIV-1 infection |
| 4. |
Dosage and Administration: |
In adults, Emtriva® should usually be administered orally at a dose of 200 mg of emtricitabine once daily. Emtriva® should be used in combination with other anti-HIV drugs. |
| 5. |
Warning: |
Sufficient caution should be exercised to patient with complication of chronic hepatitis B in case administration of Emtriva® is discontinued since exacerbation of chronic hepatitis B might be observed after discontinuation of Emtriva® administration. Especially, particular caution should be exercised to patient with complication of decompensated hepatitis B since decompensated hepatitis B might be aggravated. |
| 6. |
Contraindications: |
Patients with a previously demonstrated hypersensitivity to any of the components of the product. |
| 7. |
Adverse Drug Reactions: |
In two comparative clinical studies in foreign countries, 303 (52.5%) of 580 cases that received Emtriva® presented adverse drug reactions. The common adverse drug reactions were diarrhea, dizziness, nausea, abdominal pain, headache, insomnia, and asthenia etc. Clinically significant adverse drug reactions, including lactic acidosis, might occur. |
| 8. |
Packaging: |
Emtriva® Capsules 200mg, 30 capsules per bottle |
| 9. |
NHI Price: |
¥1,750.90 per capsule |
| 10. |
Date of NHI Price Listing: |
April 6, 2005 |
| 11. |
Marketing Authorization Holder: |
Japan Tobacco Inc. |
| 12. |
Distributed by: |
Torii Pharmaceutical Co., Ltd. |
| 13. |
Licensed by: |
Gilead Sciences, Inc. |
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