Bedaquiline how supplied: Difference between revisions
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==How Supplied== | |||
SIRTURO is supplied as uncoated white to almost white round biconvex 100 mg tablets with debossing of "T" over "207" on one side and "100" on the other side. The tablets are packaged in white high density polyethylene (HDPE) bottles with child-resistant polypropylene (PP) closure with induction seal liner. Each bottle contains 188 tablets. | SIRTURO is supplied as uncoated white to almost white round biconvex 100 mg tablets with debossing of "T" over "207" on one side and "100" on the other side. The tablets are packaged in white high density polyethylene (HDPE) bottles with child-resistant polypropylene (PP) closure with induction seal liner. Each bottle contains 188 tablets. | ||
==Storage and Handling== | |||
Keep out of reach of children. | Keep out of reach of children. | ||
Dispense in original container. Tablets dispensed outside the original container should be stored in a tight light-resistant container with an expiration date not to exceed 3 months. | Dispense in original container. Tablets dispensed outside the original container should be stored in a tight light-resistant container with an expiration date not to exceed 3 months. | ||
Latest revision as of 02:15, 31 December 2013
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]Associate Editor(s)-in-Chief: ; Chetan Lokhande, M.B.B.S [2]
How Supplied
SIRTURO is supplied as uncoated white to almost white round biconvex 100 mg tablets with debossing of "T" over "207" on one side and "100" on the other side. The tablets are packaged in white high density polyethylene (HDPE) bottles with child-resistant polypropylene (PP) closure with induction seal liner. Each bottle contains 188 tablets.
Storage and Handling
Keep out of reach of children. Dispense in original container. Tablets dispensed outside the original container should be stored in a tight light-resistant container with an expiration date not to exceed 3 months. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature][1]
References
- ↑ "SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]". Retrieved 23 December 2013.
Adapted from the FDA Package Insert.