Bedaquiline labels and packages: Difference between revisions

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==Labels and Packages==
This Medication Guide has been approved by the U.S. Food and Drug Administration
This Medication Guide has been approved by the U.S. Food and Drug Administration


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(77°F); Excursions permitted to 15°C-30°C
(77°F); Excursions permitted to 15°C-30°C
(59°F - 86°F).[See USP Controlled Room
(59°F - 86°F).[See USP Controlled Room
Temperature].
Temperature].<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1534c9ae-4948-4cf4-9f66-222a99db6d0e#nlm34089-3 | publisher =  | date =  | accessdate = 23 December 2013 }}</ref>


188 Tablets
188 Tablets
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<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1534c9ae-4948-4cf4-9f66-222a99db6d0e#nlm34089-3 | publisher =  | date =  | accessdate = 23 December 2013 }}</ref>


==References==
==References==

Latest revision as of 14:07, 24 December 2013

Bedaquiline
SIRTURO® FDA Package Insert
Description
Clinical Pharmacology
Indications and Usage
Microbiology
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Labels and Packages

This Medication Guide has been approved by the U.S. Food and Drug Administration

Issued: October 2013

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label

NDC 59676-701-01

Sirturo™ (bedaquiline) tablets

100 mg

Dispense Medication Guide to each patient

Attention Pharmacist: 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°C-30°C (59°F - 86°F).[See USP Controlled Room Temperature].[1]

188 Tablets

Rx only

Janssen a

References

  1. "SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP]". Retrieved 23 December 2013.

Adapted from the FDA Package Insert.