posaconazole 100 mg
1 INDICATIONS AND USAGE Posaconazole is an azole antifungal indicated as follows: • Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus- host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: ( 1.2 ) Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older . 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherap y [see Clinical Studies ( 14.2 )] as follows: • Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older. Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.’s NOXAFIL (posaconazole delayed-release tablets). However, due to Merck Sharp & Dohme Corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
dr.reddys laboratories inc
OVAL BROWN 470
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
POSACONAZOLE delayed-release tablets, 100 mg are available as brown, capsule shaped, bevelled edge, film-coated tablet, debossed with 470 on one side and plain on other side and free from physical defects. Bottles of 60 NDC 43598-470-60 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] .
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