País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1)
Zydus Lifesciences Limited
TRANEXAMIC ACID
TRANEXAMIC ACID 100 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Tranexamic acid Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid Injection is contraindicated: - In patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity (see WARNINGS). - In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients. - In patients with active intravascular clotting. - In patients with hypersensitivity to tranexamic acid or any of the ingredients.
Tranexamic acid Injection 100 mg/mL NDC 70771-1085-6 10 X 10 mL Single Dose Vials
Abbreviated New Drug Application
TRANEXAMIC ACID - TRANEXAMIC ACID INJECTION ZYDUS LIFESCIENCES LIMITED ---------- TRANEXAMIC ACID INJECTION 100 MG/ML, 10 ML PACKAGE LABEL.PRINCIPAL DISPLAY PANEL CONTAINER LABEL NDC 70771-1085-1 Tranexamic Acid Injection 1000 mg/10 mL (100 mg/mL) Solution for Intravenous Injection Discard any remaining portion after single use. 10 mL Single-Dose Vial Rx only zydus pharmaceuticals CARTON LABEL NDC 70771-1085-6 Tranexamic Acid Injection 1000 mg/10 mL (100 mg/mL) Solution for Intravenous Injection Discard any remaining portion after single use. 10 X 10 mL Single-Dose Vials Rx only zydus pharmaceuticals TRANEXAMIC ACID tranexamic acid injection PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:70771-1085 ROUTE OF ADMINISTRATION INTRAVENOUS ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1) TRANEXAMIC ACID 100 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70771- 1085-6 10 in 1 CARTON 10/04/2017 Zydus Lifesciences Limited 1 10 mL in 1 VIAL; Type 0: Not a Combination Product MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA205228 10/04/2017 LABELER - Zydus Lifesciences Limited (918596198) REGISTRANT - Zydus Lifesciences Limited (918596198) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1085) , MANUFACTURE(70771-1085) Revised: 11/2022 Llegiu el document complet