Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
Antithrombin Iii Human (UNII: T0LTO7L82X) (Antithrombin Iii Human - UNII:T0LTO7L82X)
GRIFOLS USA, LLC
Antithrombin Iii Human
Antithrombin Iii Human 50 [iU] in 1 mL
THROMBATE III is a human antithrombin (AT) indicated in patients with hereditary antithrombin deficiency for: - Treatment and prevention of thromboembolism - Prevention of peri-operative and peri-partum thromboembolism None. Risk Summary There are no data with THROMBATE III use in pregnant women to inform a drug-associated risk. However, there are clinical considerations [see Clinical Considerations] . It is not known whether THROMBATE III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. THROMBATE III should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to THROMBATE III. Clinical Considerations Labor or Delivery Suspend heparin (or low molecular weight heparin) administration and continue THROMBATE III administration during labor and delivery. Risk Summary There is no information regarding the presence of THROMBATE III in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for THROMBATE III and any potential adverse effects on the breastfed infant from THROMBATE III or from the underlying maternal condition. Safety and effectiveness in the pediatric population have not been established. The safety and effectiveness in the geriatric population have not been established.
THROMBATE III is supplied in a kit containing one single use vial of THROMBATE III lyophilized powder for reconstitution, one vial of Sterile Water for Injection, USP, one sterile double-ended transfer needle, and one sterile filter needle. The total activity of AT in International Units is stated on the label of the THROMBATE III vial. Components of the packaging do not contain natural rubber latex.
Biologic Licensing Application
THROMBATE III - ANTITHROMBIN III (HUMAN) THROMBATE III- ANTITHROMBIN III (HUMAN) GRIFOLS USA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE THROMBATE III SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR THROMBATE III. THROMBATE III [ANTITHROMBIN III (HUMAN)] LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION INITIAL U.S. APPROVAL: 1991 INDICATIONS AND USAGE THROMBATE III is a human antithrombin (AT) indicated in patients with hereditary antithrombin deficiency for: Treatment and prevention of thromboembolism Prevention of peri-operative and peri-partum thromboembolism (1) DOSAGE AND ADMINISTRATION FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY Individualize dose to achieve AT level of 80% to 120% of normal human plasma (2.1) Dose Target AT Level Dose (Units) Monitor AT Level Loading 120% of normal 120 % - baseline x body weight(kg) divided by 1.4% baseline 20 minutes (peak) post- injection 12 hours post-injection pre-injection (trough) Adjustment (as needed) 80% to 120% of normal Target % - trough % x body weight (kg) divided by 1.4% 20 minutes (peak) post- injection at least every 12 hours post- injection pre-injection (trough) Maintenance (every 24 hours, as needed) 80% to 120% of normal Loading Dose x 0.6 approximately every 24 hours, as needed Adapt the rate of administration to the response of the patient; typically the full dose is given over 10 to 20 minutes. (2.3) DOSAGE FORMS AND STRENGTHS For injection: approximately 500 units, lyophilized powder in single-use vial for reconstitution. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue THROMBATE III infusion and begin appropriate treatment. (5.1) Because THROMBATE III is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob (CJD) d Baca dokumen lengkapnya