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| __NOTOC__
| | #REDIRECT [[Antithrombin III#Structure]] |
| {{Antithrombin III}}
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| {{CMG}}, {{AE}}{{JH}}
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| ==Description==
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| Antithrombin III (Human), THROMBATE III® is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III (ATIII).
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| THROMBATE III is prepared from pooled units of human plasma from normal donors by modifications and refinements of the cold [[ethanol]] method of Cohn.(1) When reconstituted with Sterile Water for Injection, USP, THROMBATE III has a pH of 6.0–7.5, a sodium content of 110–210 mEq/L, a chloride content of 110–210 mEq/L, an alanine content of 0.075–0.125 M, and a heparin content of not more than 0.1 IU heparin/IU ATIII. THROMBATE III contains no preservative and must be administered by the intravenous route.
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| Each vial of THROMBATE III contains the labeled amount of antithrombin III in international units (IU) per vial. The potency assignment has been determined with a standard calibrated against a [[World Health Organization]] (WHO) antithrombin III reference preparation.
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| The capacity of the THROMBATE III manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model using a wide range of viruses with diverse physicochemical properties. There are two dedicated virus inactivation/removal steps included in the THROMBATE III manufacturing process: a heat treatment step at 60°C ± 0.5°C for not less than 10 hours for virus inactivation and a nanofiltration step for effective removal of viruses as small as 18 nm.
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| The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible [[spongiform encephalopathy]] (TSE), considered as a model for the vCJD and CJD agents.(2–5)
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| An individual production step in the THROMBATE III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.<ref>{{Cite web | last = | first = | title = THROMBATE III (ANTITHROMBIN III) KIT [GRIFOLS USA, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b2a9f856-3ef7-8da4-920c-f738e4f1f7d7 | publisher = | date = | accessdate = 7 March 2014 }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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