Dalteparin description: Difference between revisions
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Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5000 and about 90% of the material within the range 2000-9000. The molecular weight distribution is: | Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5000 and about 90% of the material within the range 2000-9000. The molecular weight distribution is: | ||
< 3000 daltons 3.0-15% | < 3000 daltons 3.0-15%<BR> | ||
3000 to 8000 daltons 65.0-78.0% | 3000 to 8000 daltons 65.0-78.0%<BR> | ||
> 8000 daltons 14.0-26.0% | > 8000 daltons 14.0-26.0% | ||
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<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = FRAGMIN (DALTEPARIN SODIUM) INJECTION [EISAI INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5cd4a8e-14c0-440b-b453-9f3d3250c951 | publisher = | date = | accessdate = 31 January 2014 }}</ref> | <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = FRAGMIN (DALTEPARIN SODIUM) INJECTION [EISAI INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5cd4a8e-14c0-440b-b453-9f3d3250c951 | publisher = | date = | accessdate = 31 January 2014 }}</ref> | ||
Revision as of 20:58, 31 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Description
FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2500, 5000, 7500, 10,000, 12,500, 15,000 or 18,000 anti-Factor Xa international units (IU), equivalent to 16, 32, 48, 64, 80, 96 or 115.2 mg dalteparin sodium, respectively. Each multiple-dose vial contains either 10,000 or 25,000 anti-Factor Xa IU per 1 mL (equivalent to 64 or 160 mg dalteparin sodium, respectively), for a total of 95,000 anti-Factor Xa IU per vial.
Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prefilled syringes are preservative-free. Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The pH of both formulations is 5.0 to 7.5. [SeeDosage and Administration (2) and How Supplied (16)]
Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5000 and about 90% of the material within the range 2000-9000. The molecular weight distribution is:
< 3000 daltons 3.0-15%
3000 to 8000 daltons 65.0-78.0%
> 8000 daltons 14.0-26.0%
 |
References
- ↑ "FRAGMIN (DALTEPARIN SODIUM) INJECTION [EISAI INC.]". Retrieved 31 January 2014.