Clinical grade Dextran 1 is available from Pharmacosmos as Active Pharmaceutical Ingredients (API) for production of solutions for injection and infusion.
Specifications for Dextran 1
Pharmacosmos supplies Dextran 1 complying with any pharmacopoeial requirements, including:
|Dextran 1||1,000 Da||Ph. Eur.|
|Dextran 1||1,000 Da||USP|
Please contact us for information about other specifications.
Documentation for Dextran 1
Pharmacosmos is the only Dextran manufacturer that has received the certificate from the European Directorate for the Quality of Medicines (EDQM) for the specific pharmacopoeial Dextran 1 clinical grade.
- European Directorate for the Quality of MedicinesPharmacosmos EDQM certificate: Dextran 1 for Injection. (Document: PDF, 2 pages, 0.44 MB)
- Danish Medicines AgencyStatement on Good Manufacturing Practices for Dextran API. (Document: PDF, 1 page, 0.41 MB)
- Dextran Powder Material Safety Data Sheet (MSDS) (Document: PDF, 4 pages, 0.14 MB)
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Dextran 1 Monograph
Packing and Storage of Clinical Dextrans
Clinical grade Dextrans from Pharmacosmos are packed and stored in safe and clean conditions in compliance with Good Manufacturing Practice (GMP).
Clinical grade Dextran 1 is available in the following pack sizes:
|100 g||Polyethylene container, FDA registrered, DMF type III|
|500 g||Polyethylene container, FDA registrered, DMF type III|
|5 kg||Polypropylene container. Dextran powder sealed in double polyethylene bags.|
|50 kg||Fiber drums. Dextran powder sealed in double polyethylene bags.|
Pharmacosmos supplies clinical grade Dextrans to all countries. The product packing meets all national and international regulations.
Clinical Use of Dextran 1
Extensive clinical studies of administration of Dextran 1 immediately preceding administration of Dextran 40 and Dextran 70 were reported in the 1980'ies and showed a significant decrease in the Dextran-induced anaphylactoid reactions (DIAR) (1-4). This discovery resulted in the FDA approval of Dextran 1 clinical grade for prophylaxis of DIAR.
A surveillance study of administration of Dextran 1 compared historical control data with data from Dextran manufactures and from the World Health Organization database INTDIS for the period 1983-1992. It showed that the introduction of Dextran 1 into clinical practice was associated with a 35-fold reduction in the incidences of severe DIAR (5).
Injection of Dextran 1 - hapten inhibition - prior to infusion of Dextran 40, and Dextran 70 has made Dextran possibly the safest plasma volume expander in clinical use (6). Common trademarks for Dextran 1 are Promit® and Promiten®.
- Ljungstrom K.-G., Renck H., Hedin H., et al., “Preventions of Dextran-induced anaphylactic reactions by hapten inhibition. I. A Scandinavian multicenter study on the effects of 10 mL Dextran 1, 15%, administered before Dextran 70 or Dextran 70”, Acta Chir Scand 149, 341-348 (1983)
- Renck H., Ljungstrom K.-G., Rosberg B., et al., “Preventions of Dextran-induced anaphylactic reactions by hapten inhibition. II. A Scandinavian multicenter study on the effects of 20 mL Dextran 1, 15%, administered either admixed to or before Dextran 70 or Dextran 40”, Acta Chir Scand 149, 349-353 (1983)
- Renck H., Ljungstrom K.-G., Rosberg B., et al., “Preventions of Dextran-induced anaphylactic reactions by hapten inhibition. III. A Scandinavian multicenter study on the effects of 20 mL Dextran 1, 15%, administered before Dextran 70 or Dextran 40”, Acta Chir Scand 149, 355-360 (1983)
- Ljungstrom K.-G., Renck H., Strandberg K., et al., “Adverse reactions to dextran in Sweden 1970-1979”, Acta Chir Scand 149, 253-265 (1983)
- Hedin H., Ljungstrom K.-G., “Prevention of dextran anaphylaxis. Ten years with hapten dextran”, Int Arch Allergy Immunol 113, 358-359 (1997)
- Ljungstrom K.-G., “Safety of Dextran in relation to other colloids - Ten years experience with hapten inhibition”, Infusionsther Transfusionsmed (1993)