PLASMANATE Solution for infusion (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

GRIFOLS USA, LLC

Λέξεις κλειδιά

13533-613

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1. Description

This product has been prepared from large pools of human plasma. Each 100 mL of Plasma Protein Fraction (Human) 5%, USP—Plasmanate contains 5 g selected plasma proteins buffered with sodium carbonate and ...

2. Clinical Pharmacology

In normal human volunteers, Plasmanate has resulted in an increased blood volume which has lasted up to 48 hours.(2) Clinical experience has indicated that it is an adequate replacement for human plasma ...

3. Indications and Usage

Treatment of Shock Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not ...

4. Contraindications

Plasmanate is contraindicated for use in patients on cardiopulmonary bypass. Severe hypotension has been reported in such patients when given Plasma Protein Fraction.(4) Plasma Protein Fraction is contraindicated ...

5. Warnings

<b>Plasmanate is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent that can cause disease. ...

6.1. General

Rapid infusion of Plasmanate (greater than 10mL/minute) has produced hypotension in patients undergoing surgery or in the preoperative or postoperative period. Blood pressure should be monitored during ...

6.4. Drug Interactions

Plasmanate is compatible with whole blood, packed red cells as well as the standard carbohydrate and electrolyte solutions intended for intravenous use. It should, however, not be mixed with protein hydrolysates ...

6.7. Pregnancy

Animal reproduction studies have not been conducted with Plasmanate. It is also not known if Plasmanate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plasmanate ...

6.10. Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

7. Adverse Reactions

Hypotension may occur, particularly following rapid infusion or intraarterial administration to patients on cardiopulmonary bypass. The blood pressure may normalize spontaneously after the slowing or discontinuation ...

10. Dosage and Administration

Dosage is based almost entirely on the nature of the individual case and response to therapy. The usual minimum effective dose in adults is 250–500 mL. As with any plasma expander, the rate should be adjusted ...

11. How Supplied

Plasmanate is available in 50 mL pediatric size, 250 mL and 500 mL rubber-stoppered vials. Each single dose vial contains plasma protein in the following approximate amounts: NDC Number Size Grams Protein ...

12. Storage and handling

Store at room temperature not exceeding 30°C (86°F). Solution that has been frozen should not be used. Do not use after expiration date.

14. References

Hink JH Jr, Hidalgo J, Seeberg VP, Johnson FF. Preparation and properties of a heat-treated human plasma protein fraction. Vox Sang. 1957;2:174–86. Bertrand JJ, Feichtmeir TV, Kolomeyer N, Beatty JO, Murphy ...