Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**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 or slowed according to the clinical response and rising blood pressure. Administration should be by vein and preferably through an area of skin at some distance from any site of infection or trauma. Plasmanate is compatible with the usual carbohydrate and electrolyte solutions. Remove seal to expose stopper. Always swab stopper top immediately with suitable antiseptic prior to entering the vial. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring. A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
INTRAVENOUS
Medical Information
**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 red blood cells. It is also effective in the emergency treatment of shock due to hemorrhage.(3,4) Following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss. In infants and small children, Plasmanate has been found to be very useful in the initial therapy of shock due to dehydration and infection. * * * **REFERENCES** 3\. Tullis JL. Albumin. 1. Background and use. 2. Guidelines for clinical use. JAMA. 1977;237:355–60;460–3. 4\. Bland JHL, Laver MB, Lowenstein E. Vasodilator effect of commercial 5% plasma protein fraction solutions. JAMA. 1973;224:1721–4.
**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 in patients with severe anemia, congestive heart failure, or increased blood volume. * * * **REFERENCES** 4\. Bland JHL, Laver MB, Lowenstein E. Vasodilator effect of commercial 5% plasma protein fraction solutions. JAMA. 1973;224:1721–4.
B05AA02
other plasma protein fractions
Manufacturer Information
GRIFOLS ASIA PACIFIC PTE. LTD.
Grifols Therapeutics LLC
Active Ingredients
Documents
Package Inserts
Plasmanate Injection PI.pdf
Approved: June 10, 2019