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Albumin (Human) U.S.P. Human Albumin Grifols 25% | Human Albumin Grifols

05:11 EDT 27th August 2014 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Albumin (Human), Human Albumin Grifols 25% is a sterile aqueous solution for single dose intravenous administration containing 25% human albumin (weight/volume). Human Albumin Grifols 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. Human Albumin Grifols 25% is osmotically equivalent to five times its volume of normal citrated plasma.

A liter of Human Albumin Grifols 25% solution contains 130-160 milliequivalents of sodium ion.

The aluminium content of the solution is not more than 200 micrograms per liter during the shelf life of the product.

The product contains no preservatives.

Human Albumin Grifols 25% is heated at 60 °C for ten hours. No positive assertion can be made, however, that this heat treatment completely destroys the causative agents of viral hepatitis. There are no known cases of viral hepatitis which have resulted from the administration of Human Albumin Grifols 25%.

Albumin is a highly soluble, globular protein (MW 66,500), accounting for 70-80% of the colloid osmotic pressure of plasma.

Therefore, it is important in regulating the osmotic pressure of plasma. Human Albumin Grifols 25% supplies the oncotic equivalent of approximately 5 times its volume of human plasma. It will increase the circulating plasma volume by an amount approximately 3.5 times the volume infused within 15 minutes, if the recipient is adequately hydrated. This extra fluid reduces hemoconcentration and decreases blood viscosity. The degree and duration of volume expansion depend upon the initial blood volume.

When treating patients with diminished blood volume, the effect of infused albumin may persist for many hours. The hemodilution lasts for a shorter time when albumin is administered to individuals with normal blood volume.

Albumin is also a transport protein and binds naturally occurring, therapeutic, and toxic materials in the circulation.

Albumin is distributed throughout the extracellular water and more than 60% of the body albumin pool is located in the extravascular fluid compartment. The total body albumin in a 70 kg man is approximately 320 g; it has a circulating life span of 15-20 days, with a turnover of approximately 15 g per day.

Albumin (Human), Human Albumin Grifols 25% is indicated:

Conditions in which Albumin (Human) use is usually not justified:

Unless the pathologic condition responsible for hypoalbuminemia can be corrected, administration of Albumin (Human) can afford only symptomatic relief. There is NO valid reason for the use of Albumin (Human) as an intravenous nutrient.

Human Albumin Grifols 25% is contraindicated in patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume.

The use of Human Albumin Grifols 25% is contraindicated in patients with a history of allergic reactions to albumin.

Solutions of Albumin (Human), Human Albumin Grifols 25% should not be used if they appear turbid or if there is sediment in the bottle. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion.

Human Albumin Grifols 25% is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating certain viruses by pasteurization. Despite these measures, such products can still potentially transmit disease. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Biologicals, at 888-GRIFOLS (888-474-3657). The physician should discuss the risks and benefits of this product with the patient.

There exists a risk of potentially fatal hemolysis and acute renal failure from the inappropriate use of Sterile Water for Injection as a diluent for Albumin (Human) 25%. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.

Human Albumin Grifols 25% should be administered with caution to patients with low cardiac reserve.

Rapid infusion may cause vascular overload with resultant pulmonary edema. Patients should be closely monitored for signs of increased venous pressure.

A rapid rise in blood pressure following infusion necessitates careful observation of injured or postoperative patients to detect and treat severed blood vessels that may have bled at a lower pressure.

Patients with marked dehydration require administration of additional fluids. Human Albumin Grifols 25% may be administered with the usual dextrose and saline intravenous solutions. However, certain solutions containing protein hydrolysates or alcohol must not be infused through the same administration set in conjunction with Human Albumin Grifols 25% since these combinations may cause the proteins to precipitate.

Pregnancy category C. Animal reproduction studies have not been conducted with Albumin (Human). It is also not known whether Albumin (Human) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Albumin (Human) should be given to a pregnant woman only if clearly needed.

Allergic or pyrogenic reactions are characterized primarily by fever and chills; urticaria, rash, nausea, vomiting, tachycardia, headache and hypotension have also been reported. Should an adverse reaction occur, slow or stop the infusion for a short period of time which may result in the disappearance of the symptoms. If administration has been stopped and the patient requires additional Human Albumin Grifols 25%, material from a different lot should be used.

Human Albumin Grifols 25% particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.

Albumin (Human), Human Albumin Grifols 25% is administered intravenously. The total dosage will vary with the individual

In the treatment of the patient in shock with greatly reduced blood volume, Human Albumin Grifols 25% may be administered as rapidly as necessary in order to improve the clinical condition and restore normal blood volume. This may be repeated in 15-30 minutes if the initial dose fails to prove adequate. In the patient with a slightly low or normal blood volume, the rate of administration should be 1 mL per minute. The usual rate of administration in children should be one-quarter the adult rate.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permit.

Flip off plastic cap on top of the vial and expose rubber stopper. Cleanse exposed rubber stopper with a suitable germicidal solution, being sure to remove any excess. Observe aseptic technique and prepare sterile intravenous equipment as follows:

Flip off plastic cap on top of the vial and expose rubber stopper. Cleanse exposed rubber stopper with a suitable germicidal solution, being sure to remove any excess. Observe aseptic technique and prepare sterile intravenous equipment as follows:

- 50 mL vial Human Albumin Grifols 25%

- 100 mL vial Human Albumin Grifols 25%

Human Albumin Grifols 25% is stable for three years providing storage temperature does not exceed 30 °C. Protect from freezing.

Caution

Federal (USA) law prohibits dispensing without a prescription.

Manufactured by Instituto Grifols, S.A. Barcelona – SPAINU.S. Licence No. 1181

Distributed by Grifols Biologicals, Inc. Los Angeles - CA 90032

Revised: January 2007

3025176

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML VIAL

NDC 61953-0002-1

Albumin (Human) U.S.P. Human Albumin Grifols 25%

12.5 g 50 mL Rx only.

Dosage and directions for administration, see package insert.

Store at temperatures not exceeding 30 °C

DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

Manufactured by Instituto Grifols, S.A. Barcelona – SPAIN U.S. License No. 1181

Distributed by Grifols Biologicals, Inc. Los Angeles – CA 90032

IMAGE huma2-0002-01.jpg

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 100 ML VIAL

NDC 61953-0002-2

Albumin (Human) U.S.P. Human Albumin Grifols 25%

25 g 100 mL Rx only.

CONTENTS: Each 100 mL contains 25 grams Albumin (Human) in aqueous diluent.

Osmotically equivalent to 500 mL of plasma. Sodium range 130-160 milliequivalents per liter.

Dosage and directions for administration, see package insert.

Contains no preservatives. Store at temperatures not exceeding 30 °C

DO NOT USE IF TURBID.

DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

Manufactured by Instituto Grifols, S.A. Barcelona – SPAIN U.S. License No. 1181

Distributed by Grifols Biologicals, Inc. Los Angeles – CA 90032

IMAGE huma2-0002-02.jpg

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML CARTON

GRIFOLS

NDC 61953-0002-1

Albumin (Human) U.S.P.

Human Albumin Grifols

25% Solution

12.5 g 50 mL

DO NOT USE IF TURBID.

DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

IMAGE huma2-0002-03.jpg

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 100 ML CARTON

GRIFOLS

NDC 61953-0002-2

Albumin (Human) U.S.P.

Human Albumin Grifols

25% Solution

25 g 100 mL

DO NOT USE IF TURBID.

DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

IMAGE huma2-0002-04.jpg

Manufacturer

Instituto Grifols, S.A.

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