Plasbutein

Plasbutein

human albumin

Manufacturer:

SK Plasma

Distributor:

International Apex
Full Prescribing Info
Contents
Human albumin.
Description
Each mL contains: Human Albumin 0.2 g.
Albumin (Human) 20% is a sterile aqueous solution for single dose intravenous administration containing 20% human albumin (weight/volume). Human Albumin 20% 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 20% is osmotically equivalent to five times its volume of normal citrate plasma. A liter of Human Albumin 20% solution contains 130-160 milliequivalents of sodium ion. The product contains no preservatives. Human Albumin 20% 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 which have resulted from the administration of Human Albumin 20%.
Action
Pharmacology: Albumin is a highly soluble, globular protein (MW 66, 500), accounting for 70-80% of colloid osmotic pressure of plasma. Therefore, it is important in regulating the osmotic pressure of plasma. Human Albumin 20% 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 initial blood volume. When treating patients with diminished blood volume, the effect of infusion 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 circulating life span of 15-20 days, with a turnover of approximately 15 g per day.
Pharmacokinetics: Under normal conditions, the total exchangeable albumin pool is 4-5 g/kg body weight of which 40-45% is present intravascularly and 55-60% in the extravascular space. Abnormal distribution may occur in conditions such as severe burns or septic shock, where capillary function is impaired. Increased capillary permeability will alter albumin kinetics. Under normal conditions, the average half-life of albumin is about 19 days. The balance between synthesis and breakdown is normally achieved by feed-back regulation. Elimination is predominantly intracellular and due to lysosome proteases. In healthy people, less than 105 infused albumin leaves the intravascular compartment during the first 2 hour following infusion. As a result, the circulation volume will increase from 1 to 3 hours administration. There is considerable individual variation in its effect of plasma volume. In some patients the plasma volume can remain increased for some hours. However, in ill patients, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate.
Indications/Uses
Used for plasma volume replacement and to restore colloid osmotic pressure; in conditions such as burns, severe acute albumin loss and acute hypovolemic shock; and used in neonatal hyperbilirubinemia associated with hemolytic disease or the new born.
Dosage/Direction for Use
Albumin (Human) 20% is administered intravenously. The total dosage will vary with the individual. In adults, an initial infusion of 100 mL is suggested. Additional amounts may be administered as clinically indicated. The initial dosage in children will vary with the clinical state and body weight. A dose one-quarter to one half the adult dose may be administered, or dosage may be calculated on the basis of 1-3 mL per kg of body weight. For infants suffering from hemolytic disease of the newborn the appropriate dose for binding the exchange bilirubin is 1 gram per kilogram of body weight. This may be administered before or during the exchange procedure. In the treatment of the patient in shock with greatly reduced blood volume, Human Albumin 20% 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 as 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 permits.
Contraindications
Human Albumin 20% is contraindicated in patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume. The use of Human Albumin 20% is contraindicated in patients with a history of allergic reactions to albumin.
Warnings
Solutions of Albumin 20% should not be used if they appear turbid or if there is sediment in the bottle. Use immediately after opening. Discard unused portion. Human Albumin 20% 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 blend at a lower pressure.
Patients with marked dehydration require administration of additional fluids: Human Albumin 20% may be administered with the usual dextrose and saline intravenous solutions. However, certain solutions containing protein hydrolyses or alcohol must not be infused through the same administration set in conjunction with Human Albumin 20% 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.
Use In Pregnancy & Lactation
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.
Adverse Reactions
Allergic or pyrogenic reactions are characterized primarily by fever and chills, urticaria, rash, nausea, vomiting, tachycardia 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 20% material from a different lot should be used. Human Albumin 20% is contraindicated in patients with a history of allergic reactions to albumin.
Caution For Usage
Directions and Use (When Administration Set is Used): Flip off plastic cap onto 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: 1. Close clamp an administration set (deliver approximately 19 drops/mL).
2. With bottle upright, thrust piercing pin straight through stopper center. Do not twist or angle.
3. Immediately invert bottle to automatically establish proper fluid level in drip chamber (half full).
4. Attach infusion set to administration set, open clamp and allow solution to expel air from tubing and needle, then close clamp.
5. Make a venipuncture and adjust flow.
6. Discard all administration equipment after use. Discard any unused contents.
Direction For Use (When Administration Set is Not Used): Flip off cap on top of the vial and expose rubber stopper. Cleanse exposed rubber stopper with a suitable germicidal solution being sure to remove excess. Observe aseptic technique and prepare sterile intravenous equipment as follows: 1. Using aseptic technique, attach filter needle to a sterile disposable plastic syringe.
2. Insert filter needle into Albumin (Human), Human Albumin 20% vial.
3. Aspirate human Albumin 20% from vial into the syringe.
4. Remove and discard the filter needle from the syringe.
5. Attach the desired needle to syringe.
6. Discard all administration equipment after use. Discard any unused contents.
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Storage
Store at temperatures not exceeding 30°C. Do not freeze.
ATC Classification
B05AA01 - albumin ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.
Presentation/Packing
Soln for infusion (vial) 0.2 g/mL x 50 mL x 1's.
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