Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/636
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rdfs:label |
Romazicon (Injection, Solution)
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dailymed-instance:dosage |
FLEXBUMIN 25%, Albumin (Human), 25% Solution
must be administered intravenously.�� This solution may be
administered in conjunction with or combined with other parenterals such as
whole blood, plasma, saline, glucose or sodium lactate.�� The
addition of four volumes of normal saline or 5% glucose to 1 volume of
FLEXBUMIN 25%, Albumin (Human), 25% Solution gives a solution, which is
approximately isotonic and isosmotic with citrated plasma. Albumin solutions should not be mixed with protein hydrolysates or
solutions containing alcohol.<br/>Recommended Dosages: 1.���� Hypovolemic ShockThe dosage of FLEXBUMIN 25%,
Albumin (Human), 25% Solution must be individualized.��
As a guideline, the initial treatment should be in the range of
100 to 200 ml for adults and 2.5 to 5 ml per kilogram body weight for
children.�� This may be repeated after 15 to 30
minutes, if the response is not adequate.�� For
patients with significant plasma volume deficits, albumin replacement is
best administered in the form of 5% Albumin
(Human). Upon administration of additional albumin
or if hemorrhage has occurred, hemodilution and a relative anemia will
follow.�� This condition should be controlled by the
supplemental administration of compatible red blood cells or compatible
whole blood. 2.���� BurnsThe optimal therapeutic
regimen for administration of crystalloid and colloid solutions after
extensive burns has not been established.�� When
FLEXBUMIN 25%, Albumin (Human), 25% Solution is administered after the
first 24 hours following burns, the dose should be determined according
to the patient���s condition and response to
treatment. 3.����
HypoalbuminemiaHypoalbuminemia is usually accompanied by a hidden
extravascular albumin deficiency of equal magnitude.��
This total body albumin deficit must be considered when
determining the amount of albumin necessary to reverse the
hypoalbuminemia.�� When using patient���s serum
albumin concentration to estimate the deficit, the body albumin
compartment should be calculated to be 80 to100 ml per kg of body
weight.�� Daily dose should not exceed
2 g of albumin per kilogram of body weight.<br/>Preparation of Administration: Check the GALAXY container for minute leaks prior to use by
squeezing the bag firmly.�� If leaks are found, discard
solution as sterility may be impaired.�� Do not add
supplementary medication.�� Do not use unless solution
is clear and seal is intact. CAUTION: Do not use plastic containers in series connections.
Such use could result in air embolism due to residual air being drawn
from the primary container before the administration of the fluid from
the secondary container is complete. Preparation for administration: 1.������ Suspend container from eyelet support. 2.������ Remove plastic protector from outlet port at bottom of
container. 3.������ Attach administration set.�� Refer to
complete directions accompanying set.�� Make certain
that the administration set contains an adequate filter.
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dailymed-instance:descripti... |
FLEXBUMIN 25%, Albumin (Human), 25% Solution is a sterile, nonpyrogenic
preparation of albumin in a single dosage form for intravenous
administration.�� Each 100 ml contains 25 g of albumin and
was prepared from human venous plasma using the Cohn cold ethanol fractionation
process.�� Source material for fractionation may be
obtained from another U.S. licensed manufacturer.�� It has
been adjusted to physiological pH with sodium bicarbonate and/orsodium
hydroxide and stabilized with�� N-acetyltryptophan and sodium
caprylate.�� The sodium content is 145 �� 15
mEq/L.�� This solution contains no preservative and none
of the coagulation factors found in fresh whole blood or plasma.�� FLEXBUMIN 25%, Albumin (Human), 25% Solution is a transparent or
slightly opalescent solution which may have a greenish tint or may vary from a
pale straw to an amber color. The likelihood of the presence of viable hepatitis viruses has been
minimized by heating the product for 10 hours at 60��
C.�� This procedure has been shown to be an
effective method of inactivating hepatitis virus in albumin solutions even when
those solutions were prepared from plasma known to be infective. The GALAXY plastic container is fabricated from a specially designed
multilayered plastic (PL 2501).�� Solutions are in contact
with the polyethylene layer of the container and can leach out certain chemical
components of the plastic in very small amounts within the expiration
period.�� The suitability and safety of the plastic have
been confirmed in tests in animals according to the USP biological tests for
plastic containers, as well as by tissue culture toxicity studies.
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dailymed-instance:clinicalP... |
Albumin is responsible for 70-80% of the colloid osmotic pressure of
normal plasma, thus making it useful in regulating the volume of circulating
blood.�� Albumin is also a transport protein
and binds naturally occurring, therapeutic and toxic materials in the
circulation. FLEXBUMIN 25%, Albumin (Human), 25% Solution is osmotically equivalent
to approximately five times its volume of human plasma.��
When injected intravenously, 25% albumin will draw about 3.5 times
its volume of additional fluid into the circulation within 15 minutes, except
when the patient is markedly dehydrated.�� This extra fluid
reduces hemoconcentration and blood viscosity.�� The degree
and duration of volume expansiondepends upon the initial blood
volume.�� With patients treated for diminished blood
volume, the effect of infused albumin may persist for many hours; however, in
patients with normal volume, the duration will be shorter. Total body albumin is estimated to be 350 g for a 70 kg man and is
distributed throughout the extracellular compartments; more than 60% is located
in the extravascular fluid compartment.�� The half-life of
albumin is 15 to 20 days with a turnover of approximately 15 g per
day. The minimum plasma albumin level necessary to prevent or reverse
peripheral edema is unknown.�� Some investigators recommend
that plasma albumin levels be maintained at approximately 2.5 g/dL.��
This concentration provides a plasma oncotic value of 20 mm
Hg. FLEXBUMIN 25%, Albumin (Human) 25% Solution is manufactured from human
plasma by the modified Cohn-Oncley cold ethanol fractionation process, which
includes a series of cold-ethanol precipitation, centrifugation and/or
filtration steps followed by pasteurization of the final product at 60�� 0.5��C
for 10 - 11 hours.�� This process accomplishes both
purification of albumin and reduction of viruses. In vitro studies, demonstrate
that the manufacturing process for FLEXBUMIN 25%, Albumin (Human), 25% Solution
provides for significant viral reduction.�� These viral
reduction studies, summarized in Table 1, demonstrate viral clearance during
the manufacturing process for FLEXBUMIN 25%, Albumin (Human), 25% Solution
using human immunodeficiency virus, type 1 (HIV-1) both as a target virus and
as model virus for HIV-2 and other enveloped RNA viruses; bovine viral
diarrheal virus (BVDV), a model for lipid enveloped RNA viruses, such as
hepatitis C virus (HCV); West Nile Virus (WNV), a target virus and model for
other similar enveloped RNA viruses; pseudorabies virus (PRV), a model for
other enveloped DNA viruses such as hepatitis B virus (HBV);��
mice minute virus (MMV), models for non-lipid enveloped DNA viruses
such as human parvovirus B 19; and hepatitis A virus (HAV), a
target virus and a model for other non-lipid enveloped RNA viruses. These studies indicate that specific steps in the manufacture of
FLEXBUMIN 25%, Albumin (Human), 25% Solution are capable of
eliminating/inactivating a wide range of relevant and model viruses.��
Since the mechanism of virus elimination/inactivation at specific
process steps is different, the overall manufacturing process of FLEXBUMIN 25%,
Albumin (Human), 25% Solution is robust in reducing viral load.
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dailymed-instance:supply |
FLEXBUMIN 25%, Albumin (Human), 25% Solution is supplied in 50 ml (NDC
0944-0493-01) and 100 ml (NDC 0944-0493-02) in single dose GALAXY plastic
container (PL 2501).
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dailymed-instance:precautio... |
FLEXBUMIN 25%, Albumin (Human), 25% Solution must be administered
intravenously at a rate not to exceed 1ml/min to patients with normal blood
volume.�� More rapid administration might cause
circulatory overload and pulmonary edema. A rise in blood pressure after 25% albumin infusion necessitates
careful observation of the injured or post-operative patient in order to detect
and treat severed blood vessels that may not have bled at a lower blood
pressure.<br/>Pregnancy-Category C: Animal reproduction studies have not been conducted with
FLEXBUMIN 25%, Albumin (Human), 25% Solution.�� It is
not known whether FLEXBUMIN 25%, Albumin (Human), 25% Solution can cause
fetal harm when administered to a pregnant woman or can affect
reproductive capacity.�� FLEXBUMIN 25%, Albumin
(Human), 25% Solution should be given to a pregnant woman only if clearly
needed.<br/>Pediatric Use: The safety of albumin solutions has been demonstrated in children
provided the dose is appropriate for body weight, however, the safety of
FLEXBUMIN 25%, Albumin (Human), 25% Solution has not been evaluated in
pediatric patients.
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dailymed-instance:genericMe... |
Albumin human
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dailymed-instance:fullName |
Romazicon (Injection, Solution)
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dailymed-instance:adverseRe... |
Untoward reactions to FLEXBUMIN 25%, Albumin (Human), 25% Solution are
extremely rare, although nausea, fever, chills or urticaria may occasionally
occur.�� Such symptoms usually disappear when the infusion
is slowed or stopped for a short period of time.
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dailymed-instance:warning |
Do not use if turbid.�� Do not
begin administration more than 4 hours after the container has been
entered.�� Discard unused portion. 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 FLEXBUMIN 25%, Albumin (Human), 25%
Solution.�� Acceptable diluents include 0.9% Sodium
Chloride or 5% Dextrose in Water. FLEXBUMIN 25%, Albumin (Human), 25% Solution 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 currentvirus infections, and by inactivating and/or removing certain viruses (See
Description).�� Despite these measures, such products
can still potentially transmit disease.�� Based on
effective donor screening and product manufacturing processes, albumin
carries an extremely remote risk for transmission of viral
diseases.�� 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.�� 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 Baxter Healthcare Corporation at
1-800-423-2862.�� The physician should discuss the
risks and benefits of this product with the patient.
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dailymed-instance:indicatio... |
1. Hypovolemia: Hypovolemia is a possible indication for FLEXBUMIN 25%, Albumin
(Human), 25% Solution. Its effectiveness in reversing hypovolemia depends
largely upon its ability to draw interstitial fluid into the
circulation.�� It is most effective with patients who are well
hydrated.When hypovolemia is long standing and hypoalbuminemia
exists accompanied by adequate hydration or edema, 25% albumin is
preferable to 5% protein solutions.���� However, in the
absence of adequate or excessive hydration, 5% protein solutions should
be used or 25% albumin should be diluted with
crystalloid.Although crystalloid solutions and
colloid-containing plasma substitutes can be used in emergency treatment
of shock, Albumin (Human) has a prolonged intravascular
half-life.�� When blood volume deficit is the result of
hemorrhage, compatible red blood cells or whole blood should be
administered as quickly as possible.<br/>2. Hypoalbuminemia: A.�� General Hypoalbuminemia is another possible indication for use of
FLEXBUMIN 25%, Albumin (Human), 25% Solution.��
Hypoalbuminemia can result from one or more of the
following: (1)������ Inadequate production (malnutrition, burns, major injury,
infections, etc.) (2)������ Excessive catabolism (burns, major injury, pancreatitis,
etc.) (3)������ Loss from the body (hemorrhage, excessive renal excretion,
burn exudates, etc.) (4)������ Redistribution within the body (major surgery, various
inflammatory conditions, etc.) When albumin deficit is the result of excessive protein loss, the
effect of administration of albumin will be temporary unless the
underlying disorder is reversed.�� In most cases,
increased nutritional replacement of amino acids and/or protein with
concurrent treatment of the underlying disorder will restore normal
plasma albumin levels more effectively than albumin solutions.��
Occasionally hypoalbuminemia accompanying severe injuries,
infections or pancreatitis cannot be quickly reversed and nutritional
supplements may fail to restore serum albumin levels.��
In these cases, FLEXBUMIN 25%, Albumin (Human), 25% Solution
might be a useful therapeutic adjunct. B.���� Burns An optimum regimen for the use of albumin, electrolytes and fluid
in the early treatment of burns has not been established, however, in
conjunction with appropriate crystalloid therapy, FLEXBUMIN 25%, Albumin
(Human), 25% Solution may be indicated for treatment of oncotic deficits
after the initial 24 hour period following extensive burns and to replace
the protein loss which accompanies any severe burn. C.���� Adult Respiratory Distress Syndrome
(ARDS) A characteristic of ARDS is a hypoproteinemic state, which may be
causally related to the interstitial pulmonary edema.��
Although uncertainty exists concerning the precise indication
of albumin infusion in these patients, if there is a pulmonary overload
accompanied by hypoalbuminemia, 25% albumin solution may have a
therapeutic effect when used with a diuretic. D.���� Nephrosis FLEXBUMIN 25%, Albumin (Human), 25% Solution
may be a useful aid in treating edema in patients with severe nephrosis
who are receiving steroids and/or diuretics.<br/>3. Cardiopulmonary Bypass Surgery: FLEXBUMIN 25%, Albumin (Human), 25% Solution has been recommended
prior to or during cardiopulmonary bypass surgery, although no clear data
exist indicating its advantage over crystalloid solutions.<br/>4. Hemolytic Disease of the Newborn (HDN): FLEXBUMIN 25%, Albumin (Human), 25% Solution may be administered
in an attempt to bind and detoxify unconjugated bilirubin in infants with
severe HDN. There is no valid reason for use of albumin as
an intravenous nutrient.
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dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Romazicon
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