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10% LMD in 5% Dextrose Injection(Dextran 40 in Dextrose Injection, USP)10% LMD in 0.9% Sodium Chloride Injection(Dextran 40 in Sodium Chloride Injection, USP)Low Molecular Weight Dextran forIntravenous AdministrationFlexible Plastic ContainerRx onlyDESCRIPTIONLMD (dextran 40) is a sterile, nonpyrogenic preparation of low molecular weightdextran (average mol.wt. 40,000) in 5% Dextrose Injection or 0.9%SodiumChlorideInjection. It is administered byintravenous infusion.Also described as low viscous or low viscosity dextran, dextran 40 is prepared by acid hydrolysis anddifferential fractionation of a crudemacromolecular polysaccharide produced from the fermentation ofsucrose by the bacterium, Leuconostoc mesenteroides(strain B-512). The crude material is composed oflinked glucose units. In the fraction represented bydextran 40, 80% of the molecules have a molecularweight ranging from 10,000 to 90,000 (average approximay 40,000) when measured by a lightscattering method. More than 90% of the linkages are of the 1,6 alpha glucosidic, straight chain type.Each 100 mL of 10% LMD (dextran 40) in 5% Dextrose Injection contains 10 g dextran 40 and 5 gdextrose hydrous in water for injection. Total osmolar concentration is 255 mOsmol/liter (calc.); pH is 4.4(3.0 to 7.0).Each 100 mL of 10% LMD (dextran 40) in 0.9% Sodium Chloride Injection contains 10 g dextran40 and 0.9 g sodium chloride in water for injection. Total osmolar concentration is 310 mOsmol/liter(calc.); pH is 4.9 (3.5 to 7.0) (may contain sodium hydroxide and/or hydrochloric acid for pH adjustment).Electrolyte concentration per liter: Na 154 mEq; Cl ? 154 mEq (not including ions for pH adjustment).The solutions contain no bacteriostat, antimicrobial agent or added bufers (except for pH adjustment)and are intended only for single-dose injection. When smaller doses are required the unused portionshould be discarded.10% LMD (dextran 40) is an artificial colloid pharmacologically classified as a plasma volumeexpander; 5% Dextrose Injection isa fluid and nutrient replenisher; 0.9% Sodium Chloride Injection is aluid and electrolyte replenisher.Dextran 40 is a linear glucose polymer (polysaccharide) chemically designated
The structural formula for dextran (repeating unit) is:Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6• H2O), a hexose sugarfreely soluble in water.Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble inwater.Water for Injection, USP is chemically designated H
2O.The flexible plastic container is fabricated from a specially formulatedpolyvinylchloride. Water canpermeate from inside the container into the overwrap but not in amounts sufficient to affect the solutionsignificantly. Solutions inside the plastic container also can leach out certain of the chemical componentsof the plastic in very small amounts before the expiration period is attained. However, safety of the plastichas been confirmed by tests in animals according to USP biological standards for plastic containers.
CLINICAL PHARMACOLOGY
The fundamental action of LMD (dextran 40) is the
enhancement of blood flow, particularly in themicrocirculation. This enhancement is due to:
1. Its primary effect of volume expansion with resultant hemodilution;
2. Maintenance of the electronegativity of red blood cells;
3. Coating of red blood cells and plaets;
4. Increase in the suspension stability of blood;
5. Decrease in the viscosity of blood.
It should be emphasized that the above
effects are not exerted separay,but conjointly they result in theenhancement of blood flow.LMD, used in the treatment of shock, produces significant increases in blood volume, central venouspressure, cardiac output, stroke volume, blood pressure and urinary output. It reduces blood viscosity,
peripheral resistance and improves peripheral blood flowwith the release of sequestered blood cells,thereby increasing venous return to the heart.When used as part of the pump prime for extracorporeal procedures, LMD, as compared to wholeblood, albumin 5%, or whole blood plus 5% dextroseand water, leads to lessdestruction of red bloodcells and plaets, reduces intravascular hemagglutination and maintains erythrocyte electronegativity.
The infusion of LMD (dextran 40) during and after surgical trauma reduces the incidence of deepvenous thrombosis (DVT) and pulmonary embolism (PE) inpatients subject to surgical procedures with ahigh incidence of thromboembolic complication. Unlike antithrombogenic agents of the anticoagulanttype, LMD does not achieve its effect so much byblocking fibrinogen-fibrin conversion but acts bysimultaneously inhibiting other mechanisms essential to thrombus formation such as vascular stasis andplaet adhesiveness and by altering the structure and thereby the lysability of fibrin clots.Histopathological studies have shown that the development of a mural plaet thrombus is the firststage of thrombus formation not only in the arterial, but also in the venous system. A number of studieshave further shown that many patients who develop thromboembolic complicationsshowan abnormallyhigh plaet adhesiveness. Infusion of LMD has been shown to reduceplaet adhesiveness as measuredby variousin vitrotests on blood samples obtained from humansand to inhibit thegrowth of a muralplaet thrombus at the site of experimental (laser beam) injury in the rabbit’s ear chamber.Studies have shown an increase in the lysability of thrombi formed in the presence of dextran. Aconsistent and characteristic alteration in fibrin structure has been observed when fibrin is formed in thepresence of dextran, and further experiments demonstrated such fibrinto be more susceptible to plasmindigestion. Other studies have shown that dextran infused into patients during surgery increases thelysability ofex vivothrombi. Controlled clinical trials have shown that thrombi in patients treated withdextran have a more pronounced tendency to undergo lysis as determined by phlebography.LMD is evenly distributed in the vascular system. Its distribution according to molecular weight shiftstoward higher molecular weights as the smaller molecules are excreted by the kidney. In normovolemicsubjects, approximay 50% is excreted within 3hours, 60% is excreted within 6 hours and about 75%within 24 hours. Reabsorption of dextran by the renaltubules is negligible. The unexcreted molecules ofdextran diffuse into the extravascular compartment and are temporarily taken up by thereticuloendothelial system. Some of these molecules are returned to the intravascular compartment via the
lymphatics. Dextran is slowly degraded
by the enzyme dextranase to glucose.
Solutions containing carbohydrate in the form of
dextrose restore blood gluc
ose levels and provide
calories. Carbohydrate in the form of dextrose may ai
d in minimizing liver glycogen depletion and exerts
a protein sparing action. Dextrose
injected parenterally undergoes ox
idation to carbon dioxide and water.
Sodium chloride in water disso
ciates to provide sodium (Na ) and chloride (Cl ? ) ions. Sodium (Na )
is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte
disturbances. Chloride (Cl ? ) has an integral role
in buffering action when oxygen and carbon dioxide
exchange occurs in red blood cells. The di
stribution and excretion of sodium (Na) and chloride (Cl ? ) are
largely under the control of the kidney, which
maintains a balance betw
een intake and output.
Water is an essential constituent
of all body tissues and accounts for
approximay 70% of total body
weight. Average normal adult daily re
quirement ranges from two to three lite
rs (1.0 to 1.5 liters each for
insensible water loss by pers
piration and urine production).
Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily
on the concentration of electrolytes in the body compartments and sodium (Na
) plays a major role in
maintaining physiologic equilibrium.
INDICATIONS AND USAGE
LMD (dextran 40) is indicated for use in the adjunc
tive treatment of shock or
impending shock due to
hemorrhage, burns, surgery or other trauma. It is no
t indicated as a replacem
ent for whole blood or blood
components if they are available. It
should not replace other forms of th
erapy known to be of value in the
treatment of shock.
LMD is also indicated for use as a priming fluid, either as a sole prime or as an additive, in pump
oxygenators during extracorporeal circulation.
LMD is also indicated for use
in prophylaxis of venous thrombosis and pulmonary embolism in
patients undergoing procedures known
to be associated with a high incidence of thromboembolic
complications, such as hip surgery.
CONTRAINDICATIONS
LMD (dextran 40) is contraindicated in patients with
known hypersensitivity to dextran, in those with
marked hemostatic defects of all types (thrombo
cytopenia, hypofibrinogenem
ia, etc.) including those
caused by drugs (heparin, warfarin, etc.), marked cardi
ac decompensation and in renal disease with severe
oliguria or anuria.
WARNINGS
Although infrequent, severe and fa
tal anaphylactoid reactions consisting of marked hypotension or
cardiac and respiratory arrest have been reported, mo
st of these reactions have
occurred in patients not
previously exposed to intravenous dextran and early in
the infusion period. It is strongly recommended,
therefore, that patients not previously exposed to de
xtran be observed closely dur
ing the first minutes of
the infusion period.
Anaphylactoid Reactions
There have been rare reports of serious and life
-threatening dextran-induced anaphylactoid reactions
(DIAR) associated with Dextran 40 and Dextran 70
administration. To reduce the likelihood of DIAR,
20 mL dextran 1 should be administered prior to infu
sion of Dextran 40 or Dextra
n 70 consistent with the
dextran 1 package insert.
1-5
See
DOSAGE AND ADMINISTRATION
. Investigators have reported a 35-
fold decrease (from 1:2000 to 1:70,000) in the incide
nce of DIAR following prophylactic use of dextran
1.6
However, serious and life-threatening reactions may still occur following initiation of an infusion of
any clinical dextran (see
ADVERSE REACTIONS).
Because of the seriousness of anaphylactoid r
eactions, it is recommended that the infusion of
intravenous dextran be stopped at th
e first sign of an allergic reac
tion provided that other means of
sustaining the circulation are availa
ble. Resuscitative measures should
be readily available for emergency
administration in the event such a reaction occurs. In circulatory collapse due to anaphylaxis, rapid
volume substitutions with an agent other than dextran should be instituted.
Because LMD (dextran 40) is a hypertonic colloid solution, it attracts water from the extravascular
space. This shift of fluid should be considered if
the drug is used for poorly hydrated patients where
additional fluid therapy will be needed. If LMD is given in excess, vascular overload could occur. The
latter possibility can be avoided with careful clinical monitoring preferably by central venous pressure.
Renal excretion of LMD causes elevations of the specific gravity of the urine. In the presence of
adequate urine flow only minor elevation will occur,
whereas in patients with reduced urine output, urine
viscosity and specific gravity can be increased markedly. Since urine osmolarity is only slightly increased
by the presence of dextran molecules, it is recommended
that, when desired, a patie
nt’s state of hydration
be assessed by determinati
on of urine or serum osmolarity. If sign
s of dehydration are present, additional
fluid should be administered. An osmotic diuretic su
ch as mannitol also can be used to maintain an
adequate urine flow.
Although numerous studies attest to the “nephrotonic”
effect of LMD, renal failure has been reported
to occur after the use of LMD.
Evidence of tubular vacuolization (osmotic nephr
osis) has been found following LMD administration
in animals and man. While this appears to be reversible experimentally in animals and to be a
consequence of high urine concentra
tion of the drug, its exact clinical
significance is presently unknown.
Occasional abnormal renal and hepatic
function values have been repo
rted following administration of
LMD. However, the specific effect of LMD on re
nal and hepatic function c
ould not be determined
because most of the patients also had undergone surgery or cardiac catheterization. A comparative study
of dextran 40 and 5% dextrose in
water as pump-priming fluids in ope
n-heart surgery has shown similar
elevations of serum glutamic oxaloacetic transaminase (SGOT), aspartate aminotransferase and serum
glutamic pyruvic transaminase
(SGPT), alanine am
inotransferase values in both groups.
Caution should be employed when LMD is administ
ered to patients with active hemorrhage as the
resulting increase in perfusion pressure and improved microcirculatory flow may result in additional
blood loss.
Administering infusions of LMD
that exceed the recommended dose s
hould be avoided, since a dose-
related increase in the incidence of wound hemato
ma, wound seroma, wound bleeding, distant bleeding
(hematuria and melena) and pulmonary edema has
been observed. Recommended doses should never be
exceeded in patients with advanced renal disease, since excessive doses may precipitate renal failure.
Dextran may interfere to some extent with plaet
function and should be used with caution in cases
with thrombocytopenia. Transient prolongation of
bleeding time and/or slightly increased bleeding
tendency may occur with the administration of doses
greater than 1000 mL. Care should be taken to
prevent a depression of hematocrit below 30% by
volume. When large volumes of dextran are
administered, plasma protein levels will be decreased.
Solutions containing sodium ions should be used with
great care, if at all, in patients with congestive
heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium
retention.
The intravenous administration of this solution can
cause fluid and/or solute overloading resulting in
dilution of serum electrolyte concen
trations, overhydration, congested
states or pulmonary edema. The
risk of dilutional states is inve
rsely proportional to the electrolyte
concentrations of administered
parenteral solutions.
The risk of solute overload causing congested states with peripheral and pulmonary edema is directly
proportional to the electrolyte concentrations of such solutions.
In patients with diminished renal function, admini
stration of solutions containing sodium ions may
result in sodium retention.
PRECAUTIONS
The possibility of circulatory overload should be kept in mind. Special care should be exercised in
patients with impaired renal clearance of dextran. When the risk of pulmonary edema and/or congestive
heart failure may be increased, dext
ran should be used with caution.
In patients with normal hemostasis, dosage of LM
D (dextran 40) approximating 15 mL/kg of body
weight may prolong bleeding time a
nd depress plaet function. Dosage
s in this range also markedly
decrease factor VIII, and decrease factors V and IX to a greater degree than would be expected to occur
from hemodilution alone. Since these changes tend to
be more pronounced following trauma or major
surgery, patients should be observed for
early signs of bleeding complications.
Since increased rouleaux formation may occur in the presence of dextran, it is recommended that
blood samples be drawn for typing a
nd cross-matching prior to the infu
sion of dextran and reserved for
subsequent use if necessary. If blood is drawn afte
r infusion of dextran, the saline agglutination and
indirect antiglobulin methods may be used for typing
and cross-matching. Difficulty may be encountered
when proteolytic enzyme techniques are used to match blood.
Consideration should be given to w
ithdrawal of blood for chemical la
boratory tests prior to initiating
therapy with dextran because of the following:
1. Blood sugar determinations that employ high con
centrations of acid may result in hydrolysis of
dextran, yielding falsely elevated glucose assay re
sults. This has been observe
d both with sulfuric acid
and with acetic acid.
2. In other laboratory tests, the presence of dext
ran in the blood may result in the development of
turbidity, which can interfere with the assay. This has been observed in bilirubin assays in which
alcohol is employed and in total prot
ein assays employing biuret reagent.
Solutions containing dextrose should be used with
caution in patients with known subclinical or overt
diabetes mellitus.
Caution must be exercised in the administration of
parenteral fluids, esp
ecially those containing
sodium ions, to patients receiving corticosteroids or corticotropin.
Do not administer unless solution is clear and
container is undamaged. Discard unused portion.
Drug Interactions.
Additive medications should not be delivered via plasma volume expanders.
Pregnancy Category C.
Animal reproduction studies have not
been conducted with dextran 40 in
dextrose or sodium chloride. It is also not known wh
ether dextran 40 in dextrose or sodium chloride can
cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. 10% LMD
(dextran 40) in dextrose or sodium chloride should
be given to a pregnant woman only if clearly needed.
Nursing Mothers.
It is not known whether this drug is excr
eted in human milk. Because many drugs are
excreted in human milk, caution shoul
d be exercised when 10% LMD (dextran 40) in dextrose or sodium
chloride is administered to a nursing woman.
Pediatric Use.
The safety and effectiveness of dextran 40
have not been establis
hed in neonates. Its
limited use in neonates has been inadequate to fu
lly define proper dosage and limitations for use.
ADVERSE REACTIONS
Antigenicity of dextrans is directly related to their degree of branching. Since LMD (dextran 40) has a
low degree of branching, it is relatively free of antigenic effect. However, a few individuals have
experienced mild urticarial reactions. More severe r
eactions, consisting of severe
anaphylactoid reaction,
generalized urticaria, tightness of the chest, wheezing, hypotension, nausea and vomiting may occur in
rare instances. Symptoms and signs of adverse
systemic reaction may be relieved by parenteral
administration of antihistamines,
ephedrine or epinephrine, while
other means of shock therapy are
instituted. The route of administration and dosages of the therapeutic agent selected will depend upon the
severity and rapidity of
progression of the reaction.
Reactions which may occur because of the solution or
the technique of admini
stration include febrile
response, infection at the site of injection, venous
thrombosis or phlebitis extending from the site of
injection, extravasation and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate
therapeutic countermeasures, and save
the remainder of the fluid for
examination if deemed necessary
(see
WARNINGS
for treatment of anaphylactic shock).
Post Marketing
Severe reactions have been observed with Dext
ran 40 and Dextran 70. Re
ported reactions include:
generalized urticaria, nausea and vomiting, wheezing
, hypotension, shock and cardiac arrest (dextran-
induced anaphylactoid reactions,
DIAR). FDA has received 94 reports
of severe DIAR since 1964.
Because these reactions are reported
voluntarily and the treated populati
on is of indeterminate size, the
frequency of reactions cannot be estimated reliably.
DOSAGE AND ADMINISTRATION
LMD (dextran 40) is administer
ed by I.V. infusion only.
Dextran 1 should be administered prior to ad
ministration of clinical dextran solutions.
1.
In shock,
it is suggested that total dosage not exceed
20 mL/kg for adults and adolescents, during the
first 24 hours. The first 10 mL/kg may be infused as
rapidly as necessary to e
ffect improvement. It is
strongly recommended that central venous pressure be monitored frequently during the initial infusion
of the drug. Should therapy continue beyond
24 hours, subsequent dosage should not exceed
10 mL/kg per day and therapy should not continue beyond five days.
2.
In extracorporeal perfusion,
the dosage of LMD used will vary with the volume of the pump
oxygenator. LMD can serve as a sole primer or as an additive to other priming fluids. For adults and
adolescents, generally 10 to 20 mL of a 10% solution (1 to 2 g) of LMD per kilogram of body weight
are added to the perfusion circuit. Usually tota
l dosage should not exceed 2 g/kg of body weight.
3.
In prophylaxis of venous thrombosis and thromboembolism,
the dosage of LMD for adults and
adolescents, should be chosen according to the risk
of thromboembolic complications, e.g., type of
surgery and duration of immobilization. In general, treatment should be initiated during surgery;
500 to 1000 mL (approximay 10 mL/kg of body we
ight) should be administered on the day of
operation. Treatment should be continued at a dose of 500 mL daily for an additional two to three
days; then, according to the risk of complications
, 500 mL may be given every second or third day
during the period of risk, for up to two weeks.
4. Infants may be given 5 mL per kg body weight and children 10 mL per kg.
Parenteral drug products should be
inspected visually for particulate
matter and discoloration prior to
administration, whenever solu
tion and container permit. See
PRECAUTIONS
Note
: When infusing concentrated LMD, the
administration set should include a filter.
Instructions for use
To Open
Tear outer wrap at notch and rem
ove solution container. Some opacity
of the plastic due to moisture
absorption during the sterilization process may be obser
ved. This is normal and does not affect solution
quality or safety. The opacity will diminish gradually.
Preparation for Administration
(Use aseptic technique)
1. Close flow control clam
p of administration set.
2. Remove cover from outlet por
t at bottom of container.
3. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated.
Note:
See full directions on administration set carton.
4. Suspend container from hanger.
5. Squeeze and release drip chamber to esta
blish proper fluid level in drip chamber.
6. Open flow control clamp and clear air from set. Close clamp.
7. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
8. Regulate rate of administra
tion with flow control clamp.
WARNING: Do not use flexible container in series connections.
HOW SUPPLIED
10% LMD in 5% Dextrose Injection (Dextran 40 in
Dextrose Injection, USP) is supplied in a 500 mL
single-dose flexible container
(NDC 0409-7418-03). 10% LMD in 0.9%
Sodium Chloride Injection
(Dextran 40 in Sodium Chloride Injection, USP) is
supplied in a 500 mL single-dose flexible container
(NDC 0409-7419-03).
Do not use if crystallization has occurred.
Store at 20 to 25°C (68 to 77°F). [See USP Contro
lled Room Temperature.] Protect from freezing.
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