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Hetastarch In Sodium Chloride (Hespan)

Trade Name : HESPAN

B. Braun Medical Inc.

INJECTION, SOLUTION

Strength 6.9 g/100mLg/100mL

HETASTARCH; SODIUM CHLORIDE Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Hetastarch In Sodium Chloride (Hespan) which is also known as HESPAN and Manufactured by B. Braun Medical Inc.. It is available in strength of 6; .9 g/100mL; g/100mL per ml. Read more

Hetastarch In Sodium Chloride (Hespan) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: u00a0u00a0u00a0u00a0u00a0u00a0u00a0MORTALITYu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0RENAL REPLACEMENT THERAPY
  • WARNING: u00a0u00a0u00a0MORTALITYu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0RENAL REPLACEMENT THERAPY
  • See full prescribing information for complete boxed warning.
  • In critically ill adult patients, including patients with sepsis, use of hydroxyethyl starch (HES) products, including HESPANu00ae, increases risk of
  • Do not use HES products, including HESPANu00ae, in critically ill adult patients including patients with sepsis
  • HESPANu00ae is indicated in the treatment of hypovolemia when plasma volume expansion is desired. It is not a substitute for blood or plasma.
  • The adjunctive use of HESPANu00ae in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means.
  • HESPANu00ae in leukapheresis has shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. ()n
  • Arrayn- Dosage for Acute Use in Plasma Volume Expansion
  • HESPANu00ae is administered by intravenous infusion only. Total dosage and rate of infusion depend upon the amount of blood or plasma lost and the resultant hemoconcentration.
  • u00a0n
  • u00a0Single-use container:
  • 30 g hetastarch in 500 mL 0.9% sodium chloride injection. ()
  • No data
  • Do not use hydroxyethyl starch (HES) products, including HESPANu00ae, in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (RRT). () n
  • Do not use HES products, including HESPANu00ae, in patients with severe liver disease () n
  • Do not use HES products, including HESPANu00ae, in patients with known hypersensitivity to hydroxyethyl starch () n
  • Do not use HES products, including HESPANu00ae, in clinical conditions where volume overload is a potential problem. () n
  • Do not use HES products, including HESPANu00ae, in patients with pre-existing coagulation or bleeding disorders ()
  • No data
  • Avoid use in patients with pre-existing renal dysfunction () n
  • Discontinue use of HESPANu00ae at the first sign of renal injury () n
  • Continue to monitor renal function in hospitalized patientsu00a0for at least 90 days as use of RRT has been reported up to 90 days after administration of HES products, including HESPANu00ae () n
  • HESPANu00ae is not recommended for use as a cardiac bypass pump prime, while the patient is on cardiopulmonary bypass, or in the immediate period after the pump has been discontinued because of the risk of increasing coagulation abnormalities and bleeding in patients whose coagulation status is already impaired.u00a0Discontinue use of HESPANu00ae at first sign of coagulopathy () n
  • The serious adverse events reported in clinical trials are increased mortality and renal replacement therapy renal in critically ill patients.
  • Most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis.
  • To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-800-227-2862 or FDA at 1-800-FDA-1088 or .
  • The serious adverse events reported in clinical trials are Increased mortality and renal replacement therapy in critically ill patientsu00a0() n
  • Most common adverse reactions are hypersensitivity, coagulopathy, hemodilution, circulatory overload and metabolic acidosis. ()
  • HESPANu00ae should be used with caution in patients who have been anticoagulated with other drugs that negatively influence the coagulation system.
  • Use with caution with drugs that negatively influence the coagulation system. () n
  • The safety and compatibility of other additives have not been established. ()
  • No data
  • HESPANu00ae (6% hetastarch in 0.9% sodium chloride injection) is a sterile, nonpyrogenic solution for intravenous administration.
  • Each 100 mL contains:
  • Hetastarch.................................................. 6 g
  • Sodium Chloride, USP............................... 0.9 g
  • Water for Injection, USP............................. qs
  • pH adjusted with Sodium Hydroxide, NF if necessary
  • Concentration of Electrolytes (mEq/L): Sodium 154, Chloride 154
  • pH: approximately 5.9 with negligible buffering capacity
  • Calc. Osmolarity: approximately 309 mOsM
  • Hetastarch is a synthetic colloid derived from a waxy starch composed almost entirely of amylopectin. Hydroxyethyl ether groups are introduced into the glucose units of the starch, and the resultant material is hydrolyzed to yield a product with a molecular weight suitable for use as a plasma volume expander and erythrocyte sedimenting agent. The molar substitution is approximately 0.75 which means hetastarch has an average of approximately 75 hydroxyethyl groups for every 100 glucose units. The weight average molecular weight is approximately 600,000 with a range of 450,000 to 800,000 and with at least 80% of the polymers falling within the range of 20,000 to 2,600,000. Hydroxyethyl groups are attached by ether linkage primarily at C-2 of the glucose unit and to a lesser extent at C-3 and C-6. The polymer resembles glycogen, and the polymerized D-glucose units are joined primarily by u03b1-1,4 linkages with occasional u03b1-1,6 branching linkages.
  • The chemical name for hetastarch is hydroxyethyl starch.
  • The structural formula is as follows:
  • Amylopectin derivative in which R and Rare H or CHCHOH and R is H, CHCHOH, or a branching point in the starch polymer connected through an u03b1-1,6 link to additional D-glucopyranosyl units.
  • HESPANu00ae is a clear, pale yellow to amber solution. Exposure to prolonged adverse storage conditions may result in a change to a turbid deep brown or the formation of a crystalline precipitate. Do not use the solution if these conditions are evident.
  • Not made with natural rubber latex, PVC or DEHP.
  • The plastic container is made from a multi-layered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
  • The closure system has two ports; the one for the administration set has a tamper evident plastic protector.
  • No data
  • Long-term studies of animals have not been performed to evaluate the carcinogenic potential of hetastarch.
  • Surgical Patients Comparative Studies
  • In randomized, controlled, comparative studies of HESPANu00ae (6% hetastarch in 0.9% sodium chloride injection) (n=92) and Albumin (n=85) in surgical patients, no patient in either treatment group had a bleeding complication and no significant difference was found in the amount of blood loss between the treatment groups.n
  • Pediatric Postoperative Volume Expander Study
  • In one small double-blind study, 47 infants, children, and adolescents (ages 1 year to 15.5 years) scheduled for repair of congenital heart disease with moderate hypothermia were randomized to receive either HESPANu00ae or Albumin as a postoperative volume expander during the first 24 hours after surgery. Thirty-eight children required colloid replacement therapy, of which 20 children received HESPANu00ae. No differences were found in the coagulation parameters or in the amount of replacement fluids required in the children receiving 20 mL/kg or less of either colloid replacement therapy. In children who received greater than 20 mL/kg of HESPANu00ae, an increase in prothrombin time was demonstrated (p=0.006).There were no neonates included in this study [see ].
  • Adult Critically Ill Studies
  • u00a0
  • One trial (N=804) in severe sepsis patients using HES product (not approved in the U.S.) reported increased mortality (relative risk, 1.17; 95% CI, 1.01 to 1.36; p=0.03) and RRT (relative risk, 1.35; 95% CI, 1.01 to 1.80; p=0.04) in the HES treatment arm.n
  • Another trial (N=196) using different HES in severe sepsis patients reported no difference in mortality (relative risk,1.20; 95% CI, 0.83 to 1.74; p=0.33) and a trend for RRT (relative risk, 1.83; 95% CI, 0.93 to 3.59; p=0.06) in HES patients.n
  • A third trial (N=7000) using different HES in a heterogeneous patient population consisting of critically ill adult patients admitted to the ICU reported no difference in mortality (relative risk, 1.06; 95% CI, 0.96 to 1.18; p=0.26) but increased use of RRT (relative risk, 1.21; 95% CI, 1.00 to 1.45; p=0.04) in HES patients.n
  • No data
  • HESPANu00ae (6% hetastarch in 0.9% sodium chloride injection) is supplied sterile and nonpyrogenic in 500 mL EXCELu00ae Containers packaged 12 per case.
  • NDCn- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- REFn- u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n- Volumen
  • Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing.
  • Store at room temperature (25u00b0C); however, brief exposure up to 40u00b0C does not adversely affect the product.
  • Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.
  • Rx only
  • EXCEL and HESPAN are registered trademarks of B. Braun Medical Inc.
  • B. Braun Medical Inc.n
  • Y36-002-894u00a0 LD-233-3
  • 6% hetastarch in 0.9% sodium chloride injection
  • HESPANu00ae
  • NDC 0264-1965-10
  • 500 mLn n- EXCELu00ae CONTAINER
  • For intravenous use only.
  • Each 100 mL contains: Hetastarch 6 g Sodium Chloride USP 0.9 g in Water for Injection, USPpH adjusted with Sodium Hydroxide, NF
  • Electrolytes (mEq/L):u00a0 Sodiumu00a0 154u00a0u00a0 u00a0 Chlorideu00a0 154
  • If administration is by pressure infusion, all air should be withdrawn or expelled from the bag through the medication port prior to infusion.
  • Sterile. Single dose container. Discard unused solution.
  • Recommended Storage: Store at room temperature, 25u00b0C (77u00b0F). Avoid excessive heat. Protect from freezing. Usual Dosage: See package insert for complete information.
  • Do not remove overwrap until ready for use. If leaks are found, discard solution as sterility may be impaired. n n
  • REF L6511
  • Not made with natural rubber latex, PVC or DEHP.
  • Rx only
  • B. Braun Medical Inc.n
  • Y94-003-305u00a0 LD-152-7
  • EXPu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 LOT
  • 6% hetastarchu00a0in0.9% sodium chlorideinjectionHESPANu00aeu00a0
  • Y94-003-184u00a0 LD-427-1u00a0n

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