Heparin Sodium And Dextrose (Heparin Sodium In Dextrose)

Trade Name : Heparin Sodium in Dextrose

B. Braun Medical Inc.

INJECTION

Strength 40005 [USP'U]/100mLg/100mL

HEPARIN SODIUM; DEXTROSE MONOHYDRATE Anti-coagulant [EPC],Heparin [CS],Unfractionated Heparin [EPC]

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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 Heparin Sodium And Dextrose (Heparin Sodium In Dextrose) which is also known as Heparin Sodium in Dextrose and Manufactured by B. Braun Medical Inc.. It is available in strength of 4000; 5 [USP'U]/100mL; g/100mL per ml. Read more

Heparin Sodium And Dextrose (Heparin Sodium In Dextrose) 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

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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
  • Heparin sodium is indicated for:
  • Heparin sodium is indicated for: ()u00a0
  • Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
  • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation;
  • Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
  • Prevention of clotting in arterial and cardiac surgery;
  • Prophylaxis and treatment of peripheral arterial embolism;
  • Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.
  • Recommended Adult Dosages:
  • * Based on 150 lb. (68-kg) patient.
  • For pediatric dosing see sectionu00a0u00a0of full prescribing information.
  • HEPARIN SODIUM IN 5% DEXTROSE INJECTION is available as:u00a0
  • u2022u00a0u00a0u00a0u00a0u00a0Heparin Sodium 20,000u00a0USP unitsu00a0per 500 mL (40u00a0USP units per mL) in 5% Dextrose Injection.
  • u2022u00a0u00a0u00a0u00a0u00a0Heparin Sodium 25,000u00a0USP units per 500 mL (50u00a0USP units per mL) in 5% Dextrose Injection.
  • u2022u00a0u00a0u00a0u00a0u00a0Heparin Sodium 25,000u00a0USP units per 250 mL (100u00a0USP units per mL) in 5% Dextrose Injection.
  • Heparin Sodium 20,000u00a0USP unitsu00a0per 500 mL (40u00a0USP units per mL) in 5% Dextrose Injection ()u00a0
  • Heparin Sodium 25,000u00a0USP units per 500 mL (50u00a0USP units per mL) in 5% Dextrose Injection ()u00a0
  • Heparin Sodium 25,000u00a0USP units per 250 mL (100u00a0USP units per mL) in 5% Dextrose Injection ()u00a0
  • u00a0The use of HEPARIN SODIUM is contraindicated in patients:
  • u2022 u00a0u00a0u00a0u00a0With history of heparin-induced thrombocytopenia (HIT) (With or Without Thrombosis) []
  • u2022 u00a0u00a0u00a0u00a0With a known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) []
  • u2022 u00a0u00a0u00a0u00a0In whom suitable blood coagulation tests u2014 e.g., the whole blood clotting time, partial thromboplastin time, etc., u2014 cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin) []
  • u2022u00a0u00a0u00a0History of Heparin-induced Thrombocytopenia (HIT) (With or Without Thrombosis) ()u00a0
  • u2022u00a0u00a0u00a0Known hypersensitivity to heparin or pork products ()u00a0
  • u2022u00a0u00a0u00a0In whom suitable blood coagulation tests cannot be performed at appropriate intervals ()
  • No data
  • Fatal Medication Errors: Confirm choice of correct strength prior to administration.u00a0 ()u00a0
  • Hemorrhage: Fatal cases have occurred. Use caution in conditions with increased risk of hemorrhage. ()
  • HIT (With or Without Thrombosis): Monitor for signs and symptoms and discontinue if indicative of HIT (With or Without Thrombosis).u00a0()u00a0
  • Monitoring: Blood coagulation tests guide therapy for full-dose heparin. Monitor platelet count and hematocrit in all patients receiving heparin.u00a0()u00a0
  • The following serious adverse reactions are described elsewhere in the labeling:
  • The following adverse reactions have been identified during post-approval use of heparin sodium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
  • Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT (with or without thrombosis), hypersensitivity reactions, and elevations of aminotransferase levels.u00a0()u00a0u00a0
  • To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-800-227-2862 or FDA at
  • No data
  • Drugs that interfere with coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding. ()u00a0
  • No data
  • Bleeding is the chief sign of heparin overdosage.
  • Neutralization of heparin effect:
  • When clinical circumstances (bleeding) require reversal of heparinization, protamine sulfate (1% solution) by slow infusion will neutralize heparin sodium. should be administered, , in any 10 minute period. Each mg of protamine sulfate neutralizes approximately 100u00a0USP Heparin Units. The amount of protamine required decreases over time as heparin is metabolized. Although the metabolism of heparin is complex, it may, for the purpose of choosing a protamine dose, be assumed to have a half-life of about 1/2 hour after intravenous injection.
  • Because fatal reactions often resembling anaphylaxis have been reported, protamine sulfate should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available.
  • For additional information, consult the prescribing information for Protamine Sulfate Injection, USP.
  • Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. u00a0It is composed of polymers of alternating derivations of u00a0alpha-L-iduronic acid 2-sulfate (1),u00a0 2-deoxy-2-sulfamino- alpha-D-glucose 6-sulfate (2),u00a0 beta-D-glucuronic acid (3),u00a0 2-acetamido-2- deoxy-alpha-D-glucose (4), and alpha-L-iduronic acid (5).
  • Structure of Heparin Sodium (representative subunits):
  • Heparin Sodium in 5% Dextrose Injection is a sterile, nonpyrogenic solution prepared from heparin sodium (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) and Hydrous Dextrose USP in Water for Injection USP. It is to be administered by intravenous injection. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram.
  • The pH range is 5.6 (4.5 u2013 7.0) and the osmolarity mOsmol/L (calc.) is 315.u00a0 The concentration of electrolytes is 38 mEq/L Sodium, 30 mEq/L Phosphate, and 15 mEq/L Citrate.
  • 40 USP units/mL: Each 100 mL of the 20,000 USP units per 500 mL preparation contains: 4,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP,u00a0 0.0686 g u00a0Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient.
  • 50 USP units/mL: Each 100 mL of the 25,000 USP units per 500 mL preparation contains: 5,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP,u00a0 0.0686 g u00a0Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient.
  • 100 USP units/mL: Each 100 mL of the 25,000 USP units per 250 mL u00a0preparation contains: 10,000 USP units of heparin sodium, 5 g Hydrous Dextrose USP, 0.41 g Dibasic Sodium Phosphate, 0.093 g Citric Acid Anhydrous USP,u00a0 0.0686 g u00a0Sodium Metabisulfite NF (antioxidant), and Water for Injection USP until quantity sufficient.
  • The plastic container is made from a multilayered 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 plastic container is not made with natural rubber latex, PVC or DEHP.
  • The closure system has two ports; the one for the administration set has a tamper evident plastic protector.
  • No data
  • Long term studies in animals to evaluate the carcinogenic potential, reproduction studies in animals to determine effects on fertility of males and females, and the studies to determine mutagenic potential have not been conducted.
  • Heparin Sodium in 5% Dextrose Injection is supplied sterile and nonpyrogenic in EXCELu00ae Containers packaged 24 per case.
  • Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored 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.
  • Arrayn- Hemorrhage
  • Inform patients that it may take them longer than usual to stop bleeding, that they may bruise and/or bleed more easily when they are treated with heparin, and that they should report any unusual bleeding or bruising to their physician. Hemorrhage can occur at virtually any site in patients receiving heparin. Fatal hemorrhages have occurred [].
  • Arrayn- Prior to Surgery
  • Advise patients to inform physicians and dentists that they are receiving heparin before any surgery is scheduled [].
  • Arrayn- Heparin-Induced Thrombocytopenia
  • Inform patients of the risk of heparin-induced thrombocytopenia (HIT). HIT may progress to the development of venous and arterial thromboses, a condition known as heparin-induced thrombocytopenia and thrombosis (HITT).u00a0HIT (With or Without Thrombosis) can occur up to several weeks after the discontinuation of heparin therapy [].
  • Arrayn- Hypersensitivityu00a0
  • Inform patients that generalized hypersensitivity reactions have been reported. [].
  • Arrayn- Other Medicationsu00a0
  • Because of the risk of hemorrhage, advise patients to inform their physicians and dentists of all medications they are taking, including non-prescription medications, and before starting any new medication [].
  • Rx only
  • EXCEL is a registered trademark of B. Braun Medical Inc.
  • B. Braun Medical Inc.n
  • Y36-002-900u00a0u00a0u00a0u00a0 LD-239-8
  • HEPARIN SODIUMn n- 20,000u00a0USP units n- per 500 mL
  • NDC 0264-9567-10
  • 500 mLn n- EXCELu00ae CONTAINER
  • 20,000u00a0USP units per 500 mLn n- HEPARIN
  • LD-306-4u00a0u00a0u00a0u00a0 Y94-003-288
  • Each 100 mL contains: Heparin Sodium USP(porcine intestinal mucosa) 4,000 USP Heparin unitsHydrous Dextrose USP 5 gDibasic Sodium Phosphateu20227HO USP 0.41 gCitric Acid Anhydrous USP 0.093 gSodium Metabisulfite NF (antioxidant) <0.07 gWater for Injection USP qs
  • Electrolytes (mEq/liter):u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Sodium 38n n- Phosphate (HPO ) 30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Citrate 15
  • WARNING: n- CONTAINS SULFITES.
  • Do not admix with other drugs.
  • Sterile. Single dose container. For intravenous use only.
  • Recommended Storage: Room temperature (25u00b0C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use.u00a0
  • REF P5671
  • B. Braun Medical Inc.n
  • EXPLOT
  • HEPARIN20,000 USP units per 500 mL
  • LD-421-1u00a0u00a0u00a0u00a0 Y94-003-168
  • HEPARIN SODIUM25,000u00a0USP units per 500 mL
  • NDC 0264-9577-10n n- Arrayn- EXCELu00ae CONTAINER
  • 25,000u00a0USP units per 500 mLn n- Array
  • Y94-003-376u00a0u00a0u00a0 LD-308-6
  • Each 100 mL contains: Heparin Sodium USP(porcine intestinal mucosa) 5,000 USP Heparin unitsHydrous Dextrose USP 5 gDibasic Sodium Phosphateu20227HO USP 0.41 gCitric Acid Anhydrous USP 0.093 gSodium Metabisulfite NF (antioxidant) <0.07 gWater for Injection USP qsn n
  • Electrolytes (mEq/liter):u00a0u00a0u00a0 Sodium 38n n- Phosphate (HPOn n- ) 30u00a0u00a0u00a0u00a0u00a0u00a0 Citrate 15
  • WARNING: n
  • Do not admix with other drugs.
  • Sterile. Single dose container. For intravenous use only.
  • Recommended Storage: Room temperature (25u00b0C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use.
  • REF P5771
  • B. Braun Medical Inc.n
  • Y94-003-289u00a0u00a0u00a0 LD-307-4
  • EXPLOTn n
  • HEPARIN SODIUM25,000 USP units per 500 mL
  • LD-422-4u00a0u00a0u00a0u00a0 Y94-003-377
  • HEPARIN SODIUM25,000u00a0USP units per 250 mL
  • Y94-003-375u00a0u00a0u00a0 LD-310-7
  • NDC 0264-9587-20n 250 mL n- EXCELu00ae CONTAINER
  • Each 100 mL contains: Heparin Sodium USP (porcine intestinal mucosa) 10,000 USP Heparin units; Hydrous Dextrose USP 5 g; n n- Dibasic Sodium Phosphateu20227HO USP 0.41 g;u00a0 Citric Acid Anhydrous USP 0.093 g; Sodiumu00a0Metabisulfite NF (antioxidant) <0.07 g; Water for Injection USP qs
  • Electrolytes (mEq/liter):u00a0u00a0 Sodium 38n n- Phosphate (HPO ) 30;u00a0u00a0u00a0 Citrate 15
  • WARNING: n n- Do not admix with n- other drugs.
  • Sterile. Single dose container. For intravenous use only.
  • Recommended Storage: Room temperature (25u00b0C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use.u00a0
  • Not made with natural rubber latex, PVC or DEHP.
  • REF P5872n- B. Braun Medical Inc.n
  • Y94-003-307u00a0u00a0u00a0LD-309-5u00a0
  • EXPLOT
  • Arrayn- HEPARIN SODIUMn
  • LD-423-4u00a0u00a0u00a0 Y94-003-378

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