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Heparin Sodium In Sodium Chloride (Heparin Sodium In Sodium Chloride)

Trade Name : Heparin Sodium in Sodium Chloride

B. Braun Medical Inc.

INJECTION

Strength 200 [USP'U]/100mL

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

Delivery Process

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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 In Sodium Chloride (Heparin Sodium In Sodium Chloride) which is also known as Heparin Sodium in Sodium Chloride and Manufactured by B. Braun Medical Inc.. It is available in strength of 200 [USP'U]/100mL per ml. Read more

Heparin Sodium In Sodium Chloride (Heparin Sodium In Sodium Chloride) 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
  • Heparin Sodium Injection in 0.9% Sodium Chloride at the concentration of 2u00a0USP units/mL is indicated as an anticoagulant to maintain catheter patency.
  • HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION at the concentration of 2 USP units/mL is an anticoagulant indicated for:
  • u2022u00a0u00a0u00a0u00a0 Maintenance of catheter patency. u00a0
  • Although the rate of infusion of the 2 USP units/mL formulation is dependent upon the age, weight, clinical condition of the patient, and the procedure being employed, an infusion rate of 3 mL/hour has been found to be satisfactory. u00a0
  • Heparin Sodium 1,000u00a0USP units per 500 mL (2u00a0USP units per mL) in 0.9% Sodium Chloride Injection u00a0
  • The use of HEPARIN SODIUM is contraindicated in patients:
  • u2022u00a0u00a0u00a0u00a0u00a0With a history of heparin-induced thrombocytopenia (HIT) (With or Without Thrombosis) []
  • u2022 u00a0u00a0u00a0u00a0With a known hypersensitivity to heparin or pork products (, anaphylactoid reactions) []
  • u2022u00a0u00a0u00a0u00a0 History of Heparin-induced Thrombocytopenia (HIT) (With or Without Thrombosis) u00a0
  • u2022 u00a0u00a0u00a0 Known hypersensitivity to heparin or pork products u00a0
  • u2022u00a0u00a0u00a0u00a0 Fatal Medication Errors: Confirm choice of correct strength prior to administration. u00a0
  • u2022u00a0u00a0u00a0u00a0 Hemorrhage: Fatal cases have occurred. Use caution in conditions with increased risk of hemorrhage. n
  • u2022u00a0u00a0u00a0u00a0 HIT (With or Without Thrombosis): Monitor for signs and symptoms and discontinue if indicative of HIT (With or Without Thrombosis). 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),u00a0 hypersensitivity reactions, and elevations of aminotransferase levels. u00a0
  • To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-800-227-2862 or FDA at
  • Drugs such as acetylsalicylic acid, dextran, phenylbutazone, ibuprofen, indomethacin, dipyridamole, hydroxychloroquine and others that interfere with platelet-aggregation reactions (the main hemostatic defense of heparinized patients) may induce bleeding and should be used with caution in patients receiving heparin sodium.
  • u2022u00a0u00a0u00a0u00a0 Drugs that interfere with platelet aggregation 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. It 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), andu00a0alpha-L-iduronic acid (5).
  • Structure of Heparin Sodium (representative subunits):
  • Heparin Sodium 1,000 USP units per 500 mL (2 USP units per mL) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution prepared from Heparin Sodium USP (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) in 0.9% Sodium Chloride Injection. 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.
  • Each 100 mL contains 0.43 g Dibasic Sodium Phosphateu20227HO USP and 0.037 g Citric Acid Anhydrous USP as a buffer system, 0.9 g Sodium Chloride USP, and Water for Injection USP qs.
  • pH: 7.0 (6.8-7.2);u00a0 Calculated Osmolarity:u00a0 360 mOsmol/liter
  • Concentration of Electrolytes (mEq/liter):u00a0 Sodium 186; Chloride 154; Phosphate (HPO) 32; Citrate 6
  • 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 studies to determine mutagenic potential have not been conducted.
  • Heparin Sodium in 0.9% Sodium Chloride Injection is supplied sterile and nonpyrogenic in Full Fill 500 mL 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.
  • 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 []n
  • Prior to Surgery
  • Advise patients to inform physicians and dentists that they are receiving heparin before any surgery is scheduled [n ].
  • 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).u00a0u00a0HIT (With or Without Thrombosis) can occur up to several weeks after the discontinuation of heparin therapy [].
  • Hypersensitivity
  • Inform patients that generalized hypersensitivity reactions have been reported.
  • Other Medications
  • 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.
  • Bethlehem, PA 18018-3524 USA
  • 1-800-227-2862
  • Y36-002-901u00a0u00a0u00a0u00a0u00a0u00a0u00a0 LD-240-8
  • HEPARIN SODIUMn
  • NDC 0264-9872-10
  • 500 mLn n- EXCELu00ae CONTAINER
  • 1,000u00a0USP units per 500 mL (2u00a0USP units per mL)HEPARINn
  • Each 100 mL contains: Heparin Sodium USP (porcine intestinal mucosa) 200 USP Heparin unitsSodium Chloride USP 0.9 gDibasic Sodium Phosphateu20227HO USP 0.43 gCitric Acid Anhydrous USP 0.037gWater for Injection USP qs
  • Electrolytes (mEq/liter):u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Sodiumu00a0 186Chlorideu00a0 154u00a0u00a0u00a0u00a0u00a0u00a0Phosphate (HPO) 32u00a0u00a0u00a0u00a0u00a0 Citrateu00a0 6
  • WARNING: 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.
  • REF P8721
  • Not made with natural rubber latex, PVC or DEHP.
  • Rx onlyn n
  • B. Braun Medical Inc.n
  • LD-311-5u00a0u00a0u00a0u00a0u00a0 Y94-003-291
  • EXP
  • LOT

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