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Dalteparin Sodium (Fragmin)

Trade Name : Fragmin

Pfizer Laboratories Div Pfizer Inc

INJECTION

Strength 2500 [iU]/.2mL

DALTEPARIN SODIUM Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [CS],Low Molecular Weight Heparin [EPC]

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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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 Dalteparin Sodium (Fragmin) which is also known as Fragmin and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 2500 [iU]/.2mL per ml. Read more

Dalteparin Sodium (Fragmin) 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

Validated Cold Chain Shipment

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.

Read more
  • No data
  • Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
  • Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
  • Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis .
  • WARNING: SPINAL/EPIDURAL HEMATOMAS
  • See full prescribing information for complete boxed warning.
  • Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
  • Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
  • Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (, ).
  • Use of indwelling epidural catheters
  • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants.
  • A history of traumatic or repeated epidural or spinal punctures
  • A history of spinal deformity or spinal surgery
  • Optimal timing between the administration of FRAGMIN and neuraxial procedures is not known
  • No data
  • FRAGMIN is a low molecular weight heparin (LMWH) indicated for
  • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction ()
  • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness ()
  • Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months ()
  • Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month of age and older ()
  • Limitations of Use
  • Do not use as intramuscular injection. FRAGMIN should not be mixed with other injections or infusions ()
  • No data
  • Injection: 2,500 IU/ 0.2 mL, 5,000 IU/ 0.2 mL, 7,500 IU/ 0.3 mL, 12,500 IU/ 0.5 mL, 15,000 IU/ 0.6 mL, and 18,000 IU/ 0.72 mL single-dose prefilled syringes ()
  • Injection: 10,000 IU/ mL single-dose graduated syringes ()
  • Injection: 95,000 IU/ 3.8 mL (25,000 IU/mL) multiple-dose vials ()
  • FRAGMIN is contraindicated in:
  • Active major bleeding ()
  • History of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis ()
  • Hypersensitivity to dalteparin sodium (, )
  • In patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN ()n
  • Hypersensitivity to heparin or pork products ()
  • No data
  • Hemorrhage: Use caution in conditions with increased risk of hemorrhage ()
  • Thrombocytopenia: Monitor thrombocytopenia of any degree closely ()
  • Benzyl Alcohol Preservative: Do not use multiple-dose formulations in neonates and infants as they contain benzyl alcohol ()
  • Laboratory Tests: Periodic blood counts recommended ()
  • The following clinically significant adverse reactions are described in more detail in other sections of the prescribing informationn
  • Most common adverse reactions (>1%) are: bleeding (including hemorrhage), thrombocytopenia (Type I), hematoma at the injection site, pain at the injection site, transient elevation of transaminases ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • The use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding .
  • The use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding ()
  • No data
  • An excessive dosage of FRAGMIN Injection may lead to hemorrhagic complications. These may generally be stopped by slow intravenous injection of protamine sulfate (1% solution), at a dose of 1 mg protamine for every 100 anti-Xa IU of FRAGMIN given. If the APTT measured 2 to 4 hours after the first infusion remains prolonged, a second infusion of 0.5 mg protamine sulfate per 100 anti-Xa IU of FRAGMIN may be administered. Even with these additional doses of protamine, the APTT may remain more prolonged than would usually be found following administration of unfractionated heparin. In all cases, the anti-Xa activity is never completely neutralized (maximum about 60 to 75%).
  • Take particular care to avoid overdosage with protamine sulfate. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, give protamine sulfate only when resuscitation techniques and treatment for anaphylactic shock are readily available. For additional information, consult the labeling of Protamine Sulfate Injection, USP, products.
  • FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2,500, 5,000, 7,500, 10,000, 12,500, 15,000 or 18,000 anti-Xa international units (IU), equivalent to 16, 32, 48, 64, 80, 96 or 115.2 mg dalteparin sodium, respectively. Each multiple-dose vial contains either 10,000 or 25,000 anti-Xa IU per 1 mL (equivalent to 64 or 160 mg dalteparin sodium, respectively), for a total of 95,000 anti-Xa IU per vial.
  • Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prefilled syringes are preservative-free. Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The pH of both formulations is 5.0 to 7.5 .
  • Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5,000 and about 90% of the material within the range 2,000u20139,000. The molecular weight distribution is:
  • Structural Formula
  • No data
  • Dalteparin sodium has not been tested for its carcinogenic potential in long-term animal studies. It was not mutagenic in the Ames Test, mouse lymphoma cell forward mutation test and human lymphocyte chromosomal aberration test and in the mouse micronucleus test. Dalteparin sodium at subcutaneous doses up to 1,200 IU/kg (7,080 IU/m) did not affect the fertility or reproductive performance of male and female rats.
  • No data
  • After first penetration of the rubber stopper, store the multiple-dose vials at room temperature for up to 2 weeks.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursion permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].
  • No data
  • This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.
  • FRAGMIN is a registered trademark of Pfizer Health AB.
  • LAB-0058-18.0
  • ttttttt0.2 mL tttttttNDC 0069-0195-01
  • Fragmin
  • 2,500 IU per 0.2 mL
  • For subcutaneous injection.Single-dose only.
  • Pfizer LabsDivision of Pfizer IncNY, NY 10017
  • Rx only
  • PAA087576
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursion permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].n See accompanyingprescribing information.ttttttDistributed by Pfizer Labs Division of Pfizer IncNew York, NY 10017
  • 0.2 mL Single-dose prefilled syringeNDC 0069-0195-01
  • Fragmin
  • 2,500 IU per 0.2 mL
  • For subcutaneous injection.
  • PAA087583
  • Rx only
  • To Open Pull Tab
  • NDC 0069-0195-02Contains 10 of NDC 0069-0195-01
  • 10 x 0.2 mL Single-dose prefilled syringes,preassembled with needle guards
  • Fragmin
  • 2,500 IU per 0.2 mL*
  • For subcutaneous injectionSterile
  • Pfizer Injectables
  • ttttttt0.2 mL tttttttNDC 0069-0196-01
  • Fragmin
  • 5,000 IU per 0.2 mL
  • For subcutaneous injection.Single-dose only.
  • Pfizer LabsDivision of Pfizer IncNY, NY 10017
  • Rx only
  • PAA087577
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursion permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].n See accompanyingprescribing information.ttttttDistributed by Pfizer Labs Division of Pfizer IncNew York, NY 10017
  • 0.2 mL Single-dose prefilled syringeNDC 0069-0196-01
  • Fragmin
  • 5,000 IU per 0.2 mL
  • For subcutaneous injection.
  • PAA087584
  • Rx only
  • To Open Pull Tab
  • NDC 0069-0196-02Contains 10 of NDC 0069-0196-01
  • 10 x 0.2 mL Single-dose prefilled syringes,preassembled with needle guards
  • Fragmin
  • 5,000 IU per 0.2 mL*
  • For subcutaneous injectionSterile
  • Pfizer Injectables
  • 0.3 mLNDC 0069-0206-01
  • Fragminn
  • 7,500 IU per 0.3 mL
  • For subcutaneous injection.Single-dose only.
  • Pfizer LabsDivision of Pfizer IncNY, NY 10017 tttttt
  • Rx only
  • PAA087578
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursion permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].n See accompanyingprescribing information.ttttttDistributed by Pfizer Labs Division of Pfizer IncNew York, NY 10017
  • 0.3 mL Single-dose prefilled syringeNDC 0069-0206-01
  • Fragmin
  • 7,500 IU per 0.3 mL
  • For subcutaneous injection.
  • PAA087585
  • Rx only
  • To Open Pull Tab
  • NDC 0069-0206-02Contains 10 of NDC 0069-0206-01
  • 10 x 0.3 mL Single-dose prefilled syringes,preassembled with needle guards
  • Fragmin
  • 7,500 IU per 0.3 mL*
  • For subcutaneous injectionSterile
  • Pfizer Injectables
  • PAA129878
  • Fragminn (dalteparin sodium) Injection1 mL
  • 10,000 IUper mL
  • For subcutaneous injection. Single-dose only.Pfizer LabsDivision of Pfizer IncNY, NY 10017
  • NDC 0069-0217-01
  • Rx only
  • LOT/EXP:
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursion permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].n See accompanyingprescribing information.ttttttDistributed by Pfizer Labs Division of Pfizer IncNew York, NY 10017
  • 1 mL Single-dose graduated syringeNDC 0069-0217-01
  • Fragmin
  • 10,000 IU per mL
  • For subcutaneous injection.
  • PAA087586
  • Rx only
  • To Open Pull Tab
  • NDC 0069-0217-02Contains 10 of NDC 0069-0217-01
  • 10 x 1 mL Single-dose graduated syringes,preassembled with needle guards
  • Fragmin
  • 10,000 IU per mL*
  • For subcutaneous injectionSterile
  • Pfizer Injectables
  • 0.5 mL NDC 0069-0220-01
  • Fragmin
  • 12,500 IU per 0.5 mL
  • For subcutaneous injection.Single-dose only.
  • Pfizer LabsDivision of Pfizer IncNY, NY 10017
  • Rx only
  • PAA087580
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursion permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].n See accompanyingprescribing information.ttttttDistributed by Pfizer Labs Division of Pfizer IncNew York, NY 10017
  • 0.5 mL Single-dose prefilled syringeNDC 0069-0220-01
  • Fragmin
  • 12,500 IU per 0.5 mL
  • For subcutaneous injection.
  • PAA087587
  • Rx only
  • To Open Pull Tab
  • NDC 0069-0220-02Contains 10 of NDC 0069-0220-01
  • 10 x 0.5 mL Single-dose prefilled syringes,preassembled with needle guards
  • Fragmin
  • 12,500 IU per 0.5 mL*
  • For subcutaneous injectionSterile
  • Pfizer Injectables
  • 0.6 mL NDC 0069-0223-01
  • Fragmin
  • 15,000 IU per 0.6 mL
  • For subcutaneous injection.Single-dose only.
  • Pfizer LabsDivision of Pfizer IncNY, NY 10017
  • Rx only
  • PAA087581
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursion permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].n See accompanyingprescribing information. ttttttDistributed by Pfizer Labs Division of Pfizer IncNew York, NY 10017
  • 0.6 mL Single-dose prefilled syringeNDC 0069-0223-01
  • Fragmin
  • 15,000 IU per 0.6 mL
  • For subcutaneous injection.
  • PAA087588
  • Rx only
  • To Open Pull Tab
  • NDC 0069-0223-02Contains 10 of NDC 0069-0223-01
  • 10 x 0.6 mL Single-dose prefilled syringes,preassembled with needle guards
  • Fragmin
  • 15,000 IU per 0.6 mL*
  • For subcutaneous injectionSterile
  • Pfizer Injectables
  • 0.72 mLNDC 0069-0228-01
  • Fragmin
  • 18,000 IU per 0.72 mL
  • For subcutaneous injection. Single-dose only.
  • Pfizer LabsDivision of Pfizer IncNY, NY 10017
  • Rx only
  • PAA087582
  • Store at 20u00b0C to 25u00b0C (68u00b0to 77u00b0F); excursion permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].n See accompanying prescribinginformation.ttttttDistributed by Pfizer Labs Division of Pfizer IncNew York, NY 10017
  • 0.72 mL Single-dose prefilled syringeNDC 0069-0228-01
  • Fragmin
  • 18,000 IU per 0.72 mL
  • For subcutaneous injection.
  • PAA087589
  • Rx only
  • To Open Pull Tab
  • NDC 0069-0228-02Contains 10 of NDC 0069-0228-01
  • 10 x 0.72 mL Single-dose prefilled syringes,preassembled with needle guards
  • Fragmin
  • 18,000 IU per 0.72 mL*
  • For subcutaneous injectionSterile
  • Pfizer Injectables
  • NDC 0069-0232-01
  • 3.8 mL multiple-dose vial
  • Fragminn
  • 95,000 IU/3.8 mL
  • For subcutaneous injection
  • NDC 0069-0232-01
  • 3.8 mL multiple-dose vial
  • Fragminn
  • 95,000 IU/3.8 mL
  • For subcutaneous injectionSterile
  • Rx only
  • Pfizer Injectables

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