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Dalteparin

Generic Name
Dalteparin
Brand Names
Fragmin
Drug Type
Small Molecule
CAS Number
9005-49-6
Unique Ingredient Identifier
S79O08V79F

Overview

Dalteparin, a low molecular weight heparin (LMWH) prepared by nitrous acid degradation of unfractionated heparin of porcine intestinal mucosa origin, is an anticoagulant. It is composed of strongly acidic sulphated polysaccharide chains with an average molecular weight of 5000 and about 90% of the material within the range of 2000-9000. LMWHs have a more predictable response, a greater bioavailability, and a longer anti-Xa half life than unfractionated heparin. Dalteparin can also be safely used in most pregnant women. Low molecular weight heparins are less effective at inactivating factor IIa due to their shorter length compared to unfractionated heparin.

Background

Dalteparin, a low molecular weight heparin (LMWH) prepared by nitrous acid degradation of unfractionated heparin of porcine intestinal mucosa origin, is an anticoagulant. It is composed of strongly acidic sulphated polysaccharide chains with an average molecular weight of 5000 and about 90% of the material within the range of 2000-9000. LMWHs have a more predictable response, a greater bioavailability, and a longer anti-Xa half life than unfractionated heparin. Dalteparin can also be safely used in most pregnant women. Low molecular weight heparins are less effective at inactivating factor IIa due to their shorter length compared to unfractionated heparin.

Indication

Dalteparin is used as a prophylaxis for deep-vein thrombosis and pulmonary embolisms in patients undergoing general surgery (e.g., abdominal, gynecologic, urologic), and in patients with acute medical conditions (e.g. cancer, bed rest, heart failure, severe lung disease). It is also used in patients who have severely restricted mobility, which poses a risk for thromboembolic complications. Dalteparin is also used concomitantly with aspirin and/or other therapy (e.g., nitrates, β-adrenergic blockers, clopidogrel, platelet glycoprotein [GP] IIb/IIIa-receptor inhibitors) to reduce the risk of acute cardiac ischemic events. The patients who undergo this treatment combination have unstable angina or non-ST-segment elevation/non-Q-wave myocardial infarction (i.e., non-ST-segment elevation acute coronary syndromes). It is also used in the prevention of clotting during hemodialysis and hemofiltration in connection with acute renal failure or chronic renal insufficiency.

Associated Conditions

  • Cardiovascular Events
  • Clotting
  • Deep Vein Thrombosis
  • Symptomatic Venous Thromboembolism
  • Venous Thromboembolism

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Pfizer Laboratories Div Pfizer Inc
0069-0220
SUBCUTANEOUS
12500 [iU] in 0.5 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0232
SUBCUTANEOUS
25000 [iU] in 1 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0253
SUBCUTANEOUS
2500 [iU] in 1 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0223
SUBCUTANEOUS
15000 [iU] in 0.6 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0228
SUBCUTANEOUS
18000 [iU] in 0.72 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0196
SUBCUTANEOUS
5000 [iU] in 0.2 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0195
SUBCUTANEOUS
2500 [iU] in 0.2 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0206
SUBCUTANEOUS
7500 [iU] in 0.3 mL
8/15/2022
Pfizer Laboratories Div Pfizer Inc
0069-0217
SUBCUTANEOUS
10000 [iU] in 1 mL
8/15/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
FRAGMIN INJECTION 2500 iu/ml
SIN05249P
INJECTION
2500 iu/ml
12/3/1990

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Dalteparin Sodium Injection
国药准字H20204000
化学药品
注射剂
10/23/2023
Dalteparin Sodium Injection
国药准字HJ20170037
化学药品
注射剂
7/1/2021
Dalteparin Sodium Injection
国药准字HJ20170043
化学药品
注射剂
7/1/2021
Dalteparin Sodium Injection
国药准字HJ20170042
化学药品
注射剂
7/1/2021
Dalteparin Sodium Injection
国药准字HJ20170040
化学药品
注射剂
7/1/2021
Dalteparin Sodium Injection
国药准字HJ20170044
化学药品
注射剂
7/1/2021
Dalteparin Sodium Injection
国药准字HJ20170041
化学药品
注射剂
7/1/2021
Dalteparin Sodium Injection
国药准字H20201000
化学药品
注射剂
5/26/2020
Dalteparin Sodium Injection
国药准字HJ20170045
化学药品
注射剂
7/1/2021
Dalteparin Sodium Injection
国药准字HJ20170038
化学药品
注射剂
7/1/2021

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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