Dalteparin

What it is used for

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 from birth (gestational age at least 35 weeks) Limitations of Use FRAGMIN is not indicated for the acute treatment of VTE 1.1 Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction FRAGMIN Injection is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy.

Prophylaxis of Deep Vein Thrombosis FRAGMIN is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): In patients undergoing hip replacement surgery; In patients undergoing abdominal surgery who are at risk for thromboembolic complications; In medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.

Extended Treatment of Symptomatic Venous Thromboembolism (VTE) in Adult Patients with Cancer FRAGMIN is indicated for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce the recurrence of VTE 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) in Pediatric Patients FRAGMIN is indicated for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients from birth (gestational age at least 35 weeks). Limitations of Use FRAGMIN is not indicated for the acute treatment of VTE.

Side effects, and when to stop

The following clinically significant adverse reactions are described in more detail in other sections of the prescribing information.

• Risk of Hemorrhage including Spinal/Epidural Hematomas
• Thrombocytopenia
• Benzyl Alcohol Preservative Risk to Premature Infants

Who should not take it

FRAGMIN is contraindicated in:

• Patients with active major bleeding.
• Patients with a history of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis.
• Patients with prior hypersensitivity to dalteparin sodium (e.g., pruritis, rash, anaphylactic reactions).
• Patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN;
  • o As a treatment for unstable angina and non-Q-wave MI.
  • o For prolonged VTE prophylaxis.
• Patients with prior hypersensitivity to heparin or pork products.

Other medicines and interactions

The use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding.

Storing it

Store at 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F).

Latex Allergy: The needle shield of the prefilled syringe may contain natural rubber latex.