FRAGMINE

This heparin is low molecular weight heparin (HBPM) with the following indications: Adult population.

• Prophylactic treatment of venous thromboembolic disease (VTE) in surgery, in moderate or high risk situations and in oncological surgery.

• Prophylactic treatment of deep venous thrombosis (PDT) in patients bedridden for acute medical condition o Stage III or Intravenous heart failure of NYHA classification o Acute respiratory failure o Acute respiratory failure or episode of acute rheumatological disease, associated with at least one other venous thromboembolic risk factor.

• Prevention of coagulation of the extracorporal circulation circuit during haemodialysis (general session ≤ 4 hours) Paediatric population Treatment of symptomatic venous thromboembolism (VTE) in paediatric patients 1 month of age and over.

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The following are the results of the study.

Approximately 3% of patients receiving prophylaxis have been reported as having side effects.

Reported adverse reactions that may be related to dalteparin sodium are listed below by system organ classification and frequency: common ( 3 1/100, < 1/10), uncommon ( 3 1/1 000, < 1/100), rare ( 3 1/10,000).

System organ class Frequency Adverse reactions

Blood and lymphatic disorders Common Moderate thrombopenia (Type I), generally reversible during heparin-induced therapy Rare Immunoallergic thrombocytopenia (Type II, with or without associated thrombotic complications) Not known Probable asymptomatic and reversible laboratory reactions Platmatic and peripheral disorders Absorbetic disorders Absorbent hypertensive disorders Absorbent hyperplasia Hemorrhagic reactions Hyperkalaemia* Nervous system disorders Not known Absorbent and peripheral disorders Absorbent and peripheral disorders of the patient's laboratory disorders Absorbetic and peripheral disorders of the patient's laboratory disorders Not known* Hemorrheas.

Disorders Uns Not known* Nervetic disorders Uncertainly hemorrheas Not known.