Dalteparin (Orthopaedic VTE Prophylaxis)

SCOPE - this covers HIP REPLACEMENT SURGERY prophylaxis only. That is this page's primary indication (page name 'Dalteparin (Orthopaedic VTE Prophylaxis)', specialty ortho-trauma) and it matches the regimen the existing entry leads with. NEITHER fetched label doses knee replacement or hip fracture surgery anywhere, so the existing entry's 'hip fracture: 5000 units once daily' and its '5 weeks post-op' continuation for THR/TKR and hip fracture are NOT sourced by this bundle and are not carried forward. The label's other prophylaxis regimens are for different populations and are recorded here for context only, not as this page's dose: abdominal surgery, 2,500 units once daily starting 1 to 2 hours before surgery, or 5,000 units the evening before surgery where risk is high such as malignant disorder, or 2,500 units 1 to 2 hours before surgery followed by 2,500 units 12 hours later then 5,000 units once daily, usual duration 5 to 10 days; medical patients with severely restricted mobility during acute illness, 5,000 units once daily, usual duration 12 to 14 days in clinical trials. PERI-OPERATIVE TIMING DETAIL (US Table 2): for the postoperative-start option, 'Allow a minimum of 6 hours between this dose and the dose to be given on Postoperative Day 1. Adjust the timing of the dose on Postoperative Day 1 accordingly'; for the evening-before-surgery option, 'Allow approximately 24 hours between doses'; the 4-to-8-hour postoperative dose is given 'Or later, if hemostasis has not been achieved.' NO MAXIMUM is stated for this indication, so maxDose is deliberately left empty - the 10,000 units ceiling in this label belongs to unstable angina and non-Q-wave MI, and the 18,000 units daily ceiling belongs to extended VTE treatment in cancer; neither may be carried across. NEURAXIAL ANAESTHESIA: the US label contraindicates administering FRAGMIN in patients undergoing epidural/neuraxial anaesthesia when it is used as treatment for unstable angina/non-Q-wave MI or for prolonged VTE prophylaxis, and section 5.1 warns that spinal or epidural haemorrhage and subsequent haematomas can occur with LMWHs or heparinoids and neuraxial anaesthesia or spinal puncture, with higher risk from post-operative indwelling epidural catheters, concomitant drugs affecting haemostasis such as NSAIDs, traumatic or repeated puncture, or a history of spinal surgery or deformity - 'Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of FRAGMIN is low'. The specific catheter timing intervals on the existing page entry (10-12 hours after the last dose, next dose 4 hours after removal) are NOT in this bundle. STRENGTHS (US section 3) include 2,500 units/0.2 mL and 5,000 units/0.2 mL single-dose prefilled syringes, so both doses shown correspond to marketed presentations. GERIATRIC (US section 8.5): 'Give careful attention to dosing intervals and concomitant medications (especially antiplatelet medications) in geriatric patients, particularly in those with low body weight (<45 kg) and those predisposed to decreased renal function.' UK SPC: 'Fragmin has been used safely in elderly patients without the need for dosage adjustment.'

THIS PAGE'S PAEDIATRIC INDICATION IS NOT SOURCEABLE. UK SPC section 4.2, verbatim: 'The safety and efficacy of dalteparin sodium for prophylaxis of VTE in children has not been established. Currently available data on prophylaxis of VTE are described in section 5.1 but no recommendation on a posology can be made.' dosePerKg is therefore null and NOTHING in this entry may be used for orthopaedic thromboprophylaxis in a child - the existing page entry's '100 units/kg once daily' paediatric prophylaxis figure is not supported by either fetched label. FOR CONTEXT ONLY, AND FOR A DIFFERENT INDICATION (treatment of symptomatic VTE, not prophylaxis), the UK SPC and the US label give identical age-banded starting doses: 1 month to less than 2 years, 150 units/kg twice daily; 2 years to less than 8 years, 125 units/kg twice daily; 8 years to less than 18 years, 100 units/kg twice daily (the US label bands these as birth, gestational age at least 35 weeks, to less than 2 years; 2 to less than 8 years; 8 to less than 17 years). Because that figure changes with age band it is not a single per-dose value valid across the paediatric range, so it is not exposed to the weight calculator. ANTI-XA MONITORING for that treatment regimen (UK SPC): 'After initiation of Fragmin, anti-Xa level should initially be measured after the first, second or third dose. Samples for anti-Xa level should be drawn 4 hours after administration. Doses should be adjusted in increments of 25 IU/kg to achieve target anti-Xa level between 0.5 IU/ml and 1 IU/ml and anti-Xa level measured after each adjustment.' 'In the case of low and changing physiologic renal function such as in neonates, close monitoring of anti-Xa levels is warranted.' FORMULATION CAUTIONS: 'A concentration of 2,500 IU/ml is recommended to ensure accuracy of dosing for the youngest age cohort'; 'For children under 3 years of age, a presentation without benzyl alcohol should be used'; 'The final volume for injection should be between 0.15 ml and 1.0 ml'; the US label adds 'Use preservative-free FRAGMIN in neonates and infants' because fatal reactions and 'gasping syndrome' occurred in premature neonates and low-birth-weight infants given benzyl alcohol preserved medications. The concentration field is null because dalteparin is dosed in anti-Xa units and no mg/mL value exists for it.