Description:

Fragmin 5000 IU / 0.2 ml solution for injection (Dalteparin sodium by Pfizer) is a low molecular weight heparin (LMWH) anticoagulant used to prevent and treat thromboembolic disorders. It is indicated for:

• Prophylaxis of venous thromboembolism (deep vein thrombosis [DVT] and pulmonary embolism [PE]) in surgical patients (especially orthopaedic and abdominal surgery), medical patients with acute illness (e.g., heart failure, acute respiratory failure, acute infection, or inflammatory disease with immobility), and during pregnancy.
• Treatment of acute DVT and PE.
• Prevention of clotting in extracorporeal circuits during haemodialysis.
• Extended treatment of symptomatic venous thromboembolism in cancer patients. It works by inhibiting factor Xa and thrombin (factor IIa) in the coagulation cascade, primarily through antithrombin III potentiation. In Ghana (Accra), it is a widely used prescription anticoagulant in hospitals, surgical wards, maternity units, and dialysis centers for VTE prevention and treatment.

Prescription:

Prescription-only (requires a doctor’s prescription in Ghana; dispensed by pharmacies or administered in hospitals/clinics with Rx; typically initiated and monitored by physicians, surgeons, haematologists, or obstetricians; not OTC due to bleeding risk and need for monitoring).

Therapeutic Category:

Anticoagulant / Low Molecular Weight Heparin (LMWH) (Parenteral antithrombotic agent.

Active Ingredients/Composition:

• Active ingredient: Dalteparin sodium – 5000 anti-Xa IU per 0.2 ml pre-filled syringe (25,000 anti-Xa IU/ml). Other ingredients: Sodium chloride, water for injection, hydrochloric acid/sodium hydroxide (pH adjustment to 5.0–7.5). The solution is clear, colourless to slightly yellow, sterile, preservative-free, and ready-to-use.

Vitamins: None.

Minerals: None (trace sodium from sodium chloride, but not therapeutic).

Variant:

• Fragmin 5000 IU / 0.2 ml pre-filled syringe (standard prophylactic dose). Related variants: Fragmin 2500 IU / 0.2 ml (lower prophylactic dose), Fragmin 10,000 IU / 0.4 ml, Fragmin 15,000 IU / 0.6 ml, Fragmin 18,000 IU / 0.72 ml, or multi-dose vials (rare). The 5000 IU / 0.2 ml syringe is the most common for general VTE prophylaxis in adults.

Consume Type:

Injectable – Subcutaneous (SC) injection (deep SC into abdomen, thigh, or upper arm; pre-filled syringe with safety needle guard; administered by healthcare professional or self-administered after training).

Directions/Usage: Administered by subcutaneous injection (never IV bolus unless specified).

• VTE prophylaxis (general surgery/medical patients): 2500 IU once daily (lower risk) or 5000 IU once daily (higher risk), usually started 1–2 hours before surgery and continued for 7–10 days or until mobilized.
• Extended prophylaxis (orthopaedic surgery): 5000 IU once daily for up to 35 days.
• Treatment of DVT/PE: 200 IU/kg once daily or 120 IU/kg twice daily (max 18,000 IU/day) for 5–10 days.
• Cancer-associated VTE: 200 IU/kg once daily for 1 month, then 150 IU/kg once daily.
• Haemodialysis: 30–40 IU/kg bolus + 10–15 IU/kg/hour infusion.
• Inject into abdomen (preferred) or alternate sites; pinch skin, insert needle at 90°, inject slowly.
• Rotate sites to avoid bruising/hematoma.
• Duration: As prescribed (days to months depending on indication).

Common Side Effects: Common:

• Injection site reactions (pain, bruising, hematoma, erythema).
• Mild bleeding (e.g., epistaxis, gingival bleeding).
• Thrombocytopenia (HIT – rare but serious).
• Increased liver enzymes. Rare/serious (seek immediate help): Major bleeding (gastrointestinal, intracranial, spinal/epidural hematoma), heparin-induced thrombocytopenia (HIT) with thrombosis, anaphylaxis, osteoporosis (with prolonged use).

Package Type:

Pre-filled single-dose syringes of 0.2 ml (each containing 5000 IU dalteparin sodium; packs of 10 syringes; blister or tray in carton with patient information leaflet and safety needle guard instructions).

Storage Advice: Store at room temperature (below 25–30°C) in original packaging, protected from light. Do not freeze. Keep out of reach of children.

Safety Advice:

• Administered only under medical supervision (risk of bleeding, HIT, and spinal/epidural hematoma with neuraxial anaesthesia).
• Contraindicated in active major bleeding, severe uncontrolled hypertension, recent cerebral haemorrhage, bacterial endocarditis, or hypersensitivity to dalteparin/heparin.
• Caution in renal impairment (dose adjustment or monitoring), elderly, bleeding disorders, recent surgery, or concurrent use of other anticoagulants/antiplatelets (increased bleeding risk).
• Spinal/epidural hematoma risk with neuraxial anaesthesia – timing and removal of epidural catheter critical.
• Monitor for bleeding signs (bruising, blood in stool/urine, headache), platelets (for HIT), and haemoglobin.
• If major bleeding, severe headache, back pain, or neurological symptoms occur, stop use and seek urgent care.
• Keep out of reach of children.

Product Substitutes: Similar low molecular weight heparin injections in Ghana include:

• Enoxaparin (Clexane or generics) – 40 mg / 0.4 ml or 60 mg / 0.6 ml pre-filled syringes.
• Dalteparin generics (Fragmin or other brands).
• Nadroparin (Fraxiparine).
• Tinzaparin (Innohep).
• Unfractionated heparin IV (for hospital use). Consult doctor/pharmacist in Accra (e.g., hospital pharmacy) for alternatives.

Manufacturer/Marketer:

Pfizer Inc. (original brand holder for Fragmin). Marketed/distributed in Ghana by Pfizer regional affiliates (Pfizer Ghana) or local importers/pharmacies (widely stocked in hospital pharmacies). Note: Some markets have generic dalteparin; the queried “Fragmin” is Pfizer’s original brand.

Country of Origin:

Varies by batch/market (original Fragmin often manufactured in Belgium, Denmark, or other Pfizer facilities; generics from India commonly imported to Ghana).