Leaflet FRAGMIN 10000UI / 0.4ml solution for injection

Indicated for: prevention and treatment of thromboembolism

Route of administration: injectable

Substance: dalteparin (anticoagulant)

ATC: B01AB04 (Blood and blood forming organs | Antithrombotic agents | Heparin group)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Bleeding risk
Bleeding risk

This medicine may increase the risk of bleeding.

Dalteparin is an anticoagulant from the low molecular weight heparin (LMWH) class, used for the prevention and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). It is also indicated for preventing thromboembolic complications in patients with unstable angina or non-Q-wave myocardial infarction and for preventing clot formation in cancer patients.

Dalteparin works by inhibiting factor Xa and thrombin, thereby reducing blood clot formation. It is administered as subcutaneous injections, with the dosage adjusted based on body weight and the patient's condition.

Side effects may include bleeding, hematomas at the injection site, thrombocytopenia (low platelet count), or allergic reactions. It is contraindicated in patients with active bleeding, heparin-induced thrombocytopenia, or hypersensitivity to dalteparin. It should be used cautiously in patients with renal impairment.

General data about FRAGMIN 10000UI / 0.4ml

  • Substance: dalteparin
  • Date of latest medicines list: 01-12-2018
  • Product code: W64853002
  • Concentration: 10000UI / 0.4ml
  • Pharmaceutical form: solution for injection
  • Packing volume: 0,4 ml
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: PFIZER MANUFACTURING BELGIUM NV - BELGIA
  • Holder: PFIZER EUROPE MA EEIG - BELGIA
  • Number: 7364/2015/02
  • Shelf life: 3 years

Concentrations available for dalteparin

  • 10000UI/0.4ml
  • 10000UI/ml
  • 12500UI/0.5ml
  • 15000UI/0.6ml
  • 18000UI/0.72ml
  • 25000UI/ml
  • 2500UI/0.2ml
  • 5000UI/0.2ml
  • 7500UI/0.3ml