Leaflet FRAGMIN 25000UI / ml solution for injection

Product code:
W64856001
Quantity:
1
Indicated for:
prevention and treatment of thromboembolism
Route of administration:
injectable
Substance:
dalteparin (anticoagulant)
ATC
B01AB04 — Blood and blood forming organs | Antithrombotic agents | Antithrombotic agents | Heparin group

Precautions:

Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Major drug interactions

This medicine may have important interactions with other medicines.

Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

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 25000UI / ml

Substance:
dalteparin
Date of latest medicines list:
01-12-2018
Product code:
W64856001
Concentration:
25000UI / ml
Pharmaceutical form:
solution for injection
Packing volume:
4ml
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:
7369/2015/01
Shelf life:
2 years-Dupa ambalare pentru comercializare;2 saptamâni-After first opening the bottle

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