COAGADEX 500UI / ml powder+solvent for injection medication leaflet

B02BD13 coagulation factor X • Blood and blood forming organs | Vitamin k and other hemostatics | Blood coagulation factors

Coagulation factor X is a medicine used for people with hereditary factor X deficiency, a rare bleeding disorder. Factor X is a protein needed for normal clot formation; when it is missing or does not work properly, bleeding may last longer after injury, surgery, dental extraction or menstruation, and some patients may have spontaneous bleeding.

The treatment temporarily replaces the missing factor and helps the blood clot more effectively. It may be used to treat active bleeding, to prevent bleeding before and after surgery, or as regular prophylaxis in selected patients. The plan depends on the severity of the deficiency, bleeding history, age, weight and the type of medical or dental procedure.

The medicine is given into a vein, usually by trained healthcare staff; some patients or caregivers may be trained for home administration. The dose is individual and may be adjusted according to factor X levels and clinical response. Keep a record of doses and tell your specialist before operations, intramuscular injections, dental work or medicines that may increase bleeding risk.

Side effects may include pain, redness or discomfort at the infusion site, tiredness, back pain or allergic reactions. Seek urgent help for hives, swelling of the face, breathing difficulty, severe dizziness or chest pain. Some products are made from human plasma, so strict safety steps are used, but patients should discuss infection risk, vaccination and ongoing monitoring with their clinician.

General data about COAGADEX 500UI / ml

Substance: coagulation factor X

Commercial code: W71793001

Concentration: 500UI / ml

Pharmaceutical form: powder+solvent for injection

Quantity: 1

Product type: generic

Prescription restrictions: S - Medicines prescription reserved for use in certain specialized fields.

Marketing authorisation

Manufacturer: PHARMAKORELL GMBH - GERMANIA

Holder: KEDRION S.P.A. - ITALIA

Number: 1087/2016/02

Shelf life: 3 years

Concentrations available for coagulation factor X

250UI/ml, 500UI/ml