سعر اميونات 250/190وحدة دولية فيال 2022

Immunate 250 IU FVIII / 190 IU VWF: plasma-derived human coagulation factor VIII / von Willebrand factor complex (Takeda, formerly Baxter AG), powder and solvent for intravenous injection, single vial.

• Treatment and prophylaxis of bleeding in patients with congenital (haemophilia A) or acquired factor VIII deficiency.Population: Adults and childrenTakeda Pharma Sp. z o.o. (Poland)
• Treatment of bleeding in von Willebrand disease with factor VIII deficiency when no specific effective VWD product is available and desmopressin (DDAVP) alone is ineffective or contraindicated.Population: Adults and childrenTakeda Pharma Sp. z o.o. (Poland)

• Hypersensitivity is uncommon (one reaction in 329 infusions in one study); factor VIII inhibition is uncommon in previously treated patients and very common in previously untreated patients.International label, same product · Takeda Pharma Sp. z o.o. (Poland)
• Frequency not known: coagulation disorder, restlessness, paraesthesia, dizziness, headache, conjunctivitis, tachycardia, palpitations, hypotension, flushing, pallor, dyspnoea, cough, vomiting, nausea, urticaria, rash, pruritus, erythema, hyperhidrosis, neurodermatitis, myalgia, chest pain or discomfort, oedema, fever, chills, injection-site reactions and pain.International label, same product · Takeda Pharma Sp. z o.o. (Poland)

• Hypersensitivity to the active substances or to any of the excipients (human albumin, glycine, sodium chloride, sodium citrate, lysine hydrochloride, calcium chloride).International label, same product · Takeda Pharma Sp. z o.o. (Poland)

• Allergic-type hypersensitivity reactions, up to anaphylactic shock, are possible; patients should stop the infusion and contact their doctor at the first signs (hives, rash, chest tightness, wheezing, hypotension).International label, same product · Takeda Pharma Sp. z o.o. (Poland)
• Neutralising antibodies (inhibitors) to factor VIII may develop, mainly within the first 50 exposure days; if expected plasma levels or bleeding control are not achieved, test for inhibitors. Patients with von Willebrand disease (especially type 3) may develop VWF inhibitors.International label, same product · Takeda Pharma Sp. z o.o. (Poland)
• Risk of thrombotic events, especially with known risk factors; because of the relatively high factor VIII content, monitor plasma FVIII:C to avoid sustained excessive levels. Factor VIII replacement may increase cardiovascular risk in patients with existing cardiovascular risk factors.International label, same product · Takeda Pharma Sp. z o.o. (Poland)

• Other medicinal productsNo interaction studies have been performed with Immunate, and no interactions of human coagulation factor VIII products with other medicines have been reported. Do not mix with other medicinal products.Takeda Pharma Sp. z o.o. (Poland)

• No animal reproduction studies; because haemophilia A is rare in women there is no experience of factor VIII use in pregnancy, so Immunate should be used in pregnancy only if clearly indicated (see parvovirus B19 warning). Effect on fertility not established.International label, same product · Takeda Pharma Sp. z o.o. (Poland)
• No experience with factor VIII during breastfeeding; use only if clearly indicated.International label, same product · Takeda Pharma Sp. z o.o. (Poland)

• Human coagulation factor VIII: Activated factor VIII acts as a cofactor for activated factor IX, accelerating conversion of factor X to activated factor X, which converts prothrombin to thrombin and allows clot formation.
• Human von Willebrand factor: Protects factor VIII and mediates platelet adhesion to sites of vascular injury; also plays a role in platelet aggregation.