Loading…
FEIBA NF is a brand name for Anti-Inhibitor Coagulant Complex, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: FEIBA NF (Anti-Inhibitor Coagulant Complex) is indicated for: • Use in Hemophilia A and B patients with inhibitors for: • Control of spontaneous bleeding episodes • Surgical interventions • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children older than 6 years of age.…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Treatment should be initiated and supervised by a healthcare practitioner experienced in the use of coagulation agents and in the management of bleeding disorders. FEIBA NF may be used for treating non-haemophiliacs with acquired inhibitors to factors VIII, XI and XII in case of life-threatening haemorrhages.
U. may be successfully treated with Antihemophilic Factor. U. may either be treated with Antihemophilic Factor or FEIBA NF. U. have generally been refractory to treatment with Antihemophilic Factor. U. U. U. AICC AICC AICC AICC = Anti-Inhibitor Coagulant Complex, FEIBA AHF = Antihemophilic Factor Inadequate response to treatment may result from an abnormal platelet count or impaired platelet function which were present before treatment with FEIBA NF.
Clinical trials have demonstrated that the response to treatment with Anti-Inhibitor Coagulant Complex, FEIBA, may differ from patient to patient with no correlation to the patient's inhibitor titer. g. joint hemorrhage vs. CNS hemorrhage).
2 Recommended Dose and Dosage Adjustment As a general guideline a dosage range of 50 to 100 FEIBA Units of FEIBA NF per kg of body weight is recommended. However, care should be taken to distinguish between the following indications, all of which have undergone careful clinical evaluation: Table 2- Recommended Dose and Dosage Adjustment FEIBA NF Anti-Inhibitor Coagulant Complex Page 7 of 32 Indication Dose Frequency and Duration Joint Hemorrhages 50-75 U/kg of body weight • 12 hour intervals • Dose can be increased to 100 U/kg of body weight at 12 hour intervals • Treatment should be continued until clear signs of clinical improvement appear, such as relief of pain, reduction of swelling or mobilization of the joint.
• A daily dosage of 200 U/kg of body weight should not be exceeded. Mucous Membrane Bleeding 50 U/kg of body weight • 6-hour intervals under careful monitoring (visible bleeding site, repeated measurements of the patient's hematocrit) • If higher dosages are given, take care to prolong dosage intervals so as to make certain that a maximum daily dosage of 200 U/kg of body weight is not exceeded.
e. retroperitoneal bleeding) 100 U/kg of body weight • 12-hour intervals are recommended • A daily dosage of 200 U/kg of body weight should not be exceeded. e. 3 Reconstitution Table 3- Reconstitution Vial Size Volume of Diluent to be Added to Vial Approximate Available Volume Concentration per mL 10 mL (350-650 U) 10 mL 10 mL 50 U 20 mL (700-1300 U) 20 mL 20 mL 50 U 50 mL (1750-3250 U) 50 mL 50 mL 50 U Instructions for use for BAXJECT II Hi-Flow: Reconstitution of powder to prepare a solution for injections.
). 1 Dosing Considerations Treatment should be initiated and supervised by a healthcare practitioner experienced in the use of coagulation agents and in the management of bleeding disorders. FEIBA NF may be used for treating non-haemophiliacs with acquired inhibitors to factors VIII, XI and XII in case of life-threatening haemorrhages.
U. may be successfully treated with Antihemophilic Factor. U. may either be treated with Antihemophilic Factor or FEIBA NF. U. have generally been refractory to treatment with Antihemophilic Factor. U. U. U. AICC AICC AICC AICC = Anti-Inhibitor Coagulant Complex, FEIBA AHF = Antihemophilic Factor Inadequate response to treatment may result from an abnormal platelet count or impaired platelet function which were present before treatment with FEIBA NF.
Clinical trials have demonstrated that the response to treatment with Anti-Inhibitor Coagulant Complex, FEIBA, may differ from patient to patient with no correlation to the patient's inhibitor titer. g. joint hemorrhage vs. CNS hemorrhage).
2 Recommended Dose and Dosage Adjustment As a general guideline a dosage range of 50 to 100 FEIBA Units of FEIBA NF per kg of body weight is recommended. However, care should be taken to distinguish between the following indications, all of which have undergone careful clinical evaluation: Table 2- Recommended Dose and Dosage Adjustment FEIBA NF Anti-Inhibitor Coagulant Complex Page 7 of 32 Indication Dose Frequency and Duration Joint Hemorrhages 50-75 U/kg of body weight • 12 hour intervals • Dose can be increased to 100 U/kg of body weight at 12 hour intervals • Treatment should be continued until clear signs of clinical improvement appear, such as relief of pain, reduction of swelling or mobilization of the joint.
• A daily dosage of 200 U/kg of body weight should not be exceeded. Mucous Membrane Bleeding 50 U/kg of body weight • 6-hour intervals under careful monitoring (visible bleeding site, repeated measurements of the patient's hematocrit) • If higher dosages are given, take care to prolong dosage intervals so as to make certain that a maximum daily dosage of 200 U/kg of body weight is not exceeded.
General). • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors (see 7 WARNINGS AND PRECAUTIONS AND
FEIBA NF is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGHTS, COMPOSITION AND PACKAGING.
The use of Anti-Inhibitor Coagulant Complex, FEIBA NF is contraindicated in patients who are known to have a normal coagulation mechanism and in patients who have hypersensitivity to the product. It should not be given to patients with significant signs of disseminated intravascular coagulation (DIC) or fibrinolysis.
In patients with a tentative or definite diagnosis of coronary heart disease as well as in patients with acute thrombosis and/or embolism (including myocardial infarction) the use of FEIBA NF is only indicated in life-threatening bleeding events.
FEIBA NF Anti-Inhibitor Coagulant Complex Page 6 of 32
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Use aseptic technique throughout entire procedure. 1. g. using a sterile water bath for warming within several minutes (max. +37°C). 2. Remove the protective caps from the FEIBA vial and solvent vial and cleanse the rubber stoppers with germicidal solution of both and allow to dry.
Place the vials on a flat surface. 3. Open the package of BAXJECT II Hi-Flow device by peeling away the paper lid without touching the inside (Fig. a). Do not remove the transfer device from the package. 4. Turn the package over and insert the clear plastic spike through the solvent stopper (Fig.
b). Grip the package at its edge and pull the package off BAXJECT II Hi-Flow (Fig. c). Do not remove the blue cap from BAXJECT II Hi-Flow. 5. With the transfer device attached to the solvent vial, invert the system so that the solvent vial is on top of the device.
Insert the purple plastic spike of BAXJECT II Hi-Flow through the FEIBA vial stopper. The vacuum will draw the solvent into the FEIBA vial (Fig. d). 6. Swirl gently until all the material is dissolved. Ensure that FEIBA is completely dissolved, otherwise active material will not pass through the device filter.
4 Administration Injection/Infusion Use aseptic technique throughout entire procedure. 1. Remove the blue cap from BAXJECT II Hi-Flow. Take the syringe and connect it to BAXJECT II Hi-Flow (DO NOT DRAW AIR INTO THE SYRINGE) (Fig. e). 2.
Invert the system (with FEIBA vial on top). Draw the FEIBA solution into the syringe by pulling the plunger back slowly (Fig. f). 3. Disconnect the syringe. 4. Slowly inject the solution intravenously with a winged set for injection. Do not exceed an infusion rate of 2 U FEIBA/kg/Body Weight per minute.
A syringe pump may be used to control the rate of administration. Do not refrigerate after […]
e. retroperitoneal bleeding) 100 U/kg of body weight • 12-hour intervals are recommended • A daily dosage of 200 U/kg of body weight should not be exceeded. e. 3 Reconstitution Table 3- Reconstitution Vial Size Volume of Diluent to be Added to Vial Approximate Available Volume Concentration per mL 10 mL (350-650 U) 10 mL 10 mL 50 U 20 mL (700-1300 U) 20 mL 20 mL 50 U 50 mL (1750-3250 U) 50 mL 50 mL 50 U Instructions for use for BAXJECT II Hi-Flow: Reconstitution of powder to prepare a solution for injections.
Use aseptic technique throughout entire procedure. 1. g. using a sterile water bath for warming within several minutes (max. +37°C). 2. Remove the protective caps from the FEIBA vial and solvent vial and cleanse the rubber stoppers with germicidal solution of both and allow to dry.
Place the vials on a flat surface. 3. Open the package of BAXJECT II Hi-Flow device by peeling away the paper lid without touching the inside (Fig. a). Do not remove the transfer device from the package. 4. Turn the package over and insert the clear plastic spike through the solvent stopper (Fig.
b). Grip the package at its edge and pull the package off BAXJECT II Hi-Flow (Fig. c). Do not remove the blue cap from BAXJECT II Hi-Flow. 5. With the transfer device attached to the solvent vial, invert the system so that the solvent vial is on top of the device.
Insert the purple plastic spike of BAXJECT II Hi-Flow through the FEIBA vial stopper. The vacuum will draw the solvent into the FEIBA vial (Fig. d). 6. Swirl gently until all the material is dissolved. Ensure that FEIBA is completely dissolved, otherwise active material will not pass through the device filter.
4 Administration Injection/Infusion Use aseptic technique throughout entire procedure. 1. Remove the blue cap from BAXJECT II Hi-Flow. Take the syringe and connect it to BAXJECT II Hi-Flow (DO NOT DRAW AIR INTO THE SYRINGE) (Fig. e). 2.
Invert the system (with FEIBA vial on top). Draw the FEIBA solution into the syringe by pulling the plunger back slowly (Fig. f). 3. Disconnect the syringe. 4. Slowly inject the solution intravenously with a winged set for injection. Do not exceed an infusion rate of 2 U FEIBA/kg/Body Weight per minute.
A syringe pump may be used to control the rate of […]