Loading…
ANTITHROMBIN III NF is a brand name for Antithrombin III, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ANTITHROMBIN III NF is indicated for: Prophylaxis and treatment of thrombotic and thromboembolic disorders in patients with hereditary antithrombin III deficiency (antithrombin III activity below 70% of normal). Infusions of antithrombin III may be particularly valuable in surgical procedures or pregnancy and…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The dosage of ANTITHROMBIN III NF, Antithrombin III (human) depends on the cause and severity of AT III deficiency. Antithrombin III activity must be determined for accurate dosage calculation. The normal range of antithrombin III activity in human plasma is between 80% and 120%.
A decrease in activity to below 70% of normal is associated with an increased risk of thrombosis. Individual doses should therefore be large enough to assure that an antithrombin III plasma level of at least 70% of normal is maintained between infusions.
The amount to be administered and the frequency of administration should always be based on the clinical efficacy and laboratory assessment in the individual case. The initial target antithrombin activity depends on the clinical situation.
When the indication for antithrombin substitution is established, the dosage should be sufficient to reach the target antithrombin activity, and to maintain an effective level. Further monitoring of the antithrombin III plasma level at regular intervals may, however, be necessary for a prolonged period of time.
5 days. In congenital Antithrombin III deficiency, dosage should be individualized for each patient taking into account the family history with regard to the thromboembolic events, the actual clinical risk factors, and Antithrombin III plasma levels.
In cases of acute consumption of antithrombin III (DIC), the half life may be reduced to only a few hours. 2 Recommended Dose and Dosage Adjustment Dosage Guidelines For Disseminated Intravascular Coagulation Dosage of ANTITHROMBIN III NF should be based on a determination of the patient's antithrombin III activity prior to therapy and thereafter at intervals of approximately 4 -6 hours.
The initial dose should be large enough to raise the plasma level to normal (80-120%). Additional doses are required whenever the antithrombin III activity has dropped to less than 70%. In patients with an acute consumption of antithrombin III, the dosage calculations can be based on the formula: Dose (in IU1) = [desired ATIII activity (%) - baseline ATIII activity (%)] x body weight (in kg) divided by 1 % Maintenance dosage is also calculated using the formula stated above, except that the 1% is substituted instead, with the actual increase in ATIII activity (in %) produced by 1 IU per kg of body weight, as determined by the measurement of ATIII activity following the administration of the initial dose.
1 Adverse Reaction Overview As with any other infused plasma derivative, anaphylactoid or anaphylactic reactions may occur, although rarely. , fever, urticarial rashes, nausea, retching, dyspnoea, anaphylactic shock) necessitates the interruption of rep lacement therapy.
Mild reactions can be managed with antihistamine; severe hypotonic reactions require immediate intervention using current principles of shock therapy. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful for identifying and approximating rates of adverse drug reactions in real-world use.
In the total of 365 patients in whom efficacy was evaluated either in clinical studies or case reports no product-related adverse drug events were reported. Viral safety was evaluated in a prospective, clinical study in which AT III recipients previously untreated with blood or blood products (PUP's) were followed up for transfusion -transmitted viral hepatitis using the criteria established by the International Society for Thrombosis and Haemostasis.
26 patients were evaluated for hepatitis non-A, non-B transmission and 27 for hepatitis B transmission. In addition, 20 patients were evaluated for HCV seroconversion and 78 for HIV seroconversion. No case of product-related transmission of viral hepatitis or HIV was observed.
5 Post-Market Adverse Reactions The following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible.
General ANTITHROMBIN III NF, Antithrombin III (human) is prepared from pooled human plasma which may contain the causative agents of hepatitis and other viral diseases. , viruses and, theoretically, the agent that causes Creutzfeldt-Jakob disease in human) cannot be totally excluded.
This also applies to unknown or emerging viruses and other pathogens. Prescribed manufacturing procedures utilized at the plasma collection centres, plasma testing laboratories, and the fractionation facilities are designed to reduce the risk of transmitting viral infection by inactivating and/or removing viruses.
However, the risk of viral infectivity from this product cannot be totally eliminated. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly non-A, non-B hepatitis.
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived antithrombin products. Patients with ATIII deficiency, who are undergoing treatment using a plasma-derived product, should be appropriately vaccinated.
Hypersensitivity Hypersensitivity reactions are possible. Hypersensitivity and anaphylactic reactions h ave been reported with the use of Antithrombin III, and in some cases may progress to severe anaphylaxis (including shock). Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
In case of shock, standar d medical treatment should be administered. Monitoring and Laboratory Tests Clinical and laboratory monitoring when antithrombin is used together with heparin: • In order to adjust heparin dosage and to avoid excessive anticoagulation, controls of the extent of anticoagulation (APPT, and where appropriate anti-FXa activity) should be performed regularly, at close intervals and in particular in the first minutes/hours following the start of antithrombin use.
Antithrombin III 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, STRENGTHS, COMPOSITION AND PACKAGING.
Known history of heparin-induced thrombocytopenia.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Antithrombin III in Canada.
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.
When using ANTITHROMBIN III NF in combination with heparin, it must be taken into account that the anticoagulant effect of heparin is accelerated by antithrombin III (see also 9 DRUG INTERACTIONS). For Other Antithrombin III Defects As a guideline, an initial dose of 1500 IU and a maintenance dose of one half the in itial dose given at 8 to 24 hour intervals is suggested for an average sized adult.
However, the dosage should be adjusted to individual needs, which can only be estimated by determination of the patient's antithrombin III activity at regular intervals. In the absence of acute consumption of AT III, dosage calculations can be based on the formula: Dose (in IU) = [desired ATIII activity (%) - baseline ATIII activity (%)] x body weight (in kg) divided by 2% Maintenance dosage is also calculated using the formula stated above, except that the 2% is substituted instead, with the actual increase in ATIII activity (in %) produced by 1 IU per kg of body weight, as determined by the measurement of ATIII activity following the administration of the initial dose.
3 Reconstitution: ANTITHROMBIN III NF is to be stored in its lyophilized condition and reconstituted immediately before application. Entered vials must not be reused. The product does not contain a preservative and must be handled with aseptic technique to prevent contamination.
P. U. antithrombin III is stated on the label of each vial. 1 IU antithrombin III (as determined w ith a standard calibrated against the 3rd International Standard for ATIII (Human) in Concentrates, Code 06/166) corresponds to the antithrombin III activity present in 1 mL of normal human plasma.
Antithrombin III NF (Antithrombin III (Human)) Page 6 of 19 For reconstitution, proceed as follows: 1. Remove the unopened bottle containing Sterile Water for Injection (diluent) from the refrigerator and allow it warm up to room temperature (not above 37°C, 98°F).
2. Remove caps from the concentrate and diluent bottles to expose central portions of the rubber stoppers (fig. A). 3. Cleanse exposed surface of the rubber stopper with germicidal solution and allow to dry. 4. Using aseptic technique, remove protective covering from one end of the double -ended needle and insert the exposed end through the diluent bottle stopper (fig.
B and C). 5. Remove protective covering from the other end of the double-ended needle, taking care not to touch the exposed end. Invert diluent bottle over the concentrate bottle, then rapidly insert free end of the needle through the concentrate bottle stopper (fig.
D). Diluent will be drawn into the concentrate bottle by vacuum. 6. Disconnect the two bottles by removing the needle from the concentrate bottle stopper (fig. E). Gently agitate or rotate the concentrate bottle until all material is dissolved.
7. Visually inspect the reconstituted product for particulate matter and discolouration prior to administration, whenever solution and container permit. Discard if particulate matter or discolouration exists. 8. Do not use solutions that are cloudy or have deposits.
Do not refrigerate after reconstitution. 4 Administration Administer ANTITHROMBIN III NF only by intravenous injection or infusion . The […]
Nervous system disorders:
Tremor Vascular disorders: Hot flush Immune System disorders: Hypersensitivity, Anaphylactic reaction Antithrombin III NF (Antithrombin III (Human)) Page 10 of 19 Class Reactions Heparin-induced antibody-mediated thrombocytopenia (type II)
• It is recommended that ATIII plasma levels be monitored daily during the treatment period in order to adjust the individual dose, due to the consumption of antithrombin by prolonged treatment with non-fractionated heparin. , using chromoge nic substrates (amidolytic method), is recommended for the determination of the patient's plasma level of antithrombin III before and during treatment with ANTITHROMBIN III NF.
1 Pregnant Women The safety of Antithrombin III NF for use in pregnant has not been established in controlled clinical trials. However, the use of Antithrombin III solutions in pregnant women is referenced in the medical literature.
ANTITHROMBIN III NF should be given to a pregnant woman only if clearly needed, taking into consideration that pregnancy confers an increased risk of thromboembolic events. 2 Breast-feeding The safety of Antithrombin III NF for use in lactating women has not been established in controlled clinical trials.
ANTITHROMBIN III NF should be given to a lactating woman only if clearly needed. 3 Pediatrics Safety and effectiveness in children have not yet been established in clinical trials. The use of Antithrombin III solutions in the pediatric population for the unapproved indication of Infan t Respiratory Distress Syndrome (IRDS), as referenced in the medical literature, suggests an increased risk of intracranial bleeding and mortality in the absence of a demonstrated beneficial effect.