ARGATROBAN PACKAGE INSERT PDF

Store in original package until time of use. Argatroban: Discard product if it contains particulate matter, is cloudy, or discolored – Do not freeze – Protect from . Baxter U.S. – Healthcare Professionals – ARGATROBAN Injection in % Sodium Chloride mg/ mL (1 mg/1 mL). Argatroban is approved by the US Food and Drug Administration .. 51 to minutes), package insert recommendations provide guidance on.

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One vial with 2. Anticoagulation in adult patients with heparin-induced thrombocytopenia type II who require parenteral antithrombotic therapy. The diagnosis should be confirmed by the HIPAA heparin induced platelet activation assay or an equivalent test. However, such confirmation must not delay the start of treatment. Currently available data are described in section 5.

Treatment with Exembol Multidose indert be initiated under the guidance of a physician with experience in coagulation disorders.

Before Exembol Multidose is administered, heparin therapy should be discontinued and a baseline aPTT value obtained. In general, therapy with Exembol Multidose is monitored using the activated partial thromboplastin time aPTT. Tests of anticoagulant effects including the aPTT attain steady-state levels typically within hours following initiation of Exembol Multidose. The target range for steady-state aPTT is 1. Thereafter, the aPTT should be monitored at least once per day.

After the initial dose of Exembol Multidose, the dose can be adjusted based on the clinical course until the steady-state aPTT is within the desired therapeutic range 1. In case of an elevated aPTT greater than 3 times baseline or secondsthe infusion should be discontinued until the aPTT is within the desired range of 1. The aPTT should be checked again after 2 hours. The maximum recommended duration of treatment is 14 days, although there is limited clinical experience of administration for longer periods see section 5.

Exembol Multidose 100 mg/ml concentrate for solution for infusion

Stop infusion until the aPTT is 1. The standard infusion rates for patients with moderate hepatic impairment Child-Pugh Class Bafter cardiac surgery and critically ill patients with a starting infusion rate of 0.

The standard initial dosage recommendations for use in adults are applicable to elderly patients. Limited data from a prospective clinical study in 18 children neonates to 16 years old and published data is available.

The safe and effective dose or the effective target range for aPTT or activated clotting arvatroban ACT of Exembol Multidose has not been clearly established in this patient population Currently available data are described in Section 5.

The standard initial dosage recommendations for use in adults are applicable to patients with renal impairment see section 5. Limited packaeg is available from the use of Exembol Multidose in haemodialysis. The infusion is stopped 1 hour before the end of the procedure. The target ACT range is seconds measured using the Haemotec device. Exembol Multidose clearance by high flux membranes used during haemodialysis and continuous venovenous haemofiltration was clinically insignificant.

For patients with moderate hepatic impairment Child-Pugh Class Ban initial dose of 0. The aPTT should be monitored closely and the dosage should be adjusted as indicated clinically. Exembol Multidose is contra-indicated in patients with severely impaired liver function. Based on the data therapy could be initiated with a starting infusion rate of 0.

The clinical status of the patient, especially acute changes in hepatic function, should be taken into account and the infusion rate should be carefully adjusted to maintain the aPTT in the desired range. An increase in the frequency of monitoring is recommended to ensure the target aPTT values are achieved and maintained. ACT should be checked 5 to 10 minutes after the bolus dose is completed. The procedure may proceed if the ACT is greater than sec. Once a therapeutic ACT between to sec has been achieved, the infusion dose should be continued for the duration of the procedure.

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ACT measurements were recorded using both Haemotec and Haemochrom devices.

Specific dosing information on patients with hepatic impairment undergoing PCI is not available. Therefore, the use of Exembol Multidose for treatment of patients with hepatic impairment requiring PCI is not recommended.

Use of oral anticoagulants of the coumarin type should be delayed until substantial resolution of thrombocytopaenia e. The intended maintenance atgatroban should be started with no loading dose. Co-administration of Exembol Multidose and oral anticoagulants of the coumarin type produces an additive effect on the INR when the Quick type PT assay is used.

When an Owren PT type assay is used the plasma samples is considerably diluted prior to analysis and the recommendations below should be considered:. The arvatroban value for INR on co- therapy should be as recommended for the oral anticoagulant alone i. Co-therapy of Exembol Multidose and oral anticoagulants of the coumarin type is recommended for a minimum of 5 packwge. INR should be measured daily while Exembol Multidose and oral anticoagulants are co-administered.

The target value for INR should be within the therapeutic range for co-therapy according to the type of assay used see above for at least 2 days before Exembol Multidose is discontinued.

If the repeat INR is below the desired therapeutic range, the infusion of Exembol Multidose should be resumed and the procedure repeated daily until the desired therapeutic range on oral anticoagulants alone is reached. Exembol Multidose causes a generally increased tendency to bleeding. An unexplained fall in haematocrit, fall in blood pressure, or any other unexplained symptom should lead to consideration of a haemorrhagic event.

Exembol Multidose should be used with extreme caution in disease states and other circumstances in which there is an increased danger of haemorrhage. These include treatment for severe hypertension; diabetic argartoban immediately following lumbar puncture; spinal anaesthesia; major surgery, insegt involving the brain, spinal cord, or eye; haematological conditions associated with increased bleeding tendencies such as congenital or acquired bleeding disorders and gastrointestinal lesions such as ulcerations.

All parenteral anticoagulants should be discontinued before administration of Exembol Multidose. When Exembol Multidose is inesrt be started after cessation pzckage heparin therapy, sufficient time should be allowed for the effect of heparin on the aPTT to decrease prior to start of Exembol Multidose therapy aratroban hours.

Caution should be exercised when administering Exembol Multidose to patients with hepatic disease, by starting with a lower dose and carefully titrating until the desired level of anticoagulation is achieved see section 4. Also, upon cessation of Exembol Multidose infusion in the hepatically-impaired patient, full reversal of anticoagulant effects may require longer than 4 hours due to decreased clearance of argatroban.

Measurements of aPTT are recommended for monitoring the infusion. Although other plasma coagulation tests including prothrombin time PT, expressed for example as the International Normalized Ratio INRthe activated clotting time ACT and thrombin time TT are affected by Exembol Multidose; the therapeutic ranges for these tests have not pacjage defined with the exception of ACT Plasma argatroban concentrations also correlate well with the anticoagulant effects. The concomitant use of Exembol Multidose and oral anticoagulants of the coumarin pacckage may result in prolongation of the PT INR beyond that produced packags oral anticoagulants alone.

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Refer to section 4. Exembol Multidose contains ethanol.

[Full text] Update on argatroban for the prophylaxis and treatment of heparin-indu | JBM

This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not use this medicinal product. Concomitant use with argxtroban agents, thrombolytics, and other anticoagulants may increase the insetr of bleeding.

Oral anticoagulant agent s: Pharmacokinetic drug interactions between Exembol Multidose and warfarin 7. However, the concomitant use of Exembol Multidose and warfarin Thrombolytics, anti-platelet and other agents: The safety and effectiveness of Exembol Multidose with thrombolytic agents have not argatroba established. The risks for interaction with argatroban have not been evaluated. Caution is needed when concomitant medicinal products are commenced for the first time.

As Exembol Multidose contains ethanol, an interaction with metronidazol or disulfiram cannot be excluded. There are no adequate data from the use of Exembol Multidose in pregnant women.

The effect of argatroban on reproduction has been incompletely studied in animal experiments, as technical issues have limited systemic exposure see section 5. The increased bleeding risk with Exembol Multidose may constitute a risk in treatment during pregnancy. Exembol Multidose pzckage be used during pregnancy only if treatment is clearly necessary. Animal studies using radiolabelled argatroban have shown that radioactivity reaches greater levels in breast milk than in maternal blood.

In theory, the packagf of ethanol in the formulation 1 g per vial may impair the patient’s unsert to drive or operate machinery. However, this is unlikely to be of clinical relevance in patients receiving Exembol Multidose. Bleeding complications, as is to be expected given the pharmacological argatrobaan, constitute the main adverse events.

The incidence of major bleeds was almost three times higher in those patients in whom the aPTT level exceeded more than three times packqge baseline value than in those whose aPTT was within the therapeutic range. The incidence of adverse reactions in clinical trials patients with HIT Type II which are considered to be possibly related to Exembol Multidose is stated below.

Infection, urinary tract infection. Blood and lymphatic system disorders. Dizziness, headache, syncope, cerebrovascular accident, hypotonia, speech disorder. Ear and labyrinth disorders. Atrial fibrillation, tachycardia, cardiac arrest, myocardial infarction, arrhythmia supraventricular, pericardial effusion, ventricular tachycardia, hypertension, hypotension. Respiratory,thoracic and mediastinal disorders.

Hypoxia, pulmonary embolism, dyspnoea, pulmonary haemorrhage, pleural effusion, hiccups. Vomiting, constipation, diarrhoea, gastritis, gastrointestinal haemorrhage, melaena, dysphagia, tongue disorder.

Hepatic function abnormal, hyperbilirubinaemia, hepatic failure, hepatomegaly, jaundice. Skin and subcutaneous tissue disorders. Musculoskeletal and connective tissue disorders.

Renal and urinary disorders. General disorders and administration site conditions. Pyrexia, pain, fatigue, application site reaction, injection site reaction, oedema peripheral.

Prothrombin complex level decreased, coagulation factor decreased, coagulation time prolonged, aspartate aminotransferase increased, alanine aminotransferase increased, blood alkaline phosphatase inert, blood lactate dehydrogenase increased.

Injury and poisoning innsert procedural complications. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Excessive anticoagulation, with or without bleeding, may be controlled by discontinuing Exembol Multidose or by decreasing the infusion rate.

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