Use of the drug , as well as other anticoagulants is recommended with caution in conditions characterized by an increased risk of bleeding. During therapy with primobolan for womenpossible development of different localization of bleeding. Reducing the concentration of hemoglobin and / or hematocrit in the blood are associated with lower blood pressure, is the basis for the search for the source of bleeding.
Treatment with requires monitoring anticoagulant activity. The test for determining the should not be used because there is evidence falsely elevated .
To detect excessive dabigatran anticoagulant activity should use the tests to determine the thrombin clotting time or ekarinovogo. In the case where these tests are not available to be used to determine the test.
In a study in atrial fibrillation patsentov excess aPTT levels 2-3 times higher than the normal limit before taking the next dose of the drug was associated with an increased risk of bleeding.
In pharmacokinetic studies shown that in patients with reduced renal function (including elderly patients), there is increasing exposure of the drug. Use of the drug is contraindicated in case of PRADAKSA severe impaired renal function (creatinine clearance <30 mL / min).
In the case of acute renal failure drug should be discontinued.
By increasing the concentration dagibatrana following factors may result in a plasma decrease in renal function (creatinine clearance of 30-50 ml / min) age ≥75 years, the simultaneous use of an inhibitor of P-glycoprotein. The presence of one or more of these factors may increase the risk of bleeding (see. “Dosage and Administration” section).
Not studied, but may increase the risk of bleeding, the simultaneous use of the drug PRADAKSA with the following drugs: unfractionated heparin (with the exception of doses required to maintain patency of venous or arterial catheter) and derivatives of heparin, low molecular weight heparins (LMWH), fondaparinux sodium, thrombolytic drugs, blockers glycoprotein GP IIb / IIIa platelet receptors, ticlopidine, dextran, rivaroxaban, ticagrelor, vitamin K antagonists and inhibitors of P-glycoprotein (itraconazole, tacrolimus, cyclosporine, ritonavir, nelfinavir and saquinavir). The risk of bleeding is increased in patients concurrently taking selective serotonin reuptake inhibitor. Also, the risk of bleeding may be increased, while the use of antiplatelet agents and anticoagulants.
The combined use of dronedarone and dabigatran is not recommended (see. “Vzamodeystviya section with other medicinal products”).
When the risk of bleeding (for example, the recent biopsy or undergoing extensive trauma, bacterial endocarditis) requires monitoring of the patient for the purpose of early detection of signs of bleeding.
Prevention of venous thromboembolism in patients undergoing orthopedic surgery
It was found that the use of for short-term anesthesia in surgical interventions at the same time with the preparation primobolan for women not accompanied by an increased risk of bleeding. There are limited data on the regular use of NSAIDs (with T1 / 2 of less than 12 hours) on the background of treatment PRADAKSA, to increase the risk of bleeding data received.
Prevention of stroke, systemic thromboembolism and reduced cardiovascular mortality in patients with atrial fibrillation
The simultaneous use, antiplatelet therapy (including ASA and clopidogrel) and increases the risk of bleeding.
The use of fibrinolytic agents can be considered only if the TV parameters, or patient does not exceed the upper limit of normal range of the local reference.
Interaction with inducers of P-glycoprotein
Application inside together with the P-glycoprotein inducer rifampicin reduces dabigatran concentration in plasma. It is expected that other inducers of P-glycoprotein, such as St. John’s wort, or carbamazepine, may also reduce the concentration of dabigatran in plasma and should be used with caution (see. “Interaction with other medicinal products” section).
Surgical intervention operations and
Patients who use the drug during surgery or invasive procedures, the risk of bleeding. Therefore, during surgery should be canceled primobolan for women drug (see. Also “Pharmacokinetics” section).
Before performing invasive procedures or surgeries preparation cancel at least 24 hours in advance. In patients with an increased risk of bleeding or prior to major surgery requiring complete hemostasis, should be discontinued drug 2-4 days before surgery. In patients with renal insufficiency, the clearance of dabigatran may be extended.
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