Pradaxa Capsules, box, 30 pcs., 110 mg, for oral administration


Pradaxa Capsules, box, 30 pcs., 110 mg, for oral administration

Directions for use and doses

Capsules should be taken orally, 1 or 2 times a day, regardless of meal time, with a glass of water to facilitate the passage of the drug into the stomach. The capsule should not be opened. To remove capsules from a blister: - tear off one individual blister from the blister package along the perforation line, - remove the capsule from the blister, peeling off the foil, - do not squeeze the capsules through the foil. The drug is prescribed to adults. Prevention of venous thromboembolism (VTE) in patients after orthopedic surgery: the recommended dose is 220 mg 1 time / day (2 capsules of 110 mg). In patients with moderate renal impairment due to the risk of bleeding, the recommended dose is 150 mg 1 time / day (2 capsules of 75 mg). Prevention of VTE after knee replacement: use of Pradaxa; should begin 1-4 hours after completion of the operation with a dose of 110 mg (1 capsule), followed by an increase in the dose to 220 mg (2 capsules)/day 1 time/day over the next 10 days. If hemostasis is not achieved, treatment should be delayed. If treatment has not started on the day of surgery, therapy should begin with 220 mg (2 caps.)/day 1 time/day. Prevention of VTE after hip replacement: use of Pradaxa; should begin 1-4 hours after completion of the operation with a dose of 110 mg (1 caps.), followed by an increase in the dose to 220 mg (2 caps.)/day 1 time/day over the next 28-35 days. If hemostasis is not achieved, treatment should be delayed. If treatment has not started on the day of surgery, therapy should begin with 220 mg (2 caps.)/day 1 time/day. Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: the use of Pradaxa is recommended; in a daily dose of 300 mg (1 capsule of 150 mg 2 times a day). Therapy must be continued for life. Treatment of acute DVT and/or PE and prevention of deaths caused by these diseases: the use of Pradaxa is recommended; in a daily dose of 300 mg (1 capsule of 150 mg 2 times a day) after parenteral anticoagulant treatment for at least 5 days. Therapy should be continued for up to 6 months. Prevention of recurrent DVT and/or PE and deaths caused by these diseases: the use of Pradaxa is recommended; in a daily dose of 300 mg (1 capsule of 150 mg 2 times a day). Therapy can be continued for life, depending on individual risk factors. Use in patients with impaired renal function: Before therapy, in order to avoid prescribing the drug to patients with severely impaired renal function (creatinine clearance less than 30 ml/min), it is necessary to first evaluate the plasmatic clearance. Due to the lack of data on the use of the drug in patients with severe renal impairment (creatinine clearance less than 30 ml/min), the use of Pradaxa; contraindicated. Renal function should be assessed during treatment when there is a suspicion of a possible decrease or deterioration in renal function (for example, with hypovolemia, dehydration, simultaneous use of certain medications). During clinical trials of the drug Pradaxa; Calculation of QC using the Cockroft-Gault formula was used as a method for assessing renal function. Dabigatran is eliminated by hemodialysis, but clinical experience with hemodialysis patients is limited. When using the drug Pradaxa; in order to prevent venous thromboembolism in patients after orthopedic surgery with moderate renal dysfunction (creatinine clearance 30-50 ml/min), the daily dose should be reduced to 150 mg (2 capsules of 75 mg 1 time/day). When using the drug Pradaxa; for the purpose of preventing stroke, systemic thromboembolism and reducing cardiovascular mortality in patients with atrial fibrillation with moderate renal impairment (creatinine clearance 30-50 ml/min), no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day). Renal function should be assessed at least once a year. When using the drug Pradaxa; for the treatment of acute DVT and/or PE and the prevention of deaths caused by these diseases, no dose adjustment is required in patients with CC greater than 30 ml/min. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day). When using the drug Pradaxa; in order to prevent recurrent DVT and/or PE and deaths caused by these diseases, no dose adjustment is required in patients with moderate renal impairment (creatinine clearance 30-50 ml/min). It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day). Renal function should be assessed at least once a year. Use in elderly patients: Due to the fact that increased drug exposure in elderly patients (over 75 years of age) is often due to decreased renal function, renal function should be assessed before prescribing the drug. Renal function should be assessed at least once a year or more frequently depending on the clinical situation. Dose adjustments should be made depending on the severity of renal dysfunction. Prevention of venous thromboembolism after orthopedic surgery in patients over 75 years of age: experience is limited. The recommended dose is 150 mg (2 capsules of 75 mg once). When using the drug Pradaxa; in patients over 80 years of age for the purpose of preventing stroke, systemic thromboembolism and reducing cardiovascular mortality in patients with atrial fibrillation, Pradaxa; should be taken in a daily dose of 220 mg (1 capsule of 110 mg 2 times a day). Treatment of acute DVT and/or PE and prevention of deaths caused by these diseases in patients over 75 years of age: no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day). Prevention of recurrent DVT and/or PE and deaths caused by these diseases in patients over 75 years of age: no dose adjustment required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day). Use in children: In patients under 18 years of age, the effectiveness and safety of Pradaxa; have not been studied, so use of the drug in children is not recommended. Patients with different body weights: There is limited experience with the prevention of venous thromboembolism after orthopedic surgery in patients weighing less than 50 kg and more than 110 kg. In accordance with pharmacokinetic and clinical data, no dose adjustment is required. However, monitoring of such patients is recommended. Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: according to pharmacokinetic and clinical data, no dose adjustment is required. However, observation is recommended for patients weighing less than 50 kg. Treatment of acute DVT and/or PE and prevention of deaths caused by these diseases: no dose adjustment is required based on body weight. Prevention of recurrent DVT and/or PE and deaths caused by these diseases: no dose adjustment is required based on body weight. Concomitant use of Pradaxa; with active P-glycoprotein inhibitors (amiodarone, quinidine, verapamil) Prevention of venous thromboembolism after orthopedic surgery: when used simultaneously with amiodarone, quinidine or verapamil, a dose of Pradaxa; should be reduced to 150 mg 1 time / day (2 capsules of 75 mg). Patients taking Pradaxa; after orthopedic operations, it is not recommended to simultaneously start using verapamil and connect it to therapy in the future. Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: no dose adjustment is required; it is recommended to use the drug in a daily dose of 300 mg (1 capsule of 150 mg 2 times a day). Treatment of acute DVT and/or PE and prevention of deaths caused by these diseases: no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day). Prevention of recurrent DVT and/or PE and deaths caused by these diseases: no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day). Use in patients at increased risk of bleeding: Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: the presence of factors such as age 75 years or older, moderate decrease in renal function (creatinine clearance 30-50 ml/min), simultaneous the use of P-glycoprotein inhibitors, or a history of gastrointestinal bleeding may increase the risk of bleeding. In patients with one or more of these risk factors, at the discretion of the physician, the daily dose of Pradaxa may be reduced; up to 220 mg (1 capsule 110 mg 2 times a day). Treatment of acute DVT and/or PE and prevention of deaths caused by these diseases: the presence of factors such as age 75 years or older, moderately reduced renal function (creatinine clearance 30-50 ml/min) or a history of gastrointestinal bleeding may increase risk of bleeding. In patients with one risk factor, no dose adjustment is required. For patients with multiple risk factors, clinical data are limited. In such patients, the drug should be used only in cases where the expected benefit outweighs the risk of bleeding. Prevention of recurrent DVT and/or PE and deaths caused by these diseases: the presence of factors such as age 75 years or older, moderately reduced renal function (creatinine clearance 30-50 ml/min) or a history of gastrointestinal bleeding may increase the risk bleeding. In patients with one risk factor: no dose adjustment is required. For patients with multiple risk factors, clinical data are limited. In such patients, the drug should be used only in cases where the expected benefit outweighs the risk of bleeding. Switching from using Pradaxa; to the parenteral use of anticoagulants: Prevention of venous thromboembolism in patients after orthopedic surgery: parenteral administration of anticoagulants should begin 24 hours after taking the last dose of Pradaxa; Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: parenteral use of anticoagulants should begin 12 hours after taking the last dose of Pradaxa; Treatment of acute DVT and/or PE and prevention of deaths caused by these diseases: parenteral anticoagulants should be started 12 hours after the last dose of Pradaxa. Prevention of recurrent DVT and/or PE and deaths caused by these diseases: parenteral anticoagulants should be started 12 hours after the last dose of Pradaxa. Transition from parenteral use of anticoagulants to the use of Pradaxa;: First dose of Pradaxa; is prescribed instead of a discontinued anticoagulant in the interval 0-2 hours before the next injection of alternative therapy or simultaneously with the cessation of continuous infusion (for example, intravenous use of unfractionated heparin). Transition from the use of vitamin K antagonists to the use of Pradaxa;: Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: the use of vitamin K antagonists is discontinued, the use of Pradaxa; possible with MHO less than 2.0. Treatment of acute DVT and/or PE and prevention of deaths caused by these diseases: the use of vitamin K antagonists is stopped, the use of Pradaxa; possible with MHO less than 2.0. Prevention of recurrent DVT and/or PE and deaths caused by these diseases: the use of vitamin K antagonists is stopped, the use of Pradaxa; possible with MHO less than 2.0. Switching from using Pradaxa; to the use of vitamin K antagonists: Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: with CC ≥50 ml/min, the use of vitamin K antagonists is possible within 3 days, and with CC 30-50 ml/min - within 2 days before stopping Pradaxa; Treatment of acute DVT and/or PE and prevention of deaths caused by these diseases: with CC ≥50 ml/min, the use of vitamin K antagonists is possible 3 days, and with CC 30-50 ml/min - 2 days before discontinuation of Pradaxa; . Prevention of recurrent DVT and/or PE and deaths caused by these diseases: with CC ≥50 ml/min, the use of vitamin K antagonists is possible 3 days, and with CC 30-50 ml/min - 2 days before discontinuation of Pradaxa; Cardioversion: Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation. Performing elective or emergency cardioversion does not require discontinuation of Pradaxa therapy; Missed dose: Prevention of venous thromboembolism in patients after orthopedic surgery: It is recommended to take the usual daily dose of Pradaxa; at normal time the next day. If you miss individual doses, you should not take a double dose of the drug. Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: missed dose of Pradaxa; can be taken if there are 6 hours or more left before taking the next dose of the drug; if the period is less than 6 hours, the missed dose should not be taken. If you miss individual doses, you should not take a double dose of the drug. Treatment of acute DVT and/or PE and prevention of deaths caused by these diseases: missed dose of Pradaxa; can be taken if there are 6 hours or more left before taking the next dose of the drug; if the period is less than 6 hours, the missed dose should not be taken. If you miss individual doses, you should not take a double dose of the drug. Prevention of recurrent DVT and/or PE and deaths caused by these diseases: missed dose of Pradaxa; can be taken if there are 6 hours or more left before taking the next dose of the drug; if the period is less than 6 hours, the missed dose should not be taken. If you miss individual doses, you should not take a double dose of the drug.

PRADAXA

Directions for use and doses

Capsules should be taken orally, 1 or 2 times a day, regardless of meal time, with a glass of water to facilitate the passage of the drug into the stomach.
The capsule should not be opened. Special instructions when removing capsules from the blister:

— tear off one individual blister from the blister pack along the perforation line;

- remove the capsule from the blister, peeling off the foil;

— do not squeeze capsules through the foil.

PRADAXA is available in 75 mg, 110 mg and 150 mg capsules.

Use in adults:

Prevention of venous thromboembolism (VTE) in patients after orthopedic surgery:

The recommended dose is 220 mg 1 time per day (2 capsules of 110 mg each).

In patients with moderate renal impairment

due to the risk of bleeding, the recommended dose is 150 mg 1 time per day (2 capsules of 75 mg).

Prevention of VTE after knee replacement:

The use of PRADAXA should begin 1-4 hours after completion of the operation with 1 capsule (110 mg), followed by an increase in dose to 2 capsules (220 mg) once a day over the next 10 days. If hemostasis is not achieved, treatment should be delayed. If treatment has not started on the day of surgery, therapy should begin with 2 capsules (220 mg) once a day.

Prevention of VTE after hip replacement:

The use of PRADAXA should begin 1-4 hours after completion of the operation with 1 capsule (110 mg), followed by an increase in dose to 2 capsules (220 mg) once a day over the next 28-35 days. If hemostasis is not achieved, treatment should be delayed. If treatment has not started on the day of surgery, therapy should begin with 2 capsules (220 mg) once a day.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

It is recommended to use PRADAXA in a daily dose of 300 mg (1 capsule of 150 mg 2 times a day). Therapy should continue for life.

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

It is recommended to use PRADAXA in a daily dose of 300 mg (1 capsule of 150 mg 2 times a day) after parenteral anticoagulant treatment for at least 5 days. Therapy should continue for up to 6 months.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

It is recommended to use PRADAXA in a daily dose of 300 mg (1 capsule of 150 mg 2 times a day). Therapy can be continued for life, depending on individual risk factors.

Use in special patient groups

Use in children

The effectiveness and safety of PRADAXA have not been studied in patients under 18 years of age, therefore use in children is not recommended (see section “Contraindications”).

Renal dysfunction

Before therapy, to avoid prescribing the drug to patients with severe renal impairment

(creatinine clearance less than 30 ml/min), it is necessary to first evaluate creatinine clearance. Due to the lack of data on the use of the drug in patients with severely impaired renal function (creatinine clearance less than 30 ml/min), the use of PRADAXA is contraindicated (see section “Contraindications”).

Renal function should be assessed during treatment when there is a suspicion of a possible decrease or deterioration in renal function (for example, with hypovolemia, dehydration, simultaneous use of certain medications, etc.).

During the clinical development of PRADAXA, the Cocroft-Gault method was used to assess renal function.

Dabigatran is eliminated by hemodialysis; however, clinical experience with hemodialysis patients is limited.

When using PRADAXA for the prevention of venous thromboembolism
in patients after orthopedic surgery
with moderate renal impairment (creatinine clearance 30 - 50 ml/min), the daily dose of the drug should be reduced to 150 mg (2 capsules of 75 mg 1 time per day).

When using PRADAXA to prevent stroke, systemic thromboembolism and reduce cardiovascular mortality in patients with atrial fibrillation

for
moderate
renal dysfunction (creatinine clearance 30 - 50 ml/min), no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day). Kidney function should be assessed at least once a year.

When using PRADAXA to treat acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevent deaths caused by these diseases

with CC ˃30 ml/min, no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day).

When using PRADAXA to prevent recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases,

for
moderate
renal dysfunction (creatinine clearance 30-50 ml/min), no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day). Kidney function should be assessed at least once a year.

Use in elderly patients

Due to the fact that increased drug exposure in elderly patients (over 75 years of age) is often due to decreased renal function, renal function should be assessed before prescribing the drug. Renal function should be assessed at least once a year or more frequently depending on the clinical situation. Dose adjustment of the drug should be carried out depending on the severity of renal dysfunction (see “Renal dysfunction”).

Prevention of venous thromboembolism in elderly patients (over 75 years of age) after orthopedic surgery:

Application experience is limited. The recommended dose is 150 mg (2 capsules of 75 mg once).

When using PRADAXA in elderly patients over 80 years of age to prevent stroke, systemic thromboembolism and reduce cardiovascular mortality in patients with atrial fibrillation

PRADAXA should be taken in a daily dose of 220 mg (1 capsule of 110 mg 2 times a day).

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases in patients over 75 years of age:

no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day).

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases in patients over 75 years of age:

no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day).

Effect of body weight

Prevention of venous thromboembolism (VTE) in patients after orthopedic surgery:

in patients weighing less than 50 kg and more than 110 kg, experience with use is limited. In accordance with pharmacokinetic and clinical data, no dose adjustment is required. However, it is recommended to monitor such patients.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

According to pharmacokinetic and clinical data, no dose adjustment is required. However, patients weighing less than 50 kg are recommended to be monitored.

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

no dose adjustment is required depending on body weight.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

no dose adjustment is required depending on body weight.

Concomitant use of PRADAXA with active P-glycoprotein inhibitors (amiodarone, quinidine, verapamil) for the prevention of venous thromboembolism in patients after orthopedic surgery:

When used concomitantly with amiodarone, quinidine or verapamil, the dose of PRADAXA should be reduced to 150 mg once a day (2 capsules of 75 mg) (see section “Interaction with other drugs”). Patients taking PRADAXA after orthopedic surgery are not recommended to start using verapamil at the same time and connect it to therapy in the future.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

no dose adjustment is required; patients are recommended to use the drug in a daily dose of 300 mg (1 capsule of 150 mg 2 times a day).

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day).

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day).

Use in patients at increased risk of bleeding

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

the presence of factors such as age 75 years or older, moderate decrease in renal function (creatinine clearance 30-50 ml/min), simultaneous use of P-glycoprotein inhibitors, antiplatelet agents, or a history of gastrointestinal bleeding may increase the risk of bleeding (see "Special Concerns" instructions"). In patients with one or more of these risk factors, at the discretion of the physician, the daily dose of PRADAXA may be reduced to 220 mg (take 1 capsule 110 mg 2 times a day).

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

the presence of factors such as age 75 years or older, moderate reduction in renal function (creatinine clearance 30-50 ml/min) or a history of gastrointestinal bleeding may increase the risk of bleeding (see "Special Instructions"). In patients with one risk factor, no dose adjustment is required. For patients with multiple risk factors, clinical data are limited. In such patients, the drug should be used only in cases where the expected benefit outweighs the risk of bleeding.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

the presence of factors such as age 75 years or older, moderate reduction in renal function (creatinine clearance 30-50 ml/min) or a history of gastrointestinal bleeding may increase the risk of bleeding (see "Special Instructions"). In patients with one risk factor, no dose adjustment is required. For patients with multiple risk factors, clinical data are limited. In such patients, the drug should be used only in cases where the expected benefit outweighs the risk of bleeding.

Transition from the use of PRADAXA to parenteral use of anticoagulants

Prevention of venous thromboembolism in patients after orthopedic surgery:

Parenteral administration of anticoagulants should begin 24 hours after taking the last dose of PRADAXA.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

Parenteral use of anticoagulants should be started 12 hours after taking the last dose of PRADAXA.

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

Parenteral use of anticoagulants should be started 12 hours after taking the last dose of PRADAXA.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

Parenteral use of anticoagulants should be started 12 hours after taking the last dose of PRADAXA.

Transition from parenteral anticoagulants to PRADAXA

The first dose of PRADAXA is prescribed instead of the discontinued anticoagulant in the interval 0-2 hours before the next injection of alternative therapy or simultaneously with the cessation of a continuous infusion (for example, intravenous use of unfractionated heparin, UFH).

Switching from vitamin K antagonists to PRADAXA

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

the use of vitamin K antagonists is discontinued; the use of PRADAXA is possible when the INR is <2.0.

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

the use of vitamin K antagonists is discontinued; the use of PRADAXA is possible when the INR is <2.0.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

the use of vitamin K antagonists is discontinued; the use of PRADAXA is possible when the INR is <2.0.

Switching from PRADAXA to vitamin K antagonists

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

with creatinine clearance ≥50 ml/min, the use of vitamin K antagonists is possible 3 days, and with creatinine clearance 30-50 ml/min - 2 days before discontinuation of PRADAXA.

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

with creatinine clearance ≥50 ml/min, the use of vitamin K antagonists is possible 3 days, and with creatinine clearance 30-50 ml/min - 2 days before discontinuation of PRADAXA.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

with creatinine clearance ≥50 ml/min, the use of vitamin K antagonists is possible 3 days, and with creatinine clearance 30-50 ml/min - 2 days before discontinuation of PRADAXA.

Cardioversion

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation

Planned or emergency cardioversion does not require discontinuation of PRADAXA therapy.

Missed dose

Prevention of venous thromboembolism in patients after orthopedic surgery:

It is recommended that you take your usual daily dose of PRADAXA at ​​your usual time the next day. If you miss individual doses, you should not take a double dose of the drug.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

a missed dose of PRADAXA can be taken if there are 6 hours or more left before taking the next dose of the drug; If the period is less than 6 hours, the missed dose should not be taken. If you miss individual doses, you should not take a double dose of the drug.

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

a missed dose of PRADAXA can be taken if there are 6 hours or more left before taking the next dose of the drug; If the period is less than 6 hours, the missed dose should not be taken. If you miss individual doses, you should not take a double dose of the drug.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

a missed dose of PRADAXA can be taken if there are 6 hours or more left before taking the next dose of the drug; If the period is less than 6 hours, the missed dose should not be taken. If you miss individual doses, you should not take a double dose of the drug.

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