Pradaxa hard capsules 150mg Boehringer prevent stroke, stroke (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Dabigatran ether

Ingredient

Composition information	Content
Dabigatran ether	150mg

Uses

Indications

Pradaxa drug are indicated in the following cases:

Prevention of venous thrombosis events (TTHKTM) in adult patients undergo surgery to replace the entire hip or knee joint. 75, heart failure (classification of NYHA 2 degrees II), diabetes , hypertension.

Treatment of deep vein thrombosis (DVT) (DVT) and/or pulmonary embolism (PE) and related deaths. EtriIlat is a small molecule with a small molecule and has no pharmacological effects. After drinking, Dabigatran Ethilat is quickly absorbed and transformed into Dabigatran thanks to the hydrolysis of the esterase in plasma and liver, dabigatran is a direct, recovery, strong and competitive thread inhibitor and is a major active substance in plasma.

Due to thrombin (serine protease) helps convert fibrinogen into fibrin during blood clotting, use thrombin inhibitors that will prevent the formation of blood clots, dabigatran also inhibit the free thrombin, thrombin linked to fibrin and platelet binding by thrombin.

pharmacokinetic

absorption

After taking Pradaxa in healthy volunteers, Dabigatran's pharmacokinetics characteristics in plasma are characterized by rapid increase in plasma concentrations with C Max achieved within 0.5 and 2.0 hours after drinking.

cmax, AUC is proportional to the dose. After CMAX, Dabigatran's plasma concentration decreases with a double exponential jaw with the average selling time of the last phase of about 11 hours in healthy elderly people. After multi -dose use, the final waste time was recorded at about 12-14 hours. The selling time does not depend on the dose. However, the sale time is prolonged if the renal function decreases.

The absolute bioavailability of Dabigatran Etrixilate with HPMC capsule cover is approximately 6.5%. Food does not affect the bioavailability of Dabigatran but delays the time to achieve the peak concentration in plasma for about 2 hours.

Oral bioavailability may increase by about 1.4 times (+37%) compared to the reference capsule formula when small particles used without HPIMC shell. Therefore, clinically. It is necessary to always protect the intactness of the HPMC capsule to avoid unintentionally enhancing the bioavailability of Dabigatran Exethat. Therefore, it is recommended that patients do not open capsules and avoid drinking drugs that are not surrounded (for example, sprinkle drugs in food or put in drinks) (see "dosage and use").

Distribution

The cohesion of dabigatran in human plasma is low (34 - 35%) and does not depend on the concentration. Dabigatran's distribution volume is about 60 - 70 l in excess of the water volume of the whole body showing the drug distributed into the tissue at an average level.

Metabolism and elimination

Dabigatran was studied after taking a single -dose of intravenously marked with radioactive isotopes in healthy men. After a dose of intravenous injection, Dabigatran has radioactive activity excreted mainly through the kidney (85%). About 6% of the dose is eliminated through feces. About 88 - 94% of the dose marking radio isotopes are collected after 168 hours of medication. After drinking, Dabigatran Ethilat quickly turned into Dabigatran, the form of active in plasma. The process of converting Dabigatran Edexilat into the main active ingredient Dabigatran thanks to the esterase hydrolysis catalyst is a major metabolic reaction, Dabigatran is an easy -to -combination substance that forms acylglucuronides with pharmacological activity. There are 4 components of the location, 1 - O, 2 - O, 3 - O, 4 - O - Acylglucuronide, each of which accounts for less than 10% of the total amount of dabigatran in plasma. The very small amount of other metabolites is only detected by highly sensitive analysis methods. Dabigatran is excreted mainly in a constant form in the urine at a speed of about 100 ml/min, corresponding to the speed of glomerular filtration.

Before taking Pradaxa hard capsules 150mg Boehringer prevent stroke, stroke (3 blisters x 10 tablets)

How to use

Should take pradaxa hard or not with food. Drink Pradaxa with a cup of water makes it easy to put the drug into the stomach. If the gastrointestinal symptoms appear, it is recommended to take a pradaxa with a meal and/or with a proton pump inhibitor like pantoprazole .

Do not open capsules.

Dosage

Adults

Prevention of TTHKTM complications in patients after surgery the program replaces the entire hip or knee joint

Prevention of venous thrombosis events (TTHKTM) after knee replacement surgery: should start treatment with oral pradaxa within 1-4 hours after the surgery with a single capsule (110 mg) then continue taking 2 capsules once a day for a total of 10 days. If the hemostasis is not guaranteed, it is advisable to delay the beginning of treatment. If you do not start taking the medication on the day of the surgery, you should start treatment later with 2 capsules, once a day. If the hemostasis is not guaranteed, it is advisable to delay the beginning of treatment. If you do not start taking the medication on the day of the surgery, you should start treatment later with 2 capsules, once a day.

Preventing stroke, systematic system embolism in adult patients with atrial fibrillation without valve disease (NVAF) has one or more risk factors (Spaf)

The daily dosage of Pradaxa is 300 mg, oral with hard capsules 150 mg twice daily. Treatment for a long time.

Treatment of deep vein thrombosis (DVT) (DVT) and/or pulmonary embolism (PE) and related death: The daily dose of Pradaxa is 300 mg oral with hard capsules 150 mg twice a day after treatment with an anticoagulant drug for at least 5 days. Treatment should be continued until 6 months.

Reduce the risk of deep vein recurrence (DVT) and pulmonary embolism (PE) in patients who have been previously treated: the daily dose of Pradaxa is 300 mg, oral with hard capsules 150mg twice daily. Treatment may last depending on the risk of each patient.

Children

Prevention of TTHKTM complications in patients after surgery the program replaces the entire hip or knee joint

Pradaxa has not been studied in patients

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to valve disease (NVAF) has one or more risk factors (Spae)

Pradaxa has not been studied in patients

Deep venous thrombosis (DVT) cable and pulmonary embolism (PE) and related deaths

has not established safety and efficiency in children. Do not recommend Pradaxa treatment in children.

Reduce the risk of deep vein recurrence (DVT) and pulmonary embolism (PE) in patients who have been previously treated.

has not established safety and efficiency in children. It is not recommended for Pradaxa treatment in children.

kidney failure

It is advisable to evaluate the kidney function by determining the clearance of creatinine (CrCl) before starting treatment with pradaxa to avoid treating patients with severe renal impairment (for example, CrCl

During treatment, kidney function should be assessed in some clinical cases when suspected kidney function may decrease or worsen (for example, reducing the volume of circulatory, dehydration, and with some simultaneous medications, etc.).

Dabigatran can be appraised: There is very little clinical experience showing the usefulness of this method in clinical studies.

Prevention of TTHKTM complications in patients after surgery the program replaces the entire hip or knee joint

Should reduce the dose of pradaxa to 150 mg once a day, use 2 capsules 75 mg in patients with medium renal impairment (clearly 30 - 50 ml/minute creatinine clearance).

should start treatment with oral Pradaxa within 1-4 hours after the surgery with a single capsule 75 mg and then continue taking 2 75 mg capsules in a total of 10 days (for knee replacement surgery) or 28 - 35 days (for hip replacement surgery).

For both cases of surgery, if the hemostasis is not guaranteed, it is advisable to delay the beginning of treatment. If you do not start taking the medication on the day of the surgery, you should start treatment later with 2 capsules a day.

Preventing stroke, systematic system embolism in adult patients with atrial fibrillation without valve disease (NVAF) has one or more risk factors (Spaf)

In patients with average renal impairment (CrCl 30 - 50 ml/minute), renal function should be evaluated at least once a year.

does not need to adjust the dose, patients should be treated with daily dose of 300mg oral with hard capsules 150 mg twice daily.

However, in patients at high risk of bleeding, considering reducing the dose of Pradaxa to 220 mg by taking 1 capsule 110 mg twice daily (see the section "Special and cautious warning" and the "pharmacokinetic" section). Clinically closely monitoring recommendations in patients with renal impairment.

Excessive venous thrombotic treatment (DVT) and/or pulmonary embolism (PE) and related death prevention

There is no need to adjust the dose in patients with CC CrCl> 30 ml/minute. Patients should be used at daily doses of 300 mg oral with hard capsules 150 mg twice daily.

Reduce the risk of deep vein recurrence (DVT) and pulmonary embolism (PE) in patients who have been previously treated.

In patients with average renal impairment (CrCl 30 - 50 ml/minute), renal function should be evaluated at least once a year. It is not necessary to adjust the dose in patients with renal impairment with CrCl> 30 ml/min. Patients should be used at daily doses of 300 mg oral with hard capsules 150 mg twice daily.

However, in patients at high risk of bleeding, considering reducing the dose of Pradaxa to 220 mg by taking 1 capsule 110 mg twice daily (see the "Special and Caution Warning" and the "Mobile Pharmacokinetic" section). Clinically closely monitoring recommendations in patients with renal impairment.

Elderly

Prevention of TTHKTM complications in patients after surgery the program replaces the entire hip or knee joint

Clinical experience and use of drugs for elderly patients (> 75 years old) are still limited. Should be cautious when treating this patient. The recommended dose is 150 mg daily in the form of 2 capsules of 75 mg (see the "special and cautious warning" and "Pharmacological Characteristics").

Due to the more common impaired renal function in the elderly (> 75 years old), the kidney function should be evaluated by determining the clear clearance of creatine (CrCl) before starting treatment with pradaxa to avoid treatment for patients with severe renal impairment (ie CrCl

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to valve disease (NVAF) has one or more risk factors (Spaf)

Due to the more common impaired renal function in the elderly (> 75 years old), the kidney function should be evaluated by determining the clearance of creatinine (CrCl) before starting treatment with pradaxa to avoid treating patients with severe renal impairment (ie CrCl

Patients 80 years old or older should be treated at daily doses of 220 mg oral with hard capsules 110 mg twice daily.

Excessive and//pulmonary thrombosis (PE) and pulmonary embolism (PE) and relevant deaths or reducing the risk of deep vein recurrence (DVT) and pulmonary embolism (PE) in patients who have been previously treated.

Due to the common impairment of kidney function, it may be common in the elderly (> 75 years old), it is advisable to assess the kidney function by determining the clearance of creatinine (CrCl) before starting treatment with pradaxa to avoid treatment for patients with severe renal impairment (CrCl

Patients from 75 - 80 years old should be treated with daily doses of 300 mg with 1 capsule 150 mg twice daily. When the risk of embolism is low and the risk of bleeding is high, the dose of 220 mg may be considered with 1 capsule 110 mg twice daily depending on the case as directed by the doctor (see the section "Special and cautious warning").

Patients 80 years old or older should be treated with daily doses of 220 mg oral with hard capsules 110 mg twice daily.

liver failure

Prevention of TTHKTM complications in patients after surgery the program replaces the entire hip or knee joint

Patients with high liver enzymes> 2 times the upper limit of normal value (ULN) is excluded in clinical trials to prevent TTTM (VTE) in patients after surgery to replace hip or knee joints. There is no treatment experience in this group of patients, so it is not recommended to use Pradaxa (see the "Special and Caution Warning" and "Dynamic pharmacokinetics"). Contraindicated in the case of liver failure or liver disease that affects life (see the "Contraindications" section).

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to valve disease (NVAF) has one or more risk factors (Spaf)

Patients with high liver enzymes> 2 times the upper limit of normal value (ULN) has been excluded in the main clinical trials. There is no treatment experience in this group of patients, so it is not recommended to use Pradaxa (see the "Special and Caution Warning" and "Dynamic pharmacokinetics"). Contraindicated in the case of liver failure or liver disease that affects life (see the "Contraindications" section).

Patients with high liver enzymes> 2 times the upper limit of the normal value (ULN) has been excluded in the main clinical trials, without treatment experience in this group of patients, so it is not recommended to use Pradaxa (see the "Special and Cautrass Warning" and "Dynamic pharmacokinetics"). Contraindicated in the case of liver failure or liver disease that affects life (see the "Contraindications" section).

weight

Prevention of TTHKTM complications in patients after surgery the program replaces the entire hip or knee joint

Clinical experience treatment in patients weighing 110 kg is very limited.

There is no need to adjust the dose based on clinical data and existing dynamic data (see the "pharmacokinetic" section), but the clinical closely monitoring recommends (see the section "Special and Caution Warning).

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to valve disease (NVAF) has one or more risk factors (Spaf)

There is no need to adjust the dose based on the available clinical data and dynamic data (see the "pharmacokinetic" section), but the clinical closely monitoring recommends in the patient's subject weighs

simultaneously use pradaxax with strong inhibitors P - Glycoprotein, for example amlodaron, quinidine or verapamil

Prevention of TTHKTM complications in patients after surgery the program replaces the entire hip or knee joint

Should reduce the dose of pradaxa to 150 mg once daily with 2 75 mg capsules in patients with simultaneous use of pradaxa and amiodarone, quinidine or verapamil (see "drug interaction").

Avoid starting to treat Verapamil in patients after surgery to replace the entire hip or knee joints that are using Pradaxa. Also avoid starting treatment simultaneously Pradaxa with Verapamil.

For both surgical cases, if the hemostatic is not guaranteed, it is advisable to delay the beginning of treatment. If you do not start taking the medication on the day of the surgery, you should start treatment later with 2 capsules a day.

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to valve disease (NVAF) has one or more risk factors (Spaf)

No need to adjust the dose, patients should treat daily dose 300 mg oral with hard capsules 150 mg twice daily.

Excessive and//pulmonary thrombosis treatment (DVT) and pulmonary embolism (PE) and related deaths

No need to adjust the dose, patients should be used in daily dose of 300 mg oral with hard capsules 150 mg twice daily.

Reduce the risk of deep vein recurrence (DVT) and pulmonary embolism (PE) in patients who have been previously treated.

No need to adjust the dose, patients should be used in daily dose of 300 mg oral with hard capsules 150 mg twice daily.

Patients at risk of bleeding

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to valve disease (NVAF) has one or more risk factors (Spaf)

The appearance of the following factors can increase the risk of bleeding: For example, age ≥ 75, average renal failure (CrCl 30 - 50 ml/min), simultaneous treatment with strong p - GP inhibitors (see "special patient group"), anti -platelet collection or stomach bleeding - previous bowel (see "special and cautious warning").

For patients with one or more than one of those risk factors, reducing daily dose to 220 mg, by taking 110 mg twice a day, can be considered as a doctor's decision.

Excessive and//pulmonary thrombosis treatment (DVT) and pulmonary embolism (PE) and related deaths

The appearance of the following factors may increase the risk of bleeding: for example, age ≥75, average renal failure (crCl 30 - 50 ml/minute), or have a history of stomach -intestinal bleeding (see "special caution and warning"). It is not necessary to adjust the dose in patients with a risk factor.

Clinical data is limited in patients with many risk factors.

In this group of patients, Pradaxa should only be used when the expected benefits outperform the risk of bleeding.

Reduce the risk of deep vein recurrence (DVT) and pulmonary embolism (PE) in those treated patients.

The appearance of the following factors may increase the risk of bleeding: for example, age ≥ 75, average renal failure (CrCl 30 - 50 ml/minute), or have a history of stomach -intestinal bleeding (see "special caution and warning"). It is not necessary to adjust the dose in patients with a risk factor.

Clinical data is limited in patients with many risk factors.

In this group of patients, Pradaxa should only be used when the expected benefits outperform the risk of bleeding.

switch from Pradaxa treatment to anticoagulant drugs

Prevention of TTHKTM complications in patients after surgery the program replaces the entire hip or knee joint

Wait 24 hours after the last dose before switching from treatment with Pradaxa to an anticoagulant drug.

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to valve disease (NVAF) has one or more risk factors (Spaf)

Wait 12 hours after the last dose before switching from treatment with Pradaxa to an anticoagulant drug.

Excessive venous thrombosis (DVT) (PE) and relevant lung obstruction (PE) and related death:

Wait 12 hours after the last dose before switching from treatment with Pradaxa to an anticoagulant drug.

Reduce the risk of deep vein recurrence (DVT) and pulmonary embolism (PE) in previous patients:

Wait 12 hours after the last dose before switching from treatment with Pradaxa to an anticoagulant drug.

switches from anticoagulant treatment to pradaxa

Use Pradaxa 0 - 2 hours before the next dose of the therapy, or at the time of stopping the drug in the case of continuous treatment (for example, intravenous heparin).

switches from treatment with vitamin K to Pradaxa

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to valve disease (NVAF) has one or more risk factors (Spaf)

Stop treatment with Vitamin K antagonistic (abbreviated VKA) Pradaxa can be used as soon as Inr

Excessive venous thrombosis (DVT) (PE) and pulmonary embolism (PE) and involved deaths

Stop treatment with antagonist vitamin K. Pradaxa can be used as soon as Inr

Reduce the risk of deep vein recurrence (DVT) and pulmonary embolism (PE) in those treated patients:

Stop treatment with antagonist vitamin K. Pradaxa can be used as soon as Inr

switches from Pradaxa treatment to vitamin K antagonists

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to valve disease (NVAF) has one or more risk factors (Spaf)

The time to start VKA treatment should be adjusted according to the patient's CrCl clearance as follows:

CrCl ≥ 50 ml/min, start using VKA 3 days before stopping using dabigatran ether.

CrCl ≥ 30 -

Excessive and//pulmonary thrombosis treatment (DVT) and pulmonary embolism (PE) and related deaths

The time to start VKA treatment should be adjusted according to the patient's CrCl clearance as follows:

CrCl ≥ 50 ml/min, start using VKA 3 days before stopping using dabigatran ether.

CrCl ≥ 30 -

Reduce the risk of deep vein recurrence (DVT) and pulmonary embolism (PE) in those treated patients:

The time to start VKA treatment should be adjusted according to the patient's CrCl clearance as follows:

CrCl ≥ 50 ml/minute, start using VKA 3 days before stopping using Dabigatran Etrixilat.

CrCl ≥ 30 -

rhythm

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to valve disease (NVAF) has one or more risk factors (Spaf)

Patients can continue to use Pradaxa while being switched.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Higher doses than recommended doses increase the risk of bleeding.

In case of an overdose suspected, blood clotting tests can help determine the risk of bleeding (see the "special caution and warning" and "pharmacological characteristics"). Check the calibration quantification or repeated DTT measurement method that allows the prediction of time when will reach dabigatran concentrations (see the "pharmacological characteristics" section), as well as in case of use of additional measures such as dialysis have been started.

may have to stop using Pradaxa when it has an excessive anticoagulant effect.

When there are complications of bleeding, it is necessary to stop treating and locate bleeding. Because Dabigatran is excreted mainly through the kidney, it is necessary to maintain the appropriate amount of urine.

Depending on the clinical situation, it is advisable to take appropriate standard treatments, such as hemostasis surgery and hematoma.

For situations that require quickly eliminate the effects of the drug, there should be specific antidote (Praxbind, Idarucizumab) against Pradaxa's learning power. (See "Special and cautious warning", "surgery and intervention procedure"; "The stage before surgery").

In addition, it is possible to consider the use of fresh blood or fresh frozen plasma.

Concentrated preparations contain coagulation factors (activated or inactive) or recombinant VLLA factors should be used together. There are some experimental evidence to support the role of these factors in reversing the effectiveness of Dabigatran's anticoagulant but their useful use has not been systematically proven. Blood coagulation tests may become unconcerned after reverse drugs are suggested.

Should be cautious for concentrated platelets in the event of a platelet deficiency or have been used for platelets with prolonged activity. All symptomatic treatment is made according to the doctor's decision.

Due to low protein links, Dabigatran may be appraised, but clinical experiences about dialysis use in this case are limited (see "special patient group").

What to do when forgetting 1 dose?

Continue with the remaining daily doses at the same time of the next day. Do not use double doses to compensate for individually forgotten doses.

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to valve disease (NVAF) has one or more risk factors (Spaf)

The forgotten dose of Pradaxa can be used if the next time when the next dose is more than 6 hours. Should ignore the forgotten dose if the time before the next dose is not exceeding 6 hours. Do not use double doses to compensate for individually forgotten doses.

Excessive and//pulmonary thrombosis treatment (DVT) and pulmonary embolism (PE) and related deaths

Reduce the risk of deep vein recurrence (DVT) and pulmonary embolism (PE) in patients who have been previously treated.

Side Effects

When using Pradaxa drug , you may experience unwanted effects (ADR).

Side effects are determined from:

Preventing the Prevention of TTH Technical Procedure after surgery to replace the entire hip or knee joint.

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to heart valve disease (NVAF) has one or more risk factors (Spaf).

Deep venous thrombosis (DVT) treatment (PE) and related deaths.

Reduce the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have been previously treated.

Blood and lymphatic disorders: Anemia , thrombocytopenia. Failure: Nose bleeding , coughing up blood.

Liver disorders: abnormalities of liver function.

Skin and tissue disorders: Skin hemorrhage.

Bone disorders, musculoskeletal and connective tissue: joint hematoma.

Systemic and urinary disorders: Hemorrhagic hemorrhage.

Systemic disorders and in use: Bleeding in the injection place, hemorrhage at the catheter placement.

Lesion, poisoning or complications after the procedure: bleeding due to trauma, bleeding at the incision.

Prevention of TTH Technology in patients after surgery the program replaces the entire hip or knee joint

vascular disorders: bleeding in the wound.

Systemic disorders and at the position of use: color secretion.

Lesion, poisoning or complications after the procedure: Hematoma after the procedure, bleeding after the procedure, postoperative anemia, secretion after the procedure, secretion wounds Risk factors (spab)

No.

Excessive and//pulmonary thrombosis treatment (DVT) and pulmonary embolism (PE) and related deaths

No.

Reduce the risk of deep vein recurrence (DVT) and pulmonary embolism (PE) in patients who have been previously treated.

No.

Instructions on how to handle ADR

Notify the doctor the unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Pradaxa drug contraindicated in the following cases:

Too hypersensitivity to dabigatran or datbigatian ether or one of the excipients of the drug.

Severe renal failure (CrCl

Symptoms of bleeding, patients with bleeding or reducing blood clotting due to drug or spontaneous use.

Loving or the conditions are considered to have a significant risk of heavy bleeding. This may include current or recent peptic ulcer, the appearance of malignant tumors is at high risk of bleeding, recent spinal or brain damage, recent brain, spinal or eye surgery, recent intracranial hemorrhage, esophageal varicose veins have known or suspected, venous dynamic deformities, blood vessels, or serious abnormalities in the spine or in the brain.

Simultaneous treatment with ketoconazole body, cyclosporin, iTraconazole and droneedaron.

Simultaneous treatment with other anticoagulants such as heparin (UFH), low molecular weight heparin (such as enoxaparin, dalteparin ), heparin derivatives (such as fondaparinux), oral anticoagulant (such as warfarin , rivaroxaban, rivaroxaban, rivaroxaban Apixaban ) Except for cases of moving or moving from pradaxa or when UFH is used in the doses needed to maintain artery catheter or central veins.

Patients with artificial cardiac valves.

Contraindicated in the case of liver failure or liver disease that affects life.

Precautions when using

liver failure

Patients with high liver enzymes> 2 times the upper limit of normal value (ULN) has been excluded in the main clinical trial. There is no experience in treating this patient group, so it is not recommended to use Pradaxa on the group of liver failures.

Hemorrhage risk

Like other anticoagulants, prudely use Pradaxa in cases where there is an increase in the risk of bleeding and in a situation -by -use situation, which affects hemostasis by inhibiting platelet aggregation. Bleeding may appear at any position during treatment with Pradaxa. Search for bleeding places if hemoglobin and/or hematocrit or blood pressure decrease without explaining the cause.

For life -threatening or uncontrolled bleeding, when required to quickly remove Dabigatran's anticoagulant effect, specific factors are available (Praxbind, Idarucizurnab) to eliminate the effect of Pradaxa (see "surgery and intervention tips", "The stage before surgery" and "overdose").

Treatment with Pradaxa does not require anti -coagulation monitoring.

However, the monitoring of Dabigatran's anticoagulant activity may be helpful to avoid excessive absorption of Dabigatran when there are many risk factors.

Inr test is not reliable in patients who are being treated with Pradaxa and have reported a fake positive increase. Therefore, the Inr test should not be conducted.

Thrombin dilution time (DTT), Ecarin blood clotting time (ECT) and Thromboplastin time (APTT) can provide useful information, but these tests have not been standardized and the results need to be carefully interpreted (see the section "Pharmacological characteristics").

Prevention of stroke, systematic systems in adult patients with atrial fibrillation not due to a valve disease (NVAF) has one or more risk factors (Spaf)

In patients with atrial fibrillation during the Re - a separation of 150 mg twice daily a value of APTT higher than 2.0 - 3.0 times the normal limit at the bottom concentration related to the risk of increased bleeding.

Mobile pharmacokinetic studies show that there is an increase in drug concentration in patients with age -acting renal function. Contraindicated use of pradaxa in cases of severe renal failure (CrCl .

Data available in patients

Stop treatment when bleeding occurs seriously and find the cause of bleeding (see overdose).

Do not simultaneously use drugs that may increase the risk of bleeding or should be used with prudent with Pradaxa (see the "drug interaction" section).

Factors, such as impaired renal function (CrCl 30 - 50 ml/min), ≥ 75 years old, mild weight

Pradaxa's simultaneous use with the following therapy has not been studied and may increase the risk of bleeding: heparin (except when used with the dose needed to maintain central venous catheter or artery) and heparin derivatives, low molecular weight heparin (LMWH), Fondaparinux, Desirudine, drugs that are resistant to blood masses, resistant drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs, resistance drugs resistant to resistance resistance Gplib/LLA, Ticlopidine, Dextran, SulfinPyrazone, Rivaroxaban, Prasugrel, Vitamin K antagonists, P -GP, Itraconazole, Tacrolismus, Cyclosporine, Ritonavir, Tipranavir, Nelfinavir, Nelfinavir and SaQavavir.

Simultaneously used with droneedarone increases the absorption of Dabigatran and is not recommended (see "special patient group").

Concentrated with Ticagrelor increases the absorption of Dabigatran and may show that pharmacological interactions lead to an increased risk of bleeding.

The risk of bleeding can increase in patients treated simultaneously with selective re -absorption inhibitors Serotonin (SSRI) or Serotonin Norepinephrine (SNRI) reabsorption inhibitors.

The presence of lesions, pathological conditions, procedures and/or medications with pharmacological effects (for example, NSAIDs, anti -platelets, selective Serotonin Rehabilitation (SSRIs) and Serotonin Rehabilitation - NorepinePhrine (SNRI), view interactive), significantly increase the risk of blood bleeding, and the risk of serious bleeding, the risk of the benefit, the risk of the benefit, the risk of the benefit, the risk of the benefit. Pradaxa should only be used if the benefits of treatment outstanding the risk of bleeding.

Use medications for fibroblasts in the treatment of stroke due to acute ischemia

The use of medications for blood -causing fibroblasts in the treatment of acute ischemic stroke may be considered if the patient has thrombin time (cont.), or Ecaine blood clotting time (ECT), or the time of thromboplastin each activated part (APTT) does not exceed the above limit (ULN) according to the reference of each country.

In cases where there is an increased risk of bleeding (for example, a biopsy or serious injury, bacterial endocarditis), generally should be closely monitored (to detect signs of bleeding or anemia).

Prevention of TTHKTM complications in patients after surgery to replace the entire hip or knee joint

Use nonsteroidal anti -inflammatory drugs (NSAID) to reduce pain in a short time before or after surgery does not increase the risk of bleeding when treated in combination with Pradaxa. Evidence of the usual use of NSAIDs has an exhaust time of less than 12 hours during treatment with Pradaxa is incomplete and does not see the risk of bleeding.

Prevention of stroke, systematic systems in adult patients with atrial fibrillation due to valve disease (NVAF) has one or more risk factors (Spaf)

In a study of stroke prevention and systemic embolism in adult patients with atrial fibrillation due to heart valve disease (NVAF), Dabigatran Etrixilat is associated with higher statistical gastric bleeding ratio when using Dabigatran Edexilate 150 mg twice a day. This risk is significantly increased in elderly patients (≥ 75 years old). Using acetylsalicylic acid (ASA), clopidogrel or nonsteroidal anti -inflammatory drugs (NSAID), as well as the appearance of esophagitis, gastritis or gastroesophageal reflux increases the risk of gastrointestinal bleeding (GL). Consider using 220 mg dabigatran by taking 110 mg capsules twice daily in these vibrating patients and should comply with the recommendation of the dose in the "Dosage and usage" item. Consider using propon pump inhibitors (PPI) to prevent stomach bleeding.

Interaction with induction drugs P - GP

Concomitance the use of pradaxa with strong P - GP induction drugs like rifampicin reduces dabigatran levels in plasma. Other P - GP induction drugs like St. John S Wort (John's plants) or carbamazepine, or Phenytoin can also reduce the concentration of dabigattan in plasma, and should be cautious when using combination (see "drug interaction" and "special patient group").

Surgery and intervention tips

Patients who are being treated with Pradaxa have undergone surgery or invasive procedures that increase the risk of bleeding. Therefore, it may be necessary to suspend the use of Pradaxa to conduct surgical interventions (see "pharmacokinetics").

In the case of emergency surgery or urgent procedures that require quickly reverse anticoagulant effects, it is necessary to have specific drugs that help reverse (Praxbind, Idarucizumab) for Pradaxa.

Dabigatran's anticoagulant reverse therapy risks thrombosis in patients with diseases.

If the patient has clinically stabilized, and the hemostasis has reached 24 hours after using Praxbind (Idarucizumab), it can be started to be treated with Pradaxa. Precautions when stopping the drug temporarily to conduct intervention procedures and ensure anticoagulant control. Dabigatran elimination in patients with renal impairment may be longer (see pharmacokinetics). It is necessary to consider this before conducting any procedure. In cases but blood clotting tests (seeing the "special and cautious warning" and "pharmacological characteristics") can help determine whether the hemostasis has achieved.

The period before surgery

Due to the risk of increased bleeding, pradaxa should be suspended before conducting invasive procedures or surgery.

Emergency surgery or urgent procedures

Should temporarily suspend dabigatran ether.

Sales surgery and emergency intervention tips

temporarily suspend dabigatran ether. If possible, it is advisable to delay the procedure of emergency intervention/surgery for at least 12 hours from the last dose. If it cannot be delayed, the risk of bleeding may be increased. Consider the risk of bleeding with the urgency of surgery.

Surgery and surgery by program

If possible, it is recommended to stop using Pradaxa at least 24 hours before the invasive or surgical procedure. In patients who are more at risk of bleeding or in surgery, it is necessary to have good blood clotting process, should stop using Pradaxa 2 - 4 days before surgery.

Spinal anesthesia/epidural anesthesia/spinal cord detection

After withdrawing the catheter, you need to wait at least 1 hour before starting the first pradaxa dose. Need to monitor the nerve signs and symptoms of epidural hematoma or spinal cord in these patients.

The following stage

Pradaxa treatment should be continued/started after the invasive procedure or surgical intervention as soon as possible with the conditions of the clinical condition and the hemostatic process was completely.

Patients with a risk of bleeding or patients with excessive risk of exposure, especially patients with average renal impairment (CrCl 30 - 50 ml/minute), should be treated carefully.

Patients for biological valve replacement

There is no evaluation on this object, so it is not recommended to use.

Patients with high risk of surgery and intrinsic factors with thrombosis

Data on safety and effectiveness of Dabigatran in these patients is limited and should be cautious when treated.

hip fracture surgery

There is no data, so the treatment is not recommended.

Myocardial infarction

In the study of phase III Re - Ly (Spaf) the general ratio of the NMCT is 0.82, 0.81 and 0.64%/year for Dabigatran Etrixilate 110 mg x 2 times/day, Dabigatran Etrixilate 150 mg x 2 times/day and Warfarin, corresponding to a relative risk of Dabigatran is 29% and 27% compared to Warfarin.

Regardless of any treatment, the highest absolute risk of the NMCT is seen in the following subgroups, with the same risk: Previous NMCT patient, patient ≥ 65 years old with diabetes or coronary artery disease, patients with left ventricular blood canal race

In three DVT/PE phase III studies, there is a positive control, the percentage of NMCT reported in patients using Dabigatran Ethilate is higher than those who use Warfarin users: 0.4% compared to 0.2% in re -cover and re -cover short -term. II Research; and 0.8% compared to 0.1% in the Re - Medy test long -term. The increase in statistical significance in this study (P = 0.022).

In the study of Re - Sonate, comparing Dabigatran Ethilate with placebo, the NMCT ratio is 0.1% in patients using Dabigatran Etrixilate and 0.2% in placebo patients.

Cancer patients are progressing

Efficiency and safety have not been established for patients with cancer DVT/PE being progressing.

The ability to drive and operate machinery

Pradaxa does not have or affect the ability to drive and use machinery.

Pregnancy

There is very little data on the use of pradaxa in pregnant women.

Animal studies show that reproducing toxicity of potential risks for humans is unknown.

Pradaxa should not be used during pregnancy unless really necessary.

Breastfeeding period

There is no clinical data on the effects of dabigatran on infants during breastfeeding.

Should stop breastfeeding during pradaxa treatment.

Drug interaction

Interaction P - Glycoprotein

dabigatran ether is a substrate for the flow of P - GP flow. Simultaneous use of P - GP inhibitors may increase the concentration of dabigatran in plasma.

If not described in detail, it is necessary to closely clinically monitor (find signs of bleeding or anemia) when Dabigatran is used simultaneously with strong P -GP inhibitors. The dose may be reduced in combination with some p - GP inhibitors.

Inhibitors p - GP

Contrain to use: Ketoconazole, droneedarone, Itraconazole, cyclosporine, glecaprevir/pibrentasvir.

Do not use simultaneously: tacrolimus.

Be careful in the case of simultaneous use: Verapamil, Amiodarone, Quinidine, Clarithromycin, Ticagrelor, Posaconazole.

touch P - GP

Should avoid simultaneous use: such as rifampicin, st. John's Wort (Hypericum Perforatum), Carbamazepine or Phenytoin. Simultaneous use is expected to reduce dabigatran levels.

Protease inhibitors like Ritonavir

Do not use simultaneously: such as ritonavir and its combination with other protease inhibitors.

The substrate p - GP

digoxin.

anticoagulant drugs and anti -platelets products

No or only limited experience in the following treatments may increase the risk of bleeding when used simultaneously with pradaxa: anticoagulant drugs such as heparin without segmentation (UFH), low molecular weight heparin (LMWH), and heparin derivatives (Fondaparinux, Desirudin), anti -blood -resistant drug products or other oral anticoagulants (see section 4.3), and platelet -binding drugs such as GPIIB/IIIA receptor receptor drugs, ticlopidine, prasugrel, ticagrelor, dextran, and sulfinPyrazone.

NSAID: NSAID used to relieve pain in a short time has been shown to be unrelated to increasing the risk of bleeding when used with Dabigatran Ethilate. With the use of chronic use in the study of Re - Ly, NSAID increases the risk of bleeding by about 50% on both Dabigatran Ethilate and Warfarin.

Clopidogrel: Concomplified use of dabigatran omexilate and clopidogrel does not extend capillary bleeding time compared to monon therapy with clopidogrel.

Asa: Simultaneous use of ASA and 150 mg of dabigatran omexilate twice a day may increase the risk of bleeding from 12% to 18% and 24% corresponding to 81 mg and 325 mg ASA.

Lmwh: Concomitant use of LMWHS, such as Enoxaparin and Dabigatran Ethilate have not been studied in detail.

Other interactions

Selective Serotonin reabsorption inhibitors (SSRIs) or Serotonin Norepinephrine reconstruction inhibitors (SNRI)

SSRI and SNRIS increase the risk of bleeding in Re - Ly in all treatment groups.

The substances that affect the stomach pH

Pantoprazole: AUC of Dabigatran decreased by about 30%. However, ppi used at the same time did not seem to reduce the effectiveness of Pradaxa.

Ranitidine: Using Ranitidine along with pradaxa has no clinical effect on the absorption level of Dabigatran.

Interactions associated with Dabigatran ether and the metabolism of Dabigatran

Dabigatran omexilate and Dabigatran are not metabolized by the cytochrom P450 system and has no vitro printing effect on human cytochrom P450 enzymes. Therefore, the drug interactions related to Cytochrom P450 may not occur with Dabigatran.

Storage

Store the whole package to avoid moisture. Storage no more than 30 ° C. Do not place capsules in drug containers or tools used for drugs, unless captures are kept in the packaging.

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Pradaxa hard capsules 150mg Boehringer prevent stroke, stroke (3 blisters x 10 tablets)

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Before taking Pradaxa hard capsules 150mg Boehringer prevent stroke, stroke (3 blisters x 10 tablets)

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The ability to drive and operate machinery

Pregnancy

Breastfeeding period

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