Pradaxa - instructions for use, reviews, analogs and formulations (capsules or tablets 75 mg, 110 mg and 150 mg) of the drug for the treatment of thrombosis, embolism and stroke prevention in adults, children and pregnancy. Composition
In this article, you can read the instructions for using the drug Pradaxa. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Pradax in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues Pradax if there are existing structural analogues. Use for the treatment of thrombosis, embolism and stroke prevention in adults, children, as well as during pregnancy and lactation. Composition of the preparation.
Pradaxa - Anticoagulant.Direct thrombin inhibitor. Dabigatran etexilate (active ingredient of the Pradax preparation) is a low molecular weight, non-pharmacologically active precursor of the active form of dabigatran. After ingestion of dabigatran, ethexylate is rapidly absorbed into the digestive tract and, by hydrolysis catalyzed by esterases, in the liver and blood plasma becomes dabigatran. Dabigatran is a powerful competitive reversible direct inhibitor of thrombin and the main active substance in the blood plasma.
Because thrombin (serine protease) converts fibrinogen into a fibrin during the cascade of coagulation, then oppression of its activity prevents the formation of a thrombus. Pradaxa inhibits free thrombin, fibrin-binding thrombin, and thrombin-induced platelet aggregation.
In experimental studies on various models of thrombosis, the antithrombotic effect and anticoagulant activity of dabigatran after intravenous administration and dabigatran etexilate after ingestion was confirmed.
A direct correlation was found between the concentration of dabigatran in blood plasma and the severity of the anticoagulant effect.Dabigatran extends APTT, ECA and thrombin time (TB).
Results of clinical trials in patients undergoing orthopedic surgery - knee and hip arthroplasty - confirmed the preservation of hemostasis parameters and the equivalence of 75 mg or 110 mg dabigatran etexilate application 1-4 h after the operation and the subsequent maintenance dose of 150 or 220 mg once a day in for 6-10 days (for operation on the knee joint) and 28-35 days (for the hip joint) as compared with enoxaparin in a dose of 40 mg once a day, which was used the day before and after the operation.
When used for the prophylaxis of venous thromboembolism after major arthroplasty, the antithrombotic effect of dabigatran etexilate at doses of 150 mg or 220 mg compared with enoxaparin at a dose of 40 mg per day is equivalent in evaluating the main endpoint that includes all cases of venous thromboembolism and mortality from any reasons.
When used to prevent stroke and systemic thromboembolism in patients with atrial fibrillation and with moderate or high risk of stroke,that dabigatran etexilate at a dose of 110 mg twice a day was not inferior to Warfarin for the prevention of stroke and systemic thromboembolism in patients with atrial fibrillation; Also in the dabigatran group, there was a decrease in the risk of intracranial bleeding and the overall incidence of bleeding. The use of a higher dose of dabigatran etexilate (150 mg twice daily) significantly reduced the risk of ischemic and hemorrhagic strokes, cardiovascular death, intracranial bleeding and the overall frequency of bleeding, compared with warfarin. A smaller dose of dabigatran was characterized by a significantly lower risk of major bleeding compared with warfarin. The net clinical effect was assessed by determining a combined endpoint, including stroke frequency, systemic thromboembolism, pulmonary thromboembolism, acute myocardial infarction, cardiovascular mortality and large bleeding. The annual incidence of these events in patients receiving dabigatran etexilate was lower than in patients receiving warfarin. Changes in laboratory parameters of liver function in patients receiving dabigatran etexilate,were observed with comparable or lower frequency compared with patients receiving warfarin.
Composition
Dabigatran etexilate mesylate + auxiliary substances.
Pharmacokinetics
After oral administration of the Pradax preparation, a rapid dose-dependent increase in its concentration in the blood plasma is noted. Absolute bioavailability of dabigatran after taking dabigatran etexilate inside capsules coated with hypromellose shell is about 6.5%. Eating does not affect the bioavailability of dabigatran etexilate.
When dabigatran etexilate is used after 1-3 h, patients after surgical treatment have a decrease in the absorption rate of the drug compared to healthy volunteers.
It should be noted that factors such as anesthesia, paresis of the gastrointestinal tract and surgical operation may be important in slowing down absorption, regardless of the dosage form of the drug. The decrease in the rate of absorption of dabigatran is usually noted only on the day of the operation.
After ingestion in the process of hydrolysis under the influence of esterase, dabigatran etexilate quickly and completely turns into dabigatran, which is the main active metabolite in the blood plasma.When dabigatran is conjugated, 4 isomers of pharmacologically active acylglucuronides are formed: 1-O, 2-O, 3-O, 4-O, each of which is less than 10% of the total dabigatran content in blood plasma. Traces of other metabolites are detected only when highly sensitive analytical methods are used.
Dabigatran is excreted unchanged, mainly by the kidneys (85%), and only 6% through the digestive tract. It has been established that 88-94% of its dose is excreted from the body 168 hours after the administration of the labeled radioactive preparation.
Dabigatran has a low ability to bind to blood plasma proteins (34-35%), it does not depend on its concentration.
Indications
- prevention of venous thromboembolism in patients after orthopedic surgery;
- prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation.
Forms of release
Capsules 75 mg, 110 mg and 150 mg (sometimes mistakenly called tablets).
Instructions for use and dosing regimen
Depending on the indications, the daily dose is 110-300 mg. Multiplicity of admission - 1-2 times a day. The treatment schedule and duration of use depend on the indications and the clinical situation.
Use in patients with an increased risk of bleeding
Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation
The presence of such factors as age 75 or older, a moderate decrease in kidney function (CK 30-50 ml / min), simultaneous use of P-glycoprotein inhibitors, or an indication of a history of gastrointestinal hemorrhage may increase the risk of bleeding. In patients with one or more of these risk factors, at the discretion of the physician, it is possible to reduce the daily dose of Pradax to 220 mg (taking 1 capsule 110 mg twice a day).
The transition from the use of Pradax to the parenteral use of anticoagulants
Prevention of venous thromboembolism in patients after orthopedic operations: parenteral administration of anticoagulants should be started 24 hours after the last dose of Pradax.
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 the last dose of Pradax.
Transition from parenteral use of anticoagulants to the use of Pradax's preparation
The first dose of drug Pradaksa assigned instead be canceled anticoagulant in the range of 0-2 hours before the next injection period alternative therapy or concurrently with the termination of a continuous infusion (e.g., intravenous administration, of unfractionated Heparin (UFH)).
The transition from the application of vitamin K antagonists to the use of Pradax's preparation
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 the Pradax preparation is possible with an MHO of less than 2.0.
The transition from the use of Pradax to the use of vitamin K antagonists
When CK is greater than 50 ml / min, use of vitamin K antagonists may, for 3 days, and under CC 30-50 ml / min - for 2 days to cancel Pradaksa preparation.
Cardioversion
Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation
Conducting routine or emergency cardioversion does not require the withdrawal of Pradax's medication.
Missing dose
Prophylaxis of venous thromboembolism in patients after orthopedic operations: it is recommended to take the usual daily dose of Pradax preparation at the usual time the next day. In the case of missing individual doses, do 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 Pradax can be taken if before taking the next dose of the drug remains 6 hours or more; if the period is less than 6 hours, the missed dose should not be taken. In the case of missing individual doses, do not take a double dose of the drug.
Treatment of acute DVT and / or PE and prevention of fatalities caused by these diseases: a missed dose of Pradax can be taken if 6 hours or more are left before taking the next dose of the drug; if the period is less than 6 hours, the missed dose should not be taken. In the case of missing individual doses, do not take a double dose of the drug.
Prevention of recurrent DVT and / or PE and fatalities,caused by these diseases: the missed dose of Pradax's preparation can be taken in the event that before taking the next dose of the drug remains 6 hours or more; if the period is less than 6 hours, the missed dose should not be taken. In the case of missing individual doses, do not take a double dose of the drug.
Side effect
- anemia;
- thrombocytopenia;
- hypersensitivity reactions, including hives, rashes and itching, bronchospasm;
- intracranial bleeding;
- hematoma;
- nose bleed;
- hemoptysis;
- gastrointestinal bleeding;
- rectal bleeding;
- hemorrhoidal hemorrhages;
- abdominal pain;
- diarrhea;
- dyspepsia;
- nausea, vomiting;
- ulceration of the mucosa of the gastrointestinal tract;
- gastroesophagitis;
- gastroesophageal reflux disease;
- dysphagia
- increased activity of hepatic transaminases;
- abnormal liver function;
- hyperbilirubinemia;
- cutaneous hemorrhagic syndrome;
- hemarthrosis;
- urogenital bleeding;
- hematuria;
- bleeding from the injection site;
- bleeding from the insertion site;
- post-traumatic hematoma;
- bleeding from the operating wound;
- bloody issues;
- drainage of the wound;
- drainage after wound treatment.
Contraindications
- renal failure of severe degree (QC less than 30 ml / min);
- active clinically significant bleeding, hemorrhagic diathesis, spontaneous or pharmacologically induced hemostasis disorder;
- organ damage due to clinically significant bleeding, including hemorrhagic stroke within the previous 6 months prior to initiation of therapy;
- simultaneous administration of ketoconazole for systemic use;
- violations of liver function and liver disease, which can affect survival;
- age under 18 years (no clinical data);
- known hypersensitivity to dabigatran or dabigatran etexilate or to one of the excipients.
Application in pregnancy and lactation
Data on the use of Pradax during pregnancy are absent. The potential risk in humans is unknown.
In experimental studies, there is no adverse effect on the fertility or postnatal development of newborns.
Women of reproductive age should use reliable methods of contraception in order to exclude the possibility of pregnancy with treatment with Pradax.When pregnancy occurs, the use of the drug is not recommended, except when the expected benefit exceeds the possible risk.
If it is necessary to use the drug during breastfeeding, because of the lack of clinical data, it is recommended to stop breastfeeding (as a precaution).
Use in children
In patients under the age of 18 years, the efficacy and safety of the Pradax preparation have not been studied, so use in children is not recommended.
Application in elderly patients
Due to the fact that increasing the exposure of the drug in elderly patients (over 75 years old) is often due to a decrease in kidney function, the function of the kidneys should be assessed before prescribing the drug. Renal function should be assessed at least 1 time per year or more, depending on the clinical situation. Correction of the dose should be carried out depending on the severity of renal dysfunction.
special instructions
Risk of bleeding
The use of Pradax, as well as other anticoagulants, is recommended with caution in conditions characterized by an increased risk of bleeding.During the treatment with Pradaxa, bleeding of various locations may develop. Reducing the concentration of hemoglobin and / or hematocrit in the blood, accompanied by a decrease in blood pressure, is the basis for the search for a source of bleeding.
Treatment with Pradax does not require monitoring of anticoagulant activity. The test for determining MHO should not be used, since there is evidence of a false overestimation of the MHO level.
To determine the excessive anticoagulant activity of dabigatran, tests should be used to determine the thrombin or ECARIN clotting time. In the case where these tests are not available, a test should be used to determine the APTT.
In the study in patients with atrial fibrillation, the APTTV level exceeded 2-3 times the norm border before receiving the next dose of the drug was associated with an increased risk of bleeding.
In pharmacokinetic studies of Pradax it was shown that in patients with decreased renal function (including in elderly patients), an increase in the exposure of the drug is observed. The use of Pradax is contraindicated in case of severe renal dysfunction (KK less than 30 ml / min).
In the case of acute renal failure, Pradax should be withdrawn.
The following factors can lead to an increase in the concentration of dibitran in the plasma: decrease in kidney function (CK 30-50 ml / min), age over 75 years, simultaneous use of an inhibitor of P-glycoprotein. The presence of one or more of these factors may increase the risk of bleeding.
The use of Pradax with the following drugs has not been studied, but may increase the risk of bleeding: the unfractionated heparin (with the exception of the doses required to maintain the permeability of the venous or arterial catheter) and heparin derivatives, low molecular weight heparins (LMWH), fondaparinux sodium, thrombolytic drugs, glycoprotein blockers GP 2b / 3a platelet receptors, ticlopidine, dextran, rivaroxaban, ticagrelor, vitamin K antagonists and P-glycoprotein inhibitors (itraconazole, tacrolimus c, cyclosporine, ritonavir, nelfinavir, and saquinavir). The risk of bleeding increases in patients who simultaneously take selective serotonin reuptake inhibitors. The risk of bleeding may also increase with simultaneous use of antiplatelet agents and other anticoagulants.
The combined use of dronedarone and dabigatran is not recommended.
If the risk of bleeding increases (for example, with a recent biopsy or extensive trauma, bacterial endocarditis), monitoring of the patient's condition is required to detect bleeding in time.
Prevention of venous thromboembolism in patients after orthopedic surgery
It has been established that the use of non-steroidal anti-inflammatory drugs (NSAIDs) for short-term anesthesia during surgical interventions simultaneously with the Pradax preparation is not accompanied by an increased risk of bleeding. There are limited data on the regular use of NSAIDs (having T1 / 2 less than 12 hours) against the background of treatment with Pradax, data on the increased risk of bleeding have not been received.
Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation
Simultaneous use of Pradax's preparation, antiplatelet agents (including ASA and clopidogrel) and NSAIDs increases the risk of bleeding.
The use of fibrinolytic drugs can only be considered if the TB,EMU or APTT in a patient does not exceed the upper limit of the local reference range norm.
Interaction with inducers of P-glycoprotein
The use of rifampicin P-glycoprotein together with Pradax reduced the concentration of dabigatran in plasma. It is suggested that other P-glycoprotein inducers, such as St. John's wort or carbamazepine, can also reduce the concentration of dabigatran in blood plasma and should be used with caution.
Surgical operations and interventions
Patients using Pradax during surgical procedures or invasive procedures increase the risk of bleeding. Therefore, during surgical interventions, Pradax should be discontinued.
Preoperative period
Before carrying out invasive procedures or surgical operations, the Pradax preparation is canceled at least 24 hours before the procedure. In patients with an increased risk of bleeding or before performing extensive operations that require complete hemostasis, Pradax should be discontinued 2-4 days before surgery. In patients with renal insufficiency, the clearance of dabigatran may be prolonged.
The drug Pradax is contraindicated in patients with severe impaired renal function (QC less than 30 ml / min), but if the drug is still used, it should be canceled no less than 5 days before the operation.
In case of necessity of carrying out an emergency surgical intervention, the preparation of Pradax should be temporarily discontinued. Surgical intervention, if possible, is expedient to be performed no earlier than 12 hours after the last administration of Pradax.
Spinal anesthesia / epidural anesthesia / lumbar puncture
Procedures such as spinal anesthesia may require complete restoration of hemostasis. In case of traumatic or repeated spinal puncture and prolonged use of the epidural catheter, the risk of developing spinal bleeding or epidural hematoma may increase. The first dose of Pradax should be taken no earlier than 2 hours after removal of the catheter. It is necessary to monitor the condition of patients to exclude neurological symptoms, which may be due to cerebrospinal bleeding or epidural hematoma.
Period after the procedure
The use of Pradaxa can be continued after complete hemostasis.
Impact on the ability to drive vehicles and manage mechanisms
The influence of the drug Pradaksa on ability to drive and engage in other potentially hazardous activities that require high concentration and psychomotor speed reactions have not been studied, but given that the use of Pradaksa drug may be associated with an increased risk of bleeding, caution should be exercised in carrying out such activities.
Drug Interactions
Co-administration with drugs that affect hemostasis or coagulation processes, including vitamin K antagonists, can significantly increase the risk of bleeding.
Pharmacokinetic interactions
In studies, no inducing or inhibitory effect of dabigatran on cytochrome P450 has been established. In studies in healthy volunteers were observed interaction between dabigatran etexilate and Atorvastatin (CYP3A4 substrate), and Diclofenac (CYP2C9 substrate).
Interaction with P-glycoprotein inhibitors / inducers
The substrate for the transport molecule of the P-glycoprotein is dabigatran etexylate. Simultaneous use of P-glycoprotein inhibitors (amiodarone, verapamil, quinidine, Ketoconazole for systemic use or clarithromycin) leads to an increase in dabigatran concentration in the blood plasma.
Simultaneous use with P-glycoprotein inhibitors
Dose selection in the case of using the listed P-glycoprotein inhibitors for the prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation is not required. In the case of the use of prophylaxis for venous thromboembolism in patients after orthopedic operations - see the sections "Dosage regimen" and "Drug interaction".
Amiodarone. With the simultaneous use of dabigatran etexilate with a single dose of Amiodarone (600 mg) ingested, the degree and rate of absorption of amiodarone and its active metabolite, desethylamiodarone, did not change. The values of AUC and Cmax of dabigatran increased approximately by 1.6 and 1.5 times (by 60% and 50%), respectively. In a study in patients with atrial fibrillation, the concentration of dabigatran increased by no more than 14%, an increased risk of bleeding was not documented.
Verapamil.With the simultaneous use of dabigatran etexilate with verapamil, administered orally, the Cmax and AUC of dabigatran increased depending on the time of application and the drug form of verapamil. The greatest increase in the effect of dabigatran was observed with the first dose of Verapamil in an immediate-release dosage form, which was used 1 h before the administration of dabigatran etexilate (Cmax increased by 180% and AUC by 150%). When using the sustained release form of verapamil, this effect progressively decreased (Cmax increased by 90% and AUC by 70%), as well as with multiple doses of verapamil (Cmax increased by 60% and AUC by 50%), which can be explained by induction of P-glycoprotein in the gastrointestinal tract with prolonged use of verapamil. When verapamil was used 2 hours after dabigatran etexilate, there was no clinically significant interaction (Cmax increased by 10% and AUC by 20%), because after 2 h the dabigatran was fully absorbed. In a study in patients with atrial fibrillation, the concentration of dabigatran increased by no more than 21%, an increased risk of bleeding was not reported.Data on the interaction of dabigatran etexilate with verapamil administered parenterally are not available; clinically significant interaction is not expected.
Ketoconazole. Ketoconazole for systemic administration after a single dose of 400 mg increases the AUC and Cmax of dabigatran by approximately 2.4 times (by 138% and 135%), respectively, and after repeated administration of ketoconazole 400 mg / day by approximately 2.5 times (by 153% and 149%), respectively. Ketoconazole did not affect Tmax and the final T1 / 2. Simultaneous use of Pradax and ketoconazole for systemic use is contraindicated.
Clarithromycin. With the simultaneous use of Clarithromycin 500 mg twice daily with dabigatran etexilate, clinically significant pharmacokinetic interaction was not observed (Cmax increased by 15% and AUC by 19%).
Quinidine. The values of AUCt, ss and Cmax, ss of dabigatran when applied twice a day in the case of simultaneous administration with quinidine at a dose of 200 mg every 2 hours until the total dose of 1000 mg was increased by an average of 53% and 56%, respectively.
Simultaneous use with substrates for P-glycoprotein
Digoxin. With simultaneous use of dabigatran etexilate with digoxin, which is a substrate of P-glycoprotein, no pharmacokinetic interaction was observed.Neither dabigatran nor the prodrug of dabigatran etexilate are clinically significant inhibitors of P-glycoprotein.
Simultaneous use with inducers of P-glycoprotein
The simultaneous administration of Pradax and P-glycoprotein inducers should be avoided, as combined use results in reduced dabigatran exposure.
Rifampicin. The preliminary application of the rifampicin test inducer at a dose of 600 mg per day for 7 days resulted in a decrease in exposure to dabigatran. After the withdrawal of rifampicin, this inductive effect decreased, on day 7 the dabigatran effect was close to the baseline level. During the next 7 days, a further increase in the bioavailability of dabigatran was not observed.
It is suggested that other P-glycoprotein inducers, such as St. John's wort or carbamazepine, can also reduce the concentration of dabigatran in blood plasma and should be used with caution.
Simultaneous use with antiplatelet agents
Acetylsalicylic acid (ASA). When studying the simultaneous use of dabigatran etexilate at a dose of 150 mg 2 times a day and ASA in patients with atrial fibrillation,that the risk of bleeding may increase from 12% to 18% (with ASA at a dose of 81 mg) and up to 24% (with the use of ASA at a dose of 325 mg). It was shown that ASA or clopidogrel, used simultaneously with dabigatran etexilate in a dose of 110 mg or 150 mg twice a day, may increase the risk of major bleeding. Hemorrhages are observed more often with simultaneous use of warfarin with ASA or clopidogrel.
NSAIDs. The NSAIDs used for short-term analgesia after surgery did not increase the risk of bleeding with simultaneous use with dabigatran etexilate. The experience of prolonged use of NSAIDs, T1 / 2 of which is less than 12 hours, with dabigatran etexilate is limited, there is no data on an additional increase in the risk of bleeding.
Clopidogrel. It has been established that simultaneous use of dabigatran etexilate and Clopidogrel does not lead to an additional increase in the time of capillary bleeding in comparison with clopidogrel monotherapy. In addition, the values of AUCt, ss and Cmax, ss of dabigatran, as well as blood coagulation parameters that were monitored to evaluate the effect of dabigatran (APTT, ejacrine coagulation time or thrombin time (anti F2a),as well as the degree of inhibition of platelet aggregation (the main indicator of the effect of clopidogrel) during the combined therapy did not change in comparison with the corresponding parameters in monotherapy. When using a "loading" dose of clopidogrel (300 or 600 mg), the values of AUCt, ss and Cmax, ss of dabigatran were increased by 30-40%.
Simultaneous use with drugs that increase the pH of the contents of the stomach
The interaction of the Pradax preparation with alcohol remains unexplored. Sharing is prohibited.
Pantoprazole. With the combined use of dabigatran etexilate and pantoprazole, a decrease in the AUC of dabigatran by 30% was observed. Pantoprazole and other proton pump inhibitors have been used in conjunction with dabigatran etexilate in clinical studies, no effect on bleeding risk or efficacy has been observed.
Ranitidine. Ranitidine when applied simultaneously with dabigatran etexilate did not have a significant effect on the degree of absorption of dabigatran. The changes in the pharmacokinetic parameters of dabigatran revealed in the course of the population analysis under the influence of proton pump inhibitors and antacid preparations were clinically insignificant,since the degree of expression of these changes was small (a decrease in bioavailability was not significant for antacids, and for inhibitors of the proton pump was 14.6%). It was found that the simultaneous use of proton pump inhibitors is not accompanied by a decrease in dabigatran concentration and, on average, only slightly reduces the concentration of the drug in blood plasma (by 11%). Therefore, the simultaneous use of proton pump inhibitors does not appear to lead to an increase in the incidence of stroke or systemic thromboembolism, especially when compared with warfarin, and therefore a decrease in the bioavailability of dabigatran caused by the simultaneous use of pantoprazole is probably of no clinical significance.
Analogues of the drug Pradaxa
Pradax has no structural analogs to the active substance.
Analogues for the pharmacological group (anticoagulants):
- Angioks;
- Angioflux;
- Anfiber;
- Acenocoumarol;
- Warfarex;
- Warfarin;
- Venabos;
- Venolife;
- Viatrom;
- Hemapaksan;
- Gepalpan;
- Heparin;
- Heparin ointment;
- Heparoid;
- Hepatrombin;
- Dolobien;
- Yellon gel;
- Calciparin;
- Clexan;
- Cleaver;
- Xarelto;
- Lavenum;
- Lyoton 1000;
- Marewan;
- Nigepan;
- Pelentan;
- Piyavit;
- Seprotin;
- Cincumar;
- Skinlight;
- Troxevasin Neo;
- Trombleuss;
- Trombleuss Plus;
- Thrombogel;
- Thrombophobia;
- Troparin;
- Phenylin;
- Fluxum;
- Fragmin;
- Fraksiparin;
- Fraksiparin Forte;
- Cibor;
- Exent;
- Eliwis;
- Emeran;
- Eniksum;
- Enoxaparin sodium;
- Essaven.
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