صيدلية اونلاين

PRADAXA 110 MG

$0.00 $66.90
PRADAXA
Cardiovascular System-Anticoagulants, Antithrombotics and Fibrinolytics
ACTIVE INGREDIENTS
= Additional active ingredients
Dabigatran etexilate (as mesilate).
DABIGATRAN ETEXILATE
PRESENTATION AND DOSSAGE
CAPS: 10 X 75 mg.
CAPS: 30 X 75 mg.
CAPS: 10 X 110 mg.
CAPS: 30 X 110 mg.
CAPS: 60 x 110 mg.
CAPS: 60 x 150 mg.
RELATED INFORMATION

INDICATIONS
Dabigatran 75 mg and 110 mg: Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Dabigatran 110 mg and 150 mg: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients. Patients with severe renal impairment (CrCL < 30 mL/min). Active clinically significant bleeding Lesion or condition, if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.   Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter. Hepatic impairment or liver disease expected to have any impact on survival Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole, and dronedarone. Prosthetic heart valves requiring anticoagulant treatment.    

SPECIAL PRECAUTIONS
Increased risk of stroke with discontinuation of Dabigatran: Discontinuing Dabigatran in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If Dabigatran must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.
Hepatic impairment: Patients with elevated liver enzymes > 2 ULN were excluded in the main trials. No treatment experience is available for this subpopulation of patients, and therefore the use of Dabigatran is not recommended in this population.
Haemorrhagic risk: Dabigatran etexilate should be used with caution in conditions with an increased risk of bleeding and in situations with concomitant use of drugs affecting haemostasis by inhibition of platelet aggregation. Bleeding can occur at any site during therapy with dabigatran etexilate. An unexplained fall in haemoglobin and/or haematocrit or blood pressure should lead to a search for a bleeding site. Factors, such as decreased renal function (30-50 mL/min CrCL), age ≥ 75 years, low body weight < 50 kg, or mild to moderate P-gp inhibitor co-medication (e.g. amiodarone, quinidine or verapamil) are associated with increased dabigatran plasma levels. The concomitant use of ticagrelor increases the exposure to dabigatran and may show pharmacodynamic interaction, which may result in an increased risk of bleeding. In a study of prevention of stroke and see in adult patients with NVAF, dabigatran etexilate was associated with higher rates of major gastrointestinal (GI) bleeding which was statistically significant for dabigatran etexilate 150 mg twice daily. This increased risk was seen in the elderly (≥ 75 years). Use of acetylsalicylic acid (ASA), clopidogrel or non steroidal antiinflammatory drug (NSAID), as well as the presence of esophagitis, gastritis or gastroesophageal reflux increase the risk of GI bleeding. In these atrial fibrillationpatients a dosage of 220 mg dabigatran given as 110 mg capsule twice daily should be considered. The administration of a PPI can be considered to prevent GI bleeding. Bleeding risk may be increased in patients concomitantly treated with selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs). Close clinical surveillance (looking for signs of bleeding or anaemia) is recommended throughout the treatment period, especially if risk factors are combined.  Factors which may increase the haemorrhagic risk – see prescribing information for full details.  Patients who develop acute renal failure must discontinue Dabigatran. Limited data is available in patients < 50 kg. When severe bleedings occur treatment must be discontinued and the source of bleeding investigated. Medicinal products that may enhance the risk of haemorrhage should not be administered concomitantly or should be administered with caution with Dabigatran. Use of fibrinolytic medicinal products for the treatment of acute ischemic strokeץ The use of fibrinolytic medicinal products for the treatment of acute ischemic stroke may be considered if the patient presents with a dTT, ECT or aPTT not exceeding the ULN according to the local reference range.
Interaction with P-gp inducers: Concomitant administration of P-gp inducers (such as rifampicin, St. John`s wort (Hypericum perforatum), carbamazepine, or phenytoin) is expected to result in decreased dabigatran plasma concentrations, and should be avoided.
Surgery and interventions: Patients on dabigatran etexilate who undergo surgery or invasive procedures are at increased risk for bleeding. Therefore surgical interventions may require the temporary discontinuation of dabigatran etexilate. Caution should be exercised when treatment is temporarily discontinued for interventions and anticoagulant monitoring is warranted. Clearance of dabigatran in patients with renal insufficiency may take longer. This should be considered in advance of any procedures. In such cases a coagulation test may help to determine whether haemostasis is still impaired.
Preoperative phase: discontinuation rules before invasive or surgical procedures – see prescribing information for full details. If an acute intervention is required, dabigatran etexilate should be temporarily discontinued. A surgery / intervention should be delayed if possible until at least 12 hours after the last dose. If surgery cannot be delayed the risk of bleeding may be increased. This risk of bleeding should be weighed against the urgency of intervention.
Spinal anaesthesia/epidural anaesthesia/lumbar puncture: Procedures such as spinal anaesthesia may require complete haemostatic function. The risk of spinal or epidural haematoma may be increased in cases of traumatic or repeated puncture and by the prolonged use of epidural catheters. After removal of a catheter, an interval of at least 2 hours should elapse before the administration of the first dose of dabigatran etexilate. These patients require frequent observation for neurological signs and symptoms of spinal or epidural haematoma.
Postoperative phase: Dabigatran etexilate should be restarted after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established. Patients at risk for bleeding or patients at risk of overexposure, notably patients with moderate renal impairment (CrCL 30-50 mL/min), should be treated with caution.
Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events: There are limited efficacy and safety data for dabigatran available in these patients and therefore they should be treated with caution.
Hip fracture surgery: There is no data on the use of Dabigatran in patients undergoing hip fracture surgery. Therefore treatment is not recommended.
Myocardial Infarction (SPAF): Irrespective of therapy, the highest absolute risk of MI was seen in the following subgroups, with similar relative risk: patients with previous MI, patients ≥ 65 years with either diabetes or coronary artery disease, patients with left ventricular ejection fraction < 40 %, and patients with moderate renal dysfunction. Furthermore a higher risk of MI was seen in patients concomitantly taking ASA plus clopidogrel or clopidogrel alone.
Myocardial Infarction (DVT/PE): In the RE-SONATE study, which compared dabigatran etexilate to placebo, the rate of MI was 0.1% for patients who received dabigatran etexilate and 0.2% for patients who received placebo.
 Active Cancer Patients (DVT/PE): The efficacy and safety have not been established for DVT/PE patients with active cancer.
Colorants: Dabigatran hard capsules contain the colorant sunset yellow (E110), which may cause allergic reactions
  

SIDE EFFECTS
Primary VTE prevention after hip or knee replacement surgery: Haemoglobin decreased, Hepatic function abnormal/ Liver function Test abnormal
Stroke and SEE prevention in patients with atrial fibrillation: Anaemia, Epistaxis, Gastrointestinal haemorrhage, Abdominal pain, Diarrhoea, Dyspepsia, Nausea, Genitourological haemorrhage, including haematuria
DVT/PE treatment and DVT/ PE prevention: Epistaxis, Gastrointestinal haemorrhage, Dyspepsia,  skin haemorrhage,  Genitourological haemorrhage, including haematuria.


DRUG INTERACTIONS
Anticoagulants and antiplatelet aggregation medicinal products: There is no or only limited experience with the following treatments which may increase the risk of bleeding when used concomitantly with Dabigatran: anticoagulants such as unfractionated heparin (UFH), low molecular weight heparins (LMWH), and heparin derivatives (fondaparinux, desirudin), thrombolytic medicinal products, and vitamin K antagonists, rivaroxaban or other oral anticoagulants , and plateletet aggregation medicinal products such as GPIIb/IIIa receptor antagonists, ticlopidine, prasugrel, ticagrelor, dextran, and sulfinpyrazone.
P-gp inhibitors: Dabigatran etexilate is a substrate for the efflux transporter P-gp. Concomitant administration of P-gp inhibitors (such as amiodarone, verapamil, quinidine, ketoconazole, dronedarone, clarithromycin and ticagrelor) is expected to result in increased dabigatran plasma concentrations. If not otherwise specifically described, close clinical surveillance (looking for signs of bleeding or anaemia) is required when dabigatran is co-administered with strong P-gp inhibitors. A coagulation test helps to identify patients with an increased bleeding risk due to increased dabigatran exposure. The following strong P-gp inhibitors are contraindicated: systemic ketoconazole, cyclosporine, itraconazole and dronedarone. Concomitant treatment with tacrolimus is not recommended. Caution should be exercised with mild to moderate P-gp inhibitors (e.g. amiodarone, posaconazole, quinidine, verapamil and ticagrelor).
P-gp inducers: Concomitant administration of a P-gp inducer (such as rifampicin, St. John´s wort (Hypericum perforatum), carbamazepine, or phenytoin) is expected to result in decreased dabigatran concentrations and should be avoided.
Other medicinal products affecting P-gp: Protease inhibitors including ritonavir and its combinations with other protease inhibitors affect P-gp (either as inhibitor or as inducer). They have not been studied and are therefore not recommended for concomitant treatment with Dabigatran.
P-gp substrate: Digoxin: In a study performed with 24 healthy subjects, when Dabigatran was co-administered with digoxin, no changes on digoxin and no clinical relevant changes on dabigatran exposure have been observed.
Co-medication with selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs): SSRIs and SNRIs increased the risk of bleeding in RE-LY in all treatment groups.
Gastric pH: Pantoprazole: When Dabigatran was co-administered with pantoprazole, a decrease in the dabigatran area under the plasma concentration-time curve of approximately 30 % was observed. Pantoprazole and other proton-pump inhibitors (PPI) were co-administered with Dabigatran in clinical trials, and concomitant PPI treatment did not appear to reduce the efficacy of Dabigatran. Ranitidine: Ranitidine administration together with Dabigatran had no clinically relevant effect on the extent of absorption of dabigatran.
             

DOSAGE
Primary prevention of Venous Thromboembolism in Orthopaedic Surgery (pVTEp orthopaedic surgery) – Dabigatran 75 mg and 110 mg.
Patients following elective knee replacement surgery: The recommended dose of Dabigatran is 220 mg once daily taken as 2 capsules of 110 mg. Treatment should be initiated orally within 1-4 hours of completed surgery with a single capsule of 110 mg and continuing with 2 capsules once daily thereafter for a total of 10 days.
Patients following elective hip replacement surgery: The recommended dose of Dabigatran is 220 mg once daily taken as 2 capsules of 110 mg. Treatment should be initiated orally within 1-4 hours of completed surgery with a single capsule of 110 mg and continuing with 2 capsules once daily thereafter for a total of 28-35 days. For the following groups the recommended daily dose of Dabigatran is 150 mg taken once daily as 2 capsules of 75 mg. Treatment should be initiated orally within 1-4 hours of completed surgery with a single capsule of 75 mg and continuing with 2 capsules once daily thereafter for a total of 10 days (knee replacement surgery) or 28-35 days (hip replacement surgery): Patients with moderate renal impairment (creatinine clearance (CrCL) 30-50 mL/min).  Patients who receive concomitant verapamil, amiodarone, quinidine. Patients aged 75 or above. For both surgeries, if haemostasis is not secured, initiation of treatment should be delayed. If treatment is not started on the day of surgery then treatment should be initiated with 2 capsules once daily.
Assessment of renal function (pVTEp orthopaedic surgery): In all patients: Renal function should be assessed by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Dabigatran to exclude patients with severe renal impairment (i.e. CrCL < 30 mL/min). Dabigatran is contraindicated in patients with severe renal impairment.  Renal function should also be assessed when a decline in renal function is suspected during treatment (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products). The method used to estimate renal function (CrCL in mL/min) during the clinical development of Dabigatran was the Cockgroft-Gault method. The formula is as follows:
For creatinine in µmol/L: {1.23 x (140-age [years]) xweight [kg] (x 0.85 if female)}/ serum creatinine [µmol/L].
 For creatinine in mg/dL: {(140-age [years]) x weight [kg] (x 0.85 if female)}/ 72 x serum creatinine [mg/dL] This method is recommended when assessing patients’ CrCL prior to and during Dabigatran treatment.
Renal impairment (pVTEp orthopaedic surgery): Treatment with Dabigatran in patients with severe renal impairment (CrCL < 30 mL/min) is contraindicated. In patients with moderate renal impairment (CrCL 30-50 mL/min), there is limited clinical experience. These patients should be treated with caution. The recommended dose is 150 mg taken once daily as 2 capsules of 75 mg.
Concomitant use of Dabigatran with mild to moderate P-glycoprotein (P-gp) inhibitors, i.e. amiodarone, quinidine or verapamil (pVTEp orthopaedic surgery): Dosing should be reduced to 150 mg taken once daily as 2 capsules of 75 mg Dabigatran in patients who receive concomitantly dabigatran etexilate and amiodarone, quinidine or verapamil. In this situation Dabigatran and these medicinal products should be taken at the same time. In patients with moderate renal impairment and concomitantly treated with dabigatran etexilate and verapamil, a dose reduction of Dabigatran to 75 mg daily should be considered.
Elderly (pVTEp orthopaedic surgery): In elderly patients (> 75 years) there is limited clinical experience. These patients should be treated with caution. The recommended dose is 150 mg taken once daily as 2 capsules of 75 mg. As renal impairment may be frequent in the elderly (>75 years), renal function should be assessed by calculating the CrCL prior to initiation of treatment with Dabigatran to exclude patients with severe renal impairment (i.e. CrCL < 30 mL/min). While on treatment the renal function should also be assessed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (such as hypovolemia, dehydration, and with certain comedications, etc).
Hepatic impairment (pVTEp orthopaedic surgery): Patients with elevated liver enzymes > 2 upper limit of normal (ULN) were excluded in clinical trials investigating the VTE prevention following elective hip or knee replacement surgery. No treatment experience is available for this subpopulation of patients, and therefore the use of Dabigatran is not recommended in this population. Hepatic impairment or liver disease expected to have any impact on survival is contraindicated.
Weight (pVTEp orthopaedic surgery): There is very limited clinical experience in patients with a body weight < 50 kg or > 110 kg at the recommended posology. Given the available clinical and kinetic data no adjustment is necessary, but close clinical surveillance is recommended.
Gender (pVTEp orthopaedic surgery: Given the available clinical and kinetic data, no dose adjustment is necessary. Switching (pVTEp orthopaedic surgery).
Dabigatran treatment to parenteral anticoagulant: It is recommended to wait 24 hours after the last dose before switching from Dabigatran to a parenteral anticoagulant.
Parenteral anticoagulants to Dabigatran: Discontinue the parenteral anticoagulant and start dabigatran etexilate 0-2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment (e.g. intravenous Unfractionated Heparin (UFH)).
Paediatric population ( pVTEp orthopaedic surgery): There is no relevant use of Dabigatran in the paediatric population in the indication: primary prevention of venous thromboembolic events in patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Missed dose (pVTEp orthopaedic surgery): It is recommended to continue with the remaining daily doses of dabigatran etexilate at the same time of the next day. No double dose should be taken to make up for missed individual doses. Posology (SPAF, DVT/PE).
Prevention of stroke and SEE in adult patients with NVAF (SPAF): The recommended daily dose of Dabigatran is 300 mg taken as one 150 mg capsule twice daily. Therapy should be continued long term. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT, and PE in adults (DVT/PE). The recommended daily dose of Dabigatran is 300 mg taken as one 150 mg capsule twice daily following treatment with a parenteral anticoagulant for at least 5 days. The duration of therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding. Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, imobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE.
Elderly (SPAF, DVT/PE): Patients between 75-80 years should be treated with a daily doseof 300 mg taken as one 150 mg capsule twice daily. A dose of 220 mg taken as one 110 mg capsule twice daily can be individually considered, at the discretion of the physician, when the thromboembolic risk is low and the bleeding risk is high. Patients aged 80 years or above should be treated with a daily dose of 220 mg taken as one 110 mg capsule twice daily due to the increased risk of bleeding in this population. As renal impairment may be frequent in the elderly (>75 years), renal function should be assessed by calculating the CrCL prior to initiation of treatment with Dabigatran to exclude patients with severe renal impairment (i.e. CrCL < 30 mL/min). The renal function should also be assessed at least once a year in patients treated with Dabigatran or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (such as hypovolemia, dehydration, and with certain comedications, etc).
Patients at risk of bleeding (SPAF. DVT/PE): Patients with an increased bleeding risk should be closely monitored clinically (looking for signs of bleeding or anaemia). Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient. A coagulation test may help to identify patients with an increased bleeding risk caused by excessive dabigatran exposure. When excessive dabigatran exposure is identified in patients at high risk of bleeding, a dose of 220 mg taken as one 110 mg capsule twice daily is recommended. When clinically relevant bleeding occurs, treatment should be interrupted. For subjects with gastritis, esophagitis, or gastroesophageal reflux, the dose of 220 mg taken as one 110 mg capsule twice daily may be considered due to the elevated risk of major gastro-intestinal bleeding.
Assessment of renal function (SPAF, DVT/PE): In all patients: Renal function should be assessed by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Dabigatran to exclude patients with severe renal impairment (i.e. CrCL < 30 mL/min). Dabigatran is contraindicated in patients with severe renal impairment.  Renal function should also be assessed when a decline in renal function is suspected during treatment (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products). Additional requirements in patients with mild to moderate renal impairment and in patients aged over 75 years: Renal function should be assessed during treatment with Dabigatran at least once a year or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products). The method used to estimate renal function (CrCL in mL/min) during the clinical development of Dabigatran was the Cockgroft-Gault method.
Renal impairment (SPAF, DVT/PE): Treatment with Dabigatran in patients with severe renal impairment (CrCL < 30 mL/min) is contraindicated. No dose adjustment is necessary in patients with mild renal impairment (CrCL 50- ≤ 80 mL/min). For patients with moderate renal impairment (CrCL 30-50 mL/min) the recommended dose of Dabigatran is also 300 mg taken as one 150 mg capsule twice daily. However, for patients with high risk of bleeding, a dose reduction of Dabigatran to 220 mg taken as one 110 mg capsule twice daily should be considered. Close clinical surveillance is recommended in patients with renal impairment.
Concomitant use of Dabigatran with mild to moderate P-glycoprotein (P-gp) inhibitors, i.e. amiodarone, quinidine or verapamil (SPAF, DVT/PE): No dose adjustment is necessary for concomitant use of amiodarone or quinidine. Dosing should be reduced to 220 mg taken as one 110 mg capsule twice daily in SPAF patients who receive concomitantly dabigatran etexilate and verapamil. In this situation Dabigatran and verapamil should be taken at the same time.
Weight (SPAF, DVT/PE): Given the available clinical and kinetic data, no dose adjustment is necessary, but close clinical surveillance is recommended in patients with a body weight < 50 kg.
Gender (SPAF, DVT/PE): Given the available clinical and kinetic data, no dose adjustment is necessary.
Hepatic impairment (SPAF, DVT/PE): Patients with elevated liver enzymes > 2 upper limit of normal (ULN) were excluded in the main trials. No treatment experience is available for this subpopulation of patients, and therefore the use of Dabigatran is not recommended in this population. Hepatic impairment or liver disease expected to have any impact on survival is contraindicated.
Switching (SPAF. DVT/PE): Dabigatran treatment to parenteral anticoagulant: It is recommended to wait 12 hours after the last dose before switching from dabigatran etexilate to a parenteral anticoagulant.
Parenteral anticoagulants to Dabigatran: Discontinue the parenteral anticoagulant and start dabigatran etexilate 0-2 hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment (e.g. intravenous Unfractionated Heparin (UFH)).
Dabigatran treatment to Vitamin K antagonists (VKA): Adjust the starting time of the VKA based on CrCL as follows:  CrCL ≥ 50 mL/min, start VKA 3 days before discontinuing dabigatran etexilate. CrCL ≥ 30-< 50 mL/min, start VKA 2 days before discontinuing dabigatran etexilate Because Dabigatran can increase INR, the INR will better reflect VKA’s effect only after Dabigatran has been stopped for at least 2 days. Until then, INR values should be interpreted with caution.
VKA to Dabigatran: The VKA should be stopped. Dabigatran etexilate can be given as soon as the International Normalized Ratio (INR) is < 2.0.
Cardioversion (SPAF, DVT/PE): Patients can stay on dabigatran etexilate while being cardioverted.
Paediatric population (SPAF): There is no relevant use of Dabigatran in the paediatric population in the indication: prevention of stroke and systemic embolism in patients with NVAF.
Paediatric population (DVT/PE): The safety and efficacy of Dabigatran in children from birth to less than 18 years of age have not yet been established. Currently available data are described in prescribing information, but no recommendation on a posology can be made.
Missed dose (SPAF, DVT/PE): A forgotten dabigatran etexilate dose may still be taken up to 6 hours prior to the next scheduled dose. From 6 hours prior to the next scheduled dose on, the missed dose should be omitted. No double dose should be taken to make up for missed individual doses.
Method of administration ( pVTEp orthopaedic surgery , SPAF, DVT/PE): Dabigatran can be taken with or without food. Dabigatran should be swallowed as a whole with a glass of water, to facilitate delivery to the stomach. Patients should be instructed not to open the capsule as this may increase the risk of bleeding.

OVERDOSE
Doses of dabigatran etexilate beyond those recommended, expose the patient to increased risk of bleeding. In case of an overdose suspicion, coagulation tests can help to determine a bleeding risk. A calibrated quantitative dTT test or repetitive dTT measurements allow prediction of the time by when certain dabigatran levels will be reached, also in case additional measures e.g. dialysis have been initiated. Excessive anticoagulation may require interruption of Dabigatran treatment. There is no specific antidote to dabigatran. In the event of haemorrhagic complications, treatment must be discontinued and the source of bleeding investigated. Since dabigatran is excreted predominantly by the renal route adequate diuresis must be maintained. Appropriate supportive treatment, such as surgical haemostasis and blood volume replacement, should be undertaken at the prescribers discretion. Activated prothrombin complex concentrates (e.g., FEIBA) or recombinant Factor VIIa or concentrates of coagulation factors II, IX and X, may be considered. There is some experimental evidence to support the role of these medicinal products in reversing the anticoagulant effect of dabigatran, but data on their usefulness in clinical settings and also on the possible risk of rebound thromboembolism is very limited. Coagulation tests may become unreliable following adminstration of suggested reversing medicinal products. Caution should be exercised when interpreting these tests. Consideration should also be given to administration of platelet concentrates in cases where thrombocytopenia is present or long acting antiplatelet drugs have been used. All symptomatic treatment should be given according to the physician’s judgement. Depending on local availability, a consultation of a coagulation expert should be considered in case of major bleedings. As protein binding is low, dabigatran can be dialysed; there is limited clinical experience to demonstrate the utility of this approach in clinical studies.

PREGNANCY & LACTATION
Pregnancy: There are no adequate data from the use of Pradaxa in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.
Women of child-bearing potential should avoid pregnancy during treatment with dabigatran etexilate.
Pradaxa should not be used during pregnancy unless clearly necessary.
Lactation: There are no clinical data of the effect of dabigatran on infants during breast feeding. Lactation should be discontinued during treatment with Pradaxa.
Fertility: No data available.

IMPORTANT NOTES
Shelf life: Blister and bottle: 3 years. Once the bottle is opened, the medicinal product must be used within 4 months.
Special precautions for disposal and other handling: When taking Dabigatran capsules out of the blister pack, the following instructions should be followed: The capsules should be taken out of the blister card by peeling off the backing foil. The capsules should not be pushed through the blister foil. The blister foil should only be peeled off, when a capsule is required.   

MANUFACTURER & DISTRIBUTER:
Manufacturer: Boehringer Ingelheim GmbH
License Holder: Boehringer Ingelheim Israel Ltd.

أعمال دابيغاتران ملزمة لالثرومبين في عملية تخثر المذكورة أعلاه ومنع عملها. وهذا يتوقف على تشكيل الليفين، وعنصرا أساسيا من جلطات الدم. وبالتالي يمكن دابيغاتران منع تجلط الدم من تطوير.

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