FRAGMIN 2500 IU. 10 ampoules

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FRAGMIN 2500 IU. 10 ampoules
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PHARMACEUTICAL FORM
Solution for injection for subcutaneous or intravenous administration.
Prefilled syringes containing 0.2 ml of 2500 IU (anti-Xa) /0.2 ml (= 12 500 IU / ml) for subcutaneous administration
Prefilled syringes containing 0.2 ml of 5000 IU (anti-Xa) /0.2 ml (= 25000 IU / ml) for subcutaneous administration
Ampoules containing 1 ml to 10,000 IU (anti-Xa) / 1 ml (= 10000 IU / 1 ml) for intravenous / subcutaneous
 
 
4. CLINICAL DATA
4.1. indications
 
FRAGMIN is indicated for:
Treatment of acute deep vein thrombosis and pulmonary embolism.
Prevention of clotting in the extracorporeal system during hemodialysis and hemofiltration in patients with acute renal failure or chronic renal failure.
Prevention of thrombosis in connection with surgery.
Prevention of thrombosis in patients with limited mobility due to severe medical conditions.
Unstable forms of ischemic heart disease (angina, and myocardial infarction without ST-segment elevation, also called non-Q myocardial infarction).
 
 
4.2. Dosage and method of administration
 
  FRAGMIN should not be administered intramuscularly.

Treatment of acute deep vein thrombosis and pulmonary embolism
Dalteparin was administered subcutaneously (SC) in the form of a single daily dose or in the form of two injections per day. Simultaneous anticoagulation with oral vitamin K antagonists can be started immediately. Combination therapy continues until samples for prothrombin complex reach therapeutic levels (usually a minimum of 5 days). Outpatient treatment is possible, using the same doses that are recommended for treatment in hospitals.
• Use once a day
200 IU / kg body weight once daily SC to a maximum dose of 18 000 IU. It is not necessary to monitor the anticoagulant effect.
 
 
• Use twice daily
Alternatively, may be administered a dose of 100 IU / kg body weight twice daily SC. It is not generally necessary monitoring of anticoagulant effect, but should be considered for specific patient groups (see. Section 4.4 Special warnings and special precautions for use). Samples for testing must be taken during maximum plasma concentrations (3 to 4 hours after SC injection). The recommended peak plasma concentrations were between 0.5 and 1.0 IU anti-Xa / ml.
 
Prevent blood clotting in the extracorporeal system during hemodialysis and hemofiltration
Dalteparin is administered intravenously (IV), by selecting the appropriate mode of administration of these below.
• patients with chronic renal insufficiency or in patients without risk of bleeding
These patients are usually rarely necessary dose adjustments and therefore do not require frequent monitoring of the levels of anti-Xa in most patients. Recommended doses typically result in plasma levels of 0.5 to 1.0 IU anti-Xa / ml during dialysis.
- Hemodialysis and hemofiltration lasts up to 4 hours, or administered IV bolus injection of 30 to 40 IU / kg body weight, followed by IV infusion of 10 to 15 IU / kg / hour, or a single IV bolus injection of 5000 IU.
- Hemodialysis and hemofiltration lasting 4 hours, applied IV bolus injection of 30 to 40 IU / kg body weight, followed by IV infusion of 10 to 15 IU / kg / hr.
 
• Patients with acute renal failure or patients at high risk of bleeding
Patients undergoing acute hemodialysis have a narrow therapeutic range of patients on chronic hemodialysis and their anti-Xa levels should be closely monitored.
Recommended plasma levels are from 0.2 to 0.4 IU anti-Xa / ml.
Apply from 5 to 10 IU / kg body weight as an IV bolus injection, followed by IV infusion for 4 to 5 IU / kg / hr.
 
Thromboprophylaxis IN CONNECTION WITH SURGICAL TREATMENT
Apply dalteparin subcutaneously (SC). It is not generally necessary monitoring of anticoagulant effect. In conducting its possible samples for testing must be taken during maximum plasma levels (3 to 4 hours after SC administration). Recommended doses generally result in peak plasma levels between 0.1 and 0.4 IU anti-Xa / ml.
 
• General Surgery
Choose the appropriate mode from the following.
Patients at risk of thromboembolic complications
2500 IU SC to 2 hours prior to surgery and 2500 IU SC each morning after surgery to movement of the patient (usually 5 to 7 days or longer).
- Patients with additional risk factors for thromboembolic events (eg. Malignancy)
Dalteparin is applied to the movement of the patient (usually 5 to 7 days or longer).
1. Initiation of treatment the day before surgery: 5000 IU SC evening before surgery. After surgery, apply 5000 IU SC every night.
2. Initiation of treatment on the day of surgery: 2500 IU SC to 2 hours prior to surgery and 2500 IU SC 8 to 12 hours later, but no sooner than 4 hours after the operation. The day after the operation began in 5000 IU SC each morning.
• Orthopedic Surgery (eg. Hip replacement surgery)
Apply dalteparin to 5 weeks after surgery, by selecting one of the following modes.
1. Initiation of treatment before surgery - the evening before surgery: 5000 IU SC evening before surgery. After surgery - 5000 IU SC every night.
2. Initiation of therapy prior to surgery - the day of surgery: 2500 IU SC to 2 hours prior to surgery and 2500 IU SC 8 to 12 hours thereafter, but no sooner than 4 hours after the operation. The day after the operation began, 5000 IU SC each morning.
3. Initiation after surgery: 2500 IU SC 4 to 8 hours after the operation, but no sooner than 4 hours after the operation. From the day after the operation is started, 5000 IU SC each day.
 
 
Prevent thrombosis in patients with impaired MOBILITY
In patients with prolonged restriction on locomotor activity was 5000 IU dalteparin administered subcutaneously (SC) once a day, usually 12 to 14 days or longer. It is not generally necessary monitoring of anticoagulant effect.
 
FORMS OF unstable ischemic heart disease (unstable angina and myocardial infarction ST-ELEVATION)
It is not generally necessary monitoring of anticoagulant effect, but it should be considered for specific patient groups (see. Section 4.4 Special warnings and special precautions for use). Samples for testing must be taken during maximum plasma levels (3 to 4 hours after SC administration). The recommended peak plasma levels are between 0.5 and 1.0 IU anti-Xa / ml. It is recommended that concurrent treatment with acetylsalicylic acid (75 to 325 mg / day). Apply dalteparin 120 IU / kg body weight subcutaneously (SC) every 12 hours to a maximum dose 10 000 IU / 12 hours. Treatment should be continued until clinical stabilization of the patient (usually at least 6 days) or longer if the doctor considers that it is beneficial. Following this prolonged treatment is recommended with a fixed dose of dalteparin to perform revascularization procedures (such as percutaneous interventions [PCI] or aortocoronary bypass [CABG]). The total duration of treatment should not exceed 45 days.
 
The dose of dalteparin is selected according to sex and weight of the patient:
- In women with a body weight below 80 kg and men weighing less than 70 kg, administer 5000 IU SC every 12 hours.
- For women weighing at least 80 kg and men weighing at least 70 kg, administer 7500 IU SC every 12 hours.
 
Compatibility with solutions for IV administration
Dalteparin is compatible with isotonic infusion solution of sodium chloride (9 mg / ml) or isotonic glucose solution for infusion (50 mg / ml) in glass bottles or plastic containers.
 
 
 
4.3. Contraindications
Dalteparin should not be administered to patients with:
• reliable data or suspected immunologically-mediated heparin-induced thrombocytopenia
• Hypersensitivity to dalteparin, other low molecular weight heparins or other heparins
"• Active clinically significant bleeding (such as gastrointestinal ulceration or bleeding or cerebral hemorrhage)
• severe bleeding disorders infective endocarditis
• recent myocardial injury or surgery of the central nervous system, eyes and / or ears.
Due to increased risk of bleeding highest dose dalteparin (such as those needed to treat acute deep vein thrombosis, pulmonary embolism and unstable form of ischemic heart disease) should not be administered to patients who are spinal or epidural anesthesia or other procedures requiring spinal puncture.
 
 
4.4. Special warnings and special precautions for use
When neuraxial (epidural / spinal) anesthesia or spinal puncture anticoagulated patients or patients who are prescribed anticoagulant treatment with low molecular weight heparins or heparinoids for prevention of thromboembolic complications are at increased risk of developing an epidural or spinal hematoma, which can result in prolonged or permanent paralysis. The risk of such accidents increases With an epidural catheters for administration of analgesia or by concomitant use of drugs affecting hemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The risk increases probably also in traumatic or repeated epidural or spinal puncture. Patients should be frequently monitored for signs and symptoms of neurological disorder. If observed neurological impairment, immediate treatment (decompression of the spinal cord).
Dalteparin should be used with caution in patients who have a potential increased risk of bleeding, such as those with thrombocytopenia, platelet
   disabilities, severe hepatic or renal insufficiency / uncontrolled hypertension or hypertensive or diabetic retinopathy. High doses of dalteparin as those required for the treatment of deep vein thrombosis, pulmonary embolism or unstable forms of coronary heart disease should be given with caution to patients who have had recent surgery.
There is no clinical experience with the use of dalteparin in patients with pulmonary embolism who also have circulatory disorder, hypotension or shock.
Particular attention is necessary if during treatment with dalteparin develop rapid or significant thrombocytopenia (less than 100,000 / ML or mm3). In both cases, it is recommended that in vitro test for anti-platelet antibodies in the presence of heparin or LMWH. If the result of in vitro is positive or inconclusive or not carried out such a test, treatment with dalteparin should be stopped (see. Section 4.3 Contraindications).
It is not generally necessary monitoring of the anticoagulant effect of dalteparin, but it must be considered for specific patient populations such as children; those with renal impairment or those which are very weak or morbidly obese, pregnant, or at increased risk of bleeding or rethrombosis. Laboratory studies with a chromogenic substrate are considered the method of choice for measuring anti-Xa levels. Activated partial thromboplastin time (APTT) and thrombin time should not be used as these tests are relatively insensitive to the activity of dalteparin. Increasing the dose of dalteparin in an attempt to prolong APTT may result in bleeding (see. Section 4.9 Overdose).
Dalteparin can not be used interchangeably (unit per unit) with unfractionated heparin or low molecular weight heparins.
 
children
Information on safety and effectiveness in the use of dalteparin in children is limited. Administration of dalteparin in such patients requires monitoring of levels of anti-Xa (see. Section 4.2. Dosage and method of administration).
 
 
4.5. Drugs and other forms of interaction
Concomitant use of drugs affecting hemostasis such as thrombolytic agents, anticoagulants, nonsteroidal anti-inflammatory drugs or platelet inhibitors may enhance the anticoagulant effect of dalteparin. However, unless specifically contraindicated, patients treated with dalteparin to unstable forms of ischemic heart disease (angina, and myocardial infarction without ST-segment elevation), must also receive aspirin (75 to 325 mg daily).
 
 
4.6. Pregnancy and lactation
Dalteparin was not teratogenic or foetotoxic in animal studies. When administered to pregnant women reported harmful effects on the course of pregnancy or health of the fetus or newborn. If dalteparin be administered during pregnancy, the risk of fetal harm appears remote. However, since the risk of damage can not be completely excluded, dalteparin should be used during pregnancy only if clearly indicated.
It is not known whether dalteparin is excreted in human milk.
 
 
4.7. Effects on ability to drive and use machines
FRAGMIN not affect your ability to drive and use machines
 
 
4.8. Undesirable effects
Clinical studies: Events reported in at least 1% of patients in clinical studies were hemorrhage (bleeding), hematoma at the injection site, reversible non-immunological mediated thrombocytopenia (type I), pain at injection site, allergic reactions and transient increase in liver transaminases (ASAT, ALAT).
Post-marketing surveillance: Other reported events are immunologically-mediated heparin-induced thrombocytopenia (type II) with or without accompanying thrombotic complications; skin necrosis; anaphylactic reactions; spinal or epidural hematoma.
 
 
4.9. overdose
The anticoagulant effect induced by dalteparin sodium, may be inhibited by protamine. Protamine, however, has an inhibiting effect on primary hemostasis and should be used only in terms of urgency. A dose of 1 mg protamine partially neutralizes the effect of 100 IU (anti-Xa) dalteparin sodium (although induced prolongation of the clotting time was neutralized completely, 25 to 50% of the anti-Xa activity is retained dalteparin).
 
 
5. PHARMACOLOGICAL
 
5.1. Pharmacodynamic properties
FRAGMIN has antithrombotic drug containing dalteparin sodium. Dalteparin sodium is low molecular weight heparin obtained from porcine intestinal mucosa with an average molecular weight of 5000. The antithrombotic effect of dalteparin sodium is due to the strengthening of the inhibition of factor Xa and thrombin by antithrombin (AT). The potentiating effect of dalteparin sodium on inhibition of Factor Xa is relatively large compared with its lengthening effect on plasma clotting time (APTT).
As dalteparin sodium has less effect on the activation and adhesion of platelets compared to heparin, it has a limited effect on primary hemostasis. It is believed, however, that some of the antithrombotic properties of dalteparin sodium due to its effect on the wall of blood vessels or on the fibrinolytic system.
 
 
5.2. Pharmacokinetic Properties
The elimination half life is 2 hours after intravenous injection, and 3-4 hours after subcutaneous injection. Bioavailability after subcutaneous injection is approximately 90%, while the pharmacokinetics generally not dose-dependent.
In patients with uremia elimination half-life is longer. FRAGMiN is mainly eliminated via the kidney.
 
 
5.3. Preclinical safety data
The acute toxicity of dalteparin sodium was significantly lower than that of heparin.
In toxicological studies local bleeding at the injection site is the only significant phenomenon observed naturally after subcutaneous administration of higher doses. The frequency and severity of this event were dose-dependent. Has not been observed cumulative effect on bleeding at the injection site.
Hemorrhagic reaction is manifested by a dose-dependent changes in the anticoagulant effect reported by APTT and anti-Xa activity.
Osteoporotic effect of dalteparin sodium does not exceed that of heparin.
The results showed the presence of organ independent of the route of administration, the dosage or duration of treatment. Was not found to be mutagenic effect. There were no embryotoxic or teratogenic effects were not observed any effects on fertility or on peri- and postnatal development.
 
Post-marketing surveillance: Other reported events are immunologically-mediated heparin-induced thrombocytopenia (type II) with or without accompanying thrombotic complications; skin necrosis; anaphylactic reactions; spinal or epidural hematoma.
 
4.9. overdose
The anticoagulant effect induced by dalteparin sodium, may be inhibited by protamine. Protamine, however, has an inhibiting effect on primary hemostasis and should be used only in terms of urgency. A dose of 1 mg protamine partially neutralizes the effect of 100 IU (anti-Xa) dalteparin sodium (although induced prolongation of the clotting time was neutralized completely, 25 to 50% of the anti-Xa activity is retained dalteparin).
 
 
5. PHARMACOLOGICAL
5.1. Pharmacodynamic properties
 
FRAGMIN has antithrombotic drug containing dalteparin sodium. Dalteparin sodium is low molecular weight heparin obtained from porcine intestinal mucosa with an average molecular weight of 5000. The antithrombotic effect of dalteparin sodium is due to the strengthening of the inhibition of factor Xa and thrombin by antithrombin (AT). The potentiating effect of dalteparin sodium on inhibition of Factor Xa is relatively large compared with its lengthening effect on plasma clotting time (APTT).
As dalteparin sodium has less effect on the activation and adhesion of platelets compared to heparin, it has a limited effect on primary hemostasis. It is believed, however, that some of the antithrombotic properties of dalteparin sodium due to its effect on the wall of blood vessels or on the fibrinolytic system.
 
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