Fragmin injection 5000me 0.2ml syringe 10 pcs

Description

Composition
Active substance:
1 the syringe comprises sodium dalteparin 2500 IU or 5,000 IU or 7,500 IU 000 IU or 10 or 12 or 15 500 IU 000 IU 000 IU or 18 1 vial contains: sodium dalteparin 10,000 IU.
Excipients:
Q.s. sodium chloride, sodium hydroxide q.s. (PH adjustment) and hydrochloric acid q.s. (PH adjustment), water for injection to 0.2 ml, 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.72 ml or 1 ml.
Description:
Transparent, colorless or yellowish white solution.
Product form:
Ampoules: A solution for intravenous and subcutaneous injection of 10 000 IU (anti-Xa) / ml. 1 ml of the drug in the vial colorless glass type I. 2 blisters 5 vials are placed in a cardboard box, together with instructions for use.
Syringes: Solution for intravenous and subcutaneous administration of 2,500 IU (anti-Xa) / 0.2 ml, 5 000 IU (anti-Xa) / 0.2 ml, 7,500 IU (anti-Xa) / 0.3 ml 10 000 IU (anti-Xa) / ml 0.4 12 500 IU (anti-Xa) / ml 0.5 15 000 IU (anti-Xa) / 0.6 mL or 18,000 IU (anti-Xa ) / 0.72 ml is placed in a syringe made of glass type I (Eur.
Pharm. ) With a stainless steel needle and latex-free protective cap. 5 syringes in a blister; 2 blisters for volumes 0.2 ml (both doses) or 0.3 ml or 1 blister to 0.4 volumes; 0.5; 0.6 or 0.72 ml was placed in a cardboard box with instructions for use.
Contraindications
Hypersensitivity to dalteparin sodium or other low molecular weight heparin and / or heparin; immune thrombocytopenia (heparin-induced history or suspicion of its existence); bleeding (clinically significant, for example, from the gastrointestinal tract against the background of gastric ulcers and / or duodenal ulcer, intracranial hemorrhage); The expressed disturbances of the blood coagulation system; bacterial endocarditis; recent injuries or surgery on the central nervous system, bodies of sight and / or hearing; due to an increased risk of bleeding, high dose Fragmin (e.g., for treatment of acute deep venous thrombosis, pulmonary embolism, unstable angina and myocardial infarction without tooth Q on ECG) can not be used in patients planned for spinal or epidural anesthesia, or the other procedures involving a lumbar puncture.
Carefully
High dose FragminO (e.g., for treatment of acute deep venous thrombosis, pulmonary embolism, unstable angina and myocardial infarction without Q-wave on EKG) should be used with caution in patients in the early postoperative period.
Caution should be exercised when using the drug Fragmin in patients with an increased risk of bleeding; this group includes patients with thrombocytopenia, platelet dysfunction, severe hepatic or renal failure, uncontrolled hypertension, hypertensive or diabetic retinopathy.
Use in children
There is limited information on the safety and efficacy of Fragmin in pediatric practice. In applying Fragmin children must monitor the level of anti-Xa (see. The section “Method of administration and dose”).
Dosage
25,000 IU / ml
Indications
Treatment of acute deep vein thrombosis and pulmonary embolism; prevention of clotting in the extracorporeal blood during dialysis or hemofiltration in patients with acute or chronic renal failure; prevention of thrombus formation during surgical procedures; prevention of thromboembolic complications in patients with therapeutic diseases in the acute phase and reduced mobility (including the conditions requiring bed rest); unstable angina and myocardial infarction (non-Q-wave on the ECG); long-term treatment (up to 6 months) in order to prevent recurrence of venous thrombosis and pulmonary thromboembolism in patients with cancer.
Interaction with other drugs
While the use of drugs affecting hemostasis, such as thrombolytic agents (alteplase, streptokinase, urokinase), oral anticoagulants, vitamin K antagonists, nonsteroidal antiinflammatory drugs (NSAIDs) (acetylsalicylic acid, indomethacin etc.), Inhibitors of platelet function or dextran , Fragmin anticoagulant effect may be enhanced (increased bleeding risk) (see. the section “method of administration and dose”).
Since NSAIDs reduce the production of therapeutic doses of vasodilating prostaglandins and thus reduce renal blood flow and renal excretion, Fragmin applied simultaneously with this group of drugs is necessary with extreme caution in patients with renal insufficiency.
Compatibility with solutions for the on / in the introduction. Fragmin compatible with 0.9% sodium chloride solution (9 mg / ml) and dextrose (50 mg / ml).
Overdose
Fragmin excessive dose may lead to hemorrhagic complications. Note that lowering blood pressure and reducing the hematocrit may indicate occult bleeding. In case of using sodium dalteparin bleeding should stop to assess the severity of bleeding, and risk of developing blood clots.
The anticoagulant effect can be eliminated Fragmin administration of protamine sulfate. However protamine has an inhibitory effect on primary hemostasis, therefore it can be used only in emergency cases. 1 mg of protamine sulfate neutralizes part 100 IU (anti-Xa) sodium dalteparin (although, as noted complete neutralization induced increase in clotting time from 25 to 50% anti-Xa activity dalteparin sodium still remains).
pharmachologic effect
Pharmacological group:
Anticoagulant means of direct action.
Pharmacological properties:
Dalteparin sodium low molecular weight heparin is selected in the process of controlled depolymerization (with nitrous acid) sodium heparin from intestinal mucosa pigs and subjected to further purification using ion exchange chromatography. The preparation consists of a sulfated polysaccharide chains having an average molecular weight of 5000 daltons; with 90% having a molecular weight of from 2000 to 9000 Daltons; degree of sulphation – from 2 to 2.5 per disaccharide.
Pharmacodynamics:
Dalteparin sodium through plasma antithrombin inhibits coagulation Factor Xa and thrombin. Dalteparin sodium anticoagulant effect is primarily due to inhibition of blood coagulation factor Xa; at the time of blood clotting medication affects slightly. Compared with dalteparin sodium heparin has little effect on platelet adhesion and thus has minimal effect on primary hemostasis.
Pharmacokinetics:
Heat-half-life after intravenous (i / v) administration – 2 hours after subcutaneous (s / c) injection – 3-5 hours. The bioavailability after SC / to the introduction of about 90%; The pharmacokinetic parameters are independent of dose.
In patients with uremia half-life of the drug is increased. Dalteparin sodium is derived primarily via the kidney, but the biological activity of the fragments that are excreted by the kidneys, poorly understood. The urine is determined by at least 5% of the anti-Xa activity. Clearance anti-Xa activity dalteparin from the plasma after a single I / administration as a bolus at a dose of 30 and 120 IU (anti-Xa) / kg averaged 24.6 ± 5.4 and 15.6 ± 2.4 ml / h / kg, respectively, while the period half-life – 1.47 ± 0.3 and 2.5 ± 0.3 h.
special groups
In patients with chronic renal failure requiring hemodialysis, the elimination half-life of anti-Xa activity after a single on / in the dalteparin at a dose of 5000 IU was 5.7 ± 2.0 h and was significantly higher than in healthy volunteers. Accordingly, such patients can expect a more pronounced accumulation of the drug.
Pregnancy and breast-feeding
The results showed a satisfactory level of security the use of sodium dalteparin in pregnant women (low incidence of clinically significant bleeding, most of which was observed in the postpartum period, have been identified cases of heparin-induced thrombocytopenia; diagnosed only one osteoporosis case, the level of spontaneous abortion and premature birth matched general population; level congenital anomalies did not exceed the average in the general population).
In experiment FragminO has no teratogenic action or foetotoxic. When used in pregnant women has not been revealed adverse effects on pregnancy and fetal and newborn health. When applying FragminaO during pregnancy on the fetus risk of adverse effects is considered low.
However, since the possibility of adverse effects still can not be completely ruled out FragminO during pregnancy can be used only when there are clear indications that the expected benefit to the mother outweighs the potential risk to the fetus.
It was found that after receiving a prophylactic doses of dalteparin breast milk was determined low activity of anti-Xa, the equivalent ratio of milk / plasma
Conditions of supply of pharmacies
On prescription.
side effects
Are the following side effects (at a frequency> 1%): bleeding, hematoma at the injection site, reversible non-immune thrombocytopenia, pain at injection site, allergic reactions, and transient increase in “liver” transaminase (alanine aminotransferase, aspartate aminotransferase). During post-marketing studies have been reported on several cases of immune thrombocytopenia (with or without thrombotic complications), as well as cases of skin necrosis, alopecia, skin rashes, allergic reactions (including rash, itching, fever, injection site reactions) anaphylactic reactions, development of spinal or epidural hematoma, wound hematoma, large and small bleeding (including intracranial and peritoneal), in some cases fatal. Also, in some cases lead to hematoma development prolonged or permanent paralysis (partial or complete).
special instructions
Fragmin should not be administered intramuscularly!
In carrying out neuraxial anesthesia (epidural / spinal anesthesia) or performing a lumbar puncture in patients receiving anticoagulant therapy, or who planned to carry out anticoagulation therapy with low molecular weight heparins or heparinoids for prevention of thromboembolic complications are at increased risk of developing an epidural or spinal hematoma, which in turn can lead to long-term or permanent paralysis. The risk of these complications increases when using permanent epidural catheters for administering analgesic or while the use of drugs affecting hemostasis, such as NSAIDs, inhibitors of platelet function and other anticoagulants. The risk also increases with injuries and after repeated epidural or lumbar puncture. In such cases, patients should be kept under constant surveillance for the early detection of abnormal neurological symptoms. In identifying neurological pathology demonstrated urgent intervention (decompression of the spinal cord).
There are no clinical data on the use of Fragmin in patients with pulmonary embolism who also noted circulatory disorders, hypotension or shock.
It is recommended to control the number of platelets in patients prior to initiating therapy Fragmin, and then regularly throughout the treatment period. Require special attention patients whose treatment with Fragmin been a rapid development of thrombocytopenia, or thrombocytopenia with platelet counts less than 100,000 / ml. In such cases it is recommended to test in vitr antiplatelet antibody in the presence of heparin or low molecular weight heparins. If the result of this test in vitr is positive or uncertain, or testing in general has not been made, the treatment of Fragmin should be discontinued (see. Section “Contraindications”).
The monitoring Fragmin anticoagulant activity is not usually necessary, but it may be necessary in the treatment of specific groups of patients: children, patients with renal failure, patients with low body weight or obesity, pregnant women, and patients with an increased risk of bleeding or recurrent thromboembolism .
Blood samples for the analysis of Fragmin activity to be performed in the period when the maximum concentration of drug in blood plasma (after 3 – 4 hours after the s / c injection).
To determine the activity of anti-Xa method of choice recognized laboratory tests, which use a chromogenic substrate. In this case the tests should not be used for determining activated partial thromboplastin time (APTT) and thrombin time as these tests are relatively insensitive to sodium dalteparin activity. Increasing doses of Fragmin to increase APTT may cause bleeding (see. The section “Overdose”).
Fragmin and low molecular weight heparin can inhibit adrenal secretion of aldosterone, resulting in hyperkalemia, especially in patients with type II diabetes mellitus, chronic renal insufficiency, metabolic acidosis, increased blood concentration or applying potassium sparing drugs. Requires monitoring of blood potassium in patients at risk.
AUs Fragmin, unfractionated heparin, low molecular weight heparins, and other synthetic polysaccharides are not equal, however replacing one other drug dose is required to make adjustments.
It is known that long-term therapy with heparin is associated with a risk of osteoporosis. Although this effect was not observed when using Fragmin, the risk of osteoporosis can not be excluded.
In patients with severe acute or chronic renal failure (creatinine clearance less than 30 mL / min) dalteparin sodium administering prophylactic doses of 5 to 000 IU did not result in excessive anticoagulation once a day due to the lack of bioaccumulation, and hence does not increase the risk of bleeding.
Elderly patients (especially in patients older than 80 years), there is an increased risk of bleeding when using the drug Fragmin at therapeutic doses. In this connection, it is recommended to closely monitor.
When using a multidose vial unused solution to be destroyed within 14 days after the first puncturing needle tube.
The effect on the ability to drive or complex mechanisms
Fragmin effect of the drug on the ability to drive or complex mechanisms have not been systematically evaluated.
Storage conditions
Ampoules: at a temperature no higher than 25 C.
Syringes: at a temperature no higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Fragmin should not be administered intramuscularly!
acute deep vein thrombosis and treatment of pulmonary embolism
Fragmin injected s / c 1-2 times per day. Thus it is possible immediately to begin therapy indirect anticoagulants (vitamin K antagonists). Combination therapy should continue as long as the prothrombin ratio reaches therapeutic value (usually it is not earlier than 5 days). Treatment of patients in an outpatient setting may be carried out in the same doses, which are recommended in the treatment in a hospital.
When administered 1 time per day – 200 IU / kg body weight of n / k. A single daily dose should not exceed 18,000 IU. Monitoring of anticoagulation activity of the drug is not mandatory.
When administered 2 times a day – 100 IU / kg body weight p / 2 times per day. Monitoring of anticoagulant activity can be omitted, but it should be borne in mind that it may be required in the treatment of specific patient populations (see. “Special Instructions” section). Recommended maximum plasma concentration of the drug should be 0.5-1 IU anti-Xa / ml.
Prevention of clotting in the extracorporeal circulation system during hemodialysis or hemofiltration
Fragmin be administered in / by the dosing regime of the following.
Patients with chronic renal failure, or patients without the risk of bleeding.
Such patients usually require a slight adjustment of dose, and because the majority of patients there is no need to carry out frequent monitoring of anti-Xa levels. When administered at the recommended doses hemodialysis time is usually achieved plasma level of 0.5 – 1 anti-Xa IU / ml.
When the duration of hemodialysis or haemofiltration not more than 4 hours – / jet at 30-40 IU / kg body weight, followed by I / drip of 10-15 IU / kg / hour, either singly / in a bolus dose of 5000 IU .
When the duration of hemodialysis or haemofiltration over 4 hours – / jet at 30 – 40 IU / kg body weight, followed by I / drip of 10 – 15 IU / kg / h.
Patients with acute renal failure or patients with high risk of bleeding
B / bolus 5 – 10 IU / kg body weight, followed by I / drip of 4 – 5 IU / kg / h. У пациентов, которым гемодиализ проводится по поводу острой почечной недостаточности, препарат характеризуется более узким терапевтическим индексом, чем у пациентов, находящихся на хроническом гемодиализе (в связи с чем им необходим адекватный мониторинг уровня анти-Ха). Рекомендованный максимальный уровень в плазме должен составлять 0,2 – 0,4 МЕ анти-Ха/мл).
Профилактика тромбообразования при хирургических вмешательствах
Фрагмин следует вводить п/к. Мониторинг противосвертывающей активности, как правило, не требуется. При применении препарата в рекомендованных дозах максимальные концентрации в плазме составляют от 0,1 до 0,4 МЕ анти-Ха/мл.
При проведении операций в общей хирургической практике – Пациенты с риском развития тромбоэмболических осложнений – п/к 2500 МЕ за 2 часа до операции, затем после операции – п/к по 2500 МЕ/сутки (каждое утро) в течение всего периода, пока пациент находится на постельном режиме (обычно 5 – 7 дней). – Пациенты с дополнительными факторами риска развития тромбоэмболических осложнений (например, пациенты со злокачественными опухолями) – Фрагмин следует применять в течение всего периода, пока пациент находится на постельном режиме (обычно 5-7 дней или более). a. при начале профилактики за день до операции:  5000 МЕ п/к вечером накануне операции, затем по 5000 МЕ п/к каждый вечер после операции. b. при начале профилактики в день проведения операции:  2500 МЕ п/к за 2 часа до операции и 2500 МЕ п/к через 8-12 часов, но не ранее, чем через 4 часа после окончания операции. Затем со следующего дня каждое утро вводят по 5000 МЕ п/к.
При проведении ортопедических операций (например, при операциях по эндопротезированию тазобедренного сустава)
Фрагмин следует вводить в течение до 5 недель после операции, выбрав один из режимов дозирования, приведенных ниже. a. при начале профилактики за день до операции:  5000 МЕ п/к вечером накануне операции, затем по 5000 МЕ п/к каждый вечер после операции. b. при начале профилактики в день проведения операции:  2500 МЕ п/к за 2 часа до операции и 2500 МЕ п/к через 8 – 12 часов, но не ранее, чем через 4 часа после окончания операции. Затем со следующего дня каждое утро – по 5000 МЕ п/к. in. при начале профилактики после операции:  2500 МЕ п/к через 4 – 8 часов после операции, но не ранее, чем через 4 часа после окончания операции. Затем со следующего дня по 5000 МЕ п/к в сутки.
Профилактика тромбоэмболических осложнений у больных с терапевтическим заболеванием в острой фазе и ограниченной подвижностью (в том числе при состояниях, требующих постельного режима)
Фрагмин следует вводить п/к по 5000 МЕ один раз в сутки обычно в течение 12 – 14 дней или дольше (у пациентов с продолжающимся ограничением подвижности). Мониторинг противосвертывающей активности, как правило, не требуется.
Нестабильная стенокардия и инфаркт миокарда (без зубца Q на ЭКГ)
Мониторинг противосвертывающей активности, как правило, не требуется, но следует иметь в виду, что он может потребоваться при лечении специальных групп пациентов (см. раздел «Особые указания»). Рекомендованная максимальная концентрация препарата в плазме должна составлять 0,5 – 1 МЕ анти-Ха/мл. Фрагмин вводят п/к по 120 МЕ/кг массы тела каждые 12 часов. Максимальная доза не должна превышать 10000 МЕ каждые 12 часов. Одновременно, в случае отсутствия противопоказаний, целесообразно проводить терапию ацетилсалициловой кислотой в дозе от 75 до 325 мг/сутки. Терапию следует продолжать до тех пор, пока клиническое состояние пациента не станет стабильным (обычно не менее 6 дней), или дольше (на усмотрение врача). Затем рекомендуется перейти к длительной терапии Фрагмином в постоянной дозе вплоть до проведения реваскуляризации (чрескожные вмешательства или аортокоронарное шунтирование). Общая длительность терапии не должна превышать 45 дней.
Доза Фрагмина подбирается с учетом пола и массы тела пациента: – женщинам с массой тела менее 80 кг и мужчинам с массой тела менее 70 кг следует вводить по 5000 МЕ п/к каждые 12 часов; – женщинам с массой тела 80 кг и более и мужчинам с массой тела 70 кг и более следует вводить по 7500 МЕ п/к каждые 12 часов.
Длительное лечение с целью предотвращения рецидива венозных тромбоэмболий у больных с онкологическими заболеваниями 1 месяц 200 МЕ/кг массы тела п/к 1 раз в сутки. Разовая дневная доза не должна превышать 18000 МЕ. 2 – 6 месяцев около 150 МЕ/кг массы тела п/к 1 раз в сутки, используя шприцы с фиксированной дозой (табл. 1).
Таблица 1. Определение дозы Фрагмина в зависимости от массы тела для периода лечения 2 – 6 месяцев.
Масса тела, кг Доза Фрагмина, МЕ
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist