Fraksiparin solution and / n / k 9500me anti-ha / ml 0.3ml 2850me anti ha syringe 10 pcs

$54.75

Fraksiparin solution and / n / k 9500me anti-ha / ml 0.3ml 2850me anti ha syringe 10 pcs

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Description

Composition
Active substance:
calcium nadroparin
nadroparin calcium content in various product forms:
Syringes 0.3 ml – 2850 IU anti-factor Xa activity.
Syringes 0.4 ml – 3800 IU anti-factor Xa activity.
Syringes 0.6 ml – 5700 IU anti-factor Xa activity.
Syringes 0.8 ml – 7600 IU anti-factor Xa activity.
Syringes 1.0 ml – 9500 IU anti-factor Xa activity.
Excipients:
A solution of calcium hydroxide (or dilute hydrochloric acid) qs pH 5.0 – 7.0 Water for injection to 1.0 ml.
Description:
Transparent or slightly opalescent, colorless or light yellow solution.
Product form:
A solution for subcutaneous administration, 9500 anti-Xa IU / ml.
0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml or 1.0 ml of the preparation in single dose glass syringe with a protective housing, with a tip stainless steel needle, a closed cap.
2 of the syringe is packaged in a transparent blister PVC / PE film.
1 or 5 blisters (2 or 10 syringes), together with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to nadroparin or any other component of the formulation;
Thrombocytopenia when applying nadroparin history;
Signs of bleeding or increased risk of bleeding associated with impaired hemostasis, except for disseminated intravascular coagulation not induced by heparin;
Organic defeat of the tendency to bleeding (eg, acute gastric ulcer or duodenal ulcer);
Injury or surgery on the brain, spinal cord or eyes;
Intracranial hemorrhage;
Acute bacterial endocarditis;
Severe renal impairment (creatinine clearance less than 30 mL / min) in patients receiving Fraksiparin to treat venous thromboembolism, unstable angina and myocardial infarction without tooth Q;
Childhood (
Precautions should be prescribed Fraksiparin in the following situations, due to the increased risk of bleeding:
In liver failure;
In renal failure;
In severe hypertension;
When peptic ulcers or a history of other diseases with an increased risk of bleeding;
When blood circulation in the choroid and retina of the eye;
In the postoperative period after operations on the brain and spinal cord or eyes;
In patients weighing less than 40 kg;
In the case of treatment duration exceeding recommended (10 days);
In cases where the recommended treatment conditions (in particular the duration and establishing dose based on body weight for a course of usage);
In combination with drugs that increase the risk of bleeding (see. The section “Interactions with other drugs”).
Indications
– Prophylaxis of thromboembolic complications: – when general surgery and orthopedic surgery; – in patients with a high risk of thrombotic events (for acute respiratory and / or heart failure) in the intensive therapy unit. – Treatment of venous thromboembolism. – Prevention of clotting during hemodialysis. – Treatment of unstable angina and myocardial infarction without tooth Q.
Interaction with other drugs
Development of hyperkalemia may depend on the simultaneous presence of several risk factors. Drugs that cause hyperkalemia: potassium salts, potassium-sparing diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, non-steroidal anti-inflammatory drugs, heparin (low molecular weight or unfractionated), cyclosporin and tacrolimus, trimethoprim. Danger of hyperkalemia increased in combination with the above means fraksiparin.
Joint application with Fraksiparina drugs affecting hemostasis, such as acetylsalicylic acid, nonsteroidal antiinflammatory drugs (NSAIDs), vitamin K antagonists, fibrinolytics and dextran, leads to mutual reinforcement effect.
Furthermore, it should be taken into account: platelet aggregation inhibitors (except acetylsalicylic acid as the analgesic and antipyretic drug, i.e. at a dose exceeding 500 mg; NSAIDs): abciximab, acetylsalicylic acid antiplatelet doses (50-300 mg) with cardiological and neurological indications, beraprost, clopidogrel, eptifibatide, iloprost, ticlopidine, tirofiban, increasing the risk of bleeding.
Fraxiparine should be used with caution in patients receiving oral anticoagulants, systemic glucocorticoids and dextran. When assigning oral anticoagulants patients receiving Fraksiparin, its application should continue to stabilize prothrombin time indicator to the desired value.
Overdose
symptoms:
The main feature of overdose by subcutaneous or intravenous administration is bleeding. It is necessary to monitor the number of platelets and other blood coagulation parameters. Minor bleeding do not require special care, it is usually sufficient to reduce or delay subsequent dose Fraksiparina.
Treatment:
The use of protamine sulfate is necessary only in severe cases. Protamine sulfate has a strong neutralizing action with respect to the anticoagulant effect of heparin, but some anti-Xa activity can be restored. 0.6 mL of the protamine sulfate neutralizes about 950 anti-Xa IU nadroparin. The dosage of protamine sulfate calculated from the time elapsed after the administration of heparin, with a possible reduction in the dose of antidote.
pharmachologic effect
Pharmacological group:
Anticoagulant line.
Pharmacological properties:
Nadroparin calcium is low molecular weight heparin (LMWH), obtained by depolymerization of standard heparin. It is a glycosaminoglycan having an average molecular weight of about 4300 daltons.
Nadroparin exhibits high binding to plasma protein antithrombin III (AT III). This binding leads to an accelerated inhibition of factor Xa, and this is due to the high antithrombotic potential of nadroparin.
Other mechanisms for antithrombotic effect nadroparin, transformation include activation of tissue factor inhibitor (TFPI), activation of fibrinolysis by direct release of tissue plasminogen activator from endothelial cells and modification of the rheological properties of the blood (reduction in blood viscosity and an increase in the permeability of membranes of platelets and granulocytes).
Pharmacodynamics:
Nadroparin characterized by high activity against Factor Xa compared to activity against factor IIa. It has both immediate and prolonged antithrombotic activity.
In comparison with unfractionated heparin, nadroparin has less influence on the platelet function and aggregation and has little effect on the expressed primary hemostasis.
The prophylactic doses causes pronounced reduction of activated partial thrombin time (APTT).
In exchange treatment in the period of maximum APTT activity can be extended to a value 1.4 times the standard. This prolongation reflects the residual antithrombotic effect of nadroparin calcium.
Pharmacokinetics:
The pharmacokinetic properties are determined based on changes in anti-Xa-factor activity of plasma.
Absorption
After subcutaneous administration, the maximum anti-Xa activity (Cmax) is reached after 3-5 hours (Tmax).
bioavailability
After subcutaneous administration, nadroparin almost completely absorbed (about 88%).
When administered intravenously, the maximum anti-Xa activity is achieved after less than 10 minutes and elimination half-life (T1 / 2) is about 2 hours.
Metabolism
Metabolism occurs primarily in the liver (desulfation, depolymerization).
breeding
The half-life after subcutaneous administration is about 3.5 hours. However, the anti-Xa activity is maintained for at least 18 hours after injection in a dose of nadroparin 1900 anti-Xa IU.
RISK GROUPS
Elderly patients
In elderly patients, due to a possible decrease in renal function, the elimination of nadroparin may slow down. Possible renal insufficiency in these patients require evaluation and appropriate dose correction
Patients with impaired renal function
In clinical studies that examine pharmacokinetics nadroparin when administered intravenously to patients with varying severity of renal failure was established correlation between nadroparin clearance and creatinine clearance. When comparing the values ​​obtained with the parameters in healthy volunteers, it was found that the AUC and half-life in patients with renal insufficiency mild (CLCr 36-43 ml / min) were increased to 52 and 39% respectively, and the plasma clearance nadroparin lowered to 63 % of normal values. In patients with severe renal failure (CLCr 10-20 ml / min) AUC and half-life were increased to 95 and 112% respectively, and the plasma clearance nadroparin reduced to 50% from normal values. In patients with severe renal impairment (CLCr 3-6 ml / min) on hemodialysis, AUC and half-life were increased to 62 and 65% respectively, and the plasma clearance nadroparin reduced to 67% from normal values.
The results showed that a small accumulation of nadroparin may occur in patients with mild or moderate renal impairment (creatinine clearance of more than or equal to 30 ml / min and less than 60 ml / min), therefore, the dose Fraksiparina should be reduced by 25% in these patients receiving Fraksiparin for the treatment of thromboembolic, unstable angina / myocardial infarction without tooth Q. Fraksiparin contraindicated in patients with severe renal failure, for the treatment of these conditions.
In patients with mild or moderate renal insufficiency Fraksiparina use to prevent thromboembolism, accumulation of nadroparin is not better than in patients with normal renal function receiving therapeutic doses Fraksiparina. Therefore, dose reduction Fraksiparina received a preventive measure in these patients is not required. In patients with severe renal insufficiency receiving Fraksiparin in prophylactic doses, you should decrease the dose by 25% compared with the doses administered to patients who had normal creatinine clearance.
Hemodialysis
Low molecular weight heparin is injected into the arterial line of the dialysis loop at high enough doses to prevent blood clotting in the loop. Pharmacokinetic parameters did not change fundamentally, with the exception of the case of overdose, when passage of the drug into the systemic circulation can lead to increased anti-Xa factor activity associated with the final phase of renal failure.
Pregnancy and breast-feeding
Pregnancy
Animal studies showed no teratogenic or foetotoxic effects of nadroparin, however, currently there are limited data regarding the penetration nadroparina the placenta in humans. Therefore, the use Fraksiparina during pregnancy is not recommended unless the potential benefit to the mother outweighs the risk to the fetus.
Lactation
The limited data currently available regarding the allocation of nadroparin in breast milk. In this regard, the use of nadroparin during breastfeeding is not recommended.
Conditions of supply of pharmacies
On prescription.
side effects
The following classification of adverse reactions, depending on the frequency of occurrence: very common (> 1/10), common (> 1/100,
special instructions
Particular attention should be paid to the specific instructions for use for each drug belonging to the class of low molecular weight heparins, because they may be used in various dosage units (IU or mg). As a consequence, unacceptable Fraksiparina alternation with other LMWHs with prolonged treatment. It is also necessary to pay attention to what kind of medication is used – or Fraksiparin Fraksiparin Forte as it affects the dosing regimen.
Graduated syringes are intended for adjustment of the dosage depending on the patient’s body weight.
Fraxiparine is not intended for intramuscular administration.
In the treatment should be conducted Fraksiparinom clinical monitoring measuring platelet number
thrombocytopenia
Since heparin is possible development of thrombocytopenia (heparin-induced thrombocytopenia) during the course of treatment should be monitored Fraksiparinom platelets.
Reported rare cases of thrombocytopenia, occasionally severe, which may be associated with arterial or venous thrombosis, it is important to take into account in the following cases: -at thrombocytopenia; -with a substantial reduction of platelet levels (30 – 50% compared with normal); -with negative dynamics from thrombosis, about which the patient is receiving treatment; -with DIC.
In these cases, treatment should be discontinued Fraksiparinom.
These effects immunoallergic nature and are usually noted between the 5 th and 21 th day of treatment, but can occur before, if the patient has a heparin-induced thrombocytopenia in history.
In the presence of heparin-induced thrombocytopenia history (in the face of conventional or LMWH) Fraksiparinom treatment may be administered, if necessary. However, in this situation, shown rigorous clinical monitoring and at least daily measurement of the number of platelets. In the event of thrombocytopenia, use Fraksiparina should be stopped immediately.
If the background of heparin (conventional or low molecular weight), thrombocytopenia occurs, you should consider the possibility of appointing anticoagulants other groups. If other drugs are not available, it is possible to use other low molecular weight heparin. It should monitor the number of platelets in the blood daily. If the symptoms continue to occur initially thrombocytopenia after replacing the drug, it should be as soon as possible to stop treatment.
It must be remembered that the control of platelet aggregation, based on in vitro tests, is of limited value in the diagnosis of heparin-induced thrombocytopenia.
Elderly patients
Before treatment Fraksiparinom necessary to assess renal function.
hyperkalemia
Heparins may inhibit the secretion of aldosterone, which may cause hyperkalemia, particularly in patients with elevated potassium in the blood or in patients with the risk of increasing the content of potassium in the blood, for example, patients with diabetes mellitus, chronic renal insufficiency, metabolic acidosis or patients taking drugs which can cause hyperkalemia. hyperkalemia risk increases with long-term therapy but is usually reversible when you cancel. In patients at risk, should monitor the level of potassium in the blood.
Spinal / epidural anesthesia / lumbar puncture and related drugs
The risk of spinal / epidural hematomas is increased in patients with established epidural catheters or concomitant use of other drugs which may affect hemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. Risk apparently also increases during traumatic or repeated epidural or spinal punctures. Thus, the question of the combined use of neuraxial blockade and anticoagulants should be decided individually after evaluating the efficiency / risk in the following situations: – in patients who are already receiving anticoagulants, should be the necessity of spinal or epidural anesthesia; – in patients who are planning elective surgery with spinal or epidural anesthesia, it must be justified by the need for anticoagulation.
If the patient is carried lumbar puncture or spinal or epidural anesthesia, it should be sufficient to comply with the time interval between the introduction Fraksiparina and insertion or removal of spinal / epidural catheter or needle.
Careful monitoring of the patient for signs and symptoms of neurological disorders. Upon detection of disorders in the neurological status of patients requiring urgent appropriate therapy.
Salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs) and platelet aggregation inhibitors
In the prevention or treatment of venous thromboembolism and for the prevention of blood clotting in the extracorporeal blood circulation system in hemodialysis is not recommended Fraksiparina coadministered with drugs such as acetylsalicylic acid, other salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs) and platelet aggregation inhibitors, since it may increase the risk of bleeding.
Effects on ability to / MECHANISMS
No data on the effect Fraksiparina on the ability to drive / mechanisms.
Storage conditions
Store at a temperature not higher than 30 C. Do not freeze.
Keep out of the reach of children.
Dosing and Administration
Subcutaneous injection technique.
Preferably, the administered patient lying in the subcutaneous tissue posterolateral or anterolateral surface of the abdomen, alternately on the right and left sides. Allowed administration to the thigh.
Во избежание потери препарата при использовании шприцев, не следует удалять пузырьки воздуха перед инъекцией.
Иглу следует вводить перпендикулярно, а не под углом, в защемленную складку кожи, которую необходимо держать между большим и указательным пальцем до конца введения раствора. Не следует растирать место введения препарата после инъекции.
Профилактика тромбоэмболии.
Общая хирургия.
Рекомендованная доза Фраксипарина составляет 0,3 мл (2850 анти-Ха МЕ) подкожно, за 2-4 часа до операции, затем Фраксипарин вводят 1 раз в день. Лечение продолжают в течение не менее 7 дней и в течение периода риска тромбообразования, до перевода пациента на амбулаторный режим.
Ортопедические операции.
Фраксипарин назначают подкожно, дозировка зависит от массы тела больного, и указана ниже из расчета 38 анти-Ха МЕ/кг веса, которая может быть увеличена до 50% на 4-ый послеоперационный день.
Начальная доза назначается за 12 часов до операции, 2-ая доза – через 12 часов после окончания операции.
Далее Фраксипарин продолжают применять 1 раз в сутки в течение периода риска тромбообразования до перевода пациента на амбулаторный режим. Минимальный срок терапии составляет 10 дней.
Доза Фраксипарина, вводимого за 12 часов до и через 12 часов после операции, далее 1 раз в сутки до 3-го дня после операции: масса тела менее 50 кг-0,2 мл (1900 МЕ); масса тела 50-69 кг-0,3 мг (2850 МЕ); масса тела более 70 кг-0,4 мл (3800 МЕ).
Доза Фракспарина, вводимого один раз в сутки, начиная с 4-го дня после операции: масса тела менее 50 кг-0,3 мг (2850 МЕ); масса тела 50-69 кг-0,4 мл (3800 МЕ); масса тела более 70 кг-0,6 мл (5700 МЕ).
Пациенты с высоким риском тромбообразования, как правило, находящиеся в отделениях реанимации и интенсивной терапии (дыхательная недостаточность и/или инфекция дыхательных путей и/или сердечная недостаточность):
Фраксипарин назначается подкожно, 1 раз в сутки.
Доза зависит от массы тела больного и указана ниже. Фраксипарин применяют в течение всего периода риска тромбообразования.
Доза Фраксипарина, вводимого 1 раз в день: масса тела менее 70 кг-0,4 мл (3800 МЕ); масса тела более 70 кг-0,6 мл (5700 МЕ);
Лечение нестабильной стенокардии и инфаркта миокарда без зубца Q.
Фраксипарин назначается подкожно 2 раза в день (каждые 12 часов). Продолжительность лечения обычно составляет 6 дней. В клинических исследованиях пациентам с нестабильной стенокардией/инфарктом миокарда без зубца Q. Фраксипарин назначался в комбинации с аспирином, в дозе 325 мг в сутки.
Начальная доза, применяемая как однократная внутривенная болюсная инъекция и последующие дозы вводятся подкожно. Доза зависит от массы тела больного и указана ниже в таблице, из расчета 86 анти-Ха МЕ/кг массы тела.
Начальная доза, для внутривенного введения (болюсная) и Подкожная инъекция (каждые 12 часов): масса тела менее 50 кг-0,4 мл (3780 МЕ); масса тела 50-59 кг-0,5 мл (4750 МЕ); масса тела 60-69 кг-0,6 мл (5700 МЕ); масса тела 70-79 кг-0,7 мл (6650 МЕ); масса тела 80-89 кг -0,8 мл (7600 МЕ); масса тела 90-99 кг -0,9 мл (8550 МЕ); масса тела более 100 кг-1 мл (9500 МЕ).
Лечение тромбоэмболии.
При лечении тромбоэмболии терапия пероральными антикоагулянтами, при отсутствии противопоказаний, должна быть начата как можно раньше. Терапия Фраксипарином не должна быть прекращена до достижения целевых значений показателя протромбинового времени.
Фраксипарин назначается подкожно 2 раза в день (каждые 12 часов), обычная продолжительность курса – 10 дней.
Доза зависит от массы тела больного и указана ниже из расчета 86 анти-Ха МЕ/кг массы тела. масса тела менее 50 кг-0,4 мл (3850 МЕ); масса тела 50-59 кг-0,5 мл (4750 МЕ); масса тела 60-69 кг-0,6 мл (5700 МЕ); масса тела 70-79 кг-0,7 мл (6650 МЕ); масса тела 80-89 кг-0,8 мл (7600 МЕ); масса тела более 90 кг-0,9 мл (8550 МЕ).
Профилактика свертывания крови в системе экстракорпорального кровообращения при гемодиализе.
Доза Фраксипарина должна быть установлена для каждого пациента индивидуально, с учетом технических условий диализа.
Фраксипарин вводиться однократно в артериальную линию петли диализа в начале каждого сеанса.
Для пациентов, не имеющих повышенных рисков развития кровотечения, рекомендованы следующие начальные дозы, в зависимости от массы тела, достаточные для проведения 4-х часового сеанса диализа: масса тела менее 50 кг-0,3 мл (2850 МЕ); масса тела 50-69 кг-0,4 мл (3800 МЕ); масса тела более 70 кг -0,6 мл (5700 МЕ).
У больных с повышенным риском кровотечения сеансы диализа могут проводиться с использованием половинной дозы препарата.
В случае если сеанс диализа продолжается дольше 4 часов, могут быть введены дополнительные небольшие дозы Фраксипарина.
При проведении последующих сеансов диализа доза должна подбираться в зависимости от наблюдаемых эффектов.
Следует наблюдать за пациентом в течение процедуры диализа в связи с возможным возникновением кровотечений или признаков тромбообразования в системе для диализа.
Elderly patients.
У пациентов пожилого возраста корректировки доз не требуется, за исключением пациентов с нарушением функции почек. До начала лечения Фраксипарином рекомендуется провести оценку функции почек.
Renal insufficiency.
Профилактика тромбоэмболий:
У пациентов с легкой и умеренной почечной недостаточностью (клиренс креатинина более 30 мл/мин и менее 60 мл/мин) снижение дозы не требуется, если Фраксипарин применяют для профилактики тромбообразования. У пациентов с тяжелой почечной недостаточностью (клиренс креатинина менее 30 мл/мин) дозу следует снизить на 25 %. У пациентов с тяжелой почечной недостаточностью (клиренс креатинина менее 30 мл/мин) доза должна быть уменьшена на 25%.
Лечение тромбоэмболий, профилактика тромбоэмболий у пациентов с высоким риском тромбообразвания (нестабильной стенокардии и инфаркта миокарда без зубца Q):
У пациентов с легкой и умеренной почечной недостаточностью, получающих Фраксипарин для лечения данных заболеваний, дозу следует снизить на 25 %. Фраксипарин противопоказан пациентам с тяжелой почечной недостаточностью.
Patients with impaired liver function.
Не проводилось специальных исследований для данной группы пациентов.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

ASPEN PHARMA

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