Universal reference book for medicines
Product name: FRACSIPARIN FORTE (FRAXIPARINE FORTE)

Active substance: nadroparin calcium

Type: Direct anticoagulant - low molecular weight heparin

Manufacturer: GlaxoSmithKline Trading (Russia) manufactured by Glaxo Wellcome Production (France)
Composition, form of production and packaging
The injection solution is
clear or slightly opalescent, colorless or slightly colored.

1 syringe

supraparin calcium 11 400 IU anti-Ha

Excipients: calcium hydroxide solution 1% or hydrochloric acid diluted 8% (to maintain the pH level) - qs to pH 4.5-7.5, water d / u - up to 0.6 ml.

0.6 ml - single-dose syringes (2) - blisters (1) - packs of cardboard.

0.6 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

The injection solution is clear or slightly opalescent, colorless or slightly colored.

1 syringe

Supraparin calcium 15 200 IU anti-Ha

Excipients: calcium hydroxide solution 1% or hydrochloric acid diluted 8% (to maintain the pH level) - qs up to 4.5-7.5, water d / u - up to 0.8 ml.

0.8 ml - single-dose syringes (2) - blisters (1) - cardboard packs.

0.8 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

The injection solution is clear or slightly opalescent, colorless or slightly colored.

1 syringe

Supraparin calcium 19 000 IU anti-Ha

Excipients: calcium hydroxide solution 1% or hydrochloric acid diluted 8% (to maintain the pH level) - qs - to pH 4.5-7.5, water q / u - up to 1 ml.

1 ml - single-dose syringes (2) - blisters (1) - packs of cardboard.

1 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

An anticoagulant of direct action is a low molecular weight heparin.

Nadroparin calcium is characterized by a higher activity with respect to the blood coagulation factor Xa compared to the blood coagulation factor IIa activity.
He has both immediate and prolonged anticoagulant activity.
Compared with unfractionated heparin, calcium supraparin has less influence on platelet function and on their aggregation and has little effect on primary hemostasis.

In preventive doses does not cause a marked decrease in activated partial thrombin time (APTTV).

At course treatment during the period of maximum activity, the APTT can be extended to a value 1.4 times higher than the standard one.
This prolongation reflects the residual anticoagulant effect of calcium supra-paryl.
Mechanism of action

Nadroparin calcium is a low molecular weight heparin (LMWH), obtained by depolymerization from standard heparin.
It is a glycosaminoglycan with an average molecular weight of about 4,300 daltons.
Nadroparin calcium shows a high ability to bind to antithrombin III (ATIII).
This binding leads to an accelerated inhibition of the coagulation factor of Ha, which is responsible for the high anticoagulant potential of the calcium supraparin. Other mechanisms providing an anticoagulant effect of calcium supaparin include activation of a tissue factor pathway inhibitor (TFPI), activation of fibrinolysis by direct release of tissue plasminogen activator from endothelial cells, and modification of rheological properties of blood (decrease in blood viscosity and increase in permeability of platelet and granulocyte membranes).
PHARMACOKINETICS

Pharmacokinetic properties are determined on the basis of a change in the anti-Xa factor activity of the plasma.

Suction

After sc administration, the maximum anti-Ha-factor activity (C max ) is achieved in 3-5 hours.

After intravenous administration, C max in plasma is reached within the first 10 min.

Distribution

After sc administration, calcium supraparin is almost completely absorbed (about 88%).

With IV introduction, the maximum anti-Ha-factor activity is achieved in less than 10 minutes, T 1/2 is about 2 hours.

Metabolism

Metabolism occurs mainly in the liver (desulphation, depolymerization).

Excretion

T 1/2 after SC administration is about 3.5 hours. However, anti-Xa factor activity persists for at least 18 hours after the injection of calcium supra-papyrin at a dose of 1900 anti-XA ME.

When I / in T 1/2 is about 2 hours.

Pharmacokinetics in special clinical cases

In elderly patients, in connection with a possible decrease in kidney function, elimination of calcium supraparin can be slowed down.
Possible renal failure in this group of patients requires evaluation and appropriate dose adjustment.
In clinical studies devoted to the study of the pharmacokinetics of calcium supra-paryrin with intravenous administration to patients with renal insufficiency of varying severity, a correlation was established between the clearance of calcium supraparrin and the clearance of creatinine.
When comparing the values ​​obtained with the indices in healthy volunteers, it was found that AUC and T 1/2 in patients with moderate renal insufficiency (creatinine clearance 36-43 ml / min) were increased by 52 and 39%, respectively, and plasma clearance of the supraparin calcium reduced to 63% of normal values. In patients with severe renal failure (creatinine clearance 10-20 ml / min), AUC and T 1/2 were increased by 95% and 112%, respectively, and the plasma clearance of the supraparrin calcium was reduced to 50% of the normal values. In patients with severe renal dysfunction (creatinine clearance 3-6 ml / min) on hemodialysis, AUC and T 1/2 were increased by 62 and 65%, respectively, and the plasma clearance of the supraparrin calcium was reduced to 67% of the normal values.
The results of the study showed that a small accumulation of calcium supraparin can be observed in patients with a moderate degree of moderate renal insufficiency (creatinine clearance is more than or equal to 30 ml / min and less than 50 ml / min), therefore, the dose of Fraxiparin Forte should be reduced by 25-33% in such patients receiving it for the purpose of treating thromboembolism.
The drug Fraxiparin Forte is contraindicated in patients with severe renal insufficiency, in order to treat these conditions.
INDICATIONS

- Treatment of thrombosis and thromboembolism.

DOSING MODE

For n / to the introduction.

The drug Fraksiparin Forte is not intended for intravenous administration.

When treating the drug Fraksiparin Forte, a clinical monitoring of the platelet count should be carried out.

When carrying out a spinal / epidural anesthesia / spinal puncture, it is also necessary to review the information presented in the "Special instructions" section.

Particular attention should be given to specific instructions for use for each drug belonging to the class of low molecular weight heparins (LMWH),
various dosage units (ED or mg) can be used in them. Because of this, the alternation of the drug Fraksiparin Forte with other LMWH during long-term treatment is not permissible.Also it is necessary to pay attention to what kind of drug is used - Fraksiparin or Fraksiparin Forte, tk. this affects the dosing regimen.
Graduated syringes are designed to adjust the dose depending on the weight of the patient's body.

Technique of SC introduction

Preferably, the drug is administered in the patient's "lying" position, in the subcutaneous tissue of the anterolateral or posterolateral surface of the abdominal wall, alternately from the right and left sides.
Admission to the hip is permissible.
To avoid loss of the drug when using syringes, do not remove air bubbles before injection.

The needle should be inserted perpendicularly, and not at an angle, into a pre-formed skin fold, which must be kept between the thumb and forefinger until the end of the solution.
Do not rub the injection site after injection.
Adults

When treating thromboembolic conditions, oral anticoagulants should be given as early as possible, provided there are no contraindications to them.
Treatment with Fraksiparin Forte should be continued until the target INR values ​​are achieved.
Recommended dosing regimen: 1 time / day, the usual course duration is 10 days.
The dose depends on the body weight of the patient and is listed below in the table, based on 171 anti-Ha IU / kg body weight.
Body weight of the patient (kg) 1 times / day duration 10 days

Volume, ml Anti-XA ME

<50 0.4 7600

50-59 0.5 9500

60-69 0.6 11 400

70-79 0.7 13 300

80-89 0.8 15 200

> 90 0.9 17 100

Children and teenagers under the age of 18

The drug Fraksiparin Forte is not recommended for use in children and adolescents, i.e.
to date, there is insufficient data on efficacy and safety, to determine the dose in patients under 18 years of age.
Elderly patients

Older patients do not need a dosage adjustment, except for patients with impaired renal function.
Before starting treatment with the drug Fraksiparin Forte, it is recommended that an evaluation of kidney function is performed.
Renal impairment

In patients with impaired renal function of moderate severity (creatinine clearance 30-50 ml / min) receiving the drug Fraksiparin Forte for the treatment of thromboembolism, the dose should be reduced by 25%.
The drug Fraksiparin Forte is contraindicated in patients with severe renal failure.
Patients with impaired hepatic function

There were no special studies for this group of patients.

SIDE EFFECT

The undesirable phenomena presented below are listed depending on the anatomical and physiological classification and frequency of occurrence.
Frequency of occurrence is defined as follows: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1 000 and <1/100), rarely (? 1/10 000 and <1/1000), very rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug and post-registration observations.
From the hematopoietic and lymphatic system: very often - bleeding of various localizations, more often in patients with other risk factors;
rarely - thrombocytopenia (including heparin-induced thrombocytopenia), thrombocytosis; very rarely - eosinophilia, reversible after discontinuation of the drug.
On the part of the immune system: very rarely - hypersensitivity reactions (including Quincke's edema and skin reactions), anaphylactoid reactions.

From the side of metabolism: very rarely - reversible hyperkalemia associated with the effect of genarins suppressing the secretion of aldosterone, especially in patients at risk.

From the liver and bile ducts: often - an increase in the activity of liver transaminases, which is usually of a transient nature.

Local reactions: very often - the formation of a hematoma at the injection site.
In some cases there is the appearance of tight knots, not meaning the encapsulation of heparin, which disappear after a few days; often - reactions at the injection site; rarely - calcification at the injection site. Calcification is more common in patients with impaired calcium and phosphate metabolism, for example, in some cases with chronic kidney failure.
On the part of the genitals: very rarely - priapism.

From the skin and subcutaneous fat: rarely - rash, hives, erythema, itching;
very rarely - skin necrosis, usually at the injection site.
CONTRAINDICATIONS

- signs of bleeding or an increased risk of bleeding due to hemostasis disorder (with the exception of DIC syndrome not caused by heparin);

- Organic damage to organs with a tendency to bleeding (eg, exacerbation of peptic ulcer of the stomach and duodenum);

- intracranial hemorrhage;

- acute septic endocarditis;

- thrombocytopenia (with application of nadroparin in the anamnesis);

- severe renal insufficiency (CK <30 ml / min) in patients receiving Fraxiparin Forte for the treatment of thromboembolism, unstable angina and myocardial infarction without Q wave;

- Children under 18 years of age (due to insufficient data);

- Hypersensitivity to the drug or other low molecular weight heparins and / or heparin in the anamnesis.

The drug Fraxiparin Forte should be administered in the following situations with caution , due to an increased risk of bleeding:

- with hepatic insufficiency;

- with renal insufficiency;

- with severe arterial hypertension;

- with peptic ulcers in a history or other diseases with an increased risk of bleeding;

- with circulatory disorders in the choroid and the retina of the eye;

- in the postoperative period after operations on the brain and spinal cord or on the eyes;

- in patients weighing less than 40 kg;

- in case of treatment duration exceeding recommended (10 days);

- in case of non-observance of the recommended treatment conditions (in particular, duration and establishment of a dose based on body weight for the course application);

- when combined with drugs that increase the risk of bleeding.

PREGNANCY AND LACTATION

There is no data on the effect of calcium supaparin on fertility.

Experiments on animals did not show teratogenic or fetotoxic effects of calcium supraparin, however, at the present time there are only limited data concerning the penetration of calcium supra-paparin through the placenta in humans.
Therefore, the appointment of the drug Fraksiparin Forte in pregnancy is not recommended, except when the potential benefit to the mother exceeds the risk to the fetus.
At present, there are only limited data on the release of calcium supra-carragein in breast milk.
In this regard, the use of calcium supra-paparin during breastfeeding is not recommended.
APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with impaired renal function of moderate severity (creatinine clearance 30-50 ml / min) receiving the drug Fraksiparin Forte for the treatment of thromboembolism, the dose should be reduced by 25%.
The drug Fraksiparin Forte is contraindicated in patients with severe renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Fraxyparin Forte should be administered with caution in case of liver failure.

APPLICATION FOR CHILDREN

Contraindicated in childhood to 18 years (due to lack of data).

APPLICATION IN ELDERLY PATIENTS

Older patients do not need a dosage adjustment, except for patients with impaired renal function.
Before starting treatment with the drug Fraksiparin Forte, it is recommended that an evaluation of kidney function is performed.
SPECIAL INSTRUCTIONS

Heparin-induced thrombocytopenia

Since the use of heparins, there is the possibility of developing thrombocytopenia (heparin-induced thrombocytopenia), during the entire course of treatment with the drug Fraksiparin Forte, the number of platelets must be monitored.

There have been reports of rare cases of thrombocytopenia, sometimes severe, that could be associated with arterial or venous thrombosis, which is important to consider in the following cases:

- with thrombocytopenia;

- with a significant decrease in platelet count (by 30-50% compared with the initial value);

- with negative dynamics on the part of thrombosis, for which the patient is receiving treatment;

- with thrombosis, developed against the background of the drug;

- with DIC-syndrome.

In these cases, treatment with Fraksiparin Forte should be discontinued.

These effects of immunoallergic nature are usually observed between the 5th and 21st days of treatment, but may occur earlier if the patient has heparin-induced thrombocytopenia in the history.

In the presence of heparin-induced thrombocytopenia in the history (on the background of unfractionated or low-molecular-weight heparins), treatment with the drug Fraksiparin Forte, if necessary, can be prescribed.
However, in this situation, strict clinical monitoring and at least a daily measurement of the number of platelets are shown. If thrombocytopenia occurs, use Fraksiparin Forte immediately.
If thrombocytopenia occurs against the background of heparins (unfractionated or low-molecular), then the use of anticoagulants of other groups should be considered.
If other drugs are not available, then another low-molecular-weight heparin may be used. It should be observed daily the number of platelets in the blood. If signs of beginning thrombocytopenia continue to occur after the drug has been changed, treatment should be stopped as soon as possible. It should be remembered that the control of platelet aggregation, based on in vitro tests, is of limited importance in the diagnosis of heparin-induced thrombocytopenia.
Elderly patients

Before starting treatment with Fraksiparin Forte, the kidney function should be evaluated.

Renal insufficiency

The decision to reduce the dose in patients with moderate renal insufficiency (creatinine clearance greater than or equal to 30 ml / min and less than 50 ml / min) should be taken by the attending physician, weighing the risk of bleeding from one side and thromboembolism on the other hand.

Hyperkalemia

Heparins can inhibit the secretion of aldosterone, which can lead to hyperkalemia, especially in patients with elevated potassium concentrations in the blood or in patients at risk of increasing potassium levels in the blood (including patients with diabetes mellitus, chronic renal failure, metabolic acidosis, or patients , taking drugs that can cause hyperkalemia (eg, ACE inhibitors, NSAIDs)).
The risk of hyperkalemia increases with prolonged therapy, but is usually reversible upon cancellation. In patients at risk, the concentration of potassium in the blood should be monitored.
Spinal / epidural anesthesia / spinal puncture and concomitant medications

The risk of spinal / epidural hematomas increases in persons with established epidural catheters or the concomitant use of other drugs that may affect hemostasis, such as NSAIDs, antiaggregants or other anticoagulants.
The risk, apparently, also increases with traumatic or repeated epidural or spinal punctures. Thus, the question of the combined use of neuraxial blockade and anticoagulants should be decided individually after evaluation of the benefit / 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.
When conducting a lumbar puncture or spinal / epidural anesthesia should pass a minimum of 12 hours between the introduction of the drug Fraksiparin Forte to prevent or 24 hours for the treatment and the insertion or removal of spinal / epidural catheter or needle. Patients with renal insufficiency may be considered an increase in the intervals of data. 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, NSAIDs and antiplatelet agents
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 suitable for the simultaneous administration of the preparation Fraksiparin Forte with drugs such as NSAIDs (including aspirin and other salicylates) and antiplatelet agents, unnecessarily . it may increase the risk of bleeding.
Allergy to latex
needle pre-filled syringe base may contain dry natural rubber latex which may cause allergic reactions in patients with hypersensitivity to latex.
skin necrosis
Cases of skin necrosis was reported very rarely. Skin necrosis is usually preceded by purpura or infiltrated or painful erythematous spot, which may be accompanied or not accompanied by common symptoms. In such cases, treatment with Fraksiparin Forte should be discontinued immediately.
Impact on the ability to drive vehicles and manage mechanisms

No data on the effect of the drug Fraksiparin Forte on the ability to drive vehicles, machinery.
OVERDOSE

Symptoms: basic feature overdose with n / k administration is bleeding.
Treatment: 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 Fraksiparin Forte.
Protamine sulfate has a strong neutralizing action with respect to the anticoagulant effect of heparin, but some anti-factor Xa activity can be maintained. The use of protamine sulfate is necessary only in severe cases.
0.6 mL of the protamine sulfate neutralizes about 950 anti-Xa ME nadroparin calcium. The dosage of protamine sulfate calculated from the time elapsed after the administration of heparin, with a possible reduction in the dose of antidote.
DRUG INTERACTION

Development of hyperkalemia may depend on the simultaneous presence of several risk factors. Drugs that cause hyperkalemia: potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, NSAIDs, heparin (low molecular weight or unfractionated), cyclosporin and tacrolimus, trimethoprim. Danger of hyperkalemia increased in combination with the above means a preparation Fraksiparin Forte.
The combined use of the drug Fraksiparin Forte with drugs affecting hemostasis, such as acetylsalicylic acid, NSAIDs, oral anticoagulants, fibrinolytics and dextran, leads to mutual reinforcement effect.
Furthermore, it should be appreciated that antiplatelet agents (excluding acetylsalicylic acid as the analgesic and antipyretic drug, i.e. at a dose exceeding 500 mg): abciximab, acetylsalicylic acid antiplatelet doses (50-300 mg) with cardiac and neurologic indications, beraprost, clopidogrel, eptifibatide, iloprost, ticlopidine, tirofiban - increase the risk of bleeding.
The drug Fraksiparin Forte should be used with caution in patients receiving oral anticoagulants, systemic corticosteroids and dextrans. When assigning anticoagulants patients receiving drug Fraksiparin Forte, its use should be continued until the stabilization MHO indicator to the desired value.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Do not freeze. Shelf life - 3 years.
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