Universal reference book for medicines
Product name: FLUXUM ® (FLUXUM ® )

Active ingredient: parnaparin sodium

Type: Direct anticoagulant - low molecular weight heparin

Manufacturer: ALFA WASSERMANN (Italy)
Composition, form of production and packaging
Solution for n / to the introduction is
transparent, from colorless to light yellow color.

0.3 ml

parnaparin sodium 3200 anti-Ha IU

Auxiliary substances: water d / and - up to 0.3 ml.

0.3 ml - glass syringes (2) complete with needles - blisters (3) - cardboard packs.

Solution for n / to the introduction is transparent, from colorless to light yellow color.

0.4 ml

parnaparin sodium 4250 anti-Ha IU

Auxiliary substances: water d / and - up to 0.4 ml.

0.4 ml - syringes glass (2) complete with needles - blisters (3) - packs cardboard.

Solution for n / to the introduction is transparent, from colorless to light yellow color.

0.6 ml

parnaparin sodium 6400 anti-Ha IU

Auxiliary substances: water d / and - up to 0.6 ml.

0.6 ml - syringes glass (2) complete with needles - blisters (3) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Anticoagulant direct action.
Fluxum ® contains active ingredient parnaparin sodium - a low molecular weight glycosaminoglycan with a molecular weight of 4000 to 6000 Da (average molecular weight of about 5000 Da), which is obtained during the depolymerization of heparin isolated from the mucous membrane of the small intestine of the pig.
Parnaparin sodium has an antithrombotic effect.
In vitro and in vivo, it suppresses, to a large extent, factor Xa, has little effect on factor IIa and on APTT.Antithrombotic activity (anti-Xa) of the drug is superior to anticoagulant (anti-IIa). Thus, the ratio of anti-Xa / anti-IIa activity is 1.5 to 3 (compared to heparin, for which this ratio is 1). Parnaparin sodium does not have a proaggregant platelet effect.
PHARMACOKINETICS

Distribution, metabolism, excretion

The pharmacokinetics of sodium paraparin is linear in the dose range from 3200 anti-XA ME to 12,800 anti-XA ME.
Bioavailability, which is estimated by anti-Xa activity, is close to 100%.
After sc administration of a single dose, the maximum anti-Xa activity in plasma is achieved after 2-3 hours. Then a decrease in activity is observed, which, after 12 hours after the administration of the drug, is still determined.
On repeated administration, a steady state of pharmacokinetics is observed on day 3 with the drug at a dose of 3200 anti-XA ME 2 times / day and on day 4 when administered at a dose of 6400 anti-XA ME 1 time / day.
AUC has a linear dose dependence.
With n / k introduction, the pharmacokinetic profile of anti-Xa activity is more favorable compared to the profile with the IV introduction, since it is characterized by a smoother curve with the presence of fewer peaks and a slower decrease in activity.
In the liver, parnaparin sodium is metabolized to inactive compounds and excreted from the body by the kidneys.
T 1/2 is about 6 hours.
INDICATIONS

deep vein thrombosis;

- postthrombophlebitic syndrome;

- chronic venous insufficiency;

- Acute thrombophlebitis of superficial veins;

- Varicophlebitis;

- prevention of deep vein thrombosis (DVT) in general surgical and orthopedic operations, as well as in patients with a high risk of developing deep vein thrombosis.

DOSING MODE

The drug is injected into the abdomen, in the thickness of the skin fold.
The needle should be positioned perpendicular to the crease, between the thumb and forefinger. The skin fold should be retained until the end of the injection. The injection site must be changed.
Fluxum ® can not be administered in / m.

For the prevention of DVT in general surgery, 0.3 ml (3200 anti-XA ME) is used 2 hours before the operation.
Then 1 time / day for at least 7 days.
For the prevention of DVT in orthopedic surgery and in patients with an increased risk of DVT , 0.4 ml (4250 anti-XA ME) are administered 12 hours before and 12 hours after the operation, then 1 time per day during the postoperative period, at least 10 days .

For the treatment of DVT , 0.6 ml (6400 anti-XA ME) 2 times / day for at least 7-10 days.
If necessary, treatment can begin with a slow infusion of 1.2 ml (12,800 anti-XA ME) for 3-5 days. After relief of the acute phase of the disease, it is recommended to continue SC administration of the drug in a dose of 0.6 ml (6400 anti-XA ME) or 0.4 ml (4250 anti-XA ME) for 10-20 days.
In posttrombophlebitic syndrome and chronic venous insufficiency , 0.6 ml (6400 anti-XA ME) or 0.4 ml (4250 anti-XA ME) or 0.3 ml (3200 anti-XA ME), depending on the severity of the disease 1 time / day for at least 30 days.

In acute thrombophlebitis of superficial veins, varicophlebitis is 0.6 ml (6400 anti-XA ME) or 0.4 ml (4250 anti-XA ME) or 0.3 ml (3200 anti-XA ME), depending on the severity of the disease 1 time / day for at least 20 days.

SIDE EFFECT

Sometimes there are cases of thrombocytopenia, allergic reactions, hematoma and necrosis of the skin at the injection site.
Necrosis of the skin may be preceded by purpura or erythematous painful foci with or without common symptoms. An increase in hepatic transaminase activity may be observed. In isolated cases, there is spinal or epidural hematoma associated with the prophylactic use of the drug during spinal, epidural and lumbar puncture. Hematoma causes various degrees of severity of neurological disorders, including persistent or irreversible paralysis.
CONTRAINDICATIONS

- conducting regional anesthesia in patients receiving Fluxum ® for medical purposes;

- conditions or diseases complicated by bleeding, as well as an increased risk of bleeding or a predisposition to bleeding in cases of hemostasis (with the exception of coagulopathy of consumption not caused by heparin), gastric ulcer and duodenal ulcer and erosive and ulcerative gastrointestinal lesions during exacerbation, angiodysplasia, chorioretinopathy , hemorrhagic stroke;

- thrombocytopenia induced by sodium parnaparin, incl.
in the anamnesis;
- acute bacterial endocarditis (with the exception of endocarditis of the prosthesis);

- severe uncontrolled arterial hypertension (BP> 180/100 mm Hg);

- severe craniocerebral injury (in the postoperative period);

- simultaneous use with salicylates and other NSAIDs, antiplatelet drugs (clopidogrel, dipyridamole), sulfinpyrazone and combination of ticlopidine with sodium parnaparin in high doses;

- children and adolescents under 18 years of age (efficacy and safety not established);

- hypersensitivity to parnaparin or other components of the drug, to heparin and pork products.

With caution: renal and hepatic insufficiency;
mild and moderate hypertension; peptic ulcer of stomach and duodenum and erosive-ulcerative lesions of gastrointestinal tract in anamnesis; Other diseases / conditions in the anamnesis, which may be complicated by bleeding; heparin-induced thrombocytopenia and thrombocytopenia caused by other low molecular weight heparins, incl. in the anamnesis; a history of chorioretinopathy; diseases of the brain and spinal cord in the postoperative period;simultaneous use with indirect anticoagulants, systemic GCS, dextran (for parenteral administration); a combination of sodium parnaparin in low doses with ticlopidine.
PREGNANCY AND LACTATION

Convincing data on the penetration through the placental barrier and the isolation of parnaparin with breast milk there.

In experimental studies on animals, there was no teratogenic and embryotoxic effect of sodium paraparin.

Since the risk of the toxic effect of sodium parapaparin on the fetus can not be ruled out completely, during pregnancy the drug should be taken only in case of emergency and under the direct supervision of a doctor.

If you need to use the drug during lactation, breastfeeding should be discontinued.

APPLICATION FOR FUNCTIONS OF THE LIVER

Caution should be used in cases of kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution , use the drug for liver failure.

APPLICATION FOR CHILDREN

Contraindicated use of the drug in children and adolescents under 18 years (efficacy and safety not established).

SPECIAL INSTRUCTIONS

Thrombocytopenia induced by heparin

It is known that Fluxum ® , like other low molecular weight heparins, can cause thrombocytopenia.
Heparin-induced thrombocytopenia usually develops 4-10 days after the start of treatment, or earlier with repeated cases. In 10-20% of patients, there is early mild thrombocytopenia (platelets> 100 000 / μL), which may persist or regress upon continued treatment. As a result of the formation of antibodies to the heparin / platelet factor 4 complex, in some cases a more severe immune form, heparin-induced thrombocytopenia of type II may develop, followed by thrombosis and thromboembolism of the arteries of the brain, lungs, lower extremities, often with a fatal outcome. During the treatment with Fluxum, patients should be carefully monitored. With long-term treatment, the platelet count should be determined before the beginning of Fluxum therapy and 2 times a week during the first month, then the monitoring of the platelet count may be more rare. With extreme caution, Fluxum® should be given to patients who have a history of thrombocytopenia caused by heparin or other low-molecular-weight heparin, the platelet count must be calculated every day. If thrombocytopenia occurs during treatment with heparin, an alternative treatment may be therapy with low molecular weight heparins. In this case, the number of platelets should be determined daily and, if thrombocytopenia persists, low-molecular-weight heparin should be discontinued as early as possible.With thrombocytopenia <100 000 / μl, with the occurrence and progression of thrombosis, Fluxum ® should be canceled and the patient transferred to alternative anticoagulant therapy. Transfer to oral anticoagulant therapy in such cases is not recommended, because this can lead to the progression of thrombosis.
If suspicion of heparin-induced thrombocytopenia, platelet aggregation tests in vitro are not of great diagnostic value, consultation of specialists is necessary.

Spinal / epidural anesthesia

Conducting spinal or epidural anesthesia, spinal epidural analgesia or lumbar puncture against the background of preventive use of Fluxum, as well as other low molecular weight heparins, can be complicated by spinal or epidural hematoma with the development of persistent or irreversible paralysis.
The risk of these complications increases with the use of epidural catheters, with simultaneous use of NSAIDs, antiplatelet drugs or anticoagulants, in trauma or repeated spinal punctures, the presence of initial hemostasis disorders or in elderly patients. If it is necessary to perform anesthesia / analgesia of this type against the background of the prophylactic use of Fluxum, the presence of these risk factors should be carefully checked before such interventions.
Usually, spinal catheters are installed no earlier than 8-12 hours after the last injection of a prophylactic dose of low molecular weight heparin.
Do not administer Fluxum ® 2-4 hours before and after catheter establishment / removal. Injection should be postponed or canceled if blood is aspirated from the spinal canal during spinal or epidural anesthesia. The catheter should be removed as late as possible (8-12 hours) after the last prophylactic administration of Fluxum.
Special attention should be given to patients who received Fluxum ® before or after an epidural or spinal anesthetic, checking for neurologic symptoms such as low back pain, sensory and motor problems (numbness or weakness in the lower extremities), impaired bowel or bladder function.
Patients should be informed of the need to seek immediate medical attention if these symptoms occur. If suspected epidural or spinal hematoma requires immediate diagnosis and treatment, including decompression of the spinal cord.
Low molecular weight heparins differ from each other in molecular weight and specific activity, in doses; therefore, it is not recommended to alternate the use of Fluxum with other low molecular weight heparins during the treatment.

With the development of skin necrosis, treatment with Fluxum should be interrupted.

Impact on the ability to drive vehicles and manage mechanisms

Fluxum ® does not affect the ability to drive vehicles and engage in activities that require increased attention and speed of psychomotor reactions.

OVERDOSE

Symptoms: with an occasional overdose, bleeding may occur, which is not observed when the drug is used in therapeutic doses.

Treatment: in order to neutralize the effect of the drug, it is necessary to inject sulphate into / in protamine from the rate of 0.6 ml of protamine sulfate per 0.1 ml of Fluxum.

DRUG INTERACTION

Unsupported combinations

With simultaneous use with acetylsalicylic acid, other salicylates, NSAIDs, the risk of bleeding is increased due to antiplatelet action and damaging effect on the mucosa of the gastrointestinal tract of these drugs.

At simultaneous application with tiklopidin the risk of a bleeding owing to antiplatelet action increases.
Contraindicated joint use with parnaparin sodium in high doses. When used together with parnaparin sodium in low prophylactic doses, careful clinical observation and control of the coagulation factors is necessary.
When used together with other antiplatelet drugs (eg, clopidogrel, dipyridamole), the risk of bleeding is increased.

Increased risk of bleeding with simultaneous application with sulfinpyrazone.

Combinations where caution should be exercised

With simultaneous use with oral anticoagulants, an anticoagulant effect may be enhanced.
When replacing parnaparin sodium with oral anticoagulants, careful monitoring of the patient is necessary. To assess the effect of these drugs on hemostasis, a blood test should be performed before the appointment of parnaparin sodium.
Increased risk of bleeding when using GCS in high doses for more than 10 days due to damage to the mucosa of the gastrointestinal tract and direct exposure to the vessel wall.
The use of sodium parnaparin concomitantly with GCS should be justified and carried out under the supervision of a physician.
When used simultaneously with dextran (for parenteral use), the risk of bleeding increases due to antiplatelet action.
With this combination, a dose adjustment of sodium paraparin is necessary, so that the reduction in blood clotting values ​​does not exceed 1.5 times.
The effect of sodium parapaparin decreases with simultaneous use with ascorbic acid, antihistamines, cardiac glycosides, penicillin (for intravenous administration), tetracycline, phenothiazine derivatives.

Incompatibility

Fluxum ® is an acidic polysaccharide that forms insoluble complexes with bases.
For this reason, sodium parnaparin solution is incompatible with solutions of vitamin K, B vitamins, hydrocortisone, hyaluronidase, calcium gluconate, quaternary ammonium bases, chloramphenicol, tetracycline and aminoglycosides.
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 25 ° C.
Shelf life - 3 years.
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