Universal reference book for medicines
Name of the drug: SEPROTIN (CEPROTIN)

Active substance: protein C

Type: Anticoagulant is an inhibitor of factors Va and VIIIa

Manufacturer: BAXTER (Austria)
Composition, form of production and packaging
Lyophilizate for the preparation of a solution for
intravenous administration of 1 vial.

protein C human 500 IU *

total protein (including human albumin) 42.5 mg (40 mg)

[PRING] sodium chloride - 44 mg, sodium citrate dihydrate - 22 mg.

Solvent: water d / u - 5 ml.

* 1 ME protein C corresponds to the measured amidolytic activity of protein C in 1 ml of normal plasma.
Activity (in IU) is determined using the chromogenic substrate method in relation to the international WHO standard.
Vials (1) complete with a solvent (fl.), A needle for transfer and a needle-filter - packs of cardboard.

Lyophilizate for the preparation of a solution for intravenous administration of 1 vial.

protein C human 1000 IU *

total protein (including human albumin) 85 mg (80 mg)

[PRING] sodium chloride - 88 mg, sodium citrate dihydrate - 44 mg.

Solvent: water d / u - 10 ml.

* 1 ME protein C corresponds to the measured amidolytic activity of protein C in 1 ml of normal plasma.
Activity (in IU) is determined using the chromogenic substrate method in relation to the international WHO standard.
Vials (1) complete with a solvent (fl.), A needle for transfer and a needle-filter - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Anticoagulant.
Protein C is a vitamin K-dependent anticoagulant glycoprotein, which is synthesized in the liver. It is activated on the surface of the vascular endothelium by means of a thrombin / thrombomodulin complex, turning into activated protein C (activated protein C-APC). APC is a serine protease with a powerful anticoagulant effect, especially in the presence of protein S. The effect of APC is associated with the inactivation of activated V and VIII clotting factors, which leads to a decrease in the formation of thrombin. ARS also has a profibrinolytic effect. In / in the introduction of sperton causes a rapid, but temporary increase in the level of protein C in the plasma. Substitution therapy in patients with protein C deficiency is designed to control thrombotic complications or prevent them when used for the purpose of prevention.
PHARMACOKINETICS

The pharmacokinetics of protein C were evaluated by HPLC.
T 1/2 ranged from 4.4 to 15.9 h using an isolated elimination model and from 5.6 to 27.7 h using the integrated model. The degree of recovery of activity of protein C in vivo was from 20.4 to 83.2%. Patients were significantly different in age, body weight and plasma volume. In patients with acute thrombosis, an increase in the activity of protein C in response to therapy, as well as T 1/2, may have lower values.
INDICATIONS

Sephrite is shown with fulminant purpura and coumarin-induced skin necrosis in patients with severe congenital insufficiency of protein C.

In addition, the short-term use of Seprotin for prophylaxis is indicated for patients with severe congenital insufficiency of protein C in the following cases:

- if surgical or invasive intervention is unavoidable;

- at the beginning of the course of treatment with coumarin;

- if the effect of treatment solely coumarin is insufficient;

- If it is not possible to conduct a course of treatment with coumarin.

Sephrite should be used only for severe congenital deficiency of protein C, because
data on the effectiveness and safety of use of the drug in other diseases are absent.
DOSING MODE

Treatment with seprotin should be started under the supervision of a doctor who has experience in conducting replacement therapy with clotting factors and fibrinolytic drugs under conditions that allow monitoring the activity of protein C.

The dose should be selected individually on the basis of laboratory tests in each individual patient.

Protein C activity in the serum of the patient should be brought to 100% at the beginning of the course of treatment and throughout the course should be maintained at a level above 25%.
The recommended initial dose is 60-80 IU / kg, which allows to determine the intensity of the therapeutic response and T 1/2 . To measure the serum activity of protein C before and during treatment with Spertin it is recommended to use the chromogenic layer method.
The dose of the drug should be determined on the basis of a laboratory measurement of the activity of protein C. In the case of acute thrombosis, the activity of protein C should be measured every 6 hours, until the stabilization of the patient's condition, and then 2 times a day and before each subsequent injection.
It should be taken into account that T 1/2 of protein C can be significantly reduced in certain clinical conditions, including acute thrombosis with fulminant purpura and necrosis of the skin.
If treatment with seprotin is started in the acute stage of the disease, an increase in the level of protein C in response to therapy can be slow.
Because response to therapy with seprotin varies in significant intervals, then patients should regularly assess coagulation rates.
Experience with seprotin in patients with renal and / or liver failure is not available, and therefore such patients require more careful observation.

If the patient is transferred to a constant intake of oral anticoagulants, substitution therapy with protein C should be interrupted only after achieving a stable effect of anticoagulants.
In this case, when treating with oral anticoagulants, it is preferable to start with a small dose with a gradual increase to the required level than from standard dosages.
Patients who are prescribed Protein C for prophylaxis, with an increased risk of thrombosis (eg, with infection, trauma or surgery), it is advisable to increase the background level of protein C.

Data on the efficacy and safety of the use of seprotin in patients with combined severe congenital deficiency of protein C and ARC resistance (APC-activated protein C) are limited.

Method of administration

Spertin is given IV, after dissolving the lyophilizate with sterile water for injection at a rate of no more than 2 ml / min;
in children weighing less than 10 kg - at a rate of no more than 0.2 ml / kg / min.
With the / in the introduction of seprotin, as in the case of the use of other protein-containing drugs, it is possible to develop allergic reactions.
In the event that allergic symptoms rapidly increase or acquire a life-threatening character, the drug should be administered at a dose sufficient to sustain the patient's life.
Rules for preparing the preparation

Dissolve lyophilized Seprotin with sterile water for injection, connecting the vials with a transfer needle.
Gently stir the contents of the vial until it dissolves completely.
The solution is filled through a filter needle with a sterile disposable syringe.
For each vial with a ready-made solution of seprotin, a separate filter needle should be used. The solution can not be used if inclusions are visible in it. Immediately after the preparation of the solution, it should be injected iv.
SIDE EFFECT

Single information about undesirable effects is known.
Targeted studies related to the safety of the drug were not conducted.
In rare cases, the symptoms of hypersensitivity to the drug and allergic reactions (such as angioedema, burning sensation at the injection site, chills, hyperemia, rash, urticaria, lowering of blood pressure, lethargy, apathy, nausea, anxiety, tachycardia, a feeling of tightness in the chest , vomiting, tingling, bronchospasm).

There are isolated reports of the occurrence of fever, arrhythmia, bleeding and thrombosis in the treatment of treatment with seprotin.

When using the drug in persons with severe congenital insufficiency of protein C, protein-C-inhibiting antibodies can be produced.

CONTRAINDICATIONS

- Hypersensitivity to the drug or to any of its components, to murine proteins or to heparin, except when it is necessary to monitor life-threatening thrombotic complications.

PREGNANCY AND LACTATION

Despite the fact that Spertin was successfully used in pregnant women with a deficiency of protein C, the safety of the drug when used in pregnancy was not supported by controlled clinical trials.
Therefore, seprotin can be prescribed during pregnancy and lactation only with obvious indications, a clear superiority of the expected benefit over the risk.
APPLICATION FOR FUNCTIONS OF THE LIVER

The experience of treatment with seprotin in patients with renal insufficiency is absent, and therefore such patients require more careful observation.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The experience of treatment with seprotinum patients with hepatic insufficiency is absent, and therefore such patients require more careful observation.

APPLICATION FOR CHILDREN

Spertin is given IV, after dissolving the lyophilizate with sterile water for injection at a rate of no more than 2 ml / min;
in children weighing less than 10 kg - at a rate of no more than 0.2 ml / kg / min.
SPECIAL INSTRUCTIONS

Because
there is a risk of developing allergic reactions, patients should be informed of early allergy symptoms, such as urticaria (including generalized), chest tightness, bronchospasm, falling blood pressure and anaphylaxis. When these symptoms appear, patients should immediately stop treatment and contact their doctor.
With the development of shock should be in accordance with the current rules of treatment of shock.

With the introduction of drugs prepared from human blood or plasma, the possibility of transmitting infectious agents can not be completely ruled out.
This also applies to pathogens of unknown nature.
In order to reduce the risk of transmission of infectious agents, a number of safety measures are included in the production process of the drug:

- Donors are selected on the basis of medical examination data and screening of blood received from each donor for markers of hepatitis B, C, HIV viruses;

- Plasma pool testing is performed for the presence of genomic material of the hepatitis C virus;

- Inactivation / deletion procedures are recognized that are effective against hepatitis A, B and C viruses, HIV.

However, the effectiveness of the inactivation / removal procedures may not be sufficient for parvovirus B19.
Parvovirus B19 can cause particularly serious consequences in immunocompromised individuals, increased erythrocyte production (eg, hemolytic anemia), and in pregnant women (fetal infection), therefore, the risk of parvovirus B19 transmission should be particularly taken into account when using the drug in these patient categories.
Patients who are prescribed drugs prepared from human blood or plasma are recommended to vaccinate against hepatitis A and B.

The amount of sodium in the maximum daily dose may exceed 200 mg.
This should be taken into account if the patient is prescribed a diet with a lower sodium content.
Seprotin may contain trace amounts of heparin.
Therefore, patients can experience heparin-induced allergic reactions accompanied by thrombocytopenia (heparin-induced thrombocytopenia). With heparin-induced thrombocytopenia (HIT), complications such as arterial or venous thrombosis, DIC syndrome, purpura, petechiae and gastrointestinal bleeding are possible. If a patient is suspected of HIT, the platelet level should be determined as soon as possible and, if necessary, interrupted by treatment with Seprotin. The detection of GIT is complicated by the fact that in the acute phase of severe hereditary protein C deficiency, similar symptoms may occur even before the beginning of treatment. Patients with HIT in the future should avoid the use of drugs containing heparin.
When using Seprotin, several cases of bleeding were noted.
This could be due to the concomitant use of anticoagulants (eg, heparin). However, it can not be ruled out that the introduction of Seprotine could also contribute to hemorrhagic episodes.
Pre-clinical trial data

Protein C, contained in Seprotin, which is isolated from human plasma, is identical in its action to natural human protein C. Therefore, experimental studies of the mutagenic and carcinogenic effects of this drug using laboratory animals are inexpedient.
The assessment of the toxicity of a single dose on laboratory animals showed that even a 10-fold excess of the recommended dose for a person per unit of body weight does not cause toxic effects. In the Ames test (Ames test), the absence of a mutagenic potential in Spertin is shown.
Impact on the ability to drive vehicles and manage mechanisms

There was no impact on the ability to drive and move vehicles.

OVERDOSE

There are no reports of symptoms of an overdose with seprotin.

DRUG INTERACTION

No interaction of siprotin with other drugs has been observed.

Prior to the onset of anticoagulant effect of seprotin in patients who started treatment with oral anticoagulants from the group of vitamin K antagonists (for example, warfarin), a transient state of hypercoagulability is possible.
This can be explained by the fact that protein C itself is a vitamin-K-dependent plasma protein and has a shorter T 1/2 than other vitamin K-dependent plasma proteins (such as factors II, IX and X). Therefore, in the initial phase of treatment, protein C is inactivated faster than procoagulant factors. It is for this reason that when transferring a patient to taking oral anticoagulants before the onset of a stable anticoagulant effect, it is necessary to continue the replacement therapy with protein C.
In the initial stage of therapy with oral anticoagulants, in any patient, warfarin-induced necrosis of the skin can develop.
Persons with congenital deficiency of protein C belong to a group with an increased risk.
Incompatibility

Studies on the incompatibility of saprotin have not been conducted, so it should not be confused with other drugs.

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, protected from light at a temperature of 2 ° to 8 ° C;
Do not freeze. Shelf life - 3 years. Do not use after the expiration date indicated on the package.
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