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Dosage form: & nbspLiofilizate for solution for infusion
Composition:1 ampoule contains 100 mg:
ceruloplasmin, which is a copper-containing glycoprotein of the alpha-globulin fraction of human blood serum; sodium chloride - no more than 50 mg.
Description:

Amorphous powder or a porous mass of blue.

Pharmacotherapeutic group:Detoxifying agent.
ATX: & nbsp
  • Antidotes
  • Pharmacodynamics:Detoxifying agent. Performs in the body a number of important functions: it is the main carrier of copper in the body; participates in the metabolism of iron; is an antioxidant, binds superoxide radicals and prevents peroxide oxidation of lipids of cell membranes, increases the stability of cell membranes; accelerates the replacement of the number of erythrocytes in the treatment of anemia of various etiologies, has a protective effect on both erythroid and on myeloid and lymphoid hematopoietic elements; participates in immune reactions; participates in ion exchange; reduces intoxication and immunodepression in the treatment of diseases associated with the use of chemotherapy and radiotherapy.
    Indications:
    • anemia of different genesis in adults and children (over 6 months);
    • leukopenia;
    • cachexia;
    • intoxication;
    • in the complex therapy of cancer patients;
    - preoperative preparation in weakened patients with anemia;
    - massive and moderate blood loss during surgery; purulent-septic complications in the early postoperative period; osteomyelitis (acute and chronic).
    Contraindications:
    Hypersensitivity to drugs of protein origin.
    Children age 0 to 6 months (due to the lack of data on the effectiveness and safety of use in this category of patients).
    Pregnancy and lactation:
    In complex therapy of anemia in the 2nd and 3rd trimesters of pregnancy. Against the background of the appointment of iron preparations (taking into account the parameters of serum iron and ferritin), additionally appoint Ceruloplasmin 100 mg daily intravenously drip for 5 days.
    It is not recommended to administer the drug in the first trimester of pregnancy and during breastfeeding (due to the lack of efficacy data and safety of use in this category of patients).
    Dosing and Administration:
    Intravenously drip with a speed in adults 30 cap / min, in children 40-50 cap / min. The contents of one ampoule are dissolved in 200 ml of 0.9% sodium chloride solution. Do not exceed the indicated rate of administration.The drug is used in a hospital.
    The following dosages are recommended:
    - oncological patients in the period of preoperative preparation of Ceruloplasmin are administered in a dose of 1.5-2.0 mg / kg of body weight per day; course of treatment 7-10 intravenous administrations, daily or every other day, depending on the patient's condition;
    - in the postoperative period, a single dose is determined by the amount of blood loss and is from 1.5 mg / kg with moderate blood loss, up to 6 mg / kg in case of massive blood loss. The course of treatment consists of daily (once a day) intravenous injections for 7-10 days;
    When conducting radio and chemotherapy, a single dose is 4-6 mg / kg of body weight, the course of treatment consists of 10-14 intravenous administrations (3 injections per week). For patients with hemoblastoses, the single dose is 1.5-3.0 mg / kg, the course of treatment is 7-10 intravenous infusions, prescribed daily 1 time per day; in acute osteomyelitis, a single dose of 2.5 mg / kg of body weight, the course of treatment consists of 5 intravenous administrations, administered daily or every other day. In chronic osteomyelitis, Ceruloplasmin is administered at 5 mg / kg 2-3 times at intervals of 1-2 days, and then 3-7 injections of 2.5 mg / kg are given.
    In pediatric practice, the following dosages are recommended:
    - children from 6 months to 1 year - 50 mg (100 ml of solution);
    - from 1 year to 12 years - 100 mg;
    - from 13 to 18 years - 200 mg.
    For the prevention and / or treatment of posthemorrhagic anemia in surgical operations in children, Ceruloplasmin is administered within 2 days prior to surgery, intraoperatively and within 2-10 days after surgery.
    For the prevention and / or treatment of anemia in children with purulent-surgical diseases, Ceruloplasmin is administered for 7-10 days daily on the days of antibiotic therapy.
    In children with oncological diseases for the prevention and / or treatment of radiation anemia with radiation therapy, Ceruloplasmin is administered once a week throughout the course of radiotherapy; for the prevention and / or treatment of toxic anemia Ceruloplasmin is administered on chemotherapy days throughout the course; To prevent and treat toxic and radiation anemia on the background of chemoradiotherapy, Ceruloplasmin is administered once a week on the day of chemotherapy throughout the course of treatment.

    Side effects:At the beginning of treatment, there may be sensations of "tidal" blood to the face, nausea, chills, short-term fever, skin rashes (urticaria).In these cases, it is necessary to reduce the dose of the drug, reduce the rate of administration, or cancel the drug.
    Interaction:

    When the drug is administered, a separate system for intravenous administration is used. Used in complex therapy with other drugs.

    Special instructions:In extremely rare cases, individuals with altered reactivity to blood products may develop anaphylactic shock, and therefore all persons who receive the drug should be under medical supervision. In the room where the drug is administered, there should be antishock therapy. The drug should be registered in the prescribed registration forms with the name of the drug, serial number, expiration date, manufacturer, date of administration and adverse reactions to the administration of the drug.
    Form release / dosage:Lyophilizate for the preparation of a solution for infusions of 100 mg.
    Packaging:Ampoules of 100 mg. For 5 or 10 ampoules in a pack of cardboard with instructions for use and a knife or scarifier ampoule if necessary.
    Storage conditions:

    Store at temperatures between 2 and 8 ° C out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-010930/09
    Date of registration:31.12.2009 / 05.12.2013
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.02.2016
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