Instruction for use: Cytotect

Dosage form: Solution for intravenous administration

Active substance: Immunoglobulin cytomegalovirus

ATX

J06BB09 human immunoglobulin antitsitomegalovirusny

Pharmacological group:

Immunoglobulins

The nosological classification (ICD-10)

B20-B24 Disease caused by human immunodeficiency virus [HIV]: Deployed stage of HIV infection; AIDS in children; HIV / AIDS infection; Infections with HIV; AIDS; Human Immunodeficiency Virus HIV-1; HIV-1 infection HIV infection; HIV

B25 Cytomegalovirus: Generalized CMV infection in patients with AIDS; Cytomegalovirus infection in patients with impaired immunity; Cytomegalovirus infection; Cytomegalovirus infection in patients with habitual miscarriage Cytomegalovirus retinitis; Cytomegalovirus retinitis in AIDS patients; CMV; CMV in AIDS patients; CMV infection; CMV infection in the presence of immunodeficiency; CMV infection in cancer patients with immunosuppression; CMV-pneumonia; CMV retinitis in patients with weakened immunity; CMV retinitis in AIDS patients

D84.9 Unspecified Immunodeficiency: Pneumonia in immunodeficient states; Autoimmune disease; Autoimmune diseases; Severe immunodeficiency; immune deficiency; Immunodeficiency; immunodeficiency diseases; Immunodeficiency states due to surgery; Immunotherapy for cancer; Immunomodulation; Infections in patients with weakened immune systems; Correction of immune deficiency; Correction of immunodeficiencies; Correction of a weakened immune system; Correction of a weakened immunity in immunodeficient states; Violation of immunity; Violation of the immune status; Immune System Disorders; Primary immunodeficiency; Maintaining immunity; Lowering the body's defenses; Lowering the immunity; Lowering the immunity of colds and infectious diseases; The decrease of the immune status; Lowered resistance to infections; Lowered resistance to infections and colds; Lowered resistance; Immunosuppression; Predisposition to colds; acquired immune deficiencies; Radiation immunodeficiency; The development of immunodeficiency; Immune dysfunction syndrome; immunodeficiency syndrome; primary immunodeficiency syndrome; Reducing the body's defenses; Immunosuppression; Reduced immune defense; Reducing local immunity; Reducing the total body resistance; The decrease in cell-mediated immunity; Reduced resistance to infections in children; Reducing the body's resistance; Reduced resistance; reduced immunity; Status immunodeficiency; Stimulation of the processes of nonspecific immunity; Heavy selective secondary immunodeficiency; immunity Oppression; Primary immunodeficiency

Z29.1 Prophylactic immunotherapy: Vaccination against viral infections; donor Vaccination; Vaccination and revaccination; Vaccination of newborns; Vaccination against hepatitis B; Immunization; Correction of the immune status; Therapeutic and prophylactic immunization; Preventive immunization; Specific immunoprophylaxis; Stimulation of the processes of nonspecific immunit

Composition and release form

Solution for injection 10% 1 ml

Human plasma proteins 100 mg

(IG ≥ 95% of them, including antibodies against CMV 50 ED of the comparative preparation of the Paul Ehrlich Institute)

In ampoules of 10 and 20 ml or in bottles of 50 ml; In a cardboard bundle 1 ampoule or 1 bottle.

Description of dosage form

Colorless or light yellow transparent or slightly opalescent solution.

Pharmachologic effect

Mode of action - immunomodulating.

Increases the body's antibodies against human CMV.

Indication of the Cytotect

Cytomegalovirus infection (CMV): prevention in patients with immunodeficiency, immunosuppression (especially after transplantation) and treatment in immunocompromised patients (preterm infants, newborns or infants, AIDS, immunosuppressant therapy, etc.).

Contraindications

Hypersensitivity.

Application in pregnancy and breastfeeding

Carefully.

Side effects

Headache, chills, fever, nausea, vomiting, aches in joints, back pain, allergic reactions. Rarely, lowering blood pressure, in a few cases - anaphylactic shock, symptoms of aseptic meningitis (severe headache, nausea, vomiting, fever, stiff neck, photosensitivity, impaired consciousness), aggravation of kidney failure in patients with impaired renal function.

Interaction

Weaken the effectiveness of live viral vaccines (against measles, rubella, mumps, chicken pox).

Dosing and Administration

IV (before the injection the solution is heated to room temperature or body temperature), at a rate of not more than 20 drops / minute (1 ml / min). Prevention of cytomegalovirus infection: in a single dose of 1 ml / kg, with organ transplantation - on the day of transplantation, with bone marrow transplantation - on the day preceding the transplantation. In CMV-seropositive patients, prevention is started 10 days before transplantation. Course - 6 single doses with an interval of 2-3 weeks.

Therapy of cytomegalovirus infection: in a single dose of 2 ml / kg every 2 days until the disappearance of clinical symptoms.

Overdose

Symptoms: hypervolemia, increased blood viscosity (especially in patients with impaired renal function or the elderly).

Special instructions

Can only be mixed with 0.9% sodium chloride solution.

Possible the appearance of false positive data for serological examination.

Storage conditions of the drug Cytotect

In the dark place at a temperature of 2-8 ° C (do not freeze).

Keep out of the reach of children.

Shelf life of the drug Cytotect

3 years.

Do not use after the expiry date printed on the package.