Human tetanus antiglobulin (Immunoglobulinum antitetanicum humanum)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsolution for intramuscular injection
Composition:

1 dose (ampoule) contains:

Active substance:

- tetanus antitoxin - not less than 250 ME.

Excipient:

- stabilizer - glycine (aminoacetic acid) - (2,25 ± 0,75)%.

The drug does not contain preservatives and antibiotics.

Description:

Transparent or slightly opalescent liquid, colorless or slightly yellow in color. During storage, a slight deposit may appear, disappearing after a slight shaking.

Characteristics of the preparation.

The preparation is a concentrated solution of the purified immunoglobulin fraction extracted by the method of ethanol fractionation from blood plasma of healthy donors immunized with tetanus toxoid and individually tested for the absence of the surface antigen of the hepatitis B virus (HBsAg), antibodies to the hepatitis C virus and human immunodeficiency virus HIV-1 and HIV-2.

Pharmacotherapeutic group:MIBP globulin
ATX: & nbsp
  • Human tetanus antiglobulin
    • Pharmacodynamics:

    Immunobiological properties.

    The active component of the drug is class G immunoglobulins, which have the activity of antibodies that neutralize tetanus toxin.The drug also has nonspecific activity, manifested in increasing the resistance of the body.

    Pharmacokinetics:The maximum concentration of antibodies in the blood is reached 24-48 hours after administration, the half-life of antibodies from the body is 3-4 weeks.
    Indications:Emergency prophylaxis of tetanus in children and adults who have not received a full course of immunization with tetanus toxoid or with an unknown vaccination history.
    Contraindications:

    - Hypersensitivity to human immunoglobulin, especially in rare cases of a deficiency in the blood of immunoglobulin class A (IgA) and the presence of antibodies against IgA;

    - hypersensitivity to the components of the drug;

    - the presence in the anamnesis of allergic reactions to blood products of a person.

    In cases of severe sepsis, the only contraindication for administration is an anaphylactic shock to a person's blood products in an anamnesis.

    Carefully:

    Precautions for use.

    Immunoglobulin is used only as directed by a doctor.

    Persons suffering from allergic diseases (bronchial asthma, atopic dermatitis,recurrent urticaria) or prone to allergic reactions, administration of antihistamines is recommended on the day of immunoglobulin administration and for the next 8 days. During the acute allergic process, the drug is administered by the conclusion of an allergist according to vital indications.

    Persons suffering from diseases in the genesis of which the immunopathological mechanisms (collagenosis, immune diseases of the blood, nephritis) are leading, the drug is appointed after consultation of the relevant specialist.

    Use with caution in the following risk groups:

    - in patients older than 65 years;

    - in patients with severe heart failure;

    - in patients with renal insufficiency.

    Pregnancy and lactation:The safety of the drug during pregnancy and during breastfeeding during controlled clinical trials has not been studied. The use of the drug during pregnancy and during breastfeeding is possible only if the potential benefit to the mother exceeds the potential risk to the fetus and the baby.Immunoglobulins penetrate into breast milk and protective antibodies during breastfeeding can be transmitted from mother to child.
    Dosing and Administration:

    The drug is administered intramuscularly in the upper outer quadrant of the gluteus muscle or in the external surface of the thigh once in a dose of at least 250 IU (1 dose), regardless of age. Do not administer the drug intravenously!

    Before the injection, the ampoule with the drug is kept for 2 hours at room temperature. Opening of ampoules and the procedure of administration are carried out with strict adherence to aseptic and antiseptic rules. To prevent the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen. The drug in the opened ampoule is not subject to storage.

    The preparation is not suitable for use in ampoules with broken integrity, marking, and also when physical properties change (color change, cloudiness of solution, presence of unbreakable flakes), expired shelf life and non-observance of storage conditions.

    Side effects:

    Frequency of occurrence of side effects is determined as follows: often (≥ 1/100 and <1/10), rarely (≥ 1/10 000 and <1/1 000), very rarely (<1/10 000, including individual cases).

    The following side effects are possible:

    General disorders and disorders at the site of administration:

    Often: soreness in the injection site.

    Rarely: chills, hyperthermia, weakness, hyperemia at the injection site.

    Immune system disorders:

    Very rarely: allergic reactions (hives, itching, rash), anaphylactic shock.

    Impaired nervous system:

    Rarely: headache.

    Very rarely: dizziness.

    Disorders from the digestive system:

    Very rarely: nausea, vomiting.

    Disorders from the musculoskeletal system:

    Very rarely: pain in the back, joint pain.

    Disorders from the cardiovascular system:

    Rarely: lowering blood pressure.

    Overdose:No cases of drug overdose have been reported.
    Interaction:

    The drug can be used in complex therapy of the disease in combination with other drugs, in particular antibiotics. It is not allowed to mix the drug with other drugs in the same syringe.

    In infants, do not apply simultaneously with calcium gluconate.

    The introduction of immunoglobulin can reduce the effectiveness of active immunization, so live vaccines (against measles,mumps, rubella, chicken pox) should be administered no earlier than 3 months. after administration of immunoglobulin. After vaccination against these infections, the immunoglobulin should be administered no earlier than 2 weeks; if immunoglobulin is required before this time, vaccination against measles, mumps, rubella, chicken pox should be repeated. Vaccinations against other infections can be carried out at any time before or after the administration of the immunoglobulin.

    In the case of measles vaccination, a decrease in the effectiveness of the vaccine is possible within 1 year after the administration of the immunoglobulin. In this regard, in patients vaccinated with the measles vaccine, it is recommended to monitor the level of antibodies.

    Special instructions:

    During the administration of the drug, the patient's condition should be carefully monitored. Persons receiving the drug should be under medical supervision for 30 minutes after the administration. Premises where the drug is administered should be provided with anti-shock therapy.

    Immunoglobulin administration may result in a traitsitic increase in various passively transmitted antibodies in the patient's blood and false positive results from serological tests (eg, Coombs test).

    The drug should be registered in the prescribed registration forms with the name of the drug, serial number, date of issue, expiration date, manufacturer, date of administration, dose and adverse reactions to the drug. Special precautions when destroying an unused preparation are not available.

    Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles, mechanisms, as well as the ability to perform actions that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:Solution for intramuscular injection 1 dose (not less than 250 ME).
    Packaging:

    In a volume of not more than 5 ml (depending on the specific activity) in the ampoule. 10 ampoules with instructions for use and ampoule ampullum in a pack of cardboard.

    When packaging ampoules that have a break ring or a point for dissection, the ampoule scapegrator is not inserted.

    Storage conditions:

    Store in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C out of the reach of children. Freezing is not allowed.

    Conditions of transportation.

    Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C.Freezing is not allowed.

    Shelf life:2 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000791/08
    Date of registration:15.02.2008 / 03.06.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.10.2017
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