Vaccine gonococcal inactivated (gonovaccine) (GONOCOCCAL VACCINE INACTIVATED (GONOVACCINE))

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the treatment and diagnosis of gonococcalVaccine for the treatment and diagnosis of gonococcal
Dosage form: & nbspsuspension for intramuscular injection
Composition:

1 ml of the preparation contains:

Active substance:

Suspension of inactivated gonococcal culture - 10 ME (international units) CCA turbidity of bacterial suspensions.

Excipients:

Sodium chloride 9 mg;

Phenol - preservative - 2.5 mg;

Water for injection up to 1 ml.

Description:

Suspension yellowish-gray with a deposit. After shaking, a liquid of a yellowish-gray color with particles distributed uniformly in it.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp
  • Other vaccines for the prevention of bacterial infections
    • Pharmacodynamics:

    Characteristics of the preparation

    The drug is a suspension of inactivated gonococcal culture in sodium chloride solution 0.9%. To produce the drug use at least 10 strains Neisseria gonorrhoeae, isolated from patients with various clinical forms of gonorrhea.

    Pharmacological properties

    Increases the specific reactivity of the body (stimulates the production of antibodies with neutralizing, opsonic and other protective effects against gonococcal infection).

    Indications:

    Treatment of gonorrhea as part of complex therapy in adults and children older than 3 years:

    - recurrent, chronic and torpid form of the disease;

    - complicated gonorrhea in men and ascending gonorrhea in women (after the subsidence of acute inflammatory phenomena).

    Diagnosis of gonorrhea in adults and children older than 3 years:

    - Diagnosis of patients with chronic diseases of the genito-urinary organs;

    - the establishment of cure for gonorrhea.

    Contraindications:

    Temporary contraindications

    1. Acute infectious and non-infectious diseases, including the period of convalescence. The introduction of the vaccine is allowed 2-4 weeks after recovery.

    In acute viral hepatitis (except for hepatitis C), the administration of the vaccine is allowed not earlier than, after 6 months. after recovery.

    With the active form of tuberculosis, the administration of the vaccine is allowed at the end of the active phase, at the conclusion of the phthisiatrician.

    2. For non-severe acute respiratory viral infections, acute intestinal diseases, etc., the administration of the vaccine is allowed after normalization of the temperature.

    3. Chronic diseases in the stage of exacerbation or decompensation. The vaccine is administered when a stable remission is achieved.

    4. Menstruation.

    Constant contraindications:

    - hypersensitivity to the components that make up the drug;

    - hepatitis C;

    - severe immunodeficiency conditions (including HIV infection);

    - diseases of the circulatory system (chronic ischemic heart disease, chronic rheumatic heart disease, atherosclerosis);

    - diseases characterized by high blood pressure (essential hypertension, hypertensive heart and kidney disease, secondary hypertension);

    - liver disease (chronic hepatitis, liver cirrhosis, toxic liver damage, acute and subacute liver failure, chronic liver failure);

    - diseases of the genitourinary system (acute renal failure, chronic renal failure, glomerulonephritis);

    - aplastic and hemolytic anemia.

    Carefully:

    There is no information.

    Pregnancy and lactation:

    The safety of the drug during pregnancy and during breastfeeding during controlled clinical trials has not been investigated.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 or newborn.

    Dosing and Administration:

    The vaccine is injected intramuscularly into the upper-upper quadrant of the buttock with pre- and post-injection injection site treatment with 70% ethyl alcohol. The preparation should have a temperature (36 ± 1) ° С before use.

    Before recruiting the ampoule with the vaccine, it must be shaken to obtain a uniform suspension. The drug in the opened ampoule is not subject to storage.

    Treatment of gonorrhea (recurrent, chronic and torpid form of the disease) as part of complex therapy in adults and children older than 3 years.

    For adults the initial dose of the vaccine is 0.3-0.4 ml.

    Injections are carried out at intervals of 1-2 days, depending on the reaction:

    - at a temperature of no more than 36.9 ° C, the dose of the vaccine is increased by 0.3 ml each time, the interval of administration is 1 day.

    - with increasing temperature (less than 1.5 ° C from normal), the dose of the vaccine is increased by 0.15 ml, the interval of administration is 2 days.

    The maximum single dose of the vaccine should not exceed 2.0 ml.

    Duration of treatment up to 6-8 injections.

    For children over 3 years old the initial dose of the vaccine is 0.05-0.1 ml.

    Injections are carried out at intervals of 1-2 days, depending on the reaction:

    - at a temperature not exceeding 36,9 ° C vaccine dose is increased each time by 0.05 mL administration interval is 1 day.

    - at higher temperatures (less than 1,5 ° C from the normal) vaccine dose each time incremented by 0.025 mL, administration interval of 2 days.

    The maximum single dose of vaccine should not exceed 0.5 ml.

    Duration of treatment up to 6-8 injections.

    Treatment of uncomplicated gonorrhea in men and rising gonorrhea in women (after decrease in acute inflammation) in the complex therapy.

    The initial dose of the vaccine is 0.2-0.3 ml.

    Injections are carried out at intervals of 1-2 days, depending on the reaction:

    - at a temperature of no more than 36.9 ° C, the dose of the vaccine is increased by 0.3 ml each time, the interval of administration is 1 day.

    - with increasing temperature (less than 1.5 ° C from normal), the dose of the vaccine is increased by 0.15 ml, the interval of administration is 2 days.

    The maximum single dose of the vaccine should not exceed 2.0 ml.

    Duration of treatment up to 6-8 injections.

    Diagnosis of gonorrhea in adults and children older than 3 years (diagnosis of patients with chronic genitourinary diseases and the establishment of cure for gonorrhea)

    As a provocation, 0.5 ml of the vaccine is administered intramuscularly once. If the vaccine was used during treatment, then twice the last therapeutic dose is prescribed for provocation, but not more than 2.0 ml.

    Side effects:

    The frequency of development of the following side effects is indicated according to the recommendations of the World Health Organization and includes the following categories:

    Very often - ≥ 10%;

    Often - ≥ 1% and <10%;

    Infrequently, ≥ 0.1% and <1%;

    Rarely ≥ 0.01% and <0.1%;

    Very rarely - <0.01%.

    Common side effects:

    Very often: malaise, fever to 39.0 ° C for 24-48 hours from the time of vaccine administration, headache, general weakness.

    Allergic reactions:

    Very rarely: anaphylactic shock, Quincke's edema, hives.

    Local reactions:

    Very often: soreness in the area of ​​injection.

    From the genitourinary system:

    Very often: increased secretion, soreness in the affected organs.

    Laboratory indicators:

    Very often: turbidity of urine.

    Overdose:

    No cases of overdose have been reported.

    Interaction:

    Possible simultaneous antibiotic therapy.

    Special instructions:

    The preparation is not suitable for use in ampoules with broken integrity or marking, with a change in physical properties (color change, the presence of a precipitate that is not broken when shaken), in the presence of foreign inclusions, violation of storage conditions.

    Precautions for use

    In order to identify contraindications, the doctor (paramedic) on the day of applying the vaccine conducts a survey and examination of the patient with mandatory thermometry. If there is an increased temperature before the first appointment of the drug (more than 36.9 ° C), vaccination is not carried out. In the following days, the vaccine should be administered in accordance with the dosing regimen.

    In case of complications (allergic reactions of immediate type: anaphylactic shock, Quincke's edema, urticaria), symptomatic therapy should be performed.

    When the temperature rises (more than 1.5 ° C from normal), deterioration of the general condition, sharp pain in the affected organ, the use of the vaccine should be discontinued.

    After each injection of the vaccine, the vaccinated should be under medical supervision for 30 minutes; Vaccination sites should be providedmeans of emergency and anti-shock therapy.

    Form release / dosage:Suspension for intramuscular injection.
    Packaging:

    In ampoules of 1 ml.

    For 10 ampoules together with instructions for use, ampoule scarifier in a pack of cardboard.

    5 ampoules in a cassette outline package. Two cassette contour packs along with instructions for use 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:

    In accordance with JV 3.3.2.3332-16, at a temperature of 2 to 8 ° C. Keep out of the reach of children. Freezing is not allowed.

    Transportation conditions

    AT according to SP 3.3.2.3332-16, at a temperature of 2 to 8 ° C. Short-term (not more than 24 hours) transportation at a temperature of 9 to 20 ° C is allowed. Freezing is not allowed.

    Shelf life:

    1 year.

    The drug with expired shelf life is not subject to application.

    Terms of leave from pharmacies:On prescription
    Registration number:P N000883 / 01
    Date of registration:31.08.2007 / 30.11.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Information update date: & nbsp06.02.2017
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