Gonococcal vaccine inactivated gonovaccine (Suspension) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07AX (Other bacterial vaccines)

Active Substance

Gonococcal vaccine for the treatment and diagnosis

Dosage Form

Gonococcal vaccine inactivated (gonovaccine)

Intramuscular suspension: 1 ml amp. 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular administration of a yellowish-gray color, with sediment; after shaking, it is a yellowish-gray liquid with uniformly distributed particles.

* International Units of the OSO opacity standard for bacterial suspensions.

Excipients: sodium chloride – 9 mg, phenol – 2.5 mg, water for injection – up to 1 ml.

1 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the treatment and diagnosis of gonorrhea

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

It increases the specific reactivity of the body (stimulates the production of antibodies with neutralizing, opsonic, and protective action).

Indications

In adults

• Gonococcal infection (as part of complex therapy) after unsuccessful antibiotic therapy for indolent relapses, for fresh torpid and chronic forms of the disease, for men with complicated and women with ascending gonorrhea (after the acute inflammatory phenomena subside);
• Diagnosis of gonorrhea (examination for gonorrhea in patients with chronic diseases of the genitourinary organs, determination of cure from gonorrhea).

In children from 3 years of age

• Gonococcal infection (as part of complex therapy) after unsuccessful antibiotic therapy for indolent relapses, for fresh torpid and chronic forms of the disease;
• Diagnosis of gonorrhea (examination for gonorrhea in patients with chronic diseases of the genitourinary organs, determination of cure from gonorrhea).

ICD codes

Dosage Regimen

The vaccine is administered intramuscularly into the upper-outer quadrant of the buttock with pre- and post-injection treatment of the injection site with 70% ethyl alcohol. The administered drug must be at body temperature.

Before drawing into a syringe, the ampoule with the vaccine must be shaken to obtain a uniform suspension. The drug in an opened ampoule must not be stored.

For gonococcal infection

Adults injections are performed at intervals of 1-2 days depending on the reaction. The initial dose of the vaccine is 0.3 – 0.4 ml (for complicated gonorrhea, the use of the vaccine should start with 0.2 – 0.3 ml).

At a temperature not exceeding 36.9°C (98.4°F) the vaccine dose is increased by 0.3 ml each time, the administration interval is 1 day.

With an increase in temperature (less than 1.5°C (34.7°F) from normal) the vaccine dose is increased by 0.15 ml each time, the administration interval is 2 days. The maximum single dose of the vaccine should not exceed 2.0 ml. The vaccine is administered once a day. The duration of treatment is up to 6 – 8 injections.

Children over 3 years old injections are performed at intervals of 1-2 days depending on the reaction. The initial dose of the vaccine is 0.05 – 0.1 ml.

At a temperature not exceeding 36.9°C (98.4°F) the vaccine dose is increased by 0.05 ml each time, the administration interval is 1 day.

With an increase in temperature (less than 1.5°C (34.7°F) from normal) the vaccine dose is increased by 0.025 ml each time, the administration interval is 2 days. The maximum single dose of the vaccine should not exceed 0.5 ml. The vaccine is administered once a day. The duration of treatment is up to 6-8 injections.

For the diagnosis of gonorrhea

To determine the cure of gonorrhea, as well as when examining for gonorrhea in patients with chronic diseases of the genitourinary organs, 0.5 ml of the vaccine is administered as a provocation. If the vaccine was used during treatment, then a doubled last therapeutic dose is prescribed for provocation, but not more than 2.0 ml.

Precautions

Possible complications: general reactions – malaise, increase in body temperature up to 39°C (102.2°F) within 24 – 48 hours from the moment of vaccine administration, headache, general weakness; focal reactions – increased discharge, pain in the affected organs, cloudiness of urine; local reactions – pain at the injection site.

In case of complications (immediate-type allergic reactions: anaphylactic shock, Quincke’s edema, urticaria), symptomatic therapy should be carried out.

If the temperature increases (more than 1.5°C (34.7°F) from normal), if the general condition worsens, or if there is sharp pain in the affected organ, the use of the vaccine should be discontinued.

After each administration of the vaccine, the vaccinated persons should be under medical supervision for 30 minutes; places where vaccination is carried out must have means for emergency and anti-shock therapy.

Adverse Reactions

The general reaction is manifested by malaise, an increase in body temperature up to 39°C (102.2°F) within 24 – 48 hours from the moment of vaccine administration, headache, general weakness; focal – by increased discharge, pain in the affected organs, cloudiness of urine; local – by pain at the injection site.

In case of complications (immediate-type allergic reactions: anaphylactic shock, Quincke’s edema, urticaria), symptomatic therapy should be carried out.

Contraindications

• Tuberculosis (active form);
• Diseases of the circulatory system (acute rheumatic fever, chronic rheumatic heart diseases, ischemic heart disease, cerebrovascular diseases, diseases of arteries, arterioles and capillaries, pulmonary heart disease and disorders of pulmonary circulation, diseases of veins, lymphatic vessels and lymph nodes, other heart diseases);
• Diseases characterized by elevated blood pressure;
• Liver diseases (fibrosis and cirrhosis of the liver, sclerosis of the liver, toxic liver damage, acute and subacute liver failure, chronic liver failure);
• Viral hepatitis (acute hepatitis A, acute hepatitis B, acute hepatitis E, acute hepatitis C, chronic viral hepatitis);
• Diseases of the genitourinary system (glomerular diseases, tubulointerstitial kidney diseases);
• Renal failure (acute renal failure, renal failure with tubular necrosis, acute renal failure with acute cortical necrosis, acute renal failure with medullary necrosis, other acute renal failure, acute renal failure unspecified, chronic renal failure, end-stage renal disease, other manifestations of chronic renal failure, chronic renal failure unspecified, renal failure unspecified);
• Personal history of allergy to drugs, medications and biological substances;
• Menstruation;
• Anemias (nutrition-related, due to enzyme disorders, aplastic and other anemias);
• Age under 3 years.

To identify contraindications, the doctor (paramedic) on the day of vaccine use conducts a survey and examination of the patient with mandatory thermometry. If an elevated temperature is detected before the first prescription of the drug (above 36.9°C (98.4°F)) vaccination is not performed. On subsequent days, the vaccine should be prescribed in accordance with the dosage regimen.

With caution if it is necessary to diagnose and treat gonococcal infection in children who have had acute diseases, the administration of the vaccine is allowed no earlier than 4 weeks after recovery; for mild forms of respiratory diseases (rhinitis, mild hyperemia of the pharynx, etc.) the administration of the vaccine is allowed 2 weeks after recovery. For patients with chronic diseases, the vaccine is administered upon achieving stable remission (not less than 4 weeks later).

Use in Pregnancy and Lactation

The safety of using this medical drug during pregnancy and breastfeeding has not been studied in controlled clinical trials. Therefore, the drug is used as prescribed by a doctor, taking into account the ratio of the expected benefit for the mother and the possible risk for the fetus and child.

Use in Hepatic Impairment

Contraindicated in liver diseases (fibrosis and cirrhosis of the liver, sclerosis of the liver, toxic liver damage, acute and subacute liver failure, chronic liver failure).

Use in Renal Impairment

Contraindicated in diseases of the genitourinary system (glomerular diseases, tubulointerstitial kidney diseases); in renal failure (acute renal failure, renal failure with tubular necrosis, acute renal failure with acute cortical necrosis, acute renal failure with medullary necrosis, other acute renal failure, acute renal failure unspecified, chronic renal failure, end-stage renal disease, other manifestations of chronic renal failure, chronic renal failure unspecified, renal failure unspecified).

Pediatric Use

Contraindicated in children under 3 years of age.

Special Precautions

The drug in ampoules with damaged integrity or labeling, with changed physical properties (change in color, presence of sediment that does not break up upon shaking), in the presence of foreign inclusions, or with violated storage conditions is not suitable for use.

Overdose

Cases of overdose have not been described.

Drug Interactions

Simultaneous antibiotic therapy is possible.

Storage Conditions

In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F). Keep out of reach of children. Freezing is not allowed.

Shelf Life

Shelf life – 1 year.

Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F). Short-term (no more than 24 hours) transportation at a temperature of 9 to 20°C (68°F) is allowed. Freezing is not allowed.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.