Vaccine gonococcal inactivated

General characteristics. Structure:

Active ingredient: 10 IU (international units) of a standard sample of a turbidity of a suspension of the inactivated culture of gonokokk.

Excipients: sodium chloride, phenol - preservative, water for injections.

Pharmacological properties:

Pharmacodynamics. Increases specific reactivity of an organism (stimulates development of antibodies with neutralized, opsonic and protective action).

Indications to use:

At adults:
• a gonorrheal infection (as a part of complex therapy) after an unsuccessful antibioticotherapia at inertly proceeding recurrence, at fresh torpid and chronic forms of a disease, to men with complicated and to women with the ascending gonorrhea (after subsiding of the acute inflammatory phenomena);
• diagnosis of gonorrhea (inspection on gonorrhea of patients with chronic diseases of urinogenital bodies, establishment of an izlechennost of gonorrhea).

At children from 3-year age:

• a gonorrheal infection (as a part of complex therapy) after an unsuccessful antibioticotherapia at inertly proceeding recurrence, at fresh torpid and chronic forms of a disease;
• diagnosis of gonorrhea (inspection on gonorrhea of patients with chronic diseases of urinogenital bodies, establishment of an izlechennost of gonorrhea).

Route of administration and doses:

The vaccine is entered intramusculary into a verkhnenaruzhny quadrant of a buttock with to - and post-injection processing of the place of an injection 70% alcohol. The administered drug has to have body temperature.

Before set in the syringe the ampoule with a vaccine needs to be stirred up for receiving a homogeneous suspension. Drug in the opened ampoule is not subject to storage.

At a gonorrheal infection:
1. Carry out by the adult of an injection with an interval of 1-2 days depending on reaction. The initial dose of a vaccine makes 0,3 - 0,4 ml (at the complicated gonorrhea use of a vaccine should be begun with 0,2 - 0,3 ml).
2. At a temperature no more than 36,9 °C the vaccine dose every time increases by 0,3 ml, the interval of introduction makes 1 days.
3. At temperature increase (less, than on 1,5 °C from normal) the vaccine dose every time increases by 0,15 ml, the interval of introduction makes 2 days.
4. The maximum single dose of a vaccine should not exceed 2,0 ml.
5. The vaccine is entered 1 time/day.
6. Duration of treatment is up to 6 - 8 injections.

To children is more senior than 3 years of an injection carry out with an interval of 1-2 days depending on reaction.

1. The initial dose of a vaccine makes 0,05 - 0,1 ml.
2. At a temperature no more than 36,9 °C the vaccine dose every time increases by 0,05 ml, the interval of introduction makes 1 days.
3. At temperature increase (less, than on 1,5 °C from normal) the vaccine dose every time increases by 0,025 ml, the interval of introduction makes 2 days.
4. The maximum single dose of a vaccine should not exceed 0,5 ml.
5. The vaccine is entered 1 time/day.
6. Duration of treatment is up to 6-8 injections.

At diagnosis of gonorrhea: for establishment of an izlechennost of gonorrhea, and also at inspection on gonorrhea of patients with chronic diseases of urinogenital bodies as provocation enter 0,5 ml of a vaccine. If the vaccine was applied during treatment, then for provocation the doubled last therapeutic dose, but no more than 2,0 ml is appointed.

Features of use:

Possible complications: the general reactions - an indisposition, fervescence to 39,0 °C within 24 - 48 hours from the moment of introduction of a vaccine, a headache, the general weakness; focal reactions - strengthening of allocations, morbidity in the struck bodies, urine opacification; local reactions – morbidity in the field of an injection.

At complications (allergic reactions of immediate type: an acute anaphylaxis, a Quincke's edema, a small tortoiseshell) it is necessary to carry out symptomatic therapy.
At temperature increase (more, than on 1,5 °C from normal), deterioration in the general state, sharp morbidity in the struck body use of a vaccine should be stopped.

After each introduction of a vaccine, vaccinated have to be under medical observation within 30 min.; in venues of vaccination it is necessary to have surely means of emergency and antishock treatment.

Use at pregnancy and during breastfeeding. Safety of use of this medical supply at pregnancy and feeding by a breast was not investigated in the course of controlled clinical tests. Therefore drug is used on doctor's orders taking into account a ratio of the expected advantage for mother and possible risk for a fruit and the child.

Side effects:

The general reaction is shown by an indisposition, fervescence to 39,0 °C within 24 – 48 hours from the moment of introduction of a vaccine, a headache, the general weakness; focal - strengthening of allocations, morbidity in the struck bodies, urine opacification; local – morbidity in the field of an injection.

At complications (allergic reactions of immediate type: an acute anaphylaxis, a Quincke's edema, a small tortoiseshell) it is necessary to carry out symptomatic therapy.

Interaction with other medicines:

Perhaps simultaneous performing antibiotic treatment.

Contraindications:

• tuberculosis (active form);
• blood circulatory system diseases (acute rheumatic fever, chronic rheumatic heart troubles, coronary heart disease, cerebrovascular diseases, diseases of arteries, arterioles and capillaries, pulmonary heart and disturbance of pulmonary blood circulation, disease of veins, absorbent vessels and lymph nodes, other heart troubles);
• the diseases which are characterized by the increased blood pressure;
• liver diseases (fibrosis and cirrhosis, liver sclerosis, toxic damage of a liver, acute and subacute liver failure, chronic liver failure);
• a viral hepatitis (an acute hepatitis And, an acute hepatitis In, an acute hepatitis E, an acute hepatitis With, a chronic viral hepatitis);
• diseases of urinogenital system (glomerular diseases, tubulointerstitsialny diseases of kidneys);
• a renal failure (an acute renal failure, a renal failure with a tubular necrosis, an acute renal failure with an acute cortical necrosis, an acute renal failure with a medullary necrosis, other acute renal failure, an acute renal failure not specified, chronic renal failure, an end-stage of damage of kidneys, other displays of a chronic renal failure, a chronic renal failure not specified, renal failure not specified);
• in the personal anamnesis an allergy to medicines, medicines and biological substances;
• periods;
• the anemias (connected with food, owing to fermental disturbances, aplastic and other anemias);
• age up to 3 years.

For the purpose of identification of contraindications, the doctor (paramedic) in day of use of a vaccine conducts survey and survey of the patient with obligatory thermometry. At identification of the increased temperature before the first purpose of drug (more than 36,9 °C) vaccination is not carried out. In the next days the vaccine has to be appointed according to the dosing mode.

Storage conditions:

According to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C to Store in the place, unavailable to children. Freezing is not allowed. A period of validity - 1 year.

Transport according to the joint venture 3.3.2.1248-03 at a temperature from 2 to 8 °C. Transportation is allowed short-term (no more than 24 h) at a temperature from 9 to 20 °C. Freezing is not allowed.

Issue conditions:

According to the recipe

Packaging:

Suspension for intramuscular introduction in ampoules on 1 ml. 10 ampoules with the application instruction, a knife ampoule or the scarificator ampoule in a pack from a cardboard. On 5 or 10 ampoules in a blister strip packaging. On 1 or 2 blister strip packagings with the application instruction, a knife ampoule or the scarificator ampoule in a pack from a cardboard. When packaging the ampoules having a ring of a break or a point for opening the knife ampoule or the scarificator ampoule is not put.