Composition, form of production and packaging
Suspension for the / m administration yellowish-gray color, with a precipitate that is easily broken when shaken, without any foreign visible inclusions.
1 ml
vaccine for the treatment and diagnosis of gonococcal 10 IU
Excipients: sodium chloride - 9 mg, phenol - 2.5 mg (preservative), water d / and - up to 1 ml.
1 ml - ampoules (10) - packs of cardboard.
1 ml - ampoules (5) - packings of cellular contour (1) - packs cardboard.
1 ml - ampoules (5) - packings the cellular contour (2) - packs cardboard.
1 ml - ampoules (10) - packings of cellular contour (1) - packs cardboard.
1 ml - ampoules (10) - packings the cellular contour (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Increases the specific reactivity of the body (stimulates the production of antibodies with neutralizing, opsonic and protective action).
INDICATIONS
In adults:
- gonorrheal infection (as part of complex therapy) after unsuccessful antibiotic therapy with relapsing relapses, with fresh torpid and chronic forms of the disease, for men with complicated and women with ascending gonorrhea (after the subsidence of acute inflammatory phenomena);
- Diagnosis of gonorrhea (examination of gonorrhea in patients with chronic diseases of the genitourinary organs, the establishment of cured gonorrhea).
In children from 3 years of age:
- gonorrheal infection (as part of complex therapy) after unsuccessful antibiotic therapy with reluctantly recurring relapse, with fresh torpid and chronic forms of the disease;
- Diagnosis of gonorrhea (examination of gonorrhea in patients with chronic diseases of the genitourinary organs, the establishment of cured gonorrhea).
DOSING MODE
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 injected drug should have a body temperature.
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.
With gonorrheal infection:
Adults receive injections at intervals of 1-2 days, depending on the reaction. The initial dose of the vaccine is 0.3-0.4 ml (with complicated gonorrhea vaccine should be started with 0.2 - 0.3 ml).
At a temperature of no more than 36.9 В° C, the dose of the vaccine is increased by 0.3 ml each, the interval of administration is 1 day.
When the temperature rises (less than 1.5 В° C from normal), the dose of the vaccine is increased by 0.15 ml each, the interval of administration is 2 days. The maximum single dose of the vaccine should not exceed 2.0 ml. The vaccine is administered 1 time / day. Duration of treatment up to 6 - 8 injections.
Children older than 3 years of injection are carried out 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 of no more than 36.9 В° C, the dose of the vaccine is increased by 0.05 ml, the interval of administration is 1 day.
When the temperature rises (less than 1.5 В° C from normal), the dose of the vaccine increases by 0.025 ml each, the interval of administration is 2 days. The maximum single dose of vaccine should not exceed 0.5 ml. The vaccine is administered 1 time / day. Duration of treatment up to 6-8 injections.
When diagnosing gonorrhea:
To establish the cure of gonorrhea, as well as in the examination of gonorrhea in patients with chronic diseases of the urogenital organs, 0.5 ml of the vaccine is administered as a provocation. If the vaccine was used during treatment, then twice the last therapeutic dose is prescribed for provocation, but not more than 2.0 ml.
Precautionary measures
Possible complications: general reactions - malaise, fever to 39.0 ° C within 24 to 48 hours from the time of vaccine administration, headache, general weakness; focal reactions - increased secretion, soreness in the affected organs, turbidity of urine; local reactions - soreness in the area of ​​injection.
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 В° 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; It is necessary to have emergency and anti-shock therapy in places of vaccination.
SIDE EFFECT
The general reaction is manifested by malaise, fever to 39.0 ° C within 24 to 48 hours from the time of vaccine administration, headache, general weakness; focal - increased secretion, soreness in the affected organs, turbidity of urine; local - pain in the area of ​​injection.
In case of complications (allergic reactions of immediate type: anaphylactic shock, Quincke's edema, urticaria), symptomatic therapy should be performed.
CONTRAINDICATIONS
- tuberculosis (active form);
- diseases of the circulatory system (acute rheumatic fever, chronic rheumatic heart diseases, coronary heart disease, cerebrovascular diseases, arterial diseases, arterioles and capillaries, pulmonary heart and pulmonary circulation, veins, lymphatic vessels and lymph nodes, other heart diseases);
- diseases characterized by high blood pressure;
- liver disease (fibrosis and cirrhosis of the liver, liver sclerosis, toxic liver damage, acute and subacute liver failure, chronic hepatic insufficiency);
- viral hepatitis (acute hepatitis A, acute hepatitis B, acute hepatitis E, acute hepatitis C, chronic viral hepatitis);
- diseases of the genitourinary system (glomerular diseases, tubulo-interstitial diseases of the kidneys);
- 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, terminal stage of kidney damage, other manifestations chronic renal failure, chronic renal failure, unspecified, renal failure unspecified naya);
- in a personal anamnesis, an allergy to medicines, medicines and biological substances;
- menstruation;
- anemia (related to nutrition, due to enzymatic disorders, aplastic and other anemia);
- age up to 3 years.
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 В° C), vaccination is not carried out. In the following days, the vaccine should be administered in accordance with the dosing regimen.
With caution: if you need to diagnose and treat gonorrheal infection in children who have had acute illnesses, the administration of the vaccine is allowed no earlier than 4 weeks after recovery; for mild forms of respiratory diseases (rhinitis, mild hyperemia, etc.), the administration of the vaccine is allowed 2 weeks after recovery.For patients with chronic diseases, the vaccine is administered after reaching a stable remission (not less, after 4 weeks).
PREGNANCY AND LACTATION
The safety of this medication during pregnancy and breastfeeding has not been investigated in controlled clinical trials. Therefore, the drug is used according to the doctor's prescription taking into account the ratio of expected benefits to the mother and the possible risk to the fetus and the baby.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in diseases of the genitourinary system (glomerular diseases, tubulo-interstitial diseases of the kidneys); with 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, terminal stage of kidney damage, other manifestations chronic renal failure, chronic renal failure, unspecified, renal failure, untidyennaya).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in liver diseases (fibrosis and cirrhosis, liver sclerosis, toxic liver damage, acute and subacute liver failure, chronic liver failure).
APPLICATION FOR CHILDREN
Contraindicated for children under 3 years.
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.
OVERDOSE
Cases of overdose are not described.
DRUG INTERACTION
Possible simultaneous antibiotic therapy.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 В° C, Keep out of the reach of children. Freezing is not allowed. Shelf life - 1 year.
Transport in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 В° C. Short-term (not more than 24 hours) transportation at a temperature of 9 to 20 В° C is allowed. Freezing is not allowed.
