Tuberculin BIOLEK PPD-L solution 2TE/dose-1ml 10 doses intradermal injection. at a price of 679.50 R buy in Irkutsk, Allergens of bacteria - instructions for use, composition and description

Indications for Tuberculin vaccination

Tuberculin is used for tuberculin diagnostics (carrying out an intradermal Mantoux tuberculin test), which is an indicative diagnostic test for the purpose of:

identifying the need for a patient to be vaccinated against tuberculosis with BCG
diagnosis of tuberculosis;
determining whether the population is infected with Mycobacterium tuberculosis (or the state of hypersensitivity to tuberculin, if the existing post-vaccination allergy does not give grounds to talk about infection).

The active substance of the drug (allergen-tuberculoprotein) causes, when performing an intradermal tuberculin test in people infected or vaccinated with BCG/BCG-M, a specific delayed-type hypersensitivity reaction in the form of a local reaction - hyperemia (redness) and infiltrate (papule formation).

Tuberculin BIOLEK PPD-L solution 2TE/dose-1ml 10 doses intradermal injection.

The drug is used to perform an intradermal Mantoux test. Administer strictly intradermally. The Mantoux test is given to patients only in a sitting position, since in emotionally labile individuals the injection can cause fainting.

To carry out an intradermal test, one-gram disposable tuberculin syringes with short thin needles are used.

It is prohibited to use insulin syringes for the Mantoux test, as well as syringes and needles that have expired.

The Mantoux test is performed as prescribed by a doctor by a specially trained nurse who has a document - permission to conduct tuberculin diagnostics.

In the case of production of the drug by PJSC PHARMSTANDARD-BIOLEK Ukraine, in the case of packaging of the drug by OJSC Pharmstandard-UfaVITA Russia, indicate:

The ampoule with the drug is thoroughly wiped with gauze moistened with 70° ethyl alcohol, then the neck of the ampoule is filed with an ampoule knife and broken off. The required amount of the drug (02 ml i.e. 2 doses of tuberculin) is taken with a one-gram disposable syringe which is used to perform the Mantoux test with a sterile extraction needle (long). Then a thin sterile needle for intradermal administration (short) is put on the syringe and the excess amount of the drug is released into a sterile cotton swab along with air bubbles up to the 01 ml mark. After opening, the ampoule can be stored under aseptic conditions for no more than 2 hours.

The skin area of the middle third of the inner surface of the forearm is treated with 70° ethyl alcohol and dried with sterile cotton wool. A thin needle, cut upward, is inserted into the upper layers of the skin parallel to its surface - intradermally. After inserting the needle into the skin, 01 ml (2 TU) of the drug is injected from the syringe strictly according to the scale division, i.e. 1 dose. With the correct injection technique, a white papule in the form of a “lemon peel” is formed in the skin, measuring 7-10 mm in diameter.

Or, in the case of production of the drug at JSC "LECCO" Russia, indicate:

Remove the top protective cap from the bottle to expose the rubber stopper. Then the stopper cap and the bottle with the drug are thoroughly wiped with gauze moistened with 70° ethyl alcohol. The rubber stopper is pierced with a one-gram disposable syringe, which is used to perform the Mantoux test with a sterile extraction needle (long) and the required amount of the drug is taken (02 ml, i.e. 2 doses of tuberculin). Then a thin sterile needle for intradermal administration (short) is put on the syringe and the excess amount of the drug is released into a sterile cotton swab along with air bubbles up to the 01 ml mark.

Evaluation of Mantoux test results

The test result is assessed by a doctor or trained nurse 72 hours after the test. A reaction to tuberculin is possible in the form of hyperemia (redness of the skin) and the formation of a papule (a dense round area rising above the skin). Assessment of the Mantoux test consists of taking into account the size of the papule and assessing the severity of hyperemia. The measurement is carried out in a direction transverse to the axis of the hand, the result is taken into account in millimeters. Only the size of the papule is measured, and not the size of the area of hyperemia (redness). The size of the redness is taken into account only when the papule has not occurred.

Reaction options for the Mantoux test:

negative - there are no changes on the skin;
doubtful - there is redness of any size without a papule, or a papule no more than 2-4 mm;
positive mild - papule size 5-9 mm;
positive of medium intensity - papule size 10-14 mm;
positive pronounced - papule size 15-16 mm;
excessive (hyperergic) - the size of the papule exceeds 17 mm or there are pronounced signs of inflammation (reaction of the lymph nodes, skin ulceration, etc.).
A negative Mantoux reaction indicates that the body does not have antibodies that are “familiar” with the tuberculosis bacterium. This means that the child is not infected, or there is no immune reaction to BCG vaccination.
A questionable sample is considered negative.
A positive test can be either a consequence of BCG vaccination or a sign of infection.

To assess the likelihood of infection, you need to look at the turn of the tuberculin test - the transition of a negative Mantoux reaction to a positive one (not associated with previous vaccination) or an increase in the diameter of the papule compared to the result of the previous test by 6 millimeters or more.

Also signs of infection are:

hyperergic reaction;
persistent (more than 4 years) persistent reaction with a papule of 12 mm or more;
gradual (over several years) increase in sensitivity to tuberculin with the formation of an infiltrate measuring 12 mm or more.

A positive Mantoux test result without taking into account other diagnostic criteria is not a basis for making a diagnosis or starting any treatment.

Only a doctor can evaluate the reaction; if necessary, the child will be referred for additional examination to a TB specialist.

BIOLEK Tuberculin PPD-L

In the case of production of the drug by PJSC PHARMSTANDARD-BIOLEK, Ukraine, indicate

3 ml (30 doses, 2 TE in 0.1 ml) or 1 ml (10 doses, 2 TE in 0.1 ml), or 0.6 ml (6 doses, 2 TE in 0.1 ml) 1 ml) in ampoules.

10 ampoules of 3 ml or 1 ml, or 0.6 ml are placed in a cardboard pack.

1 ampoule of 1 ml is placed in an individual intermediate pack. 5 sterile packages, each containing a tuberculin syringe with a needle for extraction (long) and a thin needle for intradermal injection (short), are placed in a cardboard case. One individual intermediate pack with a 1 ml ampoule and one pencil case with syringes and needles are placed in a cardboard pack.

1 ampoule of 0.6 ml is placed in an individual intermediate cardboard pack. 3 sterile packages, each containing a tuberculin syringe with a needle for extraction (long) and a thin needle for intradermal injection (short), are placed in a cardboard case. One individual intermediate pack with a 0.6 ml ampoule and one pencil case with syringes and needles are placed in a cardboard pack.

Each pack contains: instructions for use and an ampoule knife.

When using ampoules with a colored break ring or a colored break point, do not insert the ampoule knife.

In the case of packaging of the drug at JSC "Pharmstandard-Ufa VITA", Russia indicate

3 ml (30 doses, 2 TE in 0.1 ml) or 1 ml (10 doses, 2 TE in 0.1 ml), or 0.6 ml (6 doses, 2 TE in 0.1 ml) 1 ml) in ampoules.

10 ampoules of 3 ml or 1 ml, or 0.6 ml are placed in a cardboard pack.

5 ampoules of 3 ml or 1 ml each are placed in a blister pack made of film coated with aluminum foil, or without foil.

2 blister packs are placed in a cardboard pack.

Each pack contains: instructions for use and an ampoule knife.

When using ampoules with a colored break ring or a colored break point, do not insert the ampoule knife.

In the case of production of the drug at JSC JIEKKO, Russia indicate

1 ml (10 doses of 2 TE in 0.1 ml) in glass bottles of hydrolytic class 1, sealed with rubber stoppers, rolled with aluminum-plastic caps with first opening control.

5 bottles are placed in a blister film package. 2 blister packs with bottles along with instructions for use are placed in a cardboard pack.

1 bottle is placed in a contour cell made of film. 5 sterile packages, each containing a tuberculin syringe with a needle for extraction (long) and a thin needle for intradermal injection (short), are placed in a cardboard case. One contour blister pack with a bottle and one pencil case with syringes and needles are placed in a cardboard pack.

Instructions for use are included in each pack.

Indications for the Mantoux test

The Mantoux test is performed to diagnose tuberculosis.

Children vaccinated against tuberculosis:

The Mantoux test (Intradermal allergy test with tuberculin) is performed once a year, regardless of the results of previous tests, at the age of 1 to 7 years inclusive.

For children not vaccinated against tuberculosis (children who have not been vaccinated with BCG), the Mantoux test is performed 2 times a year starting at the age of 6 months

Children not vaccinated against tuberculosis:

The Mantoux test is performed - 2 times a year, starting from the age of 6 months, the Mantoux test is performed.

Contraindications

Only a doctor can decide whether the drug “Tuberculin” is suitable for testing for tuberculosis.

“Tuberculin” is contraindicated for persons with allergic and autoimmune diseases!

The use of Tuberculin is also contraindicated in the following cases:

common skin diseases
epilepsy
acute, chronic infectious and somatic diseases during exacerbation; allergic conditions (rheumatism in acute and subacute phases, bronchial asthma, idiosyncrasies with pronounced skin manifestations during exacerbation).

It is not allowed to carry out the Mantoux test in those children's groups where there is a quarantine for childhood infections. The Mantoux test is performed 1 month after all clinical symptoms disappear or immediately after quarantine is lifted.

home
Right menu
Vaccination school
Question answer
Vaccination for everyone: SIMPLE answers to DIFFICULT questions
Phenol in tuberculin: is the Mantoux test dangerous?

Phenol in tuberculin: is the Mantoux test dangerous?

— Is it true that phenol is a well-known protoplasmic poison, toxic to all cells of the body without exception!

The diagnostic tuberculin Mantoux test has been widely used in Russia since 1965, and the tuberculin used for it was approved by WHO as a standard back in 1952. For at least three generations of people have come with their children to receive a “button”, but only in recent years has tuberculin diagnostics been performed was suddenly declared a “health hazard.”

Someone suddenly read that tuberculin contains phenol. And so it began!

1) Phenol can cause shock, weakness, convulsions, kidney damage, heart failure, and is toxic to all cells of the body!

2) Phenol causes leukemia!

3) Phenol affects the nervous system!

At the same time, fighters against the Mantoux test are not embarrassed by the fact that phenol as a preservative is used, in addition to tuberculin, in a huge number of other medications, including those for parenteral administration. Mothers of children with allergies refuse the Mantoux test for fear of phenol, but do not object to the diagnostic intradermal injection of allergens containing 0.2-0.4% of the same phenol! Many people’s favorite fucorcin, which is used to treat even mouth ulcers, contains 3.9% pure phenol. Phenol as a preservative is found in insulin, suppositories, antiseptics for gargling, ear drops, and various other drugs. At the same time, phenol is very well absorbed through intact skin and mucous membranes and can actually cause poisoning, even when used externally.

That's not all. You can compile an impressive list of drugs that are converted into phenol during metabolism in the body. And this list will be headed by none other than paracetamol (paraacetylaminophenol), which, based on many studies around the world, is considered the safest children's medicine for “fever.”

So, is the pharmaceutical industry out to poison everyone?

Of course not! Phenol is toxic, but in much higher doses than those contained in medications (including tuberculin). According to reports from toxicologists, phenol poisoning is associated with its ingestion or inhalation in large doses. More often, these are industrial hazards or accidents. Chronic poisoning can develop with constant and long-term intake of small doses, for example, drinking drinking water contaminated with phenol. Also rare, but phenol poisoning occurs when it is absorbed through the skin. It is not for nothing that all phenol-containing ointments indicate that they should not be used on large areas of the body (especially in children).

Cases of phenol poisoning from the Mantoux test (or diagnostic allergens) are not described in the literature. But no one, not even the most staunch opponents of vaccination, claims that the Mantoux test can cause lethal phenolic poisoning.

Is it possible to get any health problems from the Mantoux test? We tried to find the following information in the toxicological literature: at what dose of phenol administered to the body does no biological effect occur? What dose of phenol is not associated with even minimal neurotoxicity, genotoxicity, carcinogenicity or any other consequences? In the Russian-language toxicological literature, lethal doses are mainly given for various routes of entry (higher for oral administration, smaller for inhalation). However, in English-language toxicological sources, the NOAEL indicator is used (according to observed adverse effect level), i.e., the dose at which no biological effects are OBSERVED (in laboratory studies, the minimum dose is determined at which a decrease in fetal weight in rats is not observed). So, for phenol the NOAEL is 60 mg/kg body weight.

In almost every anti-vaccination publication concerning phenol in vaccines and serums, one can find accusations that the safety of phenol in humans has not been studied. These accusations are not entirely fair. In fact, the toxic effects of phenol on humans have been studied, and studied well. However, experimental data on a safe dose of phenol during chronic intake (as for many other potentially toxic substances) are absent for an obvious reason - such experiments cannot be carried out on humans. In such cases, in world practice it is customary to use the so-called uncertainty factor (UF). The NOAEL indicator obtained for animals is reduced by 100 times - to be on the safe side. Using the NOAEL obtained from experiments on pregnant female rats and the uncertainty factor, the dose of phenol safe for daily human consumption is set at 0.6 mg per 1 kg of body weight. The harmlessness of this dose to humans has been confirmed by numerous observations of entire populations consuming water or food containing small doses of phenol: no evidence of any negative manifestations has been established. In this case, it is quite possible to extrapolate the data obtained from oral administration of phenol to its subcutaneous administration. As mentioned above, phenol is perfectly absorbed; when it enters the gastrointestinal tract and respiratory tract, it is adsorbed by 100%, and by skin contact - by 80%.

Among the studies studying the kinetics of phenol in the human body, of great interest is the study by Morrison et al., devoted to the study of the dynamics of phenol in the blood of pediatric patients to whom it was administered for the purpose of neuromuscular blockade. Even before the start of treatment (and without any vaccination), phenol was detected in the blood of children at a dose of 0.3 to 0.8 mg/ml; after the procedure it increased to 36 mg/ml, and after 2 hours it decreased by approximately 1/3.

The Mantoux sample contains 0.25 mg of phenol, i.e. for a child weighing 8 kg this is 0.03 mg/kg, which is 20 times less than the dose of safe daily intake. I would also like to emphasize - daily, but the Mantoux test is not carried out every day. And not even monthly. And if you compare it with the physiological level of phenol in the blood, you get that one dose of tuberculin contains approximately the same as 1 ml of blood (Fig. 18).

In fact, all of us, including small children, inhale, drink and eat daily amounts of phenol that are many times greater than the content in the Mantoux test. In the environment, phenol is present not only as a man-made pollutant, it also exists in nature: phenol and its derivatives are found in wood, peat, coal, and oil. These compounds are present in plant cells: for example, pine cones and needles contain quite a lot of phenol, since in biological objects phenols are involved in redox metabolic reactions. Phenol is found in cheese, fish, chicken meat, tobacco smoke and tea, and is released from resins covering furniture and synthetic fabrics. In addition, the body also contains endogenous phenol, which is formed as a metabolite in the tissues of the body itself and in the intestinal contents as a result of the activity of bacteria.

It should be added that the mutagenic effect of any doses of phenol in relation to mammals (and humans too) has never been observed. Phenol has not been proven to be carcinogenic , despite ongoing experiments and years of observation of people exposed to chronic phenolics. The International Agency for Research on Cancer does not classify phenol as a human carcinogen (2004).

Possible side effects

For most, the test process is asymptomatic.
Headaches may rarely occur
General weakness, sleep disturbances, and increased body temperature rarely develop.
Individuals with altered reactivity experience allergic reactions.
Considering the possibility of developing immediate allergic reactions (anaphylactic shock, Quincke's edema, urticaria) in particularly sensitive individuals, vaccinated persons must be provided with medical supervision for 30 minutes.

Come get vaccinated at VIRILIS. A full range of vaccines for children and adults, family vaccinations - at a special price!