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Antitubercle vaccine BCG 10

NAME OF THE MEDICINAL PRODUCT

Szczepionka przeciwgruźlicza BCG 10

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCES

One ampoule with powder contains:

  1. tubercle bacillus BCG (Bacillus Calmette - Guerin), substrain Moreau – 0.5 mg 10-dose vaccine
  2. One vaccination dose of 0.1 ml contains 50 mg semi-dry mass of tubercle bacillus BCG and at least 150,000 live particles of BCG.
  3. Excipients,

PHARMACEUTICAL FORM

Powder and diluent for preparing the suspension for intracutaneous injections.

CLINICAL PARTICULARS

Indications

The antitubercle vaccine BCG serves for preventive vaccination against tuberculosis.
Vaccinations in Poland are obligatory and performed according to the Program of Preventive Vaccinations approved annually by the Minister of Health.

Posology and method of administration

The antitubercle vaccine BCG 10 should be diluted by introducing 1 ml of isotonic solution of sodium chloride. Only 1 dose of the vaccine should be drawn into the syringe in the volume of 0.1 ml for one infant. The vaccine in the volume of 0.1 ml should be injected intracutaneously into the external 1/3 upper part of the left shoulder.

Do not inject vaccine subcutaneously and too deeply.

A proper administration technique and not too deep an injection produces a small white papule, well separated from the surrounding skin, of about 6 - 8 mm in diameter, which disappears after several minutes.

2 - 4 weeks after the vaccination an infiltration may follow, which remains for several weeks, usually forming a pustule on the top, followed by ulceration usually with a diameter of 2-5 mm, not exceeding 10 mm. The lesion heals spontaneously after 2 -3 months from the date of the vaccination, leaving a whitish scar with a diameter of several millimetres. In some individuals the pustule can exude for a longer period. This is not a complication and does not require any treatment, only the maintenance of cleanliness.

Contraindications

The physician decides, after examining each infant, about contraindications to the BCG vaccination. The physician should ask, and the vaccinated individual or his parents should notify the physician, about current or past patient history of allergic diseases, diseases weakening natural immunity (diseases of the reticuloendothelial system e.g. lymphoma, leukaemia and others) and also about taken medications: steroids, cytostatic medication, radiotherapy, or antimycobacterial drugs.
In compliance with the Guidelines of the Institute of Tuberculosis and Pneumopathies from 1995 the following individuals should not be vaccinated:

  1. newborn infants suffering from serious diseases such as: severe perinatal injury e.g. intracranial effusion, state of asphyxia, jaundice implicating the suspicion of serologic conflict, severe developmental defects and all diseases upsetting the clinical state of the newborn infant or the prematurely born infant. Diseases of the neonatal period are a contraindication until their regression;
  2. newborn infants with clinical symptoms of infection, confirmed by additional findings, until their regression;
  3. infants in the course of, and 4 weeks after recovery from, acute contagious diseases, such as: measles, pertussis, chicken-pox, rubella, Mycoplasma pneumoniae infection etc.; these infants should be vaccinated if the tuberculin test performed after 4 weeks from the end of the disease is negative;
  4. individuals with primary immunodeficiency - this is a permanent contraindication;
  5. individuals with secondary immunodeficiency, until its regression;
  6. individuals with a positive tuberculin reaction and individuals with a history of tuberculosis;
  7. individuals with clinical symptoms of AIDS; infected individuals without symptoms of the disease may be vaccinated in situations when the risk of falling ill is significant;
  8. individuals suffering from acute diseases or chronic diseases in the period of exacerbation until regression, and succeeding a stable clinical state, and also infants with fever;
  9. individuals under immunosuppressive treatment.

Premature birth as such does not determine a contraindication to the vaccination. Healthy prematurely born infants should be vaccinated. A relative contraindication is a body weight under 2000g or age under 32 weeks.

Special warnings and special precautions for use

The antitubercle vaccine BCG should be administered only intracutaneously.

Interactions with other medicinal products and other forms of interactions

  1. The interval between BCG and Hepatitis type B vaccinations in newborn infants should not exceed 24 hours.
  2. Individuals vaccinated against pertussis, diphtheria, tetanus, typhoid, rabies, influenza, ixodic brain fever or cholera can be vaccinated with BCG vaccine 4 weeks from the previous vaccination.
  3. After the BCG vaccination the break interval should be 4 weeks, after that time the individual can be vaccinated against: pertussis, diphtheria, tetanus, typhoid, rabies, influenza, ixodic brain fever and cholera.
  4. Vaccines against: poliomyelitis, measles, rubella, mumps - can be administered after a period of 6 weeks from the BCG vaccination.
  5. If the vaccine against poliomyelitis is administered simultaneously with the DTP vaccine (diphtheria-tetanus-pertussis) an interval of at least 6 weeks from the BCG vaccination should also be obligatory.

Pregnancy and lactation

The vaccine should not be administered to pregnant or breast feeding women.

Effects on ability to drive and use machines

BCG vaccine has no effect on the ability to drive or use machines.

Undesirable effects

As with any other medications, the antitubercle Vaccine BCG 10 can cause adverse reactions. Symptoms and lesions after vaccination usually regress spontaneously in the course of 3 months after vaccination.

Enlargement of the regional lymph glands, most often axillary, up to 15 mm, which may develop in vaccinated individuals should be considered as normal.

In the case of the development of post vaccination lesions, which according to a paediatrician fulfil the criteria of post vaccination complication, an infant should be directed to a consultant, who will give the final diagnosis and recommend further action:

  1. in the case of large ulcerations the vaccinated place should be protected against infection with a sterile dressing and protected against bathing in a pool with chlorinated water;
  2. in cases of large abscesses, developing sometimes as a consequence of ulcerations in the place of vaccination, or subcutaneous abscesses the procedure is similar. The abscesses tend to heal spontaneously;
  3. in the case of the occurrence of a subcutaneous abscess, and the softening and thinning of the skin over it, the abscess should be perforated, the contents evacuated and given for bacteriological examination; the possibility of the application of antibiotics e.g. erythromycin should be considered
  4. in the case of a considerable enlargement of the lymphatic gland the action should be delayed and, if lesions do not regress and a significant softening and persistent suppuration of the lymphatic gland occur, perforation of the gland and evacuation of the secretion is recommended. General bacteriological examination of the secretion, as well as for the presence of bacilli is necessary; in the case of detected non-specific flora, ethiotropic treatment is indicated;
  5. cases of a general BCG contagion (BCG itis) with ostitis (BCG ostitis) require hospitalization; in such cases, especially in babies, an examination of the infant’s immune system should be performed.

Overdose

The application of the vaccination over the recommended dose causes a significant increase in the number of complications after vaccination in lymphatic glands.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: Vaccines, code ATC: J07AN

Pharmacokinetic properties

After the injection of BCG, the bacilli multiply in the injection site, and also in local lymphatic glands. A reaction of the organism to the presence of bacilli is the development of delayed hypersensitivity, known as tuberculin allergy and the production of antitubercle immunity.

Preclinical safety data

Findings of general toxicity research performed on guinea pigs and mice on the administration of one human dose, and research on specific toxicity - harmlessness for guinea pigs after the administration of 100 human vaccination doses, and the Jensen test of skin sensitivity guarantee the therapeutic product.

PHARMACEUTICAL PARTICULARS

List of excipients

  1. monosodium glutamate – 2.5 mg
  2. diluent: isotonic solution of sodium chloride – 1.0 ml

Incompatibilities

None

Shelf life

  1. 2 years.
  2. The vaccine, after the introduction of the isotonic solution of sodium chloride, should be used directly after dissolving.

Special precautions for storage

  1. BCG vaccine should be stored at 2˚C - 8˚C (in a refrigerator).
  2. Keep away from light.
  3. Keep away from children.

Nature and composition of the immediate package

  1. Package contains 5 ampoules with powder and 5 ampoules with diluent of 1 ml each.
  2. Package contains 1 ampoule with powder and 1 ampoule with diluent of 1 ml each.
  3. Ampoules with powder are thick-walled, made of neutral orange glass, and the ampoules with diluent are made of neutral transparent glass, in a cardboard box.

Instructions for use and handling and disposal

Before the use of the vaccine the following information should be checked on the label: type of vaccine, quantity of dose in one ampoule, and expiry date. It should also be observed and made sure that all the dry powder vaccine remains at the bottom of the ampoule.

The neck of the ampoule with the diluent and the ampoule with the vaccine should, before and after oversawing, be carefully disinfected with a swab moistened with 70% ethyl alcohol and left to dry.

Contaminated ethyl alcohol may also be used.

After opening the ampoule with the powdered vaccine, introduce with a syringe exactly 1 ml of the isotonic solution of sodium chloride.

Draw diluent in a gentle stream on the side of the ampoule. After that withdraw all the content to the syringe and gently back to the ampoule avoiding foaming; repeat the action until a fine even suspension results.

The vaccine should be used immediately after dilution.

Attention:

  1. In all actions related with opening the ampoules, drawing diluent and dissolving the powder, contamination of the vaccine should be avoided.
  2. Only disposable needles and syringes may be used for BCG vaccinations.
  3. Unused vaccine should be destroyed in the method conforming with obligatory regulations.