Universal reference book for medicines
Product name: BUBO-KOK (BUBO-KOK)

Active substance: hepatitis B vaccine (rDNA), nonappropriate

Type: Vaccine for the prevention of diphtheria, tetanus, pertussis and hepatitis B

Manufacturer: КОМБИОТЕХ НПК (Russia)
Composition, form of production and packaging
Suspension for intramuscular injection
0.5 ml

Bordetella pertussis 10 billion cells

diphtheria toxoid 15 FU

tetanus toxoid 5 EC

HBS-protein, which is the main surface antigen of the hepatitis B virus (HBsAg) 5 μg

0.5 ml - ampoules (10) - packings of cellular contour (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

The introduction of the drug in accordance with the approved scheme causes the formation of specific immunity against pertussis, diphtheria, tetanus and hepatitis B.

INDICATIONS

- prevention of pertussis, diphtheria, tetanus and hepatitis B in children.

DOSING MODE

Vaccinations against Bubo-Kok are administered to children until the age of 4 years.

The vaccine is administered in accordance with the national calendar of preventive vaccinations at a time that provides simultaneous vaccinations against hepatitis B, pertussis, diphtheria and tetanus.

Children not vaccinated against hepatitis B before 3 months of age receive the vaccine three times according to the scheme of 3 months, 4.5 months and 6 months.

Reduction of intervals is not allowed.
If it is necessary to increase the intervals, the next vaccination should be carried out as soon as possible, determined by the state of children's health. In the presence of one or two inoculations of the LDCS vaccine in children not vaccinated against hepatitis B, the vaccine quantity that is missing up to 3 can be carried out with the Bubo-Kok vaccine. At the same time, the number of vaccinations against hepatitis B lacking up to 3 is carried out with a monovalent against hepatitis B.
Revaccination against pertussis, diphtheria and tetanus is carried out by the DTP vaccine once at the age of 18 months (if the timing of vaccinations is violated - 12-13 months after the completed vaccination course).
In the event that the booster against pertussis, diphtheria and tetanus coincides in time with the hepatitis B vaccination, it can be carried out with the Bubo-Kok vaccine.
Note: if the child has not received a DTP vaccine or Bubo-Kok vaccine after 4 years of age, then it is performed with LDS-anatoxin for ages 4 years - 5 years 11 months.
29 days or for ages 6 years and older with the ADS-M vaccine, anatoxin. In the event that the booster against diphtheria and tetanus coincides in time with the vaccination against hepatitis B, it can be carried out with the Bubo-M vaccine.
The drug is injected intramuscularly into the upper outer quadrant of the buttock or into the anterior thoracic region of the thigh at a dose of 0.5 ml (single dose).Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.

Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules.
The drug in the opened ampoule is not subject to storage.
The preparation is not suitable for use in ampoules with broken integrity, lack of marking, changing physical properties (discoloration, presence of non-developing flakes), expired shelf life, improper storage.

The introduction of the drug is registered in the prescribed registration forms with the indication of the serial number, expiration date, manufacturer, date of introduction, the nature of the reaction to the administration of the drug.

SIDE EFFECT

A part of the vaccinated in the first two days can develop short-term general (fever, malaise) and local (soreness, hyperemia, swelling) reactions.
In rare cases, complications may develop: seizures (usually associated with fever), episodes of piercing screaming, allergic reactions (Quincke's edema, urticaria, polymorphic rash).
Given the possibility of developing allergic reactions of immediate type in particularly sensitive children, it is necessary to provide medical supervision for vaccinated people within 30 minutes.
Vaccination sites should be provided with anti-shock therapy.
Note: if the child develops a strong general reaction (an increase in temperature in the first two days above 40 ° C, at the injection site - swelling and hyperemia over 8 cm in diameter) or postvaccinal complications, further vaccinations with Bubo-Kok vaccine stop him.
If the child was vaccinated twice, the vaccination against diphtheria and tetanus is considered complete, and hepatitis B vaccination is terminated with the monovaccine one month after the second vaccination with Bubo-Kok. If the child received one inoculation, the vaccination can be continued with Bubo-M, which is administered once no earlier than 3 months. Vaccination against hepatitis B in this case is terminated with a monovaccine once a month. In both cases, the first revaccination is performed with ADS-M toxoid 9-12 months after the last inoculation of Bubo-Kok or Bubo-M. If the complication develops after the third vaccination of Bubo-Kok, the first revaccination is performed with ADS-M toxoid after 12-18 months. Subsequent revaccinations are carried out in decremented ages of ADS-M by an anatoxin.
If the temperature rises above 38.5 ° C, more than 1% of the vaccinated or the occurrence of pronounced local reactions (swelling of soft tissue with a diameter of more than 5 cm, infiltration with a diameter of more than 2 cm), more than 4% of the vaccinated, and the development of post-vaccination complications, terminate.The question of its further use is solved by the FGUN GISK them.
L.L. Tarasevich Rospotrebnadzor.
CONTRAINDICATIONS

Progressive diseases of the nervous system, afefrilnye convulsions in the anamnesis, allergic reactions to yeast, strong reactions and postvaccinal complications for the introduction of a previous dose of DTP vaccine, hepatitis B vaccine, vaccine Bubo-Kok.

The presence of febrile seizures with the introduction of a previous dose of the vaccine is not a contraindication to the introduction of Bubo-Kok, after its introduction, it is advisable to administer paracetamol (10-15 mg / kg 3-4 times a day) for 1-2 days.

Children who have had acute illnesses are vaccinated not earlier than four weeks after recovery, with mild forms of respiratory diseases (rhinitis, mild hyperemia of the throat, etc.), inoculation is allowed 2 weeks after recovery.

Patients with chronic diseases are vaccinated no earlier than four weeks after reaching a stable remission.

Stable manifestations of an allergic disease (localized skin manifestations, latent bronchospasm, etc.) are not contraindications to vaccination, which can be performed against the background of appropriate therapy.

In order to identify contraindications, the doctor (paramedic at the FAP) on the day of vaccination is conducting a survey of parents and examining the child with mandatory thermometry.
Children temporarily released from vaccination should be monitored and accounted for and promptly vaccinated.
APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with chronic diseases are vaccinated no earlier than four weeks after reaching a stable remission.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Patients with chronic diseases are vaccinated no earlier than four weeks after reaching a stable remission.

APPLICATION FOR CHILDREN

Vaccinations against Bubo-Kok are administered to children until the age of 4 years.

DRUG INTERACTION

Vaccinations vaccine Bubo-Kok can be carried out simultaneously with other vaccines of the National calendar of preventive vaccinations or after 1 month.
After vaccinations against other infections. The Bubo-Coke vaccine can be given with antiallergic drugs. Interaction with other drugs has not been established.
TERMS OF RELEASE FROM PHARMACY

For treatment and preventive and sanitary facilities.

TERMS AND CONDITIONS OF STORAGE

The preparation is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C.
Freezing is not allowed. Keep out of the reach of children. Shelf life - 18 months
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