Bubo^®-Kok (Suspension) Instructions for Use

Marketing Authorization Holder

NPC Kombioteh, CJS (Russia)

ATC Code

J07CA05 (Vaccine against diphtheria, hepatitis B, pertussis and tetanus)

Active Substance

Diphtheria, tetanus, pertussis and hepatitis B (rDNA) vaccine (adsorbed)

Diphtheria, tetanus, pertussis and hepatitis B (rDNA) vaccine (adsorbed) (Ph.Eur. European Pharmacopoeia)

Dosage Form

Bubo®-Kok

Suspension for intramuscular administration 0.5 ml/1 dose: amp. 10 pcs.

Dosage Form, Packaging, and Composition

0.5 ml – ampoules (10) – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

Diphtheria, tetanus, pertussis and hepatitis B vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Administration of the drug in accordance with the approved schedule induces the formation of specific immunity against pertussis, diphtheria, tetanus, and hepatitis B.

Indications

• Prophylaxis of pertussis, diphtheria, tetanus, and hepatitis B in children.

ICD codes

Dosage Regimen

Vaccinations with Bubo^®-Kok are given to children until they reach the age of 4 years.

The vaccine is administered in accordance with the national immunization schedule at times providing for simultaneous vaccination against hepatitis B, pertussis, diphtheria, and tetanus.

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

Shortening the intervals is not allowed. If it is necessary to extend the intervals, the next vaccination should be carried out at the earliest possible time, determined by the child’s health status.

If a child has received one or two DTP vaccinations and is not vaccinated against hepatitis B, the missing number of vaccinations (up to 3) can be administered with the Bubo^®-Kok vaccine. In this case, the missing number of vaccinations against hepatitis B (up to 3) is administered with a monovalent hepatitis B vaccine.

Revaccination against pertussis, diphtheria, and tetanus is carried out with DTP vaccine once at the age of 18 months (if vaccination schedules are violated – 12-13 months after the completed vaccination course). If revaccination against pertussis, diphtheria, and tetanus coincides in time with vaccination against hepatitis B, it can be carried out with the Bubo^®-Kok vaccine.

Note if a child has not received revaccination with DTP vaccine or Bubo^®-Kok vaccine by the age of 4 years, it is carried out with ADS toxoid for ages 4 years – 5 years 11 months 29 days or with ADS-M toxoid vaccine for ages 6 years and older. If revaccination against diphtheria and tetanus coincides in time with vaccination against hepatitis B, it can be carried out with the Bubo-M vaccine.

The drug is administered intramuscularly into the upper outer quadrant of the buttock or the anterolateral area of the thigh in a dose of 0.5 ml (single dose). Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.

Ampoules are opened and the vaccination procedure is carried out in strict compliance with the rules of asepsis and antisepsis. The drug in an opened ampoule must not be stored.

The drug is unsuitable for use in ampoules with damaged integrity, missing labeling, changed physical properties (change in color, presence of non-dispersible flakes), expired shelf life, or improper storage.

The administration of the drug is recorded in the established accounting forms indicating the batch number, expiration date, manufacturer, date of administration, and the nature of the reaction to the administration of the drug.

Adverse Reactions

Some vaccinated individuals may develop short-term general (fever, malaise) and local (pain, hyperemia, swelling) reactions within the first two days. In rare cases, complications may develop: convulsions (usually associated with fever), episodes of high-pitched crying, allergic reactions (Quincke’s edema, urticaria, polymorphic rash).

Considering the possibility of immediate-type allergic reactions in particularly sensitive children, medical supervision should be provided for vaccinated individuals for 30 minutes. Vaccination sites must be equipped with anti-shock therapy means.

Note if a child develops a severe general reaction (fever in the first two days above 40°C (104°F), at the injection site – swelling and hyperemia over 8 cm in diameter) or a post-vaccination complication, further vaccinations with Bubo^®-Kok vaccine are discontinued.

If the child received two vaccinations, the vaccination course against diphtheria and tetanus is considered complete, and vaccination against hepatitis B is completed with a monovalent vaccine once, one month after the second Bubo^®-Kok vaccination. If the child received one vaccination, vaccination can be continued with Bubo-M, which is administered once no earlier than 3 months later. Vaccination against hepatitis B in this case is completed with a monovalent vaccine once, one month later. In both cases, the first revaccination is carried out with ADS-M toxoid 9-12 months after the last Bubo^®-Kok or Bubo-M vaccination.

If a complication developed after the third Bubo^®-Kok vaccination, the first revaccination is carried out with ADS-M toxoid in 12-18 months. Subsequent revaccinations are carried out at the prescribed ages with ADS-M toxoid.

If fever above 38.5°C (101.3°F) occurs in more than 1% of vaccinated individuals or pronounced local reactions (soft tissue swelling over 5 cm in diameter, infiltrate over 2 cm in diameter) occur in more than 4% of vaccinated individuals, as well as in case of development of post-vaccination complications, vaccinations with this batch of the drug are discontinued. The decision on its further use is made by the L.L. Tarasevich State Research Institute for Standardization and Control of Medical Biological Preparations of Rospotrebnadzor.

Contraindications

Progressive diseases of the nervous system, history of afebrile seizures, allergic reactions to yeast, severe reactions and post-vaccination complications to the administration of a previous dose of DTP vaccine, hepatitis B vaccine, Bubo^®-Kok vaccine.

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

Children who have had acute diseases are vaccinated no earlier than four weeks after recovery; for mild forms of respiratory diseases (rhinitis, mild pharyngeal hyperemia, etc.), vaccination is allowed 2 weeks after recovery.

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

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

To identify contraindications, the doctor (paramedic at a feldsher-midwife station) on the day of vaccination conducts a parent interview and examines the child with mandatory thermometry. Children temporarily exempted from vaccination should be placed under observation and registered and vaccinated in a timely manner.

Use in Hepatic Impairment

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

Use in Renal Impairment

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

Pediatric Use

Vaccinations with Bubo^®-Kok are given to children until they reach the age of 4 years.

Drug Interactions

Vaccinations with Bubo^®-Kok vaccine can be carried out simultaneously with other vaccines of the National Immunization Schedule or 1 month after vaccinations against other infections. Bubo^®-Kok vaccine can be administered with antiallergic drugs. Interaction with other medicinal products has not been established.

Storage Conditions

The drug is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F). Freezing is not allowed. Keep out of reach of children.

Shelf Life

Shelf life – 18 months

Dispensing Status

For medical-prophylactic and sanitary-prophylactic institutions.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.