Bubo-M

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Bubo-M: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. Drug interactions
12. Analogs
13. Terms and conditions of storage
14. Terms of dispensing from pharmacies
15. Reviews
16. Price in pharmacies

Latin name: Bubo-M

ATX code: J07CA07; J07BC01

Active ingredient: vaccine for the prevention of viral hepatitis B, diphtheria and tetanus (Diphtheria, tetanus and hepatitis B vaccine)

Manufacturer: ZAO NPK Kombiotech (Russia)

Description and photo update: 2019-07-05

Suspension for intramuscular administration of Bubo-M

Bubo-M is a combination vaccine for the prevention of tetanus, diphtheria and hepatitis B with a reduced antigen content.

Release form and composition

The vaccine is produced in the form of a suspension for intramuscular administration: homogeneous, white with a slight yellowish tinge, separating upon standing into two fractions - a transparent colorless liquid and a loose white precipitate with a light yellow tint, which is easily broken when shaken, without visible foreign inclusions (0.5 ml in ampoules, in a blister pack of 10 ampoules, in a cardboard box one blister pack and a medical instruction for the use of Bubo-M).

Composition for 0.5 ml (one inoculation dose):

active ingredients: HBsAg (HBS protein, which is the main surface antigen of the hepatitis B virus) - 10 μg; tetanus toxoid - 5 EU (antitoxin-binding units); diphtheria toxoid - 5 Lf (flocculating units);
auxiliary components: aluminum hydroxide, merthiolate (thiomersal).

Pharmacological properties

When Bubo-M is administered in accordance with the approved vaccination schedule, specific immunity is formed against diphtheria, tetanus and hepatitis B.

Pharmacodynamics

The Bubo-M vaccine is a combination of diphtheria and tetanus toxoids, purified from ballast proteins, and recombinant hepatitis B virus surface antigen (HBsAg), sorbed on aluminum hydroxide.

Pharmacokinetics

Data on the pharmacokinetics of Bubo-M are not provided.

Indications for use

Bubo-M is used in children over the age of 6 years, adolescents, as well as adults in order to prevent tetanus, diphtheria and hepatitis B. The vaccine is administered in the following cases:

conducting a course of vaccination in children over 6 years old who have not previously been vaccinated against tetanus, diphtheria and hepatitis B;
planned age-related revaccinations (according to the ADS-M vaccine administration scheme) of children aged 6 years, adolescents and adults who have not previously been vaccinated against hepatitis B;
coincidence of the terms of revaccination against tetanus and diphtheria with one of the vaccinations against hepatitis B (in children and adolescents).

Contraindications

The absolute contraindications for Bubo-M vaccination are:

strong and unusual reactions to the previous administration of the vaccine against hepatitis B or diphtheria-tetanus toxoid (severe edema, hyperemia at the injection site more than 8 cm in diameter, increased body temperature up to 40 ° C, etc.);
exacerbation of chronic diseases and any diseases in the acute phase (until the end of the exacerbation);
allergy to yeast and / or other components of the vaccine.

In case of acute intestinal diseases, mild acute respiratory viral infections, vaccination can be carried out immediately after the normalization of body temperature.

Patients with chronic diseases are vaccinated after partial or complete remission. With neurological changes, the progression of the process should be excluded and only after that the Bubo-M vaccine should be given. In patients with allergies, vaccination is carried out 2–4 weeks after the end of the exacerbation. Stable symptoms of allergic diseases (latent bronchospasm, localized skin manifestations) are not a contraindication to the use of the vaccine. In this case, the drug is administered against the background of appropriate treatment.

HIV infections, immunodeficiency states, supportive course therapy (including psychopharmaceuticals and steroid hormones) are not contraindications to vaccination.

Bubo-M, instructions for use: method and dosage

The Bubo-M vaccine is injected intramuscularly in a single dose of 0.5 ml into the deltoid muscle of the shoulder. Before use, the ampoule is thoroughly shaken until a homogeneous suspension is obtained.

It is not recommended to inject the vaccine subcutaneously or into the gluteus muscle, as this can reduce the effectiveness of the hepatitis component and increase local reactions.

Primary vaccination schedule for children aged 6 years and older and adolescents who have not previously been vaccinated against tetanus, diphtheria and hepatitis B:

the first dose - on the selected day;
second dose - 1 month after the first dose;
the third dose is 6 months after the first dose.

If it is necessary to increase the intervals between doses, the Bubo-M vaccination is carried out as soon as possible, which is determined by the state of health of the person being vaccinated. In case of an increase in the interval between the first and second dose by 5 months or more, the third dose can be administered no earlier than 1 month after the second. Further revaccinations with ADS-M toxoid are established in accordance with the national vaccination schedule.

Persons previously vaccinated against tetanus and diphtheria, but have not received the hepatitis B vaccine, are revaccinated with the Bubo-M vaccine once. Subsequently, the missing vaccinations against hepatitis B are given separately with the hepatitis B vaccine in a dosage corresponding to age.

The drug in ampoules with impaired integrity, altered physical properties (the appearance of unbreakable flakes, change in the color of the suspension), lack of labeling, with improper storage and with an expired shelf life is not suitable for use.

For the introduction of Bubo-M, you must use only a disposable syringe.

During the opening of the ampoules and the vaccination, the rules of antisepsis and asepsis should be strictly observed. Opened ampoules with suspension cannot be stored. The introduction of the vaccine is recorded in special registration journals, which indicate the batch number, control number, manufacturer, expiration date and date of drug administration.

Side effects

The likelihood of side effects with the introduction of Bubo-M is low. In 3-5% of cases in the first two days after vaccination, short-term local (redness, swelling, soreness) and general (malaise, dizziness, fever, muscle and joint pain) reactions are possible.

In isolated cases, allergic reactions were slightly exacerbated and side effects such as polymorphic rash, urticaria, and Quincke's edema developed. In persons with hypersensitivity, immediate allergic reactions may occur, therefore, in the first 30 minutes after the administration of the vaccine, it is necessary to ensure that the vaccinated is monitored.

Anti-shock therapy should be available at vaccination sites.

Overdose

There is no information on drug overdose.

special instructions

The Bubo-M vaccine is included in the National Calendar of Preventive Vaccinations, is recommended for the immunization of children aged 6 and over, as well as for the revaccination of adolescents and adults who are in the epidemiological risk groups for hepatitis B.

On the day of vaccination, the doctor or paramedic should interview the parents and / or examine the vaccinated person with the obligatory temperature measurement in order to exclude possible contraindications. If adults are vaccinated, it is possible to pre-select those who need vaccination, followed by questioning and thermometry by the immunization health worker immediately on the day of vaccination.

Patients who are temporarily exempted from vaccination are taken into account and monitored and in the future must also be vaccinated.

Application during pregnancy and lactation

The effect of the Bubo-M vaccine on the developing fetus has not been studied.

The possibility of vaccination of a pregnant or breastfeeding woman is considered individually. The decision is made by the doctor.

Pediatric use

The drug should not be used in children under the age of 6 years.

Drug interactions

The Bubo-M vaccine can be administered simultaneously with other vaccines that are included in the national immunization schedule or at an interval of 1 month after vaccinations against other infectious diseases.

The drug can be combined with antiallergic drugs. Drug interactions with other drugs have not been established.

Analogs

An analogue of Bubo-M is the combined vaccine of hepatitis B and diphtheria-tetanus toxoid with a reduced content of antigens.

Terms and conditions of storage

Store and transport at + 2 … + 8 ° C. Do not freeze! Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

The vaccine is sold only for sanitary-prophylactic and medical-prophylactic institutions.

Reviews about Bubo-M

There are very few reviews of the Bubo-M vaccine. Parents whose children were given this vaccine report such adverse reactions as fever, fever, chills. Doctors say that the vaccine is well tolerated and the likelihood of unwanted negative effects is low.

Price for Bubo-M in pharmacies

The vaccine cannot be purchased commercially, as it is intended only for the respective healthcare facility. The actual price of Bubo-M is unknown. The last sale price was about RUB 1,700. per package containing 10 ampoules of 0.5 ml.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!