Brucella vaccine live (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07AD01 (Brucella antigen)

Active Substance

Vaccine for preventing of new coronavirus infection caused by the SARS-CoV-2 virus (Grouping name)

Dosage Form

Brucella vaccine live

Lyophilizate for the preparation of suspension for subcutaneous injection and epicutaneous scarification administration: 4-10 doses amp. 5 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of a suspension for subcutaneous administration and epicutaneous scarification application in the form of a porous mass of white or white with a yellowish tint.

Excipients: sucrose 0.015 g, sodium glutamate monohydrate 0.00225 g, thiourea 0.00075 g, gelatin 0.00225 g.

4-10 epicutaneous doses – ampoules (5) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of brucellosis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine provides immunity development 20-30 days after vaccination, lasting 10-12 months, with maximum immunity intensity maintained for 5-6 months.

Indications

Prevention of goat-sheep type brucellosis in adults.

Persons performing the following work are subject to vaccination:

• Procurement, storage, processing of raw materials and livestock products obtained from farms where livestock brucellosis is registered;
• Slaughter of livestock sick with brucellosis, procurement and processing of meat and meat products obtained from it.

Livestock breeders, veterinary workers, zootechnicians in farms enzootic for brucellosis.

Persons working with live cultures of the brucellosis pathogen.

ICD codes

Dosage Regimen

Vaccination is performed once, epicutaneously or subcutaneously. One dose for epicutaneous administration is 2 drops (0.1 ml) and contains 1×10¹⁰ microbial cells, for subcutaneous administration it is 0.5 ml and contains 4×10⁸ microbial cells. Revaccination is performed according to indications after 10-12 months epicutaneously, using a half dose, which is 1 drop (0.05 ml) and contains 5 x 10⁹ microbial cells.

To identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the vaccinee with mandatory thermometry. If the temperature is above 37°C (98.6°F), the vaccination is postponed. If necessary, the necessary laboratory examination is performed.

Before each vaccination, the presence of specific immunity in the vaccinee is mandatorily determined using one of the serological or skin-allergic tests. Persons with a negative reaction are subject to vaccination.

Vaccinations should be carried out no later than 3-4 weeks before the start of work associated with the risk of infection.

The performed vaccination is registered in the established accounting forms, indicating the name of the drug, date of vaccination, dose, name of the manufacturer, batch number, and reaction to the vaccination.

Epicutaneous vaccination

The drug is dissolved with 0.9% sodium chloride injection solution, which is added to the ampoule with a sterile syringe with a needle at the rate of 0.1 ml per one vaccination dose. The ampoule is shaken until a uniform suspension is formed. The dissolution time of the vaccine should not exceed 1 min. The dissolved preparation should not contain sediment or flakes. The vaccination site – the outer surface of the middle third of the shoulder – is treated with alcohol or a mixture of alcohol and ether; the use of other disinfectants is not allowed. After the alcohol and ether evaporate, without touching the skin, two drops of the vaccine are applied at a distance of 30-40 mm from each other, the skin is stretched, and with a sterile scarifier, 6 scratches (3 longitudinal and 3 transverse) 10 mm long each are made through each applied drop of vaccine, with a distance of 3 mm between scratches. The scratches should not bleed; blood should only appear as dewdrops.

With the flat side of the scarifier, the vaccine is rubbed into the scratches for 30 seconds and allowed to dry for 5 minutes.

For revaccination, a half dose is used, i.e., 1 drop of vaccine, through which 6 scratches are made.

Subcutaneous vaccination

The vaccination dose of the drug with this method is 25 times less than with epicutaneous vaccination; the vaccine is diluted at the rate of 12.5 ml of 0.9% sodium chloride injection solution per one dose of vaccine for epicutaneous scarification application (subcutaneous dose – 0.5 ml x 25 = 12.5 ml).

The drug is dissolved in the same way as for epicutaneous vaccination, after which the resulting suspension is transferred to a sterile vial for an injector, into which the required volume of solvent is added (for example, if the ampoule contains 7 epicutaneous doses of the vaccine, then the contents should be suspended in 12.5 ml x 7, i.e., in 87.5 ml).

The vaccine is administered with an injector designed for subcutaneous administration (BI-ZM or anti-infective protector PPI-2), according to the Instructions for use of the injector, in a volume of 0.5 ml.

Vaccinations are performed in the area of the outer surface of the shoulder at the border between the upper and middle third. The injection site is treated in the same way as for epicutaneous vaccination.

Adverse Reactions

Local and general reactions to vaccination are insignificant. The local reaction to epicutaneous vaccination may appear after 24-48 hours as redness, skin infiltration, or as pink-red nodules along the scratches, sometimes merging into a ridge or forming a slight swelling. With the needle-free injection method, after 12-24 hours, redness, infiltration up to 25 mm in diameter, and slight pain may appear at the injection site. A general reaction occurs in the first 24 hours in 1-2% of vaccinees and is expressed as malaise, headache, and an increase in body temperature to 37.5 – 38°C (100.4°F).

Contraindications

• History of brucellosis. Positive serological or skin-allergic test for brucellosis;
• Acute infectious and non-infectious diseases, chronic diseases in the acute phase – vaccinations are carried out no earlier than 1 month after recovery (remission);
• Primary and secondary immunodeficiencies. When treating with steroids, antimetabolites, chemotherapy and radiotherapy, vaccinations are carried out no earlier than 6 months after the end of treatment;
• Systemic connective tissue diseases;
• Malignant neoplasms and malignant blood diseases;
• Widespread recurrent skin diseases;
• Allergic diseases (bronchial asthma, history of anaphylactic shock, angioedema);
• Pregnancy and lactation period.

Use in Pregnancy and Lactation

The use of the drug is contraindicated.

Special Precautions

Precautions for use

It is strictly forbidden to administer the vaccine diluted for epicutaneous scarification application subcutaneously.

The vaccine should not be used if the integrity of the packaging is damaged, with changed physical properties (foreign impurities, insoluble flakes), expired shelf life, or if the storage conditions have been violated.

Opening of ampoules and the administration procedure are carried out in strict compliance with the rules of asepsis and antisepsis. The diluted vaccine, stored in compliance with aseptic rules, can be used within 2 hours.

Considering the possibility of anaphylactic shock development in some highly sensitive individuals, the vaccinated person should be under medical supervision for at least 30 minutes. Vaccination sites must be equipped with anti-shock therapy means.

Information on possible influence on the ability to drive vehicles and operate machinery

None.

Special precautions for the disposal of unused medicinal product.

Ampoules with unused vaccine are inactivated by boiling for 30 minutes, after which they are disposed of in accordance with SanPiN 2.1.7.728-99 “Rules for the collection, storage and disposal of waste from medical and preventive institutions”

Overdose

Not established.

Drug Interactions

Vaccinations against brucellosis are carried out no earlier than 1 month after other prophylactic vaccinations or 1 month before them.

Simultaneous epicutaneous vaccination with live vaccines against brucellosis with vaccinations against one of the following infections is allowed: Q-rickettsiosis, tularemia and plague.

Storage Conditions

In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F) in a place inaccessible to children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

For medical and preventive 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.