Live tularemia vaccine (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07AX (Other bacterial vaccines)

Dosage Form

Live tularemia vaccine

Lyophilisate for preparation of suspension for intradermal administration and cutaneous scarification application 0.1 ml/dose: 15-50 doses amp. 5 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of suspension for intradermal administration and cutaneous scarification application in the form of a porous mass, white with a yellowish tint.

Excipients: sucrose – 0.0033 g, sodium glutamate monohydrate – 0.00495 g, thiourea – 0.00165 g, gelatin – 0.0033 g.

Solvent composition: water for injections.

15-50 cutaneous doses – ampoules (5) in a kit with a solvent 5 ml amp. 5 pcs. – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of tularemia

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine induces immunity development 20-30 days after vaccination, lasting up to 5 years.

Indications

Prevention of tularemia from 7 years of age (from 14 years – in field-type foci).

The vaccine is indicated for the population living in territories enzootic for tularemia, as well as persons arriving in these territories who perform the following work:

• Agricultural;
• Hydromelioration;
• Construction;
• Other work on soil excavation and movement;
• Procurement;
• Commercial hunting/trapping;
• Geological;
• Surveying;
• Expeditionary;
• Deratization and disinsection;
• Logging, forest clearing and improvement, areas for population health improvement and recreation.

ICD codes

Dosage Regimen

Vaccination is performed once, cutaneously or intradermally. Revaccination is performed as indicated after 5 years with the same dose.

To identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the vaccinee with mandatory temperature measurement. If the temperature is above 37°C (98.6°F), the vaccination is postponed. If necessary, a 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 allergy tests. Persons with a negative reaction are subject to vaccination.

The performed vaccination is recorded 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.

Cutaneous vaccination:

The dry vaccine is diluted with water for injections supplied with the drug, at the rate of 0.1 ml per dose. The ampoule is shaken for 3 minutes until a homogeneous suspension is formed.

The vaccination is performed on the outer surface of the middle third of the upper arm. The skin before vaccination 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, one drop of the diluted vaccine is applied with a sterile eye pipette to the treated skin area in two places 30-40 mm apart. The skin of the upper arm is slightly stretched, and with a sterile scarifier (vaccination lancet), two parallel scratches 10 mm long are made through each applied drop of vaccine.

The scratches should not bleed; blood should appear only as small dewdrops. Using the flat side of the vaccination lancet, the vaccine is rubbed into the scratches for 30 seconds and allowed to dry for 5-10 minutes.

Intradermal vaccination:

For intradermal needle-free administration, the vaccine is diluted in the same way as for cutaneous scarification application. Then, 1 ml is transferred with a sterile syringe into a sterile vial for the injector, to which 19 ml of 0.9% sodium chloride injection solution is added. 20 ml of the resulting suspension contains 200 doses of the vaccine for intradermal administration. The injection site is pre-treated with alcohol or a mixture of alcohol and ether. The vaccine is administered intradermally in a volume of 0.1 ml into the outer surface of the middle third of the upper arm according to the instructions for use of the BI-ZM injector with the PPI-2 anti-infective protector set to the mode calculated for intradermal injection.

Precautions for use.

It is strictly forbidden to administer the vaccine diluted for cutaneous scarification application intradermally!

The vaccine must not be used if the integrity of the packaging is damaged, if it has altered physical properties (foreign impurities, insoluble flakes), if the expiration date has passed, 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.

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

Adverse Reactions

A local reaction should develop in all vaccinated individuals with the cutaneous method. At the scratch sites from day 4-5, and in some vaccinated individuals at a later time (up to day 10), redness and swelling up to 15 mm in diameter develop. Vesicles the size of a millet grain may appear along the scratches. From day 10-15, a crust forms at the vaccination site, local symptoms subside, and after the crust falls off, a scar remains on the skin. Sometimes a slight short-term enlargement and tenderness of the regional lymph nodes may be observed. With a negative result, only slight redness along the scratches is noted for 1-2 days.

With the intradermal method of administration, the local reaction lasting up to 9 days is characterized by moderately pronounced redness and skin infiltration up to 40 mm in diameter, rarely by enlargement of regional lymph nodes. A general reaction occurs in isolated cases from day 3-4 and is expressed as malaise, headache, less often – a short-term temperature increase to 38°C (100.4°F). These phenomena disappear after 2-3 days. Very rarely, vaccinated individuals may experience general and local reactions of an allergic nature in the third or fourth week after vaccination.

In individuals who have previously had tularemia or are being revaccinated, the general and local reactions to the vaccination develop more intensely. The fading of vaccination reactions in these cases proceeds faster than in primarily vaccinated individuals.

The effectiveness of cutaneous scarification vaccination is checked after 5-7 days, and in the absence of a skin reaction, it is rechecked on day 12-15. Evaluation of the results of intradermal vaccination is carried out 4-5 days after vaccination. A positive reaction is considered the presence of redness and infiltration with a diameter of at least 5 mm. Persons without a positive vaccination result are subject to re-vaccination 30 days after determining the presence of specific immunity.

Contraindications

• History of tularemia;
• Positive serological or skin allergy test for tularemia;
• Acute infectious and non-infectious diseases, chronic diseases in the acute stage – vaccinations are carried out no earlier than 1 month after recovery (remission);
• Primary and secondary immunodeficiencies. During treatment 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

Use of the drug is contraindicated.

Pediatric Use

Children from 7 years of age are subject to vaccination.

Special Precautions

Effect on ability to drive vehicles and operate machinery

No information available.

Special precautions for 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 healthcare facilities”.

Overdose

Symptoms of overdose and measures for assistance in case of overdose have not been established.

Drug Interactions

Simultaneous cutaneous vaccination of adults with live vaccines against tularemia, brucellosis, and plague is allowed (on different parts of the body).

Storage Conditions

Store in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (46.4°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

For healthcare facilities.

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.