Yellow fever vaccine, live, dry (Lyophilisate) Instructions for Use

Marketing Authorization Holder

M.P. Chumakov Institute of Poliomyelitis and Viral Encephalitides Enterprise for the Production of Bacterial and Viral Preparations of the RAMS Federal State Unitary Enterprise (Russia)

ATC Code

J07BL01 (Yellow fever virus live attenuated)

Active Substance

Yellow fever prevention vaccine

Dosage Form

Yellow fever vaccine, live, dry

Lyophilisate for preparation of solution for subcutaneous administration 0.5 ml/1 dose: 1 ml, 2.5 ml, or 5 ml amp. 5 or 10 pcs. in a kit with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for subcutaneous administration is a porous mass in the form of a light pink tablet.

Excipients: lactose monohydrate 20 mg, sorbitol 10 mg, L-histidine 1.2 mg, L-alanine 0.7 mg.
Solvent: water for injection.

1 ml (2 doses) – ampoules (10) in a kit with solvent 1.25 ml – ampoules (10) in a separate cardboard pack – carton packs.
2.5 ml (5 doses) – ampoules (10) in a kit with solvent 3 ml – ampoules (10) in a separate cardboard pack – carton packs.
5 ml (10 doses) – ampoules (10) in a kit with solvent 6 ml – ampoules (10) in a separate cardboard pack – carton packs.
1 ml (2 doses) – ampoules (5) in a kit with solvent 1.25 ml – ampoules (5) – carton packs.
2.5 ml (5 doses) – ampoules (5) in a kit with solvent 3 ml – ampoules (5) – carton packs.
5 ml (10 doses) – ampoules (5) in a kit with solvent 6 ml – ampoules (5) – carton packs.

Clinical-Pharmacological Group

Yellow fever vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine stimulates the production of immunity to the yellow fever virus lasting 10-15 years.

Indications

• Prophylaxis of yellow fever in children from 9 months of age and adults traveling abroad to yellow fever enzootic areas, as well as in persons working with live cultures of the yellow fever pathogen.

ICD codes

Dosage Regimen

Vaccination is performed once subcutaneously, with a syringe under the outer angle of the scapula or in the deltoid muscle area, in a dose of 0.5 ml for all age groups no later than 10 days before departure to the enzootic area. Revaccination, if necessary, is carried out 10 years after vaccination with the same dose.

The drug in ampoules with damaged integrity and labeling, with changed physical properties (deformation of the “tablet” – the porous light pink mass changes shape and sharply decreases in volume, non-homogeneity of the dissolved drug, etc.), with an expired shelf life, or in case of violation of the temperature regime of storage and transportation is not suitable for use.

Ampoule opening and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis.

The entire contents of the ampoule with the solvent are used to dissolve the vaccine. The vaccine should dissolve completely within 5 minutes. The dissolved vaccine is an opalescent liquid of a yellowish-pink color. The dissolved vaccine is kept for 10-15 minutes, then the ampoule is shaken and one inoculation dose of 0.5 ml is drawn into a syringe. Storage of the dissolved vaccine, covered with a sterile napkin, for no more than 1 hour at a temperature of 2 to 8°C (46.4°F) is allowed.

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

Adverse Reactions

After vaccine administration, local and general reactions may develop in some cases.

The local reaction manifests as hyperemia and edema (with a diameter of no more than 2.5 cm), which may appear after 12-24 hours and disappears 2-3 days after the injection. In extremely rare cases, induration of the subcutaneous tissue develops, accompanied by itching, pain, and enlargement of regional lymph nodes.

The general reaction may develop in the interval between 4 and 10 days after vaccination in the form of a temperature increase to 38.5°C (101.3°F), malaise, dizziness, headache, chills. The duration of the general reaction does not exceed 3 days.

In rare cases, complications of an allergic nature are possible. In this regard, vaccination points should be equipped with anti-shock therapy means, and the vaccinated person must remain under medical supervision for 30 minutes after vaccination.

Persons predisposed to allergic reactions are prescribed antihistamines for 2-4 days before and after vaccination.

Contraindications

• Acute infectious and non-infectious diseases, chronic diseases in the stage of exacerbation or decompensation – vaccinations are carried out no earlier than one month after recovery (remission);
• History of allergic reaction to chicken egg protein;
• Primary (congenital) immunodeficiencies;
• Secondary (acquired) immunodeficiencies: treatment with immunosuppressants, antimetabolites, X-ray therapy – vaccinations are carried out no earlier than 12 months after recovery (end of treatment);
• Pregnancy.

To identify contraindications, the doctor on the day of vaccination conducts a survey and examination of the vaccinees with mandatory thermometry. The specific decision on the need for vaccinations for certain groups of persons (pregnant women, patients with chronic diseases, malignant blood diseases and neoplasms, etc.) living in yellow fever enzootic areas depends on the degree of risk of the disease.

Use in Pregnancy and Lactation

Contraindicated during pregnancy.

Pediatric Use

Used in children from 9 months of age.

Drug Interactions

For persons over 15 years of age, yellow fever vaccination is allowed to be carried out simultaneously (on the same day) with other vaccinations of the national preventive vaccination calendar, provided that the drugs are administered into different parts of the body. For children under 15 years of age, the interval between the previous vaccination against another infection and yellow fever vaccination should be at least 2 months.

The use of the yellow fever vaccine simultaneously with vaccines intended for the prevention of cholera and paratyphoid A and B is contraindicated. In this case, an interval of 3 months should be observed between both vaccinations.

Storage Conditions

Transportation in accordance with SP 3.3.2.2329-08 at a temperature of 2 to 8°C (46.4°F) in thermal containers. The vaccine is stored at a temperature of 2 to 8°C (46.4°F). The solvent is stored at a temperature of 2 to 8°C (46.4°F) when packaged together with the vaccine and from 2 to 25°C (77°F) – when packaged separately from the vaccine. Freezing of the solvent is not allowed. Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

For therapeutic-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.