SinSaVac^® Yellow fever vaccine, live, attenuated (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Smartbiotech, LLC (Russia)

Manufactured By

Fncirip Named After M.P. Chumakov Ran, Fsbsi (Russia)

ATC Code

J07BL01 (Yellow fever virus live attenuated)

Active Substance

Yellow fever prevention vaccine (Grouping name)

Dosage Form

SinSaVac® (Yellow fever prevention vaccine live attenuated)

Lyophilisate for preparation of solution for subcutaneous administration 0.5 ml/1 dose: vial 10 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for the preparation of a solution for subcutaneous administration in the form of a light pink porous mass, hygroscopic; the reconstituted preparation is an opalescent yellowish-pink liquid; the solvent is a colorless transparent liquid without odor.

1 dose of the reconstituted preparation is 0.5 ml.

Excipients: lactose monohydrate – 20 mg, sorbitol – 10 mg, L-histidine – 1.2 mg, L-alanine – 0.7 mg, gelatin – 5 mg.
The vaccine does not contain preservatives or antibiotics.

Solvent water for injections – 6 ml.

10 doses – dark glass vials (10) in a set with solvent (amp. 6 ml 10 pcs. in a separate cardboard pack) – cardboard 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 areas endemic for yellow fever, as well as in persons working with live cultures of the yellow fever pathogen.

ICD codes

Dosage Regimen

Administer the vaccine as a single subcutaneous injection of 0.5 ml for all age groups.

Inject under the outer angle of the scapula or into the deltoid muscle of the shoulder.

Complete vaccination no later than 10 days before departure to an endemic area.

For revaccination, administer the same 0.5 ml dose after an interval of 10 years.

Reconstitute the lyophilisate immediately before use with the provided solvent.

Use aseptic technique for reconstitution and administration.

Discard any unused reconstituted vaccine.

Do not administer intravenously.

Adverse Reactions

Medical literature describes very rare cases of serious reactions from the nervous system and life-threatening side effects with the possible development of functional insufficiency of internal organs when using vaccines from other manufacturers: vaccine-associated neurotropic disease, manifested by high body temperature with headache and confusion, increased fatigue, neck muscle stiffness, convulsions, numbness of the limbs or the whole body, muscle pain, decreased blood pressure, and vaccine-associated viscerotropic disease, resembling a fulminant infection with the wild-type virus. Vaccine-associated neurotropic disease can develop after primary vaccination within 30 days, viscerotropic – within 10 days. The vaccinated person is recommended to pay attention to their well-being for at least ten days after vaccination.

Possible side reactions (based on previous experience with the use of the yellow fever prevention vaccine).

Infections and infestations rarely – rhinitis; very rarely – vaccine-associated viscerotropic disease.

From the hematopoietic organs frequency unknown – lymphadenopathy.

From the immune system frequency unknown – anaphylactic reactions and angioedema.

From metabolism and nutrition often – decreased appetite.

From the nervous system often – headache, drowsiness (in children); rarely – dizziness; very rarely – vaccine-associated neurotropic disease.

From the digestive system often – vomiting (in children), nausea; rarely – abdominal pain, diarrhea.

From the skin and subcutaneous tissue often – rash, urticaria, skin itching.

From the musculoskeletal system often – myalgia, arthralgia.

General reactions often – irritability, tearfulness, increased body temperature; rarely – headache. An increase in body temperature up to 38.5°C (101.3°F), malaise, dizziness, headache, chills, development of urticaria and other local and general allergic reactions, including anaphylactoid ones, is possible. Persons predisposed to allergic reactions are prescribed antihistamines for 2-4 days before and after vaccination.

Local reactions often – pain and tension at the injection site; infrequently – hyperemia, swelling, infiltration at the injection site; rarely – papule at the injection site.

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); diseases of the thymus gland; serious adverse reactions to other yellow fever prevention vaccines (body temperature above 40°C (104°F), swelling and hyperemia at the injection site more than 8 cm in diameter); pregnancy, breastfeeding period.

With caution

Patients with asymptomatic HIV infection without signs of immunodeficiency who cannot avoid traveling to endemic areas, due to the lack of sufficient data to determine the immunological parameters that determine the safety and efficacy of vaccination. Such patients should consider the potential risks and benefits of vaccination, taking into account the available recommendations.

Within 14 days after vaccination, one cannot be a blood donor, because during this period there is a risk of virus transmission through blood products.

Vaccination of patients aged 60 years and older may be associated with an increased risk of adverse reactions, including vaccine-associated neurotropic and viscerotropic diseases. If it is impossible to avoid visiting areas endemic for yellow fever, patients 60 years and older must consult a doctor regarding vaccination.

In each case of a disease not listed in this list of contraindications, vaccination is carried out with the permission of a doctor, based on the health status of the vaccinated person and the risk of yellow fever infection.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pregnant women and nursing mothers should postpone or refuse a trip to regions endemic for yellow fever.

Special Precautions

To identify contraindications, on the day of vaccination, the doctor conducts a survey and examination of the vaccinated persons with mandatory thermometry. Vaccination sites must be equipped with anti-shock therapy means in case of anaphylaxis or another severe hypersensitivity reaction after vaccine administration.

Syncope (fainting) may occur after or even before any vaccination as a psychogenic response to the needle injection, so vaccination sites should be equipped to prevent injury in case of syncope. The vaccinated person should be under medical supervision for at least 30 minutes after vaccination.

Effect on the ability to drive vehicles and mechanisms

Considering the possibility of neurological symptoms (dizziness, weakness), it is recommended to drive vehicles and moving mechanisms with caution for up to 10 days after immunization.

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 calendar of preventive vaccinations, 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

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.