Pneumovax^® 23 (Solution) Instructions for Use

Marketing Authorization Holder

Merck Sharp & Dohme, B.V. (Netherlands)

ATC Code

J07AL01 (Pneumococcal purified polysaccharide antigen)

Active Substance

Pneumococcal polysaccharide vaccine (Ph.Eur.)

Dosage Form

Pneumovax® 23

Solution for intramuscular and subcutaneous injection 0.5 ml/1 dose: syringes 1 or 10 pc. or vial 1 pc.

Dosage Form, Packaging, and Composition

Solution for intramuscular and subcutaneous injection in the form of a clear, colorless liquid.

* according to the Danish nomenclature, serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F – 25 mcg of each serotype

Excipients: sodium chloride – 4.5 mg, phenol – 1.25 mg, water for injection – up to 0.5 ml.

0.5 ml (1 dose) – vials of colorless glass with a capacity of 3 ml (1) with first opening control – cardboard boxes^x.

0.5 ml (1 dose) – disposable syringes with a capacity of 1.5 ml (1) – contour packs (1) – cardboard boxes^x.

0.5 ml (1 dose) – disposable syringes with a capacity of 1.5 ml (1) with a needle (1 pc.) – contour packs (1) – cardboard boxes^x.

0.5 ml (1 dose) – disposable syringes with a capacity of 1.5 ml (1) – contour packs (10) – cardboard boxes^x.

0.5 ml (1 dose) – disposable syringes with a capacity of 1.5 ml (1) with a needle (10 pcs.) – contour packs (10) – cardboard boxes^x.

^x packaging opening control may be present

Clinical-Pharmacological Group

Vaccine for the prevention of diseases caused by Streptococcus pneumoniae

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

It is a highly purified polyvalent vaccine. It is a purified polysaccharide of Streptococcus pneumoniae 23 serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F.

It induces immunity to the specified serotypes of Streptococcus pneumoniae. Immunity is acquired 10-15 days after a single vaccination and persists for at least 5 years. After administration of this vaccine, seroconversion is observed in at least 90% of vaccinated individuals.

Indications

Prevention of infections of pneumococcal etiology, especially respiratory tract infections, in individuals at risk, starting from 2 years of age.

ICD codes

Dosage Regimen

Administer a single 0.5 ml dose by subcutaneous or intramuscular injection.

Perform primary vaccination as a one-time injection.

Administer revaccination every five years.

Shorten the revaccination interval for individuals at high risk of pneumococcal infection.

Shorten the interval for patients receiving immunosuppressive therapy.

Do not administer to individuals who have received any antipneumococcal vaccine or had confirmed pneumococcal infection within the previous five years.

Avoid revaccination earlier than the recommended interval due to the risk of severe local reactions.

Use in children from 2 years of age and older.

Adverse Reactions

Weakness, slight increase in body temperature, chills, headache (duration – no more than 24 hours) may occur; local reactions – redness, slight soreness or induration at the injection site.

Contraindications

Severe reaction to previous administration of the vaccine; antipneumococcal vaccination or past pneumococcal infection (caused by one of the serotypes contained in the vaccine) within a period of up to 5 years before the planned vaccination with this vaccine.

Use in Pregnancy and Lactation

Although there is no information on the adverse effects on the fetus when using this vaccine during pregnancy, vaccination of pregnant women at risk is not recommended.

Pediatric Use

Used in children from 2 years of age according to indications.

Special Precautions

Vaccination is especially indicated for patients with sickle cell anemia, as well as for individuals with asplenia, who have undergone splenectomy or before splenectomy.

Severe local reactions may occur with revaccination performed earlier than the due date.

Although there is no information on the adverse effects on the fetus when using this vaccine during pregnancy, vaccination of pregnant women at risk is not recommended.

Due to the possibility of developing serious side effects (such as the Arthus phenomenon) during vaccination, contraindications should be strictly observed, and the benefits of vaccination should be assessed. It should be taken into account that the determination of the effectiveness of antipneumococcal vaccination was carried out only in individuals at risk.

Immunosuppressive therapy may reduce or completely suppress the immune response to the administration of this vaccine.

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.