Pnemotex^® (Suspension) Instructions for Use

Marketing Authorization Holder

NANOLEK LLC (Russia)

ATC Code

J07AL02 (Pneumococcal purified polysaccharide antigen conjugated)

Active Substance

Pneumococcal polysaccharide conjugate vaccine (adsorbed), 13 valent (Ph.Eur.)

Dosage Form

Pnemotex®

Intramuscular injection suspension 0.5 ml/1 dose: 0.5 ml bottle 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular injection white in color, homogeneous.

Excipients: sodium chloride – 4.250 mg, succinic acid – 0.295 mg, polysorbate 20 – 0.025 mg, aluminum phosphate – 0.565 mg (in terms of aluminum – 0.125 mg), water for injection – up to 0.5 ml.

0.5 ml – injection bottles of nominal capacity 4 ml made of transparent colorless type I glass (1) – cardboard boxes.
0.5 ml – injection bottles of nominal capacity 4 ml made of transparent colorless type I glass (10) – cardboard boxes.

Clinical-Pharmacological Group

Vaccine for the prevention of diseases caused by Streptococcus pneumoniae

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The thirteen-valent adsorbed pneumococcal polysaccharide conjugate vaccine induces the production of antibodies to the capsular polysaccharides of Streptococcus pneumoniae, thereby providing specific protection against infections caused by the 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F serotypes of pneumococcus included in the vaccine.

This vaccine meets the criteria for assessing the immunogenicity of conjugated polysaccharide vaccines for the prevention of pneumococcal infection based on the number of subjects who achieved a concentration of specific antibodies to capsular polysaccharides IgG ≥0.35 mcg/ml after immunization, the level of geometric mean concentrations of immunoglobulins and the titer of bactericidal antibodies based on opsonophagocytic activity (OPA) of at least 1:8.

Administration of this vaccine induces the production of antibodies to the capsular polysaccharides of Streptococcus pneumoniae, thereby providing specific protection against infections caused by the 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F serotypes of pneumococcus included in the vaccine.

This vaccine includes up to 90% of all serotypes that cause invasive pneumococcal infections (IPI), including those resistant to antibiotic treatment.

Indications

Prevention of pneumococcal infection caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in adults and children from 2 months of age.

Vaccination is carried out within the framework of the national calendar of preventive vaccinations and the national calendar of preventive vaccinations for epidemic indications according to approved schedules, including for persons at risk of developing pneumococcal infection: with immunodeficiency conditions, including HIV infection, cancer, receiving immunosuppressive therapy; with anatomical/functional asplenia; with a cochlear implant installed or planning this operation; patients with cerebrospinal fluid leakage; patients with chronic diseases of the lungs, cardiovascular system, liver, kidneys and diabetes mellitus; patients with bronchial asthma; premature infants; persons in organized groups (orphanages, boarding schools, army groups); convalescents of acute otitis media, meningitis, pneumonia; children who are frequently and long-term ill; patients infected with Mycobacterium tuberculosis; all persons over 50 years of age; tobacco smokers.

ICD codes

Dosage Regimen

Vaccination is carried out according to a special schedule.

The vaccine is administered in a single dose of 0.5 ml intramuscularly. For children in the first years of life, the vaccine is administered into the upper-outer surface of the middle third of the thigh; for persons over 2 years of age – into the deltoid muscle of the shoulder. The vaccine should not be administered into the gluteal region or areas where a major nerve trunk and/or blood vessel may pass.

The vaccine must not be administered intravenously, subcutaneously or intradermally.

Adverse Reactions

Most frequently: reactions at the injection site, increased body temperature, irritability, decreased appetite and sleep disturbance, decreased activity level, vomiting and diarrhea.

Very common hyperthermia; irritability; skin redness; pain, induration or swelling measuring 2.5-7.0 cm at the injection site; vomiting; drowsiness; sleep deterioration; appetite deterioration; headache; generalized new or exacerbation of existing joint and muscle pains; chills; fatigue.

Common hyperthermia above 39°C (102.2°F); pain at the injection site leading to short-term limitation of limb movement range; hyperemia; diarrhea; rash.

Uncommon skin redness; induration or swelling larger than 7.0 cm at the injection site; convulsions (including febrile convulsions); hypersensitivity reactions at the injection site (urticaria, dermatitis, itching), nausea.

Rare: cases of hypotonic collapse; facial flushing; hypersensitivity reaction, including shortness of breath, bronchospasm, angioedema of various locations; including facial edema; anaphylactic/anaphylactoid reaction, including shock, lymphadenopathy in the injection site area, leukopenia, thrombocytopenia.

Very rare regional lymphadenopathy, polymorphic erythema, nasopharyngitis, apathy.

Contraindications

Hypersensitivity to any component of the vaccine used; severe reaction (temperature above 40°C (104°F), swelling and hyperemia over 8 cm in diameter at the injection site) or post-vaccination complications (anaphylactic shock, severe generalized allergic reactions, encephalitis or encephalopathy, convulsive syndrome) to previous administration of vaccines containing similar components; acute infectious or non-infectious diseases, exacerbation of chronic diseases – vaccination is carried out 2-4 weeks after recovery or during remission. For mild acute respiratory viral infections, acute intestinal diseases and other mild infections, vaccination is carried out after temperature normalization.

Use in Pregnancy and Lactation

The safety of using the vaccine during pregnancy has not been established. There are no data on the use of this vaccine during pregnancy. Information on the penetration of the vaccine antigen or antibodies into breast milk is not available. As a precautionary measure, it is preferable to avoid using the drug during pregnancy and breastfeeding.

Pediatric Use

Used according to the schedule in children aged 2 months and older.

Special Precautions

As with the administration of other injectable vaccines, the necessary equipment for emergency intervention in case of a possible anaphylactic reaction following vaccine administration should be prepared. After vaccination, the vaccinee should be under medical supervision for at least 30 minutes. Immunization sites should be equipped with anti-shock therapy means.

Vaccination of premature (as well as full-term) infants should begin from the 2nd month of life (chronological age). When deciding to vaccinate a premature infant (born before 37 weeks of gestation), especially one with a history of respiratory system immaturity, it should be taken into account that the benefit of immunization against pneumococcal infection in this group of patients is particularly high and one should neither refuse vaccination nor postpone its timing. Due to the potential risk of apnea, which exists with the use of any vaccines, the first vaccination with this vaccine of a premature infant is possible under medical supervision (for at least 48 hours) in a hospital at the 2nd stage of nursing care.

This vaccine should not be administered to persons with thrombocytopenia or any coagulation disorders that contraindicate intramuscular injections, unless the potential benefit of the injection outweighs the possible risks.

This vaccine provides protection only against those serotypes of Streptococcus pneumoniae that are included in its composition, and does not provide protection against other microorganisms that cause invasive diseases, pneumonia or otitis media.

As with other pneumococcal vaccines, this vaccine may not protect all individuals to whom it is administered from pneumococcal infection.

In people with impaired immune reactivity due to the use of immunosuppressive therapy, genetic defect, HIV infection or other reasons, a reduced antibody response to active immunization may be observed.

Effect on ability to drive vehicles and machinery

Some adverse reactions associated with vaccine administration may affect concentration and speed of psychomotor functions. For persons with such adverse reactions, driving vehicles and working with machinery are possible only after the symptoms have completely disappeared.

Drug Interactions

When immunizing simultaneously with different vaccines, injections are given in different parts of the body.

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.