Pneumo 23 (Pneumo 23)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceVaccine for the prevention of pneumococcal infectionsVaccine for the prevention of pneumococcal infections
Dosage form: & nbspsolution for intramuscular and subcutaneous administration
Composition:

One dose of vaccine (0.5 ml) contains:

Active components: purified capsular polysaccharides 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 - 25 micrograms each.

Excipients:

phenol - preservative ≤ 1.25 mg

sodium chloride - 4.15 mg

sodium hydrogen phosphate dihydrate - 0.065 mg

sodium dihydrogen phosphate dihydrate 0.023 mg

water for injection - up to 0.5 ml.

Description:

Transparent colorless liquid.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07   Vaccines

J.07.A.L   Vaccine for the prevention of pneumococcal infection

Pharmacodynamics:

Vaccine Pneumo 23 contains purified polysaccharides of 23 serotypes Streptococcus pneumoniae, which is approximately 90% or more of the serotypes that cause invasive pneumococcal infections in developed and developing countries. The nature of the immune response is T-independent, characterized by low immunogenicity in children less than two years old and lack of the effect of revaccination after repeated injections.

Specific immunity develops 2-3 weeks after immunization.

In a study of the immunogenicity of the Pneumo 23 vaccine, the overall epidemiological effectiveness of preventing infections caused by serotypes included in the vaccine was 57% (95% confidence interval (CI) 45-66%.

Efficacy in patients with diabetes was 84% ​​(95% CI 50-95%), coronary heart disease 73% (95% CI 23-90%), congestive heart failure 69% (95% CI 17-88%) , chronic lung diseases - 65% (95% CI 26-83%), anatomical aspiration - 77% (95% CI 14-95%). With alcoholism or cirrhosis, sickle-cell anemia, chronic renal failure, lymphoma, leukemia, myeloma, epidemiological efficacy was not determined, since the sample sizes in these groups were small. The effectiveness of immunocompetent persons over 65 years was 75% (95% CI 57-85%).As the time frame after vaccination increased, the efficacy did not decrease: after 5-8 years after vaccination, it was 71% (95% CI 24-89%), and 9 or more years after vaccination 80% (95% CI 16-95% ).

Antibody titers> 300 ng / ml (measured by antibody nitrogen) after vaccination were achieved in more than 84% of the subjects for 21 serotypes of 22, 100% of the subjects had 16 serotypes and 60% of the vaccines for serotype 9N. Moreover, vaccination with serotype 6B stimulated the production of antibodies to serotype 6A: 80% of non-immune individuals achieved ≥ 2-fold seroconversion, with an average increase in antibody titer of 5.4-fold.

This vaccine was ineffective against infections caused by serotypes not included in the vaccine (95% CI of epidemiological efficacy from -73 to 18%, p ~ 0.15).

Indications:

Specific prophylaxis of pneumococcal pneumonia and generalized pneumococcal infections caused by serotypes Streptococcus pneumoniae presented in the vaccine, in persons at risk from the age of two.

The risk group includes: persons 65 years and older; people with chronic diseases (eg, cardiovascular disease, lung disease, diabetes, alcoholism,cirrhosis); persons with weakened immune system (absence or disorder of the spleen function, sickle cell disease, Hodgkin's disease, lymphoma, multiple myeloma, oncohematological diseases, chronic renal failure, nephrotic syndrome, organ transplantation); people with HIV infection (asymptomatic and with clinical manifestations); patients with leakage of cerebrospinal fluid; people who are in special care institutions for the elderly or disabled; working in conditions that increase the risk of pneumococcal infections or their complications; located in organized collectives (students, servicemen living in dormitories).

Contraindications:

- Anaphylactic reaction to any of the components included in the vaccine or the previous administration of the pneumococcal vaccine;

- acute infectious and non-infectious diseases, exacerbation of chronic diseases.

Pregnancy and lactation:

Due to the limited amount of data on the use of the vaccine in pregnant women, its use during pregnancy is not recommended.

It is not known whether the vaccine is excreted in breast milk.

The decision to vaccinate women during pregnancy and lactation should be taken only on the basis of an assessment of the real risk of pneumococcal infection.

The use of the vaccine is possible only if it is clearly necessary and in cases where the potential benefit to the mother exceeds the possible risk to the fetus or the child.

Dosing and Administration:

Pneumo 23 is administered intramuscularly or subcutaneously, intramuscular administration is preferred. Do not enter the vascular bed. Before administration, it must be ensured that the needle does not enter the blood vessel, by slightly displacing the syringe plunger toward itself, which should not lead to the appearance of blood inside the syringe.

Primary immunization: a single injection of 0.5 ml.

Revaccination: a single injection of 0.5 ml.

The interval between the previous administration of Pneumo 23 or any other pneumococcal polysaccharide vaccine and the introduction of Pneumo 23 should be at least 3 years.

Before use, the vaccine should be kept at room temperature for several minutes after being removed from the refrigerator.

Shake before use.

The remains of unused vaccine or medical waste must be destroyed (disposed of) in accordance with national requirements.

Side effects:

Like any biologically active drug, this vaccine can cause side reactions in some patients:

- tenderness, redness, denseness or swelling at the injection site. These reactions are of moderate character and quickly pass; reported the occurrence of peripheral edema of the extremity into which the vaccine was introduced;

- an increase in body temperature (very rarely exceeding 39 ° C) on the day of vaccination, lasting no more than 24 hours;

- in very rare cases, the development of pronounced local reactions that are reversible and suitable without any consequences is possible; as a rule, these reactions develop in individuals with a high level of anti-pneumococcal antibodies;

- in very rare cases: headache, myalgia, malaise and fatigue, lymphadenopathy, arthralgia, rash and allergic reactions - hives, Quincke's edema, anaphylactic reaction including shock, febrile convulsions, inflammation of subcutaneous tissue at the injection site.

Medical supervision is necessary within 30 minutes after the introduction of the vaccine with the availability of anti-shock therapy.

The patient should be informed of the need to inform the doctor of all cases of adverse reactions, including those not listed in this manual.

Overdose:

Not applicable.

Interaction:

Pneumo 23 can be administered simultaneously (on the same day) with other vaccines (with the exception of vaccines for the prevention of tuberculosis) in different parts of the body using different syringes.

The patient should be informed of the need to inform the physician of any treatment that precedes the vaccination or coincides with the vaccination.

Special instructions:

It is recommended that Pneumo 23 be administered at least two weeks prior to splenectomy or the initiation of immunosuppressive therapy (chemotherapy, etc.).

With immunosuppressive therapy, the immune response to the administration of the vaccine can be reduced. In this case it is recommended to postpone the vaccination before the completion of the course.

Nevertheless, vaccination of individuals with chronic immunodeficiency, such as HIV infection, is recommended even if the immune response can be limited.

Carefully apply for violations of blood clotting (hemophilia, thrombocytopenia), as well as in patients undergoing anticoagulant therapy, due to the increased risk of formation of hematomas with intramuscular injection.Children with hemophilia because of the danger of bleeding with intramuscular injection are vaccinated subcutaneously in the area where it is possible to squeeze the injection site against the background of the administration of preparations of clotting factors.

Effect on the ability to drive transp. cf. and fur:

Studies to study the effect of the vaccine on the ability to drive cars and other mechanisms were not conducted.

Form release / dosage:

Solution for intramuscular and subcutaneous injection, 0.5 ml / dose.

Packaging:

One dose in a syringe with a capacity of 1 ml of type I glass with a chlorobromobutyl piston with a fixed needle and a protective cap for the needle.

1 syringe per closed cell pack (blister) (PET / PVC).

For 1 closed cell package (blister) (PET / PVC) containing 1 syringe with a fixed needle in a pack of cardboard with instructions for use.

Storage conditions:

Store at a temperature of 2 to 8 ° C in a dark place.

Do not freeze.

Store in a place inaccessible to the user.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription
Registration number:P N011092
Date of registration:02.07.2010
The owner of the registration certificate:Sanofi Pasteur S.A.Sanofi Pasteur S.A. France
Manufacturer: & nbsp
Representation: & nbspSanofi Aventis GroupSanofi Aventis Group
Information update date: & nbsp17.12.2015
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