Synflorix, 0.5 ml/dose, suspension for intramuscular administration, 0.5 ml, 1 pc.

"SINFLORIX" - vaccination for the prevention of pneumococcal infection and untyped Haemophilus influenzae infection

Pneumococcal vaccine, antihemophilic, conjugate, adsorbed

, Belgium.

Protects against disease: a vaccine to prevent pneumococcal infection.

For use: only in children aged from birth (6 weeks) to 5 years.

Included in the national vaccination calendar.

Description

The Synflorix vaccine is administered into the anterolateral thigh when immunizing children under 1 year of age and into the deltoid muscle of the shoulder when immunizing children over 1 year of age. A single dose of the vaccine is 0.5 ml. This drug does not provide immunization against diseases caused by serotypes for which antigens are not included in this vaccine.

The optimal level of protection against pneumococcal infection in children aged 6 weeks to 6 months is provided by 3 vaccinations and subsequent booster vaccinations. It is recommended to start vaccination with Synflorix at the age of 2 months, subsequent vaccinations should be done at intervals of 1 month. Revaccination in this case is carried out no earlier than six months after the last vaccination with this vaccine was given - approximately at the age of 12-15 months. Children aged 7-11 months who have not been immunized during the first six months of life can be immunized with this drug using two vaccinations with an interval of 1 month between them and a booster dose administered at least 2 months after the last vaccination of this drug. vaccine - in the second year of life. For children over 12 months of age, a vaccination schedule with Synflorix is ​​recommended, consisting of two vaccinations with a 2-month interval between them.

Benefits of the Synflorix vaccine

• The vaccine contains antigens of 10 serotypes of Streptococcus pneumoniae (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F), which cause the largest number of cases of invasive pneumococcal infection - pneumonia (50-96%) in children under 5 years of age in world.
• After the first vaccination, immune protection will be developed to most classes of pneumococcus.
• Clinical studies have confirmed the high immunogenicity of the Synflorix vaccine when using two-dose and three-dose primary immunization regimens in children under 2 years of age and 2 to 5 years of age.
• The effectiveness of the vaccine in children under 7 months of age is 100% when vaccinated according to the 3+1 schedule and 91.8% when vaccinated according to the 2+1 schedule.

Special conditions

This vaccine must be administered intramuscularly only. Intravascular or intradermal administration of this drug is prohibited. If immunization was started with the Synflorix vaccine, then the remaining vaccinations should be given with the same drug. Before vaccinating with Synflorix, the doctor must examine the child and find out the medical history in order to identify contraindications to this vaccination. After the vaccine is administered, the child must be under medical supervision for 30 minutes.

Children who have a weakened immune system (due to HIV, immunosuppressive therapy, or a genetic defect) may experience decreased antibody production after receiving this vaccine.

Synflorix, Prevenar, Prevenar-13, Pneumo-23 - what's the difference?

• Prevenar and Prevenar 13 are close analogues of the Synflorix vaccine. The Prevenar vaccine has been used longer, it includes the 7 most common serotypes of streptococcus, Synflorix - 10, Prevenar-13 - respectively, 13.
• Synflorix and Prevenar-13 are produced in Russia under an agreement with the Pfizer concern.
• Prevenar is manufactured in the USA.
• All three vaccines can be used to vaccinate children under 2 years of age.

As for Pneumo-23, this vaccine is intended for vaccination of children from 2 years of age and protects against the 23 most common serotypes of streptococcus. This vaccine is produced in France.

Drug interactions

This vaccine should not be mixed in the same syringe with other medications. Synflorix can be given on the same day as hepatitis B, chickenpox, rotavirus, polio and other routine vaccines such as DTP.

To reduce the intensity of post-vaccination febrile conditions when Synflorix is ​​administered at the same time as the whole-cell pertussis vaccine, the doctor may prescribe the child a prophylactic antipyretic drug.

Vaccination against pneumococcus in medical

Medical center specialists carry out vaccinations only after a thorough examination by a general practitioner and a positive conclusion about the patient’s health. For injection, high-quality high-quality instruments and certified drugs with high efficiency are used.

Strict adherence to the vaccination protocol allows you to reduce the risk of complications and make vaccination easier. Vaccination is an easy way to avoid serious illnesses and health problems. Take care of the future and protect yourself and your loved ones.

Contraindications

An absolute contraindication to the use of this drug is hypersensitivity to any of its components. Temporary contraindications to the administration of this vaccine are infectious and non-infectious diseases in acute form, as well as exacerbation of chronic diseases. If the child suffered from a mild ARVI or acute intestinal disease, then the vaccination can be done immediately after the body temperature has normalized, and in other cases - 2-4 weeks after recovery from an acute illness or the onset of remission of a chronic disease.

1 dose (0.5 ml) contains: 1 mcg of pneumococcal polysaccharide of serotypes 1(*, **); 5(*, **); 6B(*, **); 7F(*, **); 9V(*, **); 14(*, **); 23F(*, **); and 3 mcg of pneumococcal polysaccharide of serotypes 4(*, **); 18С(*, ***) and 19F(*, ****). *Adsorbed on aluminum phosphate - 0.5 mg Al3+. **Conjugated to protein D (derived from an untyped strain of Haemophilus influenzae) ~ 13 mcg. ***Tetanus toxoid protein conjugated ~ 8 mcg. ****Diphtheria toxoid protein conjugated ~ 5 mcg. Excipients: sodium chloride, aluminum phosphate (Al3+), water for injection.

No. 850/11-300200000 from 07/21/2011 to 07/21/2016

CHARACTERISTIC:

Sinflorix is ​​a vaccine for the prevention of pneumococcal infection (polysaccharide antigen) and untyped Haemophilus influenzae infection, conjugated, adsorbed, containing polysaccharides of Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, each of which is conjugated with carrier protein D (PD), or tetanus toxoid (TT), or diphtheria toxoid (DT). The vaccine is a preservative-free liquid, aluminum phosphate is used as an adjuvant. Synflorix meets WHO requirements for the production of biological substances and conjugate adsorbed vaccines. Efficacy against invasive pneumococcal diseases (including sepsis, meningitis, bacterial pneumonia and bacteremia). According to WHO recommendations, the assessment of the potential effectiveness of the vaccine against invasive pneumococcal diseases was based on a comparison of the immune response to the antigens of the 7 serotypes of Streptococcus pneumoniae that were part of the Synflorix vaccine and another pneumococcal conjugate vaccine, the effectiveness of which has been previously proven (in this case, the 7-valent Prevenar vaccine). The immune response to antigens of 3 more serotypes of Streptococcus pneumoniae, which are part of the Synflorix vaccine, was also assessed. According to comparative studies of the Synflorix vaccine and the 7-valent Prevenar vaccine, it was found that the immune response to the administration of the Synflorix vaccine, assessed by ELISA, for all serotypes, with the exception of 6B and 23F, was at the level of the reference drug. In 65.9 and 81.4% of infants immunized with the Synflorix vaccine according to scheme 2; 3 and 4 months, the level of antibodies against antigens of serotypes 6B and 23F, respectively, reached the threshold value (0.20 μg/ml) 1 month after the administration of the 3rd dose. With the introduction of the Prevenar vaccine, corresponding indicators were obtained in 79.0 and 94.1% of vaccinated infants. The clinical significance of these differences is unknown. Threshold values ​​for immune response to antigens of three additional pneumococcal serotypes of the Synflorix vaccine (1, 5 and 7F) were achieved at 97.3; 99.0 and 99.5% of cases, respectively, which was at least as successful as the overall immune response to 7 serotypes (95.8%) with the Prevenar vaccine. The same study showed that the Synflorix vaccine induces the formation of functional antibodies to all pneumococcal serotypes included in the vaccine. Overall, for each of the 7 serotypes, 87.7–100% of infants immunized with Synflorix and 92.1–100% of infants immunized with Prevenar achieved an OPT titer of ≥8 at 1 month after 3rd dose. For serotypes 1, 5 and 7F, OFT titers ≥8 were achieved in 65.7; 90.9 and 99.6% of cases after the initial vaccination course of Synflorix and in 91.0; 96.3 and 100% after administration of a booster dose. The introduction of the 4th dose (booster dose) in the 2nd year of life stimulated the immune response when assessed by ELISA and OFT for 10 serotypes included in the vaccine, which confirms the induction of immune memory after a 3-dose primary course. Efficacy in relation to acute otitis media. In a large, randomized, double-blind clinical trial (Pneumococcal Otitis media Efficacy Trial, POET) of vaccine efficacy in acute otitis media caused by pneumococci, conducted in the Czech Republic and Slovakia, 4968 infants received the 11-valent study vaccine (11pn-PD), in which included 10 serotypes of the Synflorix vaccine and serotype 3, the effectiveness of which has not previously been established, or a control vaccine (hepatitis A vaccine) according to vaccination schedule 3; 4; 5 and 12–15 months. The effectiveness of the 11pn-PD vaccine against the first incident of acute otitis media was 52.6% (95% CI: 35.0, 65.5). Serotype-specific activity against a first episode of acute otitis media was demonstrated for serotypes 6B (86.5%; 95% CI: 54.9, 96.0), 14 (94.8%; 95% CI: 61.0, 99.3 ), 19F (43.3%; 95% CI: 6.3, 65.4) and 23F (70.8%; 95% CI: 20.8, 89.2). Relative to other serotypes, the number of cases of acute otitis media was insignificant to draw a conclusion regarding the effectiveness of the vaccine. The effectiveness for acute otitis media caused by any pneumococcal serotype was 51.5% (95% CI: 36.8, 62.9). There was no increased incidence of acute otitis media caused by other bacterial pathogens or pneumococcal serotypes not included in the vaccine in this study. The expected vaccine effectiveness against any clinical cases of acute otitis media, regardless of its etiology, was 33.6% (95% CI: 20.8, 44.3). Based on a comparison of the immunological functional response (IFR) between Synflorix and the 11-valent vaccine used in the POET study, Synflorix would be expected to have similar protective efficacy against acute otitis media of pneumococcal etiology. Additional data regarding the immunogenicity of the 3-dose primary regimen. Eight studies conducted in different European countries, as well as in Chile and the Philippines, assessed the immunogenicity of Synflorix after an initial 3-dose course (n=3089) according to different vaccination schedules (age 6-10-14 weeks, 2-3-4 ; 3–4–5 or 2–4–6 months). A fourth (booster) dose was administered to 1976 subjects in 6 clinical studies. In a clinical study in which infants received vaccination at 6; 10; 14 weeks, the proportion of those immunized with the Synflorix vaccine with an antibody level ≥0.20 μg/ml and with an OFT titer ≥8 was similar to this general indicator for 7 serotypes in those vaccinated with the Prevenar vaccine. The difference in the percentage of individuals with OFT titers ≥8 was <5% for all serotypes except 19F (the percentage was higher in the Synflorix group). A clinical study demonstrated that Synflorix can be safely given as a booster dose in the 2nd year of life in children who have received 3 primary doses of the 7-valent Prevenar vaccine. Premature babies. Immunogenicity of the Synflorix vaccine in stage III–IV premature infants (born at 27–30 weeks of pregnancy) (n=42), stage I–II premature infants (born at 31–36 weeks of pregnancy) (n=82) and full-term ( born after the 36th week of pregnancy) (n=132) infants were assessed after three doses of a course of primary vaccination at the age of 2–4–6 months. Immunogenicity was studied in 44 grade III–IV preterm infants, 69 grade I–II preterm infants, and 127 full-term neonates following a repeat dose at 15–18 months of age. Regardless of gestational age, 1 month after the primary course of vaccination, at least 92.7% of patients had antibodies in a concentration of >0.2 μg/ml, determined by ELISA, and at least 81.7% had OFT titers >8 for all vaccine serotypes except serotype 1 (not less than 58.8% by OFT titers >8). Similar geometric mean antibody concentrations (GMC) and geometric mean antibody titers with OFT (GMT) were noted in all newborns, except for low levels of GMC antibodies for serotypes 4, 5 and 9V in premature infants of III–IV degrees, serotype 9V in premature infants and more low GST indicators according to OFT for serotype 5 in stage III–IV premature infants. An increase in GCT, calculated by ELISA, and GCT of antibodies according to OFT, were observed for all serotypes 1 month after the booster dose, which indicated the presence of immunological memory. Similar SHT and SHT were observed in all newborns, except for a low SHT indicator according to the OFT for serotype 5 preterm grades III–IV. Overall, at least 97.6% of individuals had antibody concentrations >0.2 μg/mL by ELISA and at least 91.9% had OPT titers >8 for all vaccine serotypes. The immune response to protein D after primary and booster vaccinations is similar in grades III–IV preterm, grade I–II preterm, and full-term neonates. 2-dose primary regimen. In addition to the 3-dose primary regimen, the immunogenicity of Synflorix was assessed in 2 clinical studies following a 2-dose primary vaccination regimen in infants <6 months of age. In the first study, immunogenicity 2 months after the second dose of Synflorix was compared with the immunogenicity of the 7-valent vaccine Prevenar. The proportion of individuals with antibody levels determined by ELISA and amounting to ≥0.2 μg/ml had similar values ​​for each of the serotypes included in both vaccines, with the exception of serotypes 6B (higher for Synflorix) and 18C (higher for the 7-valent Prevenar vaccine). The proportion of individuals whose titers, determined by OPT, reached ≥8, was also close for each of the serotypes included in both vaccines. The second study compared immunogenicity after 2 or 3 doses of Synflorix. Despite the absence of differences in individuals with antibody levels ≥0.2 μg/ml (ELISA), a decrease in the number of individuals with respect to some serotypes with OFT titers ≥8 was noted among those who underwent primary vaccination using a 2-dose regimen, compared with individuals vaccinated according to 3-dose regimen. When using both regimens, a booster response was noted, which indicates the formation of immunological memory. After the booster dose, among individuals vaccinated according to the 2+1 scheme, a decrease in their proportion with OFT titers ≥8 for serotype 5 was noted (87.2% for the 2+1 scheme and 97.5% for the 3+1 scheme). Because the clinical significance of these findings remains uncertain, a second study assessed the durability of the immune response. In individuals after primary vaccination using a 2-dose regimen, the presence of antibodies was detected at the age of 36–46 months (at least 83.7% of individuals remained seropositive to the vaccine serotypes, that is, they had an antibody level ≥0.05 μg/ml). In individuals who underwent primary vaccination using a 2- or 3-dose regimen, a single dose of Synflorix, which was administered additionally in the 4th year of life, led to an increase in the SGC of antibodies, determined by ELISA, 7-10 days after vaccination, in contrast to unvaccinated persons. This indicated the presence of an anamnestic immune response in vaccinated individuals to all vaccine serotypes. The multiple increase in GCT antibodies determined by ELISA and GCT by OFT in the period before and after vaccination in individuals vaccinated with a 2-dose regimen coincided with the multiple increase in these indicators in individuals vaccinated with a 3-dose regimen. The response to protein D was greater with the 3-dose schedule than with the 2-dose schedule. An anamnestic immune response to protein D was observed with both regimens, but the clinical significance of these findings remains unknown. The clinical consequences of a less intense immune response after primary vaccination and after administration of a booster dose with a 2-dose schedule are unknown. Additional vaccination according to age. The immune response in unvaccinated older children was studied in 2 clinical studies. The first study examined vaccination outcomes in children aged 7–11 months, 12–23 months and 2–5 years. In the 7–11 month age group, children received 2 doses of the vaccine followed by a booster dose in the 2nd year of life. The immune response following a booster dose of Synflorix in this age group was generally similar to the immune response observed following a booster dose in infants vaccinated with 3 doses before 6 months of age. The immune response after 2 doses of Synflorix in children 12–23 months of age is similar to that after 3 doses in infants, except for the response to serotypes 18C and 19F. In the 2–5 year age group in which children received 1 dose of Synflorix, antibody SCRs for pneumococcal vaccine serotypes determined by ELISA were similar to those after vaccination with a 3-dose regimen in infants, with the exception of antibodies to serotypes 1. 5, 14 and 23F and protein D. Antibody SGCs by OPT after a single dose were similar to or higher than with a 3-dose primary course in infants, with the exception of serotype 5. A second clinical study showed that administration of 2 doses at an interval 2 months in children aged 36–46 months led to an increase in the GCT of antibodies determined by ELISA and the GCT of antibodies by OFT compared with the same indicators that were noted 1 month after vaccination with 3 doses, for each vaccine serotype and protein D.

INDICATIONS:

active immunization of infants and children aged 6 weeks to 5 years to prevent pneumococcal infection caused by Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteremia and acute otitis media), as well as infection caused by untyped Haemophilus influenzae (acute otitis media).

APPLICATION:

children aged 6 weeks to 6 months Primary vaccination schedule consisting of 3 doses The recommended vaccination schedule that provides optimal protection includes 4 doses of 0.5 ml each. The primary regimen for infants consists of 3 doses, with the first dose usually given at 2 months of age, with an interval of at least 1 month between doses. The first dose can be given as early as 6 weeks of age. The 4th dose is recommended no earlier than 6 months after the 3rd dose (see CHARACTERISTICS). Primary 2-dose regimen Alternatively, if Synflorix is ​​administered as part of a routine infant immunization program, a 3-dose regimen of 0.5 ml each may be used. The 1st dose can be administered starting at 2 months of age, the 2nd dose is administered after 2 months. The next dose is recommended no earlier than 6 months after the last dose of the primary vaccination regimen (see CHARACTERISTICS). Children born after the 27th week of gestation The recommended vaccination schedule includes 4 doses of 0.5 ml each. The primary regimen for infants consists of 3 doses, with the first dose usually given at 2 months of age, with an interval of at least 1 month between doses. The next dose is recommended at least 6 months after the last dose of the primary vaccination regimen (see CHARACTERISTICS). Previously unvaccinated children over 6 months of age and children:

• children aged 7–11 months: the vaccination schedule includes 2 doses of 0.5 ml with an interval of at least 1 month between doses. The 3rd dose is recommended in the second year of life at intervals of at least 2 months;
• children aged 12–23 months: the vaccination schedule includes 2 doses of 0.5 ml with an interval of at least 2 months between doses. The need for a booster dose after this immunization regimen has not been established;
• children aged 24 months–5 years: the vaccination schedule includes 2 doses of 0.5 ml with an interval of at least 2 months between doses.

Individuals who have received the first dose of Synflorix are recommended to complete the full course of immunization with Synflorix. Vaccination of children on the territory of Ukraine is carried out in accordance with the requirements of the current orders of the Ministry of Health of Ukraine regarding immunization regimens, contraindications and interactions with other medications. The vaccine is administered intramuscularly into the anterolateral thigh area for children under 3 years of age, and into the deltoid muscle of the arm for children over 3 years of age. Instructions for using the vaccine During storage of the syringe/vial, a white precipitate with a clear, colorless supernatant may form, which does not indicate a deterioration in the quality of the vaccine. Before administration, the contents of the syringe/vial are inspected for the presence of foreign mechanical impurities and/or inconsistencies in physical appearance both before and after shaking. If there are foreign impurities or inappropriate appearance, the vaccine should be destroyed. Shake the vaccine well before use. Instructions for administering the vaccine in a pre-filled syringe 1. Holding the syringe body in one hand (do not hold the syringe by the plunger), unscrew the syringe cap by rotating it counterclockwise. 2. In order to attach the needle to the syringe, screw in the needle, rotating it clockwise until it feels firm. 3. Remove the protective cap from the needle; it may be difficult to remove. 4. The vaccine is administered. Any unused drug or used materials must be destroyed in accordance with applicable law.

CONTRAINDICATIONS:

hypersensitivity to any component of the vaccine (see Qualitative and quantitative composition).

SIDE EFFECTS:

In clinical studies, approximately 7,000 healthy children and 137 premature infants received approximately 21,000 doses of Synflorix vaccine in their primary vaccination. In addition, approximately 5,800 healthy children and 116 premature infants received a booster dose of Synflorix vaccine during the 2nd year of life. Safety was also assessed in approximately 400 children aged 2 to 5 years. In all studies, Synflorix was administered concomitantly with other vaccines recommended for children. When subsequent doses of the vaccine were administered according to the primary vaccination schedule, no increase in the frequency or severity of adverse reactions was observed. During primary vaccination with Synflorix, a higher incidence of local reactions was detected in children aged >12 months compared to infants. The reactogenicity of the Synflorix vaccine was higher in children simultaneously vaccinated with a vaccine for the prevention of whooping cough with a whole cell component. The most common adverse reactions observed after primary vaccination were redness at the injection site and irritability, which occurred in 38.3 and 52.3% of the total doses administered, respectively. Most of these reactions were mild or moderate and short-lived. Adverse reactions (for all age groups) that are considered at least least likely to be related to the use of the vaccine are divided into categories depending on the frequency of occurrence: very common (≥1/10); often (≥1/100 – <1/10), infrequently (≥1/1000 – <1/100), rarely (≥1/10000 – <1/1000).

Following booster vaccination, children over 12 months of age experienced a higher incidence of injection site reactions such as rash (uncommon) and high-pitched screaming (uncommon) compared with infants receiving primary immunization with Synflorix.

SPECIAL INSTRUCTIONS:

Before vaccination, it is necessary to review the child’s medical record (especially regarding previous vaccinations and possible cases of side effects), and conduct a medical examination immediately before vaccination. As with other injectable vaccines, in the rare event of an anaphylactic reaction, prompt medical attention and follow-up should be available. As with other vaccines, Synflorix vaccination is delayed in individuals with symptoms of acute disease and exacerbation of chronic disease. Acute mild respiratory disease is not a contraindication for vaccination. Synflorix should not be administered IV or IV under any circumstances. There are no data regarding subcutaneous administration of Synflorix. As with other injectable vaccines, Synflorix should be administered with caution to persons with thrombocytopenia or bleeding disorders, as bleeding may occur in such persons when administered intramuscularly. Immunization with the Synflorix vaccine does not protect against diseases caused by pneumococcal serotypes other than those included in the vaccine. Although immunization with Synflorix vaccine develops an immune response to diphtheria toxoid, tetanus toxoid and protein D (protein D is highly stable in all strains of Haemophilus influenzae, including untyped strains), it cannot replace the immunization that is provided in the vaccination schedule against diphtheria, tetanus or Haemophilus influenzae type b. As with other vaccines, a protective immune response may not be seen in all vaccine recipients. There are no data regarding safety and immunogenicity when used in children with an increased risk of pneumococcal infections (sickle cell anemia, congenital or acquired splenic dysfunction, HIV infection, malignant neoplasms, nephrotic syndrome). When immunizing children whose immune status is weakened due to the use of immunosuppressive drugs or a genetic defect, or HIV infection, or any other reason, the immune response may be reduced. For immunization of children at high risk of developing diseases of pneumococcal etiology (sickle cell anemia, asplenia, HIV infection, chronic diseases or immunocompromised children), it is recommended:

• children under 2 years of age should be immunized with the Synflorix vaccine according to age recommendations (see APPLICATION);
• Children aged 2 years and older should be immunized with the 23-valent pneumococcal polysaccharide vaccine.

Prophylactic administration of antipyretic drugs before or immediately after vaccine administration can reduce the frequency and intensity of post-vaccination febrile reactions. However, there is evidence that prophylactic use of paracetamol may reduce the immune response to pneumococcal vaccines. The clinical implications of these data are unknown. When prescribing primary immunization to premature infants (≤28 weeks of gestation), it is necessary to take into account the potential risk of developing apnea and the need to monitor respiratory function for 48–72 hours after vaccination, especially if the infant has a history of underdevelopment of the respiratory system . Because the benefit of vaccination is high in this group of children, vaccination should not be withheld or delayed. Fainting (dizziness) may occur during or before any vaccination as a psychogenic response to the needle. It is important to take steps to prevent injuries due to dizziness. During pregnancy and breastfeeding. Since the Synflorix vaccine is not intended for use in adults, studies of the drug's effect on pregnancy and lactation, as well as reproductive studies in animals, have not been conducted.

INTERACTIONS:

Synflorix can be co-administered with any of the following monovalent or combination vaccines, including DTPa-HBV-IPV/Hib and DTPw-HBV/Hib. These include: diphtheria, tetanus and pertussis vaccine with acellular component (DTPa); vaccine to prevent hepatitis B (HBV); inactivated polio vaccine (IPV); vaccine to prevent Haemophilus influenzae type b (Hib); tetanus, diphtheria and pertussis vaccine with whole cell component (DTPw); measles, mumps, and rubella (MMR) vaccine; vaccine to prevent chickenpox; conjugate vaccine for the prevention of diseases caused by meningococci of serogroup C (CRM197 and TT conjugates), oral vaccines for the prevention of polio (OPV) and rotavirus infection. Different vaccines can be given to different areas of the body during the same doctor's visit. Clinical studies have shown that the immune response and safety profile of vaccines administered concomitantly were not altered, with the exception of inactivated poliovirus type 2, for which conflicting results were obtained throughout the studies (seroprotection ranging from 78–100%). The clinical significance of this observation is unknown. No adverse interactions were observed with meningococcal conjugate vaccines, regardless of the carrier protein (CRM and TT conjugates). At the same time, an increase in the humoral immune response to the Hib-TT conjugate, diphtheria and tetanus antigens was detected. As with other vaccines, an incomplete immune response can be expected when immunizing individuals taking immunosuppressive drugs.

STORAGE CONDITIONS:

at a temperature of 2–8 °C (in the refrigerator). Do not freeze. Store in original packaging to protect from light. GNRL/11/UA/27.09.2013/7916

Date added: 04/10/2012 Date modified: 18/11/2013

Side effects

In approximately 40% of cases, children experience redness at the site where Synflorix was administered. In approximately 50% of cases, children develop irritability after this vaccination. Very often (more than 10% of cases), children after vaccination become drowsy, they may experience loss of appetite, pain and swelling may occur at the injection site, and body temperature may rise above 38 degrees.

During clinical trials, it was found that in children under the age of 12 months, the frequency of local reactions to the administration of this vaccine was less than in children over the age of 1 year. Side effects such as pathological crying, vomiting or diarrhea do not occur often after such vaccination (less than 1 case per 100-1000 vaccinations).

Preparing a child for vaccination

For successful immunization and minimizing side effects, the baby must be prepared in advance and follow some rules before and after vaccination:

• It is necessary to undergo an examination by a pediatrician and neurologist in advance. Possible reasons for delaying vaccination include: acute viral and bacterial diseases, severe anemia, high fever, etc. After eliminating the acute form of the disease, immunization is carried out according to the course;
• It is not advisable to walk for a long time after vaccination;
• Avoid hypothermia and overheating;
• Prepare in advance for a possible increase in temperature (have paracetamol or ibuprofen at home). Fever is a predicted response to vaccination;
• After the injection, remain under medical supervision for at least 30 minutes.

All the vaccines we use comply with WHO standards, which guarantees their effectiveness, safety and reduced risk of side effects.