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  • Prevenar 13
    / Pfizer


    Active Ingredient
    Polysaccharides serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 23F, CRM carrier protein.

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe

    1 x 0.5 ml

    partial basket chart 21669 16831

    Related information


    Dosage

    Infants and children aged 2 months to 5 years It is recommended that infants who receive a first dose of Prevenar 13 complete the vaccination course with Prevenar 13.
    Infants aged 2 months -6 months
    Three-dose primary series: The recommended immunisation series consists of four doses, each of 0.5 ml. The primary infant series consists of three doses, with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age.
    Two-dose primary series: Alternatively, when Prevenar 13 is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0.5 ml, may be given. The first dose may be administered from the age of 2 months, with a second dose 2 months later. The third (booster) dose is recommended
    Preterm infants (< 37 weeks gestation):In preterm infants, the recommended immunisation series consists of four doses, each of 0.5 ml. The primary infant series consists of three doses, with the first dose given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age. between 11 and 15 months of age.
    Unvaccinated infants ≥ 7 months of age: Two doses, each of 0.5 ml, with an interval of at least 1 month between doses. A third dose is recommended in the second year of life.
    Infants aged 7-11 months: Two doses, each of 0.5 ml, with an interval of at least 1 month between doses. A third dose is recommended in the second year of life.
    Children aged 12-23 months: Two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
    Children aged 2-5 years: One single dose of 0.5 ml.
    Prevenar 13 vaccine schedule for infants and children previously vaccinated with Prevenar (7-valent) (Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F): Prevenar 13 contains the same 7 serotypes included in Prevenar, using the same carrier protein CRM197. Infants and children who have begun immunisation with Prevenar may switch to Prevenar 13 at any point in the schedule. Young Children (12-59 months) completely immunized with Prevenar (7-valent) Young children who are considered completely immunised with Prevenar (7-valent) should receive one dose of 0.5 ml of Prevenar 13 to elicit immune responses to the 6 additional serotypes. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent).
    Children and adolescents aged 2-17 years: One single dose of 0.5 ml. Vaccine schedule for infants and children previously vaccinated with Prevenar (7-valent) (Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F)Infants and children who have begun immunisation with Prevenar may switch to this drug  at any point in the schedule.
    Young Children (12-59 months) completely immunised with Prevenar (7-valent):  Young children who are considered completely immunised with Prevenar (7-valent) should receive one dose of 0.5 ml of to elicit immune responses to the 6 additional serotypes. This dose of  should be administered at least 8 weeks after the final dose of Prevenar (7-valent).
    Children and adolescents 5 –17 years Children 5 to 17 years of age may receive a single dose if they have been previously vaccinated with one or more doses of Prevenar. This dose of this agent should be administered at least 8 weeks after the final dose of Prevenar (7-valent).
    Adults aged 50 years and older: One single dose. The need for revaccination with a subsequent dose of Prevenar 13 has not been established. Regardless of prior pneumococcal vaccination status, if the use of 23-valent polysaccharide vaccine is considered appropriate, Prevenar 13 should be given first.
    Special Populations: Individuals who have underlying conditions predisposing them to invasive pneumococcal disease (such as sickle cell disease or HIV infection) including those previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine may receive at least one dose of this drug.
    Method of administration: The vaccine should be given by intramuscular injection. The preferred sites are the anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in children and adults.
    For full details see prescribing information.


    Indications

    Active immunization against invasive disease (including sepsis, meningitis, bacteremic pneumonia, bacteremia) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F in: Infants and young children from 2 months of age to 2 years of age, and in previously unvaccinated children aged 2 years to 5 years. For active immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine. However, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease. Additionally, because otitis media is caused by many organisms other than serotypes of S. pneumoniae represented in the vaccine, protection against all causes of otitis media is expected to be low. May not be effective in cases of recurrent otitis media in children over one year of age.


    Contra-Indications

    Hypersensitivity to the active substances, to any of the excipients, or to diphtheria toxoid. As with other vaccines, the administration of this drug should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.


    Special Precautions

    This drug must not be administered intravascularly, This vaccine should not be given as an intramuscular injection to individuals with thrombocytopaenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks. Parenteral drug products should be inspected visually for particulate matter. Should not be used if particulate matter or discoloration is found. The vaccine should be injected I.M. The preferred sites are the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in toddlers and young children. Should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel. After insertion of the needle, aspirate and wait to see if any blood appears in the syringe. If blood appears, withdraw the needle and prepare for a new injection at another site. This vaccine will not protect against S. Pneumoniae disease caused by serotypes unrelated to those in the vaccine, nor will it protect against other microorganisms that cause invasive infection such as bacteremia and meningitis. Patients with a possible history of latex sensitivity since the packaging contains dry natural rubber. Prior to administration, the following should be ascertained: Patient’s previous immunization history, current health status and occurrence of any symptoms and/or signs of an adverse event after previous immunizations. Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunization. The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal poly-saccharide vaccine in children 24 months of age or older, with sickle cell disease, asplenia, HIV infection, chronic illness or who are immunocompromised. The vaccine is to be administered immediately after being drawn up into a syringe. Prevenar has been shown to be usually well-tolerated and immunogenic in infants. The safety and effectiveness of in children below the age of 6 weeks, or on or after the 10th birthday have not been established.
    For full details see prescribing information.


    Side Effects

    Infants and children aged 8 weeks to 5 years: The safety of the vaccine was assessed in controlled clinical studies where 14,267 doses were given to 4,429 healthy infants from 6 weeks of age at first vaccination and 11-16 months of age at booster dose. In all infant studies, Prevenar 13 was co-administered with routine paediatric vaccines. Safety in 354 previously unvaccinated children (7 months to 5 years of age) was also assessed. The most commonly reported adverse reactions in children 8 weeks to 5 years of age were vaccination-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep. In a clinical study in infants vaccinated at 2, 3, and 4 months of age, fever ≥ 38°C was reported at higher rates among infants who received Prevenar (7-valent) concomitantly with Infanrix hexa (28.3% to 42.3%) than in infants receiving Infanrix hexa alone (15.6% to 23.1%). After a booster dose at 12 to 15 months of age, the rate of fever ≥ 38°C was 50.0% in infants who received Prevenar (7-valent) and Infanrix hexa at the same time as compared to 33.6% in infants receiving Infanrix hexa alone. These reactions were mostly moderate (less than or equal to 39 °C) and transient. An increase in vaccination site reactions was reported in children older than 12 months compared to rates observed in infants during the primary series with Prevenar 13. Erythema, tenderness, interference with limb movement, fever, irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, rash or hives.
    For full details see prescribing information.


    Drug interactions

    Infants & children aged 6 weeks to 5 years: Prevenar 13 can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B, meningococcal.
    Children and adolescents 6 to 17 years of age: No data are currently available regarding concomitant use with other vaccines. serogroup C, measles, mumps, rubella,varicella and rotavirus vaccine.
    Adults aged 50 years and older: Prevenar 13 may be administered concomitantly with the seasonal trivalent inactivated influenza vaccine (TIV). In two studies conducted in adults aged 50-59 and 65 years and older, it was demonstrated that Prevenar 13 may be given concomitantly with trivalent inactivated influenza vaccine (TIV). The responses to all three TIV antigens were comparable when TIV was given alone or concomitantly with Prevenar 13. When Prevenar 13 was given concomitantly with TIV, the immune responses to Prevenar 13 were lower compared to when Prevenar 13 was given alone. The clinical significance of this is unknown. Concomitant use with other vaccines has not been investigated. Different injectable vaccines should always be given at different – vaccination sites. Concomitant administration of Prevenar 13 and 23-valent polysaccharide vaccine has not been studied. In clinical studies when Prevenar 13 was given 1 year after 23-valent polysaccharide vaccine the immune responses were lower for all serotypes compared to when Prevenar 13 was given to subjects not previously immunized with 23-valent polysaccharide vaccine. The clinical significance of this is unknown.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: There are no data from the use of pneumococcal 13-valent conjugate in pregnant women.
    Breast-feeding: It is unknown whether pneumococcal 13-valent conjugate is excreted in human milk.
    Fertility: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity


    Overdose

    Overdose with Prevenar 13 is unlikely due to its presentation as a pre-filled syringe. However, in infants and children there have been reports of overdose with Prevenar 13 defined as subsequent doses administered closer than recommended to the previous dose. In general, adverse events reported with overdose are consistent with those that have been reported with doses given in the recommended paediatric schedules of Prevenar 13.


    Manufacturer
    Wyeth
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