Prevenar 13^® ABBREVIATED PRESCRIBING INFORMATION
Prevenar 13 suspension for injection
Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Presentation: Each 0.5 ml dose of Prevenar 13 contains 2.2 micrograms of each of the following polysaccharide serotypes: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F and 4.4 micrograms of polysaccharide serotype 6B, all conjugated to the CRM197 carrier protein and adsorbed on aluminum phosphate (0.125 mg aluminum). 
Indications: Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age. Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly. The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

Dosage and Administration: For intramuscular injection. It is recommended that infants and children aged 6 weeks to 5 years who receive a first dose of Prevenar 13 complete the vaccination course with Prevenar 13. 
Infants aged 6 weeks-6 months: 
Three-dose primary series: The recommended immunization 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 immunization program, 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 between 11 and 15 months of age. 
Preterm infants (< 37 weeks gestation): In preterm infants, the recommended immunization 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.
Unvaccinated infants and children ≥ 7 months of age:
Infants aged 7-11 months: Two doses, 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 and adolescents aged 2-17 years: One single dose. 
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 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 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 5 to 17 years of age: Children 5 to 17 years of age may receive a single dose of Prevenar 13 if they have been previously vaccinated with one or more doses of Prevenar. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent). 
Adults ≥18 years of age, and the elderly: One single dose of Prevenar 13. 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 Prevenar 13. In individuals with an haematopoietic stem cell transplant (HSCT), the recommended immunization series consists of four doses of Prevenar 13. The primary series consists of three doses, with the first dose given at 3 to 6 months after HSCT and with an interval of at least 1 month between doses. A fourth (booster) dose is recommended 6 months after the third dose. 

Contra-indications: Hypersensitivity to the active substances, to any of the excipients, or to diphtheria toxoid. As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as common cold, should not result in the deferral of vaccination. 

Warnings and Precautions: Prevenar 13 must not be administered intravascularly. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. It should not be given as an intramuscular injection to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks. Prevenar 13 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia, or otitis media. As with any vaccine, Prevenar 13 may not protect all individuals receiving the vaccine from pneumococcal disease. For the most recent epidemiological information, please consult with the relevant national organization. Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunization. Safety and immunogenicity data are available for a limited number of individuals with sickle cell disease, HIV infection, or with an haematopoetic stem cell transplant. Safety and immunogenicity data for Prevenar 13 are not available for individuals in other specific immuno-compromised groups (e.g., malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis. Infants and children aged 6 weeks to 5 years: Limited data have demonstrated that Prevenar 7 valent (three-dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups. Children younger than 2 years old should receive the appropriate-for-age Prevenar 13 vaccination series. The use of pneumococcal conjugate vaccine does not replace the use of 23-valent polysaccharide vaccine in children ≥2 years of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness or those who are immunocompromised) placing them at higher risk for invasive disease due to Streptococcus Pneumoniae. Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Prevenar 13 should receive 23-valent pneumococcal polysaccharide vaccine. The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. For vaccine serotypes, protection against otitis media is expected to be lower than protection against invasive disease. When Prevenar 13 is administered concomitantly with Infanrix hexa (DTPa-HBV-IPV/Hib), the rates of febrile reactions are similar to those seen with concomitant administration of Prevenar (7-valent) and Infanrix hexa. Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Prevenar 13 and Infanrix hexa. Antipyretic treatment should be initiated according to local treatment guidelines for children with seizure disorders or a prior history of febrile seizures and for all children receiving Prevenar 13 simultaneously with vaccines containing whole cell pertussis. 

Fertility, Pregnancy and Lactation: 
Pregnancy: There are no data from the use of pneumococcal 13-valent conjugate in pregnant women. Therefore the use of Prevenar 13 should be avoided during pregnancy. 
Lactation: 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. 

Effects on ability to drive and use machines: Prevenar 13 has no or negligible influence on the ability to drive and use machines. However, some of the “Undesirable effects” may temporarily affect the ability to drive or use machines. 

Interaction with other medicinal products: 
Infants and 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 influenza type b, inactivated poliomyelitis, hepatitis B, meningococcal serogroup C, measles, mumps, rubella, varicella and rotavirus vaccine. Data from a post-marketing clinical study evaluating the impact of prophylactic use of antipyretics on the immune response to Prevenar 13 suggest that administration of paracetamol concomitantly or within the same day of vaccination may reduce the immune response to Prevenar 13 after the infant series. Responses to the booster dose administered at 12 months were unaffected. The clinical significance of this observation is unknown. 
Children and adolescents 6 to 17 years of age and Adults 18 to 49 years of age: 
No data are available regarding concomitant use with other vaccines. 
Adults aged 50 years and older: Prevenar 13 may be administered concomitantly with the seasonal trivalent inactivated influenza vaccine (TIV). Concomitant use with other vaccines has not been investigated. Different injectable vaccines should always be given at different injection sites. 

Side Effects: The most common adverse reactions reported in clinical studies or from post-marketing experience include: 
Infants and children aged 6 weeks to 5 years: Very common (≥1/10): Decreased appetite, pyrexia, irritability, any vaccination-site erythema, induration/swelling 2.5 cm–7.0 cm (after the booster dose and in older children [age 2 to 5 years]) or pain/tenderness, somnolence, poor quality sleep. Common (≥1/100 to < 1/10): Pyrexia over 39°C, vaccination-site movement impairment (due to pain), vaccination-site erythema or induration/swelling 2.5 cm – 7.0 cm (after infant series), vomiting, diarrhea, rash. 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, fever ≥ 38°C was reported in 50.0% of infants who received Prevenar (7-valent) and Infanrix hexa at the same time as compared to 33.6% of infants receiving Infanrix hexa alone. These reactions were mostly moderate (less than or equal to 39°C) and transient. 
Additional information in special populations: Apnea in very premature infants (≤28 weeks of gestation). 
Children and adolescents aged 6 to 17 years of age: Very common (≥1/10):  Decreased appetite, Irritability, any vaccination-site erythema, induration/swelling or pain/tenderness, somnolence, poor quality sleep, vaccination-site tenderness (including impaired movement). Common (≥1/100 to < 1/10):Headaches, vomiting, diarrhoea, rash; urticaria or urticaria-like rash, pyrexia.Additional information in special populations: Children and adolescents with sickle cell disease, HIV infection, or haematopoietic stem cell transplant have similar frequencies of adverse reactions, except that headaches, vomiting, diarrhoea, pyrexia, fatigue, arthralgia, and myalgia were very common. 
Adults ≥18 years and the elderly: Very Common (≥1/10): Decreased appetite, headaches, diarrhoea, vomiting (in adults aged 18 to 49 years), rash, chills, fatigue, vaccination-site erythema, vaccination-site induration/swelling, vaccination-site pain/tenderness (severe vaccination-site pain/tenderness very common in adults aged 18 to 39 years); limitation of arm movement (severe limitation of arm movements very common in adults aged 18 to 39 years), arthralgia; myalgia. Common (≥1/100 to < 1/10):  Vomiting (in adults aged 50 years and over), pyrexia (very common in adults aged 18 to 29 years)
Additional information in special populations: Adults with HIV infection have similar frequencies of adverse reactions, except that pyrexia and vomiting were very common and nausea common. Adults with haematopoietic stem cell transplant have similar frequencies of adverse reactions, except that pyrexia and vomiting were very common. Higher frequency in some solicited systemic reactions was observed when Prevenar 13 was administered concomitantly with trivalent inactivated influenza vaccine (TIV) compared to TIV given alone (headache, chills, rash, decreased appetite, arthralgia, and myalgia) or Prevenar 13 given alone (headache, fatigue, chills, decreased appetite, and arthralgia).

Adverse reactions from Prevenar 13 postmarketing experience: Lymphadenopathy (localised to the region of the vaccination-site), Anaphylactic/anaphylactoid reaction including shock; angioedema, Erythema multiforme, Vaccination-site urticaria; vaccination-site dermatitis; vaccination-site pruritus; flushing. 

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.

Shelf life: 3 years.
Special precautions for storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Prevenar 13 is stable at temperatures up to 25°C for four days. At the end of this period Prevenar 13 should be used or discarded. These data are intended to guide health care professionals in case of temporary temperature excursions.
Special precautions or disposal and other handling: During storage, a white deposit and clear supernatant can be observed. This does not constitute a sign of deterioration. The vaccine should be shaken well to obtain a homogeneous white suspension prior to expelling air from the syringe, and should be inspected visually for any particulate matter and/or variation of physical aspect prior to administration. Do not use if the content appears otherwise. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Reference: Egyptian Drug Authority Prevenar 13 Leaflet approval date: 7/4/2021, Revision Date: November 2020. Date of revision of abbreviated prescribing information January 2023.
Full prescribing information is available upon request.
-Always read the full prescribing information
− Healthcare professionals should report any suspected adverse reactions to the Egyptian Pharmacovigilance center (EPVC number:15301 ) Email: [email protected] & for reporting adverse events please contact: [email protected]
− Egyptian Drug Authority Prevenar 13 leaflet approval date 7/4/2021, revision date: November 2020
-Approved by Egyptian Drug Authority: BF0098OA922/062023; Invalidation date: 26/06/2025.
-Kindly report any violated online promotional, educational and awareness material not having this message to the General administration for regulation of Marketing & Advertising Materials at: www.edaegypt.gov.eg



Reference:

1. Egyptian drug authority Prevenar 13 leaflet approval date 7/4/2021, revision date November 2020.