Prevenar 13 Vaccine 0.5 Ml

PREVENAR 13 VACCINE 0.5 ML by WYETH

Prevenar 13 is a pneumococcal conjugate vaccine, developed by Wyeth (now Pfizer), designed to protect against diseases caused by Streptococcus pneumoniae bacteria.

• Name:

  • Common Name: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
  • Brand Names: Prevenar 13, Prevnar 13

• Composition: Each 0.5 mL dose contains purified capsular polysaccharides from 13 different Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), each individually conjugated to a non-toxic diphtheria CRM197 protein. It also contains aluminum phosphate (as an adjuvant), sodium chloride, succinic acid, polysorbate 80, and water for injections.

• Uses: Prevenar 13 is used for active immunization to prevent invasive disease, pneumonia, and acute otitis media caused by the 13 serotypes of Streptococcus pneumoniae included in the vaccine. It is indicated for:

  • Infants and children from 6 weeks to 17 years of age.
  • Adults aged 18 years and older.

• Dosage and Administration: The vaccine is administered as a 0.5 mL intramuscular injection.

  • Infants: A primary series typically consists of three doses (e.g., at 2, 4, and 6 months of age) followed by a booster dose between 12-15 months. The first dose can be given as early as 6 weeks of age.
  • Children (6-17 years): A single dose is typically recommended.
  • Adults (18 years and older): A single dose is usually administered.

• Side Effects: Common side effects include:

  • Injection site reactions (pain, redness, swelling, tenderness)
  • Fever (often below 39°C), chills
  • Irritability, drowsiness, changes in appetite
  • Headache, muscle and joint pain
  • Vomiting, diarrhea
  • Rash Serious side effects, though rare, can include allergic reactions (e.g., anaphylaxis, breathing problems) and seizures.

• Precautions:

  • Do not administer intravenously or intravascularly.
  • Vaccination should be delayed in individuals with a high fever or acute infection.
  • Inform your doctor if you or your child have bleeding problems, a weakened immune system, or were born prematurely (increased risk of apnea).
  • Avoid if allergic to any component of the vaccine, including diphtheria toxoid.

• Storage: Prevenar 13 should be stored refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze; discard if the vaccine has been frozen. Keep in the original packaging until use.

Here are the most frequently asked questions about PREVENAR 13 VACCINE 0.5 ML by WYETH, along with concise answers:

What is Prevenar 13 used for?

Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) is used for active immunization to prevent diseases caused by 13 types of Streptococcus pneumoniae bacteria (pneumococcus). These diseases include pneumonia (lung infection), invasive pneumococcal disease (such as meningitis—brain infection, bacteremia—bloodstream infection, and sepsis), and acute otitis media (ear infections), primarily in infants and children. It is also approved for older children, adolescents, and adults for the prevention of pneumonia and invasive disease caused by these serotypes.

How does Prevenar 13 work?

Prevenar 13 is a vaccine that stimulates the body's immune system to produce antibodies against the 13 specific serotypes of Streptococcus pneumoniae bacteria included in the vaccine. The vaccine contains capsular polysaccharides from these bacteria conjugated to a non-toxic diphtheria CRM197 protein, which elicits a T-cell dependent immune response. These antibodies help protect against future infections by eliminating the pneumococci.

What is the usual dosage of Prevenar 13?

The dosage of Prevenar 13 is 0.5 mL per injection and varies depending on age and vaccination history.

• Infants: Typically administered as a four-dose series at 2, 4, 6, and 12-15 months of age, with the first dose given as early as 6 weeks of age.
• Children 7 months to 5 years old (unvaccinated): The number of doses depends on age, determined by a healthcare provider.
• Children 6 through 17 years of age: A single dose is usually administered.
• Adults 18 years of age and older: A single dose is administered.
• Special Populations (e.g., individuals with underlying conditions like sickle cell disease or HIV infection): May receive at least one dose, and the schedule is guided by official recommendations.

What are the possible side effects of Prevenar 13?

Most side effects are mild to moderate and temporary. Common side effects include:

• Injection site reactions: Pain, tenderness, redness, swelling, or hardening at the injection site.
• Systemic reactions: Irritability, drowsiness, increased sleep, decreased appetite, fever, headache, muscle pain, joint pain, chills, and limited arm movement. Less common side effects can include diarrhea, vomiting, and rash. Serious adverse events, such as severe allergic reactions (e.g., anaphylaxis) or apnea in very premature infants, are rare but possible.

Is Prevenar 13 safe during pregnancy or breastfeeding?

Information regarding the use of Prevenar 13 during pregnancy and breastfeeding is limited. Available data on pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Animal studies in rabbits showed no evidence of harm to the fetus. It is recommended to consult a doctor before receiving the vaccine if pregnant, breastfeeding, or planning to become pregnant.

Can Prevenar 13 be taken with other medications or vaccines?

Prevenar 13 can generally be administered at the same time as other routine childhood vaccines, but at different injection sites. In adults aged 50 years and older, it can be given concomitantly with the seasonal inactivated influenza vaccine. However, its effectiveness may be reduced in individuals taking immunosuppressant medications. It should not be mixed with other vaccines or products in the same syringe. Always inform your doctor about all other medicines and vaccines being taken.

What precautions should be taken before receiving Prevenar 13?

You or your child should not receive Prevenar 13 if there has been a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or any diphtheria toxoid-containing vaccine. Vaccination should be delayed if you or your child has a fever or an acute infection. For very premature infants (born at or before 28 weeks of gestation), longer gaps than normal between breaths (apnea) may occur for 2-3 days after vaccination, and respiratory monitoring should be considered. Individuals with altered immunocompetence, bleeding problems, or those on anticoagulant therapy should also discuss precautions with their doctor.

What happens if a dose of Prevenar 13 is missed?

If a dose of Prevenar 13 is missed, it is important to talk to your doctor or clinic nurse. They will advise on the appropriate catch-up schedule, as the total number of injections needed depends on the age when the first dose was received and the previous vaccination status.

How should Prevenar 13 be stored?

Prevenar 13 should be stored in a refrigerator at temperatures between 2°C and 8°C (36°F to 46°F). It must not be frozen, as the vaccine should not be used if it has been frozen. It should be kept in its original packaging and shaken vigorously immediately prior to use to ensure a homogenous, white suspension.