Prevenar is a pneumococcal vaccine. Prevenar helps protect your child against diseases such as:
meningitis, sepsis or bacteraemia (bacteria in the blood), pneumonia and ear infection
caused by seven types of the bacteria Streptococcus pneumoniae.
The vaccine works by helping the body to make its own antibodies, which
protect your child against these diseases.
2. BEFORE YOU USE PREVENAR
Do not use Prevenar:
- If your child is allergic (hypersensitive) to the active substances or any of the
other ingredients or to diphtheria toxoid.
Take special care with Prevenar:
- If your child has any present or past medical problems after any dose of Prevenar.
- If your child has bleeding problems.
- If your child is sick with a high fever.
Prevenar will only protect against ear infections caused by the types of Streptococcus pneumoniae,
for which the vaccine has been developed. It does not protect against other infectious agents - agents
Using other medicines / vaccines:
Please tell your doctor, nurse or pharmacist if your child is taking or has recently epriemalo other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
3. HOW TO USE PREVENAR
The doctor or nurse will inject the recommended dose (0,5 ml) vaccine.
Prevenar can be given with other childhood vaccines; in this case must
using different injection sites.
Prevenar should not be mixed with any other vaccines in the same syringe.
Prevenar will be injected into your child's muscle.
Typically, your child should receive four doses of the vaccine. In accordance with
official recommendations in your country, a person who cares for your child can use an alternative schedule. Each dose will be injected at different times. It is important to follow the instructions of the doctor / nurse so that your child completes the course of injections.
If you forget to visit the doctor or nurse at the scheduled time, ask them what to do.
4. POSSIBLE SIDE EFFECTS
Like all vaccines, Prevenar can cause side effects, although not everybody
The terms used to describe the frequency of side effects is as follows
Very common: side effects which may occur in more than 1 in 8,026,210
Common: side effects which may occur in less than 1 in 10 patients.
Uncommon: side effects which may occur in less than 1 in 100 patients.
Rare: side effects which may occur in less than 1 in 1,000 patients.
Very rare: side effects which may occur in less than 1 in 10,000
• Blood and lymphatic system
Very rare: enlarged lymph nodes (lymphadenopathy) in the injection
• Reactions of the nervous system
Rare: seizures; seizures associated with fever
• Gastrointestinal reactions
Very common: decreased appetite, vomiting, diarrhea
• Skin reactions
Uncommon: rash / hives (urticaria)
Very rare: erythema multiforme
• Injection site reactions and systemic reactions
Very common: pain, tenderness, redness, swelling or induration of
injection site; temperature of 38 ° C or higher, irritability,
crying, drowsiness, restless sleep
Common: redness, swelling or induration at the injection site, more than
2,4 cm; tenderness at the injection site, which prevents
movement; temperature 39 ° C or higher
Rare: hypersensitivity reactions at the injection site as
rash / hives (urticaria) or itching at the injection site;
hypotonic hyporesponsive (collapse or shock-like
• Reactions of the immune system:
Rare: severe hypersensitivity / allergic reactions, which can
include swelling of the face and / or lips, difficulty breathing, and / or shock
In babies born very prematurely (at or before 28 weeks of gestation), 2-3 days
after vaccination may have longer gaps than normal between breaths.
Please speak with your doctor or pharmacist if you have any questions or
worries. If any of the side effects gets serious, or
not listed in this leaflet, please tell your doctor or
5. HOW TO STORE PREVENAR
Keep out of reach of children.
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze.
Do not use Prevenar after the expiry date stated on the carton and
label. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Prevenar contains
Each dose of 0,5 ml contains:
Pneumococcal polysaccharide serotype 4 * 2 micrograms
Pneumococcal polysaccharide serotype 6B * 4 micrograms
Pneumococcal polysaccharide serotype 9V * 2 micrograms
Pneumococcal polysaccharide serotype 14 * 2 micrograms
Oligosaccharide pneumococcal serotype 18C * 2 micrograms
Pneumococcal polysaccharide serotype 19F * 2 micrograms
Pneumococcal polysaccharide serotype 23F * 2 micrograms
* Conjugated to CRM197 carrier protein and adsorbed onto aluminum phosphate (0,5 mg)
The other ingredients are sodium chloride and water for injection.
What Prevenar looks like and contents of the pack
The vaccine is a suspension for injection and comes in single-dose prefilled
syringe (0,5 ml). Packs of 1 and 10 with or without needle.
Multipack of 5 packs of 10 pre-filled syringes without needles.