injection, suspension in a single-dose vial
Polysaccharide vaccine against pneumococcal infections, conjugated, adsorbed, 13-valent
What Prevenar 13 is and what it is used for
Prevenar 13 is a pneumococcal vaccine for:
- children aged 6 weeks to 17 years who help protect your child against diseases such as meningitis ( meningitis ), sepsis or bacteremia (bacteria in the blood), pneumonia ( pneumonia ), an ear infection
- adults aged 18 years or older who help protect against diseases such as pneumonia ( pneumonia ), sepsis or bacteremia (bacteria in the blood), and meningitis ( meningitis ),
caused by 13 different types of the bacterium Streptococcus pneumonia.
Prevenar 13 protects against 13 types of the bacterium Streptococcus pneumoniae and replaces Prevenar which protected 7 types.
The vaccine helps the body make antibodies that protect you or your child against these diseases.
What you need to know before you or your child receive Prevenar 13
Do not use Prevenar 13
- if you or your child are allergic (hypersensitive) to active substances or any of the other ingredients of this medicine (listed in section 6) or any other vaccine containing diphtheria toxoid.
- if you or your child have a severe infection with a high fever (above 38 ° C). If this applies to you or your child, the vaccination will be postponed until you or your child feels better. A mild infection, such as a cold, should not be a problem but talk to a doctor, pharmacist, or nurse first.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before vaccination if you or your child:
- have or have had a health problem after any previous dose of Prevenar or Prevenar 13 such as an allergic reaction or breathing problem,
- have bleeding problems, or easily getting bruises.
- has a weakened immune system (eg due to HIV infection ), in which case he/she may not get the full benefit of Prevenar 13.
- had seizures, antipyretic drugs may then need to be given before Prevenar 13 is given. If your child has a seizure or becomes absent after vaccination, contact a doctor immediately. See also section 4.
Talk to your doctor, pharmacist, or nurse before vaccination if your baby is born very prematurely (in or before week 28), as there may be longer breaks between breaths than normal for 2 to 3 days after vaccination. See also section 4.
As with all vaccines, Prevenar 13 does not provide full protection to all vaccinated individuals.
Prevenar 13 only protects against ear infections in children caused by the types of the bacterium Streptococcus pneumonia, for which the vaccine has been developed. Prevenar 13 will not protect against other infectious agents that can cause ear infections.
Other medicines/vaccines and Prevenar 13
Your doctor may ask you to give your child paracetamol or any other antipyretic before taking Prevenar 13. This will help reduce any of the possible side effects that may occur with Prevenar 13.
Tell your doctor, pharmacist, or nurse if you or your child are receiving or have recently received any other medicines, including medicines obtained without a prescription, or have recently been vaccinated with another vaccine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Prevenar 13 has no or negligible effect on the ability to drive and use machines. However, some of the effects mentioned in section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.
Prevenar 13 contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
3. How Prevenar 13 is given
Your doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine into a muscle on your upper arm or your baby’s upper arm or a muscle in your leg.
Infants aged 6 weeks to 6 months
Generally, the child should be vaccinated with three doses of the vaccine, followed by a booster dose.
- The first injection can be given from 6 weeks of age.
- Each injection is given at least one month apart.
- A fourth injection (booster dose) is given when the baby is between 11-15 months.
- You will be told when the child will return for the next vaccination.
By official recommendations in your country, an alternative dosing schedule can be used. Talk to a doctor, pharmacist, or nurse for more information.
Premature infants
Your child will be initially vaccinated with three doses of the vaccine. The first injection can be given as early as 6 weeks of age and then at least one month apart. Your baby gets a fourth injection (booster) between 11 and 15 months of age.
Unvaccinated infants, children, and adolescents over 7 months of age
Infants aged 7 to 11 months should receive two injections. The injections are given at least one month apart. A third injection is given during the second year of life.
Children aged 12 to 23 months should receive two injections. The injections are given at least two months apart.
Children aged 2 to 17 years should receive an injection.
Infants, children, and adolescents previously vaccinated with Prevenar
Infants and children who have previously received Prevenar may receive Prevenar 13 to complete the vaccination program.
For children aged 1-5 years who have previously received Prevenar, your doctor or nurse will recommend how many doses of Prevenar 13 are needed.
Children and adolescents aged 6-17 years should receive an injection.
You must follow the instructions of the doctor, pharmacist, or nurse so that the child undergoes the entire vaccination program.
If you forget to go back in time, ask your doctor, pharmacist, or nurse for advice.
Adults
Adults are given an injection.
Tell your doctor, pharmacist, or nurse if you have previously been vaccinated against pneumococci.
If you have any further questions on the use of Prevenar 13, ask your doctor, pharmacist, or nurse.
Special patient groups
Individuals who are considered to be at higher risk for pneumococcal infection (eg patients with sickle cell disease or HIV infection ) may receive at least one dose of Prevenar 13. This also applies to those previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine.
Individuals who have undergone transplantation of blood-forming stem cells may receive three injections, the first of which is given 3 to 6 months after the transplant at an interval of at least one month between doses. A fourth injection (booster) is recommended 6 months after the third injection.
Possible side effects
Like all vaccines, Prevenar 13 can cause side effects, although not everybody gets them.
The following side effects have been reported with Prevenar 13 in infants and children (6 weeks to 5 years):
The most common side effects (which may occur with more than 1 in 10 doses of the vaccine) are:
- Decreased appetite
- Fever, irritability, pain, tenderness, redness, swelling or hardening at the vaccination site, drowsiness, restless sleep
- Redness, hardening, swelling at the vaccination site of 2.5 cm – 7.0 cm (after the booster dose and in older children [aged 2 to 5 years])
Common side effects (which may occur with up to 1 in 10 doses of the vaccine) are:
- Vomiting, diarrhea
- Fever above 39 ° C, tenderness at the vaccination site affecting mobility, redness, hardening, swelling at the vaccination site of 2.5 cm – 7.0 cm (after the basic vaccination)
- Rash
Uncommon side effects (which may occur with up to 1 in 100 doses of the vaccine) are:
- Seizures including seizures caused by high fever
- Hives ( urticaria or urticaria-like rash)
- Redness, swelling, or hardness at the vaccination site, greater than 7 cm, persistent crying
Rare side effects (which may occur with up to 1 in 1,000 doses of the vaccine) are:
- Collapse or shock-like state (hypotonic-hyporesponsive episodes)
- Allergic (hypersensitivity) reactions, including swelling of the face and/or lips, difficulty breathing
The following side effects have been reported with Prevenar 13 in children and adolescents (6 to 17 years of age):
The most common side effects (which may occur with more than 1 in 10 doses of the vaccine) are:
- Decreased appetite
- Irritability, pain, tenderness, redness, swelling or hardening at the vaccination site, drowsiness, restless sleep, and tenderness at the vaccination site affect mobility
Common side effects (which may occur with up to 1 in 10 doses of the vaccine) are:
- Headache
- Vomiting, diarrhea
- Skin rash, hives ( urticaria or urticaria-like rash)
- Fever
Children and adolescents with either HIV infection, sickle cell disease, or who have had a blood-forming stem cell transplant had similar side effects, except that headaches, vomiting, diarrhea, fever, fatigue, and joint and muscle pain were very common.
In children who are born very prematurely (born in pregnancy week 28 or earlier), the child may have a longer break than usual between breaths, which can last for 2-3 days after vaccination.
The following side effects have been reported with Prevenar 13 in adults:
The most common side effects (which may occur with more than 1 in 10 doses of the vaccine) are:
- Decreased appetite, headache, diarrhea, vomiting (for people aged 18 to 49 years)
- Chills, fatigue, rash, pain, redness, swelling, or tenderness at the vaccination site affecting arm mobility (severe pain or tenderness at the vaccination site for persons aged 18 to 39 years and severe reduction of arm mobility for persons aged 18 to 39 years)
- Worsening of new-onset pain in joints, worsening or new-onset pain in muscles
- Fever (for people aged 18 to 29 years)
Common side effects (which may occur with up to 1 in 10 doses of the vaccine) are:
- Vomiting (for people 50 years and older), fever (for people aged 30 years and older)
Uncommon side effects (which may occur with up to 1 in 100 doses of the vaccine) are:
- Nausea
- Allergic (hypersensitivity) reactions, including swelling of the face and/or lips, difficulty breathing
- Enlarged lymph nodes ( lymphadenopathy ) in the vicinity of the vaccination site, e.g. in armpits
Adults with HIV infection had similar side effects except that fever, and vomiting was very common and nausea was common.
Adults undergoing hematopoietic stem cell transplantation had similar side effects except that fever and vomiting were very common.
The following additional side effects have been observed with Prevenar 13 after the marketing authorization:
- Severe allergic reaction, including shock ( cardiovascular collapse), angioedema (swelling of the lips, face, or throat)
- Hives ( urticaria ), redness and irritation (skin inflammation) or itching ( pruritus ) at the vaccination site, redness
- Enlarged lymph nodes ( lymphadenopathy ) in the vicinity of the vaccination site, e.g. in the armpits or groin
- Skin rash with itchy red spots (erythema multiforme)
How to store Prevenar 13
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
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.
Contents of the pack and other information
Content declaration
The active substance is polysaccharides conjugated to carrier protein CRM 197, consisting of:
- 2.2 μg polysaccharide from serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F
- 4.4 μg polysaccharide from serotype 6B
One dose (0.5 ml) contains approximately 32 µg of carrier protein CRM 197, adsorbed to aluminum phosphate (0.125 mg aluminum).
The other ingredients are sodium chloride, succinic acid, polysorbate 80, and water for injections.
What the medicine looks like and the contents of the pack
The vaccine is a white suspension for injection and is supplied in a single-dose vial (0.5 ml). Pack sizes of 1, 5, 10, 25, and 50 vials. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
| Marketing Authorisation Holder: Pfizer Europe MA EEIGBoulevard de la Plaine 171050 BrusselsBelgium | Manufacturer responsible for batch release: Pfizer Manufacturing Belgium NVRijksweg 12B-2870 PuursBelgium |
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienLuxembourg / LuxemburgPfizer NV / SATel: + 32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000 |
| BulgariaPfizer Emperor Hamburg, Clone of BulgariaTel: +359 2 970 4333 | HungaryPfizer KftTel: +36 1 488 3700 |
| Czech RepublicPfizer, spol. s roTel: +420 283 004 111 | MaltaVivian Corporation Ltd.Tel: +35621 344610 |
| DenmarkPfizer ApSTel: + 45 44 201 100 | The NetherlandsPfizer BVTel: +31 (0) 10 406 43 01 |
| GermanyPfizer Pharma GmbHTel: +49 (0) 30 550055-51000 | NorwayPfizer ASTel. + 47 67 526 100 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel .: +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| GreecePfizer Aλλάς AE.:Ηλ .: +30 210 6785 800 | PolandPfizer Polska Sp. z ooTel: +48 22 335 61 00 |
| SpainPfizer, SLTel: +34914909900 | PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500 |
| FrancePfizerTel: + 33 (0) 1 58 07 34 40 | RomaniaPfizer Romania SRLTel: + 40 (0) 21 207 28 00 |
| CroatiaPfizer Croatia dooTel: + 385 1 3908 777 | SloveniaPfizer Luxembourg SARLPfizer, underwriting and dryingpharmacevtske dejavnosti, LjubljanaTel .: + 386 (0) 1 52 11 400 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | Slovak RepublicPfizer Luxembourg SARL, organizer of services: + 421 2 3355 5500 |
| IcelandIcepharma hfPhone: +354 540 8000 | Finland / FinlandPfizer OyPuh / Tel: + 358 (0) 9 430 040 |
| ItalyPfizer SrlTel: +39 06 33 18 21 | SwedenPfizer ABTel: +46 (0) 8 550 520 00 |
| ΎπροςPfizer Aλλάς AE (Cyprus Branch):Ηλ: +357 22 817690 | United Kingdom (Northern Ireland)Pfizer LimitedTel: +44 (0) 1304 616161 |
| LatviaPfizer Luxembourg SARL subsidiary LatvijāTel .: + 371 670 35 775 |