solution for injection, suspension
Polysaccharide vaccine against pneumococcal infections, conjugated, adsorbed
What Synflorix is and what it is used for
Synflorix is a vaccine against pneumococcal infections. A doctor or nurse will inject your child with this vaccine.
It is used from 6 weeks up to 5 years of age to protect your child against:
a bacterium called ” Streptococcus pneumoniae “. This bacterium can cause serious illnesses, including meningitis, blood poisoning, and bacteremia (bacteria in the bloodstream) as well as ear infection or pneumonia.
How Synflorix works
Synflorix helps the body produce its antibodies. Antibodies are part of the immune system that will protect your child against these diseases.
What you need to know before your child receives Synflorix
Synflorix should not be given if:
- your child is allergic to the active substances or to any of the other ingredients in this vaccine (the ingredients are listed in section 6). Signs of an allergic reaction may include an itchy rash, shortness of breath, and swelling of the face or tongue.
- your child has a serious infection with a high fever (above 38°C). If this is the case, the vaccination can be postponed until your child is better. A mild infection such as a cold should not be a problem. However, talk to your doctor first.
Synflorix should not be given if any of the above applies to your child. If you are not sure, talk to your doctor or pharmacist before your child receives Synflorix.
Warnings and Precautions:
Check with your doctor or pharmacist before giving this vaccine if:
- your child has problems with bleeding or bruises easily.
In children from the age of 2, fainting may occur after, or even before, any needle injection. Therefore, tell the doctor or nurse if your child has fainted during a previous injection.
As with all vaccines, full protection may not be achieved in all children vaccinated with Synflorix.
Synflorix only protects against infection caused by the bacteria for which the vaccine has been developed.
Children with a weakened immune system (e.g. due to infection with the human immunodeficiency virus ( HIV ) or immunosuppressive treatment) may not get the full benefit of Synflorix.
If you are not sure, talk to your doctor or pharmacist before your child receives Synflorix.
Children over 5 years
The safety and efficacy of the vaccine have not been established for children older than 5 years and therefore vaccination of these children is not recommended.
Other medicines and Synflorix
Tell the doctor or pharmacist if your child is taking, has recently taken, or maybe taking other medicines, or if the child has recently received any other vaccine. Synflorix may not work as well if the child is taking medicines that affect the immune system’s ability to fight infection.
Synflorix can be given simultaneously with other childhood vaccines such as vaccine against diphtheria, tetanus, whooping cough (pertussis), Haemophilus influenzae type b, polio (oral or inactivated), hepatitis B, measles-mumps-rubella, chicken pox, rotavirus (oral) and also meningococcal serogroup C and serogroup A, C, W‑135, Y (conjugated). Different sites are used for injecting the different vaccines.
The doctor may ask you to give the child an antipyretic medicine (such as paracetamol ) before or immediately after Synflorix is given, especially if the child is vaccinated with the whole-cell pertussis vaccine at the same time as Synflorix. Antipyretic drugs are also recommended for children who have convulsive disorders or who have previously had febrile convulsions.
If your child has received paracetamol before or immediately after Synflorix has been given, the level of antibody obtained may decrease slightly. It is not known whether the reduced antibody level affects protection against pneumococcal disease.
Synflorix contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is almost “sodium-free”.
How Synflorix is given
How the vaccine is given
Synflorix is always injected into a muscle. This is usually done in the thigh or upper arm.
How much is given
Usually, your child (from 6 weeks to 6 months of age) receives a vaccination series consisting of 4 injections according to official recommendations or another dosage according to official recommendations followed by the healthcare professional. It is important to follow the doctor’s or nurse’s instructions to complete the vaccination schedule.
- Each injection is given at least one month apart, except for the last injection one (booster) which is given at least 6 months after the third injection one.
- The first injection can be given from 6 weeks of age and up. The last injection (booster) can be given from 9 months of age and up.
- You will be told when your child should return for the next vaccination.
Premature babies (born after 27 weeks and before 37 weeks of pregnancy):
Your child (from 2 months to 6 months of age) will receive 3 injections with an interval of at least one month between each dose. At least six months after the last injection, your child will receive an additional dose (booster dose).
Infants aged 7 to 11 months will receive 2 injections. Each injection will be given at least one month apart. A third injection (booster) will be given during the second year of life at least two months apart.
Children from 12 months to 5 years of age will receive 2 injections. Each injection is given at least two months apart.
Special patient groups
Children from 6 weeks to 5 years of age who are considered to be at higher risk of pneumococcal infections (such as children with HIV infection, sickle cell anemia, or impaired or abnormal spleen function) can receive Synflorix. Ask the doctor how many injections your child should receive and when they should be given.
If your child misses an injection
If your child misses an injection, you must get a new appointment. This is so that you and your doctor can talk about what should be done next to protect your child.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Serious allergic reactions may occur in very rare cases (up to 1 in 10,000 vaccine doses). Such reactions are recognized by:
- raised and itchy rash ( hives )
- swelling, sometimes of the face and mouth ( angioedema ), causing difficulty in breathing
- collapse.
These reactions normally occur before leaving the doctor’s office. If your child develops any of these symptoms, contact a doctor immediately.
Very common (these may occur with more than 1 in 10 vaccine doses)
- pain, redness, or swelling where the injection has been given
- fever, 38 °C or higher
- feeling sleepy
- feeling of irritation
- loss of appetite.
Common (these may occur with up to 1 in 10 vaccine doses)
- induration at the injection site.
Uncommon (these may occur in up to 1 in 100 vaccine doses)
- itching, bruising, bleeding, or a small lump where the injection has been given
- nausea, diarrhea, or vomiting
- persistent crying
- a temporary pause in breathing ( apnea ) if your baby is born prematurely (before or in the 28th week of pregnancy)
- headache
- rash
- diffuse swelling of the injected body part, which sometimes also includes nearby joints
- hives.
Rare (these may occur with up to 1 in 1,000 vaccine doses)
- convulsions without fever or due to high fever
- allergic reactions e.g. skin allergies
- collapse (sudden onset of muscle weakness), periods of unconsciousness or reduced consciousness, and paleness or bluish discoloration of the skin.
Very rare (these may occur in up to 1 in 10,000 vaccine doses)
- Kawasaki disease (the main signs of the disease are, for example, fever, skin rash, swollen lymph nodes, inflammation, and rash on the mucous membranes of the mouth and throat).
Booster doses of Synflorix can increase the risk of side effects.
For children >12 months of age, the risk of pain at the injection site may increase with increasing age.
In very premature babies (born at 28 weeks of pregnancy or earlier), there may be long pauses between breaths than normal for 2-3 days after vaccination.
How to store Synflorix
Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 °C-8 °C).
- Store in the original packaging. Light sensitive.
- Do not freeze.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
| The active substances are: A dose of 0.5 ml contains: Pneumococcal polysaccharide serotype 1 1,2Pneumococcal polysaccharide serotype 4 1,2Pneumococcal polysaccharide serotype 5 1,2Pneumococcal polysaccharide serotype 6B 1,2Pneumococcal polysaccharide serotype 7F 1,2Pneumococcal polysaccharide serotype 9V 1.2Pneumococcal polysaccharide serotype 14 1,2Pneumococcal polysaccharide serotype 18C 1,3Pneumococcal polysaccharide serotype 19F 1.4Pneumococcal polysaccharide serotype 23F 1,2 1 adsorbed on aluminum phosphate2 conjugated to protein D (derived from non-typeable Haemophilus influenzae ) carrier protein3 conjugated to tetanus toxoid carrier protein4 conjugated to diphtheria toxoid carrier protein | 1 microgram 3 micrograms 1 microgram 1 microgram 1 microgram 1 microgram 1 microgram 3 micrograms 3 micrograms 1 microgram a total of 0.5 milligrams of Al 3+ 9–16 micrograms 5–10 micrograms 3–6 micrograms |
| The other ingredients are: sodium chloride (see section 2 for more information) and water for injections |
Appearance and package sizes of the medicine
- Solution for injection, suspension.
- Synflorix is a cloudy white suspension.
- Synflorix is available as vials for 1 dose in packs of 1, 10, or 100.
- Not all pack sizes may be marketed.
GlaxoSmithKline Biologicals said
Rue de l’Institut 89
B-1330 Rixen species
Belgium
| Belgique/België / BelgiumGlaxoSmithKline Pharmaceuticals sa/nvTel/Tel: + 32 10 85 52 00 | LithuaniaGlaxoSmithKline Biologicals SAPhone: +370 80000334 |
| BulgariaGlaxoSmithKline Biologicals Satel.: + 359 80018205 | Luxembourg/LuxembourgGlaxoSmithKline Pharmaceuticals sa/nvTel/Tel: + 32 10 85 52 00 |
| Czech RepublicGlaxoSmithKline s.r.oPhone: + 420 2 22 00 11 11cz.info@gsk.com | MagyarországGlaxoSmithKline Biologicals SATel.: + 36 80088309 |
| DenmarkGlaxoSmithKline Pharma A/SPhone: + 45 36 35 91 00dk-info@gsk.com | MaltaGlaxoSmithKline Biologicals SAPhone: + 356 80065004 |
| DeutschlandGlaxoSmithKline GmbH & Co. KGPhone: + 49 (0)89 360448701product.info@gsk.com | The NetherlandsGlaxoSmithKline BVPhone: + 31 (0)33 2081100 |
| EstoniaGlaxoSmithKline Biologicals SAPhone: + 372 8002640 | NorwayGlaxoSmithKline iPhone: + 47 22 70 20 00 |
| GreeceGlaxoSmithKline ΜονοπροσωπηA.EBETel: + 30 210 68 82 100 | AustriaGlaxoSmithKline Pharma GmbH.Tel: + 43 (0)1 97075 0at.info@gsk.com |
| SpainGlaxoSmithKline, SAPhone: + 34 900 202 700es-ci@gsk.com | PolishGSK Services Sp. z o. oTel.: + 48 (22) 576 9000 |
| France Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44diam@gsk.com | PortugalGlaxoSmithKline – Produtos Farmacêuticos, Lda.Phone: + 351 21 412 95 00FI.PT@gsk.com |
| HrvatskaGlaxoSmithKline Biologicals SATel.: + 385 800787089 | RomaniaGlaxoSmithKline Biologicals SAPhone: + 40 800672524 |
| IrelandGlaxoSmithKline (Ireland) LtdPhone: + 353 (0)1 495 5000 | SlovenijaGlaxoSmithKline Biologicals SAPhone: + 386 80688869 |
| IcelandVistor hf.Telephone: +354 535 7000 | Slovenian RepublicGlaxoSmithKline Biologicals SAPhone: + 421 800500589 |
| ItalyGlaxoSmithKline SpATel: + 39 (0)45 7741 111 | Finland/FinlandGlaxoSmithKline OyPhone/Tel: + 358 10 30 30 30 |
| CyprusGlaxoSmithKline Biologicals Satel: + 357 80070017 | SwedenGlaxoSmithKline ABPhone: + 46 (0)8 638 93 00info.produkt@gsk.com |
| LatviaGlaxoSmithKline Biologicals SAPhone: + 371 80205045 | United Kingdom (Northern Ireland)GlaxoSmithKline Biologicals SAPhone: +44 (0)800 221 441customercontactuk@gsk.com |