Synflorix suspension for injection in pre-filled syringePneumococcal polysaccharideconjugate vaccine (adsorbed)

Synflorix is a pneumococcal conjugate vaccine. Your doctor or nurse will inject your child with this vaccine.

It is used to help protect your child from 6 weeks up to 2 years of age against: a bacteria called ?Streptococcus pneumoniae?. This bacteria can cause serious illnesses including meningitis, sepsis or bacteraemia (bacteria in blood stream) or ear infection and pneumonia.

How the vaccine works

Synflorix helps your body to make its own antibodies. The antibodies form a part of the immune system that will protect your child against these diseases.

Synflorix should not be given if:

• your child has ever had an allergic reaction (is hypersensitive) to the active substance, or any of the other ingredients in this vaccine (listed in Section 6). Signs of an allergic reaction may include itchy skin rash, being short of breath and swelling of the face or tongue.
• your child has a severe infection with a high temperature (over 38°C). If this applies to your child then the vaccination will be postponed until your child is feeling better. A minor infection such as a cold should not be a problem. However, talk to your doctor first.

Synflorix should not be given to your child if any of the above applies to them. If you are not sure, talk to your doctor or pharmacist before they receive Synflorix.

Take special care with Synflorix:

Check with your doctor or pharmacist before giving this vaccine if:

• your child has a bleeding problem or bruises easily.

As with all vaccines, Synflorix may not fully protect all children who are vaccinated.

Synflorix will only protect against infections caused by the bacteria for which the vaccine has been developed.

Children with a weakened immune system (such as due to HIV infection) may not get the full benefit from Synflorix.

If you are not sure, talk to your doctor or pharmacist before having Synflorix.

Using other medicines

Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines. This includes medicines obtained without a prescription or if they have recently received any other vaccine. Synflorix may not work as well if your child is taking medicines that affect the immune system to fight infection.

Synflorix can be given at the same time as other childhood vaccines such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B, measles-mumps-rubella, varicella, oral rotavirus vaccines as well as meningococcal serogroup C conjugate vaccines. A different place for the injection will be used for each vaccine.

Your doctor may ask you to give your child paracetamol or other medicines that lower fever before Synflorix is given. This will help to lower some of the side effects of Synflorix. However if your child has paracetamol, their protection against pneumococcal diseases may not be as good.

Important information about some of the ingredients of Synflorix

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ?sodium-free?.

How the vaccine is given

Synflorix is always injected into a muscle. This is usually in the thigh or upper arm.

How much is given

Usually, your child will receive a course of 4 injections according to official recommendations or an alternative schedule may be used by the health care professional. It is important to follow the instructions from the doctor or nurse to complete the courses of injections.

• Each injection will be given at least one month apart except for the last injection, which will be given at least 6 months after the third injection.
• The first injection can be given from the age of 6 weeks onwards.
• You will be told when your child should come back for their next injection.

Preterm infants
Your child will receive three 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 injection (booster).

Infants aged 7 to 11 months will receive 2 injections. Each injection will be given at least one month apart. A third injection will be given in the second year of life with at least two months apart.

Children aged 12 to 23 months will receive 2 injections. Each injection will be given at least two months apart.

If your child misses an injection

If your child misses an injection, it is important that you make another appointment. This is so that you and your doctor can talk about what steps need to be taken to protect your child.

Like all medicines, Synflorix can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Very common (these may occur with more than 1 in 10 doses of the vaccine)

• pain, redness and swelling where the injection is given
• high temperature of 38°C or higher (fever)
• feeling sleepy
• feeling irritable
• loss of appetite.

Common (these may occur with up to 1 in 10 doses of the vaccine)

• hardness where the injection is given.

Uncommon (these may occur with up to 1 in 100 doses of the vaccine)

• blood clot, bleeding or a small lump where the injection is given
• diarrhoea or feeling sick (vomiting)
• unusual crying.
• temporarily stopping breathing (apnoea) if your child is born prematurely (before or at 28 weeks of pregnancy).

Rare (these may occur with up to 1 in 1,000 doses of the vaccine)

• fits without temperature or due to high temperature (fever)
• rash, hives, allergic reactions such as skin rash or allergies

Booster doses of Synflorix may increase the risk of side effects.

In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

• Do not use Synflorix after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C - 8°C).
• Store in the original package in order to protect from light.
• 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.

What Synflorix contains

• The active substances are:

One 0.5 ml dose contains Pneumococcal polysaccharide serotype 11,2Pneumococcal polysaccharide serotype 41,2Pneumococcal polysaccharide serotype 51,2Pneumococcal polysaccharide serotype 6B1,2Pneumococcal polysaccharide serotype 7F1,2Pneumococcal polysaccharide serotype 9V1,2Pneumococcal polysaccharide serotype 141,2Pneumococcal polysaccharide serotype 18C1,31,4Pneumococcal polysaccharide serotype 19FPneumococcal polysaccharide serotype 23F1,21 microgram 3 micrograms 1 microgram 1 microgram 1 microgram 1 microgram 1 microgram 3 micrograms 3 micrograms 1 microgram

1 adsorbed on aluminium phosphate 0.5 milligram Al32 conjugated to protein D derived from non-typeable Haemophilus influenzae carrier protein 9-16 micrograms 3 conjugated to tetanus toxoid carrier protein 5-10 micrograms 4 conjugated to diphtheria toxoid carrier protein 3-6 micrograms

• The other ingredients are: sodium chloride and water for injections

What Synflorix looks like and contents of the pack

• Suspension for injection in pre-filled syringe
• Synflorix is a turbid white suspension.
• Synflorix is available in pre-filled syringes with or without needles in packs of 1, 10 or 50.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals s.a.Rue de l?Institut 89
B-1330 Rixensart
Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11

Magyarország GlaxoSmithKline Kft. Tel. 36-1-2255300 . .10 1408 . 359 2 953 10 34

eská republika Malta

GlaxoSmithKline Malta Tel 356 21 238131 GlaxoSmithKline s.r.o. Tel 420 2 22 00 11 11 gsk.czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 dk-infogsk.com Nederland GlaxoSmithKline BV Tel 31 030 69 38 100 nlinfogsk.com

Deutschland GlaxoSmithKline GmbH Co. KG Tel 49 089 360448701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OÜ Tel 372 667 6900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH. Tel 43 1 970 75-0 at.infogsk.com

GlaxoSmithKline A.E.B.E T 30 210 68 82 100 Polska GSK Commercial Sp. z o.o. Tel. 48 22 576 9000

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal GlaxoSmithKline, Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.com

România GlaxoSmithKline GSK SRL Tel 40 021 3028 208 France Laboratoire GlaxoSmithKline Tél 33 0 1 39 17 84 44 diamgsk.com

Ireland GlaxoSmithKline Ireland Ltd Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 0 1 280 25 00 medical.x.sigsk.com

Ísland GlaxoSmithKline ehf. Sími 354-530 3700 Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel 421 0 2 48 26 11 11 recepcia.skgsk.com

Italia GlaxoSmithKline S.p.A. Tel 39 04 59 21 81 11 SuomiFinland GlaxoSmithKline Oy PuhTel 358 10 30 30 30 Finland.tuoteinfogsk.com

GlaxoSmithKline Cyprus Ltd 357 22 39 70 00 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.com

Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline UK Tel 44 0808 100 9997 customercontactukgsk.com

Lietuva
GlaxoSmithKline Lietuva UAB
Tel. +370 5 264 90 00
info.lt@gsk.com

This leaflet was last approved in

------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:

A fine white deposit with a clear colourless supernatant may be observed upon storage of the pre-filled syringe. This does not constitute a sign of deterioration.

The content of the pre-filled syringe should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, discard the vaccine.

The vaccine should be allowed to reach room temperature before use.

The vaccine should be well shaken before use.

The vaccine is for intramuscular use only. Do not administer intravascularly.

If Synflorix is co-administered with other vaccines, different injection sites should be used.

Synflorix should not be mixed with other vaccines. If a vaccine dose is withdrawn into a syringe for injection, the needle used for withdrawal must be replaced by a needle suitable for intramuscular injection.

Instructions for administration of the vaccine presented in pre-filled syringe

1. Holding the syringe barrel in one hand avoid holding the syringe plunger, unscrew the syringe cap by twisting it anticlockwise. Syringe plunger Syringe barrel Syringe cap

2. To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock. 3. Remove the needle protector, which on occasion can be a little stiff. Needle protector

Any unused product or waste material should be disposed of in accordance with local requirements.