Synflorix suspension for injection
Pneumococcal polysaccharideconjugate vaccine (adsorbed)
What is it and how is it used?
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.
What do you have to consider before using it?
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 is it used?
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 dose.
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.
What are possible side effects?
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.
How should it be stored?
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.
** One voucher is only valid for one dose.
Pneumococcal polysaccharideconjugate vaccine (adsorbed)
What is it and how is it used?
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.
What do you have to consider before using it?
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 is it used?
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 dose.
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.
What are possible side effects?
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.
How should it be stored?
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.
** One voucher is only valid for one dose.