SYNFLORIX antipnevmokokova vaccine
Adsorbed pneumococcal polysaccharide conjugate vaccine
Pneumococcal polysaccharide conjugate vaccine (adsorbed)
SYNFLORIX antipnevmokokova vaccine
What Synflorix is and what it is used
Synflorix e pneumococcal conjugate vaccine. Your doctor or nurse will inject the vaccine for your child.
It helps to protect your child is aged 6 weeks to 5 years against:
bacteria called 'Streptococcus pneumoniae'. This bacteria can cause serious illnesses including meningitis , sepsis or bacteraemia (bacteria in the blood stream) or ear infection and pneumonia.
How does Synflorix
Synflorix helps your body to make its own antibodies. Antibodies are part of the immune system that will protect your child against these diseases.
2 . What you should know before receives Synflorix your child
Synflorix should not apply if :
• your child has had an allergic reaction ( is hypersensitive ) to the active substance or to any of the other ingredients in this vaccine (listed in section 6).
Signs of an allergic reaction may include itchy skin rash, shortness 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's vaccination will be postponed until it felt better. A minor infection such as a cold should not be a problem , but first consult your doctor.
Synflorix should not be given to your child if any of the above applies to them . If you are unsure , before they receive Synflorix consult your doctor or pharmacist.
Warnings and Precautions :
Before the vaccine , tell your doctor or pharmacist if:
• your child has problems with bleeding or bruises easily .
Like all vaccines , Synflorix may not fully protect all vaccinated children.
Synflorix will only protect against infections caused by bacteria for which the vaccine has been .
Children with a weakened immune system (such as due to HIV infection) may not get the full benefit from Synflorix.
Ask your doctor or pharmacist before having Synflorix, if you are not sure about something.
Other medicines and Synflorix
Tell your doctor or pharmacist if your child has recently taken or take other medicines. This includes medicines obtained without a prescription or has 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 to your child at the same time as other childhood vaccines such as diphtheria, tetanus , pertussis (whooping cough) disease caused by Haemophilus influenzae type b, poliomyelitis ( oral or inactivated ) and hepatitis B, measles - mumps- rubella , varicella , oral rotavirus vaccines and conjugate vaccines against meningococcal serogroup C. For each vaccine should be used in a different injection site.
Before Synflorix Your doctor may advise you to give your child paracetamol or other medicines to reduce fever . This will help reduce some of the side effects of Synflorix. However , if your child paracetamol, protection against pneumococcal diseases may not be as good.
This product contains less than 1 mmol of sodium (23 mg) per dose, ie essentially ' sodium-free ' .
3 . How to use Synflorix
How the vaccine is
Synflorix always injected into a muscle , usually the hip or arm .
How many of the vaccine is administered
Usually, your child will receive a course of 4 injections according to official recommendations or medical professional can use an alternative scheme . It is important to follow the instructions of the physician or nurse to complete the courses of injections .
• Each injection will be administered after an interval of at least one month with the exception of the last injection has to be administered for at least 6 months after the third injection.
• The first injection can be given from the age of 6 weeks .
• You will be notified when your child should come back for the next injection.
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 ) .
? In infants aged 7 to 11 months will receive 2 injections. The interval between two injections is at least one month. During the second year of life is applied after a third injection interval of at least two months.
? Children aged 12 months to 5 years 2 injections. The interval between two injections is at least two months.
If your child misses an injection
If your child misses injections under the vaccination , it is important that you make another appointment. You and your doctor can discuss the next steps to be taken to protect your child .
4 . Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them. With use of this medicine may experience the following side effects:
Very common (these can be seen in more than 1 in 10 doses of the vaccine):
• pain , redness and swelling at the injection site
• high temperature of 38 ° C or more ( fever)
• feeling sleepy
• feeling irritable
• loss of appetite.
Common ( these can be up to 1 in 10 doses of the vaccine):
• hardening of the injection site.
Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
• clot , bleeding or a small lump at the injection site
• diarrhea or vomiting
• unusual crying
• temporarily stopping breathing ( apnea) if your child was born prematurely (before or at 28 weeks of pregnancy ) .
Rare (these can be up to 1 per 1000 doses of vaccine) :
• fits without temperature or due to high temperature (fever)
• rash , hives , allergic reactions such as skin rash or allergies.
• collapse ( acute muscle relaxation ) or periods of unconsciousness or lack of awareness , and paleness or bluish skin
Booster doses Synflorix may increase the risk of side effects.
In children aged > 12 months , the risk of pain at the injection site may be increased with age .
In premature infants ( at or before 28 weeks of gestation ) for 2-3 days after vaccination may be larger pauses between breaths .
If your child experiences any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .
5 . How to store Synflorix
Keep out of reach of children.
• Do not use this medicine after the expiry date 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 to protect from light.
• Do not freeze .
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What Synflorix contains
• The active substances are:
A dose of 0,5 ml contains :
Pneumococcal polysaccharide serotype 1 microgram 11.2
Pneumococcal polysaccharide serotype 3 41.2 micrograms
Pneumococcal polysaccharide serotype 1 microgram 51.2
Pneumococcal polysaccharide serotype 6B1, 2 1 microgram
Pneumococcal polysaccharide serotype 7F1, 2 1 microgram
Pneumococcal polysaccharide serotype 9V1, 2 1 microgram
Pneumococcal polysaccharide serotype 141.2 1 microgram
Pneumococcal polysaccharide serotype 18C1, 3 3 micrograms
Pneumococcal polysaccharide serotype 19F1, 4 3 micrograms
Pneumococcal polysaccharide serotype 23F1, 2 1 microgram
1 adsorbed on aluminum phosphate 0.5 milligrams Al3 +
2 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 injection.
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.
The following information is intended for healthcare professionals only :
During storage of the pre -filled sprentsovka can be observed fine white deposit with a clear colorless supernatant . It does not show deterioration of the vaccine.
The content of the pre-filled syringe should be inspected visually for particulate matter and / or abnormal physical appearance , both before and after shaking . In the event of either being observed , the vaccine should be discarded .
The vaccine should be allowed to reach room temperature.
The vaccine vaccine should be well shaken .
The vaccine is for intramuscular use only . Do not apply intravascularly.
If Synflorix simultaneously with other vaccines should be used different injection sites .
Synflorix should not be mixed with other vaccines. If the vaccine dose is withdrawn into a syringe for injection , the needle used for withdrawal must be replaced with a needle suitable for intramuscular injection.
Instructions for administration of the vaccine presented in pre-filled syringe
1. While holding the barrel of the syringe with one hand ( and avoid holding plunger
syringe ) , unscrew the syringe cap by turning it counterclockwise arrow.
2 . To attach the needle to the syringe , twist the needle onto the syringe towards
clockwise until you feel it lock .