Synflorix (Pneumococcal-vaccine-conjugated) belongs to a group of medications known as vaccines. It is used to prevent pneumonia (lung infection), Meningitis (brain lining infection), ear infections, pleural empyema (pus buildup in the space between the lung and the chest wall), bacteraemia (bacterial blood infection), and sepsis (a life-threatening infection causing rapid breathing and heart rate, organ shutdown, and dangerously Low Blood Pressure) caused by various types of pneumococcal bacteria. This medication is used for infants and children.

The pneumococcal vaccine increases a person's defences against infection with pneumococcal bacteria by introducing very small amounts of bacterial components (not live bacteria) into the bloodstream. These components of bacteria are enough to stimulate the production of a person's own antibodies (cells designed to attack that particular bacteria), which will remain in the body ready to attack any bacteria that could cause infection in the future.

It is important to remember that vaccination only protects a person from those bacteria that are actually contained in the vaccine. The vaccine is designed to prevent infection caused by the most common types of pneumonia-causing bacteria.

Your doctor may have suggested this vaccine for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why your child is receiving this vaccine, speak to your child's doctor.

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Immunization with the pneumococcal vaccine requires 1 to 4 doses of the vaccine, depending on the person's age at the first dose. This vaccine may be given at the same time as other routine vaccinations.

The vaccine will be injected into a muscle (preferably in the thigh or upper, outer arm) by a qualified health professional.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. Your doctor may recommend a dose different from the ones listed here.

It is important Synflorix (Pneumococcal-vaccine-conjugated) be given exactly as recommended by your doctor. If your child misses an appointment to receive the pneumococcal vaccine, contact your doctor as soon as possible to reschedule the appointment. Add all vaccines your child receives to their immunization record.

The vaccine should be kept in a refrigerator until it is ready to be used. Keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this vaccine. If you are concerned about side effects, discuss the risks and benefits of Synflorix (Pneumococcal-vaccine-conjugated) with your child's doctor.

The following side effects have been reported by at least 1% of people taking Synflorix (Pneumococcal-vaccine-conjugated). Many of these side effects can be managed, and some may go away on their own over time.

Contact your child's doctor if your child experiences these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• decreased appetite
• Diarrhea
• drowsiness
• Fever of less than 39°C (102.2°F)
• headache
• irritability
• reaction at place of injection such as:
• hard lump
• pain
• redness
• soreness
• swelling
• restless sleep
• unusual crying
• vomiting
• skin rash

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your child's doctor or seek medical attention.

Check with your child's doctor as soon as possible if any of the following side effects occur:

• fever over 39°C (102.2°F)
• prolonged fever (lasting longer than 5 days)
• rash all over the body

Seek immediate medical attention if any of the following occur:

• temporarily stopping breathing
• collapse
• seizures
• signs of an allergic reaction:
• difficulty breathing or swallowing
• Hives
• itching, especially of feet or hands
• reddening of skin, especially around the ears
• swelling of eyes, face, or inside of nose
• unusual tiredness or weakness (sudden or severe)

Some people may experience side effects other than those listed. Check with your child's doctor if you notice any symptom that worries you.

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Each 0.5 mL dose contains 1 µg Streptococcus pneumoniae polysaccharides, serotypes 1, 5, 6B, 7F, 9V, 14, and 23F as well as 3 µg of serotypes 4, 18C, and 19F, adsorbed on aluminum phosphate and conjugated to protein D (derived from non-typeable H. Influenzae) carrier protein, Tetanus toxoid carrier protein, and diphtheria toxoid carrier protein. Nonmedicinal ingredients: sodium chloride and water for injection. Prefilled syringes also contain latex.

Pneumococcal vaccine should not be used by anyone who is allergic to pneumococcal vaccine or to any of the ingredients of the vaccine, including diphtheria toxoid.

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There may be an interaction between pneumococcal vaccine (for infants and children) and any of the following:

• Acetaminophen
• immunosuppressants
• Azathioprine
• Belimumab
• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
• Cyclosporine
• eculizumab
• Etanercept
• Fingolimod
• Golimumab
• hydroxychloroquine
• Infliximab
• Leflunomide
• medications to treat cancer (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• Rituximab
• Tacrolimus
• other vaccines

If your child is taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want your child to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that your child must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your child's doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications your child is taking. Also tell them about any supplements your child takes.

Before your child begins using a medication, be sure to inform your child's doctor of any medical conditions or Allergies your child may have, any medications your child is taking, and any other significant facts about your child's health. These factors may affect how your child should use this medication.

Fever: A doctor may decide to delay this vaccine if the child receiving the vaccine has an acute infection or fever. Mild infections without fever, such as colds, usually do not require delay of the vaccine.

Medical conditions: Parents of children who were born prematurely or have problems with blood clotting or bleeding, a weakened immune system (due to conditions such as HIV, cancer, spleen problems, or medications that suppress the immune system such as those used for cancer, Rheumatoid Arthritis, or organ transplants) should discuss with their doctor how this vaccine may affect their child's medical condition, how their child's medical condition may affect the dosing and effectiveness of this vaccine, and whether any special monitoring is needed.

Vaccine protection: As with any vaccine, this vaccine may not protect 100% of people who receive it.

Pregnancy: Studies of the effects of this vaccine during pregnancy have not been done. This vaccine should not be given to adults, including pregnant women.

Breast-feeding: It is not known if the vaccine passes into breast milk. This vaccine is not recommended for use by adults, including breast-feeding women.

Children: This vaccine is not recommended for infants under the age of 6 weeks. It is not intended to be given to children older than 5 years of age.

Adults and seniors: Synflorix (Pneumococcal-vaccine-conjugated) should not be used by adults, including seniors.

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