Prevnar 13 (Pneumococcal-vaccine-conjugated) belongs to a group of medications known as vaccines. It is used to prevent pneumonia (lung infection), Meningitis (brain lining infection), 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.

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 future bacteria that may cause infection.

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 you are receiving this vaccine, speak to your doctor.

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Immunization with the pneumcocccal vaccine requires 1 to 4 doses of the vaccine, depending on your 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 Prevnar 13 (Pneumococcal-vaccine-conjugated) be given exactly as recommended by your doctor. If you miss an appointment to receive the pneumococcal vaccine, contact your doctor as soon as possible to reschedule your appointment. Add all vaccines you receive to your 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 Prevnar 13 (Pneumococcal-vaccine-conjugated) with your doctor.

The following side effects have been reported by at least 1% of people taking Prevnar 13 (Pneumococcal-vaccine-conjugated). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience 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
• fatigue
• Fever of less than 39°C (102.2°F)
• headache
• increased crying (infants)
• irritability
• joint pain
• muscle pain
• reaction at place of injection such as a hard lump, pain, redness, soreness, swelling
• restless sleep
• 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 doctor or seek medical attention.

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

• apnea (longer gaps between breaths) in premature babies
• enlarged lymph nodes
• fever over 39°C (102.2°F)

Seek immediate medical attention if any of the following occur:

• collapse
• seizures
• signs of an allergic reaction (e.g., 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 doctor if you notice any symptom that worries you.

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Each 0.5 mL dose contains 2.2 µg of Streptococcus pneumoniae polysaccharides serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F, as well as 4.4 µg of serotype 6B, conjugated to diphtheria CRM197 carrier protein. Nonmedicinal ingredients: aluminum phosphate adjuvant, polysorbate 80, sodium chloride, succinic acid, and water for injection.

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.

Prevnar 13 (Pneumococcal-vaccine-conjugated) is not intended for children under 6 weeks old.

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There may be an interaction between pneumococcal vaccine and any of the following:

• Acetaminophen
• immunosuppressants:
• Abatacept
• Anakinra
• Azathioprine
• Belimumab
• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
• Cyclosporine
• eculizumab
• Fingolimod
• Glatiramer
• Hydroxyurea
• Leflunomide
• Infliximab
• Methotrexate
• medications to treat cancer (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• mycophenolate
• Rituximab
• Romidepsin
• Tacrolimus
• Tocilizumab
• Vedolizumab
• other vaccines

If you or your child is taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you or 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 you or 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 Prevnar 13 (Pneumococcal-vaccine-conjugated). Tell your doctor or your child's doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you or your child is taking. Also tell them about any supplements you or your child takes.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Prevnar 13 (Pneumococcal-vaccine-conjugated).

Bleeding problems: There is a risk of increased bleeding or bruising when any intramuscular injection is given to a person who has a bleeding disorder or is taking medications to thin the blood. The safety and effectiveness of this vaccine have not been established for people with thrombocytopenia (low platelets) or bleeding disorders. If you have these conditions, discuss the risks and benefits of this vaccine with your doctor.

Fever: A doctor may decide to delay this vaccine if the person 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 used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using Prevnar 13 (Pneumococcal-vaccine-conjugated), contact your doctor immediately.

Breast-feeding: It is not known if this vaccine passes into breast milk. If you are a breast-feeding mother and are taking this vaccine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: This vaccine is not recommended for infants under 6 weeks old.

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