How does this medication work? What will it do for me?
This medication belongs to the class of medications called vaccines. This vaccine helps protect against infections caused by diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and disease caused by Haemophilus influenzae type b for infants and children 6 weeks to 2 years.
It works by increasing a child's defenses against the bacteria and viruses that cause these infections, by stimulating the production of the child's own antibodies. These antibodies remain in the body until needed to fight off the viruses and bacteria causing these infections if the child is exposed to them.
Your child's doctor may have suggested this vaccine for conditions other than those listed in these drug information articles. As well, some forms of this vaccine may not be used for all of the conditions discussed here. If you have not discussed this with your child's doctor or are not sure why your child is receiving this vaccine, speak to your child's doctor.
What form(s) does this medication come in?
After reconstitution, each 0.5 ml dose contains 25 limit of flocculation (Lf) [30 International Units (IU)] diphtheria toxoid; 10 Lf (40 IU) tetanus toxoid; 25 µg of pertussis toxoid (PT); 25 µg of filamentous haemagglutinin (FHA); 8 µg of pertactin; 10 µg of hepatitis B surface antigen (HBsAg); 40 D- antigen units (DU) of type 1 poliovirus, 8 DU of type 2 poliovirus, and 32 DU of type 3 poliovirus; 10 µg of adsorbed purified capsular polysaccharide of Haemophilus influenzae type b (Hib) (PRP) covalently bound to approximately 25 µg of tetanus toxoid per 0.5 mL dose. Nonmedicinal ingredients: lactose, sodium chloride, aluminum adjuvant (as aluminum salts), water for injection, residual formaldehyde, polysorbate 20 and 80 (Tween 20 and 80), M199, potassium chloride, disodium phosphate, monopotassium phosphate, glutaraldehyde, glycine, neomycin sulphate and polymyxin B sulphate.
How should I use this medication?
The usual dose of this vaccine is 0.5 mL given as an injection into the muscle of the outer thigh or the outer side of the upper arm.
This vaccine is given by a health care professional in a doctor's office, hospital, or clinic.
Immunization should begin no sooner than 6 weeks of age, and 2 or 3 doses should be given (0.5 mL per dose). Your doctor will decide which schedule is right for your child. Injections are usually given at least one month apart, with a booster dose given at a later date. It is very important that this vaccine be given on a regular schedule as prescribed by the doctor. If your child misses a dose of this vaccine, check with your child's health care professional. Your child may not be fully protected against these illnesses if doses are missed. Add all vaccines your child receives to their immunization record.
This medication should be stored in the refrigerator, in its original package to protect it from light, and it should not be allowed to freeze.
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.
Who should NOT take this medication?
Your child should not receive this medication if they:
- are allergic to diphtheria, tetanus, pertussis, hepatitis B, poliovirus, or Haemophilus influenzae type b vaccines, or any ingredients of this medication
- have had an allergic reaction to any injection containing diphtheria, tetanus, pertussis, hepatitis B, poliovirus, or Haemophilus influenzae type b vaccines
- have previously had encephalopathy (abnormal brain function) within 7 days of receiving pertussis vaccine
- are currently experiencing a severe, acute illness
Do not give this medication to children 7 years of age and older.
What side effects are possible with this medication?
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 medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your child's 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.
- fever (usually lasts less than 48 hours)
- loss of appetite
- pain, soreness, redness, swelling, or a lump at the place of injection
- unusual crying
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your child's doctor as soon as possible if any of the following side effects occur:
- bleeding or bruising more easily
- slowed breathing
- swelling of the arm receiving the injection
- symptoms of a cold, sinus, or ear infection
- temporary breathing interruptions (more likely to occur with children born at 28 weeks of pregnancy or less)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- collapse or loss of consciousness
- signs of a severe allergic reaction (e.g., difficulty breathing or swallowing; hives; swelling of the eyes, face, or mouth)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before your child receives this vaccine, 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 the vaccine your child is receiving.
Allergic reactions: In rare cases, this vaccine may cause severe allergic reactions. For this reason, doctors often ask people to stay in the office for about 30 minutes after having the vaccine so they can receive medical care if an allergic reaction occurs. If you notice signs of a severe allergic reaction in your child (hives; trouble breathing or swallowing; or swelling of the lips, face, throat, or tongue), get medical attention immediately.
Bleeding disorders: If your child has a bleeding disorder or is taking medications that make them more likely to bleed (i.e., warfarin, acetylsalicylic acid [ASA]) tell the person giving the injection. There is a risk of excessive bleeding where the injection is given if it is not done carefully.
Immune system: As with any vaccine, this vaccine may not be as effective for people with a weakened immune system (e.g., people with AIDS or cancer, people taking antirejection medications after an organ transplant, people receiving chemotherapy, people taking any medication that suppresses the immune system). If your child has a weakened immune system, their doctor may decide to postpone the vaccine till their immune system recovers.
Infection or fever: This vaccine should not be given to anyone who has an active infection or an illness associated with fever, unless the doctor decides that the benefits outweigh the risks.
Seizures: People who have a history of seizures or seizure disorders may be at an increased risk of experiencing seizures with this vaccine. Your child's doctor may suggest that you give your child a dose of medication to prevent fever. If your child has a history of seizures, discuss with their doctor whether any special precautions are needed.
Vaccine protection: As with any vaccine, this vaccine may not protect 100% of people who receive it and may not prevent infection for people who are already infected with the bacteria.
Pregnancy and breast-feeding: Studies have not been conducted with this vaccine during pregnancy or breast-feeding. This vaccine is not recommended for anyone 7 years of age or older.
Children: The safety and effectiveness of this vaccine have not been established for infants younger than 6 weeks or children 2 years of age or older.
What other drugs could interact with this medication?
There may be an interaction between this medication and any of the following:
- medications that suppress the immune system:
- corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
- medications used to treat conditions such as cancer, inflammatory bowel disease, multiple sclerosis, psoriasis, rheumatoid arthritis, or medications used after a transplant
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you 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 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 doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2023. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Infanrix-hexa