Patient Medication Information: uses, side effects, how to take - Infanrix-Ipv/Hib
What is INFANRIX-IPV/Hib used for?
INFANRIX-IPV/Hib is a vaccine used in children for protection against diphtheria, tetanus (lockjaw), pertussis (whooping cough), poliomyelitis, and haemophilus type b (Hib) infection.
Vaccination is the best way to protect against these diseases.
How does INFANRIX-IPV/Hib-work?
INFANRIX-IPV/Hib works by helping the body make its own protection (antibodies) which protect your child against these diseases.
What are the ingredients in INFANRIX-IPV/Hib?
Medicinal ingredients: Diphtheria toxoid, tetanus toxoid, three purified pertussis antigens [pertussis toxoid, filamentous haemagglutinin and pertactin (69 kiloDalton outer membrance protein)], inactivated poliovirus types 1 (Mahoney), 2 (MEF1) and 3 (Saukett), and polyribosyl-ribitol-phosphate (PRP) capsular polysaccharide of Haemophilus Influenzae type b conjugated to tetanus toxoid. None of the components in the vaccine are infectious. You cannot get the diseases from the INFANRIX-IPV/Hib vaccine.
Non-medicinal ingredients: Aluminum (as aluminum salts), lactose, Medium 199, sodium chloride, and water for injection. Clinically relevant residues from the manufacturing process: neomycin sulphate and polymyxin B sulphate in trace amounts.
INFANRIX-IPV/Hib comes in the following dosage form:
INFANRIX-IPV/Hib consists of 2 components:
- a liquid vaccine component (DTaP-IPV component) in a pre-filled syringe
- a lyophilized vaccine component (Hib component) in a vial.
The 2 components are mixed together before they are given to your child.
Do not use INFANRIX-IPV/Hib if:
INFANRIX-IPV/Hib should not be used:
- If your child has known allergy to any component of the vaccine (see: What are the ingredients in INFANRIX-IPV/Hib?) or children having shown signs of an allergic reaction after a previous dose of this vaccine or any injection containing diphtheria, tetanus, pertussis, poliovirus or haemophilus type b. Signs of an allergic reaction may include shortness of breath and swelling of the face or tongue.
if your child has an infection or a high temperature (over 38°C). A minor infection such as a cold should not be a problem, but talk to your healthcare professional first.
- vaccination should not be received if your child’s defences against infections (immunity mechanisms) are impaired.
- in children 7 years of age or older.
- in infants who experienced problems of the nervous system within 7 days following previous vaccination with a pertussis (whooping cough) vaccine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive INFANRIX-IPV/Hib. Talk about any health conditions or problems, including if your child:
- had any previous problems (such as high fever, collapse or shock-like state or persistent crying lasting 3 hours or more) within 48 hours or fits/convulsions (with or without a fever) within 3 days of vaccination with INFANRIX-IPV/Hib or another vaccine against pertussis (whooping cough).
- has a family history of convulsions.
- is suffering from neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy (disease of brain).
- has a bleeding problem or bruises easily. INFANRIX-IPV/Hib should be given with caution since bleeding may occur following vaccination.
- has an infection, or a temperature over 38°C, or both.
- has any known allergies.
- is taking any other medicine or has recently received any other vaccine.
- has any serious health problem.
has breathing difficulties, please contact your healthcare professional. This may be more common in the first three days following vaccination if your child is born prematurely (before or at 28 weeks of pregnancy).
Please tell your healthcare professional if your child has had an allergic reaction to neomycin or polymyxin (antibiotics).
Fainting can occur following, or even before, any needle injection; therefore, tell the healthcare professional if your child fainted with a previous injection.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with INFANRIX-IPV/Hib:
INFANRIX-IPV/Hib may be given at the same time as hepatitis B vaccine. Measles-Mumps-Rubella (MMR) vaccine may be given simultaneously with INFANRIX-IPV/Hib, but at a different site.
As with other vaccines given intramuscularly, INFANRIX-IPV/Hib should not be given to children on anticoagulant therapy (i.e., medicines that prevents blood from clotting) unless the benefits clearly outweigh the risks.
If your child is on immunosuppressive therapy (i.e., medicines that lower the body’s normal immune system response), your healthcare professional may delay giving INFANRIX-IPV/Hib until your child is off this therapy for 3 months to increase chances of a strong immunization response. If unable to stop, then your child will receive INFANRIX-IPV/Hib vaccine while still on therapy.
How to take INFANRIX-IPV/Hib:
Usual dose:
Your child will usually receive a total of 4 injections of INFANRIX-IPV/Hib. Each injection will be given intramuscularly (into a muscle) usually at 2, 4 and 6 months of age with a fourth dose (booster) given in the second year of life (i.e., 12 to 23 months) usually at 18 months of age.
Overdose:
| If you think your child has received too much INFANRIX-IPV/Hib, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If your child misses a scheduled injection, talk to your healthcare professional and arrange another visit.
Make sure your child finishes the complete vaccination course. If not, your child may not be fully protected against infections covered by this vaccine.
What are possible side effects from using INFANRIX-IPV/Hib?
These are not all the possible side effects you may have when taking INFANRIX-IPV/Hib. If you experience any side effects not listed here, tell your healthcare professional.
Like all vaccines, INFANRIX-IPV/Hib may occasionally cause unwanted side effects.
As with other vaccines in any age group, allergic reactions may occur very rarely (in less than 1 in 10,000 doses of the vaccine). This can be recognised by symptoms such as itchy rash of the hands and feet, swelling of the eyes and face and difficulty in breathing or swallowing and a sudden drop in blood pressure and loss of consciousness. Such reactions will usually occur before leaving the healthcare professional’s office. However, if your child gets any of these symptoms, you should seek immediate medical attention.
Seek immediate medical attention, if your child has any of the following serious side effects:
- collapse
- times when the child loses consciousness or has a lack of awareness
- fits or convulsions – this may be when the child has a fever
These side effects have happened very rarely with other vaccines against whooping cough. They usually happen within 2 to 3 days after vaccination.
Other side effects:
Very common side effects (in more than 1 in 10 doses of the vaccine) after having INFANRIX-IPV/Hib are loss of appetite, irritability, unusual crying, restlessness, pain, redness and swelling at injection site, fever more than 38°C and sleepiness.
Common side effects (in more than 1 in 100 doses of the vaccine) after having INFANRIX-IPV/Hib are vomiting, diarrhea, swelling larger than 5 cm at injection site and a hard lump at injection site.
Uncommon side effects (in more than 1 in 1,000 doses of the vaccine) after having INFANRIX-IPV/Hib are upper respiratory tract infection, swollen glands in the neck, armpit or groin, cough, bronchitis, runny nose, rash, hives, fever more than 39.5°C, feeling tired and swelling occurring over a large area of the injected limb.
Rare side effects (in more than 1 in 10,000 doses of the vaccine) after having INFANRIX-IPV/Hib are itching and skin rash.
Very rare side effects (in less than 1 in 10,000 doses of the vaccine) after having INFANRIX-IPV/Hib are bleeding or bruising more easily than normal, temporarily stopping breathing, 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, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, discoloured skin, swelling of the legs, swelling of the entire injected limb and blisters at the injection site.
If these symptoms continue or become severe, tell your healthcare professional.
If your child develops any other symptom within days following the vaccination, tell your healthcare professional as soon as possible.
Do not be alarmed by this list of possible side effects. It is possible that your child will have no side effects from vaccination.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Suspected Side Effects for Vaccines For the general public: Should you experience a side effect following immunization, please report it to your healthcare professional. Should you require information related to the management of the side effect, please contact your healthcare professional. The Public Health Agency of Canada, Health Canada and GSK cannot provide medical advice. For healthcare professionals: If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (http://www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php) and send it to the appropriate public health agency in your province/territory. |
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Storage:
Store INFANRIX-IPV/Hib at 2° to 8°C. Do not freeze. Discard if the vaccine has been frozen. Store in the original package in order to protect from light.
After reconstitution immediate use is recommended.
Do not use after expiration date shown on the label. The date for last use corresponds to the last day of the month mentioned.
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.
Keep out of sight and reach of children.
If you want more information about INFANRIX-IPV/Hib:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.gsk.ca, or by calling 1-800-387-7374.
Last Revised: February 27, 2025
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