Patient Medication Information: uses, side effects, how to take - Infanrix-Ipv
ABOUT THIS MEDICATION
What the medication is used for:
INFANRIX®-IPV is a vaccine used in children for protection against diphtheria, tetanus (lockjaw), pertussis (whooping cough) and poliomyelitis (polio) diseases.
Vaccination is the best way to protect against these diseases.
What it does:
INFANRIX®-IPV works by helping the body makes its own protection (antibodies) which protect your child against these diseases.
When it should not be used:
INFANRIX®-IPV should not be used:
- in children with known allergy to any component of the vaccine (see “What the important nonmedicinal ingredients are” section) or children having shown signs of an allergic reaction after a previous dose of this vaccine or any injection containing diphtheria, tetanus (lockjaw), pertussis (whooping cough) and poliomyelitis (polio). Signs of an allergic reaction may include skin rash, 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, talk to your doctor.
- vaccination should not be received if your child’s defences against infections (immunity mechanisms) are impaired.
- in persons 7 years of age or older.
- in infants who experienced problems of the nervous system within 7 days following previous vaccination with pertussis (whopping cough) vaccine.
What the medicinal ingredient is:
INFANRIX®-IPV contains the following medicinal ingredients: diphtheria and tetanus toxoids, three purified pertussis antigens [pertussis toxoid, filamentous haemagglutinin and pertactin (69 kiloDalton outer membrane protein]) and inactivated polio virus types 1, 2 and 3.
None of the components in the vaccine are infectious. You cannot get the diseases from the INFANRIX®-IPV vaccine.
What the important nonmedicinal ingredients are:
INFANRIX®-IPV contains the following nonmedicinal ingredients: sodium chloride, aluminum salts, Medium 199 (as stabilizer including amino acids, mineral salts and vitamins), water for injections and may contain trace amounts of neomycin and polymixin.
What dosage forms it comes in:
INFANRIX®-IPV is supplied as a cloudy suspension for injection in a pre-filled glass syringe.
WARNINGS AND PRECAUTIONS
Before you use INFANRIX®-IPV talk to your doctor or pharmacist if:
- your child had any problems (such as high fever, collapse or shock-like state or persistent crying lasting 3 hours or more) with 48 hours or fits (with or without a fever) within 3 days of vaccination with INFANRIX®-IPV or another vaccine against pertussis (whooping cough).
- you have a family history of convulsions.
- your child is suffering from neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy (disease of brain).
- your child has a bleeding problem or bruises easily. INFANRIX®-IPV should be given with caution since bleeding may occur following vaccination.
- your child has an infection with a high temperature (over 38°C).
- your child has any known allergies.
- your child is taking any other medicine or has recently received any other vaccine.
- your child has any serious health problem.
your child has breathing difficulties, please contact your doctor. 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).
- 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 doctor or nurse if your child fainted with a previous injection.
INTERACTIONS WITH THIS MEDICATION
INFANRIX®-IPV can be given at the same time as other pediatric vaccines provided that a different syringe and needle are used at different sites, such as Haemophilus influenzae type b vaccine or hepatitis B vaccine.
PROPER USE OF THIS MEDICATION
Usual dose:
Your child should receive 1 booster dose at 15 to 18 months of age and a 2nd booster dose at 4 to 6 years of age. Each injection will be given intramuscularly (into a muscle).
Missed Dose:
If your child misses a scheduled injection, talk to your doctor and arrange another visit.
Make sure your child finishes the complete vaccination course. If not, your child may not be fully protected against infection.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all vaccines, INFANRIX®-IPV may occasionally cause unwanted 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, difficulty in breathing or swallowing and a sudden drop in blood pressure and loss of consciousness. Such reactions will usually occur before leaving the doctor’s office. However, you should seek immediate treatment in any event.
See your doctor straight away if your child has any of the following serious side effects:
- collapse
- times when they lose consciousness or have a lack of awareness
- fits – this may be when they have 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 are headache, 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 are nausea, vomiting, diarrhea, fatigue, generally feeling unwell, 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 are skin allergies, fever more than 39.5°C 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 are swollen glands in the neck, armpit or groin, bronchitis, cough, hives and rash.
Very rare side effects (in less than 1 in 10,000 doses of the vaccine) after having INFANRIX®-IPV 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, itching, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, swelling of the entire injected limb and blisters at the injection site.
If these symptoms continue or become severe, tell the doctor or nurse.
If your child develops any other symptom within days following the vaccination, tell your doctor 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
This is not a complete list of side effects. For any unexpected effects while taking INFANRIX®-IPV, contact your doctor or pharmacist.
HOW TO STORE IT
Store INFANRIX®-IPV in a refrigerator between 2° and 8°C. Do not freeze. Discard if the vaccine has been frozen.
Do not use after expiration date shown on the label. The date for last use corresponds to the last day of the month mentioned.
Store in the original package in order to protect from light.
Store all vaccines out of the reach and sight of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor vaccine safety, the Public Health Agency of Canada collects case reports on adverse events following immunization. For health care professionals: If a patient experiences an adverse event following immunization, please complete the appropriate Adverse Events following Immunization (AEFI) Form and send it to your local Health Unit in your province/territory. For the General Public: Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events following Immunization (AEFI) Form. If you have any questions or have difficulties contacting your local health unit, please contact Vaccine Safety Section at Public Health Agency of Canada: By toll-free telephone: 1-866-844-0018 By toll-free fax: 1-866-844-5931 By email: caefi@phac-aspc.gc.ca At the following website: http://www.phac-aspc.gc.ca/im/vs-sv/index-eng.php By regular mail: The Public Health Agency of Canada Vaccine Safety Section 130 Colonnade Road Ottawa, Ontario K1A 0K9 Address Locator 6502A NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying the Public Health Agency of Canada. The Public Health Agency of Canada does not provide medical advice. |
MORE INFORMATION
This document plus the full INFANRIX®-IPV monograph, prepared for health professionals can be found at:
http://www.gsk.ca or by contacting the sponsor,
GlaxoSmithKline Inc.,
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
Last revised:
©2014 GlaxoSmithKline Inc., All Rights Reserved
® INFANRIX and HIBERIX are registered trademarks, used under license by GlaxoSmithKline Inc.