Details for: SYNFLORIX
Company: GLAXOSMITHKLINE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02320541 | SYNFLORIX | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO PROTEIN D CARRIER PROTEIN; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO PROTEIN D CARRIER PROTEIN; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO PROTEIN D CARRIER PROTEIN; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO PROTEIN D CARRIER PROTEIN; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO PROTEIN D CARRIER PROTEIN; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO PROTEIN D CARRIER PROTEIN; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO PROTEIN D CARRIER PROTEIN; PNEUMOCOCCAL POLYSACC. SEROT. 18C CONJUG. TO TETANUS TOXOID CARRIER PROT.; PNEUMOCOCCAL POLYSACCHARID SEROT. 19F CONJUG. TO DIPHTHERIA TOXOID CARRIER PROT.; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO PROTEIN D CARRIER PROTEIN | 1 MCG / 0.5 ML; 3 MCG / 0.5 ML; 1 MCG / 0.5 ML; 1 MCG / 0.5 ML; 1 MCG / 0.5 ML; 1 MCG / 0.5 ML; 1 MCG / 0.5 ML; 3 MCG / 0.5 ML; 3 MCG / 0.5 ML; 1 MCG / 0.5 ML | SUSPENSION | INTRAMUSCULAR |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
SYNFLORIX is a vaccine that will help protect your child against diseases caused by some types of a bacteria called Streptococcus pneumoniae. This bacteria can cause serious illnesses including meningitis, pneumonia, ear infection and blood infection.
What it does
SYNFLORIX works by helping the body to make its own antibodies, which protect your child against these diseases.
As with all vaccines, SYNFLORIX may not fully protect all children who are vaccinated.
SYNFLORIX will not protect against pneumococcal serogroups or serotypes that are not included in the vaccine except the crossreactive serotype 19A.
Children with a weakened immune system, for example due to Human Immunodeficiency Virus (HIV) infection, may not get the full benefit from SYNFLORIX.
When it should not be used
SYNFLORIX should not be given if your child has previously had any allergic reaction to SYNFLORIX, or any ingredient contained in SYNFLORIX. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
What the medicinal ingredient is
- Pneumococcal polysaccharide serotypes 1, 4, 5, 6B, 7F, 9V, 14 and 23F conjugated to Non-Typeable Haemophilus influenzae (NTHi) protein D
- Pneumococcal polysaccharide serotype 18C conjugated to tetanus toxoid carrier protein
- Pneumococcal polysaccharide serotype 19F conjugated to diphtheria toxoid carrier protein
What the non-medicinal ingredients are
SYNFLORIX contains the following nonmedicinal ingredients: aluminium (as aluminium phosphate), sodium chloride, and water for injections.
What dosage form it comes in
SYNFLORIX is presented as a suspension for injection.
Warnings and precautions
Take special care with SYNFLORIX
Before your child is vaccinated, make sure your doctor knows if any of the following apply to your child:
- has a severe infection with a high temperature. It might be necessary to postpone the vaccination until recovery. A minor infection such as a cold should not be a problem, but talk to your doctor first.
- has a bleeding problem or bruise easily.
- 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).
Fainting can occur following, or even before, any needle injection; therefore, tell the doctor or nurse if you or your child fainted with a previous injection.
Interactions with this medication
Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
SYNFLORIX may not work as well if your child is taking medicines that reduce the effectiveness of their immune system to fight infection.
SYNFLORIX can be given at the same time as other childhood vaccines. A different injection site will be used for each type of vaccine.
Proper use of this medication
Usual Dose
SYNFLORIX is always injected into a muscle, usually in the thigh or upper arm.
Infants from 6 weeks to 6 months of age
Usually, your child will receive three injections with an interval of at least one month between each one. The first injection can be given from the age of 6 weeks onwards. At least six months after the third injection and from the age of 9 months onwards, your child will receive an additional injection (booster).
Alternatively, your child may receive two injections with an interval of two months between injections. The first injection can be given from the age of 6 weeks onwards. At least six months after the second injection and from the age of 9 months onwards, your child will receive an additional injection (booster).
Previously unvaccinated older infants and children
Infants aged 7-11 months:
Your child will receive two injections with an interval of at least one month between injections. At least two months after the last injection and during his/her second year of life, your child will receive a third injection (booster).
Children aged 12 months-5 years:
Your child will receive a total of two injections with an interval of at least two months between injections.
You will be informed when your child should come back for their next injection.
Infants from 6 weeks to 6 months of age born prematurely (born between 27 and 36 weeks of gestation)
Your child will receive a total of three injections with an interval of at least one month between each one. At least six months after the last (third) injection, your child will receive an additional injection (booster).
Immunocompromised populations
If your child is considered to be at a higher risk of pneumococcal infection (due to HIV infection, sickle cell disease, or impaired or abnormal functioning of the spleen), your child may receive SYNFLORIX. The number and timing of injections your child will receive will be as prescribed by your doctor. Please speak to your doctor for additional information.
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.
Missed Dose
If your child misses a scheduled injection, it is important that you make another appointment.
Make sure your child finishes the complete vaccination course.
Side effects and what to do about them
Like all medicines, SYNFLORIX can cause side effects, although not everybody gets them.
Side effects that occurred during clinical trials with SYNFLORIX were as follows:
Very common (these may occur in 1 in 10 doses or more of the vaccine):
- Pain, redness and swelling at the injection site
- Fever (38°C or higher)
- Drowsiness
- Irritability
- Loss of appetite
Common (these may occur in up to 1 in 10 doses of the vaccine):
- Hardness at the injection site
Uncommon (these may occur in up to 1 in 100 doses of the vaccine):
- Itching, blood clot, bleeding and small lump at the injection site
- Nausea, diarrhoea, vomiting
- Unusual crying
- Temporarily stopping breathing (apnoea)
- Headache
- Skin rash
- Swelling larger than 5 cm where the injection was given
- Hives
Rare (these may occur in up to 1 in 1,000 doses of the vaccine):
- Allergic reactions such as skin allergies
- Fits without temperature or due to high temperature (fever)
- Collapse (sudden onset of muscle floppiness), periods of unconsciousness or lack of awareness, and paleness or bluish skin discoloration.
Very rare (these may occur in up to 1 in 10,000 doses of the vaccine):
- Severe allergic reactions which can be
recognised by:
- raised and itchy rash (hives)
- swelling, sometimes of the face or mouth (angioedema) causing difficulty in breathing – collapse
These reactions will usually occur before leaving the doctor’s clinic. However, if your child gets any of these symptoms you should contact a doctor urgently.
- Kawasaki disease (major signs of the illness are for instance: fever which lasts for more than five days, associated with a rash on the trunk sometimes followed by a peeling of the skin on the hands and fingers, swollen glands in the neck, red eyes, lips, throat and tongue)
Following booster vaccination, children > 12 months of age are more likely to experience injection site reactions such as rash (uncommon) and crying abnormal (uncommon) compared to the rates observed in infants during the primary series with SYNFLORIX.
Other side effects have been seen with SYNFLORIX since being introduced onto the market:
- An extreme, often life-threatening, allergic reaction (on very rare instances)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If your child is more than 12 months of age when he/she receives his/her booster injection, he/she is more likely to experience reactions at the site of injection.
How to store
- Keep out of the reach and sight of children.
- Do not use SYNFLORIX after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
- Store in a refrigerator (2°C – 8°C).
- Do not freeze.
- Store in the original package in order to protect from light.
- Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.
Reporting 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
E-mail: 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 product monograph, prepared for health professionals can be found at: http://www.gsk.ca or can be obtained by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
This leaflet was prepared by GlaxoSmithKline Inc
Last revised: November 13, 2019
©2019 GSK group of companies or its licensor Trademarks are owned by or licensed to the GSK group of companies