injection, suspension in pre-filled syringe
Vaccine against diphtheria, tetanus and pertussis, acellular, component and against polio, inactivated, adsorbed
1. What Infanrix Polio is and what it is used for
Infanrix Polio is a vaccine that is intended as a supplement dose to protect your child against four diseases:
- Diphtheria – a serious bacterial infection that mainly affects the airways and sometimes the skin. The airways become swollen, which causes severe breathing problems and, in the worst case, suffocation. The bacteria also release a poison. This can cause nerve damage, heart problems and in the worst case, death.
- Tetanus ( tetanus ) – tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Injuries that are particularly prone to tetanus infection are burns, fractures , deep wounds and wounds that have received soil, dust, horse manure / manure or wood chips. The bacteria release a toxin that can cause muscle stiffness, painful muscle spasms, seizures and even death. Muscle spasms can be so severe that they cause bone fractures in the spine.
- Whooping cough (pertussis) – a highly contagious disease that affects the respiratory tract. The disease causes severe attacks of coughing that can cause breathing problems. The cough often has a “peeping” sound and can last for one to two months or longer. Whooping cough can also cause ear infections, respiratory infections ( tracheal catarrh ) that can last for a long time, lung infections ( pneumonia ), seizures, brain damage and in the worst case, death.
- Polio (poliomyelitis) – is a viral infection. Polio is often a mild disease, but can sometimes be serious and cause permanent damage or, in the worst case, death. Polio can prevent the muscles from moving (paralysis of the muscles). This also includes the muscles needed to breathe and to be able to walk. Arms or legs affected by the disease can become painfully twisted (deformed).
Infanrix Polio is for children from 16 months to 13 years of age. The vaccine is not intended for use in adolescents over 14 years of age.
How Infanrix Polio works
- Infanrix Polio helps your baby’s body produce its own protection ( antibodies ). This protects your child from these diseases.
- The vaccine can not cause the disease that it protects your child against.
2. What you need to know before your child receives Infanrix Polio
Infanrix Polio should not be given:
- If your child is allergic to
- any of the ingredients of this medicine (listed in section 6)
- or neomycin or polymyxin (types of antibiotics )
- or formaldehyde.
Signs of an allergic reaction may include itchy skin rash, shortness of breath, and swelling of the face or tongue.
- If your child has previously had an allergic reaction to a vaccine against diphtheria , tetanus, pertussis or polio
- If your child has a neurological disease ( encephalopathy ) within 7 days of previous vaccination with pertussis vaccine
- If your child has a severe infection with a high fever (above 38 ° C). A mild infection such as a common cold is probably not a problem, but talk to your doctor first.
Infanrix Polio should not be given if any of the above apply to your child. If you are not sure, talk to your doctor or pharmacist before taking your child Infanrix Polio.
Warnings and cautions
Talk to your doctor or pharmacist before giving your child Infanrix Polio about:
- your child has previously had a health problem related to previous vaccination with Infanrix Polio or any other pertussis vaccine, such as:
- high fever (above 40 ° C) within 48 hours after vaccination
- collapse or shock-like condition within 48 hours after vaccination
- persistent, inconsolable crying that lasted 3 hours or longer, within 48 hours after vaccination
- seizures with or without fever within 3 days after vaccination
- your child suffers from an undiagnosed or progressive brain disease or epilepsy that is out of control. When the disease is under control, the vaccine can be given.
- your child has an increased risk of bleeding or is prone to bruising
- Your child has a tendency to get cramps due to fever or if there are such ailments within the family
- your child has problems with their immune system (including HIV – infection ). Your child may still get Infanrix Polio, but the protection against infection after vaccination may not be as strong.
Fainting can occur (mainly in adolescents) after, or even before, any needle injection. Therefore, tell your doctor or nurse if your child has fainted from a previous injection.
If any of these apply to your child (or you are not sure) talk to your doctor or pharmacist before taking your child Infanrix Polio.
Other medicines and Infanrix Polio
Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if your child uses any of the following:
- drugs or other treatments (such as radiation therapy) that affect the immune system. Your child may still get Infanrix Polio, but Infanrix Polio may not protect as well. If possible, the vaccine should be given after treatment.
- other vaccines. Infanrix Polio can be given at the same time as other vaccines, but each vaccine should be given at different injection sites.
Pregnancy, breastfeeding and fertility
Infanrix Polio is unlikely to be given to pregnant or breastfeeding women as it is only intended for use in children from 16 months to 13 years of age.
The use of this vaccine is not recommended during pregnancy or lactation.
Consult a doctor or pharmacist before using the medicine.
Driving and using machines
Infanrix Polio is unlikely to be given to people who drive or use machines, as the medicine is only intended for use in children from 16 months to 13 years of age.
Your child may feel tired after receiving the vaccine. If this happens, your child should not drive, cycle or use any tools or machines.
Ifanrix Polio contains neomycin, polymyxin (antibiotics) and formaldehyde
If your child is allergic to any of these ingredients, Infanrix Polio should not be given. Tell your doctor if your child has had an allergic reaction to these ingredients.
How to give Infanrix Polio
When the vaccine will be given
- Your doctor or nurse will tell you when your child should receive this vaccine. This is determined by official recommendations.
How Infanrix Polio is given
- Your child will receive an injection of Infanrix Polio.
- Infanrix Polio should always give in a muscle.
- The vaccine is usually given in the shoulder muscle. In young children, the vaccine can also be given in the thigh.
- The vaccine should never be given to a friend.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur when using this vaccine:
Allergic reactions
If your child has an allergic reaction, contact a doctor immediately. The signs of this can be:
- skin rash that may itch or blister
- swelling of eyes and face
- difficulty breathing or swallowing
- sudden drop in blood pressure
- unconsciousness
These signs usually occur very soon after receiving an injection. Take your child to a doctor immediately if this happens after the reception has left. Allergic reactions are very rare (less than 1 in 10,000 doses of the vaccine).
Contact your doctor immediately if your child has any of the following serious side effects:
- collapse
- lose consciousness
- impaired consciousness
- cramps
Contact a doctor immediately if you notice any of the above. These side effects have occurred with other pertussis vaccines. They usually appear within 2 to 3 days after vaccination.
Other side effects include:
- Very common (may affect more than 1 in 10 doses of the vaccine)
- somnolence
- headache
- loss of appetite
- fever above 38 ° C or higher
- pain, redness and swelling at the injection site
- inconsolable crying
- feeling of irritability or restlessness
- Common (may affect up to 1 in 10 doses of the vaccine)
- diarrhea
- nausea, vomiting (feeling of nausea or vomiting)
- fever 39.5 ° C or higher
- general malaise
- hard lump at the injection site
- impotence
- Less common (may occur in up to 1 in 100 dose s of the vaccine)
- skin allergy or rash
- Rare (may occur in up to 1 in 1000 dose s of the vaccine)
- swollen lymph nodes in the neck, armpit and groin ( lymphadenopathy )
- cough or pneumonia ( bronchitis )
- itching
- lumpy rash (hives)
- Very rare (may affect up to 1 in 10,000 doses of the vaccine)
- bleeds or bruises more easily than normal ( thrombocytopenia )
- temporary respiratory arrest ( apnea )
- swelling of the face, lips, mouth, tongue or throat which may lead to difficulty swallowing or breathing ( angioneurotic edema )
- blisters at the injection site
Topical doses of Infanrix Polio may increase the risk of local reactions at the injection site. Some of these affect the whole arm or leg where the injection was made. Usually, these reactions occur within 48 hours after injection one and disappear after 4 days.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Infanrix Polio
- Keep this medicine out of the sight and reach of children.
- Store in a refrigerator (2 ° C to 8 ° C).
- Store in the original package. Sensitive to light.
- Do not freeze. Freezing destroys the vaccine.
- Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
- 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.
6. Contents of the packaging and other information
Content declaration
- The active substances are:
| Diphtheria toxoid 1 | not less than 30 IU | |
| Tetanus toxoid 1 | not less than 40 IU | |
| Bordetella pertussis – antigen | ||
| Pertussis toxoid 1 | 25 micrograms | |
| Filamentous hemagglutinin 1 | 25 micrograms | |
| Pertactin 1 | 8 micrograms | |
| Poliovirus (inactivated) 2 | ||
| type 1 (Mahoney strain) | 40 D antigen units | |
| type 2 (MEF-1 strain) | 8 D antigen units | |
| type 3 (Saukett strain) | 32 D antigen units | |
| 1 adsorbed on hydrated aluminum hydroxide2 grown in VERO cells | 0.5 milligrams Al 3+ |
Aluminum hydroxide is included in this vaccine as an adjuvant . Adjuvants are substances that are included in certain vaccines to accelerate and improve and/or prolong the protective effect of the vaccine.
The other ingredients are sodium chloride, Medium 199 (containing mainly amino acids, mineral salts, vitamins ), and water for injections.
What the medicine looks like and contents of the pack
- Infanrix Polio is a suspension in a pre-filled syringe (0.5 ml).
- Suspension one is a white, milk-like liquid.
- Packs of 1 or 10 pre-filled syringes with or without needles.
- Not all packaging may be marketed.
Marketing Authorisation Holder:
GlaxoSmithKline AB, Box 516, 169 29 Solna
Tel: 08 – 638 93 00
E-mail: info.produkt@gsk.com
This medicinal product is authorized under the European Economic Area under the names:
Greece, France, Portugal, Cyprus: InfanrixTetra
Czech Republic, Estonia, Latvia, Lithuania, Norway, Slovakia, Sweden: Infanrix Polio
Finland: Infanrix-Polio
Poland, UK: Infanrix-IPV
Hungary: Infanrix IPV
Ireland: IPV Infanrix
Italy: Polioinfanrix