PolioInfanrix

Package leaflet: Information for the user

PolioInfanrix – injectable suspension in a pre-filled syringe

Diphtheria, tetanus, pertussis (acellular component) and poliomyelitis (inactivated) vaccine (adsorbed).
Please read this leaflet carefully before your child is vaccinated because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This vaccine has been prescribed for your child only. Never give it to others.
• If your child experiences any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What PolioInfanrix is and what it is used for
2. What you need to know before your child receives PolioInfanrix
3. How to use PolioInfanrix
4. Possible side effects
5. How to store PolioInfanrix
6. Contents of the pack and other information

1. WHAT POLIOINFANRIX IS AND WHAT IT IS USED FOR

PolioInfanrix is a vaccine used as a booster dose to protect the child against 4 diseases:

• Diphtheria: a serious bacterial infection that mainly affects the upper respiratory tract and sometimes the skin. The respiratory tract swells, causing severe breathing problems and sometimes suffocation. The diphtheria bacterium also releases a toxin. This can damage the nervous system, cause heart problems, and even lead to death.
• Tetanus: the tetanus bacterium enters the body through cuts, scratches, or skin wounds. Wounds most at risk of tetanus infection include burns, fractures, deep wounds, or wounds contaminated with soil, dust, manure, or wood splinters. The bacterium releases a toxin. This can cause muscle stiffness, painful muscle spasms, convulsions, and even death. Muscle spasms can be so severe that they cause fractures of the spinal bones.
• Pertussis (whooping cough): a highly contagious disease affecting the respiratory tract. It causes severe coughing that may lead to breathing difficulties. The cough often has a characteristic "whooping" sound. The cough may last for one or two months or longer. The pertussis bacterium may also cause ear infections, chest infections (bronchitis) that can persist for a long time, lung infections (pneumonia), seizures, brain damage, and even death.
• Polio (poliomyelitis): a viral infection. Polio often causes only mild discomfort. However, sometimes it can be very severe and cause permanent damage or even death. Polio can cause muscle paralysis. This includes muscles involved in breathing and movement. The arms or legs affected by this disease may become painfully deformed.

PolioInfanrix is indicated for children aged from 16 months to 13 years, inclusive. It is not intended for individuals over 14 years of age.
How PolioInfanrix works

• PolioInfanrix helps the child's body produce its own protection (antibodies). In this way, it will protect the child against these diseases.
• The vaccine cannot cause the diseases it protects against.

2. WHAT YOU SHOULD KNOW BEFORE YOUR CHILD RECEIVES POLIOINFANRIX

PolioInfanrix must not be given:

• If your child is allergic to any of the components of this vaccine (listed in section 6) or to neomycin, polymyxin (types of antibiotics), or formaldehyde. Signs of allergic reactions may include itchy red rash, shortness of breath, or swelling of the face or tongue.
• If your child has had or currently has an allergic reaction to any other vaccine against diphtheria, tetanus, pertussis, or poliomyelitis;
• If your child has experienced neurological problems (encephalopathy) within 7 days after a previous vaccination with a pertussis-containing vaccine;
• If your child has a serious infection with high fever (over 38°C). A mild illness such as a cold does not pose a problem, but discuss this with your doctor first. PolioInfanrix must not be administered if any of the above conditions apply to your child. If in doubt, speak with your doctor or pharmacist before the vaccine is given.

Warnings and precautions
Talk to your doctor or pharmacist before administering the vaccine to your child if:

• Your child has experienced any of the following after a previous dose of PolioInfanrix or another pertussis-containing vaccine:
  • High fever (over 40°C) within 48 hours after vaccination;
  • Collapse or shock-like state within 48 hours after vaccination;
  • Persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours after vaccination;
  • Seizures with or without fever occurring within 3 days after vaccination;
• Your child has an undiagnosed or progressive brain disorder or uncontrolled epilepsy. The vaccine should be given only after the condition has been brought under control;
• Your child has bleeding problems or bruises easily;
• Your child has a history of febrile seizures or there is a family history of such events;
• Your child has problems with the immune system (including HIV infection). PolioInfanrix may still be given to your child. However, protection against infection may not be optimal.

Fainting (especially in adolescents) may occur during or even before any needle injection. Therefore, inform the doctor or nurse if your child has previously fainted after an injection.
If any of the above conditions apply to your child (or if you are unsure), discuss this with your doctor or pharmacist before PolioInfanrix is administered.

Other medicines and PolioInfanrix
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if your child is taking any of the following:

• Medicines or other treatments (such as radiotherapy) that affect the immune system. Your child may still receive PolioInfanrix. However, the vaccine may not work as effectively. If possible, vaccination should be scheduled at the end of the treatment period.
• Other vaccines. PolioInfanrix can be administered at the same time as other vaccines. A different injection site must be used for each vaccine.

Pregnancy and breastfeeding
It is unlikely that PolioInfanrix will be administered to pregnant or breastfeeding women. This is because it is intended for use only in children aged between 16 months and 13 years.
Administration of this vaccine is not recommended during pregnancy or while breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is unlikely that PolioInfanrix will be administered to people who drive or operate tools or machinery. This is because it is intended for use only in children aged between 16 months and 13 years.
Your child may feel sleepy after receiving this vaccination. If this occurs, your child should not drive, ride a bicycle, or operate any tools or machinery.

PolioInfanrix contains neomycin, polymyxin (antibiotics), para-aminobenzoic acid, phenylalanine, sodium, potassium, and formaldehyde
PolioInfanrix must not be given to your child if he or she is allergic to any of these components.
Inform your doctor if your child has ever had an allergic reaction to any of these components.
PolioInfanrix contains para-aminobenzoic acid, which may cause allergic reactions (including delayed reactions) and, rarely, bronchospasm.
The vaccine contains 0.036 micrograms of phenylalanine per dose. Phenylalanine may be harmful if your child has phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot properly eliminate it.
The vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".
The vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e., essentially "potassium-free".

3. HOW TO TAKE POLIOINFANRIX

When the vaccine is administered

• Your doctor or nurse will inform you when your child should receive this vaccination. This will be in accordance with official recommendations.

How to take PolioInfanrix

• Your child will receive a single injection of PolioInfanrix.
• The PolioInfanrix injection is always given into the muscle.
• It is usually administered into the muscles of the shoulder. However, in younger children, it may be given in the thigh.
• The vaccine must never be administered intravenously.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. The following adverse reactions may occur with this vaccine:
Allergic reactions
If the child has an allergic reaction, immediate medical attention is required. Reactions may include:

• skin rashes, which may be itchy or accompanied by blisters,
• swelling of the eyes and face,
• difficulty breathing or swallowing,
• sudden drop in blood pressure,
• loss of consciousness.

These reactions usually begin immediately after administration. If they occur after leaving the doctor's office, take the child to a doctor immediately. Allergic reactions are very rare (less than 1 case per 10,000 doses of vaccine).
If your child experiences any of the following serious adverse reactions, consult a doctor immediately:

• collapse
• loss of consciousness
• loss of awareness
• seizures If you notice any of these adverse reactions, consult a doctor immediately. These adverse reactions have also been reported with other pertussis vaccines. They usually occur within 2 to 3 days after vaccination.

Other adverse reactions include:
Very common (may occur in more than 1 case out of every 10 doses of vaccine): drowsiness, headache, loss of appetite, elevated temperature of 38°C or higher, pain, redness and swelling at the injection site, unusual crying, irritability, restlessness.
Common (may occur in up to 1 case out of every 10 doses of vaccine): diarrhoea, nausea, vomiting (feeling or being unwell), elevated temperature of 39.5°C or higher, general feeling of malaise, hard lump at the injection site, feeling weak.
Uncommon (may occur in up to 1 case out of every 100 doses of vaccine): skin allergy or rash.
Rare (may occur in up to 1 case out of every 1,000 doses of vaccine): swelling of the glands in the neck, armpits and groin (lymphadenopathy), cough or lung infection (bronchitis), itching, nodular skin rash (urticaria).
Very rare (may occur in up to 1 case out of every 10,000 doses of vaccine): tendency to bleed or bruise more easily than normal (thrombocytopenia), temporary suspension of breathing (apnea), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioneurotic oedema), blisters at the injection site.
Booster doses of PolioInfanrix vaccine may increase the risk of injection site reactions, some of which may affect the entire arm or leg where the injection was given. These reactions usually begin within 48 hours after vaccination and resolve within 4 days.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE POLIOINFANRIX

• Keep this medicine out of the sight and reach of children.
• Store in the refrigerator (2 °C - 8 °C).
• Keep in the original packaging to protect the medicine from light.
• Do not freeze. Freezing damages the vaccine.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used by your child. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What PolioInfanrix contains

• The active substances are:
  Diphtheria toxoid not less than 30 IU
  Tetanus toxoid not less than 40 IU
  Bordetella pertussis antigens:
  Pertussis toxoid 25 micrograms
  Filamentous haemagglutinin 25 micrograms
  Pertactin 8 micrograms
  Inactivated poliovirus:
  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
  Adsorbed on aluminium hydroxide hydrate 0.5 milligrams Al
  Propagated on VERO cells

Aluminium hydroxide is included in the vaccine as an adjuvant. Adjuvants are substances included in some vaccines to accelerate, enhance, and/or prolong the protective effects of the vaccine.

• The excipients are: sodium chloride, Medium 199 (containing amino acids (including phenylalanine), mineral salts (including sodium and potassium), vitamins (including para-aminobenzoic acid) and other substances), water for injections.

Description of the appearance of PolioInfanrix and pack contents

• PolioInfanrix is an injectable suspension in a pre-filled syringe (0.5 ml).
• The suspension is white and slightly opalescent.
• PolioInfanrix is available in single-dose pre-filled syringes, with or without separate needles, in packs of 1 and 10.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura 7 - 37135 Verona - Italy
Manufacturer
GlaxoSmithKline Biologicals S.A., rue de l’Institut 89 – 1330 Rixensart (Belgium)
Primary packaging also carried out at:

• GlaxoSmithKline Biologicals - Nl der SmithKline Beecham Pharma GmbH & Co. KG - Zirkusstrasse 40 - Dresden (Germany)
• GlaxoSmithKline Biologicals S.A. - Parc de la Noire Epine - Rue Fleming, 20 - 1300 Wavre (Belgium)

This medicinal product is authorised in the European Economic Area countries under the following names:
Greece, France, Portugal, Cyprus: InfanrixTetra
Czech Republic, Estonia, Latvia, Lithuania, Norway, Slovakia, Sweden: Infanrix Polio
Finland: Infanrix-Polio
Poland, Spain: Infanrix-IPV
Hungary: Infanrix IPV
Ireland: IPV Infanrix
Italy: PolioInfanrix

Further information
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco)

The following information is intended for healthcare professionals only:

During storage, formation of a white deposit and a clear supernatant may be observed. This
does not indicate deterioration.
The syringe must be shaken well to obtain a homogeneous, white, cloudy suspension.
The suspension should be inspected visually for the presence of foreign particles and/or any change in physical appearance. If either is observed, the vaccine must be discarded.
Instructions for the pre-filled syringe

Hold the syringe by the barrel, not by the plunger.
Luer Lock adapter
Plunger
Barrel
Cap
To attach the needle to the syringe, gently connect the
Hub
needle hub to the Luer Lock adapter and rotate one-quarter turn clockwise until a click is felt, indicating secure attachment.
Do not remove the syringe plunger from the barrel. If this occurs, do not administer the vaccine.
Disposal
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.