Infanrix-IPV injectable suspension in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Infanrix-IPV, injectable suspension in pre-filled syringe

Diphtheria, tetanus, pertussis (acellular component) and poliomyelitis (inactivated) vaccine (adsorbed)

Package leaflet contents

1. What Infanrix-IPV is and what it is used for
2. What you need to know before your child receives Infanrix-IPV
3. How Infanrix-IPV is administered
4. Possible side effects
   1. How to store Infanrix-IPV
   2. Contents of the pack and other information

1. What Infanrix-IPV is and what it is used for

Infanrix-IPV is a vaccine used as a booster dose to protect your child against 4 diseases:

• Diphtheria – a serious bacterial infection that mainly affects the respiratory tract and sometimes the skin. The respiratory tract swells, causing severe breathing problems and sometimes suffocation. The bacteria also release a toxin that can damage nerves, cause heart problems, and even lead to death.

• Tetanus – tetanus bacteria enter the body through cuts, scratches, or wounds in the skin. Wounds most likely to become infected with tetanus include burns, fractures, deep wounds, or wounds containing dirt, dust, horse manure, or wood splinters. The bacteria release a toxin that can cause muscle stiffness, painful muscle spasms, seizures, and even death. Muscle spasms can be strong enough to cause spinal fractures.

• Pertussis (whooping cough) – a highly contagious disease affecting the respiratory tract. It causes severe coughing that may interfere with breathing. The cough often produces a characteristic "whooping" sound. The cough may last one to two months or longer. Pertussis can also lead to ear infections, chest infections (bronchitis) that may persist, lung infections (pneumonia), seizures, brain damage, and even death.

• Polio – a viral infection. Polio is often a mild illness, but sometimes it can be very severe and cause permanent damage or even death. Polio can cause muscles to become unable to move (paralysis). This includes muscles needed for breathing and walking. Arms or legs affected by the disease may become twisted (deformed) in a painful way.

Infanrix-IPV is for children from 16 months to 13 years of age (both inclusive). It is not indicated for individuals over 14 years of age.

How Infanrix-IPV works

• Infanrix-IPV helps the body develop its own protection (antibodies). This will protect your child against these diseases.
• The vaccine cannot cause the diseases it protects against.

2. What you need to know before your child receives Infanrix-IPV

Infanrix-IPV must not be given

• If your child is allergic to the active substances or to any of the other ingredients of the vaccine (listed in section 6), or to neomycin or polymyxin (types of antibiotics) or to formaldehyde. Signs of an allergic reaction may include itchy skin rash, difficulty breathing, and swelling of the face or tongue.
• If your child has had any allergic reaction to vaccines against diphtheria, tetanus, pertussis, or polio.
• If your child has experienced neurological problems (encephalopathy) within 7 days following administration of a pertussis-containing vaccine.
• If your child has a serious infection with fever (above 38°C). A mild infection, such as a cold, should not be a problem, but consult your doctor first.

Infanrix-IPV must not be given if any of the above situations apply to your child. If you are unsure, speak with your doctor or pharmacist before your child receives Infanrix-IPV.

Warnings and precautions

Talk to your doctor or pharmacist before your child receives Infanrix-IPV if:

• after a previous dose of Infanrix-IPV or another pertussis-containing vaccine, your child has experienced any problems, especially:

• fever (above 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, within 3 days after vaccination

• your child has an undiagnosed or progressive brain disorder or uncontrolled epilepsy. The vaccine should be administered only once the condition is under control

• your child has a bleeding disorder or bruises easily

• your child has a tendency to have seizures triggered by fever, or has a family history of febrile seizures

• your child has problems with their immune system (including HIV infection). In this case, your child may still be vaccinated with Infanrix-IPV. However, the protection provided against infections may not be as effective.

Fainting (especially in adolescents) may occur before or after any injection. Inform your doctor or nurse if your child has previously fainted after receiving an injection.

If any of the above situations apply to your child (or if you are unsure), speak with your doctor or pharmacist before Infanrix-IPV is administered.

Other medicines and Infanrix-IPV

Tell your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines.

Specifically, 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 be vaccinated with Infanrix-IPV. However, Infanrix-IPV may not work as well. If possible, the vaccine should be given after completion of such treatment.

• Infanrix-IPV may be administered at the same time as other vaccines. Different injection sites will be used for each vaccine.

Pregnancy and breastfeeding

Infanrix-IPV is unlikely to be administered to pregnant or breastfeeding women. This is because the vaccine is indicated only for children aged 16 months to 13 years (inclusive).

Administration of this vaccine during pregnancy or breastfeeding is not recommended.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Infanrix-IPV is unlikely to be administered to individuals who drive or operate tools or machinery. This is because the vaccine is indicated only for children aged 16 months to 13 years (inclusive).

Your child may feel drowsy after vaccination. If this occurs, your child should not drive, ride a bicycle, or operate tools or machinery.

Infanrix-IPV contains neomycin, polymyxin (antibiotics), para-aminobenzoic acid, phenylalanine, sodium, potassium, and formaldehyde. Infanrix-IPV must not be given to your child if they are allergic to any of these components. Please consult your doctor if your child has had an allergic reaction to these components.

Infanrix-IPV contains para-aminobenzoic acid. It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm.

This vaccine contains 0.036 micrograms of phenylalanine per dose. Phenylalanine may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

This vaccine contains potassium, less than 1 mmol (39 mg) per dose; this is essentially “potassium-free”.

3. How Infanrix-IPV is administered

When the vaccine is given

• Your doctor or nurse will inform you when your child should receive this vaccine. This depends on official recommendations.

How Infanrix-IPV is administered

• Your child will receive a single injection of Infanrix-IPV.

• Infanrix-IPV is always injected into a muscle.

• The injection is usually given in the muscle of the shoulder. However, in young children, it may be administered in the thigh.

• The vaccine must never be administered into a vein.

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

4. Possible adverse effects

Like all medicines, this vaccine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this vaccine:

Allergic reactions

If your child has an allergic reaction, seek medical attention immediately. Signs may include:

• skin rash with itching or blistering
• swelling of the eyes and face
• difficulty breathing or swallowing
• sudden drop in blood pressure
• loss of consciousness.

These symptoms usually begin shortly after receiving the injection. Take your child to a doctor immediately if they occur after leaving the clinic. Allergic reactions are very rare (less than 1 in every 10,000 doses of vaccine).

Contact your doctor immediately if your child experiences any of the following serious adverse effects:

• collapse
• loss of consciousness
• seizures

Contact your doctor immediately if any of the situations described above occur. These adverse effects have been reported with other pertussis vaccines. They usually appear within 2 or 3 days after vaccination.

Other adverse effects include:

Very common (may occur in more than 1 in every 10 doses of vaccine): drowsiness, headache, loss of appetite, high temperature of 38°C or higher, pain, redness and swelling at the injection site, abnormal crying, irritability or restlessness.

Common (may occur in up to 1 in every 10 doses of vaccine): diarrhoea, nausea, vomiting, high temperature of 39.5°C or higher, feeling unwell, lumpy rash at the injection site, feeling weak.

Uncommon (may occur in up to 1 in every 100 doses of vaccine): skin allergies or rashes.

Rare (may occur in up to 1 in every 1,000 doses of vaccine): swelling of the lymph nodes in the neck, armpits or groin (lymphadenopathy), cough or chest infection (bronchitis), itching, lumpy rash (urticaria).

Very rare (may occur in up to 1 in every 10,000 doses of vaccine): bleeding or bruising more easily than normal (thrombocytopenia), temporary stoppage of breathing (apnoea), swelling of the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing (angioneurotic oedema), blisters at the injection site.

Booster doses of Infanrix-IPV may increase the risk of injection site reactions. Some of these reactions may affect the entire arm or leg where the injection was given. These reactions usually start within 48 hours of the injection and resolve within 4 days.

Reporting of adverse effects

If your child experiences any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Infanrix-IPV

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (between 2°C and 8°C).
• Keep in the original packaging to protect from light.
• Do not freeze. Freezing will destroy the vaccine.
• Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
• Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Infanrix-IPV

• The active substances are:

Diphtheria toxoid1 not less than 30 IU

Tetanus toxoid1 not less than 40 IU

Bordetella pertussis antigens

Pertussis toxoid1 25 micrograms

Filamentous haemagglutinin1 25 micrograms

Pertactin1 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 aluminium hydroxide 0.5 milligrams Al3+

2 propagated on VERO cells

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

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

Appearance of the product and contents of the pack

• Infanrix-IPV is an injectable suspension in a pre-filled syringe (0.5 ml).
• The suspension is white and slightly milky.
• Infanrix-IPV is available in 1-dose pre-filled syringes with or without separate needles; pack sizes of 1 and 10.
• Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Spain

Tel: +34 900 202 700

[email protected]

Manufacturer

GlaxoSmithKline Biologicals S.A.,

Rue de l'Institut 89

1330 Rixensart, Belgium

This medicinal product is authorized in the European Economic Area member states under the following names:

Greece, France, Portugal, Cyprus: InfanrixTetra

Czech Republic, Estonia, Latvia, Lithuania, Norway, Slovak Republic, Sweden: Infanrix Polio

Finland: Infanrix-Polio

Poland, Spain: Infanrix-IPV

Hungary: Infanrix IPV

Ireland: IPV Infanrix

Italy: PolioInfanrix

Date of the most recent review of this leaflet: April 2023

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

After storage, a white deposit and a clear supernatant may be observed. This does not indicate deterioration.

The syringe must be shaken well to obtain a white, turbid, and homogeneous suspension.

The suspension should be visually inspected for the presence of foreign particles and/or any change in physical appearance. If any such changes are observed, the vaccine should be discarded.

Instructions for the pre-filled syringe

Waste disposal

Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations.