Infanrix-ipv suspension inyectable en jeringa precargada

Prospecto: information for the user

Infanrix-IPV, pre-filled syringe suspension

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

1.What is Infanrix-IPV and how it is used

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

3.How Infanrix-IPV is administered

4.Possible adverse effects

1. Storage of Infanrix-IPV
2. Contents of the package and additional information

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

• Diphtheria- a severe bacterial infection that mainly affects the respiratory tract and, sometimes, the skin. The respiratory tract swells, causing severe respiratory problems and, sometimes, asphyxiation. The bacteria also release a toxin that can cause nerve damage, heart problems, and even death.

• Tetanus- the tetanus bacteria enters the body through cuts, scratches, or skin wounds. Wounds with a higher risk of tetanus infection are burns, fractures, deep wounds, or wounds containing dirt, horse manure, or wooden splinters. The bacteria release a toxin that can cause muscle stiffness, painful muscle spasms, convulsions, and even death. Muscle spasms can be strong enough to cause spinal column bone fractures.

• Pertussis (whooping cough)- a highly contagious disease that affects the respiratory tract. It causes severe coughing that can cause breathing problems. The cough often sounds like a "howl". The cough can last from one to two months or more. Pertussis can also cause ear infections, prolonged chest infections (bronchitis), lung infections (pneumonia), convulsions, brain damage, and even death.

• Polio- a viral infection. Polio is often a mild disease, but it can be very severe and cause permanent damage or even death. Polio can make muscles unable to move (paralysis). This includes muscles needed for breathing and walking. The affected arms or legs can twist (deform) painfully.

Infanrix-IPV is for children from 16 months to 13 years (inclusive). It is not indicated for people over 14 years old.

How Infanrix-IPV works

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

Do not administer Infanrix-IPV

• If your child is allergic to the active substances or any of the other components of the vaccine (listed in section 6) or to neomycin or polymyxin (types of antibiotics) or to formaldehyde. The signs of an allergic reaction may include skin rash with itching, 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 had problems with the nervous system (encephalopathy) within 7 days after administration of a vaccine against pertussis.
• If your child has a severe infection with fever (above 38°C). A mild infection, such as a cold, should not be a problem, but consult your doctor first.

Do not administer Infanrix-IPV if any of the above situations affect your child. If you are unsure, speak with your doctor or pharmacist before your child receives Infanrix-IPV.

Warnings and precautions

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

• after a previous administration of Infanrix-IPV or another vaccine against pertussis, your child has had any problem, especially:

• fever (above 40°C) in the 48 hours following vaccination
• collapse or a state similar to “shock” in the 48 hours following vaccination
• prolonged crying, lasting 3 hours or more, produced in the 48 hours following vaccination
• convulsions, with or without fever in the 3 days following vaccination

• your child suffers from an undiagnosed or progressive cerebral disease or uncontrolled epilepsy. The vaccine should be administered once the disease is controlled
• your child has any bleeding disorder or easily develops petechiae
• your child is prone to febrile convulsions or has a family history of febrile convulsions
• your child has problems with their immune system (including HIV infection). In this case, your child may be vaccinated with Infanrix-IPV. However, the protection obtained against infections may not be as high.

Before or after any injection, dizziness may occur (especially in adolescents), so inform your doctor or nurse if your child has fainted on previous occasions after receiving an injection.

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

Other medicines and Infanrix-IPV

Inform your doctor or pharmacist if your child is using, has used recently, or may need to use any other medicine.

Specifically, inform your doctor or pharmacist if your child is using any of the following:

• medicines or other treatments (such as radiation therapy) that affect their immune system. Your child may be vaccinated with Infanrix-IPV. However, Infanrix-IPV may not work as well. If possible, the vaccine should be administered once the treatment has ended.

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

Pregnancy and breastfeeding

It is unlikely that Infanrix-IPV will be administered to pregnant women or those breastfeeding their children. This is because the vaccine is only indicated 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 operating machinery

It is unlikely that Infanrix-IPV will be administered to individuals who drive or use tools or machinery. This is because the vaccine is only indicated 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 use tools or machinery.

Infanrix-IPV contains neomycin, polymyxin (antibiotics), para-aminobenzoic acid, phenylalanine, sodium, potassium, and formaldehyde.Do not administer Infanrix-IPV 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 cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

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

When the vaccine is administered

• 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 will normally be in the deltoid 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. This vaccine may cause the following side effects:

Allergic reactions

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

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

These signs usually start shortly after receiving the injection. Take your child to the doctor immediately if they appear after leaving the clinic. Allergic reactions are very rare (less than 1 in 10,000 vaccine doses).

Seek immediate medical attention if your child experiences any of the following severe side effects:

• collapse
• loss of consciousness
• seizures

Seek immediate medical attention if you notice any of the situations described above. These side effects have occurred with other pertussis vaccines. They usually appear within 2 or 3 days after vaccination.

Other side effects include:

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

Common(may occur in up to 1 in 10 vaccine doses): diarrhea, nausea, vomiting, temperature of 39.5°C or higher, general feeling of discomfort, nodular rash at the injection site, feeling of weakness.

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

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

Very rare(may occur in up to 1 in 10,000 vaccine doses): bleeding or appearance of petechiae more easily than normal (thrombocytopenia), temporary cessation of breathing (apnea), inflammation of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioneuritic edema), blisters at the injection site.

The booster doses of Infanrix-IPV may increase the risk of reactions at the injection site. Some of them affect the entire arm or leg where the injection was administered. These reactions usually start within 48 hours of the injection and resolve within 4 days.

Reporting of side effects

If your child experiences any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Store in refrigerator (between 2°C and 8°C).
• Store in the original packaging to protect it from light.
• Do not freeze. Freezing destroys the vaccine.
• Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.
• Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Infanrix-IPV

• The active principles are:

Diphtheria toxoid1no less than 30 UI

Tetanus toxoid1no less than 40 UI

Antigens ofBordetella pertussis

Pertussis toxoid125 micrograms

Filamentous haemagglutinin125 micrograms

Pertactin18 micrograms

Poliovirus (inactivated)2

type 1 (strain Mahoney) 40 units of antigen D

type 2 (strain MEF-1) 8 units of antigen D

type 3 (strain Saukett) 32 units of antigen D

1adsorbed on hydrated aluminium hydroxide0.5 milligrams Al3+

2propagated in cellsVERO

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

• The other components are: 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 injection.

Appearance of the product and contents of the pack

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

Marketing authorisation holder and manufacturer responsible

Marketing authorisation holder

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Spain

Tel: +34 900 202 700

es-ci@gsk.com

Manufacturer responsible

GlaxoSmithKline Biologicals S.A.,

Rue de l' Institut 89

1330 Rixensart,Belgium

This medicinal product is authorised in the Member States of the European Economic Area 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 last revision of this leaflet:April 2023

Other sources of information

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

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This information is intended solely for healthcare professionals:

Once stored, a white deposit and a clear supernatant may be observed. This does not constitute a sign of deterioration.

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

The suspension must be visually examined to observe any foreign particles and/or variation in physical appearance. In case of observing any of these circumstances, discard the vaccine.

Instructions for the pre-filled syringe

Disposal of residues

The disposal of unused medicinal product and all materials that have been in contact with it, shall be in accordance with local regulations.