Infanrix hexa polvo y suspension para suspension inyectable

Prospect: information for the user

Infanrix hexa,Powder and injectable suspension in pre-filled syringe

Diphtheria toxoid (D), tetanus toxoid (T), pertussis component (acellular) (Pa), hepatitis B (recombinant DNA) (VHB), inactivated poliovirus (VPI), andHaemophilus influenzaetype b (Hib) conjugate (adsorbed).

Read this prospect carefully before your child receives this vaccine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This vaccine has been prescribed only for your child, and it should not be given to other people.
• If your child experiences adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Infanrix hexais a vaccine used to protect your child from six diseases:

• Diphtheria: a serious bacterial disease that mainly affects the respiratory tract and, sometimes, the skin, causing severe respiratory problems and, sometimes, suffocation. The bacteria also release a toxin that can cause nerve damage, heart problems, and even death.

• Tetanus: the tetanus bacteria, usually found in soil, dust, horse manure, and wooden splinters, enters the body through cuts, scratches, or skin wounds and releases a toxin. This can cause muscle stiffness, painful muscle spasms, convulsions, and even death.

• Pertussis (Whooping Cough): a highly contagious bacterial infection that affects the respiratory tract, causing a prolonged cough that often has a characteristic sound known as “whoop”. It can also cause ear infections, bronchitis, pneumonia, convulsions, brain damage, or even death.

• Hepatitis B: caused by the hepatitis B virus, which attacks the liver.The virus can cause a lifelong infection and may lead to cirrhosis and liver cancer.

• Polio:an infection caused by a virusthat, sometimes, causes nerve damage and permanent damage, making muscles unable to move (paralysis), including muscles necessary for breathing and walking. It can cause permanent damage or even death.

• Haemophilus influenzaetype b (Hib): a bacterial infection. It can cause meningitis (inflammation of the brain), which can cause mental retardation (delay), cerebral palsy, hearing loss, epilepsy, or partial blindness. It can also cause throat swelling, leading to suffocation death. It can also infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth.

How Infanrix hexa works

• Infanrix hexa helps the body develop its own protection (antibodies). This will protect your child from these diseases.
• Like all vaccines, Infanrix hexa may not protect all vaccinated children completely.
• The vaccine cannot produce the diseases it protects your child from.

Do not administer Infanrix hexa

• if your child is allergic to:

• Infanrix hexa or any of the other components of this vaccine (listed in section 6).
• Formaldehyde.
• Neomycin or polymyxin (antibiotics).

The signs of an allergic reaction may include itching of the skin, rash, decreased breathing, and swelling of the face or tongue.

• if your child has had an allergic reaction to any vaccine against diseases: diphtheria, tetanus, pertussis, hepatitis B, polio orHaemophilus influenzaetype b.

• if your child has had neurological problems in the 7 days following the previous administration of a vaccine against pertussis.
• if your child has a severe infection with fever (above 38 °C). A minor infection, such as a cold, should not be a problem for vaccination, but tell your doctor first.

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

Warnings and precautions

Consult your doctor or pharmacist before your child receives Infanrix hexa:

• if after a previous administration of Infanrix hexa 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

- persistent crying for 3 hours or more in the 48 hours following vaccination

- seizures with or without fever in the 3 days following vaccination

• ifyour child has an undiagnosed or progressive cerebral disease or uncontrolled epilepsy. The vaccine can be administered once the disease is controlled
• if your child has any bleeding disorder or bruises easily

• if your child tends to have seizures when they have a fever, or if there are family antecedents.
• if your child stops responding or has seizures (attacks) after vaccination, contact your doctor immediately. See section 4 Possible adverse effects.
• if your baby was born very prematurely (at 28 weeks of gestation or earlier) they may experience longer pauses in breathing than normal during the 2-3 days after vaccination. These babies may require respiratory monitoring during the 48-72 hours following administration of the two or three first doses of Infanrix hexa.

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

Use of Infanrix hexa with other medicines

Your doctor may ask you to administer a medicine that reduces fever (such as paracetamol) before or immediately after administration of Infanrix hexa. This may help reduce some of the adverse effects (febrile reactions) of Infanrix hexa.

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

Infanrix hexa contains neomycin, polymyxin, para-aminobenzoic acid, phenylalanine, sodium and potassium

This vaccine contains neomycin and polymyxin (antibiotics). Inform your doctor if your child has had an allergic reaction to these components.

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

This vaccine contains 0.0298 micrograms of phenylalanine in each dose. Phenylalanine may be harmful in cases of phenylketonuria (PKU), a rare genetic disease 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; this is essentially "sodium-free".

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

How Much is Administered

• Your child will receive a total of two or three injections with an interval of at least 2 or 1 month between each injection.
• The doctor or nurse will tell you when your child should return for the next injections.
• The doctor will inform you if additional injections (booster doses) are needed.

How the Vaccine is Administered

• Infanrix hexa is injected into a muscle.
• The vaccine should never be injected into a blood vessel or into the skin.

What to Do if Your Child Misses a Dose

• If your child misses a scheduled injection, it is essential that you schedule another appointment.
• Make sure your child completes the full vaccination series. Otherwise, your child may not be fully protected against diseases.

Like all medicines, this vaccine may cause side effects, although not everyone will experience them.

The following side effects may occur with this vaccine:

Allergic reactions

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

• eruptions that may cause itching or blisters
• swelling of the eyes and face
• difficulty breathing or swallowing
• sudden drop in blood pressure and loss of consciousness.

These signs usually start shortly after receiving the injection. Speak with a doctor immediately if this occurs when leaving the consultation.

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

• collapse
• occasionally, when they lose consciousness
• seizures (with or without fever).

These side effects have occurred very rarely with both Infanrix hexa and other pertussis vaccines. They usually occur within 2 or 3 days after vaccination.

Other side effects include:

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

Common(may occur in up to 1 in 10 doses of the vaccine): diarrhea, vomiting, temperature of more than 39.5°C, inflammation greater than 5 cm or hardening at the injection site, feeling of nervousness.

Uncommon(may occur in up to 1 in 100 doses of the vaccine): upper respiratory tract infection, fatigue, cough, extensive inflammation in the limb where the injection was administered.

Rare(may occur in up to 1 in 1,000 doses of the vaccine): bronchitis, rash, swelling of the neck, armpit, and groin lymph nodes (lymphadenopathy), bleeding or bruising more easily than normal (thrombocytopenia), in premature children (born at 28 weeks of gestation or earlier) the periods between breaths may be longer than normal during the 2-3 days following vaccination, temporary cessation of breathing (apnea), inflammation of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema), inflammation in the entire limb where the injection was administered, blisters.

Very rare(may occur in up to 1 in 10,000 doses of the vaccine): itching (dermatitis).

Experience with the hepatitis B vaccine

In extremely rare cases, the following side effects have been reported with the hepatitis B vaccine: paralysis, numbness or weakness of the arms and legs (neuropathy), inflammation of some nerves, possibly with tingling or loss of normal sensation or movement (Guillain-Barré syndrome), inflammation or infection of the brain (encephalopathy, encephalitis), infection around the brain (meningitis).

No causal relationship has been established with the vaccine.

Bleeding or bruising more easily than normal (thrombocytopenia) have been reported with hepatitis B vaccines.

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 national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this vaccine out of sight and reach of children.
• Do not use this vaccine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
• Store in a refrigerator (between 2 °C and 8 °C).
• Store in the original packaging to protect it from light.
• Do not freeze. Freezing destroys the vaccine.
• Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that your child no longer needs. In this way, you will help protect the environment.

Composition of Infanrix hexa

The active ingredients are:

Diphtheria toxoid1not less than 30 International Units

Tetanus toxoid1not less than 40 International Units

Antigens ofBordetella pertussis

Pertussis toxoid125 micrograms

Filamentous haemagglutinin125 micrograms

Pertactin18 micrograms

Surface antigen of the hepatitis B virus2,310 micrograms

Inactivated poliovirus

type 1 (Mahoney strain)440 antigen units D

type 2 (MEF-1 strain)48 antigen units D

type 3 (Saukett strain)432 antigen units D

Polysaccharide ofHaemophilus influenzaetype b10 micrograms

(polyribosylribitol phosphate)3

conjugated with tetanus toxoid as carrier proteinapprox. 25 micrograms

1adsorbed on hydrated aluminium hydroxide (Al(OH)3)0.5 milligrams Al3+

2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology

3adsorbed on aluminium phosphate (AlPO4)0.32 milligrams Al3+

4propagated in VERO cells

The othercomponentsare:

Dried powder of Hib: anhydrous lactose

SuspensionDTPa-VHB-VPI:sodium chloride (NaCl), medium 199 (containing amino acids (including phenylalanine), mineral salts (including sodium and potassium), vitamins (including para-aminobenzoic acid) and other substances) and water for injection.

Appearance of the product and contents of the package

• The diphtheria, tetanus, pertussis acellular, hepatitis B, inactivated poliovirus (DTPa-VHB-VPI) component is a white, slightly milky liquid, presented in a pre-filled syringe (0.5 ml).
• The Hib component is a white lyophilized powder, presented in a glass vial.
• Both components are mixed just before the child receives the injection. The appearance of the mixture is a white, slightly milky liquid.
• Infanrix hexa is available in a vial of 1 dose + pre-filled syringe, sizes of packaging 1 and 10 with and without separate needles, and a multiple pack of 5 packs, containing each 10 vials (1 dose) and 10 pre-filled syringes (1 dose), without separate needles.
• Only some sizes of packaging may be commercially available.

Marketing authorization holder and manufacturer

GlaxoSmithKline Biologicals s.a.

Rue de l´Institut 89

B-1330 Rixensart

Belgium

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu/

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

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This information is intended for healthcare professionals only:

After storage, a clear liquid and a white deposit may be observed in the pre-filled syringe containing the DTPa-VHB-VPI suspension. This is a normal observation.

The vaccine should be shaken well before administration.

The vaccine is reconstituted by adding the entire contents of the pre-filled syringe to the vial containing the lyophilized powder. The mixture should be shaken well until the powder is completely dissolved before administration.

The reconstituted vaccine appears as a slightly more turbid suspension than the single component. This is a normal observation.

The vaccine suspension should be visually inspected before and after reconstitution to observe any foreign particles or variation in physical appearance. If any of these circumstances are observed, do not administer the vaccine.

Instructions for the pre-filled syringe

Disposal of residues

The disposal of unused medicinal product and of any waste materials derived from the use of this product should be in accordance with local requirements.