Prospect: information for the user

Hiberix powder and solvent for injectable solution

Conjugated Haemophilus influenzae type b vaccine

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

- Keep this prospect, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This vaccine has been prescribed only for your child and 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.

Hiberix is a vaccine used to protect your child from the disease caused byHaemophilus influenzaetype b.

Haemophilus influenzaetype b (Hib) can cause brain inflammation. This can lead to serious problems such as: mental retardation, cerebral palsy, deafness, epilepsy, or partial blindness. It can also cause throat inflammation that can lead to death by asphyxiation. Less frequently, the bacteria can also infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth.

Hiberix is indicated in the primary vaccination of children from 2 months of age and included in some of the following groups:

• Children with splenectomy, sickle cell anemia, or immunodeficiency.
• Children infected with asymptomatic or symptomatic HIV.
• In situations determined by the corresponding Health Authorities.

Hiberix helps your child's body to create its own protection (antibodies). This will protect them from the disease.

Like all vaccines, Hiberix may not protect all vaccinated children completely.

Hiberix only protects against infections caused byHaemophilus influenzaetype b, for which the vaccine was developed.

Children with a weakened immune system (due to HIV infection, for example)may not be completely protectedby Hiberix.

The vaccine cannot cause the disease it protects your child from.

Hiberix should not be administered

• If your child is allergic (hypersensitive) to the active principles or to any of the other components of the vaccine (listed in section 6). At the end of the prospectus, there is a list of the active principles and the other components of Hiberix. Signs of an allergic reaction may include skin rash with itching, difficulty breathing, and facial or tongue inflammation.

Warnings and precautions

Consult your doctor or pharmacist before your child receives Hiberix if:

• Your child has a severe infection with high fever. In these cases, vaccination will be postponed until they recover. A minor infection, such as a cold, should not be a problem, but consult your doctor first.
• Your child has difficulty breathing, inform your doctor. This may be more frequent during the first three days after vaccination, if your child is premature (born at 28 weeks of gestation or earlier).

Before or after any injection, a fainting spell may occur, so inform your doctor or nurse if your child has fainted on previous occasions after receiving an injection.

Use of Hiberix with other medications

• Inform your doctor or pharmacist that your child is using, has used recently, or may need to use any other medication, including those purchased without a prescription or if they have recently received another vaccine.
• Inform your doctor or pharmacist especially if your child is using any medication or has an infection that affects the immune system (the body's natural defense system), as your child may not be completely protected with Hiberix.
• Hiberix can be administered at the same time as other infant vaccines. Different injection sites will be used for each vaccine.

Hiberixshould not be mixed in the same syringe with other vaccines except for Tritanrix HepB.

Hiberix contains sodium

This medication contains less than 23 mg (1mmol) of sodium per 0.5 ml; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Your doctor or nurse will administer the recommended dose for your child. This will depend on official recommendations.
• Normally, the primary vaccination schedule consists of administering 3 doses of Hiberix separated by an interval of 1-2 months in the first 6-7 months of life, and it may start from 2 months of age.
• An additional dose (booster) may be necessary in the second year of life, for example in children who have not completed the primary vaccination. If necessary, your doctor or nurse will inform you.
• Hiberix is administered in the muscle.
• The vaccine should never be administered in a vein.
• You will be informed of when your child should receive the next dose.

If more Hiberix is administered than it should be

No cases of overdose have been reported. Since the package contains only one dose, an overdose is unlikely.

If your child does not receive a dose of Hiberix

• If your child misses a scheduled dose, it is essential to schedule another appointment. If the administration of a dose does not occur according to the planned schedule, it can be delayed, as long as the 3 doses are administered within the first year of life, maintaining an interval of 1-2 months between doses.
• If the complete cycle of vaccination with the three injections is not completed, your child may not obtain the best immunological response or protection against the disease.

Like all medicines, Hiberix can cause side effects, although not everyone will experience them.

The side effects that occurred during clinical trials were as follows:

Allergic reactions

As with all injectable vaccines, your child may experience an allergic reaction, although these are very rare (less than 1 in 10,000 vaccine doses).

The signs of an allergic reaction may be:

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

These symptoms usually appear immediately after the injection. Take your child to the doctor immediately if they start while leaving the clinic.

Seek medical attention immediately if your child has any of the following severe side effects

Very common(may occur in more than 1 in 10 vaccine doses):

• irritability
• drowsiness
• fever
• swelling, pain, and redness at the injection site
• loss of appetite
• crying
• restlessness
• diarrhea

Common(may occur in up to 1 in 10 vaccine doses):

• vomiting

Rare(may occur in up to 1 in 1,000 vaccine doses):

• seizures (including seizures due to fever)

In addition, other side effects not observed during clinical trials, but reported after the commercialization of Hiberix, are:

Very rare(may occur in less than 1 in 10,000 vaccine doses):

• syncope due to injection
• collapse (sudden loss of muscle tone), periods of unconsciousness or loss of consciousness, and pallor or blue discoloration of the skin
• temporary interruption of breathing
• urticaria, localized skin rash in one or several areas, or throughout the body
• swellingof the limb where the vaccine was injected
• hard lump at the injection site

Reporting of side effects

If you experience 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 the 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 the refrigerator (between 2°C and 8°C).
• Do not freeze.
• Store in the original packaging to protect it from light.
• Do not use Hiberix 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 packaging and unused medicines at the SIGRE collection point at 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 Hiberix

• The active principles are:

Polysaccharide from Haemophilus influenzae type b 10 micrograms

conjugated with tetanus toxoid as a carrier protein approximately 25 micrograms

• The other components are:

Dry powder: lactose

Vehicle: sodium chloride and water for injection

Appearance of the product and contents of the package

Hiberix is presented as a powder in a glass vial and a pre-filled syringe.

The powder is white and the vehicle is transparent and colorless.

Marketing Authorization Holder

GlaxoSmithKline, S.A.

PTM - C/ Severo Ochoa, 2

28760 Tres Cantos

Madrid

Phone: 900 202 700

e-mail: [email protected]

Responsible for manufacturing

GlaxoSmithKline Biologicals S.A.

Rue de L’Institut 89; 1330 Rixensart

Belgium

or

SMITHKLINE BEECHAM, S.A.

Ctra. de Ajalvir Km. 2,5. (Alcalá de Henares (Madrid)) – 28806

Spain

Last review date of this leaflet: 12/2019

The detailed and updated information on this medicine 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:

Before reconstitution or administration, visually inspect the vehicle and the reconstituted vaccine for any foreign particles and/or physical appearance variations. If any are observed, do not use the vehicle or the reconstituted vaccine.

Instructions for reconstituting the vaccine with the pre-filled syringe vehicle

Hiberix must be reconstituted by adding the entire contents of the pre-filled syringe to the vial containing the powder.

To learn how to insert the needle into the pre-filled syringe, read the instructions provided with images 1 and 2. However, the pre-filled syringe provided with Hiberix may be slightly different (without a screw thread) from the syringe in the image. In this case, the needle must be inserted without screwing.

Always hold the pre-filled syringe by the barrel, not by the plunger or the Luer Lock adapter (LLA), and keep the needle in line with the syringe (as shown in image 2). Otherwise, the LLA may become deformed and cause leaks.

If the LLA becomes detached during syringe assembly, use a new dose of the vaccine (new syringe and vial).

1. Remove the syringe cap by turning it counterclockwise (as shown in image 1).

Please follow the next steps regardless of whether the LLA turns or not :

1. Insert the needle into the syringe by gently engaging the needle cone with the LLA and turning it clockwise until it locks (as shown in image 2).

1. Remove the needle cap (it may be difficult).

1. Add the vehicle to the powder. The mixture must be shaken well until the powder is completely dissolved.

The reconstituted vaccine is a transparent to opalescent and colorless solution.

After reconstitution, the vaccine must be administered promptly. If it is not used within 8 hours after reconstitution, it must be discarded.

1. A new needle must be used to administer the vaccine. Remove the needle from the syringe and insert the injection needle, repeating step 2.

Hiberix can be mixed in the same syringe with the monodose vaccine Tritanrix HepB. Check that the vaccine to be mixed with Hiberix is presented in a monodose package. From the Hiberix packaging, discard the container containing the vehicle. In this case, the vehicle included in the Hiberix packaging will be replaced by the liquid vaccine from Tritanrix HepB. The combined vaccine must be reconstituted by adding the entire contents of the Tritanrix HepB container to the vial containing the white powder of Hib. This extemporaneously combined vaccine should be handled in the same way as the monocomponent reconstituted Hiberix vaccine.