Hiberix

Package leaflet: Information for the user

Hiberix powder and solvent for solution for injection for intramuscular use

Conjugate vaccine against Haemophilus influenzae type b (Hib)
Please read this leaflet carefully before your child receives this vaccine 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; therefore, it must not be given to other people.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Hiberix is and what it is used for

Hiberix is a vaccine used to protect infants against diseases caused by the bacterium Haemophilus influenzae type b.
Haemophilus influenzae type b (Hib) can cause inflammation of the brain, leading to serious problems such as: mental retardation, cerebral palsy, deafness, epilepsy, or partial blindness. The bacterium may also cause inflammation of the throat, which can result in death by suffocation. Less frequently, the bacterium can infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth.
Hiberix is indicated for primary vaccination of infants from the age of two months.
Hiberix helps the child's body to develop its own defences (antibodies) against the disease.
Like all vaccines, Hiberix may not fully protect all vaccinated children.
Hiberix provides protective activity only against infections caused by the bacterium Haemophilus influenzae type b, for which it was specifically developed.
Children with a weakened immune system (for example, due to HIV infection) may not be fully protected by Hiberix.
The vaccine cannot cause the disease it is intended to prevent.

2. What you should know before your child receives Hiberix

Hiberix must not be given

• If your child is allergic (hypersensitive) to the active substances or to any of the vaccine components (see Section 6). A list of the active substances and
  other components of Hiberix is provided at the end of this leaflet. Signs of an allergic reaction include:
  skin rash with itching, difficulty breathing, and swelling of the face or tongue.

Warnings and precautions

Talk to your doctor or pharmacist before your child receives Hiberix if:

• Your child has a severe illness with high fever. In such cases, vaccination should be postponed until recovery. A minor infection, such as a cold, is not a concern, but you should still consult your doctor.
• If your child has breathing difficulties, inform your doctor immediately. This condition may be more frequent during the first three months after vaccination if your child was born prematurely (before 28 weeks of gestation).

Fainting may occur following or even before any injection with a needle. Therefore, inform the doctor or nurse if your child has previously fainted after an injection.

As with all injectable vaccines, appropriate medical treatment and supervision must be readily available in case of an allergic reaction following administration of the vaccine.

Hiberix contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

Other medicines or vaccines and Hiberix

• Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those not requiring a prescription, or if your child has recently received another vaccination.
• Inform your doctor or pharmacist if your child has an infection or is taking any medicines that affect the immune system (the body's natural defence system), as they may not be fully protected by Hiberix.
• Hiberix can be given at the same time as, before, or after other vaccines. Hiberix must not be mixed with other vaccines in the same syringe. When administered simultaneously, each vaccine should be injected at different sites.

3. How Hiberix is administered

• The doctor or nurse will administer the recommended doses to the child according to official recommendations.

When vaccination is started during the first 6 months of life, the primary schedule consists of 3 doses and may begin at the age of 2/3 months. The efficacy of the vaccine has been demonstrated with both the 0, 1, 2 schedule (doses administered at 1-month intervals at approximately 3, 4 and 5 months of age) and the 0, 2, 4 schedule (doses administered at 2-month intervals at approximately 2, 4 and 6 months of age).
A booster dose is recommended within the second year of life to ensure long-term protection.
In children aged between 6 and 12 months who have not been previously vaccinated, administration of 2 doses one month apart is recommended. A booster dose is recommended during the second year of life.
In children aged between 13 and 48 months who have not been previously vaccinated, administration of a single dose of vaccine is recommended.
Routine vaccination of children older than 4 years of age and adolescents is not recommended.
Immunization of children with a Haemophilus influenzae type b conjugate vaccine is optimal when vaccination begins at around two months of age, as invasive Haemophilus influenzae infections are more frequent and potentially very severe in children under 3 years of age.

• The reconstituted vaccine should be administered by intramuscular injection.
• The vaccine must never be administered intravenously.
• You will be informed when your child should receive the next dose.

If your child misses a dose of Hiberix

• If your child does not receive a scheduled dose, it is important that you arrange another appointment.
• If the three-dose vaccination series is not completed, your child may not achieve the best immune response or adequate protection against the disease.

4. Possible side effects

Like all medicines, Hiberix can cause side effects, although not everybody gets them.
The adverse reactions observed during clinical studies are as follows:
Allergic reactions
As with all injectable vaccines, the child may experience an allergic reaction, although rarely (less than 1 case in 10,000 vaccine doses).
Signs of an allergic reaction include:

• Skin rashes which 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 occur immediately after the injection. Seek medical attention immediately if they occur after leaving the doctor's office.

Seek immediate medical attention if the child experiences any of the following serious adverse reactions
Very common (may occur in more than 1 case in 10 doses of vaccine):

• Irritability
• Drowsiness
• Fever
• Swelling, pain and redness at the injection site
• Loss of appetite
• Crying
• Restlessness
• Diarrhea

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

• Vomiting

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

• Seizures (including febrile seizures)

In addition, other effects not observed during clinical studies but reported after marketing of Hiberix include:
Very rare (occurring less frequently than 1 case in 10,000 doses of vaccine):

• Fainting due to the injection
• Collapse (sudden onset of muscle floppiness), periods of unconsciousness or unresponsiveness, pallor or bluish skin colour
• Apnoea in very premature infants (born at 28 weeks of gestation or earlier)
• Urticaria, skin rash affecting one or more areas or the entire body
• Swelling of the extremities of the limb where the vaccine was administered
• Transient nodule at the injection site

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hiberix

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

6. Package Contents and Other Information

What Hiberix Contains
After reconstitution, 1 dose (0.5 ml) contains:
Haemophilus influenzae type b PRP polysaccharide 10 micrograms
conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
Hiberix is a white powder.
The diluent is a clear, colourless liquid.
Excipient:
lactose
A pre-filled syringe of solvent contains: sodium chloride, water for injections

Description of the Appearance of Hiberix and Contents of the Pack
Powder and solvent for injectable solution.
1 vial containing 1 dose of lyophilized vaccine + 1 pre-filled syringe of solvent (0.5 ml) with 1 separate needle.
1 vial containing 1 dose of lyophilized vaccine + 1 pre-filled syringe of solvent (0.5 ml) without needle.

Name and Address of the Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura 7 - 37135 Verona - Italy

Manufacturer
GlaxoSmithKline Biologicals s.a. – Rue de l'Institut 89 - Rixensart (Belgium)

The following information is intended exclusively for healthcare professionals:

INSTRUCTIONS FOR USE
As with all injectable vaccines, appropriate medical supervision and treatment must be immediately available in case of a rare anaphylactic reaction following vaccine administration.
The solvent and the reconstituted vaccine should be visually inspected prior to reconstitution or administration for the presence of foreign particles and/or physical changes. If such changes are observed, do not use the solvent or the reconstituted vaccine.
Hiberix must be reconstituted by adding the entire contents of the pre-filled syringe of solvent provided to the vial containing the powder.
To insert the needle into the syringe, carefully read the instructions provided with images 1 and 2. However, the syringe supplied with Hiberix may be slightly different (without threading) from the one illustrated in the drawing. In this case, the needle must be inserted without screwing.
Needle

Syringe

Figure 1 Figure 2
Always hold the syringe by the barrel, not by the plunger or the Luer Lock adapter (LLA), and keep the needle aligned with the syringe (as shown in Figure 2). Otherwise, the LLA may deform and cause leakage.
During syringe assembly, if the LLA becomes detached, a new dose of vaccine (new syringe and vial) must be used.

1. Unscrew the syringe cap by turning it counterclockwise (as shown in Figure 1).

Whether or not the LLA rotates, follow the steps below:

2. Attach the needle to the syringe by gently connecting the needle hub to the LLA and rotate one-quarter turn clockwise until it locks into place (as shown in Figure 2).
3. Remove the needle protective cover, which may require some effort.
4. Add the solvent to the powder. The mixture should be shaken well until the powder is completely dissolved in the solvent. The reconstituted vaccine is a clear, colorless solution.

After reconstitution, the vaccine should be administered immediately.

5. Withdraw the entire contents of the vial.
6. A new needle must be used to administer the vaccine. Unscrew the needle from the syringe and attach the injection needle by repeating step 2 above.

Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.