Act-hib

Package Leaflet: Information for the User

Act-HIB

10 micrograms/0.5 ml, powder and solvent for solution for injection
Vaccine against Haemophilus type b, conjugated

Read the package leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed specifically for this person. Do not pass it on to others.
• If the patient experiences any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Act-HIB and what is it used for
• 2. Important information before using Act-HIB vaccine
• 3. How to use Act-HIB vaccine
• 4. Possible side effects
• 5. How to store Act-HIB vaccine
• 6. Contents of the pack and other information

1. What is Act-HIB and what is it used for

Act-HIB (Hib) is a vaccine. Vaccines are used to protect against infectious diseases.
After injection of the Act-HIB vaccine (against invasive infections caused by Haemophilus
influenzaetype b), the body's natural defense system produces its own protection against these diseases.
This vaccine is indicated for the prevention of invasive diseases caused by Haemophilus
influenzaetype b (meningitis, septicemia, cellulitis, arthritis, epiglottitis, and others) in children from 2 months of age.
The vaccine does not provide protection against infections caused by other types of Haemophilus influenzae
or against meningitis caused by other microorganisms. In no case can the diphtheria toxoid contained in this vaccine replace routine diphtheria vaccination.

2. Important information before using Act-HIB vaccine

When not to use Act-HIB vaccine:

• if the child is allergic (hypersensitive) to any of the vaccine components (listed in section 6), to diphtheria toxoid, formaldehyde, or if the child has had an allergic reaction after administration of a vaccine containing such substances,
• if the child has had an allergic reaction after previous administration of a conjugated Haemophilus influenzaetype b vaccine,
• if the child has a fever or sudden illness (acute illness), vaccination should be postponed.

Warnings and precautions

Before using the Act-HIB vaccine, discuss it with your doctor.

When to exercise special caution when using Act-HIB vaccine:

• in the case of a child with immune deficiencies or during treatment with corticosteroids, cytotoxic drugs, radiotherapy, or other drugs that may lower immunity, the immune response after vaccination may be weakened. The doctor may decide to postpone vaccination until the end of treatment,
• if the child has blood disorders such as low platelet count (thrombocytopenia) or bleeding disorders, as there is a risk of bleeding during intramuscular administration.
• if the child has an allergic reaction to latex. The tips of the ampoule-syringes contain a derivative of natural latex, which can cause an allergic reaction.

Fainting can occur after, or even before, any needle injection. Therefore, inform your doctor or nurse if the patient has experienced fainting during previous injections.

Act-HIB vaccine and other medicines

In the event of concurrent administration of this vaccine with measles, mumps, and rubella vaccine, as well as with vaccines against diphtheria, tetanus, pertussis, poliomyelitis, and hepatitis B virus, two injections will be given at two separate sites, such as the other arm or leg.
Tell your doctor or pharmacist about all medicines the child is taking or has recently taken, including those planned for use.

Pregnancy and breastfeeding

Not applicable.
Before using any medicine, consult your doctor.

Act-HIB vaccine contains sodium

Act-HIB vaccine contains less than 1 mmol (23 mg) of sodium per dose, which means the vaccine is considered "sodium-free".

3. How to use Act-HIB vaccine

Dosage

Up to 6 months of age:
3 consecutive doses of 0.5 ml administered at intervals of 1 or 2 months and a booster dose (0.5 ml) 1 year after the third dose.
Between 6 and 12 months of age:
2 doses of 0.5 ml administered at an interval of 1 month and a booster dose (0.5 ml) at 18 months of age.
From 1 to 5 years of age:
1 dose of vaccine of 0.5 ml.
In the event of contact with a person suffering from an invasive disease caused by Haemophilus influenzaetype b (e.g., sibling or other children who have had contact with the patient), the vaccine should be administered according to the age schedule of the child who had contact with the patient.
The patient (index case: the first identified case of invasive disease caused by Haemophilusinfluenzaetype b) must also be vaccinated.

Method of administration

This vaccine will be administered to the child by a healthcare professional in the muscle (im.) or deep subcutaneously (sc.), in the thigh or arm.
Never administer this vaccine intravascularly.

Missed dose of Act-HIB vaccine:

In the event of a missed dose of vaccine, the doctor will decide when to administer it.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Act-HIB vaccine can cause side effects, although not everybody gets them.
Very common side effects (reported by more than 1 in 10 people):

• reactions at the injection site such as pain, redness, swelling, and/or inflammation, induration
• irritability

Common side effects (reported by less than 1 in 10 people but more than 1 in 100 people):

• crying (unconsolable or unusual)
• fever
• vomiting

Uncommon side effects (reported by less than 1 in 100 people but more than 1 in 1000 people):

• fever (above 39°C)

Side effects with unknown frequency (as they are reported voluntarily and very rarely):

• extensive swelling (large swelling) of the limb into which the vaccine was administered, which may extend to the entire arm or leg into which the vaccine was administered
• large reactions at the injection site, larger than 5 centimeters, such as pain, redness (erythema), swelling (edema), and/or inflammation or induration of the skin
• swelling of the legs and feet (edematous reactions affecting the lower limbs). These reactions may be accompanied by crying, blue discoloration of the skin (cyanosis), or redness and small transient red spots (petechiae) occurring within a few hours after vaccination and resolving quickly without treatment (within 24 hours) and without sequelae
• swelling of the face and/or neck, allergic reactions (hypersensitivity reactions)
• seizures with or without fever
• skin rashes, sometimes swollen and itchy (hives, rash, generalized rash, itching)

In premature infants (born at 28 weeks of gestation or earlier), within 2-3 days after vaccination, longer pauses between breaths may occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the vaccine.

5. How to store Act-HIB vaccine

Store the vaccine out of sight and reach of children.
Do not use Act-HIB vaccine after the expiry date stated on the carton after: Expiry Date (EXP). The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Act-HIB contains

• The active substance of the vaccine in one dose (0.5 ml) is: Haemophilus influenzae type b polysaccharide 10 micrograms conjugated with diphtheria toxoid 18-30 micrograms
• Other ingredients: Powder: trometamol, sucrose, and hydrochloric acid (to adjust pH) Solvent: sodium chloride and water for injections

What Act-HIB looks like and contents of the pack

The vaccine is available as a powder in a vial and solvent for solution for injection in a pre-filled syringe (0.5 ml in a pre-filled syringe with or without a needle). Pack of 1.
The powder is white. The solvent is clear and colorless.

Marketing authorization holder

Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly, France

Manufacturer

Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
69280 Marcy l’Etoile
France
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France
Date of last revision of the leaflet:December 2024

Information intended for healthcare professionals only:

Method of administration

Reconstitute the solution by injecting the contents of the syringe with solvent into the vial with powder or by injecting the contents of the syringe containing the combined vaccine against diphtheria, tetanus, and pertussis or against diphtheria, tetanus, pertussis, and poliomyelitis.
Shake until the powder is completely dissolved.
The white, cloudy appearance of the suspension after reconstitution with the vaccine against diphtheria, tetanus, and pertussis or against diphtheria, tetanus, pertussis, and poliomyelitis contained in the syringe is normal.
Regarding syringes without attached needles, a separate needle must be securely attached to the syringe by twisting it a quarter turn.
Do not administer intravascularly.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Administer intramuscularly (im.) or deep subcutaneously (sc.): it is recommended to administer in the middle of the anterolateral surface of the thigh in infants and young children, and in the area of the deltoid muscle in older children.

Effect on laboratory tests

After vaccination, the Hib polysaccharide is excreted in the urine, so within 1-2 weeks, positive urine test results for Hib infection may be observed.
During this time, other tests should be performed to confirm Hib infection.