Sanofi AB

Powder and solvent for solution for injection 
(powder: white; diluent: clear and colorless; vaccine after reconstitution: clear and colorless)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Act-HIB is and what it is used for 
2. What you need to know before you use Act-HIB 
3. How to use Act-HIB 
4. Possible side effects 
5. How Act-HIB must be stored 
6. Package contents and other information

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

Act-HIB Haemophilus influenzae type b, the conjugate vaccine is a bacterial vaccine used to prevent infection caused by Haemophilus influenzae type b (such as meningitis, blood poisoning, cellulite, joint inflammation, laryngitis, pneumonia, bone rot from 2 months of age).

The vaccine activates the body’s immune system to provide protection ( antibodies ) against Haemophilus influenzae type b.

2. What you need to know before using Act-HIB

Do not use Act-HIB

If the child to be vaccinated:

  • is allergic (hypersensitive) to any of the ingredients of Act-HIB, especially the tetanus protein and formaldehyde.
  • previously had a severe reaction after vaccination with Act-HIB or any other vaccine containing the same substances.
  • have a high fever or an acute infection, the vaccination should be postponed.

Warnings and precautions

Talk to a doctor before the child is vaccinated.

  • if your child has a latex allergy. The syringe tip cap on the prefilled syringes contains latex. May cause severe allergic reactions.

Act-HIB does not protect against infection caused by other types of Haemophilus influenzae or against meningitis of other origins.

The tetanus protein contained in the Act-HIB can under no circumstances be used to replace the standard vaccination against tetanus ( tetanus ).

Before Act-HIB is given, the recipient’s parent or guardian or the adult recipient must be asked about personal history, family history, and recent health status, including vaccination history, current health status, and any side effects from previous vaccinations. The vaccination procedure must be well considered for patients who have had a severe reaction within 48 hours after a previous injection containing similar ingredients.

A treatment that lowers the immune system or a condition with a reduced immune response can cause a weakened immune response to the vaccine. The recommendation is therefore to wait with the vaccination until after the end of treatment or to ensure that the patient is well protected. Vaccination of patients with chronic immune suppression in HIV – infection, asplenia, or sickle cell disease is still recommended even if the antibody response may be limited.

As with all injectable vaccines, the vaccine must be given with caution to patients with thrombocytopenia or bleeding disorders as bleeding may occur after intramuscular injection in these patients.

Effect on blood tests

Because antigen in the urine has been detected in some cases within 2 weeks of the patient receiving Act-HIB, false-positive reactions are possible in suspected positive Haemophilus influenzae type b disease. Therefore, in such cases, the detection of antigen in the urine may not have a decisive diagnostic value in suspected Haemophilus influenzae type b disease.

Children

The possible risk of respiratory arrest ( apnea ) and the need for respiratory monitoring during the first 48-72 hours after administration of the basic vaccination schedule to very premature infants (born at gestational week ≤28) should be considered and especially for children who have had a respiratory immaturity.

As the benefit of vaccination is great within this group of children, one should not refrain from or postpone vaccination.

Other medicines and Act-HIB

Tell your doctor or pharmacist if the child to be vaccinated is taking, has recently taken, or might take other medicines.

Tell your doctor if your child is taking so-called immunosuppressive drugs as the effect of the vaccination may be worse.

Act-HIB can be injected at the same time as other recommended vaccines against diphtheria, tetanus (tetanus), pertussis (pertussis), and polio, at the same injection site if combined or at two different injection sites if given simultaneously but as two different injections.

Act-HIB can be given concomitantly with the hepatitis B or MPR (measles-mumps-rubella) vaccine at two different injection sites.

Pregnancy and breastfeeding

Pregnancy

Vaccination of adults against Haemophilus influenzae type b is uncommon. Data on the use of this vaccine in pregnant women are limited. Therefore, administration of the vaccine during pregnancy is not recommended. Act-HIB should be given to pregnant women only if there is a clear need and after an assessment of the risks and benefits.

Breast-feeding

Vaccination of adults against Haemophilus influenzae type b is uncommon. It is not known if this vaccine is excreted in human milk. Therefore, caution should be exercised when administering Act-HIB to a nursing mother.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed

Act-HIB contains sodium

Act-HIB contains less than 1 mmol (23 mg) per dose of sodium, ie is essential ‘sodium-free’.

3. How to use Act-HIB

The vaccine is given by a doctor or healthcare professional.

The recommended dose is:

Children 2-3 months:

Basic protection (basic immunization) is achieved by giving 3 doses at intervals of:

  • 1 to 2 months, starting at 2-3 months of age or
  • 2 doses at intervals of 2 months, starting at 3 months of age, and the third dose at 12 months of age.

A fourth dose (booster vaccination) should be given within the second year of life in children who have received a three-dose basic immunization at the age of 2-6 months.

Children between 6 and 12 months of age:

2 doses are given at one-month intervals and a 3rd dose (booster dose) at 18 months of age.

Children between 1 to 5 years of age:

1 dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common adverse reactions that occurred shortly after Act-HIB administration (within 6-24 hours) were local reactions at the injection site, fever, and irritability. They are transient and mild or moderate.

No increase in incidence or severity has been noted for these adverse reactions at subsequent doses in the basic immunization.

Contact a doctor immediately if your child develops any of the following symptoms:

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing.

Other side effects are:

Common (affects 1 to 10 users in 100):

  • crying (uncontrolled or abnormal)
  • vomiting

Less common (affects 1 to 10 users in 1000):

  • fever above 39 ° C

Unknown frequency (as these are voluntarily reported and very rare, the frequency cannot be calculated from the available data):

  • hypersensitivity s
  • cramps with or without fever
  • hives, rash, itching, widespread rash
  • facial swelling, swelling in the throat (hint of a possible hypersensitivity reaction )
  • swelling in legs and feet
  • the strong reaction at the injection site (> 50 mm)
  • swelling in the lower part of the legs: with bluish discoloration of the skin (cyanosis) or small transient red rashes (transient purpura) that appear during the first hours after vaccination and which disappear quickly and spontaneously without any suites. These reactions are not associated with signs of heart-lung problems.

Respiratory arrest ( apnea ) in premature babies (born in or before the 28th week of pregnancy).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Act-HIB

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.

The vaccine must be used immediately after reconstitution.

Do not use this medicine after the expiry date which is stated on the carton after “EXP” or “EXP”

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

1 reconstituted dose (0.5 ml) contains:

  • The active substance is Haemophilus influenzae type b polysaccharide (polyribosyl ribitol phosphate) 10 micrograms conjugated to tetanus protein, 24 micrograms.
  • The other ingredients are tromethanol, sucrose, concentrated hydrochloric acid(for pH adjustment), sodium chloride solution, water for injections.

What the medicine looks like and the contents of the pack

Powder and solvent for solution for injection.

White powder in a vial and a clear and colorless diluent in a syringe.

Powder for vial (type ‑ 1 glass) with stopper (chlorobutyl) and 0.5 ml suspension solution in a pre-filled disposable syringe (type ‑ 1 glass) with a plunger stopper (halobutyl) with or without the needle in pack sizes of 1 or 10 doses.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sanofi Pasteur Europe

14 Henry Vallée Space

69007 Lyon

France

Manufacturer

Sanofi Pasteur

1541 Avenue Marcel Mérieux

69280 Marcy l’Etoile, Lyon

France

Local representative:

Sanofi AB

Box 30052

104 25 Stockholm

Tel: +46 8-634 50 00

This leaflet was last modified on 11/16/2020.

The following information is intended for healthcare professionals only:

In accordance with the immunization programs for children, the recommendations of the WHO (World Health Organization) and ACIP (Advisory Committee on Immunization Practices) administered Act-HIB is rarely alone but is often given at the same time as, or combined with other vaccines, such as vaccines against diphtheria-tetanus (lockjaw ) -pertussis). The side effects of Act-HIB reflect this concomitant use

To think about before and during vaccination

  • Vaccination should be postponed in case of fever or acute febrile illness.
  • Do not give as an intravascular injection: make sure that the needle does not penetrate any blood vessels.
  • As with all injectable vaccines, the vaccine must be administered with caution to patients with thrombocytopenia or hemorrhagic disease, as bleeding may occur during intramuscular administration to these patients.
  • Before any biological product is injected, the person in charge of administration must take all known precautions to prevent an allergic reaction or a reaction of any other type. As with all injectable vaccines, appropriate medical treatment and monitoring should always be readily available in the event of a rare anaphylactic reaction following vaccination.
  • Any unused product or waste material should be disposed of in accordance with local requirements.

Reconstitution

Reconstitute the vaccine by injecting the contents of the supplied disposable syringe with diluent (0.5 ml) into the powder vial and shaking vigorously until the powder is completely dissolved. The vaccine is then drawn into the disposable syringe and injected. Shake again just before injecting one.

Use the product immediately after reconstitution.

After reconstitution, the vaccine is clear and colorless.

Act-HIB can be given in the same syringe as the inactivated polio vaccine. Act-HIB can be given at the same time as other vaccines. In such cases, separate syringes and injection sites must be used.

Administration

The reconstituted vaccine should preferably be administered intramuscularly, although it may also be given subcutaneously.

The recommended site of administration in infants is the anterolateral part of the thigh and in children the deltoid region.

Muhammad Nadeem

Leave a Reply