ACTHIB 0,5 ML Powder and solvent for injectable solution

Зміст інструкції

1. What is ACT-HIB and what it is used for
2. What you need to know before your child is given ACT-HIB
3. How ACT-HIB will be administered to the child
4. Possible side effects
5. How to store ACT-HIB
6. Package Contents and Other Information

ACT-HIB
powder and solvent for injectable solution
Haemophilus influenzaetype b conjugate vaccine with tetanus toxoid

Read this leaflet carefully before the medicine is administered to the child
as it contains important information for you and/or the child.

• 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 only for the child. Do not give it to other people, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ACT-HIB is and what it is used for
• 2. What you need to know before ACT-HIB is administered to the child
• 3. How ACT-HIB will be administered to the child
• 4. Possible side effects
• 5. How to store ACT-HIB
• 6. Contents of the pack and other information

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

ACT-HIB (Hib) is a vaccine.
Vaccines work by stimulating the body to produce its own protection against the disease for which the
vaccine is specific.
ACT-HIB is a vaccine that helps protect children from 2 months of age against infections
caused by the bacterium Haemophilus influenzaetype b.
Haemophilus influenzaetype b bacterium can cause serious infections affecting various organs such as:

• the membranes covering the brain (meningitis),
• the blood (sepsis),
• the tissue under the skin and around internal organs (cellulitis),
• the joints (arthritis) and bones (osteomyelitis),
• the membrane at the base of the tongue, which makes breathing difficult (epiglottitis),
• the lungs (pneumonia).

2. What you need to know before your child is given ACT-HIB

Do not give ACT-HIB to your childif your child

• is allergic to the active substance or any of the other ingredients of this medicine, especially tetanus toxoid or a substance called formaldehyde (listed in section 6);
• has had an allergic reaction following a previous vaccination with ACT-HIB or with another vaccine containing the same components;
• suffers from a brain disease, such as uncontrolled epilepsy (a condition characterized by involuntary body movements and loss of consciousness), for which the child is not taking medication.

Warnings and precautions
Consult your doctor before ACT-HIB is given to your child.
In particular, tell your doctor beforevaccination if your child:
is ill and has a high fever. In this case, the vaccination should be postponed until
your child has recovered. The presence of a minor infection does not constitute
a contraindication to vaccination. Always ask your doctor for advice.
is receiving immunosuppressive treatment (treatment that reduces the activity of the
immune system, for example after an organ transplant) or has problems with the immune system (the
system that protects the body from infections). The doctor may decide to postpone the
vaccination until the end of treatment or the illness. However, if your child has chronic
problems with the immune system (for example in case of HIV infection) vaccination with
ACT-HIB can be performed.
has had their spleen removed;
suffers from a blood disease called sickle cell anemia;
suffers from thrombocytopenia (reduced number of platelets in the blood) or blood clotting disorders
(such as hemophilia), as the child may have bleeding
after vaccination;
has had allergic reactions to previous vaccinations in the past.
if the child has an allergy to latex. The cap on the prefilled syringe
contains a derivative of natural rubber latex which may cause an allergic reaction.
The decision to administer any vaccine must be carefully evaluated by the doctor in
consideration of the potential benefits and possible risks to the child.
Fainting may occur following, or even before, any injection with a needle. Therefore, inform
the doctor or nurse if you or your child have fainted after a previous injection.

Children and adolescents
In case of primary vaccination in newborns, tell your doctor if the newborn was born very prematurely
(at 28 weeks of gestation or earlier), and especially if they have had respiratory problems. In this
case the doctor will monitor the newborn's breathing for the 48-72 hours following vaccination, due to a potential risk of apnea (longer than normal intervals between breaths).
Since the benefit of vaccination in this group of newborns is high, vaccination should not
be suspended or postponed (see section 4 “Additional undesirable effects in children”).

Other medicines and ACT-HIB
Tell your doctor or pharmacist if the child is taking, has recently taken or might
take any other medicines.
ACT-HIB can be given to the child in the same vaccination session together with vaccines
against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or the measles-mumps-
rubella vaccine. If administered concurrently with other vaccines, healthcare professionals will use
the same injection site or separate sites, as appropriate.
In particular, tell your doctor:

• if the child is receiving immunosuppressive treatment (treatment that reduces the activity of the immune system), for example:
• hormones (long-term therapy)
• chemotherapy
• radiotherapy as the response to the vaccine may be reduced. In this case, the doctor may decide to postpone the vaccination until the end of treatment.

Pregnancy and breastfeeding
It is rare for adults to be vaccinated against Haemophilus influenzaetype b.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
ACT-HIB will notbe given to you if you are pregnant, unless your doctor considers it
absolutely necessary.

Breastfeeding
ACT-HIB will notbe given to you if you are breastfeeding, unless your doctor considers it
absolutely necessary.

Driving and using machines
No studies have been conducted on the ability to drive vehicles and use machines.

ACT-HIB contains sodium

Sodium: this medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say it is practically
‘sodium-free’.

3. How ACT-HIB will be administered to the child

This medicine will be prepared and administered to the child only by healthcare professionals,
through an injection into a muscle of the thigh (anterolateral region) or of the arm (deltoid region) or under the skin.

Children over 2 months of age
➢ Primary vaccination(vaccination for primary prevention against infections)
Children starting from two months of age:3 injections of 0.5 ml at 1-2 months intervals from each other.
Children between six and twelve months of age:2 injections of 0.5 ml at 1 month intervals from each other.
Children from 1 to 5 years of age: a single injection is sufficient.
➢ Booster(to strengthen protection against infections)
Children starting from two months of age:one injection of 0.5 ml 1 year after the third injection of the
primary vaccination
Children between six and twelve months of age: 1 injection of 0.5 ml at 18 months of age

If the child receives more ACT-HIB than they should
Since this medicine is prepared and administered by healthcare professionals, it is unlikely that the
child will receive an excessive dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since ACT-HIB is usually given together with the diphtheria-tetanus-pertussis vaccine,
If your child experiences the following side effects, which are symptoms of an allergic reaction,
immediately after the administration of the vaccine or after leaving the place where the
vaccine was administered, consult a doctor IMMEDIATELY:

• difficulty breathing or swallowing, bluish discoloration of the tongue or lips.
• sudden allergic reactions such as skin rashes, swelling of the face, lips, tongue or other parts of the body (edema, angioedema).
• low blood pressure (causing dizziness) and fainting (collapse).

In addition, the following side effects may occur, which usually appear shortly
after the injection (6-24 hours) and are transient, listed according to frequency of occurrence:

Very common side effects (reported in more than 1 in 10 people):

• pain, redness and swelling at the injection site
• inflammation and hardening of the injection site irritability

Common side effects (reported in less than 1 in 10 people):

• vomiting, fever
• Prolonged and inconsolable crying

Uncommon side effects (may affect up to 1 in 100 children) are:

Fever equal to or greater than 39°C

Side effects with unknown frequency (cannot be determined based on available data)
Diarrhea

• Decreased appetite
• Allergic reactions, including skin rash, itching, skin reaction (urticaria, hives) that may include skin eruptions, skin peeling (erythema multiforme) and generalized rash.
• Headache State similar to shock or paleness, weakness and unresponsiveness for a certain period of time or fainting (episodes of hypotonia-hyporesponsiveness or collapse).
• Drowsiness
• Convulsions (seizures), with or without fever
• Restlessness
• Bruise-like skin spots due to reduced platelets (purpura). This reaction has been observed in temporal association with the administration of ACT-HIB, but the correlation has not been established.
• Extensive reactions at the injection site (greater than 5 cm), such as pain, redness, swelling and/or inflammation or hardening.
• Extensive swelling of the limb in the limb in which the vaccination was performed (from the injection site to beyond one or both joints).
• Swelling of one or both legs. This may occur simultaneously with the appearance of bluish skin discoloration (cyanosis), redness, small areas of bleeding under the skin (transient purpura) and loud crying. If this reaction occurs, it will mainly occur after the first (primary) injections and within the first few hours of vaccine administration. All symptoms will resolve completely within 24 hours, without the need for any specific treatment.

Additional side effects in children
In very premature infants (at the 28th week of gestation or earlier), especially those
with a previous history of respiratory failure, the potential risk of
apnea (longer than normal intervals between breaths) and the need to
monitor breathing for the 48-72 hours following vaccination should be considered.

Reporting of side effects
If your child experiences any side effect, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting side effects you
can contribute to providing more information on the safety of this medicine.

5. How to store ACT-HIB

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “EXP”. The
expiry date refers to the last day of that month.
Store and transport in a refrigerator (2  C – 8  C). Do not freeze.
Keep the vial of powder in the outer packaging to protect the medicine from light.
Do not dispose of any medicine in 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 ACT-HIB contains

• the active ingredients are: Haemophilus influenzaetype b polysaccharide 10 micrograms, conjugated to tetanus toxoid
• the other components are: trometamol, sucrose, glacial acetic acid and/or sodium hydroxide for pH adjustments, sodium chloride (contains sodium. See section 2. "ACT-HIB contains sodium”), concentrated hydrochloric acid for pH adjustments, water for injections.

Description of the appearance of ACT-HIB and package contents
ACT-HIB is a powder and solvent for injectable solution in a prefilled syringe.
0.5 ml of injectable solution for intramuscular or subcutaneous administration.
The powder is white and the solvent is clear and colorless.
The packs contain 1 vial of powder and 1 prefilled syringe of diluent of 0.5 ml.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Representative for Italy
Sanofi S.r.l. - Viale L. Bodio, 37/B – 20158 Milano

Manufacturer
Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
69280 Marcy l’Etoile
France
And/or
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France
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The following information is intended exclusively for healthcare professionals.
Dosage
a) Infants:

• up to 6 months of age: it is recommended to administer 3 successive doses of 0.5 ml at intervals of 1-2 months and a fourth dose (booster) one year after the third injection.
• between 6 and 12 months of age: two injections of 0.5 ml at 1 month intervals are sufficient, followed by a booster dose at 18 months of age.

b) Children from 1 to 5 years of age: a single injection is sufficient.
If a subject who has not been vaccinated or has been incompletely vaccinated comes into contact with a
case of invasive disease due to Haemophilus Influenzaetype b, vaccination must be
implemented or completed following the appropriate vaccination schedule for age, in association
with the recommended chemoprophylaxis.

Route of administration
The preferred route of administration for the reconstituted vaccine is intramuscular, although it can
also be administered subcutaneously.
The recommended injection sites are the antero-lateral region of the thigh in infants and the
deltoid region in children.
ACT-HIB must not be administered intravenously under any circumstances.

Instructions for use
To reconstitute the powder contained in the vial with the solvent contained in the prefilled syringe
proceed as follows:
Shake the prefilled syringe containing the solvent to obtain a homogeneous suspension;
Add the suspension to the vial and shake carefully until the lyophilized substance is completely
dissolved.
Shake again immediately before injection.
After reconstitution, the vaccine appears as a clear and colorless solution.
The reconstituted medicine must be used immediately after reconstitution.

Further warnings
As with any other vaccine, the administration of ACT-HIB should be postponed in
subjects affected by acute febrile illnesses. The presence of a minor infection, however, does not constitute
a contraindication to vaccination.
Immunosuppressive treatment or a condition of immunodeficiency may induce a
reduction in the immune response to the vaccine. In these cases, it is recommended to postpone
vaccination until the end of treatment or the illness.
However, vaccination of subjects affected by chronic immunodepression, such as HIV infection,
asplenia or sickle cell anemia, is recommended, even if there is a risk of a suboptimal immune response.
ACT-HIB does not protect against diseases due to other serotypes of Haemophilus influenzae, nor
against other forms of meningitis caused by other pathogens.
Under no circumstances can the tetanus toxoid present in ACT-HIB replace classical
tetanus vaccination.
Do not administer intravascularly: ensure that the needle does not penetrate a blood vessel.
In case of subcutaneous administration, it is possible that an extensive swelling occurs
of the limb in which the vaccine was administered; for this reason, the intramuscular route is preferred.
As with any other vaccine, vaccination with ACT-HIB may not ensure complete protection of all
vaccinated subjects.
As with all injectable vaccines, the vaccine must be administered with caution in subjects with
thrombocytopenia or a coagulation disorder, as bleeding may occur in these subjects following
intramuscular administration.
Before administering any dose of ACT-HIB, it is necessary to ask the parent or guardian
of the recipient subject or the recipient subject himself, if an adult, for information regarding personal history,
family history, recent health status, including previous immunizations, current health status and any adverse effects
occurred after a previous immunization. In subjects with a history of severe adverse reactions occurring within 48 hours
following a previous injection with a vaccine containing similar components, the vaccination course must be
carefully monitored.
Syncope (fainting) may occur following, or even before, any vaccination as a psychogenic response to needle injection.
It may be accompanied by various neurological signs such as transient visual disturbances, paresthesia and tonic-clonic
movements of the limbs during the recovery phase. It is important that adequate procedures are in place to prevent
injuries resulting from fainting.
Before injecting any biological product, the person responsible for administration
must take all known precautions to prevent allergic reactions or any other
type. As with all injectable vaccines, adequate treatment and medical supervision
must always be readily available in the event of a rare anaphylactic reaction following
vaccine administration.

Paediatric population
When the primary immunization series is carried out in very premature infants (born at 28
weeks of gestation or earlier), especially those with a previous history of respiratory failure, the potential risk of
apnea and the need to monitor breathing for the 48-72 hours following vaccination should be considered,
Since the benefit of vaccination in this group of infants is high, vaccination should not
be suspended or delayed.