HIBERIX 0,5 ML Powder and solvent for injectable suspension
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Інструкція із застосування IBERIX
Зміст інструкції
- What is Hiberix and what it is used for
- What you need to know before your child receives Hiberix
- How Hiberix is administered
- Possible side effects
- How to store Hiberix
- Contents of the pack and other information
Hiberix powder and solvent for injectable solution for intramuscular use
Anti Haemophilus influenzaetype b (Hib) conjugate vaccine
Read this leaflet carefully before your child receives this vaccine as it contains
important information for him.
- 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 your child, therefore it should not be administered to other people.
- If any side effects occur, including those not listed in this leaflet, ask 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 is Hiberix and what it is used for
Hiberix is a vaccine used to protect the child from a disease caused by the bacterium Haemophilus
influenzaetype b.
Haemophilus influenzaetype b (Hib) can cause brain inflammation, responsible for serious
problems such as: mental retardation, cerebral palsy, deafness, epilepsy or partial blindness. The bacterium can also
cause inflammation of the throat, which in turn can cause death by suffocation. Less frequently,
the bacterium can infect blood, heart, lungs, bones, joints and the tissues of eyes and mouth.
Hiberix is indicated for primary vaccination of children starting from two months of age.
Hiberix helps the child's body develop its own defenses (antibodies) against the disease.
Like all vaccines, Hiberix may not completely protect all vaccinated children.
Hiberix has a protective action only against infections caused by the bacterium Haemophilus influenzae
type b, for which it was specifically developed.
It is possible that children with a weakened immune system (due, for example, to HIV infection)
may not be fully protected with Hiberix.
The vaccine cannot cause the disease it prevents.
2. What you need to know before your child receives Hiberix
Hiberix must not be administered
- If the child is allergic (hypersensitive) to the active substances or to any of the other ingredients of the vaccine
of the other components of Hiberix. 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:
- The child suffers from severe inflammation and has a high fever. In these cases, vaccination will be postponed after recovery. The presence of a minor infection, such as a cold, is not a problem, but it is still recommended to consult your doctor.
- If the child has difficulty breathing, inform your doctor immediately. This problem may be more frequent in the first three months after vaccination, if the child is premature (born before 28 weeks of pregnancy). Fainting may occur following, or even before, any injection with a needle, so inform the doctor or nurse if your child has fainted with a previous injection.
As with all injectable vaccines, appropriate medical treatment and supervision must be readily available
in case of an allergic reaction after vaccine administration.
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
- Tell your doctor or pharmacist if the child is taking, has recently taken or might take any other medicines, including those available without a prescription, or if the child has recently received another vaccination.
- Tell your doctor or pharmacist if the child has an infection or is taking any medicine that affects the immune system (the body's natural defense system) as they may not be fully protected by Hiberix.
- Hiberix can be given at the same time, before or after the administration of other vaccines. Hiberix can be mixed in the same syringe with Infanrix. Except for authorised combinations, Hiberix should not be mixed with other vaccines in the same syringe. In case of simultaneous administration, the individual vaccines must be administered at different injection sites.
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Обговоріть симптоми та можливі варіанти лікування з лікарем онлайн.
3. How Hiberix is administered
- The doctor or nurse will administer the recommended doses to the child, based on official recommendations.
When vaccination is started within the first 6 months of life, the primary schedule consists of 3 doses and
can begin from the age of 2/3 months. The efficacy of the vaccine has been demonstrated with both the 0, 1, 2
schedule (doses spaced by a 1-month interval administered at approximately 3, 4 and 5 months)
and the 0, 2, 4 schedule (doses spaced by a 2-month interval administered at approximately 2, 4 and 6 months).
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, it is recommended to
administer 2 doses one month apart. A booster dose is
recommended in the second year of life.
In children aged between 13 and 48 months, who have not been previously vaccinated, it is recommended to
administer a single dose of vaccine.
Routine vaccination of children over 4 years of age and adolescents is
not recommended.
Immunization of children with a conjugate vaccine against Haemophilus influenzaetype b is
optimal when its administration begins at around two months of life, as invasive infections from Haemophilus influenzaeare more frequent and potentially very serious in children of
under 3 years of age.
- The reconstituted vaccine must be administered by intramuscular injection.
- The vaccine should never be administered intravenously.
- You will be informed when the child needs to receive the next dose.
If the child does not receive a dose of Hiberix
- If the child does not receive a scheduled dose, it is important that you request another appointment.
- If the three-dose vaccination schedule is not completed, the child may not achieve the best immune response or adequate protection from the disease.
4. Possible side effects
Like all medicines, Hiberix can cause side effects, although not everybody gets them.
The adverse reactions that emerged during clinical studies are as follows:
Allergic reactions
As with all injectable vaccines, the child may experience an allergic reaction, albeit in
rare cases (less than 1 case per 10,000 doses of vaccine).
Signs of an allergic reaction include:
- 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. Normally, these symptoms occur immediately after the injection. Take the child to the doctor immediately if they occur after leaving the doctor's office.
Go to the doctor immediately if the child presents any of the following serious
side effects
Very common (may happen in more than 1 in 10 doses of vaccine):
- irritability
- drowsiness
- fever
- swelling, pain and redness at the injection site
- loss of appetite
- crying
- restlessness
- diarrhoea
Common (this can happen in up to 1 in 10 doses of vaccine):
- Vomiting
Rare (this can happen in up to 1 in 1000 doses of vaccine):
- Convulsions (including febrile convulsions)
In addition, other effects not observed during clinical trials but reported after the marketing of
Hiberix include:
Very rare(with a frequency of less than 1 in 10,000 doses of vaccine):
- Fainting due to the injection
- Collapse (sudden onset of muscle flaccidity), periods of unconsciousness or loss of awareness, paleness or skin that becomes bluish
- Apnea, in very premature infants (at 28 weeks of gestation or earlier)
- Urticaria, rash present on one or more areas or all over the body
- Swelling of the extremities of the limb where the vaccine was injected
- Transient nodule at the injection site
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the system
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.
Виникли питання під час прийому ліків?
Обговоріть свої симптоми та лікування з лікарем онлайн.
5. How to store Hiberix
Keep the medicine out of sight and reach of children.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original package to protect from light.
Do not use Hiberix after the expiry date indicated on the package. The expiry date
corresponds to the last day of the month indicated.
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. Contents of the pack and other information
What Hiberix contains
After reconstitution, 1 dose (0.5 ml) contains:
polysaccharide PRP of Haemophilus influenzaetype b 10 micrograms
conjugated to tetanus toxoid as a carrier protein approximately 25 micrograms
Hiberix is a white powder.
The diluent is a clear and colourless liquid.
Excipient:
lactose
A pre-filled syringe of solvent contains: sodium chloride, water for injections
Description of Hiberix and contents of the pack
Powder and solvent for injectable solution.
1 vial of 1 dose of lyophilised vaccine + 1 pre-filled syringe of solvent (0.5 ml) with 1 separate needle.
1 vial of 1 dose of lyophilised vaccine + 1 pre-filled syringe of solvent (0.5 ml) without a needle
Name and address of the Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura 7 - 37135 Verona - Italy
Manufacturer
GlaxoSmithKline Biologicals s.a. – Rue de l'Institut 89 - Rixensart (Belgium)
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The following information is intended for healthcare professionals only:
INSTRUCTIONS FOR USE
As with all injectable vaccines, in the event of a rare anaphylactic event following the administration of the
vaccine, supervision and appropriate medical treatment must always be immediately available.
The solvent and reconstituted vaccine must be visually inspected to ensure there are no
foreign particles and/or changes in physical appearance before reconstitution or administration. If the
above is 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
Always hold the syringe by the cylinder, not by the syringe plunger or the Luer Lock Adapter (LLA),
and keep the needle in line with the syringe (as shown in figure 2). Otherwise, the LLA may
Figure 1Figure 2
deform and cause leakage.
During syringe assembly, if the LLA detaches, a new dose of vaccine (new syringe and vial) must be used.
- 1. Unscrew the syringe cap by rotating it counterclockwise (as shown in figure 1).
Whether the LLA is rotating or not, follow these steps:
- 2. Attach the needle to the syringe by gently connecting the needle hub to the LLA and rotating a quarter turn clockwise until you feel it lock (as shown in figure 2).
- 3. Remove the needle protection, which may be a little difficult.
- 4. Add the solvent to the powder. The mixture must be shaken well until the powder is completely dissolved in the solvent. The reconstituted vaccine is a clear and colourless solution.
After reconstitution, the vaccine must be injected 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, repeating step 2 above. Hiberix can be mixed with Infanrix or Infanrix HepB. In this case, the solvent of Hiberix is replaced by the liquid vaccine Infanrix or Infanrix HepB.
Ensure that the vaccine container intended for mixing with Hiberix is a single-dose container.
From the Hiberix pack, discard the container containing the solvent.
The combined vaccine is prepared by transferring the liquid vaccine into the vial containing the
lyophilised powder of Hiberix.
This extemporaneously prepared combined vaccine must be treated in the same way as the reconstituted
Hiberix monocomponent vaccine.
Unused medicinal product or waste material derived from such medicinal product should be disposed of in
accordance with local regulations.
- Країна реєстрації
- Лікарська формаPowder and solvent for injectable suspension, 0,5 ML
- Код АТХJ07AG51
- Діюча речовина
- Потрібен рецептНі
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до IBERIXЛікарська форма: Powder and solvent for injectable solution, 0,5 MLДіюча речовина: haemophilus influenzae B, combinations with toxoidsВиробник: SANOFI WINTHROP INDUSTRIEПотрібен рецептЛікарська форма: Injectable suspension in pre-filled syringe, 0.5MLДіюча речовина: meningococcus B, multicomponent vaccineВиробник: GLAXOSMITHKLINE VACCINES S.R.L.Рецепт не потрібенЛікарська форма: Injectable suspension, 0.5 MLДіюча речовина: pertussis, purified antigen, combinations with toxoidsВиробник: GLAXOSMITHKLINE S.P.A.Рецепт не потрібен
Аналоги IBERIX в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог IBERIX у Іспанія
Лікарі онлайн щодо IBERIX
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на IBERIX онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
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Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
IBERIX не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у IBERIX — haemophilus influenzae B, combinations with toxoids. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
IBERIX виробляється компанією GLAXOSMITHKLINE S.P.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування IBERIX з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати IBERIX у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (haemophilus influenzae B, combinations with toxoids) включають AKTIB, BEXSERO, BOOSTRIX. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
