HEPLISAV 0.5 ML Injectable solution in pre-filled syringe
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Інструкція із застосування EPLISAV B
Зміст інструкції
HEPLISAV B 20 micrograms injectable solution in pre-filled syringe
Hepatitis B vaccine (recombinant DNA, adjuvated)
This medicinal product is subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for information
on how to report adverse effects.
Read this leaflet carefully before the vaccine is administered to you as 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 nurse. - If any side effects occur, including those not listed in this leaflet, ask your doctor,
or nurse. See section 4.
Contents of this leaflet
- 1. What HEPLISAV B is and what it is used for
- 2. What you need to know before you receive HEPLISAV B
- 3. How HEPLISAV B is administered
- 4. Possible side effects
- 5. How to store HEPLISAV B
- 6. Contents of the pack and other information
1. What is HEPLISAV B and what is it used for
HEPLISAV B is a vaccine indicated in adults starting from 18 years of age as protection against
infection from the hepatitis B virus.
HEPLISAV B can also provide protection against hepatitis D, which can occur only in patients
affected by hepatitis B.
What is hepatitis B?
- Hepatitis B is an infectious disease of the liver caused by a virus. Infection with the hepatitis B virus can cause serious liver problems such as "cirrhosis" (formation of scar tissue in the liver) or liver cancer.
- Some individuals infected with the hepatitis B virus become carriers of the infection, meaning they may not show symptoms of the disease but continue to have the virus in their body and therefore infect other people.
- The disease spreads when the hepatitis B virus enters the body after contact with body fluids from an infected person, including vaginal secretions, blood, semen or saliva. A mother carrying the virus can also transmit it to the baby at birth.
- The main signs and symptoms of the disease include mild flu-like symptoms (such as headache, fever and severe fatigue), dark urine, pale stools, yellowing of the skin and eyes (jaundice). However, some people with hepatitis B may not appear or feel sick.
How does HEPLISAV B work
When a person is vaccinated with HEPLISAV B, the vaccine helps the body's natural defense
system (immune system) to produce specific protective substances (antibodies) against the
hepatitis B virus.
- HEPLISAV B contains an adjuvant, a substance that improves the body's production of antibodies and increases the duration of protection.
- To provide full protection against hepatitis B, a two-injection cycle of HEPLISAV B is necessary.
- HEPLISAV B is not indicated for the treatment of people who have already contracted the hepatitis B virus, including people infected with the hepatitis B virus who have become carriers of the infection.
2. What you need to know before you receive HEPLISAV B
Do not get vaccinated with HEPLISAV B:
- if you are allergic to any of the ingredients of this vaccine, including yeast (listed in section 6). Signs of an allergic reaction can include itching, rash, shortness of breath and swelling of the face or tongue.
- if you have had a sudden, potentially life-threatening allergic reaction after receiving HEPLISAV B in the past.
Do not get vaccinated with HEPLISAV B if any of the above conditions apply to you. If you are unsure, ask your doctor, pharmacist or nurse before getting vaccinated with HEPLISAV B.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you receive HEPLISAV B:
- if you are allergic to any of the ingredients of HEPLISAV B (see section 6),
- if you have had health problems after receiving a vaccine in the past.
- Before an injection, or sometimes even after an injection, fainting may occur. Therefore, tell your doctor, pharmacist or nurse if you have fainted before or after an injection in the past.
- If you have a high fever, your doctor, pharmacist or nurse will postpone the vaccination until you feel better. A minor infection such as a cold should not be a problem, but it is up to your doctor, pharmacist or nurse to decide whether it is appropriate to proceed with the vaccination.
If you are on dialysis for a kidney problem or if your immune system is weakened, your doctor may need to perform a blood test to check if the vaccination has worked sufficiently to protect you from hepatitis B.
HEPLISAV B does not protect against other liver infections such as hepatitis A, C and E.
Like any other vaccine, HEPLISAV B may not protect all vaccinated individuals.
If you are not sure whether any of the above conditions apply to you, talk to your doctor, pharmacist or nurse before getting vaccinated with HEPLISAV B.
Children and adolescents
Since HEPLISAV B has not been fully tested in young people under the age of 18, it should not be used in this age group.
Other medicines and HEPLISAV B
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or may take any other medicines or vaccines.
If HEPLISAV B is given at the same time as an injection of hepatitis B "immuno-globulins", which are given to provide immediate, short-term protection against hepatitis B virus infection, your doctor, pharmacist or nurse will ensure that the two medicines are administered in different parts of the body.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding, ask your doctor for advice before getting vaccinated with this vaccine.
It is not known whether HEPLISAV B is excreted in breast milk. The risk to infants cannot be excluded. Consult your doctor or nurse to assess whether to discontinue breastfeeding or forgo vaccination with HEPLISAV B, considering the benefit of breastfeeding for the child and the benefit of vaccination for you.
Driving and operating machinery
After vaccination with HEPLISAV B you may feel tired or have a headache. If this happens, do not drive vehicles or use tools or machinery.
HEPLISAV B contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
3. How HEPLISAV B is administered
HEPLISAV B will be administered to you by a doctor,
usually in the upper arm.
In adults the vaccination schedule is 2 injections:
- the first injection on a date agreed with the doctor or nurse;
- the second injection 1 month after the first.
For adults with kidney problems, including those undergoing hemodialysis, the vaccination schedule is
4 injections:
- The first injection on a date agreed with the doctor or nurse.
- The second injection 1 month after the first.
- The third injection 2 months after the first.
- The fourth injection 4 months after the first
The doctor will tell you if you will need additional or “booster” injections in the future.
If you forget to attend the appointment for the administration of the second dose of
HEPLISAV B
Contact your doctor and make another appointment.
Make sure to complete the vaccination schedule to avoid not being fully protected. After
receiving a first injection of HEPLISAV B, all subsequent injections must also be of
HEPLISAV B (and not of another type of hepatitis B vaccine).
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
The side effects observed during clinical trials conducted with HEPLISAV B were the
following.
Serious side effects
Very rare (may affect up to 1 in 10,000 people)
Seek medical attention immediately if you notice signs of a severe allergic reaction.
These signs may include: swelling of the face, low blood pressure, difficulty breathing,
loss of consciousness, fever, joint stiffness and rash. These reactions usually start
shortly after the injection.
Other side effects
Very common (may affect more than 1 in 10 people)
- Headache
- Muscle pain
- Feeling tired
- Pain at the injection site
- Feeling unwell
Common (may affect up to 1 in 10 people)
- Swelling or redness at the injection site
- Fever
Uncommon (may affect up to 1 in 100 people)
- Nausea
- Vomiting
- Diarrhoea
- Abdominal pain (stomach ache)
- Allergic reactions (urticaria, rash and itching)
- Itching at the injection site
Rare (may affect up to 1 in 1,000 people)
- Dizziness
- Tingling and prickling sensations
Reporting of side effects
If you get any side effects, talk to your doctor,
directly through the national reporting system listed in Annex V. By reporting side effects you can help
provide more information on the safety of this
medicine.
5. How to store HEPLISAV B
Keep the vaccine out of sight and reach of children.
Do not use the vaccine after the expiry date stated on the label and packaging after the
word "Exp.". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C-8 °C). Do not freeze.
Store the pre-filled syringe in the outer packaging to protect it 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 HEPLISAV B contains
Each dose (0.5 mL) contains:
active ingredients:
Hepatitis B surface antigen (HBsAg) 20 micrograms
With the addition of 3000 micrograms of CpG 1018 adjuvant, an immunostimulatory 22-mer sequence
oligonucleotide
Produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology
The CpG 1018 substance is included in the vaccine as an adjuvant. Adjuvants are substances introduced in
certain vaccines to accelerate, improve and/or prolong their protective effects.
The other components are:
- sodium chloride
- disodium hydrogen phosphate dodecahydrate
- disodium phosphate dihydrate
- polysorbate 80 (E 433)
- water for injections
Description of the appearance of HEPLISAV B and contents of the pack
HEPLISAV B is an injectable liquid in a pre-filled syringe, from clear to slightly milky, of
color from colorless to slightly yellow.
HEPLISAV B is available in packs of 1 and 5 pre-filled syringes without a needle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dynavax GmbH
Eichsfelder Strasse 11
D-40595 Düsseldorf
Germany
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien, България, Česká
republika, Danmark, Eesti, Ελλάδα, España,
France, Hrvatska, Ireland, Ísland, Italia,
Κύπρος, Latvija, Lietuva,
Luxembourg/Luxemburg, Magyarország,
Malta, Nederland, Norge, Österreich, Polska,
Portugal, România, Slovenija, Slovenská
republika, Suomi/Finland, Sverige, United
Kingdom (Northern Ireland)
Dynavax GmbH
Tel/Tlf/Τηλ/Sími/Puh:
+49 211 758450
Deutschland
Bavarian Nordic A/S
Tel: +49 89 26200980
More detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu .
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The following information is intended for healthcare professionals only:
HEPLISAV B:
- is a solution from clear to slightly opalescent, from colorless to slightly yellow, and must be substantially free of visible particles. The medicine should be discarded if the contents appear different;
- must be injected intramuscularly (i.m.) into the deltoid muscle of the arm;
- must not be administered into the gluteus;
- must not be administered intravenously, subcutaneously or intradermally;
- must not be administered to subjects with hypersensitivity to the active substance or to any of the excipients;
- must not be administered to subjects suffering from severe acute febrile illnesses. The presence of a minor infection, such as a cold, is not a contraindication to immunization;
- must not be mixed in the same syringe with other vaccines.
As with all injectable vaccines, appropriate medical therapy must be immediately available
in the event of rare anaphylactic reactions following the administration of
HEPLISAV B.
Unused medicine and waste materials derived from such medicine should be disposed of in accordance
with local regulations.
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- Країна реєстрації
- Лікарська формаInjectable solution in pre-filled syringe, 0.5 ML
- Код АТХJ07BC01
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до EPLISAV BДіюча речовина: hepatitis B, purified antigenВиробник: GLAXOSMITHKLINE BIOLOGICALS S.A.Рецепт не потрібенЛікарська форма: Injectable suspension, 0.5MLДіюча речовина: hepatitis B, purified antigenВиробник: GLAXOSMITHKLINE BIOLOGICALS S.A.Рецепт не потрібенЛікарська форма: Injectable suspension in pre-filled syringe, 720 U. + 20 MCGДіюча речовина: combinationsВиробник: GLAXOSMITHKLINE BIOLOGICALS S.A.Рецепт не потрібен
Аналоги EPLISAV B в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог EPLISAV B у Іспанія
Аналог EPLISAV B у Польща
Аналог EPLISAV B у Україна
Лікарі онлайн щодо EPLISAV B
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на EPLISAV B онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
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Лікар розглядає ваш випадок
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Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
EPLISAV B потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у EPLISAV B — hepatitis B, purified antigen. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
EPLISAV B виробляється компанією DYNAVAX GMBH. 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 EPLISAV B 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 EPLISAV B 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 (hepatitis B, purified antigen) включають ENJERIX B, FENDRIX, AMBIRIX. 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.
