NIULIVA 250 I.U./ML Infusion solution
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Інструкція із застосування NIULIVA
Зміст інструкції
Niuliva 250 U.I./ml solution for infusion
Human anti-hepatitis B immunoglobulin
Read this leaflet carefully before using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally. Never give it to others. Indeed, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
- If any undesirable effect occurs, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Niuliva is and what it is used for
- 2. Before you use Niuliva
- 3. How to use Niuliva
- 4. Possible side effects
- 5. How to store Niuliva
- 6. Further information
1. WHAT IS NIULIVA AND WHAT IS IT USED FOR
Niuliva is an intravenous infusion solution containing 250 U.I./ml of human anti-hepatitis B immunoglobulins.
This medicine belongs to the pharmacotherapeutic group called immune sera and immunoglobulins.
Niuliva is indicated for:
Prevention of re-infection from hepatitis B virus (HBV) after liver transplantation for
liver failure from hepatitis B in patients without active viral replication pre-transplant.
Hepatitis B immunoprophylaxis
- In case of accidental exposure in non-immunized subjects (including people with incomplete or unknown vaccination status).
- In patients undergoing hemodialysis, until vaccination becomes effective.
- In newborns of mothers carrying the hepatitis B virus.
- In subjects who have not shown an immune response after vaccination (anti-HB antibodies not measurable) and for those who need continuous prevention, given the constant risk of being infected with hepatitis B.
If you have any questions about the use of Niuliva, ask your doctor.
2. BEFORE USING NIULIVA
Do not use Niuliva
- if you are allergic (hypersensitive) to human immunoglobulins or to any of the excipients of Niuliva.
- if you have hereditary fructose intolerance, a rare genetic disease in which the enzyme that metabolizes fructose is missing. (See special warnings about excipients at the end of this paragraph).
Take particular care with Niuliva
Some adverse reactions may occur more frequently
- in case of a high infusion rate.
- if you have hypo- or agammaglobulinemia (a condition that implies a low level of immunoglobulins in your blood) with or without IgA deficiency.
Adverse reactions at the pulmonary level (acute lung injury related to transfusion, TRALI) may
manifest if you receive intravenous immunoglobulins.
True hypersensitivity reactions are rare. Symptoms of hypersensitivity reactions are:
urticaria, widespread hives, a feeling of tightness in the chest, wheezing, hypotension and anaphylaxis.
Niuliva contains a small amount of IgA. If you have IgA deficiency, you are at risk of developing anti-IgA
antibodies and may experience anaphylactic reactions after administration of blood derivatives
containing IgA. The doctor must therefore assess the benefit of treatment with Niuliva against the
potential risk of hypersensitivity reactions.
Rarely, human anti-hepatitis B immunoglobulin may cause a sudden drop in
blood pressure with an allergic reaction, even if you have tolerated a previous treatment with
immunoglobulins.
Patients with pre-existing risk factors
Tell your doctor if you have any other illness or unfavorable condition, as caution is necessary.
In particular, tell your doctor if you have thrombotic risk factors.
Also, inform your doctor in cases where you have experienced any of these circumstances in the past.
Special warnings
When medicines are produced from human plasma or blood, precautionary measures are taken to
prevent infections that could be transmitted to patients. These measures include careful
selection of donor plasma and blood to ensure that donors at risk of infection
are excluded, while each donation and each plasma pool are tested for viruses or infections. Manufacturers of these types of medicines also include viral inactivation or
removal procedures in the plasma or human blood processing process. Despite these measures,
when medicines produced from plasma or human blood are administered, the possibility of transmission of an infection cannot be completely excluded.
This applies to all viruses of still unknown origin, emerging viruses or other types of infections.
The measures taken are considered effective for enveloped viruses, such as the human immunodeficiency
virus (HIV), hepatitis B and hepatitis C, as well as for non-enveloped viruses, such as the hepatitis A virus. The
measures taken may be of limited value against non-enveloped viruses, such as parvovirus
B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections,
probably because the antibodies against these infections contained in the product have a protective effect.
For your benefit, whenever you are administered Niuliva, it is recommended to record each time the name
and lot number of the product.
Use with other medicines
- Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those available without a prescription.
- Effects on vaccines: Niuliva may reduce the effectiveness of some types of vaccines, such as measles, rubella, mumps and varicella.
Effects on blood tests
If you are about to have blood tests after taking Niuliva, tell the nurse or doctor that you have
taken this medicine. The level of some antibodies may increase.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or breastfeeding, tell your doctor. The doctor will decide whether Niuliva can be used during
pregnancy or breastfeeding.
Driving and operating machinery
No impairment of the ability to drive or operate machinery has been observed.
Important information about some excipients of Niuliva
This medicine contains 50 mg of sorbitol per ml.If your doctor has told you that you have
an intolerance to certain sugars, consult him before taking this medicine.
In newborns and infants up to weaning age, hereditary fructose intolerance may not have been diagnosed yet and the administration of Niuliva may
cause serious reactions. When treatment in newborns and infants (especially up to
weaning) is deemed appropriate, caution should be exercised before and during the
administration of Niuliva due to the sorbitol content in the product. This is
particularly important when more than one administration is necessary to
achieve the protective antibody level.
No interference with blood glucose determination is expected.
3. HOW TO USE NIULIVA
Follow these instructions, unless your doctor prescribes otherwise:
Prevention of hepatitis B virus (HBV) reinfection after liver transplantation for
liver failure due to hepatitis B in patients without active viral replication pre-transplant:
In adults:
- 10,000 IU on the day of transplantation, peri-operatively. Subsequently, 2,000 - 10,000 IU/day for 7 days, and as needed to maintain an antibody level above 100 - 150 IU/l in HBV-DNA negative patients. In children:
The dosage must be adjusted to the body surface area, based on a value of 10,000 IU/1.73 m2.
Hepatitis B immunoprophylaxis:
- Prevention of hepatitis B in case of accidental exposure in non-immunized subjects:
At least 500 IU, according to the intensity of exposure, as soon as possible after exposure and
preferably within 24 - 72 hours.
- Hepatitis B immunoprophylaxis in patients undergoing hemodialysis:
- 8 - 12 IU/kg up to a maximum of 500 IU, every 2 months until seroconversion following vaccination.
- Prevention of hepatitis B in newborns born to mothers carrying the hepatitis B virus, at birth or shortly after birth:
- 30 - 100 IU/kg. The administration of hepatitis B immunoglobulins may be repeated until seroconversion following vaccination.
In all these situations, vaccination against hepatitis B is strongly recommended. The first dose
of vaccine can be injected on the same day as the administration of human hepatitis B
immunoglobulin, but at different sites.
In subjects who, after vaccination, have not shown an immune response (non-measurable anti-HB antibodies) and for those who require continuous prevention, the administration of
500 IU to adults and 8 IU/kg to children every 2 months may be considered; 10 mIU/ml is considered as the minimum protective antibody titer.
Niuliva must be administered intravenously at a maximum initial rate of
0.02 ml/kg/minute for the first 10 minutes. If well tolerated, the administration rate may be
gradually increased by the doctor up to a maximum of 0.04 ml/kg/minute. Therefore, in general, the
administration of 5,000 IU will be carried out in less than 15 minutes.
If no adverse reactions occur, the maximum initial rate of subsequent infusions will always be
0.02 ml/kg/minute and, if well tolerated, the administration rate may be gradually
increased by the doctor up to a maximum of 0.1 ml/kg/minute. In general, the administration time
of 5,000 IU will be less than 10 minutes.
Niuliva must not be mixed with other drugs or intravenous fluids and must be
administered through a separate intravenous line.
If you use more Niuliva than you should
If you have taken more Niuliva than you should, inform your doctor or pharmacist immediately.
The consequences of an overdose are not known.
If you forget to use Niuliva
Inform your doctor or pharmacist immediately and follow their instructions.
Do not use a double dose to make up for a missed dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Niuliva can cause side effects, although not everybody gets them.
manifest.
Tell your doctor if you experience any of the following side effects during or after
infusion:
- Chills
- Headache
- Fever
- Nausea
- Vomiting
- Allergic reactions
- Arthralgia
- Hypotension
- Moderate back pain
Rare adverse reactions:
- A sudden drop in blood pressure and, in isolated cases, anaphylactic shock, even if you have not shown hypersensitivity in previous administrations
- Cases of temporary meningitis (reversible aseptic meningitis)
- Cases of temporary reduction of red blood cells in the blood (hemolytic anemia/reversible hemolysis)
- Cases of temporary skin reactions
- Increased serum creatinine levels and/or acute renal failure
Very rare adverse reactions:
- Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis
The following side effects were observed in two clinical studies conducted with Niuliva:
Not common (may occur in 1 in 100 patients):
- Reduction of white blood cells
- Transplant rejection
- Hypokinesia
- Hypotension, hypertension
- Dry mouth
- Joint pain
- Renal insufficiency, acute renal failure
- Increased liver enzymes, positive pharyngeal swab
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly to
http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help to
provide more information on the safety of this medicine.
5. HOW TO STORE NIULIVA
Keep Niuliva out of the reach and sight of children.
Do not use Niuliva after the expiry date which is reported on the label and on the carton after Exp.
The expiry date refers to the last day of the month.
Store in a refrigerator (2 °C - 8 °C). Do not freeze.
The product should be brought to room temperature or body temperature before use.
The solution must be clear or slightly opalescent. Do not use Niuliva if you notice that the solution is
cloudy or has a precipitate.
All unused products or waste materials must be disposed of in accordance with current laws.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
6. OTHER INFORMATION
What Niuliva contains
The active substance is:
Human anti-hepatitis B immunoglobulin. One millilitre of Niuliva contains 50 mg of protein, of which
at least 97% consists of IgG.
The content of human anti-hepatitis B immunoglobulin is 250 IU/ml (600 IU/2.4 ml, 1,000 IU/4 ml,
- 5,000 IU/20 ml, 10,000 IU/40 ml).
The percentage distribution of IgG subclasses, determined by immunonephelometry, is approximately
74.3% of IgG, 22.1% of IgG, 1.99% of IgG, 1.61% of IgG.
It contains IgA in trace amounts (less than 0.05 mg/ml).
The excipients are sorbitol and water for injections.
(See section 2. “Before using Niuliva” for further information on the excipients).
Description of the appearance of Niuliva and contents of the pack
Niuliva is an infusion solution. The solution is clear or slightly opalescent and colourless or
pale yellow.
Formats:
Niuliva
600 IU/2.4 ml and 1,000 IU/4 ml syringes.
- 5,000 IU/20 ml and 10,000 IU/40 ml vials.
Pack: 1 syringe or 1 vial.
Marketing authorisation holder and manufacturer
Instituto Grifols, S.A.
Can Guasch, 2 - Parets del Vallès
08150 Barcelona - SPAIN
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- Країна реєстрації
- Лікарська формаInfusion solution, 250 I.U./ML
- Код АТХJ06BB04
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до NIULIVAЛікарська форма: Injectable solution, 600 UI/3 MLДіюча речовина: hepatitis B immunoglobulinВиробник: INSTITUTO GRIFOLS S.A.Потрібен рецептЛікарська форма: Injectable solution, 180 U.I./1 MLДіюча речовина: hepatitis B immunoglobulinВиробник: KEDRION S.P.A.Потрібен рецептЛікарська форма: Injectable solution, 180 IU/1 MLДіюча речовина: hepatitis B immunoglobulinВиробник: KEDRION S.P.A.Потрібен рецепт
Аналоги NIULIVA в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог NIULIVA у Іспанія
Аналог NIULIVA у Польща
Лікарі онлайн щодо NIULIVA
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на NIULIVA онлайн
Заповніть форму за 2 хвилини
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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
NIULIVA потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у NIULIVA — hepatitis B immunoglobulin. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
NIULIVA виробляється компанією INSTITUTO GRIFOLS S.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 NIULIVA 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 NIULIVA 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 immunoglobulin) включають IGANTIBE, IMMUNOBS, KEDBS. 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.
