Інструкція із застосування GOIBIK
Зміст інструкції
Gohibic 200 mg concentrate for solution for infusion
Vilobelimab

Medicinal product 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 this medicine is administered to you because
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 Gohibic is and what it is used for
- 2. What you need to know before you are given Gohibic
- 3. How Gohibic will be administered
- 4. Possible side effects
- 5. How to store Gohibic
- 6. Contents of the pack and other information
1. What is Gohibic and what is it used for
Gohibic contains the active substance vilobelimab belonging to a class of medicines called
monoclonal antibodies.
Gohibic is used in the treatment of adults with severe acute respiratory problems caused by SARS-CoV-2
(the virus that causes COVID-19), who are on mechanical ventilation (a device that helps the
patient to breathe) with or without ECMO (life support that can help a person whose lungs
and heart are not working properly). Gohibic is used in patients who are already treated with
corticosteroid medicines.
Monoclonal antibodies such as vilobelimab are types of proteins that can bind to specific
targets present in the body. Vilobelimab binds to a protein called C5a to block its
action. C5a is part of the so-called complement system, a part of the immune system
(the body's natural defenses). High levels of C5a can cause damage to lung tissue,
as observed in patients with severe COVID-19. By blocking the C5a protein, Gohibic
helps to prevent such damage, allowing the lungs to put oxygen into the blood.
2. What you need to know before you take Gohibic
Do not take Gohibic
- if you are allergic to vilobelimab or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Your doctor or nurse will monitor you during treatment with Gohibic to check if you
experience:
- allergic reactions or infusion-related reactions. Your doctor may need to stop treatment with Gohibic if you experience symptoms such as:
- low or high blood pressure
- fast or slow heartbeat
- difficulty breathing
- lack of oxygen in body tissues
- wheezing
- fever
- chills
- severe allergic reactions causing swelling of the face or throat
- rash
- nausea
- vomiting
- excessive sweating
- a new infection Your doctor may need to perform further tests and treat the new infection if you experience symptoms such as:
- fever
- fatigue
- congestion
- cough
- body aches
- headache
- chills
- nausea, vomiting, diarrhea
- swelling, redness, warmth at the local site
Children and adolescents
Gohibic is not recommended in children and adolescents under 18 years of age, as
studies have not been conducted in this age group.
Other medicines and Gohibic
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice.
Gohibic is not recommended in pregnant women, as it has not been tested in this group.
It is not known whether vilobelimab is excreted in breast milk and a risk to the
newborn cannot be excluded. Your doctor will decide whether to discontinue breastfeeding while taking
Gohibic.
Driving and using machines
Gohibic should not have any effect on your ability to drive and operate machines.
Gohibic contains sodium
This medicine contains 296.8 mg of sodium (the main component of table salt/cooking salt) in
each dose of 4 vials, which is equivalent to 15% of the maximum recommended daily intake of sodium
for an adult.
3. How Gohibic will be administered
Gohibic will be administered by infusion (drip) into a vein for 30-60 minutes by a doctor or a
nurse.
The recommended dose of this medicine is 800 mg (4 vials), diluted in the infusion solution.
Treatment should begin (day 1) within 48 hours of mechanical ventilation administration. If you are still in hospital, other doses are administered on days 2, 4, 8, 15 and 22.
If you have any questions about the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common(may affect more than 1 in 10 people)
- severe lung infection that can be caused by bacteria, viruses or fungi (pneumonia)
Common(may affect up to 1 in 10 people)
- potentially life-threatening condition where the body damages its own tissues and organs in response to an infection (sepsis)
- fungal infection of the lungs (bronchopulmonary aspergillosis)
- blisters or painful sores on the mouth or genitals caused by a virus (herpes simplex)
- decrease in the number of cells that help the blood clot (thrombocytopenia)
- sudden and very fast heartbeat affecting the upper chambers of the heart (supraventricular tachycardia)
- skin rash.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. You can also report side effects 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 Gohibic
The doctor, pharmacist or nurse are responsible for the storage of this medicine and
for the correct disposal of any unused medicine. The following information is intended for
healthcare professionals.
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 vial and the carton after
“EXP.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ºC – 8 ºC). Do not freeze or shake.
Store in the original packaging to protect the medicine from light.
Use the product immediately after dilution. If not used immediately, the conditions
and duration of storage of the product until its use are the responsibility of the user; the
product must be stored for a time usually not exceeding 24 hours at a temperature
between 2 ºC and 8 ºC, unless the reconstitution/dilution (etc.) has been carried out under
aseptic, controlled and validated conditions.
6. Package Contents and Other Information
What Gohibic contains
- The active substance is vilobelimab. Each vial contains 200 mg of vilobelimab in 20 mL (10 mg/mL).
- The other ingredients are sodium chloride, disodium hydrogen phosphate dihydrate, disodium phosphate dihydrate, polysorbate 80, water for injections. See section 2 for further information on sodium.
Description of Gohibic appearance and package contents
Gohibic is a concentrate for infusion solution (sterile concentrate). It is a colorless concentrate,
from clear to slightly opalescent, in a glass vial.
Each pack contains 4 vials.
Marketing Authorisation Holder
InflaRx GmbH
Winzerlaer Strasse 2
07745 Jena
Germany
Manufacturer
Almac Pharma Services Ltd.
Finnabair Industrial Estate
Dundalk
Co. Louth
A91 P9KD
Ireland
This medicinal product has been granted an authorisation in “exceptional circumstances”. This means that
due to the rarity of the disease, complete information on this medicinal product could not be obtained.
The European Medicines Agency will annually review any new information on this
Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu.
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The following information is intended exclusively for healthcare professionals:
Traceability
In order to improve the traceability of biological medicines, the name and batch number of the
administered medicine must be clearly recorded.
General information on handling
- This medicinal product must be diluted by a healthcare professional using aseptic technique in a controlled/dedicated area in accordance with and in compliance with applicable local regulations and requirements for intravenous administration.
- Gohibic must not be diluted or administered with products/disposable products containing sensitizing substances such as latex (rubber latex) or silicone oil.
Preparation of the infusion
- To obtain a dose of 800 mg of vilobelimab for intravenous infusion, 80 mL of Gohibic (4 vials) are diluted in 170 mL of sodium chloride solution for injection 9 mg/mL (0.9 %) at room temperature.
- Use a 250 mL infusion bag of sodium chloride solution for injection 9 mg/mL (0.9 %) as follows:
- withdraw 80 mL of sodium chloride solution for injection 9 mg/mL (0.9 %) from the infusion bag and discard it;
- withdraw 80 mL of Gohibic from the 4 vials and slowly add to 170 mL of sodium chloride solution for injection 9 mg/mL (0.9 %) contained in the infusion bag;
- to mix the solution, gently invert the bag to avoid foaming.
- Before administration, visually inspect the vial for the presence of particles or discoloration. The product should not be used if the solution is discolored or contains particles.
Storage conditions of the diluted solution
Chemical and physical stability during use has been demonstrated for 72 hours at 2 º -8 ºC and for 4 hours up to 25 º
- C. From a microbiological point of view, the product must be used immediately. If not used immediately, the conditions and duration of storage of the product until its use are the responsibility of the user; the product must be stored for a time usually not exceeding 24 hours at a temperature between 2 º and 8 ºC, unless the reconstitution/dilution (etc.) has been carried out under aseptic, controlled and validated conditions.
Instructions for use
Treatment should be initiated within 48 hours of intubation (day 1) followed by
administration on days 2, 4, 8, 15 and 22, provided the patient is hospitalised,
even if discharged from the ICU.
The infusion must be administered over 30-60 minutes and must be administered with an
infusion set.
Gohibic must not be infused simultaneously with other medicines in the same intravenous
line. Compatibility studies, physical or biochemical, have not been conducted to evaluate the co-
administration of Gohibic with other medicines.
Disposal
Unused medicine or waste material should be disposed of in accordance with local
regulations.
ANNEX IV
CONCLUSIONS RELATING TO THE GRANT OF THE MARKETING
AUTHORISATION IN EXCEPTIONAL CIRCUMSTANCES
PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Conclusions presented by the European Medicines Agency on:
- marketing authorisation in exceptional circumstancesFollowing the examination of the marketing authorisation application, the CHMP considers that the benefit-risk ratio is favourable to recommend the grant of the marketing authorisation in exceptional circumstances as further described in the European Public Assessment Report (EPAR).

- Країна реєстрації
- Лікарська формаConcentrate for infusion solution, 200 mg
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до GOIBIKЛікарська форма: Infusion solution, 1080 mgДіюча речовина: ПегцетакопланВиробник: SWEDISH ORPHAN BIOVITRUM AB (PUBL)Потрібен рецептЛікарська форма: Concentrate for infusion solution, 300 mgДіюча речовина: ЭкулизумабВиробник: AMGEN TECHNOLOGY (IRELAND) UCПотрібен рецептЛікарська форма: Infusion solution, 50 mg / mlДіюча речовина: sutimlimabВиробник: RECORDATI RARE DISEASES SARLПотрібен рецепт
Аналоги GOIBIK в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог GOIBIK у Іспанія
Лікарі онлайн щодо GOIBIK
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на GOIBIK онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
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
GOIBIK потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
GOIBIK виробляється компанією INFLARX 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 GOIBIK 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 GOIBIK 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 () включають ASPAVELI, BEKEMV, ENJAYMO. 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.
















