Інструкція із застосування BEYFORTUS
Зміст інструкції
Beyfortus 50 mg injectable solution in pre-filled syringe, 100 mg injectable solution in pre-filled syringe
nirsevimab
▼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 by your child 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 giving this medicine to the child as it contains
important information for you and the child.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- If your child experiences any side effects, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Beyfortus is and what it is used for
- 2. What you need to know before your child uses Beyfortus
- 3. How and when Beyfortus is administered
- 4. Possible side effects
- 5. How to store Beyfortus
- 6. Contents of the pack and other information
1. What is Beyfortus and what is it used for
What is Beyfortus
Beyfortus is a medicine given as an injection to protect infants and children under 2 years of age from respiratory syncytial virus (RSV). RSV is a common respiratory virus that usually causes mild symptoms, similar to those of a common
cold. However, especially in infants, vulnerable children and
older adults, RSV can cause serious illnesses, including bronchiolitis (inflammation of the
small airways of the lung) and pneumonia (lung infection) that can lead to hospitalisation or even death. The virus is usually more common during the winter.
Beyfortus contains the active substance nirsevimab, an antibody (a protein designed to attach to
a specific target) that binds to a protein that RSV needs to infect the body.
By binding to this protein, Beyfortus blocks its action, preventing the virus from entering and infecting
human cells.
What is Beyfortus used for
Beyfortus is a medicine that protects the child from RSV disease.
2. What you need to know before your child uses Beyfortus
Your child must not use Beyfortus if they are allergic to nirsevimab or to any of the other
ingredients of this medicine (listed in section 6).
Tell your child's doctor, pharmacist or nurse if this applies to your child. If
you are not sure, check with your child's doctor, pharmacist or nurse before
the medicine is given.
If the child shows signs of a severe allergic reaction, contact the doctor immediately.
Warnings and precautions
Tell the doctor immediately or seek immediate medical attention if you notice the
appearance of any signs of an allergic reaction, such as:
- difficulty breathing or swallowing,
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or bumps
Consult your doctor before Beyfortus is given to your child if your child has a
low number of platelets (which help blood to clot), has bleeding problems,
has frequent bruising or is taking an anticoagulant (a medicine to prevent blood
clotting).
In some chronic health conditions, where too much protein is lost through the urine or
intestine, for example nephrotic syndrome and chronic liver disease, the level of protection from
Beyfortus may be reduced.
Beyfortus contains 0.1 mg of polysorbate 80 in each 50 mg dose (0.5 mL) and 0.2 mg in each 100 mg
dose (1 mL). Polysorbates can cause allergic reactions. Tell the doctor if the child
suffers from known allergies.
Children and adolescents
Do not give this medicine to children aged between 2 and 18 years because it has not
been studied in this group.
Other medicines and Beyfortus
No interactions of Beyfortus with other medicines are known. However, tell your
doctor, pharmacist or nurse if your child is taking, has recently taken or might
take any other medicine.
Beyfortus can be given at the same time as vaccines that are part of the national
immunisation schedule.
3. How and when Beyfortus is administered
Beyfortus is administered by a healthcare professional as an injection into the muscle. Usually, it is
administered in the outer thigh.
The recommended dose is:
- 50 mg for children weighing less than 5 kg and 100 mg for children weighing 5 kg or more in their first RSV season.
- 200 mg for children who remain vulnerable to severe RSV disease in their second RSV season (administered as 2 injections of 100 mg at separate sites).
Beyfortus should be administered before the RSV season. The virus is usually more common
during the winter (known as the RSV season). If your child was born during the winter, Beyfortus
should be administered after birth.
If your child needs to undergo heart surgery (cardiac surgery), they
may be given an additional dose of Beyfortus after the surgery, to
ensure adequate protection for the rest of the RSV season.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may include:
Uncommon(may affect up to 1 in 100 children)
- skin rash
- reaction at the injection site (i.e., redness, swelling, and pain at the place where the injection is given)
- fever
Not known(frequency cannot be estimated from available data)
- allergic reactions
Reporting of side effects
If your child gets any side effects, talk to your doctor, pharmacist 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 Beyfortus
The doctor, pharmacist or nurse are responsible for the storage of this medicine and the
correct disposal of unused product. 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 stated on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). After removal from the refrigerator, Beyfortus must be
protected from light and used within 8 hours or discarded.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Do not freeze, shake or expose to direct heat.
Unused medicine and waste materials from this medicine must be disposed of in accordance with
current local regulations.
6. Contents of the pack and other information
What Beyfortus contains
- The active substance is nirsevimab.
- A pre-filled syringe of 0.5 mL solution contains 50 mg of nirsevimab.
- A pre-filled syringe of 1 mL solution contains 100 mg of nirsevimab.
- The other components are L-histidine, L-histidine hydrochloride, L-arginine hydrochloride, sucrose, polysorbate 80 (E433) and water for injections.
Description of Beyfortus and contents of the pack
Beyfortus is an injectable solution from colourless to yellow.
Beyfortus is available as:
- 1 or 5 pre-filled syringe(s) without needles.
- 1 pre-filled syringe packaged with two distinct needles of different sizes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France
Manufacturer
AstraZeneca AB
Karlebyhusentren, Astraallen
152 57 Södertälje
Sweden
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 2 710.54.00
Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40
България
Swixx Biopharma EOOD
Тел.: +359 2 4942 480
Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 2 710.54.00
Česká republika
Sanofi
s.r.o.
Tel: +420 233 086 111
Magyarország
sanofi-aventis zrt
Tel.: +36 1 505 0055
Danmark
Sanofi A/S
Tfl: +45 4516 7000
Malta
Sanofi S.r.l.
Tel: +39 02 39394275
Deutschland
Sanofi-Aventis Deutschland GmbH
Tel.: 0800 54 54 010
Tel. aus dem Ausland: +49 69 305 21 130
Nederland
Sanofi B.V.
Tel: +31 20 245 4000
Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30
Norge
Sanofi-aventis Norge AS
Tfl: + 47 67 10 71 00
Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ: +30.210.8009111
Österreich
Sanofi-Aventis GmbH
Tel: +43 1 80 185-0
España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00
Polska
Sanofi Pasteur Sp. z o. o.
Tel.: +48 22 280 00 00
France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23
Portugal
Sanofi – Produtos Farmacêuticos, Lda.
Tel: + 351 21 35 89 400
Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40(21) 317 31 36
Ireland
sanofi-aventis Ireland T/A SANOFI
Tel: + 353 (0) 1 4035 600
Slovenija
Swixx Biopharma d.o.o
Tel: +386 1 235 51 00
Ísland
Vistor
Sími: +354 535 7000
Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600
Italia
Sanofi S.r.l.
Tel: 800536389
Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300
Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741
Sverige
Sanofi AB
Tel: +46 8-634 50 00
Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50
United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .
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The following information is intended for healthcare professionals only:
In order to improve the traceability of biological medicinal products, it is necessary to clearly record the
name and batch number of the administered product.
Visually inspect Beyfortus to exclude the presence of particulate matter and colour changes
before administration. Beyfortus is a solution from clear to opalescent, from colourless to
yellow. Do not inject Beyfortus if the liquid is cloudy, discoloured or if it contains large or foreign
particles.
Do not use this medicinal product if the pre-filled syringe of Beyfortus has been dropped or is damaged or if the
safety seal on the box has been broken.
Administer the entire contents of the pre-filled syringe as an injectable preparation by the
intramuscular route, preferably in the anterolateral part of the thigh. The gluteal muscle should not
be used frequently as an injection site as there is a risk of damage to the sciatic nerve.
- Країна реєстрації
- Лікарська формаInjectable solution in pre-filled syringe, 50 mg
- Код АТХJ06BD08
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до BEYFORTUSЛікарська форма: Injectable or infusion solution, 300 mgДіюча речовина: Antiviral monoclonal antibodiesВиробник: ASTRAZENECA ABПотрібен рецептЛікарська форма: Injectable or infusion solution, 300 mg / 300 mgДіюча речовина: casirivimab and imdevimabВиробник: ROCHE REGISTRATION GMBHПотрібен рецептЛікарська форма: Injectable solution, 100 MG/MLДіюча речовина: palivizumabВиробник: ASTRAZENECA ABПотрібен рецепт
Аналоги BEYFORTUS в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог BEYFORTUS у Іспанія
Лікарі онлайн щодо BEYFORTUS
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на BEYFORTUS 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
BEYFORTUS потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у BEYFORTUS — Нирсевимаб. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
BEYFORTUS виробляється компанією SANOFI WINTHROP INDUSTRIE. 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 BEYFORTUS 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 BEYFORTUS 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 (Нирсевимаб) включають KAVIGALE, RONAPREVE, SYNAJIS. 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.
















