VUEWAY 0.5 mmol/mL Injectable solution
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Інструкція із застосування VUEWAY
Зміст інструкції
Vueway 0.5 mmol/mL injectable solution
gadopiclenol
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
while taking this medicine. See the end of section 4 for information on how
to report adverse effects.
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, radiologist or pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor, radiologist or pharmacist. See section 4.
Contents of this leaflet
- 1. What Vueway is and what it is used for
- 2. What you need to know before you receive Vueway
- 3. How Vueway will be administered to you
- 4. Possible side effects
- 5. How to store Vueway
- 6. Contents of the pack and other information
1. What is Vueway and what is it used for
Vueway is a contrast agent that improves the contrast of images obtained during magnetic resonance imaging (MRI) examinations. Vueway contains the active substance gadopiclenol.
It improves the visualization and delineation of abnormal structures or lesions in some parts of the body and
helps to distinguish between healthy and diseased tissue.
It is used in adults and children (aged 2 years and over).
It is administered with an injection into a vein. This medicine is for diagnostic use only and
can only be administered by healthcare professionals experienced in the clinical practice of magnetic
resonance imaging.
2. What you need to know before receiving Vueway
Vueway must not be administered
- if the patient is allergic to gadopiclenol or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, radiologist or pharmacist before you receive Vueway:
- if you have had a previous reaction to any contrast agent,
- if you suffer from asthma,
- if you have a history of allergy (such as hay fever, urticaria),
- if you suffer from kidney disorders,
- if you have had seizures (fits) or are being treated for epilepsy,
- if you suffer from a disease involving the heart or blood vessels.
In all these cases, the doctor will decide whether the planned examination is possible or not. If Vueway is administered,
the doctor or radiologist will take the necessary precautions and the administration of Vueway
will be carefully monitored.
The doctor or radiologist may decide to perform a blood test to check kidney function before deciding to use Vueway, especially if the patient is 65
years of age or older.
Other medicines and Vueway
Tell your doctor, radiologist or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, you should inform your doctor, radiologist or pharmacist if you are taking or have recently
taken medicines for heart and blood pressure disorders, such as beta-blockers, vasoactive substances, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor
antagonists.
Pregnancy and breastfeeding
Pregnancy
Gadopiclenol can cross the placenta. It is not known whether it has effects on the baby. Tell your doctor or
radiologist if you suspect you are pregnant or if there is a possibility that you may become pregnant, as
Vueway should not be used during pregnancy unless strictly necessary.
Breastfeeding
Tell your doctor or radiologist if you are breastfeeding or are about to start breastfeeding.
The doctor will advise whether it is appropriate to continue or interrupt breastfeeding for a period of
24 hours after the administration of Vueway.
Driving and using machines
Vueway does not alter or negligibly alters the ability to drive vehicles and use machines.
However, if you feel unwell after the examination, do not drive or use machines.
Vueway contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 15 mL vial, i.e. it is
essentially "sodium-free".
3. How Vueway will be administered to you
Vueway will be injected into a vein by a qualified healthcare professional, using a small needle.
It can be administered manually or by means of an automatic injector.
The doctor or radiologist will determine the dose to be administered and will monitor the injection.
The usual dose of 0.1 mL/kg of body weight is the same for adults and children aged 2 years or older.
In children, the doctor or radiologist will use Vueway in vials with a single-use syringe, in order to
achieve better accuracy of the injected volume.
After the injection, you will be monitored for at least 30 minutes. Most adverse reactions (such as allergic reactions) can occur during this period. However, in rare cases,
reactions may occur after hours or days.
Use in patients with severe kidney problems
The use of Vueway is not recommended in patients with severe kidney problems. However, if use is
necessary, the patient should receive only one dose of Vueway during the examination and should not be
subjected to a second injection for at least 7 days.
Use in elderly patients
It is not necessary to modify the dose in patients aged 65 years or older, but they may be
subjected to a blood test to check kidney function.
If you receive more Vueway than you should
It is highly unlikely that you will receive an overdose of Vueway, as it will be administered by a
qualified healthcare professional. In this event, Vueway can be removed from the body
by hemodialysis (blood cleansing).
For further questions regarding the use of this medicine, please contact your doctor, radiologist or
pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
After the administration of Vueway, you will be kept under observation. Most side
effects occur within minutes. There is a small risk of allergic reaction to Vueway. These
effects can occur immediately, and up to seven days after the injection. Such reactions may
be serious and cause shock (a case of allergic reaction that can be life-threatening).
Immediately inform the doctor, radiologist or healthcare professional if you experience any of the
following side effects, as they could be the first signs of shock:
- swelling of the face, lips, tongue or throat
- dizziness (low blood pressure)
- difficulty breathing
- skin rash
- coughing, sneezing or runny nose
The possible side effects that have been observed during clinical trials with Vueway are listed below
according to their probability:
*"Reaction at the injection site" includes: pain, swelling, feeling of cold, feeling of heat,
bruising or redness.
**"Allergic reaction" may include: skin inflammation, skin redness, difficulty
breathing, hoarseness, throat tightness, throat irritation, abnormal sensation
in the mouth, transient facial flushing (early reactions) and eye swelling, swelling, rash and
itching (late reactions).
| Frequency | Possible side effects |
| a Common (may affect 1 in 10 people) | Reaction at the injection site* Headache |
| i Uncommon z (may affect 1 in 100 people) n e | Allergic reaction** Diarrhoea Nausea (feeling sick) Fatigue (tiredness) Abdominal pain Strange taste in mouth Feeling of heat Vomiting (being sick) |
Cases of nephrogenic systemic fibrosis (NSF) (which causes hardening of the skin and can
also affect soft tissues and internal organs) have been reported with other contrast agents containing gadolinium,
however, no cases of NSF have been reported with Vueway during clinical trials.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects through the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Vueway
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 label of the vial or the
pre-filled syringe and on the cardboard box after the date "Exp.". The expiry date refers to the
last day of that month.
This medicine is a clear solution, from colourless to pale yellow.
Do not use this medicine if the solution is not clear or if it contains visible particles.
For vials: this medicine does not require any special storage conditions.
Chemical and physical stability in use has been demonstrated for 24 hours up to 25 °C. From a
microbiological point of view, the medicine must be used immediately after opening.
For pre-filled syringes: do not freeze.
Do not dispose of any medicine in waste water 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 Vueway contains
- The active substance is gadopiclenol. Each mL of solution contains 485.1 mg of gadopiclenol (equivalent to 0.5 mmol of gadopiclenol and 78.6 mg of gadolinium).
- The other ingredients are tetraxetan, trometamol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections. See section 2 “Vueway contains sodium”.
Description of the appearance of Vueway and contents of the pack
It is a clear solution, from colourless to pale yellow.
It is available in packs comprising:
- 1 vial containing 3, 7.5, 10, 15, 30, 50 or 100 mL of injectable solution.
- 25 vials containing 7.5, 10 or 15 mL of injectable solution.
- 1 or 10 (10 x 1) pre-filled syringes containing 7.5, 10 or 15 mL of injectable solution.
- 1 pre-filled syringe containing 7.5, 10 or 15 mL of injectable solution with administration kit for manual injection (one extension tube and one catheter).
- 1 pre-filled syringe containing 7.5, 10 or 15 mL of injectable solution with administration kit for Optistar Elite injector (one extension tube, one catheter and one empty 60 mL plastic syringe).
- 1 pre-filled syringe containing 7.5, 10 or 15 mL of injectable solution with administration kit for Medrad Spectris Solaris EP injector (one extension tube, one catheter and one empty 115 mL plastic syringe).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bracco Imaging SPA
Via Egidio Folli, 50
20134 Milan
Italy
Manufacturer
Guerbet
16 rue Jean Chaptal
93600 Aulnay-sous-Bois
France
BIPSO GmbH
Robert-Gerwig-Strasse 4
Singen (Hohentwiel)
78224
Germany
Other sources of information
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 exclusively for healthcare professionals:
For details on how to use the product, please refer to section 6.6 Precautions for disposal and handling of this product’s Summary of Product Characteristics.
ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR VARIATION(S)
TO THE MARKETING AUTHORISATION(S)
Scientific conclusions
In light of the assessment by the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for gadopiclenol, the PRAC’s scientific conclusions are as follows:
In the light of the available data on administration during pregnancy and the available data on intrathecal administration from the literature, spontaneous reports and in the light of a plausible mechanism of action, the PRAC considers that a causal relationship between gadopiclenol and the risks associated with use during pregnancy and intrathecal administration is at least a reasonable possibility. The PRAC concluded that the product information for medicines containing gadopiclenol should be amended accordingly.
Having examined the PRAC recommendation, the Committee for Medicinal Products for Human Use (CHMP) agrees with the PRAC’s overall conclusions and with the justification for the recommendation.
Justification for variation(s) to the marketing authorisation(s)
Based on the scientific conclusions on gadopiclenol, the CHMP considers that the benefit-risk balance of the medicine containing/medicines containing gadopiclenol remains unchanged, subject to the proposed changes to the product information.
The CHMP recommends the variation(s) to the marketing authorisation(s).
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- Країна реєстрації
- Лікарська формаInjectable solution, 0.5 mmol/mL
- Код АТХV08CA12
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до VUEWAYЛікарська форма: Injectable solution, 0.5 mmol / mLДіюча речовина: ГадопикленолВиробник: GUERBETПотрібен рецептЛікарська форма: Injectable solution, 0,5 MMOL/MLДіюча речовина: Гадотеровая кислотаВиробник: GE HEALTHCARE ASПотрібен рецептЛікарська форма: Injectable solution, 0.5 mmol/mLДіюча речовина: Гадотеровая кислотаВиробник: BAYER S.P.A.Потрібен рецепт
Аналоги VUEWAY в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог VUEWAY у Іспанія
Аналог VUEWAY у Польща
Лікарі онлайн щодо VUEWAY
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на VUEWAY 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
VUEWAY потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у VUEWAY — Гадопикленол. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
VUEWAY виробляється компанією BRACCO IMAGING 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 VUEWAY 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 VUEWAY 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 (Гадопикленол) включають ELUKIREM, KLARIKYKLIK, DOTAGRAF. 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.
