ELUCIREM 0.5 ммоль/мл Инъекционный раствор
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Инструкция по применению ELUKIREM
Содержание инструкции
Elucirem 0.5 mmol/mL injectable solution
gadopiclenol
Medicinal product subject to additional monitoring. This will allow the rapid identification of new
information on safety. 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.
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 Elucirem is and what it is used for
- 2. What you need to know before you are given Elucirem
- 3. How Elucirem will be given to you
- 4. Possible side effects
- 5. How to store Elucirem
- 6. Contents of the pack and other information
1. What is Elucirem and what is it used for
Elucirem is a contrast agent that improves the contrast of images obtained during magnetic resonance imaging (MRI) examinations. Elucirem 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 Elucirem
Elucirem must not be administered
- if the patient is allergic to gadopiclenol or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, radiologist or pharmacist before you receive Elucirem:
- 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. In case of administration
of Elucirem, the doctor or radiologist will take the necessary precautions and the administration of Elucirem
will be carefully monitored.
The doctor or radiologist may decide to perform a blood test to check kidney function
before deciding to use Elucirem, especially if the patient is 65 years of age or older
years.
Other medicines and Elucirem
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, substances
vasoactive, 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 Elucirem should not be used during pregnancy unless it is
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 Elucirem.
Driving and using machines
Elucirem 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.
Elucirem 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 Elucirem will be administered to you
Elucirem 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 Elucirem in vials with a single-use syringe, in order to
achieve better precision in the volume injected.
After the injection, you will be monitored for at least 30 minutes. In this period, most adverse reactions (such as allergic reactions) may occur. However, in rare cases,
reactions may occur after hours or days.
Use in patients with severe kidney problems
The use of Elucirem is not recommended in patients with severe kidney problems. However, if use is
necessary, the patient should receive a single dose of Elucirem 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 Elucirem than you should
It is highly unlikely that you will receive an overdose of Elucirem, as it will be administered by a
qualified healthcare professional. In this eventuality, Elucirem 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 Elucirem, you will be kept under observation. Most side
effects occur within minutes. There is a small risk of allergic reaction to Elucirem.
These effects can occur immediately, and up to seven days after the injection. Such reactions
can 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 Elucirem 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, impaired voice, 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** Diarrhea 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 Elucirem during clinical trials.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. 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 Elucirem
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 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 Elucirem contains
- The active ingredient 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 “Elucirem contains sodium”.
Description of the appearance of Elucirem and package contents
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
Guerbet
15 rue des Vanesses
93420 Villepinte
France
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 website of the European
Medicines Agency: http://www.ema.europa.eu .
<------------------------------------------------------------------------------------------------------------------------>
The following information is intended exclusively for healthcare professionals:
For details on how to use the product, please refer to section 6.6 Special precautions for
disposal and handling in the Summary of Product Characteristics of this product.
Annex IV
Scientific conclusions and justification for the variation of the terms of the marketing
authorisation/authorisations
Scientific conclusions
Taking into account the assessment of the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report/Periodic Safety Update Reports (PSUR) for gadopiclenol, the scientific conclusions of the PRAC are as follows:
In light of the available data on use during pregnancy and the available data on intrathecal administration drawn from the literature, spontaneous reports and in 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 Human Medicinal Products
(CHMP) agrees with the PRAC’s overall conclusions and with the justification for the recommendation.
Justification for the variation of the terms of the marketing
authorisation/authorisations.
Based on the scientific conclusions on gadopiclenol, the CHMP considers that the benefit/risk
ratio of the medicine containing/medicines containing gadopiclenol is unchanged, subject to the proposed changes to the product information.
The CHMP recommends the variation of the terms of the marketing authorisation/authorisations.
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- Страна регистрации
- Форма выпускаInjectable solution, 0.5 mmol / mL
- Код АТХV08CA12
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги ELUKIREMФорма выпуска: Injectable solution, 0.5 mmol/mLДействующее вещество: ГадопикленолПроизводитель: BRACCO IMAGING S.P.A.Отпускается по рецептуФорма выпуска: Injectable solution, 0,5 MMOL/MLДействующее вещество: Гадотеровая кислотаПроизводитель: GE HEALTHCARE ASОтпускается по рецептуФорма выпуска: Injectable solution, 0.5 mmol/mLДействующее вещество: Гадотеровая кислотаПроизводитель: BAYER S.P.A.Отпускается по рецепту
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Часто задаваемые вопросы
ELUKIREM требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ELUKIREM — Гадопикленол. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ELUKIREM производится компанией GUERBET. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения ELUKIREM с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить ELUKIREM в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Гадопикленол) включают VUEWAY, KLARIKYKLIK, DOTAGRAF. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
