SONOVUE 8 MCG/ML Порошок и раствор для инъекционной суспензии
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Инструкция по применению SONOVUE
Содержание инструкции
- What is SonoVue and what is it used for
- What you need to know before SonoVue is administered to you
- How SonoVue is administered
- Possible side effects
- How to store SonoVue
- Contents of the pack and other information
SonoVue, 8 microliters/mL, powder and solvent for injectable dispersion
Sulfur hexafluoride
Read this leaflet carefully before you are given this medicine because
it contains important information for you
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What SonoVue is and what it is used for
- 2. What you need to know before you are given SonoVue
- 3. How SonoVue is given
- 4. Possible side effects
- 5. How to store SonoVue
- 6. Contents of the pack and other information
1. What is SonoVue and what is it used for
SonoVue is used only for diagnostic use.
SonoVue is an ultrasound contrast agent containing microbubbles filled with a gas called
sulfur hexafluoride.
If you are an adult, SonoVue will allow you to obtain clearer ultrasound images of the heart,
blood vessels and/or tissues of the liver and breast.
SonoVue will allow you to obtain more defined images of the urinary tract in children.
2. What you need to know before SonoVue is administered to you
Do not use SonoVue:
- if you are allergic to sulfur hexafluoride or any of the other ingredients of this medicine (listed in section 6),
- if you have been told you have a right-to-left shunt in the heart,
- if you have severe pulmonary hypertension (pressure in the pulmonary artery > 90 mmHg),
- if you have uncontrolled hypertension,
- if you have adult respiratory distress syndrome (a serious condition characterized by widespread inflammation in the lungs),
- if you have been told not to take dobutamine (a medicine that stimulates the heart) due to your serious heart condition.
Warnings and precautions
Tell your doctor if you have had:
- frequent and/or recurrent episodes of angina or chest pain or if you have a history of heart disease,
- recent changes in your electrocardiogram. See your doctor before SonoVue is administered to you if:
- you have recently had a myocardial infarction or undergone coronary artery surgery,
- you suffer from angina or chest pain or severe heart disease,
- you suffer from severe cardiac arrhythmias,
- your heart condition has recently worsened,
- you have acute inflammation of the cardiac envelope (endocarditis),
- you have artificial heart valves,
- you have acute general inflammation or infection,
- you have known coagulation problems,
- you have severe kidney or liver disease.
If SonoVue has been given to you together with a medicine, exercise or device that stimulates the heart
to visualize the heart under stress, your heart activity, blood pressure and
heart rate will be monitored.
SonoVue contains macrogol, an ingredient also known as polyethylene glycol (PEG). Serious allergic
reactions have been reported. There may be an increased risk of serious reactions in
patients with a history of allergic reactions to PEG. Tell your doctor if you have had previous allergic
reactions to products containing PEG.
Close medical supervision for at least 30 minutes is necessary after
administration of SonoVue to monitor the risk of serious allergic reactions.
Children and adolescents
For patients under 18 years of age, SonoVue can only be used for ultrasound of the
urinary tract.
Other medicines and SonoVue
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
In particular, tell your doctor if you are taking beta-blockers (medicines for heart disease and
for hypertension or for glaucoma in the form of eye drops).
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 before you are given this medicine.
It is not known whether SonoVue passes into breast milk. However, you should stop breastfeeding for two or three
hours after the ultrasound examination.
Driving and using machines
SonoVue does not affect the ability to drive vehicles and use machines.
SonoVue contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. practically sodium-free.
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3. How SonoVue is administered
SonoVue is administered by medical or healthcare personnel who have experience in this type of
examinations.
For use in heart and vessel and/or liver and breast tissue ultrasound in adults,
the dose to be administered intravenously will be calculated based on the part of the body to be examined. The recommended dose is 2 or 2.4 mL per patient. This dose may be repeated, if necessary, up to 4.8 mL.
For use in urinary tract ultrasound in children, the recommended dose is 1 mL per patient
to be administered into the bladder as follows: after bladder emptying, some
physiological solution will be introduced into the bladder via a thin catheter; then SonoVue will be administered
via the catheter, followed by further physiological solution to continue bladder filling.
Bladder filling and emptying with saline solution can be repeated, if necessary.
Close clinical monitoring will be maintained during and for at least 30 minutes after the injection of
SonoVue if you have severe pulmonary or cardiac problems.
If you are given more SonoVue than you should
Overdosage is unlikely as SonoVue is administered by a doctor. In case of
overdosage the doctor will take appropriate action.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the side effects of SonoVue are rare and generally not serious. However, some patients may experience serious side effects and may require therapies.
Inform your doctor immediatelyif any of the following side effects occur, as medical treatment may be needed:
- swelling of the face, lips, mouth, or throat that may make it difficult to swallow or breathe; skin rash; hives; swelling of the hands, feet or ankles.
The following side effects have been reported with SonoVue:
Not common(may affect up to 1 in 100 people):
- Headache,
- Numbness,
- Dizziness,
- Taste alteration,
- Flushing,
- Chest discomfort,
- Feeling unwell (nausea),
- Abdominal pain,
- Skin redness,
- Feeling of warmth,
- Local reaction at the injection site: pain and unusual sensation at the injection site,
Rare(may affect up to 1 in 1000 people):
- Blurred vision,
- Decreased blood pressure,
- Itching
- Back pain
- Pain in general,
- Chest pain,
- Fatigue,
- Severe and moderate allergic reaction (including skin flushing, decreased heart rate, decreased blood pressure, shortness of breath, loss of consciousness, cardiac/cardiorespiratory arrest or more severe reaction with difficulty breathing and dizziness).
With unknown frequency(frequency cannot be estimated from available data):
- Chest pain, radiating to the neck or left arm, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.
- Fainting,
- In some cases of allergic reactions, lack of oxygen supply to the heart or cardiac arrest has been reported in patients with heart disease of the blood vessels.
- Vomiting
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at the address given in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.
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5. How to store SonoVue
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. The expiry date refers to
the last day of that month.
This medicine does not require any particular storage conditions.
SonoVue must be administered within 6 hours of preparation.
6. Contents of the pack and other information
What SonoVue contains
- The active ingredient is sulfur hexafluoride in the form of microbubbles,
- The other ingredients are: Macrogol 4000, distearoylphosphatidylcholine, sodium dipalmitoylphosphatidylglycerol, palmitic acid. The glass syringe contains sodium chloride 9 mg/mL (0.9%) in injectable solution.
Description of the appearance of SonoVue and contents of the pack
SonoVue is a kit that includes a glass vial containing white powder, a glass syringe
containing the solvent and a transfer system.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bracco International B.V.
Strawinskylaan 3051
NL-1077 ZX Amsterdam
Netherlands.
Manufacturer
Bracco Imaging S.p.A
Via Ribes 5, Bioindustry Park
Colleretto Giacosa-10010 ( TO )
Italy
This leaflet was last updated
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:
If SonoVue is not used immediately after reconstitution, the dispersion must be shaken
again before being drawn up into a syringe.
This product is for a single examination. Any unused liquid remaining at the end of an examination
must be discarded.
Instructions for reconstitution:
23
45
678
- 1. Connect the plunger by screwing it into the syringe clockwise.
- 2. Open the packaging of the MiniSpike transfer system and remove the needle cap of the syringe.
- 3. Open the cap of the transfer system and connect the syringe to the transfer system by screwing it clockwise.
- 4. Remove the protective disc from the vial. Insert the vial into the transparent sleeve of the transfer system and press firmly to lock the vial into place.
- 5. Empty the contents of the syringe into the vial by pressing on the plunger.
- 6. Shake vigorously for 20 seconds to mix all the contents of the vial (to obtain a homogeneous milky white liquid).
- 7. Invert the system and carefully draw SonoVue into the syringe.
- 8. Unscrew the syringe from the transfer system.
After reconstitution, SonoVue is a homogeneous milky white dispersion.
Do not use if the resulting liquid is clear and/or if solid particles
of lyophilized material are visible in the suspension.
SonoVue must be administered within six hours of preparation.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
- Страна регистрации
- Форма выпускаPowder and solvent for injectable suspension, 8 MCG/ML
- Код АТХV08DA05
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги SONOVUEФорма выпуска: Injectable solution, 1,5 MLДействующее вещество: perflutren, phospholipid microspheresПроизводитель: LANTHEUS EU LIMITEDОтпускается по рецептуФорма выпуска: Injectable suspension, 5-8X108/ML, 0.22MGДействующее вещество: perflutren, human albumin microspheresПроизводитель: GE HEALTHCARE ASОтпускается без рецептаФорма выпуска: Injectable solution, 0,5 MMOL/MLДействующее вещество: Гадотеровая кислотаПроизводитель: GE HEALTHCARE ASОтпускается по рецепту
Аналоги SONOVUE в других странах
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Аналог SONOVUE в Испания
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
SONOVUE не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество SONOVUE — sulfur hexafluoride, phospholipid microspheres. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
SONOVUE производится компанией BRACCO INTERNATIONAL B.V.. 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 SONOVUE 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 SONOVUE 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 (sulfur hexafluoride, phospholipid microspheres) включают LUMINITY, OPTISON, KLARIKYKLIK. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
