IONOVOL 500 ML Инфузионный раствор
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Инструкция по применению IONOVOL
Содержание инструкции
Ionovol solution for infusion
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you want any more information or advice, ask your doctor or pharmacist.
- If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Ionovol is and what it is used for
- 2. What you need to know before you are given Ionovol
- 3. How Ionovol is administered
- 4. Possible side effects
- 5. How to store Ionovol
- 6. Contents of the pack and other information
1. What is Ionovol and what is it used for
Ionovol is an infusion solution.
Ionovol is used for the treatment of:
- Extracellular dehydration (loss of water)
- Hypovolemia (sudden decrease in circulating blood volume)
- Mild metabolic acidosis (increase in blood acidity caused by metabolic disorder)
2. What you need to know before you are given Ionovol
Do not use Ionovol
- If you are allergic to sodium acetate trihydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate or any of the other ingredients of this medicine (listed in section 6).
You must not receive Ionovol if you have:
- Hyperhydration (too much fluid in the body), especially in cases of pulmonary edema (fluid accumulation in the lungs) and congestive heart failure (the heart is unable to pump a sufficient amount of blood into the body)
- Severe impairment of kidney function
- Metabolic alkalosis (decrease in blood acidity caused by metabolic disorders)
- Hyperkalemia (too high levels of potassium in the blood)
The doctor will check these conditions.
Particular attention will be paid with Ionovol if:
- You have heart failure
- You have serious disturbances of the heart rate
- You have impaired kidney function
- You have severe electrolyte disturbances (for example, too high levels of potassium, sodium, magnesium or chloride in the blood)
- You have high blood pressure
- You suffer from eclampsia (complication of pregnancy that mainly manifests with high blood pressure and significant amounts of protein in the urine)
- you suffer from aldosteronism (syndrome of high blood pressure and low potassium levels in the blood caused by an excess of the natural hormone aldosterone)
- You have other treatments or conditions associated with sodium retention (for example corticosteroids / steroids)
- You are taking potassium-sparing diuretics (used to increase urine volume)
- You have a severe potassium deficiency
- You have taken high doses of digitalis (a medicine used to treat heart disease)
- You suffer from myasthenia gravis (a disease involving severe muscle weakness)
- You have recently undergone surgery in which a muscle relaxant (neuromuscular block) was used
- large amounts of this solution are used
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ionovol.
Children and adolescents
There are no particular warnings and precautions.
Other medicines and Ionovol
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Ionovol is not recommended if you are taking/using:
- corticosteroids / steroids and carbenoxolone (for the treatment of ulcers of the digestive tract) because these are associated with sodium and water retention (with fluid accumulation in the tissues and high blood pressure)
- potassium-sparing diuretics (used to increase urine volume, such as amiloride, spironolactone, triamterene, administered alone or in combination)
- angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists (medicines that are mainly used to control blood pressure and treat heart failure)
- tacrolimus and cyclosporine (medicine used to prevent organ rejection)
- Muscle relaxants
- salicylates (used to relieve pain and reduce fever)
- lithium (antidepressant)
- alkaline medicines such as sympathomimetics (such as amphetamines).
Ionovol with food and drink
There is no known negative effects of Ionovol when administered together with food and drink.
Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with milk
ask your doctor for advice before taking this medicine.
This medicine can be used safely during pregnancy and breastfeeding as long as
electrolyte and fluid balance is controlled.
When another medicine is added to Ionovol, the nature of the drug and its use during
pregnancy and breastfeeding must be considered separately. The doctor will discuss this with
you.
Driving and operating machinery
Ionovol has no effects on your ability to drive vehicles or operate machinery.
3. How Ionovol is administered
Ionovol will be administered to you in hospital by a doctor or nurse.
It will be administered by intravenous infusion (infusion into a vein).
The amount and the rate at which the infusion is administered depends on your condition. The
doctor will decide the correct dose to receive.
If you receive more Ionovol than you should
It is very unlikely that you will receive more infusion than you should, because the medicine will be
administered by the doctor or nurse who will monitor you during treatment. However, inform the
doctor or nurse if you have any concerns.
In the event of accidental overdose, treatment will be stopped and you will be monitored for signs and
symptoms related to the drug. Fluid removal therapy may be necessary.
If you have any doubts 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.
Very common (may affect more than 1 in 10 people):
- hyperhydration (too much fluid in the body) and heart failure in patients with heart disorder or pulmonary edema (fluid accumulation in the lungs)
Common (may affect up to 1 in 10 people):
- Large volumes of this solution may lead to dilution of blood components and a decrease in hematocrit (percentage of blood volume occupied by red blood cells)
Other side effects include:
- fluid accumulation in the tissues (edema)
- fever
- Infection at the injection site, pain or local reaction
- venous irritation, venous thrombosis (blood clot formation) or phlebitis (inflammation of the veins) extending from the injection site
- extravasation (leakage of fluid from the vein)
You will be monitored by the doctor or nurse during treatment with this medicine. If any
of these side effects occur, treatment will be stopped.
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 at http:// www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Ionovol
Do not refrigerate or freeze.
Keep this medicine out of sight and reach of children.
The medicine must be used immediately after opening.
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.
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 Ionovol contains
The active ingredients are
500 ml 1000 ml
Sodium acetate trihydrate 2.32 g 4.63 g
Sodium chloride 3.01 g 6.02 g
Potassium chloride 0.15 g 0.30 g
Magnesium chloride hexahydrate 0.15 g 0.30 g
Electrolytes:
Na 137.0 mmol/l
K 4.0 mmol/l
Mg 1.5 mmol/l
Cl 110.0 mmol/l
CH COO 34.0 mmol/l
Theoretical osmolarity: 286.5 mOsm/l
Titratable acidity: < 2.5 mmol NaOH/l
pH: 6.9 – 7.9
The other components are:
water for injections
sodium hydroxide (to adjust the pH)
hydrochloric acid (to adjust the pH)
Description of the appearance of Ionovol and package contents
Ionovol is a clear and colorless solution packaged in a flexible plastic bag sealed
known as a freeflexbag or in a plastic bottle known as KabiPac .
The solution is available in bags or bottles of 500 ml and 1000 ml.
Polyolefin bag (freeflex®) with overpouch: 20 x 500 ml, 10 x 1000 ml
LDPE bottle (KabiPac ): 10 x 500 ml, 20 x 500 ml, 10 x 1000 ml
Not all pack sizes may be marketed.
Marketing authorization holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala, Verona
Manufacturer responsible for batch release
Fresenius Kabi Deutschland GmbH
61169 Friedberg
Fresenius Kabi France
6 rue du Rempart
27400 Louviers
This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
| Belgium | Ionolyte, solution for infusion |
| Bulgaria | Ionolyte инфузионен разтвор |
| a Croatia | Ionolyte, otopina za infuziju |
| i Cyprus | Ionolyte, διάλυμα για έγχυση |
| Repubblica Ceca | Isolyte, Infuzní roztok |
| z France | Ionoven, solution for perfusion |
| Greece | Ionolyte, διάλυμα για έγχυση |
| n Hungary | Isolyte, oldatos infúzió |
| e Ireland | Ionolyte Solution for infusion |
| Italy | Ionovol |
| g Malta | Ionolyte Solution for infusion |
| Netherlands | Ionolyte, oplossing voor infusie |
| Norway | Ionolyte infusjonsvæske, oppløsning |
| A Poland | Venolyte |
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The following information is intended for healthcare professionals only:
Posology
Adult and paediatric patients
The dose and rate of administration depend on the patient's age, body weight, clinical and
biological conditions (including acid-base balance) and concomitant therapy
Recommended dosage:
The maximum daily dose corresponds to the fluids and electrolytes needed by the patient. To
temporarily restore blood volume, 3 to 5 times the volume of blood lost is required.
Typical recommended dosages are:
For adults, the elderly and adolescents (aged 12 years and over): from 500 ml to 3 litres/24 hours.
For neonates, infants and children (from 28 days to 11 years of age): from 20 ml/kg to 100 ml/kg/24
hours.
Rate of administration:
In continuous treatment outside of acute fluid losses, the infusion rate is generally
40 ml/kg/24 hours in adults.
In paediatric patients, the infusion rate is 5 ml/kg/hour on average, but the value varies with age: 6-8
ml/kg/hour for neonates, 4-6 ml/kg/hour for infants, and 2-4 ml/kg/hour for children.
Route of administration
For intravenous use.
| Portugal | o Ionoven, solução para perfusão |
| Romania | Ionolyte soluţie perfuzabilă |
| Slovacchia | c Isolyte, infúzny roztok |
| Slovenia | Ionolyte raztopina za infundiranje |
| Spain | a IONOLYTE solución para perfusión |
| United Kingdom | Ionolyte Solution for infusion |
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- Страна регистрации
- Форма выпускаInfusion solution, 500 ML
- Код АТХB05BB01
- 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 IONOVOLФорма выпуска: Infusion solution, 500 MLДействующее вещество: electrolytesПроизводитель: BAXTER S.P.A.Отпускается по рецептуФорма выпуска: Infusion solution, 100 MLДействующее вещество: electrolytesПроизводитель: INDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L.Отпускается по рецептуФорма выпуска: Infusion solution, 100 MLДействующее вещество: electrolytesПроизводитель: BAXTER S.P.A.Отпускается по рецепту
Аналоги IONOVOL в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог IONOVOL в Польша
Аналог IONOVOL в Украина
Аналог IONOVOL в Испания
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
IONOVOL требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество IONOVOL — electrolytes. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
IONOVOL производится компанией FRESENIUS KABI ITALIA S.R.L.. 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 IONOVOL 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 IONOVOL 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 (electrolytes) включают KRYSTALSOL, ELETTROLITIKA BILANKIATA DI MANTENIMENTO KON LUKOSIO GALENIKA SENESE, ELETTROLITIKA DI REINTEGRATSIONE KON SODIO LUKONATO BAXTER. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
