Инструкция по применению TRAKYELT
Содержание инструкции
- What is TRACYELT and what is it used for
- What you need to know before using TRACYELT
- How to use TRACYELT
- Possible side effects
- How to store TRACYELT
- Package Contents and Other Information
TRACYELT, Concentrate for infusion solution
(For term and preterm newborns, infants and children)
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 have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
This medicine is called TRACYELT, Concentrate for infusion solution, but will be referred to as
TRACYELT throughout this leaflet.
Contents of this leaflet
- 1. What TRACYELT is and what it is used for
- 2. What you need to know before you use TRACYELT
- 3. How to use TRACYELT
- 4. Possible side effects
- 5. How to store TRACYELT
- 6. Contents of the pack and other information
1. What is TRACYELT and what is it used for
TRACYELT is a concentrate for infusion solution, specifically designed for term and preterm newborns, infants and children.
It contains five trace elements (zinc, copper, manganese, iodine, selenium) considered essential because
the body is unable to produce them but needs them in minimal quantities to function properly.
Trace elements are normally provided by a balanced diet.
TRACYELT is used to provide trace elements to term and preterm newborns, infants and children, who are unable to
eat normally and require intravenous nutrition (in the vein).
2. What you need to know before using TRACYELT
Your child should not receiveTRACYELTif:
- they are allergic (hypersensitive) to any of the ingredients of TRACYELT (see section 6 of this leaflet).
- they suffer from Wilson's disease (an inherited disorder in which copper accumulates in the body).
- their blood shows unusually high levels of any of the medicinal product's components (If you have any doubts, consult your doctor).
Warnings and precautions
Consult your doctor before using TRACYELT if your child suffers from:
- liver or kidney problems.
- thyroid gland problems.
During treatment, your doctor will regularly monitor the levels of trace elements in the blood and adjust
the dosage of TRACYELT accordingly.
Other medicines and TRACYELT
Inform your doctor if your child is taking, has recently taken, or might take any
other medicines, including those available without a prescription.
TRACYELT contains sodium and potassium
This medicine contains less than 1 µmol (11.6 µg) of sodium per vial and less than 1 µmol (3.1 µg) of
potassium per vial, meaning it is essentially “sodium-free” and “potassium-free”.
3. How to use TRACYELT
TRACYELT will be administered to your child intravenously (into a vein) by infusion (EV drip) by a nurse or doctor. They will determine the correct dose for him/her.
Dosage
Full-term and premature neonates, infants and children (weighing 20 kg or less):
The basal requirement of the included trace elements is covered by 1 ml of TRACYELT per kilogram of body weight
per day, up to a maximum daily dose of 20 ml.
Children (weighing more than 20 kg):
A daily dose of 20 ml of TRACYELT meets the basal requirement of trace elements.
TRACYELT must be supplemented with a single injectable zinc solution in case of administration
to premature children to achieve a total zinc intake of 450-500 µg/kg/day via
parenteral route.
A daily iron infusion is recommended for premature children receiving long-term parenteral nutrition (> 3 weeks) and addition of molybdenum in case of parenteral nutrition >
4 weeks.
TRACYELT should not be administered directly to a patient but must be diluted before use.
If your child receives more TRACYELT than they should
It is extremely unlikely that your child could receive more infusion than they should, as
they will be monitored by the doctor or nurse during treatment. However, if you believe that your child
has received an excessive amount of TRACYELT, inform the doctor or nurse immediately.
The doctor will interrupt the treatment with TRACYELT and perform the necessary laboratory tests in case of
suspected overdose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, TRACYELT may cause side effects, although not everybody gets them.
Tell your doctor if you experience any of the following symptoms:
Frequency not known (cannot be estimated from the available data): pain at the application site.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store TRACYELT
After dilution, chemical and physical stability during use has been demonstrated for 48 hours at 25°C.
From a microbiological point of view, the product must be used immediately after dilution. If not
used immediately, the storage times during use and the conditions prior to use are
the responsibility of the user.
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 after SCAD. The expiry
date refers to the last day of that month.
Do not freeze.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What the medicine containsTRACYELT
The active ingredients are:
For 10 ml of TRACYELT (1 vial)
Zinc (Zn) 1,000 µg (as Zinc gluconate)
Copper (Cu) 200 µg (as Copper gluconate)
Manganese (Mn) 5 µg (as Manganese gluconate)
Iodine (I) 10 µg (as Potassium iodide)
Selenium (Se) 20 µg (as Sodium selenite)
The other ingredients are hydrochloric acid and water for injections.
Description of the appearance of TRACYELT and contents of the pack
TRACYELT is a clear and colourless concentrate for infusion solution, in 10 ml vials.
TRACYELT is packaged in boxes of 10 and 50 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoire AGUETTANT
1 rue Alexander Fleming
69007 LYON
France
Manufacturer responsible for batch release
Laboratoire AGUETTANT
Lieu-dit « Chantecaille »
07340 CHAMPAGNE
France
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The following information is intended exclusively for doctors or healthcare professionals.
Pharmaceutical information
Density 1.0
pH from 2.7 to 3.3
Osmolality 15 mosm/kg
Osmolarity 15 mosm/l
Incompatibilities:
TRACYELT must not be used as a vehicle for other medicines.
This medicine must not be mixed with other medicines except for 0.9% sodium chloride
and 5% glucose.
Shelf life:
24 months
After dilution, chemical and physical stability during use has been demonstrated for 48 hours at 25°C.
From a microbiological point of view, the product must be used immediately after dilution. If not
used immediately, the storage times during use and the conditions prior to use are
the responsibility of the user.
Special precautions for storage:
Do not freeze.
Instructions for use and handling:
Before use, check that the concentrate for infusion solution is homogeneous and that the vial is
intact and free from particles.
TRACYELT is not intended to be administered in its current formulation. TRACYELT must be
diluted or mixed with gentle agitation during preparation under strict aseptic conditions, before
infusion.
TRACYELT must be diluted in accordance with the appropriate final osmolarity.
For example:
- 5 or 10 ml of TRACYELT can be diluted in at least 50 ml of 0.9% sodium chloride solution for infusion or 5% glucose solution for infusion,
- 10 or 20 ml of TRACYELT can be diluted in at least 100 ml of 0.9% sodium chloride solution for infusion or 5% glucose solution for infusion.
- For these dilutions, the pH values vary approximately between 3.5-4.5. The reconstituted infusion solution must be visually inspected before use. Only a clear solution free from particles must be used. Do not store partially used containers and discard all equipment after use. Compatibility with solutions administered simultaneously via a common inlet cannula must be ensured.
- Страна регистрации
- Форма выпускаConcentrate for infusion solution, 10 ML
- Код АТХB05XA31
- 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 TRAKYELTФорма выпуска: Concentrate for injectable/infusion solution, 10MLДействующее вещество: electrolytes in combination with other drugsПроизводитель: LABORATOIRE AGUETTANTОтпускается без рецептаФорма выпуска: Concentrate for infusion solution, 1 G/10 MLДействующее вещество: Хлорид кальцияПроизводитель: BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI S.P.A.Отпускается по рецептуФорма выпуска: Concentrate for injectable/infusion solution, 500 MG/10 MLДействующее вещество: Хлорид кальцияПроизводитель: INDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L.Отпускается по рецепту
Аналоги TRAKYELT в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог TRAKYELT в Польша
Аналог TRAKYELT в Украина
Аналог TRAKYELT в Испания
Врачи онлайн по TRAKYELT
Обсудите применение TRAKYELT и возможные следующие шаги — по оценке врача.
Получите рецепт на TRAKYELT онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
TRAKYELT требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество TRAKYELT — electrolytes in combination with other drugs. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
TRAKYELT производится компанией LABORATOIRE AGUETTANT. 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 TRAKYELT 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 TRAKYELT 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 in combination with other drugs) включают SUPPLYELT, KALKIO KLORURO BIOINDUSTRIA L.I.M., KALKIO KLORURO GALENIKA SENESE. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















