POTASSIO 3 MEQ/ML Концентрат для инфузионного раствора
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Инструкция по применению POTASSIO AKETATO MONIKO
Содержание инструкции
POTASSIO ACETATO MONICO
3 mEq/ml concentrate for infusion solution
Potassio acetato
Generic medicine
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.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of this leaflet:
- 1. What POTASSIO ACETATO MONICO is and what it is used for
- 2. What you need to know before you use POTASSIO ACETATO MONICO
- 3. How to use POTASSIO ACETATO MONICO
- 4. Possible side effects
- 5. How to store POTASSIO ACETATO MONICO
- 6. Contents of the pack and other information
1. What is POTASSIO ACETATO MONICO and what is it used for
POTASSIO ACETATO MONICO is a saline solution for direct intravenous injection, which contains the
active ingredient potassium acetate.
This medicine is indicated:
- to provide the body with potassium and acetate when the administration of mineral salts by mouth (orally) is not possible;
- in addition to solutions for artificial nutrition when standard electrolyte solutions or nutrient solutions are not sufficient; for the treatment of moderate acidosis (conditions in which there is a significant increase in the amount of acid in the blood)
2. What you need to know before using POTASSIO ACETATO MONICO
Do not use POTASSIO ACETATO MONICO
- if you are allergic to potassium acetate or any of the other ingredients of this medicine (listed in section 6);
- if you have high levels of potassium in your blood (hyperkalaemia, potassium retention);
- if you suffer from severe liver, kidney or adrenal gland problems (hepatic, renal and adrenal insufficiency);
- if you have a disease of the adrenal glands (Addison's disease) that is not being treated;
- if you suffer from severe fluid loss from the body (acute dehydration);
- if you experience intense muscle pain (heat cramps);
- if you suffer from an inherited condition that causes muscle paralysis (episodic adynamia);
Warnings and precautions
Talk to your doctor or nurse before you are given POTASSIO ACETATO MONICO.
This medicine must be given to you very slowly via an intravenous infusion, because potassium intoxication may occur, which can lead to death due to loss of heart function (cardiac depression) and irregular heartbeat (arrhythmias) up to loss of heart activity (cardiac arrest) (See section 3).
This medicine must be administered with great cautionand under close medical supervision in the following cases:
- if you have heart problems (cardiopaties) and are taking other medicines for the heart (digitalis);
- if you have kidney problems (renal insufficiency), because it can cause potassium retention and therefore an increase in potassium concentration in the blood (hyperkalaemia);
- if you have adrenal gland problems (adrenal insufficiency);
- if you have liver problems (hepatic insufficiency);
- if you have an increase in blood pH (metabolic and respiratory alkalosis);
- in the presence of periodic familial paralysis (a disorder characterized by attacks of sudden muscle weakness);
- if you have congenital myotonia, a condition characterized by muscle stiffness;
- if you have had surgery recently.
During treatment with this medicine, your doctor will need to periodically check the concentration of potassium in your blood and heart function using serial electrocardiograms.
During treatment, you will be monitored for the amount of fluids in your body, the salts (electrolytes) present in your blood and the regulation of acidic substances in your blood (acid-base balance).
Children
In children, the safety and efficacy of potassium acetate have not been established, therefore this medicine should only be administered if absolutely necessary.
Other medicines and POTASSIO ACETATO MONICO
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
This medicine must be administered with cautionif you are taking medicines used to lower blood pressure such as potassium-sparing diuretics, especially if you have kidney problems, ACE inhibitors or other medicines that cause a decrease in aldosterone hormone levels, because they can lead to an increase in potassium in the blood (hyperkalaemia); in such cases, serum potassium levels must be closely monitored.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or nurse for advice before this medicine is given to you, as in these cases, the medicine can only be used if your doctor considers it absolutely necessary.
POTASSIO ACETATO MONICO should not be used during pregnancy or breastfeeding unless absolutely necessary.
Driving and operating machinery
Not applicable.
3. How to use POTASSIO ACETATO MONICO
This medicine will be administered to you by qualified healthcare personnel. If you have any doubts, consult your doctor or
nurse.
This medicine will be administered by direct injection into a vein (intravenous infusion), after
appropriate dilution and at a controlled rate, only if your kidney function is intact. An infusion that is too
fast can cause local pain.
The doctor will adjust the dosage and flow rate based on age, weight, your health conditions and
blood potassium levels.
The recommended dosein adults should ensure 40-80 mEq per day. The total dose should not exceed
200 mEq per day.
In case of emergency (when potassium levels in the blood are very low), the infusion rate and dose
may be increased by the doctor under careful electrocardiographic monitoring.
Use in children:
In children, this medicine should only be administered in cases of absolute necessity as the
safety and efficacy of the use of potassio acetato have not been determined. The recommended dose is 2-3
mEq per kg of body weight per day.
Preparation of the medicine:dilute the solution immediately after opening the container; the diluted solution
must be used immediately. This must be clear, colorless and free of visible particles. It is intended
for a single and uninterrupted administration and any residue cannot be used.
Shake well during the preparation of the dilution and before administration. Do not use the medicine if
the solution is not clear, colorless or if it contains particles. This medicine must not be
injected as is. It can cause death if injected undiluted.
This medicine must be diluted with a 5% glucose solution or a 0.9% sodium chloride solution (physiological
saline) and must not be mixed with other medicines.
Make sure to take all precautions to maintain sterility before and during intravenous
infusion.
If you use more POTASSIO ACETATO MONICO than you should
This medicine will be administered by qualified personnel, so it is unlikely that you will be
administered an excessive dose. However, if you think that you have been given an excessive dose of this
medicine, inform your doctor or another healthcare professional immediately, who will stop the
administration and adopt appropriate therapies.
If you have any doubts about the use of this medicine, ask your doctor or nurse for advice.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Not known(frequency cannot be estimated from available data)
- stomach and intestinal disorders (gastrointestinal);
- muscle and nerve disorders (neuromuscular), altered sensation in the limbs (paresthesia), flaccid paralysis, weakness;
- mental confusion;
- heartbeat alterations (arrhythmias), conduction disturbances, disappearance of the P wave, QRS widening on electrocardiogram;
- reduction of blood pressure (hypotension), cardiac arrest;
- fever, infection at the infusion site, inflammation of the veins at the injection site (phlebitis);
- circulation problems due to blood clot formation (thrombosis);
- leakage of the medicine into the tissues around the injection site (extravasation);
- increased blood volume in circulation (hypervolemia).
If side effects occur, administration should be stopped and the unadministered portion should be kept for
possible examinations.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor
or pharmacist. You can also report side effects directly through the national reporting system at 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 POTASSIO ACETATO MONICO
Keep this medicine out of sight and reach of children.
Medical and nursing staff are aware of the methods for storing the medicine.
Do not use this medicine after the expiry date which is stated on the pack after “EXP.”.
The expiry date refers to the last day of that month.
Store in the original packaging and in the original container tightly closed. Do not refrigerate or freeze.
The solution must be clear, colourless and free from visible particles. The diluted solution must be used
immediately and any unused residual medicine must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines
that you no longer use. This will help protect the environment.
6. Package contents and other information
WhatPOTASSIO ACETATO MONICO contains
POTASSIO ACETATO MONICO vials of 10 ml
- The active ingredient is potassium acetate. Each vial contains 2.94 g of potassium acetate (corresponding to 30 mEq/10 ml of potassium and 30 mEq/10 ml of acetate), pH 7.10 ÷ 7.70.
- The other component is water for injections.
POTASSIO ACETATO MONICO ampoules of 30 ml
- The active ingredient is potassium acetate. Each ampoule contains 8.83 g of potassium acetate (corresponding to 90 mEq/30 ml of potassium and 90 mEq/30 ml of acetate), pH 7.10 ÷ 7.70.
- The other component is water for injections.
Description of the appearance of POTASSIO ACETATO MONICO and package contents
Package containing 5 or 10 glass vials of 10 ml of concentrate for solution for infusion.
Package containing 10 glass ampoules of 30 ml of concentrate for solution for infusion.
Marketing Authorisation Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy
-----------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals
Dosage and administration
The dose is dependent on the age, weight and clinical condition of the patient, taking into consideration that the
daily potassium requirement is as follows.
Adults:40-80 mEq per day. The total dose should not exceed 200 mEq per day.
Children:2-3 mEq/kg per day.
In children, the safety and efficacy of potassium acetate use have not been established.
The medicine must not be injected as is.It is fatal if infused undiluted.
The medicine must be administered intravenously only after dilutionin 5% glucose solution or
0.9% sodium chloride solution (physiological saline).
The medicine must be administered intravenously only after dilutionwith compatible solutions and at a
controlled infusion rate.
The medicine must be administered only with intact renal function and at a rate not exceeding 10
mEq potassium/hour.
Infusions that are too rapid can cause local pain and the infusion rate must be adjusted according to
tolerance.
Dilute the solution immediately after opening the container; the diluted solution must be used
immediately. This must be clear, colorless and free of visible particles. It is for single and
uninterrupted administration and any remaining solution cannot be used.
Shake well during preparation of the dilution and before administration.
Emergency conditions
In emergency conditions (potassium levels less than or equal to 2 mEq/l with electrocardiographic changes and
muscle paralysis) do not exceed an infusion rate of 40 mEq/hour, under
electrocardiographic monitoring and do not exceed a dose of 400 mEq in 24 hours.
OVERDOSAGE
In case of overdose, immediately stop the infusion of the solution containing potassium and initiate
corrective therapy to reduce elevated plasma potassium levels and restore, if necessary, acid-base balance.
Incompatibilities
Unless otherwise indicated, and with the exception of the solutions indicated in the paragraph “Dosage and administration”,
mixing potassium acetate solution with other medicines is not recommended.
Special precautions for disposal and handling
Do not use the medicine if the solution is not clear, colorless or if it contains particles.
Take all usual precautions to maintain sterility before and during intravenous infusion.
Unused medicine and waste derived from such medicine must be disposed of in accordance with
current local regulations.
For further information, see the Summary of Product Characteristics.
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- Страна регистрации
- Форма выпускаConcentrate for infusion solution, 3 MEQ/ML
- Код АТХB05XA17
- 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 POTASSIO AKETATO MONIKOФорма 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 рецептуФорма выпуска: Concentrate for infusion solution, 1 G/10 MLДействующее вещество: Хлорид кальцияПроизводитель: S.A.L.F. SPA LABORATORIO FARMACOLOGICOОтпускается по рецепту
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Действующее вещество POTASSIO AKETATO MONIKO — Ацетат калия. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
POTASSIO AKETATO MONIKO производится компанией MONICO S.P.A.. 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 POTASSIO AKETATO MONIKO с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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