SODIO AKETATO MONIKO 3 MEQ/ML Concentrate for infusion solution
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Інструкція із застосування SODIO AKETATO MONIKO
Зміст інструкції
APPENDIX
The changes relating to the medicinal product Sodio Acetato Monico, with procedure code
N1B/2015/3508, covered by this notification, are reported below.
SODIO ACETATO MONICO
3 mEq/ml/ml concentrate for infusion solution
Sodium acetate trihydrate
Generic medicine
Read this leaflet carefully before you are administeredthis medicine because
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 for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If any undesirable effects occur, including any not listed in this leaflet, tell your doctor or nurse. See section 4.
Contents of this leaflet:
- 1. What SODIO ACETATO MONICO is and what it is used for
- 2. What you need to know before you are administered SODIO ACETATO MONICO
- 3. How to use SODIO ACETATO MONICO
- 4. Possible side effects
- 5. How to store SODIO ACETATO MONICO
- 6. Contents of the pack and other information
1. What is SODIO ACETATO MONICO and what it is used for
SODIO ACETATO MONICO is a saline (electrolytic) solution for intravenous injection that contains the
active ingredient sodium acetate.
This medicine is indicated to provide the body with sodium and acetate, in order to restore the
correct concentration of salts in fluids and re-establish the normal pH of the blood, when a
significant increase in the amount of acids occurs (moderate metabolic acidosis).
2. What you need to know before you are given SODIO ACETATO MONICO
Do not use SODIO ACETATO MONICO
- if you are allergic to sodium acetate, to other similar substances or to any of the other ingredients of this medicine (listed in section 6);
- if you suffer from severe liver problems (severe hepatic insufficiency, with inability to metabolize the acetate ion);
- if you have low levels of calcium in the blood (hypocalcemia).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given SODIO
ACETATO MONICO.
This medicine must be administered to you with great care and under strict medical supervision in the following cases:
- if you suffer from heart problems (congestive heart failure, cardiac insufficiency);
- if you have severe kidney problems (severe renal insufficiency, reduced kidney function);
- if you experience swelling due to fluid retention, with salt reabsorption (saline retention). Swelling may affect the legs, ankles (peripheral edema), or the lungs (pulmonary edema);
- if you are taking medicines:
- that increase or reduce the force of heart contraction (cardiac inotropic drugs),
- used for the treatment of inflammation and allergies (corticosteroids),
- that stimulate the production of steroid hormones (corticotropic) (See section “Other medicines and SODIO ACETATO MONICO”);
- if you suffer from high blood pressure (hypertension);
- if you are pregnant and suffer from a condition called pre-eclampsia characterized by high blood pressure, swelling due to fluid retention and the presence of protein in the urine;
- if you suffer from other conditions that occur when the body retains a lot of sodium (sodium retention);
- if you have an increase in the amount of basic substances in the blood (increase in pH, metabolic and respiratory alkalosis);
- if you suffer from non-severe liver problems (mild or moderate hepatic insufficiency).
During treatment, the doctor will monitor the amount of fluids in the body,
the salts (electrolytes) present in the blood (plasma osmolarity) and the regulation of acidic
substances in the blood (acid-base balance).
Other medicines and SODIO ACETATO MONICO
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines.
This medicine must be administered with caution if you are taking medicines for the
treatment of inflammation (corticosteroids) or medicines that contain sodium (sodium salts)
because they prevent the body from eliminating sodium and water, causing fluid accumulation
(edema) and increased blood pressure (hypertension).
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or nurse for advice before you are given this
medicine.
If you are pregnant or breastfeeding, use this medicine only when absolutely
necessary and under the direct supervision of your doctor.
Driving and using machines
This medicine does not impair the ability to drive vehicles and operate machinery.
3. How to use SODIO ACETATO MONICO
This medicine will be administered to you by qualified healthcare personnel. If you have any doubts, consult your
doctor, pharmacist or nurse.
This medicine will be administered by intravenous infusion (endovenous), after appropriate
dilution.
The doctor will adjust the dosage and flow rate based on: age, weight, health conditions, amount of
fluids in the body, the amount of salts (electrolytes) present in the blood (plasma osmolarity) and the
acid substances in the blood (acid-base balance).
If you use more SODIO 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.
Following the administration of an excessive dose of this medicine, the following may occur:
- increased levels of sodium in the blood (hypernatremia);
- increased blood volume circulating in the body (hypervolemia). If sodium levels in the blood increase too much, a loss of fluids from internal organs (dehydration) may occur, particularly in the brain, and an accumulation of extracellular fluids that may affect the cerebral, pulmonary and peripheral circulation, leading to fluid accumulation around the lung (pulmonary edema) or swelling in the legs and ankles (peripheral edema).
If you think that you have been administered an excessive amount of this medicine, contact your
doctor or nurse immediately.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist 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(the frequency of which cannot be estimated from available data)
- increased levels of sodium in the blood (hypernatremia);
- increased blood volume circulating in the body (hypervolemia);
- alteration of the levels of fluids and substances in the blood (hypoosmolality);
- headache;
- dizziness;
- restlessness;
- fever, weakness;
- irritability;
- muscle stiffness;
- convulsions;
- coma and death;
- drowsiness, confusion;
- difficulty breathing (dyspnea);
- cessation of breathing (respiratory arrest);
- swelling due to fluid accumulation around the lungs (pulmonary edema) or at the level of the legs and ankles (peripheral edema);
- thirst, reduced salivation and tear production;
- nausea, vomiting, diarrhea;
- abdominal pain;
- increased heart rate (tachycardia);
- kidney problems (renal failure);
- increase (hypertension) or decrease (hypotension) in blood pressure;
- infection, pain and irritation at the injection site of the medicine;
- circulation problems due to the formation of blood clots (thrombosis);
- inflammation of the veins at the injection site (phlebitis);
- damage and death of the tissue where the medicine was administered (tissue necrosis).
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 SODIO ACETATO MONICO
Keep this medicine out of sight and reach of children.
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 package and in the original container, tightly closed. Do not refrigerate or
freeze.
Medical and nursing staff are aware of the storage conditions of the medicine.
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
WhatSODIO ACETATO MONICO contains
- The active ingredient is sodium acetate trihydrate.
- 10 ml of solution contains 4.08 g of sodium acetate trihydrate.
- 30 ml of solution contains 12.25 g of sodium acetate trihydrate. (each ml contains 3 mEq of sodium and acetate)
- The other ingredients (excipients) are: water for injections (pH: 7.1 - 7.7).
Description of the appearance of SODIO ACETATO MONICO and contents of the pack
Package containing 5 or 10 vials of 10 ml concentrate for solution for infusion.
Package containing 10 glass bottles of 30 ml 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 for healthcare professionals only
Dosage and method of administration
Adults
Initial dose of 2 to 5 mEq/kg of body weight over 4-8 hours depending on the severity
of the acidosis. The dose should then be adjusted based on blood bicarbonate concentrations
measured or the results of blood gas analysis (increase of 20-22 mmol/L).
Children
Initial dose of 1 mEq/Kg administered by slow intravenous infusion, diluting the solution to 0.5
mEq/ml, up to a maximum dosage of 8 mEq/kg of body weight per day to avoid
excessive decrease in cerebrospinal fluid pressure and possible intracranial haemorrhages.
In children, the safety and efficacy of sodium acetate have not been established.
Elderly
In elderly patients over 60 years of age, the maximum dose is 90-100 mEq of acetate per day.
It is advisable NOT to achieve full correction of acidosis within the first 24 hours to avoid
alkalosis related to excessive respiratory overcompensation.
Overdosage
Treatment
Immediately stop the infusion and institute corrective therapy to reduce plasma levels
of ions that are in excess and restore, if necessary, acid-base balance.
The patient should be kept under observation to assess the appearance of any signs and
symptoms related to the drug administered, providing the patient with appropriate symptomatic
and supportive measures as needed.
In these cases, intravenous administration of 5% glucose or hypotonic or isotonic sodium
chloride solutions is recommended (as they are hypotonic for hypernatremic patients).
In case of high natremia, loop diuretics can be used.
A natremia greater than 200 mmol/l may require dialysis.
Incompatibilities
Solutions for use for dilution of SODIO ACETATO MONICO: 0.9% Sodium Chloride (physiological
saline) or 5% Glucose.
Special precautions for disposal and handling.
For single and uninterrupted use only and any remaining solution cannot be used.
Dilute the solution immediately after opening the container; the diluted solution must be used
immediately.
Shake well during preparation of the dilution and before administration. Do not use the
medicine if the solution is not clear, colorless and 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.
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- Країна реєстрації
- Лікарська формаConcentrate for infusion solution, 3 MEQ/ML
- Код АТХB05XA08
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до SODIO AKETATO MONIKOЛікарська форма: Concentrate for infusion solution, 1 G/10 MLДіюча речовина: Хлорид кальцияПотрібен рецептЛікарська форма: Concentrate for injectable/infusion solution, 500 MG/10 MLДіюча речовина: Хлорид кальцияПотрібен рецептЛікарська форма: Concentrate for infusion solution, 1 G/10 MLДіюча речовина: Хлорид кальцияВиробник: S.A.L.F. SPA LABORATORIO FARMACOLOGICOПотрібен рецепт
Аналоги SODIO AKETATO MONIKO в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог SODIO AKETATO MONIKO у Польща
Аналог SODIO AKETATO MONIKO у Іспанія
Лікарі онлайн щодо SODIO AKETATO MONIKO
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на SODIO AKETATO MONIKO онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
SODIO AKETATO MONIKO потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у SODIO AKETATO MONIKO — Ацетат натрия. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
SODIO AKETATO MONIKO виробляється компанією MONICO S.P.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування SODIO AKETATO MONIKO з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати SODIO AKETATO MONIKO у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Ацетат натрия) включають KALKIO KLORURO BIOINDUSTRIA L.I.M., KALKIO KLORURO GALENIKA SENESE, KALKIO KLORURO S.A.L.F.. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
