ТАЙМСОЛ 3,6% Инъекционный или инфузионный раствор
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Инструкция по применению TAMESOL
Содержание инструкции
Thamesol 36 mg/ml solution for infusion
Trometamol
Read this leaflet carefully before you are given 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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Thamesol is and what it is used for
- 2. What you need to know before you are given Thamesol
- 3. How to use Thamesol
- 4. Possible side effects
- 5. How to store Thamesol
- 6. Contents of the pack and other information
1. What is Thamesol and what is it used for
Thamesol contains the active ingredient trometamol, an alkalizing medicine (which lowers the acidity of the
blood), belonging to the category of solutions that influence the electrolytic balance (of salts).
Thamesol is indicated for:
- Metabolic acidosis (increased blood acidity) and cardiac arrest.The administration of Thamesol has restored cardiac rhythm in numerous patients with cardiac arrest who did not respond to other treatments.
- Metabolic acidosis in cardiac surgery.
- Blood transfusions:to effectively correct the acidity of stored blood and blood used in cardiac surgery.
- Respiratory acidosis.
- Diabetic acidosis.
- Renal acidosis.
- Exogenous intoxications.From barbiturates (sedatives or anesthetics), from salicylates (medicines similar to aspirin).
- Respiratory and mixed acidosis in pediatrics.
2. What you need to know before you are given Thamesol
Thamesol must not be given to you
- If you are allergic to trometamol or any of the other ingredients of this medicine (listed in section 6).
- If you suffer from kidney failure, anuria, uremia
- In case of pregnancy.
- In newborns; the medicine is contraindicated in chronic respiratory acidosis and salicylate poisoning. Warnings and precautionsTalk to your doctor or nurse before you are given Thamesol.
- During the administration of the medicine, your respiratory rate, blood pressure, diuresis (ability to eliminate urine) and your condition must be kept under constant medical control.
During transfusions, the doctor must frequently determine the acidity of the blood and urine and
the concentration in the blood of sugars and salts, especially potassium.
- An excess of Thamesol can cause metabolic alkalosis (decrease in blood acidity).
- Thamesol may cause excessive loss of fluids and salts such as changes in potassium levels;
- The administration of Thamesol may cause difficulty breathing (respiratory depression) which may be more easily manifested if you have been treated with other drugs that depress breathing and if you have chronic respiratory difficulties.
- Large doses of Thamesol can cause hypoglycemia (reduction of blood sugar).
- Care must be taken to avoid leakage of the medicine from blood vessels as this can cause inflammation, necrosis and gangrene (tissue death).
- Thamesol should not be administered for more than one day, except in life-threatening situations.
Children
In small children, the mechanisms that maintain the state of equilibrium (homeostasis) are reduced. Thamesol
should be administered to children up to 6 years of age only in specialized centers. Hypoglycemia
(reduction of blood sugar) may occur in both premature and normal newborns.
Other medicines and Thamesol
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Concomitant use with medicines that depress breathing may develop respiratory problems.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor for advice before using this medicine.
During pregnancy and breastfeeding, this medicine should only be given to you if absolutely
necessary, under the direct supervision of your doctor.
Driving and operating machinery
Ask your doctor for any information.
3. How to use Thamesol
Thamesol must be administered only in the strictly necessary amount to restore the normality of blood acidity.
Therefore, the dose depends on the severity, the progression of the acidosis and its health status, e.g. if you suffer from kidney problems.
The average single recommended dose in adults is approximately 300 mg/kg of body weight.
This medicine will be administered to you in the presence of adequately trained medical and/or nursing personnel only by slow intravenous route over no less than one hour.
For more information see below the paragraph “The following information is intended exclusively for healthcare professionals:”.
If you are given more Thamesol than you should
In case of overdose, respiratory problems, alkalosis, hypoglycemia, excessive fluid and electrolyte loss, and in patients with kidney problems, also hyperkalemia may occur. If respiratory problems occur, the medicine will be discontinued and, if necessary, appropriate supportive measures will be implemented (such as mechanical ventilation).
If you have any doubts about the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the administration of Thamesol, the following side effects have been observed:
- respiratory depression (see section “Warnings and precautions”)
- temporary hypoglycemia (decrease in blood sugar)
- hyperkalemia (increased potassium in the blood)
- inflammation at the injection site
- necrosis (tissue death)
- gangrene (tissue decay)
- phlebitis (inflammation of the veins)
- venous spasm (contraction of the vein wall).
Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at http://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 Thamesol
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after Scad.. The expiry
date refers to the product in intact packaging, correctly stored.
Use the solution only if it is clear and if the vacuum is present.
Each vial must be used for a single administration; even if partially used, the remaining solution must not
be used again.
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. Contents of the pack and other information
What Thamesol contains
- The active ingredient is Trometamol. 1 ml of solution for infusion contains 36 mg of trometamol.
- The other ingredients are: glacial acetic acid, water for injections
Description of the appearance of Thamesol and contents of the pack
Solution for infusion
Bottle of 250 ml.
Marketing authorisation holder and manufacturer
Diaco Biofarmaceutici S.r.l.
Via Flavia 124 – 34147 Trieste
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The following information is intended exclusively for healthcare professionals:
Recommended dose:
Thamesol is generally administered only in the strictly necessary amount to restore
blood pH to normal (7.4). Therefore, the dose depends on the severity and progression of the acidosis. It is also important to consider
the possibility of some retention of the medicine, especially in patients with renal dysfunction.
The average single dose in adults is approximately 300 mg of Trometamol/kg of body weight, which is 500 ml of
Thamesol. This dose should be administered over no less than one hour.
To determine the approximate dose, the following empirical formula can be used:
Thamesol needed (ml)
Body weight (kg) x Base deficit (mEq/l).
A patient weighing 70 kg with a Base deficit of 10 mEq/l should receive approximately 700 ml of Thamesol.
According to the storage duration, the pH of the stored blood varies from 6.80 to 6.22. The amount of
Thamesol used to correct this acidity varies from 15 ml to 77 ml per 500 ml of blood.
For the correction of blood acidity in ACD, the average dose of Thamesol is approximately 2 g of Trometamol =
55 ml of Thamesol/500 ml of blood.
Method of administration:
Administer only by intravenous route.
Insert the needle well into a vein; if possible, use plastic intravenous catheters.
In open-chest surgery, in case of cardiac arrest, Thamesol can be injected directly into the
ventricular cavity.
Thamesol should be administered by slow intravenous infusion, as an addition to the oxygenator blood or other priming fluids, or in addition to blood in ACD.
Inspect each vial before use. Use the solution only if it is clear and if the vacuum is present.
Invert the vial and carefully check the solution in optimal visibility conditions to detect
any particles or turbidity; check that the vial does not have cracks or other damage.
The presence of a vacuum ensures the integrity of the vial; to verify this, attach the vial connector
inverted or horizontally.
If no vigorous bubbling is observed, discard the vial.
During administration, re-check the vial at least once every hour. If signs of
contamination of the solution are noticed or if the patient develops fever or chills, immediately stop
administration and inform the doctor.
Each vial is for single use only; even if partially used, the remaining solution should not
be used anymore.
Use in children
In small children, homeostatic defenses have reduced power; Thamesol should be administered to children
under 6 years of age only in specialized centers. Hypoglycemia may occur in both premature and
full-term newborns.
OverdoseOverdoses are possible when the administered dose is not related to the patient's acid-base balance, or the rate of administration is excessive, or anuria is present; manifestations of overdose are respiratory depression, alkalosis, hypoglycemia, excessive fluid and electrolyte losses, and, in nephropathic patients, also hyperpotassemia. It has not been demonstrated that Thamesol can increase coagulation time in humans, however, this possibility should be kept
in mind as it has been noted in dogs during animal experiments.
If respiratory depression occurs, stop the administration of Thamesol and provide mechanical ventilation if necessary.
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- Страна регистрации
- Форма выпускаInjectable or infusion solution, 3,6%
- Код АТХB05BB03
- 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 TAMESOLФорма выпуска: Infusion solution, 500 MLДействующее вещество: electrolytesПроизводитель: BAXTER S.P.A.Отпускается по рецептуФорма выпуска: Infusion solution, 50 MLДействующее вещество: electrolytes with carbohydratesПроизводитель: BAXTER S.P.A.Отпускается по рецептуФорма выпуска: Infusion solution, 50 MLДействующее вещество: electrolytes with carbohydratesПроизводитель: BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI S.P.A.Отпускается по рецепту
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Аналог TAMESOL в Испания
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Действующее вещество TAMESOL — Трометамол. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
TAMESOL производится компанией DIACO BIOFARMACEUTICI 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 TAMESOL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Другие лекарства с тем же действующим веществом (Трометамол) включают KRYSTALSOL, ELETTROLITIKA BILANKIATA DI MANTENIMENTO KON LUKOSIO BAXTER, ELETTROLITIKA BILANKIATA DI MANTENIMENTO KON LUKOSIO BIOINDUSTRIA L.I.M.. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
