Thamesol

Package leaflet: Information for the user

Thamesol 36 mg/ml solution for infusion

Trometamol
Please read this leaflet carefully before you are given this 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 they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including 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 Thamesol is and what it is used for

Thamesol contains the active substance trometamol, an alkalising medicine (which reduces the acidity of the
blood), belonging to the category of solutions affecting the electrolyte (salt) balance.
Thamesol is indicated for:

• Metabolic acidosis (increased blood acidity) and cardiac arrest. 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 anaesthetics), from salicylates (medicines similar to aspirin).
• Respiratory and mixed acidosis in paediatrics.

2. What you need to know before you are given Thamesol

Do not be given Thamesol if:

• You are allergic to tromethamine or to any of the other ingredients of this medicine (listed in section 6).
• You have renal insufficiency, anuria, or uremia.
• If you are pregnant.
• In newborns; the medicine is contraindicated in chronic respiratory acidosis and in salicylate intoxication.

Warnings and precautions
Talk to your doctor or nurse before you are given Thamesol.

• During administration of the medicine, your respiratory rate, blood pressure, urine output (ability to excrete urine), and general condition must be kept under constant medical supervision.
  In transfusions, the doctor must frequently monitor blood and urine acidity, and blood concentrations of sugars and salts, especially potassium.

• An excess of Thamesol may cause metabolic alkalosis (decrease in blood acidity).

• Thamesol may cause excessive loss of fluids and salts, including changes in potassium levels.

• Administration of Thamesol may cause breathing difficulties (respiratory depression), which may occur more easily if you are being treated with other medicines that depress respiration, or if you have chronic respiratory disorders.

• High doses of Thamesol may cause hypoglycemia (reduction of blood sugar).

• Care must be taken to avoid leakage of the medicine from blood vessels, as this may cause inflammation, necrosis, and gangrene (tissue death).

• Thamesol must not be administered for longer than one day, except in life-threatening situations.

Children
In young children, the mechanisms maintaining homeostasis (internal balance) are less developed. 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 full-term newborns.

Other medicines and Thamesol
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Concomitant use with medicines that depress respiration may lead to respiratory problems.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
During pregnancy and breastfeeding, this medicine should only be administered when clearly needed and under direct medical supervision.

Driving and using machines
Consult your doctor for any further information.

3. How to use Thamesol

Thamesol should be administered only in the amount strictly necessary to restore normal blood acidity. Therefore, the dose depends on the severity and progression of acidosis, as well as on your general health status, e.g. whether you have kidney problems.
The recommended single dose in adults is approximately 300 mg/kg body weight.
This medicine will be administered to you in the presence of appropriately trained medical and/or nursing personnel, by slow intravenous infusion over no less than one hour.
For further information, see the section below entitled “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 losses may occur, and in patients with kidney problems, hyperkalemia may also occur. If respiratory problems occur, the medicine will be discontinued and, if necessary, appropriate supportive measures (such as mechanical ventilation) will be implemented.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects have been observed with the administration of Thamesol:

• respiratory depression (see section “Warnings and precautions”)
• temporary hypoglycaemia (reduction in blood sugar levels)
• hyperkalaemia (increased blood potassium levels)
• inflammation at the injection site
• necrosis (tissue death)
• gangrene (tissue decay)
• phlebitis (vein inflammation)
• venous spasm (contraction of the venous wall).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via 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 stated on the packaging after Exp.. The expiry date refers to the product in its original, unopened packaging, properly stored.
Use the solution only if it is clear and if the vacuum is present.
Each vial is for single use only; even if partially used, any remaining solution must not be reused.
Do not dispose of medicines via 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 Thamesol contains

• The active substance is Trometamol. 1 ml of infusion solution contains 36 mg of trometamol.
• The other components are: glacial acetic acid, water for injections

Description of the appearance of Thamesol and contents of the pack
Infusion solution
250 ml vial.
Marketing Authorisation Holder and Manufacturer
Diaco Biofarmaceutici S.r.l.
Via Flavia 124 – 34147 Trieste

The following information is intended exclusively for healthcare professionals:

Recommended dose:
Thamesol is generally administered only in the amount strictly necessary to restore normal blood pH (7.4). Therefore, the dose depends on the severity and progression of acidosis. One must also consider the possibility of some retention of the drug, especially in patients with renal dysfunction.
The average single dose in adults is approximately 300 mg of Tromethamine per kg of body weight, i.e., 500 ml of Thamesol. This dose should be administered over no less than one hour.
To estimate the approximate dose, the following empirical formula may be used:
Thamesol required (ml) =
Body weight (kg) × Base deficit (mEq/l).
A 70 kg patient with a base deficit of 10 mEq/l should receive approximately 700 ml of Thamesol.
Depending on storage duration, the pH of stored blood varies from 6.80 to 6.22. The amount of Thamesol needed to correct this acidity ranges from 15 ml to 77 ml per 500 ml of blood.
For correction of blood acidity in ACD, the average dose of Thamesol is approximately 2 g of Tromethamine = 55 ml of Thamesol/500 ml of blood.

Administration method:
Administer only by intravenous route.
Insert the needle properly into the vein; preferably use plastic intravenous catheters.
In open-heart surgery, in case of cardiac arrest, Thamesol may be injected directly into the ventricular cavity.
Thamesol should be administered by slow intravenous infusion, either added to the blood in the oxygenator pump or to other priming fluids, or added directly to ACD blood.
Inspect each vial before use. Use the solution only if it is clear and if vacuum is present.
Invert the vial and carefully examine the solution under optimal lighting conditions to detect any particles or turbidity; check that the vial shows no cracks or other damage.
The presence of vacuum ensures vial integrity; to verify, attach the vial adapter to an inverted or horizontal vial.
If brisk bubbling is not observed, discard the vial.
During administration, re-examine the vial at least once every hour. If signs of solution contamination are observed or if the patient develops fever or chills, discontinue administration immediately and notify the physician.
Each vial is for single use only; any remaining solution, even if partially used, must not be reused.

Use in children
In young children, homeostatic defenses are reduced; Thamesol should be administered to children up to 6 years of age only in specialized centers. Hypoglycemia may occur in both premature and full-term neonates.

Overdose
Overdoses may occur when the administered dose is not adjusted according to the patient's acid-base balance, when the infusion rate is too high, or in the presence of anuria. Manifestations of overdose include respiratory depression, alkalosis, hypoglycemia, excessive loss of fluids and electrolytes, and, in patients with kidney disease, hyperkalemia as well. It has not been demonstrated that Thamesol prolongs coagulation time in humans; however, this possibility should be considered, as it has been observed in dogs during animal testing.
If respiratory depression occurs, discontinue administration of Thamesol and provide mechanical ventilation if necessary.