Sodium bicarbonate Diaco

Package leaflet: Information for the user

Sodium bicarbonate DIACO 1.4% infusion solution, 5% infusion solution, 7.5% infusion solution, 8.4% infusion solution

Read all of this leaflet carefully before you start using 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 yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Sodio bicarbonato DIACO is and what it is used for
2. What you need to know before using Sodio bicarbonato DIACO
3. How to use Sodio bicarbonato DIACO
4. Possible side effects
5. How to store Sodio bicarbonato DIACO
6. Contents of the pack and other information

1. What Sodio bicarbonato DIACO is and what it is used for

Sodio bicarbonato DIACO contains the active substance sodium bicarbonate and belongs to the category of solutions that affect electrolyte balance (body salts).
Sodio bicarbonato DIACO is indicated for:

• Metabolic acidosis
• Shock (cardiocirculatory collapse)
• Barbiturate (sedative drugs), salicylate (such as aspirin), and methanol poisoning
• Hemolytic (due to breakdown of blood cells) and rhabdomyolytic syndromes (due to breakdown of muscle cells)
• Hyperuricemia (increased blood concentration of uric acid, resulting from protein metabolism)
• Intestinal bicarbonate losses (resulting from diarrhea)

2. What you need to know before using Sodium Bicarbonate DIACO

Do not use Sodium Bicarbonate DIACO

• if you are allergic to sodium bicarbonate or to any of the other ingredients of this medicine (listed in section 6);
• if you have metabolic or respiratory alkalosis (decreased acidity of the blood), especially if caused by reduced chloride levels (e.g. due to vomiting, gastrointestinal losses, or diuretic therapy);
• if you have hypocalcemia (low calcium levels).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Sodium Bicarbonate DIACO.
The solution must be clear, colourless, and free from visible particles.
Use immediately after opening the container. The container is intended for single, uninterrupted administration; any remaining solution must not be used.
Use with caution if you have congestive heart failure, severe renal insufficiency, or clinical conditions associated with edema and salt and fluid retention.
Use with caution if you are being treated with cardiac inotropic agents (drugs that increase heart contraction), corticosteroids (e.g. cortisone and similar drugs), or corticotropin agents (drugs that increase levels of cortisone-like hormones).
Sodium salts should be administered with caution if you have high blood pressure, heart failure, pulmonary or peripheral edema, impaired renal function, pre-eclampsia (a pregnancy-related condition involving edema, high blood pressure, and protein loss in urine), or other conditions associated with sodium retention (see section “Other medicines and Sodium Bicarbonate DIACO”).
During infusion, it is advisable to monitor fluid balance, electrolytes (salts), plasma osmolarity (salt concentration in blood), and acid-base balance (blood acidity level). Correct any potassium or calcium deficiencies as needed to prevent episodes of tetany (characterized by pathological muscle spasms and contractions).
Observe all standard precautions to maintain sterility before and during intravenous infusion.

Other medicines and Sodium Bicarbonate DIACO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Corticosteroids are associated with sodium and water retention, which may lead to edema and increased blood pressure. Therefore, caution is required when administering sodium salts together with corticosteroids (see section 4.4).
Sodium bicarbonate increases renal excretion of tetracyclines (a class of antibiotics).
Concomitant administration of sodium bicarbonate and drugs that promote potassium loss increases the risk of hypochloremic alkalosis (decreased blood acidity with reduced chloride levels).
Sodium bicarbonate increases the blood retention time, and thus the duration of action, of basic drugs such as quinidine (used in certain heart rhythm disorders), ephedrine (used for bronchial constriction and to prevent excessive drop in blood pressure during anaesthesia), and pseudoephedrine (used as a nasal decongestant).
Do not use with solutions containing noradrenaline, dobutamine (substances that stimulate the heart), or calcium.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
There are no data available on potential adverse effects of this medicine when administered during pregnancy or breastfeeding, or on reproductive capacity.
Therefore, this medicine should not be used during pregnancy or breastfeeding unless absolutely necessary and only after careful assessment of the risk-benefit balance.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

3. How to use Sodio bicarbonato DIACO

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The 1.4% solution is isotonic with blood (has the same salt concentration); the 5%, 7.5%, and 8.4% solutions are hypertonic with blood (have a higher salt concentration).
The solutions must be administered by intravenous infusion with caution and at a controlled infusion rate, avoiding the infusion of large volumes at high speed.
Do not use this medicine unless specifically prescribed.
In general, the dose depends on your age, body weight, clinical condition, electrolyte status, acid-base balance, and osmolarity, with the aim of restoring normal pH and electrolyte levels (in cases of shock, hemolytic syndromes, rhabdomyolysis, and bicarbonate loss) or reducing urine acidity in cases of intoxication or hyperuricemia.

Recommended dose:
Acute and subacute forms of metabolic acidosis
Adults
Initial dose of 2 to 5 mEq/kg body weight over 4–8 hours, depending on the severity of acidosis. The dose should then be adjusted based on blood bicarbonate levels or blood gas analysis results (a blood test to assess acidity and concentrations of certain salts and gases such as oxygen and carbon dioxide) (target 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 body weight per day to avoid excessive reduction of cerebrospinal pressure and possible intracranial hemorrhage.
In children, the safety and efficacy of sodium bicarbonate have not been established.

Elderly
In elderly patients over 60 years of age, the maximum daily dose is 90–100 mEq of bicarbonate.
It is advisable NOT to achieve full correction of acidosis within the first 24 hours to avoid alkalosis due to excessive respiratory compensation.

Incompatibilities with Sodio bicarbonato DIACO
Do not use with solutions containing noradrenaline, dobutamine, or calcium.

Use in children
In children, the safety and efficacy of sodium bicarbonate have not been established.

Use the solution immediately after opening the container.
It is intended for single, uninterrupted administration; any remaining solution must not be used.
Do not use the medicine if the solution is not clear and colourless or if it contains particles.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.

If you use more Sodio bicarbonato DIACO than you should
Symptoms
Excessive administration of sodium bicarbonate solutions may lead, depending on your clinical condition, to alkalemia (reduced blood acidity), hypernatremia (increased sodium in the blood), and/or hypervolemia (increased blood volume).
Hypernatremia and excessive sodium retention in cases of impaired renal sodium excretion may cause dehydration of internal organs, particularly the brain, and accumulation of extracellular fluid leading to edema affecting the cerebral, pulmonary, and peripheral circulation, potentially resulting in pulmonary and peripheral edema (in peripheral body regions and organs such as the liver).
Symptoms of alkalosis include muscle weakness associated with reduced potassium, increased muscle tone, muscle spasms, and tetany, which may especially occur if hypocalcemia (reduced calcium in the blood) is present.

Treatment
You must immediately stop the infusion and initiate corrective therapy to reduce elevated blood electrolyte levels and, if necessary, restore acid-base balance (see section 4.4).
You should be closely monitored for any signs and symptoms related to the administered drug, with appropriate symptomatic and supportive measures provided as needed.
In case of high sodium concentration, loop diuretics (diuretics promoting sodium excretion) may be used.
A sodium concentration exceeding 200 mmol/L may require dialysis (a blood purification method).
Hyperirritability and tetany associated with alkalosis can be managed by administering appropriate doses of calcium gluconate. In cases of severe alkalosis, ammonium chloride administration is recommended, except in patients with liver disease.

In case of accidental ingestion/overdose of Sodio bicarbonato DIACO, contact your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are the side effects associated with sodium bicarbonate. There are insufficient data to
establish the frequency of individual listed side effects.

• Alkalemia (reduced blood acidity), hypernatremia (increased sodium levels in the blood), hypovolemia (reduced blood volume), hyperosmolarity (increased concentration of salts in the blood).
• Febrile episodes, infusion site infections, pain or local reaction, venous irritation, thrombosis or venous phlebitis (inflammation and blood clot formation in veins), chemical cellulitis (inflammation of cells) with tissue necrosis due to accidental extravasation into soft tissues.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly via 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 bicarbonato DIACO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the product kept in its original, undamaged packaging and stored correctly.
Store in the original packaging and in a tightly closed container.
Do not refrigerate or freeze.
Do not dispose of any medicine 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 Sodio bicarbonato DIACO contains

• The active substance is: sodium bicarbonate.
• The other components are: edetate disodium, water for injections.

Sodio bicarbonato DIACO 1.4% solution for infusion
1000 ml contain:
Active substance: Sodium bicarbonate 14.0 g
Edetate disodium (stabilizer) 0.05 g
Water for injections q.s.
mEq/litre Na 167
HCO 167
Theoretical osmolarity (mOsm/litre) 334
pH: 7.0–8.5

Sodio bicarbonato DIACO 5% solution for infusion
1000 ml contain:
Active substance: Sodium bicarbonate 50.0 g
Edetate disodium (stabilizer) 0.10 g
Water for injections q.s.
mEq/litre Na 595
HCO 595
Theoretical osmolarity (mOsm/litre) 1190
pH: 7.0–8.5

Sodio bicarbonato DIACO 7.5% solution for infusion
1000 ml contain:
Active substance: Sodium bicarbonate 75.0 g
Edetate disodium (stabilizer) 0.10 g
Water for injections q.s.
mEq/litre Na 893
HCO 893
Theoretical osmolarity (mOsm/litre) 1785
pH: 7.0–8.5

Sodio bicarbonato DIACO 8.4% solution for infusion
1000 ml contain:
Active substance: Sodium bicarbonate 84.0 g
Edetate disodium (stabilizer) 0.10 g
Water for injections q.s.
mEq/litre Na 1000
HCO 1000
Theoretical osmolarity (mOsm/litre) 2000
pH: 7.0–8.5

Description of the appearance of X and package contents
Solution for infusion, sterile and pyrogen-free.
Available in vials of 50 – 100 – 250 – 500 – 1000 ml.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Diaco Biofarmaceutici S.r.l.
Via Flavia 124 – 34147 Trieste, Italy

Manufacturer
S.M. FARMACEUTICI S.R.L.
Via Flavia n. 124 – 34147 – Trieste (Italy)