Glycerol with sodium chloride Bioindustria L.I.M.

BIOINDUSTRIA Italian Medicinal Laboratory S.p.A.

PATIENT LEAFLET

GLYCEROL WITH SODIUM CHLORIDE BIOINDUSTRIA L.I.M. (10% 0.9%)

S
PHARMACOTHERAPEUTIC CATEGORY
Solutions promoting osmotic diuresis.

THERAPEUTIC INDICATIONS
Intracranial and ocular hypertension.

CONTRAINDICATIONS

• Hypersensitivity to the active substances or to any of the excipients;
• Anuria due to severe renal impairment;
• Pulmonary congestion or pulmonary edema;
• Active cerebral or intracranial hemorrhage;
• Severe dehydration;
• Hypernatremia;
• Hydro-saline plethora;
• Heart failure;
• Renal failure;
• Hepatic failure.

When administered concomitantly with blood transfusions, glycerol solutions must not be infused through the same catheter as whole blood due to the potential risk of hemolysis. This medicinal product must not be used as a vehicle for other drugs.

PRECAUTIONS FOR USE
Use with caution in patients with congestive heart failure, severe renal failure, and clinical conditions associated with edema and salt retention; in patients receiving cardiac inotropic agents or corticosteroid or corticotropin medications.

Sodium salts should be administered cautiously in patients with hypertension, heart failure, peripheral or pulmonary edema, reduced renal function, pre-eclampsia, or other conditions associated with sodium retention (see Interactions).

This medicinal product must be used with caution in diabetic patients, as it may cause hyperosmolar non-ketotic coma.

Continuous administration without potassium supplementation may lead to hypokalemia.

During administration, the following parameters must be monitored:

• Fluid balance, electrolytes, plasma osmolarity, and acid-base balance;
• Renal function, to prevent irreversible osmotic nephrosis;
• Urine output, to avoid glycerol accumulation, which may lead to heart failure;
• Cerebral perfusion pressure, which must always be maintained above 70 mmHg.

In patients with severe renal failure, an initial test dose should be administered to assess patient tolerance.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines,
including those without a prescription.
Corticosteroids are associated with sodium and water retention, leading to edema and hypertension. Therefore, caution is required when administering sodium salts concomitantly with corticosteroids (see Precautions for Use).

BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.

SPECIAL WARNINGS
Use immediately after opening the container. The container is intended for single, uninterrupted administration; any residual solution must not be used.

The solution must be clear, colorless, and free from visible particles.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
There are no available data on possible adverse effects of this medicinal product when administered during pregnancy or breastfeeding, or on reproductive capacity.
Therefore, this medicinal product should not be used during pregnancy or breastfeeding unless absolutely necessary and only after careful assessment of the risk/benefit ratio.

Effects on ability to drive vehicles and use machinery
This medicinal product does not impair the ability to drive vehicles or operate machinery.

For individuals engaged in sports
Use of this drug without therapeutic need constitutes doping, may result in a positive anti-doping test, and may harm health.

Important information about certain excipients: none.

DOSAGE, ADMINISTRATION, AND DURATION
The solution is hypertonic relative to blood and must be administered by intravenous infusion with caution and at a controlled infusion rate. This solution must not be used unless specifically prescribed.

Dosage depends on age, body weight, and clinical condition of the patient.

Typically, 500 ml of solution (equivalent to 50 g of glycerol) is administered every six hours at a rate of approximately 1–2 mg of glycerol per kg of body weight per minute.

The safety and efficacy of Glycerol with Sodium Chloride have not been established in children.

Incompatibility with Glycerol with Sodium Chloride Bioindustria L.I.M.
If used to dilute medicinal products, consult a pharmacist, if available, before adding any drugs; consider the characteristics of the products to be added; use aseptic techniques.

Use immediately after opening the container. The container is intended for single, uninterrupted administration; any residual solution must not be used.

Do not use the medicinal product if the solution is not clear and colorless or if it contains particles.

Adopt all standard precautions to maintain sterility before and during intravenous infusion.

OVERDOSE
Symptoms
When administered at infusion rates equal to or greater than 7 mg of glycerol per kg of body weight per minute (approximately six times the recommended rate), hemolytic reactions, hemoglobinuria, and acute renal failure secondary to hemolysis may occur.

Excessive dosing may lead to hypernatremia and/or hypervolemia, depending on the patient's clinical condition.

Hypernatremia and excessive sodium retention in the presence of impaired renal sodium excretion may cause dehydration of internal organs, particularly the brain, and accumulation of extracellular fluid leading to edema affecting cerebral, pulmonary, and peripheral circulation, potentially resulting in pulmonary and peripheral edema.

Accumulation of chloride ions may reduce bicarbonate ion concentration, leading to acidosis.

BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.

Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of excess ions and, if necessary, restore acid-base balance (see Precautions for Use).

The patient should be closely monitored for any signs or symptoms related to the administered drug, and appropriate symptomatic and supportive measures should be provided as needed.

In cases of severe hypernatremia, loop diuretics may be used.

A serum sodium concentration exceeding 200 mmol/L may require dialysis.

In case of accidental ingestion/overdose of Glycerol with Sodium Chloride Bioindustria L.I.M., contact a doctor immediately or go to the nearest hospital.

If you have any doubts about the use of Glycerol with Sodium Chloride Bioindustria L.I.M., consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, Glycerol with Sodium Chloride may cause adverse effects, although not everyone experiences them.

Listed below are the adverse effects associated with Glycerol with Sodium Chloride. There are insufficient data to determine the frequency of individual listed effects.

Immune system disorders
Hypersensitivity reactions, urticaria.

Nervous system disorders
Headache, dizziness, restlessness, irritability, weakness, muscle rigidity, convulsions, coma, death.

Psychiatric disorders
Somnolence, confusion.

Eye disorders
Reduced lacrimation, blurred vision.

Cardiac disorders
Congestive heart failure, tachycardia.

Gastrointestinal disorders
Nausea, vomiting, diarrhea, abdominal pain, thirst, reduced salivation.

Renal and urinary disorders
Urinary retention, renal failure, hemoglobinuria.

Vascular disorders
Hypotension, hypertension, peripheral edema.

Blood and lymphatic system disorders
Hemolysis.

Metabolism and nutrition disorders
Hyperosmolar non-ketotic coma in diabetic patients.

Respiratory, thoracic and mediastinal disorders
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Dyspnea, pulmonary edema, respiratory arrest.

Fluid and electrolyte imbalance disorders
Electrolyte and acid-base imbalances, hypernatremia, dehydration, hypervolemia, hyperchloremia.

General disorders and administration site conditions
Fever, chills, pain and infection at the infusion site, venous thrombosis, phlebitis extending from the infusion site, extravasation, tissue necrosis.

Following the instructions in this leaflet reduces the risk of adverse effects.
If any of the adverse effects worsen, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

EXPIRY DATE AND STORAGE
Expiry date: see the date on the packaging.
The expiry date refers to the product stored unopened and under recommended conditions.

Caution: Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

Keep this medicine out of the reach and sight of children.

COMPOSITION
1000 ml contains:
Active substances: Glycerol 100 g
Sodium chloride 9.0 g
mEq/liter: Na 154
Cl 154
mmol/liter: glycerol 1085
Theoretical osmolarity (mOsm/liter): 1394
pH: 5.0 – 7.0
Excipients: water for injections.

PHARMACEUTICAL FORM AND CONTENT
Infusion solution, sterile and pyrogen-free.
Capacities:
50 ml vial;
100 ml vial;
250 ml vial;
500 ml vial;
50 ml in 100 ml vial;
100 ml in 250 ml vial;
250 ml in 500 ml vial.

BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.

MARKETING AUTHORIZATION HOLDER
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 - Novi Ligure (AL).

MANUFACTURER
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 - Novi Ligure (AL).
AIFA Determination of 02/20/2013