Sodium chloride Bioindustria L.I.M.

BIOINDUSTRIA Italian Medicinal Laboratory S.p.A.

PACKAGE LEAFLET

Sodio cloruro Bioindustria L.I.M. 2mEq/ml concentrate for solution for infusion, 3mEq/ml concentrate for solution for infusion

PHARMACOTHERAPEUTIC CATEGORY
Additive intravenous solutions.

THERAPEUTIC INDICATIONS
Exogenous supply of sodium and chloride during Total Parenteral Nutrition (TPN) in adult and pediatric patients who have developed a deficiency of these ions due to excessive diuresis or excessive salt restriction.
In the treatment of pathological conditions where it is necessary to restore osmolarity by providing sodium and chloride ions.

CONTRAINDICATIONS
Hypernatremia.
Hydrosaline plethora.

PRECAUTIONS FOR USE
Sodium salts must be administered with caution in patients with hypertension, heart failure, peripheral or pulmonary edema, reduced renal function, pre-eclampsia, or other conditions associated with sodium retention (see Interactions).
The medicinal product must be used with care and at a controlled infusion rate.
Use with great caution in patients with congestive heart failure, severe renal failure, and clinical conditions presenting edema with salt retention; in patients receiving corticosteroid or corticotropin drugs.
Continuous administration without potassium supplementation may cause hypokalemia.
Use with caution in children.
During infusion, it is advisable to monitor fluid balance, electrolytes, plasma osmolarity, and acid-base balance.
This medicinal product is a concentrated solution not intended for direct administration unless diluted in a large volume of fluid; it must not be injected undiluted but only after appropriate dilution and mixing, and must be used exclusively as an additive solution in mixtures for Total Parenteral Nutrition (TPN).

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).
Although sodium chloride is compatible with a wide range of solutions and medicinal products, compatibility should always be verified with other components of the TPN mixture and with any co-administered medicinal products.

BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.

SPECIAL WARNINGS
Use immediately after opening the container. The solution must be clear, colorless, and free from visible particles. It is intended for single, uninterrupted administration; any remaining solution must not be used.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Although no adverse effects on fetal development have been demonstrated, the medicinal product should be administered only when clearly needed and only after evaluating the risk/benefit ratio with your doctor.
The medicinal product is compatible with breastfeeding.

Effects on ability to drive and use machines
Not applicable.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The medicinal product must be administered by intravenous infusion after appropriate dilution.
Dosage depends on age, weight, clinical condition, electrolyte profile, and osmolarity, and is proportional to the calculated sodium deficit. Therefore, dosing is based on individual patient metabolic requirements determined from laboratory data and clinical assessment.
The theoretical sodium deficit can be calculated using the following formula:
DEFICIT (mEq) = (140 – P) × V
P = plasma sodium concentration (in mEq/L)
V = body water volume (equal to 60% of body weight
for children and adult males, 50% for adult females,
50% and 45% respectively for elderly men and women).
When using hypertonic solutions, administer half the dose over the first 8 hours, up to a maximum of 100 mL/hour; then administer the remaining dose until plasma sodium concentration reaches 130 mEq/L or until symptoms improve.
In cases of severe sodium depletion and in the treatment of severe symptoms related to chronic hyponatremia, administer hypertonic sodium chloride solutions to increase plasma sodium concentration by 1–2 mmol/L/hour. Ensure that correction does not exceed 10–12 mmol/L in 24 hours and 18 mmol/L in 48 hours.
For compatibility with other components of the TPN mixture and any co-administered medicinal products, refer to the respective Summary of Product Characteristics (SmPC).

OVERDOSE
Symptoms
Excessive administration of isotonic and hypertonic sodium chloride solutions may lead, depending on the patient's clinical condition, to hypernatremia, hyperchloremia, and/or hypervolemia.
Hypernatremia (mainly associated with hypertonic solutions) and excessive sodium retention when renal sodium excretion is impaired 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.
Accumulation of chloride ions reduces bicarbonate concentration, leading to acidosis.

Treatment
In case of accidental excessive infusion, treatment should be discontinued and the patient monitored for any signs or symptoms related to the administered medicinal product, with appropriate symptomatic and supportive measures provided as needed.
In case of overdose, therapy should aim to restore physiological sodium ion concentrations.
In such cases, intravenous administration of 5% glucose or hypotonic or isotonic sodium chloride solutions (which are effectively hypotonic in hypernatremic patients) is recommended.
Loop diuretics may be used in cases of marked hypernatremia.
A serum sodium concentration exceeding 200 mmol/L may require dialysis.
In case of accidental ingestion or administration of an excessive dose of Sodio cloruro Bioindustria L.I.M., contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Sodio cloruro Bioindustria L.I.M., consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, Sodio cloruro may cause adverse effects, although not everyone experiences them.
The following are the adverse effects associated with Sodio cloruro. There are insufficient data to determine the frequency of individual listed effects.

Disorders of water and electrolyte balance
Hypernatremia, hypervolemia, plasma hypoosmolarity (with 0.45% solutions), hyperchloremia (which may cause bicarbonate loss leading to acidosis)

Nervous system disorders
Headache, dizziness, restlessness, fever, irritability, weakness, muscle rigidity, seizures, coma, death

Psychiatric disorders
Somnolence, confusion

Respiratory, thoracic and mediastinal disorders
Dyspnea, respiratory arrest

Gastrointestinal disorders
Thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain

Cardiac disorders
Tachycardia

Eye disorders
Reduced lacrimation

Renal and urinary disorders
Renal failure

Vascular disorders
Hypotension, hypertension, pulmonary and peripheral edema

General disorders and administration site conditions
Infusion site infection, pain or local reaction, venous irritation, thrombosis or phlebitis extending from the infusion site, extravasation

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.
WARNING: do not use the medicinal product after the expiry date stated on the packaging.
Use immediately after opening the container. The solution must be clear, colorless, and free from visible particles. It is intended for single, uninterrupted administration; any remaining solution must not be used.

Storage conditions:
Store in a tightly closed container. Do not freeze or refrigerate.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep the medicinal product out of the reach and sight of children.

COMPOSITION
Sodio cloruro Bioindustria L.I.M. 2 mEq/ml concentrate for solution for infusion
1 mL of solution contains:
Active substance: sodium chloride 0.117 g
mEq/mL: Na 2
mEq/mL: Cl 2
Theoretical osmolarity (mOsm/L): 4000
pH: 4.5 – 7.0
Excipients: water for injections.

Sodio cloruro Bioindustria L.I.M. 3 mEq/ml concentrate for solution for infusion
1 mL of solution contains:
Active substance: sodium chloride 0.175 g
mEq/mL: Na 3
mEq/mL: Cl 3
Theoretical osmolarity (mOsm/L): 6000
pH: 4.5 – 7.0
Excipients: water for injections.

BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.

PHARMACEUTICAL FORM AND CONTENT
Concentrate for solution for infusion (to be diluted before use).
Sterile, pyrogen-free, clear, colorless solution.

Sodio cloruro Bioindustria L.I.M. 2 mEq/ml concentrate for solution for infusion
AIC 031101506 – 10 vials 10 mL

Sodio cloruro Bioindustria L.I.M. 3 mEq/ml concentrate for solution for infusion
AIC 031101532 - 10 vials 10 mL
AIC 031101482 – 10 bottles 30 mL
AIC 031101470 – 1 bottle 30 mL
AIC 031101761 – 1 bottle 250 mL

MARKETING AUTHORISATION HOLDER
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 – 15067 Novi Ligure (AL)

MANUFACTURER
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 – 15067 Novi Ligure (AL)

REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
AIFA Determination of 23/04/2012.

BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.

INSTRUCTIONS FOR USE

Sodium Chloride Bioindustria L.I.M. 0.9% solvent for parenteral use

PHARMACOTHERAPEUTIC CATEGORY
All other non-therapeutic products – solvents and diluents.
THERAPEUTIC INDICATIONS
Preparation of injectable formulations.
CONTRAINDICATIONS
Hypernatremia.
Hydro-saline plethoric states.
For contraindications, refer also to the Summary of Product Characteristics (SmPC) of the medicinal product intended for administration.
PRECAUTIONS FOR USE
Sodium salts must be administered with caution in patients with hypertension, cardiac insufficiency, peripheral or pulmonary edema, reduced renal function, pre-eclampsia, or other conditions associated with sodium retention (see Interactions).
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal product,
including those without a prescription.
Corticosteroids are associated with sodium and water retention, which may lead to edema and hypertension; therefore, caution is required when administering sodium salts concomitantly with corticosteroids (see Precautions for Use).
Although sodium chloride is compatible with a large number of medicinal products, refer to the SmPC of the medicinal product intended for administration to confirm compatibility.
SPECIAL WARNINGS
The solution must be clear, colourless, and free from visible particles.
Use immediately after opening the container and ensure that preparation is carried out as quickly as possible under conditions and procedures that preserve the sterility of the solution to the greatest extent possible. Any unused medicinal product remaining must be discarded.
PREGNANCY AND BREAST-FEEDING
Consult your doctor or pharmacist before taking any medicinal product.
Although no adverse effects on fetal development have been observed, the medicinal product should be administered only when clearly needed and only after careful assessment of the risk/benefit ratio.
The medicinal product is compatible with breast-feeding.
For precautions to be taken during pregnancy and breast-feeding, refer also to the SmPC of the medicinal product intended for administration.
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
The medicinal product does not affect the ability to drive or use machinery.
For effects on the ability to drive and use machines, refer also to the SmPC of the medicinal product intended for administration.
DOSAGE, METHOD AND TIME OF ADMINISTRATION
Use for solutions, dilutions, or extemporaneous suspensions of injectable medicinal products or other sterile preparations. Select the volume to be used according to the dilution requirements of the injectable preparation.
For compatibility, refer to the SmPC of the medicinal product intended for administration.
OVERDOSE
Administration of excessive doses of isotonic or hypertonic sodium chloride solutions may lead, depending on the patient's clinical condition, to hypernatremia, hyperchloremia and/or hypervolemia.
For overdose, refer also to the SmPC of the medicinal product intended for administration.
In case of accidental ingestion/overdose of 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 Sodium Chloride Bioindustria L.I.M., consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicinal products, Sodium Chloride may cause adverse effects, although not everyone experiences them.
Adverse effects following administration of sodium chloride are mainly related to disturbances in water and electrolyte balance (hypernatremia, hyperchloremia, hypervolemia) and site-related problems (infection at infusion site, pain or local reaction, venous irritation, thrombosis or phlebitis extending from the infusion site, extravasation).
For adverse effects, refer also to the SmPC of the medicinal product intended for administration.
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 AND STORAGE
Expiry date: see the date indicated on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Caution: do not use the medicinal product after the expiry date stated on the packaging.
Use immediately after opening the container and ensure that preparation is carried out as quickly as possible under conditions and procedures that preserve the sterility of the solution to the greatest extent possible. Any unused medicinal product remaining must be discarded.
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Storage conditions:
Store in a tightly closed container. Do not freeze or refrigerate.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep the medicinal product out of the reach and sight of children.
COMPOSITION
100 ml of solution contain:
Active substance: sodium chloride 0.9 g
mEq/ml: Na 0.154
mEq/ml: Cl 0.154
Theoretical osmolarity (mOsm/l): 308
pH: 4.5 – 7.0
Excipients: water for injections.
PHARMACEUTICAL FORM AND CONTENT
Solvent for parenteral use.
10 vials of 2 ml.
10 vials of 5 ml.
10 vials of 10 ml.
5 vials of 20 ml.
MARKETING AUTHORISATION HOLDER
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 – 15067 Novi Ligure (AL)
MANUFACTURER
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 – 15067 Novi Ligure (AL)
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
AIFA Determination of 23/04/2012.
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.

INSTRUCTIONS FOR USE

Sodio cloruro Bioindustria L.I.M. 0.9% solution for infusion

THERAPEUTIC PHARMACOLOGICAL CATEGORY
Solutions affecting electrolyte balance.
THERAPEUTIC INDICATIONS
Replacement of fluids and sodium chloride.
CONTRAINDICATIONS
Hypernatremia.
Hydrosaline plethoric states.
PRECAUTIONS FOR USE
Sodium salts must be administered with caution in patients with hypertension, cardiac failure, peripheral or pulmonary edema, reduced renal function, pre-eclampsia, or other conditions associated with sodium retention (see Interactions).
Solutions with a concentration higher than 0.9% (hypertonic solutions) must be used cautiously, administered at a controlled infusion rate, and only when specifically prescribed.
Use with great caution in patients with congestive heart failure, severe renal failure, and clinical conditions presenting edema with salt retention; in patients receiving corticosteroid or corticotropin medications.
Continuous administration without potassium supplementation may lead to hypokalemia.
Use with caution in children.
During infusion, it is advisable to monitor fluid balance, electrolytes, plasma osmolarity, and acid-base balance.
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).
Although sodium chloride is compatible with a large number of solutions and medicinal products, compatibility should always be verified in the SmPC of the medicinal product intended for co-administration.
SPECIAL WARNINGS
The solution must be clear, colorless, and free from visible particles. Use immediately after opening the container. The container is intended for single, uninterrupted administration and any residual solution must not be used.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Although no adverse effects on fetal development have been demonstrated, the medicinal product should be administered only when clearly needed and after careful assessment of the risk/benefit ratio.
The medicinal product is compatible with breastfeeding.
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Effects on ability to drive and use machines
The medicinal product does not affect the ability to drive or use machinery.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The medicinal product must be administered by intravenous infusion.
Treatment of isotonic fluid depletion (extracellular dehydration)
Adults and adolescents: 500 ml to 3 liters within 24 hours.
Neonates and children (up to 12 years of age): 20 to 100 ml per kg of body weight within 24 hours, depending on age and total body weight.
Dosage should be appropriately reduced in patients with renal failure.
Treatment of sodium deficit
Dosage depends on age, weight, clinical condition, electrolyte profile, osmolarity, and the calculated sodium deficit.
The theoretical sodium deficit can be calculated using the following formula:
DEFICIT (mEq) = (140 – P) × V
P = plasma sodium concentration (in mEq/l)
V = total body water volume (equal to 60% of body weight in children and adult males, 50% in adult females, 50% and 45% respectively in elderly men and women).
When using hypertonic solutions (2%, 3%, 5%), administer half the dose within the first 8 hours, up to a maximum of 100 ml/hour; then administer the remaining dose until plasma sodium concentration reaches 130 mEq/l or until symptoms improve.
In cases of severe sodium depletion and in the treatment of severe symptoms related to chronic hyponatremia, administer hypertonic sodium chloride solutions to increase plasma sodium concentration by 1–2 mmol/l/hour. Care must be taken not to exceed a correction rate of 10–12 mmol/l within 24 hours and 18 mmol/l within 48 hours.
When sodium chloride solutions, particularly 0.9% solutions, are used as diluents for intravenous administration of drugs requiring prior dilution, the compatibility of such drugs with sodium chloride and the most suitable concentration must be verified beforehand in the SmPC of the medicinal product to be diluted. If no concentration is specified, use the 0.9% solution.
For compatibility information, refer to the SmPC of the medicinal product to be administered.
OVERDOSAGE
Symptoms
The 0.45% solution is hypotonic compared to blood and reduces plasma osmolarity: overdosage may therefore lead to plasma hypoosmolarity.
Excessive administration of isotonic and hypertonic sodium chloride solutions may lead, depending on the patient's clinical condition, to hypernatremia, hyperchloremia, and/or hypervolemia.
Hypernatremia (mainly associated with hypertonic solutions) and excessive sodium retention when renal sodium excretion is impaired cause dehydration of internal organs, particularly the brain, and accumulation of extracellular fluid causing edema that may affect cerebral, pulmonary, and peripheral circulation, leading to pulmonary and peripheral edema.
Accumulation of chloride ions reduces bicarbonate concentration, leading to acidosis.
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Treatment
In case of accidental excessive infusion, treatment should be discontinued and the patient should be closely monitored for any signs or symptoms related to the administered drug, with appropriate symptomatic and supportive measures provided as needed.
In case of overdosage, therapy should aim to restore physiological sodium ion concentrations.
In these cases, intravenous administration of 5% glucose or hypotonic or isotonic sodium chloride solutions (which are hypotonic relative to the hypernatremic patient) is recommended.
In cases of marked hypernatremia, loop diuretics may be used.
A serum sodium concentration exceeding 200 mmol/l may require dialysis.
In case of accidental ingestion/overdose of Sodio cloruro Bioindustria L.I.M., contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Sodio cloruro Bioindustria L.I.M., consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, Sodio cloruro Bioindustria L.I.M. may cause adverse effects, although not everyone experiences them.
The following are adverse effects associated with sodium chloride. Sufficient data are not available to determine the frequency of the individual effects listed.
Disorders of water and electrolyte balance
Hypernatremia, hypervolemia, plasma hypoosmolarity (with 0.45% solutions), hyperchloremia (which may cause bicarbonate loss leading to acidosis)
Neurological disorders
Headache, dizziness, restlessness, fever, irritability, weakness, muscle rigidity, convulsions, coma, death.
Psychiatric disorders
Somnolence, confusion.
Respiratory, thoracic and mediastinal disorders
Dyspnea, respiratory arrest.
Gastrointestinal disorders
Thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain.
Cardiac disorders
Tachycardia.
Eye disorders
Reduced lacrimation.
Renal and urinary disorders
Renal failure.
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Vascular disorders
Hypotension, hypertension, pulmonary and peripheral edema.
Systemic disorders and administration site conditions
Infection at infusion site, pain or local reaction, venous irritation, thrombosis or phlebitis extending from the infusion site, extravasation.
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 effects not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see date on the packaging.
The expiry date refers to the product when unopened and properly stored.
Warning: do not use the medicinal product after the expiry date stated on the packaging.
Use immediately after opening the container. The container is intended for single, uninterrupted administration and any residual solution must not be used.
Storage conditions:
Store in a tightly closed container. Do not freeze or refrigerate.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep the medicinal product out of the reach and sight of children.
COMPOSITION
1000 ml contains:
Sodium chloride 9.0 g
mEq/l: Na 154
Cl 154
Theoretical osmolarity: (mOsm/l) 308
pH 4.5 – 7.0
1 g NaCl = 394 mg Na or 17.1 mEq or 17.1 mmol of Na and Cl
1 mmol Na = 23 mg Na
Excipients: water for injections.
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
PHARMACEUTICAL FORM AND CONTENT
Infusion solution.
Sterile, pyrogen-free, clear and colorless solution.
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.
MARKETING AUTHORISATION HOLDER
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 – 15067 Novi Ligure (AL)
MANUFACTURER
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 – 15067 Novi Ligure (AL)
The 250 ml and 500 ml formats may also be manufactured and controlled by:
BIEFFE MEDITAL
Via Provinciale
Grosotto (SO)
The 100 ml and 50 ml in 100 ml formats may also be manufactured and controlled (excluding batch release) by:
BIEFFE MEDITAL
Via Provinciale
Grosotto (SO)
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
AIFA Determination of 23/04/2012.