Sodium chloride Monico

SODIUM CHLORIDE – PACKAGE LEAFLET INFUSION SOLUTIONS – BAGS AND BOTTLES

SODIUM CHLORIDE 0.45% MONICO infusion solutions

SODIUM CHLORIDE 0.9% MONICO infusion solutions
SODIUM CHLORIDE 3% MONICO infusion solutions
SODIUM CHLORIDE 5% MONICO infusion solutions
PHARMACOTHERAPEUTIC CATEGORY
Solutions affecting electrolyte balance.
THERAPEUTIC INDICATIONS
Replacement of fluids and sodium chloride.
CONTRAINDICATIONS
Hypernatraemia.
Hydro-saline plethora.
PRECAUTIONS FOR USE
Sodium salts must be administered with caution in patients with hypertension, cardiac failure,
peripheral or pulmonary oedema, 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 with
caution, at a controlled infusion rate, and only when specifically prescribed.
Use with great caution in patients with congestive heart failure, severe renal failure, and in
clinical conditions associated with oedema and salt retention; in patients receiving corticosteroid or
corticotropin drugs.
Continuous administration without potassium supplementation may lead to hypokalaemia.
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 oedema 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, compatibility should
nonetheless be verified in the package leaflet of the medicine intended for co-administration.
SPECIAL WARNINGS
The solution must be clear, colourless, and free from visible particles. Use immediately after opening the
container. The container is intended for a single, uninterrupted administration; any unused portion must not be saved.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Although no adverse effects on fetal development have been observed, the medicine should be administered only if clearly needed and only after assessing the risk/benefit ratio.
The medicine is compatible with breastfeeding.
Effects on ability to drive and use machines
The medicine does not affect the ability to drive or operate machinery.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The medicine must be administered by intravenous infusion.
Treatment of isotonic fluid depletion (extracellular dehydration)
Adults and adolescents: 500 ml to 3 litres 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 insufficiency.
Treatment of sodium deficit
Dosage depends on age, weight, clinical condition, electrolyte status, and osmolarity, and is related to the
calculated sodium deficit.
The theoretical sodium deficit can be calculated using the following formula:

P = plasma sodium concentration (in mEq/l);
V = 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 (3%-5%), administer half the dose within the first 8 hours at a maximum rate 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 hyponatraemia,
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.
When Sodium Chloride solutions, particularly 0.9% solutions, are used as diluents for intravenous administration of drugs requiring prior dilution, verify beforehand the compatibility of such drugs with sodium chloride and the most suitable concentration as indicated in the Summary of Product Characteristics (SmPC) of the drug to be diluted. If no concentration is specified, use the 0.9% solution.
For compatibility information, refer to the SmPC of the medicine to be administered.
OVERDOSE
Symptoms
The 0.45% solution is hypotonic relative to blood and reduces plasma osmolarity: overdose may therefore lead to plasma hypo-osmolarity.
Excessive administration of hypotonic or hypertonic Sodium Chloride solutions may lead, depending on the patient's clinical condition, to hypernatraemia, hyperchloraemia and/or hypervolaemia.
Hypernatraemia (mainly associated with administration of hypertonic solutions) 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 oedema affecting cerebral, pulmonary, and peripheral circulation, resulting in cerebral and peripheral oedema.
Accumulation of chloride ions reduces bicarbonate ion concentration, leading to acidosis.
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 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 hypotonic relative to the hypernatraemic patient) is recommended.
Loop diuretics may be used in cases of severe hypernatraemia.
A serum sodium level exceeding 200 mmol/l may require dialysis.
If you have any doubts about the use of Sodium Chloride MONICO, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, Sodium Chloride MONICO can cause side effects, although not everyone experiences them.
The following undesirable effects of Sodium Chloride are listed below. There are insufficient data to determine the frequency of individual listed effects.
Disorders of water and electrolyte balance: hypernatraemia, hypervolaemia, plasma hypo-osmolarity (with 0.45% solutions), hyperchloraemia (which may cause bicarbonate loss leading to acidosis).
Nervous system disorders: headache, dizziness, restlessness, fever, irritability, weakness, muscle rigidity, convulsions, coma, death.
Psychiatric disorders: somnolence, confusion.
Respiratory, thoracic and mediastinal disorders: dyspnoea, respiratory arrest.
Gastrointestinal disorders: thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain.
Cardiac disorders: tachycardia.
Eye disorders: reduced lacrimation.
Renal and urinary disorders: renal failure.
Vascular disorders: hypotension, hypertension, pulmonary and peripheral oedema.
Systemic 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 undesirable effects.
If any of the side effects worsens, or if you notice any side 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 in its original, undamaged packaging under recommended conditions.
Caution: do not use the medicine after the expiry date stated on the packaging.
Use immediately after opening the container. The container is intended for a single, uninterrupted
administration and any unused portion must not be saved.
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 helps protect the environment.
Keep the medicine out of the reach and sight of children.
COMPOSITION
1000 ml of solution contains:
0.45% 0.9% 3% 5%
sodium chloride g 4.5 g 9.0 g 30.0 g 50.0
mEq/l: Na 77 154 513 856
Cl 77 154 513 856
Theoretical osmolarity (mOsm/l): 154 308 1026 1712
pH: 4.5 ÷ 7.0 4.5 ÷ 7.0 4.5 ÷ 7.0 4.5 ÷ 7.0
1 g NaCl = 394 mg Na or 17.1 mEq of Na and Cl
1 mmol Na = 23 mg Na
Excipients: water for injections.
PHARMACEUTICAL FORM AND CONTENT
Infusion solution.
Sterile, pyrogen-free, clear and colourless solution.
Glass bottles of 50, 100, 250, 500 or 1000 ml.
Polypropylene bags of 50, 100, 250, 500, 1000, 2000, 3000, 4000 or 5000 ml.
MARKETING AUTHORISATION HOLDER
MONICO SPA - via Ponte di Pietra 7, VENEZIA/MESTRE.
MANUFACTURER
MONICO SPA - via Ponte di Pietra 7, VENEZIA/MESTRE.
18 May 2012

SODIUM CHLORIDE – PACKAGE LEAFLET CONCENTRATE FOR INFUSION SOLUTION – VIALS AND BOTTLES

SODIUM CHLORIDE 2 mEq/ml MONICO concentrate for infusion solution
SODIUM CHLORIDE 3 mEq/ml MONICO concentrate for infusion solution
PHARMACOTHERAPEUTIC CATEGORY
Solutions affecting electrolyte balance.
THERAPEUTIC INDICATIONS
Exogenous supply of sodium and chloride during Total Parenteral Nutrition (TPN) in adult and paediatric 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
Hypernatraemia.
Hydro-saline plethora.
PRECAUTIONS FOR USE
Sodium salts must be administered with caution in patients with hypertension, cardiac failure,
peripheral or pulmonary oedema, reduced renal function, pre-eclampsia, or other conditions associated with
sodium retention (see Interactions).
The medicine must be used with caution and at a controlled infusion rate.
Use with great caution in patients with congestive heart failure, severe renal failure, and in clinical conditions with oedema and salt retention; in patients receiving corticosteroid or corticotropin drugs.
Continuous administration without potassium supplementation may lead to hypokalaemia.
Use with caution in children.
During infusion, it is advisable to monitor fluid balance, electrolytes, plasma osmolarity, and acid-base balance.
This medicine is a concentrate and must not be administered directly without prior dilution 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 to 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 oedema 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 nonetheless be verified with other components of the TPN mixture and with any other medicines intended for co-administration.
SPECIAL WARNINGS
Use immediately after opening the container. The solution must be clear, colourless, and free from visible particles. It is intended for a single, uninterrupted administration; any unused portion must not be saved.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Although no adverse effects on fetal development have been observed, the medicine should be administered only if clearly needed and only after assessing the risk/benefit ratio.
The medicine is compatible with breastfeeding.
Effects on ability to drive and use machines
Not applicable.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The medicine must be administered by intravenous infusion after appropriate dilution.
Dosage depends on age, weight, clinical condition, electrolyte status, and osmolarity, and is related to the calculated sodium deficit.
The theoretical sodium deficit can be calculated using the following formula:

P = plasma sodium concentration (in mEq/l);
V = 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 (3%-5%), administer half the dose within the first 8 hours at a maximum rate 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 hyponatraemia,
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 medicines, refer to the respective package leaflets.
OVERDOSE
Symptoms
Excessive administration of hypotonic or hypertonic Sodium Chloride solutions may lead, depending on the patient's clinical condition, to hypernatraemia, hyperchloraemia and/or hypervolaemia.
Hypernatraemia (mainly associated with administration of hypertonic solutions) 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 oedema affecting cerebral, pulmonary, and peripheral circulation.
Accumulation of chloride ions reduces bicarbonate ion concentration, leading to acidosis.
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 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 hypotonic relative to the hypernatraemic patient) is recommended.
Loop diuretics may be used in cases of severe hypernatraemia.
A serum sodium level exceeding 200 mmol/l may require dialysis.
If you have any doubts about the use of Sodium Chloride MONICO, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, Sodium Chloride MONICO can cause side effects, although not everyone experiences them.
The following undesirable effects of Sodium Chloride are listed below. There are insufficient data to determine the frequency of individual listed effects.
Disorders of water and electrolyte balance: hypernatraemia, hypervolaemia, hyperchloraemia (which may cause bicarbonate loss leading to acidosis).
Nervous system disorders: headache, dizziness, restlessness, fever, irritability, weakness, muscle rigidity, convulsions, coma, death.
Psychiatric disorders: somnolence, confusion.
Respiratory, thoracic and mediastinal disorders: dyspnoea, respiratory arrest.
Gastrointestinal disorders: thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain.
Cardiac disorders: tachycardia.
Eye disorders: reduced lacrimation.
Renal and urinary disorders: renal failure.
Vascular disorders: hypotension, hypertension, pulmonary and peripheral oedema.
Systemic 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 undesirable effects.
If any of the side effects worsens, or if you notice any side 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 in its original, undamaged packaging under recommended conditions.
Caution: do not use the medicine after the expiry date stated on the packaging.
Use immediately after opening the container. The container is intended for a single, uninterrupted
administration and any unused portion must not be saved.
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 helps protect the environment.
Keep the medicine out of the reach and sight of children.
COMPOSITION
1 ml of solution contains:
2 mEq/ml 3 mEq/ml
Active substance sodium chloride g 0.117 g 0.175
mEq/l: Na 2 3
Cl 2 3
Theoretical osmolarity (mOsm/l): 4000 6000
pH 4.5 ÷ 7.0 4.5 ÷ 7.0
Excipients: water for injections.
PHARMACEUTICAL FORM AND CONTENT
Concentrate for infusion solution (to be diluted before use)
Sterile, pyrogen-free, clear and colourless solution
Carton containing 5 or 10 vials of 10 ml.
Bottles containing 30, 50, 100, 250 or 500 ml of solution.
MARKETING AUTHORISATION HOLDER
MONICO SPA - via Ponte di Pietra 7, VENEZIA/MESTRE.
MANUFACTURER
MONICO SPA - via Ponte di Pietra 7, VENEZIA/MESTRE.
18 May 2012