Sodium chloride Eurospital 0.9% 100 ml solution for infusion

Sodium chloride Eurospital 0.9% 100 ml solution for infusion is an isotonic solution based on sodium chloride 0.9% , specifically formulated for the reintegration of fluids and the restoration of electrolyte balance in situations of fluid depletion or extracellular dehydration . This product, packaged in a 100 ml bottle, is indicated for intravenous use in both adults and children, proving particularly useful in the treatment of dehydration and in support in case of sodium deficit. The 0.9% physiological solution is widely used in hospital and outpatient settings as an infusion solution and as a diluent for the administration of other compatible drugs.

The composition of Sodium Chloride Eurospital 0.9% guarantees a balanced supply of sodium and chloride, with a theoretical osmolarity of 308 mOsm/l and a pH between 4.5 and 7.0, making it ideal for maintaining hydro-electrolytic homeostasis. The only excipient present is water for injections , ensuring maximum purity and safety for infusion. Thanks to its efficacy and versatility, this solution is a reference hospital drug for the management of numerous clinical conditions that require the restoration of fluids and electrolytes , both in acute and chronic situations.

Sodium chloride Eurospital 0.9% 100 ml solution for infusion represents a reliable choice for fluid replenishment and support of electrolyte balance in patients of all ages, offering a ready-to-use solution, safe and compliant with the quality standards required in the healthcare sector.

ACTIVE INGREDIENTS

Active ingredients contained in Sodium chloride Eurospital 0.9% 100 ml solution for infusion - What is the active ingredient of Sodium chloride Eurospital 0.9% 100 ml solution for infusion?

1000 ml contains:
	0.45%	0.9%	2%	3%	5%
Sodium chloride	g 4.5	g 9.0	g 20.0	g 30.0	g 50.0
mEq/l: Na +	77	154	342	513	856
Cl -	77	154	342	513	856
Theoretical osmolarity (mOsm/l)	154	308	684	1026	1712
pH:	4.5-7.0	4.5-7.0	4.5-7.0	4.5-7.0	4.5-7.0

1g NaCl = 394mg Na ⁺ or 17.1mEq oO 17.1 mmol Na ⁺ and Cl ^- 1 mmol Na ⁺ = 23mg Na ⁺ For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Sodium chloride Eurospital 0.9% 100 ml solution for infusion - What does Sodium chloride Eurospital 0.9% 100 ml solution for infusion contain?

Water for injections.

DIRECTIONS

Therapeutic indications Sodium chloride Eurospital 0.9% 100 ml solution for infusion - Why is Sodium chloride Eurospital 0.9% 100 ml solution for infusion used? What is it used for?

Fluid and sodium chloride replacement.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Sodium chloride Eurospital 0.9% 100 ml solution for infusion - When should Sodium chloride Eurospital 0.9% 100 ml solution for infusion not be used?

Plethora of salt marshes.

DOSAGE

Quantity and method of taking Sodium chloride Eurospital 0.9% 100 ml solution for infusion - How is Sodium chloride Eurospital 0.9% 100 ml solution for infusion taken?

The medicinal product should be administered by intravenous infusion Treatment of isotonic fluid depletion (extracellular dehydration) Adults and adolescents : 500 ml to 3 litres in 24 hours Neonates and children (up to 12 years of age): 20 to 100 ml in 24 hours and per kg of body weight, depending on age and total body weight. The dosage should be appropriately reduced in patients with renal insufficiency. Treatment of sodium deficit The dose depends on age, weight, clinical condition, electrolyte profile and osmolarity, and is related to the calculated sodium deficit. The theoretical sodium deficit can be calculated using the following formula: DEFICIT (mEq) = (140-P) x PV = 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% for males and elderly females, respectively). Using hypertonic solutions (2%-3%-5%), administer half the dose in the first 8 hours up to a maximum of 100 ml/hour; then administer the remaining dose until a plasma sodium concentration of 130 mEq/l is reached or until symptoms improve. In conditions of severe sodium depletion and in the treatment of severe symptoms related to chronic hyponatremia, administer hypertonic sodium chloride solutions to increase the plasma sodium concentration by 1-2 mmol/l/hour. Care should be taken to ensure that the correction does not exceed 10-12 mmol/l in 24 hours and 18 mmol/l in 48 hours. In case sodium chloride solutions, and in particular 0.9% solutions, are used as diluent solutions for the intravenous administration of drugs that must be previously diluted, check in advance the compatibility of these drugs with sodium chloride and its most suitable concentration for administration in the RCP of the drug to be diluted. If the concentration is not indicated, use the 0.9% solution.

CONSERVATION

Storage Sodium chloride Eurospital 0.9% 100 ml solution for infusion - How is Sodium chloride Eurospital 0.9% 100 ml solution for infusion stored?

Keep this medicine out of the sight and reach of children. Do not release into the environment. Store in normal ambient conditions. Store in a tightly closed container. Do not freeze or refrigerate.

WARNINGS

Warnings Sodium chloride Eurospital 0.9% 100 ml solution for infusion - It is important to know that:

Sodium salts should be administered with caution in patients with hypertension, heart failure, peripheral or pulmonary edema, impaired renal function, pre-eclampsia, or other conditions associated with sodium retention (see section 4.5). Solutions with a concentration greater than 0.9% (hypertonic solutions) should be used with caution, at a controlled rate of infusion and only when specifically prescribed. Use with great caution in patients with congestive heart failure, severe renal insufficiency and in clinical conditions in which there is edema with salt retention; in patients treated with corticosteroids or corticotropins. Continuous administration without the addition of potassium may cause hypokalemia. Use with caution in children. During infusion it is good practice to monitor fluid balance, electrolytes, plasma osmolarity and acid-base balance. 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 and any residue cannot be used.

INTERACTIONS

Interactions Sodium chloride Eurospital 0.9% 100 ml solution for infusion - Which medicines or foods can modify the effect of Sodium chloride Eurospital 0.9% 100 ml solution for infusion?

Corticosteroids are associated with sodium and water retention, resulting in edema and hypertension: therefore, caution should be exercised when sodium salts and corticosteroids are administered concomitantly (see section 4.4). Although sodium chloride is compatible with a large number of solutions and medicinal products, it is advisable to check its compatibility in the RCP of the medicinal product that is intended to be co-administered.

SIDE EFFECTS

Like all medicines, Sodium chloride Eurospital 0.9% 100 ml solution for infusion can cause side effects - What are the side effects of Sodium chloride Eurospital 0.9% 100 ml solution for infusion?

The following are the adverse reactions of sodium chloride, organised according to the MedDRA system organ classification. There are insufficient data to establish the frequency of the individual effects listed. Water and electrolyte balance disorders Hypernatremia, hypervolemia, plasma hypoosmolarity (for 0.45% solutions), hyperchloremia (which may cause bicarbonate loss with consequent acidosis). Nervous system disorders Headache, dizziness, restlessness, fever, irritability, weakness, muscle stiffness, convulsions, coma, death. Psychiatric disorders Drowsiness, confusional states. Respiratory, thoracic and mediastinal disorders Dyspnoea, respiratory arrest. Gastrointestinal disorders Thirst, decreased salivation, nausea, vomiting, diarrhoea, abdominal pain. Cardiac disorders Tachycardia. Eye disorders Decreased lacrimation. Renal and urinary disorders Renal failure. Vascular disorders Hypotension, hypertension, pulmonary and peripheral oedema. Systemic disorders and conditions related to the administration site Infection at the infusion site, pain or local reaction, venous irritation, thrombosis or venous phlebitis extending from the infusion site, extravasation.

OVERDOSE

Overdose Sodium chloride Eurospital 0.9% 100 ml solution for infusion - What are the risks of Sodium chloride Eurospital 0.9% 100 ml solution for infusion in case of overdose?

Symptoms The 0.45% solution is hypotonic with blood and causes a reduction in plasma osmolarity: overdose can therefore lead to plasma hypoosmolarity. The administration of excessive doses of isotonic and hypertonic sodium chloride solutions can lead, depending on the patient's clinical conditions, to hypernatremia, hyperchloremia and/or hypervolemia. Hypernatremia (mainly associated with the administration of hypertonic solutions) and excessive sodium retention where there is defective sodium excretion at renal level causes dehydration of internal organs, particularly the brain, and the accumulation of extracellular fluids with edema that can affect the cerebral, pulmonary and peripheral circulation with the appearance of pulmonary and peripheral edema. The accumulation of chloride ions causes a reduction in the concentration of bicarbonate ions leading to acidosis. Treatment In case of accidental excessive infusion, treatment should be suspended and the patient should be kept under observation for the appearance of any signs and symptoms related to the drug administered, ensuring the patient receives the relevant symptomatic and supportive measures as needed. In case of overdose, therapy should be aimed at restoring physiological sodium ion concentrations. In these cases, intravenous administration of 5% glucose or hypotonic or isotonic sodium chloride solutions is recommended (as they are hypotonic for the hypernatremic patient). In case of high natremia, loop diuretics can be used. Natremia greater than 200 mmol/l may require the use of dialysis.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Sodium chloride Eurospital 0.9% 100 ml solution for infusion.

Although no effects on fetal development have been observed, the medicine should be administered only if really necessary and only after evaluating the risk/benefit ratio. The medicine is compatible with breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Sodium chloride Eurospital 0.9% 100 ml solution for infusion before driving or using machines - Does Sodium chloride Eurospital 0.9% 100 ml solution for infusion affect driving or using machines?

The medicine does not affect the ability to drive or use machines.