Sodium chloride SALF 0.9% 100 ml solution for infusion

Sodium chloride SALF 0.9% 100 ml solution for infusion is a sterile physiological solution based on 0.9% sodium chloride , ideal for replenishing fluids and electrolytes in cases of dehydration or loss of body fluids. This product, packaged in a practical 100 ml bottle , is indicated for intravenous use and is used in adults and adolescents as well as in newborns and children , ensuring a balanced intake of sodium and chlorine to maintain water and electrolyte balance.

SALF isotonic saline solution is characterized by a theoretical osmolarity of 308 mOsm/l and a pH between 4.5 and 7.0 , making it perfectly compatible with body fluids. Thanks to its composition, it is particularly indicated for the treatment of isotonic fluid depletion (such as extracellular dehydration) and for the treatment of sodium deficit . It can also be used as a diluent solution for the intravenous administration of other drugs that require safe and controlled dilution.

The active ingredient of this solution is sodium chloride, present in a concentration of 9 g per liter, corresponding to 154 mEq/l of sodium and 154 mEq/l of chlorine. Water for injectable preparations guarantees maximum purity and safety during infusion. The electrolytic solution Sodium chloride SALF 0.9% is a fundamental aid in hospital and home settings for the rapid restoration of fluids and support in situations of water imbalance.

Trust Sodium Chloride SALF 0.9% 100 ml infusion solution for effective rehydration and maintenance of electrolyte balance , with the guarantee of a sterile, safe and quality product, suitable for all age groups.

ACTIVE INGREDIENTS

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

1000 ml contain: Active substance: sodium chloride 9 g mEq/l: Na ⁺ 154 mEq/l: 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 Na ⁺ and Cl ^- 1 mmol Na ⁺ = 23 mg Na ⁺ For the full list of excipients, see section 6.1.

EXCIPIENTS

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

Water for injections.

DIRECTIONS

Therapeutic indications Sodium chloride SALF 0.9% 100 ml solution for infusion - Why is Sodium chloride SALF 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 SALF 0.9% 100 ml solution for infusion - When should Sodium chloride SALF 0.9% 100 ml solution for infusion not be used?

Hypernatremia. Hydrosaline plethora.

DOSAGE

Quantity and method of taking Sodium chloride SALF 0.9% 100 ml solution for infusion - How is Sodium chloride SALF 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 per 24 hours. Infants and children (up to 12 years of age) : 20 to 100 ml per 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 deficiency 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 women, respectively). 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/h. 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 SALF 0.9% 100 ml solution for infusion - How is Sodium chloride SALF 0.9% 100 ml solution for infusion stored?

Store in tightly closed container. Do not freeze or refrigerate. The solution should be clear, colorless and free from visible particles.

WARNINGS

Warnings Sodium chloride SALF 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). 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 receiving corticosteroid or corticotropin drugs. Continuous administration without the addition of potassium may cause hypokalemia. Use with caution in children. During the 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 for a single, uninterrupted administration and any residue cannot be used.

INTERACTIONS

Interactions Sodium chloride SALF 0.9% 100 ml solution for infusion - Which medicines or foods can modify the effect of Sodium chloride SALF 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 SALF 0.9% 100 ml solution for infusion can cause side effects - What are the side effects of Sodium chloride SALF 0.9% 100 ml solution for infusion?

The following are 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, hypervolaemia, hyperchloremia (which may cause bicarbonate loss resulting in 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 SALF 0.9% 100 ml solution for infusion - What are the risks of Sodium chloride SALF 0.9% 100 ml solution for infusion in case of overdose?

Symptoms The administration of excessive doses of isotonic and hypertonic sodium chloride solutions may 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 may 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 to evaluate 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 above 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 SALF 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 having evaluated the risk/benefit ratio with your doctor. The medicine is compatible with breastfeeding.

DRIVING AND USE OF MACHINERY

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

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