Sodium chloride SALF 0.9% 100 ml solution for infusion

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Fluid and sodium chloride replacement.

ACTIVE INGREDIENTS

1000 ml contain: Active ingredient: sodium chloride 9 g mEq/l: Na⁺ 154 mEq/l: Cl^- 154 Theoretical osmolarity (mOsm/l): 308 pH: 4.5 - 7.0 1 g of NaCl = 394 mg of Na⁺ or 17.1 mEq or 17.1 mmol Na⁺ and Cl^- 1 mmol Na⁺ = 23 mg of Na⁺ For the full list of excipients, see section 6.1.

EXCIPIENTS

Water for injections.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypernatremia. Hydrosaline plethora.

DOSAGE

The medicine must be administered by intravenous infusion. Treatment of isotonic fluid depletion (extracellular dehydration) Adults and adolescents: from 500 ml to 3 liters in 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 must be appropriately reduced in patients with renal insufficiency. Treatment of sodium deficiency The dose depends on age, weight, clinical conditions, electrolyte status and osmolarity, and is in relation to the calculated sodium deficit. The theoretical sodium deficit can be calculated using the following formula: DEFICIT (mEq) = (140 - P) x 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 women, 50% and 45% for men 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 in order to increase the plasma sodium concentration by 1-2 mmol/l/hour. Pay attention that the correction does not exceed 10-12 mmol/l in 24 hours and 18 mmol/l in 48 hours. In the event that sodium chloride solutions, and in particular 0.9% solutions, are used as diluting solutions for the intravenous administration of medicines that must be previously diluted, check beforehand the compatibility of these medicines with sodium chloride and its most suitable concentration for administration in the SmPC of the medicine to be diluted. If the concentration is not indicated, use the 0.9% solution.

CONSERVATION

Store in hermetically closed container. Do not freeze or refrigerate. The solution must be clear, colorless and free of visible particles.

WARNINGS

Sodium salts should 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 section 4.5). Use with great caution in patients with congestive heart failure, severe renal insufficiency and in clinical states where edema with salt retention exists; in patients being treated with corticosteroids or corticotropin drugs. Continuous administration without 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, colorless and free of visible particles. Use immediately after opening the container. The container is used for a single, uninterrupted administration and any residue cannot be used.

INTERACTIONS

Corticosteroids are associated with sodium and water retention, resulting in edema and hypertension: therefore, caution should be used in the simultaneous administration of sodium salts and corticosteroids (see section 4.4). Although sodium chloride is compatible with a large number of solutions and medicines, it is advisable to check its compatibility in the SmPC of the medicine you intend to co-administer.

SIDE EFFECTS

Below are the side effects of sodium chloride, organized according to the MedDRA system organic classification. There is insufficient data to establish the frequency of the individual effects listed. Disorders of water and electrolyte balance Hypernatremia, hypervolemia, hyperchloremia (which can cause a loss of bicarbonates resulting in acidosis) Nervous system disorders Headache, dizziness, restlessness, fever, irritability, weakness, muscle stiffness, seizures, coma, death Psychiatric disorders Drowsiness, confusional states Respiratory, thoracic and mediastinal disorders Dyspnea, respiratory arrest. Gastrointestinal disorders Thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain. Cardiac diseases Tachycardia. Eye pathologies Reduced tearing. Renal and urinary disorders Renal failure. Vascular pathologies Hypotension, hypertension, pulmonary and peripheral edema. Systemic pathologies and conditions relating to the administration site Infection at the infusion site, local pain or reaction, venous irritation, venous thrombosis or phlebitis extending from the infusion site, extravasation.

OVERDOSE

Symptoms 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 a defective excretion of sodium at the renal level leads to dehydration of the internal organs, especially the brain, and the accumulation of extracellular fluids with edema which can affect the cerebral, pulmonary and peripheral circulation with the appearance of pulmonary and peripheral edema. The accumulation of chlorine ions causes a reduction in the concentration of bicarbonate ions, leading to acidosis. Treatment In case of accidental excessive infusion, the treatment must be suspended and the patient must be kept under observation to evaluate the appearance of any signs and symptoms related to the drug administered, guaranteeing the patient the relevant symptomatic and support measures as necessary. In case of overdose, therapy must 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. A blood sodium level above 200 mmol/l may require the use of dialysis.

PREGNANCY AND BREASTFEEDING

Although no effects on the development of the fetus have been highlighted, the medicine should be administered only in case of actual need and only after evaluating the risk/benefit ratio with your doctor. The medicine is compatible with breastfeeding.

EFFECTS ON DRIVING ABILITY

The medicine does not affect the ability to drive and use machinery.