Sodium chloride eurospital 0.9% 100 ml

Product Description

Eurospital Sodium Chloride 0.9% is a solution for fluid and sodium chloride replacement.

Indications

Fluid and sodium chloride replacement.

Composition

Active ingredients

1g Nacl = 394mg Na⁺ or 17.1meq oo 17.1 mmol Na⁺ and Cl^- 1 mmol Na⁺ = 23 mg Na⁺ For a full list of excipients, see section 6.1.

Excipients

Water for injections.

Method of administration Directions for Use and Dosage

The medicine should be administered by intravenous infusion

Treatment of isotonic fluid depletion (extracellular dehydration)

• Adults and adolescents: 500 ml to 3 liters per 24 hours
• Infant 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 is 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 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% for men and elderly women, 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 achieved 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/h. Care should be taken that the correction does not exceed 10-12 mmol/l in 24 hours and 18 mmol/l in 48 hours. If sodium chloride solutions, particularly 0.9% solutions, are used as diluent solutions for the intravenous administration of drugs that must be diluted beforehand, check 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.

Interactions

Corticosteroids are associated with sodium and water retention, resulting in edema and hypertension: therefore, it is advisable to consult a doctor beforehand. Caution should be exercised when administering sodium salts and corticosteroids 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 SmPC of the medicinal product to be co-administered.

Warnings

Sodium salts should 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 section 4.5). 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 insufficiency and in clinical conditions in which edema with salt retention exists; in patients being treated with corticosteroids or corticotropins. 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, osmolarity and blood pressure. plasma and acid-base balance. The solution must be clear, colorless, and free of visible particles. Use immediately after opening the container. The container is for a single, uninterrupted administration, and any residue cannot be used.

Contraindications

Pletore idrosaline.

Side effects

The side effects of sodium chloride are listed below, organized according to the Meddra system organ classification. There are insufficient data to determine the frequency of the individual effects listed.

Fluid and electrolyte balance disorders
Hypernatremia, hypervolemia, plasma hypoosmolality (for 0.45% solutions), hyperchloremia (which may cause bicarbonate loss resulting in acidosis).

Nervous system disorders
Headache, dizziness, restlessness, fever, irritability, weakness, stiffness. Muscle weakness, convulsions, coma, death.

Psychiatric disorders: Drowsiness, confusional states.

Respiratory, thoracic and mediastinal disorders: Dyspnea, respiratory arrest.

Gastrointestinal disorders: Thirst, decreased salivation, nausea, vomiting, diarrhea, abdominal pain.

Cardiac disorders: Cardiac disorders: />Tachycardia.

Eye disorders
Decreased lacrimation.

Renal and urinary disorders
Renal failure.

Vascular disorders
Hypotension, hypertension, pulmonary and peripheral edema.

General disorders and administration site conditions
Infection at the infusion site, pain or local reaction, venous irritation, venous thrombosis or phlebitis extending from the infusion site, Extravasation.

Overdose

Symptoms
The 0.45% solution is hypotonic with blood and causes a reduction in plasma osmolality: overdose can therefore lead to plasma hypoosmolality. 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 the renal level cause dehydration of the 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 administered drug, ensuring the patient receives the relevant symptomatic and supportive measures as needed. In case of overdose, therapy must be aimed at restoring physiological sodium ion concentrations. In these cases, it is advisable to reduce sodium ion concentrations. 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 serum natremia, loop diuretics can be used. A serum natremia above 200 mmol/l may require the use of dialysis.

Pregnancy and breastfeeding

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

Storage

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

Size

100 ml bottle