SODIUM CHLORIDE 0,9% 500 ML BAC

WORLD CLORUAL SUMMARY

active ingredients

1000 ml of solution contain:

	0,45%	0,9%	%	5%
sodium chloride	g 4,5	g 9.0	g 30,0	g 50,0
mEq/l: Nana+	77	154	513	856
C-	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 or 17,1 mmol of Na⁺and Cl^- 1 mmol Na⁺= 23 mg Na⁺ For the full list of excipients, see the Paragraph 6.1.

Excellent

Water for injectable preparations.

Therapeutic indications

Reintegration of fluids and chloride sodium.

Contraindications

Hypernatriemia. Pletore hydrosaline.

Population

The medicinal product must be administered by intravenous infusion. Treatment of isotonic fluid depletion (extracellular dehydration) Adults and teenagers: 500 ml to 3 liters in 24 hours. Infants and children (up to 12 years of age): 20 to 100 ml in 24 hours and per kg body weight, depending on age and total body weight. The dosage should be properly reduced in patients with kidney failure. Treatment of sodium deficiency The dose is dependent on age, weight, clinical conditions, electrolytic framework and osmolarity, and is in relation to the calculated sodium deficit. The theoretical deficit of sodium can be calculated by the following formula: DEFICIT (mEq)=(140-P) x V P = sodium plasma 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% respectively for older men and women). Using hypertonic solutions (3%-5%), administer half dose in the first 8 hours up to a maximum of 100 ml/hour; then administer the remaining dose until it reaches a plasma sodium concentration of 130 mEq/l or until the symptoms do not improve. In the event of severe sodium depletion and the treatment of serious symptoms related to chronic iponatriemia, administer hypertonic solutions of chloride sodium in order to increase the plasma concentration of sodium of 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 solutions to 0.9%, are used as diluent solutions for intravenous administration of drugs that must be previously diluted, check in advance the compatibility of such medicines with chloride sodium and its most suitable concentration for administration in the RCP of the medicinal product to be diluted. If the concentration is not indicated, use the solution to 0.9%. In particular for Sodium Chloride MONICO 0.45% may be necessary to monitor the electrolytic balance, serum electrolytes and the acid-base balance before and during administration, with particular attention to serum sodium in patients with increased non-osmotic release of vasopressin (inappropriate secretion syndrome of antidiuretic hormone, SIADH) and in patients subjected to treatment 4.5. Sieric sodium monitoring is particularly important for hypotonic solutions. MONICO Sodium Tonicity 0.45%: 77 mOsm/L. Infusion frequency and volume depend on the age, weight and clinical conditions of the patient (e.g. burns, surgery, head injuries, infections) and concomitant therapy must be determined by a doctor with experience in pediatric therapy with intravenous solutions (see paragraphs 4.4 and 4.8).

Conservation

Store in hermetically closed container. Do not refrigerate or freeze.

Warnings

Sodium salts should be administered with caution in patients with hypertension, heart failure, peripheral or lung edema, reduced kidney function, pre-eclampsia or other conditions associated with sodium retention (see Paragraph 4.5). Solutions with a concentration greater than 0.9% (hypertonic solutions) must be used with precaution, at controlled infusion speed and only in cases where they are specifically prescribed. Use with great caution in patients with congestive heart failure, severe kidney failure and in clinical states where edema exists with salina retention; in patients in treatment with corticosteroid or corticotropic drugs. Continuous administration without addition of potassium can cause hypokaliemia. Use carefully in children. During infusion it is good to monitor the balance of fluids, electrolytes, plasma osmolarity and acid-base balance. The infusion of high volumes of the presentation to 0.45% must be used in specific monitoring conditions in patients with heart or lung failure and in patients with non-osmotic release of vasopressin (including SIADH), for the risk of iponatremia acquired in hospital (see below). Iponatremy Patients with non-osmotic release of vasopressin (e.g. in the acute phase of the disease, post-operative stress pains, infections, burns and diseases of the central nervous system), patients with cardiopathy, hepatopathy and nephropathy, and patients treated with vasopressin agonists (see paragraph 4.5) are particularly at risk of acute hypotonic hypotonic solutions. Acute isponatremia can cause acute hypothoramic encephalopathy (brain edema) characterized by cephalea, nausea, convulsive crisis, lethargy and vomiting. Patients with brain edema are particularly at risk of severe, irreversible and life-threatening brain lessons. Children, women in fertile age and patients with reduced cerebral compliance (e.g. meningitis, intracranial bleeding, contusion and brain edema) are particularly at risk of severe and dangerous brain edema for life caused by acute hypothremia. The solution must be clear, colourless and free of visible particles. Use immediately after opening the container. The container serves for one and uninterrupted administration and the eventual residue cannot be used.

Interactions

Corticosteroids are associated with sodium and water retention, resulting in edema and hypertension: therefore, it is necessary to use caution in the contemporary administration of sodium salts and corticosteroids (see Paragraph 4.4). Medicines that cause an increase in vasopressin effect In the following list are indicated medicines that increase the effect of vasopressin, causing a reduction of the excretion of water free from kidney electrolytes and can increase the risk of iponatremia acquired in hospital after a treatment not adequately balanced with intravenous solutions (see paragraphs 4.2, 4.24 and 4.8). • Medicines that stimulate the release of vasopressin include: chlorpropamide, chlofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylndioxides-N-methylamfetamine, ifosfamide, antipsychotics, narcotics• Medicines that enhance the action of vasopressin include: chlorpropamide, FANS, cyclophosphamide • Vastopressin analogues include: desmopressin, oxytocin, vasopressin, terlipressin Other medicines that increase the risk of iponatremia also include diuretics in general and antiepileptics such as oxcarbazepine. Although chloride sodium is compatible with a high number of medicines, it is appropriate to verify compatibility in the CPR of the medicinal product that is intended to administer.

Effects

Below are the undesirable effects of chloride sodium, organized according to the organic systemic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Disorders of water and electrolytic balance Hypernatriemia, hypervolemia, plasma hypoosmolarity (for 0.45% solutions), hyperchloremia (which can cause loss of bicarbonates resulting in acidosis). Diseases of the nervous system Cephalea, dizziness, restlessness, fever, irritability, weakness, muscle stiffness, acute hypothetical encephalopathy (for presentation at 0.45%)** convulsions, coma, death Psychiatric disorders Sleep, confusion. Respiratory, chest and mediastinic pathologies Dispnea, respiratory arrest. Gastrointestinal diseases Silk, reduced salivation, nausea, vomiting, diarrhea, abdominal pain. Heart disease Tachycardia. Pathologies of the eye Reduced tearing. Kidney and urinary pathologies Renal failure. Vascular diseases Hypotension, hypertension, pulmonary and peripheral edema. Systemic pathologies and conditions for administration Infection in the infusion site, pain or local reaction, venous irritation, thrombosis or venous phlebite that extends from the infusion site, extravarous. Disorders of metabolism and nutrition Iponatremia acquired in the hospital (for presentation at 0.45%)************* The hypothesizes acquired in the hospital may cause irreversible and dead brain injury, due to the development of acute hypothetical encephalopathy, with a frequency not known (see paragraphs 4.2, 4.4 and 4.5) Reporting of suspected adverse reactions. Healthcare workers are required to report any suspected adverse reaction through the national reporting system to initiation www.agenziafarmaco.gov/content/come-sgenalare-una -suspect-reaction-adversa.

Overdosing

Synonyms The 0.45% solution is hypotonic with blood and results in a reduction in plasma osmolarity: overdose can therefore lead to plasma hyposmolarity. The administration of excessive doses of isotonic and hypertonic solutions of chloride sodium can lead, depending on the patient's clinical condition, to hypernatriemia, hyperchloremia and/or hypervolemia. Hypernatriemia (associated mainly with the administration of hypertonic solutions) and excessive sodium retention where a defective excretion of sodium at the renal level causes dehydration of the internal organs, especially the brain, and the accumulation of extracellular fluids with edemi that may affect the cerebral, pulmonary and periphery circle with the appearance of lungs. The accumulation of chloride ions causes reduction of the concentration of bicarbonate ions leading to acidosis. Treatment In case of excessive accidental infusion, the treatment will have to be suspended and the patient will have to be kept under observation to assess the appearance of any signs and symptoms that can be correlated to the drug administered, ensuring the patient with the related symptomatic and support measures depending on the need. In case of overdose, the therapy should be aimed at restoring the physiological concentrations of the sodium ion. In these cases the intravenous administration of glucose 5% or sodium hypotonic or isotonic chloride solutions (as they are hypotonic for the hypernactic patient). In case of high natremia, diuretics of the ansa can be used. A natremia exceeding 200 mmol/l may require dialysis.

Although there is no evidence of the effects on the development of the fetus, the medicinal product should only be administered in case of actual need and only after evaluating the risk/benefit ratio. The medicine is compatible with breastfeeding. Sodium MONICO 0,45% must be given with particular caution in pregnant women during labor, especially for serum sodium, if administered in association with oxytocin (see paragraphs 4.4, 4.5 and 4.8).

Source: Farmadati