Sodium Chloride 0,9 %/10 ml Injection

SODIUM CHLORIDE 0,9 % FLEXIVIAL FRESENIUS is for use as a diluent for reconstitution of a compatible medicinal product.

Posology
SODIUM CHLORIDE 0,9 % FLEXIVIAL FRESENIUS is intended for use as a diluent for reconstitution of a compatible medicinal product. The amount to be used will depend on the concentration wanted for the administration of the medicine to be dissolved.

Method of administration
Intravenous, intramuscular or subcutaneous use.

Intravenously, SODIUM CHLORIDE 0,9 % FLEXIVIAL FRESENIUS should be administered cautiously to young children and elderly patients. Due to the indications of the product, contraindications depend on the medicine to be dissolved. In general, the administration of this product is contraindicated in the following situations:

• Hypernatraemia
• Hypertonia
• Cardiac insufficiency
• Oedematous states in patients with cardiac, hepatic or renal disorders
• Severe hypertension
• Metabolic acidosis

See section 4.3. Once the container is opened the solution should be used immediately. In case of subcutaneous administration, no supplement should be added, since isotonicity would change. Do not use the solution if it is not clear or have visible precipitates. Before adding the medicine to the SODIUM CHLORIDE 0,9 % FLEXIVIAL FRESENIUS ampoule compatibility between the substance to be administered and sodium chloride should be checked. Sodium chloride should be used with precaution in patients with hypertension, cardiac failure, pulmonary or peripheral oedema, renal impairment, pre-eclampsia, hyperaldosteronism, cirrhosis and other disorders of liver, hypervolaemia, urinary tract obstruction, hypoproteinaemia and other sicknesses and treatments (e.g., corticosteroids) associated to sodium retention.

Paediatric population
Newborns, whether premature or not, can present too high sodium levels due to immaturity of renal function. Therefore, in newborns, whether premature or not, repeated injections of sodium chloride can only be administered after sodium levels in the blood have been determined.

Interactions depend on the medicine to be dissolved. Sodium chloride is incompatible with lithium carbonate, whose renal excretion is directly proportional to the sodium levels in the body. Administration of sodium chloride accelerates renal excretion of lithium, causing a decrease of its therapeutical action. The addition of alcohol to sodium chloride solutions should be avoided.

Women of childbearing potential/ Contraception in males and females
No information available.

Pregnancy
Safety in pregnancy has not been established; therefore, it is recommended to be used with precaution if it is administered during pregnancy.

Breastfeeding
Safety in lactation has not been established; therefore, it is recommended to be used with precaution if it is administered during lactation.

Not relevant.

Convulsions may result from iatrogenically induced hypernatraemia. General disorders and administration site conditions may be provoked. Inadequate or excessive administration of physiologic saline solution may produce hyperhydration, hypernatraemia, hyperchloraemia and related signs such as metabolic acidosis because of decrease of bicarbonate concentration and oedema formation. An excess of sodium chloride may produce nausea, vomiting and headache.

As SODIUM CHLORIDE 0,9 % FLEXIVIAL FRESENIUS solvent for parenteral use is used as a diluent of injectable preparations, the nature of the product added determine the probability of appearance of undesirable effects. In case of adverse reactions due to the associated medicine, infusion should be immediately discontinued, the patient should be evaluated, suitable corrective measures should be established, and the solution should be kept for a later analysis should it become necessary.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. Healthcare providers are asked to report any suspected adverse drug reactions to the Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicineu2019s regulatory authority in the country where the product is marketed.

In cases of patients unable to retain the sodium selectively, the treatment must be discontinued. An excess of sodium chloride, in its most acute form, produces dehydration of internal organs, nausea, vomiting, diarrhoea, abdominal cramps, thirst, decrease of salivation, water, sweat, fever, hypotension, tachycardia, renal failure, pulmonary oedema, acidosis, respiratory insufficiency, headache, vertigo, irritability, muscle spasms, rigidity, coma and death. Due to the nature of the product, if its indication and administration are correct and controlled there is no risk of intoxication.