Sodium chloride Eurospital

Package Leaflet

Sodium Chloride Eurospital 0.9% infusion solution

PHARMACOTHERAPEUTIC CATEGORY:
Solutions affecting electrolyte balance
THERAPEUTIC INDICATIONS:
Replenishment of fluids and sodium chloride
CONTRAINDICATIONS:
Hypernatraemia
Hydro-saline plethora.
PRECAUTIONS FOR USE:
Sodium salts must be administered with caution in patients with hypertension, cardiac failure, peripheral or pulmonary oedema, reduced renal function, pre-eclampsia, or other conditions associated with sodium retention (see interactions).
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 failure, and clinical conditions involving oedema with salt retention; in patients receiving corticosteroid or corticotropin drugs. Continuous administration without potassium supplementation may lead to hypokalaemia.
Use with caution in children.
During infusion, it is good practice to monitor fluid balance, electrolytes, plasma osmolarity, and acid-base balance.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines,
including those not requiring a prescription.
Corticosteroids are associated with sodium and water retention, leading to oedema and hypertension: therefore, caution is required when administering sodium salts concomitantly with corticosteroids (see Precautions for Use).
Although sodium chloride is compatible with a large number of solutions and medicinal products, compatibility should always be verified in the Summary of Product Characteristics (SmPC) of the medicinal product intended for co-administration.
SPECIAL WARNINGS
The solution must be clear, colourless, and free from visible particles. Use immediately after opening the container. The container is intended for single, uninterrupted administration; any remaining solution must not be used.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Although no adverse effects on fetal development have been demonstrated, the medicine should be administered only when clearly needed and only after careful assessment of the risk/benefit ratio.
The medicine is compatible with breastfeeding.
Effects on ability to drive and use machines
The medicine does not affect the ability to drive or operate machinery.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The medicine must be administered by intravenous infusion.
Treatment of isotonic fluid depletion (extracellular dehydration)
Adults and adolescents: 500 ml to 3 litres within 24 hours.
Neonates and children (up to 12 years of age): 20 to 100 ml per 24 hours per kg of body weight, depending on age and total body weight.
Dosage should be appropriately reduced in patients with renal impairment.
Treatment of sodium deficit
Dosage depends on age, weight, clinical condition, electrolyte profile, osmolarity, and the calculated sodium deficit.
The theoretical sodium deficit can be calculated using the following formula:
DEFICIT (mEq) = (140 - P) x V
P
V = total body water volume (equal to 60% of body weight in children and adult males, 50% in adult females, 50% and 45% respectively in elderly men and women).
When using hypertonic solutions (2%, 3%, 5%), administer half the dose within the first 8 hours, up to a maximum of 100 ml/hour; then administer the remaining dose until plasma sodium concentration reaches 130 mEq/l or until symptoms improve.
In cases of severe sodium depletion and in the treatment of severe symptoms related to chronic hyponatraemia, administer hypertonic sodium chloride solutions to increase plasma sodium concentration by 1–2 mmol/l/hour. Ensure that correction does not exceed 10–12 mmol/l in 24 hours or 18 mmol/l in 48 hours.
When sodium chloride solutions, particularly 0.9% solutions, are used as diluents for intravenous administration of drugs requiring prior dilution, verify in advance the compatibility of such drugs with sodium chloride and the most suitable concentration for administration, as specified in the SmPC of the drug to be diluted. If no concentration is specified, use the 0.9% solution.
For compatibility information, refer to the SmPC of the medicinal product to be administered.
OVERDOSE
Symptoms
The 0.45% solution is hypotonic compared to blood and reduces plasma osmolarity: overdose may therefore lead to plasma hypo-osmolarity.
Excessive administration of isotonic and hypertonic sodium chloride solutions may lead, depending on the patient's clinical condition, to hypernatraemia, hyperchloraemia and/or hypervolaemia.
Hypernatraemia (mainly associated with hypertonic solutions) and excessive sodium retention when renal sodium excretion is impaired cause dehydration of internal organs, particularly the brain, and accumulation of extracellular fluid leading to oedema affecting the cerebral, pulmonary, and peripheral circulation, potentially resulting in pulmonary and peripheral oedema.
Accumulation of chloride ions reduces bicarbonate ion concentration, leading to acidosis.
Treatment
In case of accidental excessive infusion, treatment should be discontinued and the patient kept under observation to monitor for any signs or symptoms related to the administered drug, providing appropriate symptomatic and supportive measures as needed.
In cases of overdose, therapy should aim to restore physiological sodium ion concentrations.
In such cases, intravenous administration of 5% glucose or hypotonic or isotonic sodium chloride solutions (which are hypotonic relative to the hypernatraemic patient) is recommended.
Loop diuretics may be used in cases of marked hypernatraemia.
A serum sodium level exceeding 200 mmol/l may require dialysis.
In case of accidental ingestion/overdose of Sodio Cloruro Eurospital, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Sodio Cloruro Eurospital, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, Sodio Cloruro may cause side effects, although not everybody experiences them.
The following are undesirable effects associated with sodium chloride. There are insufficient data to determine the frequency of the individual effects listed.
Disorders of water and electrolyte balance
Hypernatraemia, hypervolaemia, plasma hypo-osmolarity (with 0.45% solutions), hyperchloraemia (which may cause bicarbonate loss leading to acidosis).
Disorders of the nervous system
Headache, dizziness, restlessness, fever, irritability, weakness, muscle rigidity, convulsions, coma, death
Psychiatric disorders
Somnolence, confusion
Respiratory, thoracic and mediastinal disorders
Dyspnoea, respiratory arrest.
Gastrointestinal disorders
Thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain.
Cardiac disorders
Tachycardia.
Eye disorders
Reduced lacrimation.
Renal and urinary disorders
Renal failure.
Vascular disorders
Hypotension, hypertension, pulmonary and peripheral oedema.
Systemic disorders and administration site conditions
Infection at the infusion site, pain or local reaction, venous irritation, thrombosis or phlebitis extending from the infusion site, extravasation.
Following the instructions in this leaflet reduces the risk of undesirable effects.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date indicated on the packaging.
The expiry date refers to the product kept in its original, undamaged packaging and stored correctly.
WARNING: do not use the medicine after the expiry date stated on the packaging.
Use immediately after opening the container. The container is intended for single, uninterrupted administration; any remaining solution must not be used.
Storage conditions:
Store at room temperature (8°–30°C).
Keep in the tightly closed container. Do not freeze or refrigerate.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.
Keep the medicine out of the reach and sight of children.
COMPOSITION
1000 ml contains:
0.45% 0.9% 2% 3% 5%
Sodium Chloride g 4.5 g 9.0 g 20.0 g 30.0 g 50.0
mEq/l: Na 77 154 342 513 856
Cl 77 154 342 513 856
Theoretical osmolarity (mOsm/l) 154 308 684 1026 1712
pH: 4.5 - 7.0 4.5 - 7.0 4.5 - 7.0 4.5 - 7.0 4.5 - 7.0
1g NaCl = 394 mg Na or 17.1 mEq or 17.1 mmol of Na and Cl
1 mmol Na = 23 mg Na
Excipients:
Water for injections q.s.
PHARMACEUTICAL FORM AND CONTENT
Infusion solution
100 ml vial
250 ml vial
500 ml vial
1000 ml vial
Sterile, pyrogen-free, clear and colourless solution.
MARKETING AUTHORISATION HOLDER
Eurospital S.p.A., via Flavia 122 – Trieste.
MANUFACTURER:
SM. Farmaceutici Srl, via Flavia 124 – Trieste – For all authorized packages
Laboratorios Grifols (S.A.), Pol. Ind. Autopista- Passeig Fluvial 24-08150 Parets Del Valles
Barcelona, Spain – For the following packages:
0.9% vial 100 ml – A.I.C. 032182014;
0.9% vial 250 ml – A.I.C. 032182026;
0.9% vial 500 ml – A.I.C. 032182038