Sodium Chloride Injection Bp / Sodium Chloride 0.9% W/V For Intravenous Infusion Bp.
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride Injection BP / Sodium Chloride 0.9% w/v for Intravenous Infusion BP.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride BP 0.9% w/v
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Recommended in the treatment of dehydration to correct water and electrolyte depletion. Also in the treatment of Addison’s disease.
4.2 Posology and method of administration
Adults:
The normal dosage is 1 litre over 6-8 hours, increasing the flow rate up to a maximum of 1 litre per hour.
Paediatric population:
The normal dosage should be adjusted depending on the body weight and condition of the patient. Should not be administered over prolonged periods.
Elderly:
The normal dosage should be adjusted according to the condition of the patient. Should not be administered over prolonged periods.
For intravenous infusion.
The effect of saline therapy can be assessed by the relief of symptoms, observation of blood pressure and measurement of volume and concentration of urine output.
4.3 Contraindications
The solution is contraindicated in patients presenting hypernatremia or hyperchloremia.
The contraindications related to the added medicinal product should be considered.
4.4 Special warnings and precautions for use
Fluid balance/renal function
Use in patients with (severe) renal impairment
Sodium Chloride 0.9% should be administered with particular caution to patients with or at risk of severe renal impairment. In such patients administration of Sodium Chloride 0.9% may result in sodium retention. (See “Use in patients at risk for sodium retention, fluid overload and oedema” below, for additional considerations.)
Risk of fluid and/or solute overload and electrolyte disturbances Depending on the volume and rate of infusion, intravenous administration of Sodium Chloride 0.9% can cause:
• Fluid and/or solute overload resulting in overhydration/hypervolemia and, for example, congested states, including central and peripheral oedema.
• Clinically relevant electrolyte disturbances and acid-base imbalance.
In general, the risk of dilutional states (retention of water relative to sodium) is inversely proportional to the electrolyte concentrations of Sodium Chloride 0.9% and its additions. Conversely, the risk of solute overload causing congested states (retention of solute relative to water) is directly proportional to the electrolyte concentrations of Sodium Chloride 0.9% and its additions.
Special clinical monitoring is required at the beginning of any intravenous infusion. Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.
Use in patients at risk for sodium retention, fluid overload and oedema Sodium Chloride 0.9% should be used with particular caution, if at all, in patients with or at risk for:
• Hypernatraemia. Rapidly correcting hypernatremia once adaptation has occurred may lead to cerebral oedema, potentially resulting in seizures, permanent brain damage, or death.
• Hyperchloraemia
• Metabolic acidosis, which may be worsened by prolonged use of this product, especially in patients with renal impairment.
• Hypervolemia such as congestive heart failure and pulmonary oedema may be precipitated, particularly in patients with cardiovascular disease.
• Iatrogenic hyperchloremic metabolic acidosis (e.g., during intravenous volume resuscitation)
• Conditions that may cause sodium retention, fluid overload and oedema (central and peripheral), such as patients with
o primary hyperaldosteronism,
o secondary hyperaldosteronism, associated with, for example,
- hypertension,
- congestive heart failure,
- liver disease (including cirrhosis),
- renal disease (including renal artery stenosis, nephrosclerosis) or preeclampsia.
Medications that may increase the risk of sodium and fluid retention, such as Corticosteroids
Infusion reactions
Symptoms of unknown aetiology which can appear to be hypersensitivity reactions have been reported very rarely in association with infusion of Sodium Chloride 0.9 %. These have been characterized as hypotension, pyrexia, tremor, chills, urticaria, rash and pruritus. Stop the infusion immediately if signs or symptoms of these reactions develop. Appropriate therapeutic countermeasures should be instituted as clinically indicated.
Specific patient groups
The consulting physician should be experienced in this product’s use and safety in these special populations that are especially sensitive to rapid changes in serum sodium levels.
Rapid correction of hyponatraemia and hypernatremia is potentially dangerous (risk of serious neurologic complications). See section “Hyponatraemia/hypernatraemia” above.
Paediatric population
Plasma electrolyte concentrations should be closely monitored in the paediatric population as this population may have impaired ability to regulate fluids and electrolytes. Repeated infusions of sodium chloride should therefore only be given after determination of the serum sodium level.
Elderly population
When selecting the type of infusion solution and the volume/rate of infusion for an elderly patient, consider that geriatric patients are generally more likely to have cardiac, renal, hepatic, and other diseases or concomitant drug therapy.
4.5 Interaction with other medicinal products and other forms of interaction
Caution is advised in patients treated with lithium. Renal sodium and lithium clearance may be increased during administration of Sodium Chloride 0.9%. Administration of Sodium Chloride 0.9% may result in decreased lithium levels.
Corticoids/Steroids and carbenoxolone, are associated with the retention of sodium and water (with oedema and hypertension). See Section 4.4 Special warnings and precautions for use.
4.6 Fertility, pregnancy and lactation
Should only be used in pregnancy and lactation under close medical supervision. There are no adequate data from the use of Sodium Chloride 0.9% in pregnant or lactating women. The physician should carefully consider the potential risks and benefits for each specific patient before administering Sodium Chloride 0.9%.
Caution is advised with patients with pre-eclampsia (See Section 4.4. Special warnings and precautions for use).
When a medicinal product is added, the nature of the drug and its use during pregnancy and lactation has to be considered separately.
4.7 Effects on ability to drive and use machines
Sodium chloride 0.9% has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
|
System Organ Class |
Symptoms (LLT terms MedDRA) |
Frequency |
|
Vascular disorders |
Thrombophlebitis* |
Not known |
|
General disorders and administration site conditions |
Oedema* | |
|
Skin and subcutaneous tissue disorders |
Skin necrosis* Extravasation* | |
|
*Adverse reactions associated wit |
i the administration technique | |
The following adverse reactions have not been reported with this product but may occur:
• Hyperchloraemic metabolic acidosis
• Infusion reactions, including hypotension, tremor, chills, urticaria, rash, and pruritus.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
General adverse effects of sodium excess in the body include nausea, vomiting, diarrhea, abdominal cramps, thirst, reduced salivation and lacrimation, sweating, fever, tachycardia, hypertension, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma, and death.
An excessive volume of Sodium Chloride 0.9% may lead to hypernatraemia (which can lead to CNS manifestations, including seizures, coma, cerebral oedema and death) and sodium overload (which can lead to central and/or peripheral oedema) and should be treated by an attending specialised physician.
Excess chloride in the body may cause a loss of bicarbonate with an acidifying effect.
When overdose occurs measures should be taken to correct the fluid and electrolyte imbalance. An excess of sodium can be removed by the injection of a diuretic. The relevant and supportive measures should be provided as necessary.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group “Electrolyte solutions”, ATC code B05XA03
Sodium chloride is present in all body fluids but is mainly found in the extracellular fluid. Sodium chloride is the principal salt involved in maintaining the osmotic tension of the blood and tissues.
Sodium Chloride 0.9% is an isotonic solution. The pharmacodynamic properties of the solution are those of the sodium and chloride ions in maintaining the fluid and electrolyte balance. Ions, such as sodium, circulate through the cell membrane, using various mechanisms of transport, among which is the sodium pump (Na-K-ATPase). Sodium plays an important role in neurotransmission and cardiac electrophysiology, and also in its renal metabolism.
5.2 Pharmacokinetic properties
Sodium is predominantly excreted by the kidney, but there is extensive renal reabsorption. Small amounts of sodium are lost in the feces and sweat.
5.3 Preclinical safety data
None stated. The safety of sodium chloride in animals is not relevant in view of its presence as a normal component in animal and human plasma.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections BP
Incompatibilities
6.2
Sodium Chloride 0.9% should not be mixed with any other agents unless their compatibility has been established.
6.3 Shelf life
24 months from the date of manufacture.
6.4 Special precautions for storage
Store below 25oC. Do not refrigerate.
6.5 Nature and contents of container
PVC containers.
Closures:
(a) radiofrequency weld
(b) polycarbonate plug
(c) PVC plug
Pack Sizes: 2000ml, 1000ml, 500ml, 250ml, 100ml, 70ml and 50ml Not all pack sizes may be marketed.
6.6 Special precautions for disposal
For single use only.
Discard any unused portion.
Do not reconnect partially used bags.
Use only if the solution is clear without visible particles and the container is undamaged.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
CaridianBCT Northern Ireland Ltd
T/A Ivex Pharmaceuticals
Old Belfast Road
Millbrook
Larne
Northern Ireland BT40 2SH United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 21538/0003
OF
9. DATE OF FIRST AUTHORISATION/RENEWAL AUTHORISATION
1st March 2005
10 DATE OF REVISION OF THE TEXT
14/09/2016