Sodium Chloride Injection Bp 0.9%W/V
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride Injection BP 0.9% w/v
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride BP / Ph Eur. 0.9% w/v
3. PHARMACEUTICAL FORM
Solution for Injection.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Sodium chloride 0.9% injections are often used as diluents for the infusion of drug additives.
4.2 Posology and method of administration
Adults, the elderly and children.
The concentration and dosage of sodium chloride for intravenous use is determined by several factors including age, weight and the clinical condition of the patient.
4.3 Contraindications
Sodium chloride should be administered with caution to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function, or pre-eclampsia.
4.4 Special warnings and precautions for use
Care should be taken when administering sodium chloride intravenously to very young or elderly patients. Excessive administration should be avoided as this may result in hypokalaemia, sodium accumulation and oedema.
Caution should be used when administering sodium chloride to patients with hypertension.
Pseudohyponatraemia, a condition where spuriously low concentrations of sodium are found, occurs when a high concentration of solid matter (such as lipids and protein) is present in the plasma. This has been reported in patients with diabetes mellitus. False readings for plasma concentrations may be obtained as sodium is present only in the aqueous phase of plasma. Correct values are obtained by referring the concentration to plasma water, thus avoiding unnecessary, and possibly dangerous, treatment with sodium chloride.
4.5 Interaction with other medicinal products and other forms of interaction
Streptomycin sulphate is stated to have its activity inhibited by sodium chloride.
4.6 Pregnancy and lactation
Use during pregnancy and lactation under medical supervision only unless as a diluent for drugs.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
General adverse effects of excess sodium chloride in the body include nausea, vomiting, diarrhoea, abdominal cramps, thirst, reduced salivation and lachrymation, sweating, fever, hypertension, tachycardia, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death.
Excess chloride in the body may cause a loss of bicarbonate with an acidifying effect.
Infants may appear not to be severely dehydrated, but coma and convulsions may persist due to vascular injury. They may show respiratory distress with tachypnoea and flaring nostrils.
Intra-amniotic injection of hypertonic solutions of sodium chloride can lead to serious adverse effects including disseminated intravascular coagulation, renal necrosis, cervical and uterine lesions, haemorrhage, pulmonary embolism, pneumonia and death.
Overdose
4.9
Excessive administration of sodium chloride causes hypernatraemia, the most serious effect of which is dehydration of internal organs, especially the brain, which may lead to thrombosis and haemorrhage.
Normal serum-sodium concentrations should be carefully restored at a rate not exceeding 10 to 15 mmol per day by administration of hypotonic saline solutions intravenously. Dialysis may be necessary if there is significant renal impairment, the patient is moribund, or if the serum-sodium concentration is greater than 200 mmol per litre.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Sodium is the principle cation in the extracelluar fluid and is the main osmotic component in the control of blood volume.
5.2 Pharmacokinetic properties
The body contains 40 - 60 mmol of sodium per kg body weight, approximately 40% of which is found in the skeleton.
The normal concentration range of extracelluar fluid is 135 - 154 mmol per litre.
The intracellular sodium concentration is about 5 - 10 mmol per litre.
5.3 Preclinical safety data
None stated
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections. The pH of this product may have been adjusted using 10% hydrochloric acid or 10% sodium hydroxide.
6.2 Incompatibilities
The addition of sodium chloride to mannitol 20% - 25% may cause precipitation of the mannitol. Reject if solid particles are present.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store at a temperature not exceeding 25°C.
6.5 Nature and contents of container
The product is available in 2ml, 5ml, 10ml, 20ml and 50ml type 1 colourless glass ampoules, fusion sealed. Packed into cartons of 10 ampoules.
6.6 Instructions for use/handling
Reject if solid particles are present.
7. MARKETING AUTHORISATION HOLDER
Macarthys Laboratories T/A Martindale Pharmaceuticals
Bampton Road
Harold Hill
Romford
Essex
England
RM3 8UG
8. MARKETING AUTHORISATION NUMBER
PL 1883/6157R
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9.
10.
First Authorised: 4th October 1988
Last renewal: 4th October 1993
DATE OF (PARTIAL) REVISION OF TEXT
December 2003