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 0.9%w/v
3. PHARMACEUTICAL FORM
Solution for Injection
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Diluent for the administration of other drugs given intravenously, intramuscularly or subcutaneously
4.2 Posology and method of administration
The amount of diluent used should be sufficient to produce a solution of the required concentration.
4.3 Contraindications
Disease states with an already expanded extracellular fluid volume and those with the inability to excrete sodium rapidly due to kidney disfunction.
4.4 Special warnings and precautions for use
Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema and toxemia of pregnancy. Care should be taken when administering sodium chloride intravenously to very young children and the elderly.
Caution should be observed in patients suffering from cirrhosis of the liver.
4.5 Interactions with other medicinal products and other forms of interaction
Not applicable
4.6 Pregnancy and lactation
Sodium Chloride Injection should be administered with caution in preeclampsia.
4.7 Effects on ability to drive and use machines
Not applicable
4.8 Undesirable effects
Sodium excess is known as hypernatremia, is a rise in the extracellular concentration of sodium, which may be the consequence of too little available water or over provision of sodium against a low excretion rate. It may produce some or all of the following symptoms:
Nausea, vomiting, diarrhoea, abdominal cramps, thirst sweating, fever, abnormally high heart rate, high blood pressure, kidney failure, water retention in the extremities and lungs, 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.
4.9 Overdose
In the event of recent acute ingestion of sodium chloride, induction of emesis or gastric lavage should be carried out along with general symptomatic and supportive treatment.
PHARMACOLOGICAL PROPERTIES
5.
5.1 Pharmacodynamic properties
The body contains about 4 moles of sodium of which about one third is found in the skeleton and approximately half is present in extracellular fluid.
The body can adapt to a wide range of intakes by adjustment of renal excretion through physical and hormonal factors.
5.2 Pharmacokinetic properties
Sodium Chloride is well absorbed from the gastrointestinal tract. Sodium is predominately excreted by the kidney, but there is extensive renal reabsorption. Small amounts of sodium are lost in the faeces and sweat.
5.3 Preclinical safety data
This product has been available for many years and its side effects and clinical profile are well understood, therefore no further data is provided
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Dilute Hydrochloric acid Sodium Hydroxide 0.1N Water for Injections.
6.2 Incompatibilities
Not applicable
6.3
Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25 °C
6.5 Nature and contents of container
Type I clear glass prefilled syringes 10ml stopper rubber PH 50/701C with tip cap rubber W1883, containing 0.9% Sodium Chloride in Water for Injections.
6.6 Instructions for use and handling
No needle is provided with this syringe
Discard any unused solution at the end of the session in the appropriate manner
Do not use the product if the packaging is damaged
7 MARKETING AUTHORISATION HOLDER
Aurum Pharmaceuticals Ltd Bampton Road,
Harold Hill,
Romford,
RM3 8UG UK
8. MARKETING AUTHORISATION NUMBER
PL 12064/0025
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
September 1999/ June 2004
10. DATE OF (PARTIAL) REVISION OF TEXT
June 2004