Solvent or diluent for compatible electrolyte concentrates or drugs

Dosage
The quantity to be chosen depends on the desired concentration of the
medicinal product to be dissolved.

Method of administration
Intravenous or subcutaneous use.
For the use of this solution as solvent/diluent for compatible electrolyte
concentrates or medicinal products, the instructions for use relating to the
medicinal product to be added must be observed.

 

None

0.9 % w/v Sodium Chloride Injection BP should only be administered with
caution in cases of

• hypernatraemia
• hyperchloraemiaƠrA

None known   

Pregnancy
Specific risks regarding the use during pregnancy are not known.
Lactation
Specific risks regarding the use during lactation are not known.
 

0.9 % w/v Sodium Chloride Injection BP has no influence on the ability to
drive and use machines.

None to be expected if the product is used according to directions.

To report any side effects :
Vigilance and Crisis Management Executive Directorate
Saudi Arabia
Fax : 011 2057662
Email : npc.drug@sfda.gov.sa
Website : www.sfda.gov.sa/npc

Symptoms
Overdose of 0.9 % w/v Sodium Chloride Injection BP may result in hypernatraemia,
hyperchloraemia, hyperhydration, hyperosmolarity of the
serum and metabolic acidosis.

Treatment
Immediate stop of administration, administration of diuretics with continuous
monitoring of serum electrolytes, correction of electrolyte and
acid-base imbalances.

Pharmacotherapeutic group: Solvents and diluting agents, including irrigating
solutions
ATC Code: V07AB

Mechanism of action and therapeutic effect
Sodium is the primary cation of the extracellular space and together with
various anions, regulates the size of this. Sodium and potassium are the
major mediators of bioelectric processes within the body.
The sodium content and the liquid metabolism of the body are closely
coupled to each other. Each deviation of the plasma sodium concentration
from the physiological one simultaneously affects the fluid status of the
body.

An increase in the sodium content of the body also means reduction of the
body's free water content independent of the serum osmolality.
A 0.9 per cent sodium chloride solution has the same osmolarity as plasma.
Administration of this solution primarily leads to a replenishment of
the interstitial space which is about 2/3 of the entire extracellular space.

Only 1/3 of the administered volume remains in the intravascular space.
Therefore the haemodynamic effect of the solution is of short duration
only.

 

Distribution
The total sodium content of the body is ca. 80 mmol/kg of which ca. 97
% is extracellular and ca. 3 % intracellular. The daily turnover is ca. 100 -
180 mmol (corresponding to 1.5 - 2.5 mmol/kg body weight).

Metabolism and elimination
The kidneys are the major regulator of the sodium and water balances. In
co-operation with the hormonal control mechanisms (renin-angiotensinaldosterone system, antidiuretic hormone) and the hypothetical natriuretic
hormone they are primarily responsible for keeping the volume of the
extracellular space constant and regulating its fluid composition.
Chloride is exchanged for hydrogen carbonate in the tubule system and is,
thus, involved in the regulation of the acid base balance.

Non-clinical data reveal no special hazard for humans based on conventional
studies of safety pharmacology, repeated dose toxicity, genotoxicity,
carcinogenic potential, toxicity to reproduction.

Water for injections

When mixing with other medicaments, possible incompatibilities should
be considered

unopened 3 years after first opening The product must be used immediately after opening the container, see also section 6.6. after preparation of the ready-to-use mixture From a microbiological point of view, dilutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 C, unless dilution has taken place in controlled and validated aseptic conditions.

Do not store above 25 C.
Storage conditions of ready-to use mixtures see section 6.3

Polyethylene ampoules containing: 10 ml, 20 ml,
supplied in packs of 20 x10 ml, 20 x20 ml

Not all pack sizes may be marketed.

Containers are for single use only. Discard container and unused content
after use.

Solution should be used immediately after opening of the container or
after preparation of the ready-to-use mixture.
Do not use if the solution is not clear or the container or its closure show
visible signs of damage.