SODIUM CHLORIDE 0.9%W/V INTRAVENOUS INFUSION BP - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Sodium Chloride 0.9 % w/v Intravenous Infusion BP

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1000 ml of solution contain

Sodium chloride

Theoretical osmolarity:

Titration acidity:

pH:

9.00 g

308 mOsm/l < 0.3 mmol/l

4.5 – 7.0

Electrolyte concentrations:

Sodium

154 mmol/l

Chloride

154 mmol/l

For excipients see section 6.1.

3. PHARMACEUTICAL FORM

Solution for infusion

A clear, colourless aqueous solution

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

– Fluid and electrolyte substitution in hypochloraemic alkalosis,

– Chloride losses,

– Short-term intravascular volume substitution,

– Hypotonic dehydration or isotonic dehydration,

– Vehicle solution for compatible electrolyte concentrates and medicaments,

4.2 Posology and method of administration

Adults and the elderly

Recommended dosage schedule:

The dose and rate of infusion are adjusted according to the weight, actual requirements of water and electrolytes and the clinical condition of the patient, especially renal and cardiovascular status. Monitoring of serum electrolytes is essential.

Maximum daily dose:

40 ml/kg BW, corresponding to 6 mmol of sodium per kg BW

Infusion rate:

Up to 5 ml/kg BW/hour.

In the management of shock higher volumes and higher rates of infusion may be administered.

In patients with chronic hyponatraemia the rate of infusion should be slow, so that the resulting increase of the serum sodium level is limited to a maximum of 0.35 mmol/l/h.

Children

In children the posology for adults should be used as a guide.

Method of administration

Intravenous infusion.

The polyethylene plastic container contains a significant volume of air. To avoid risk of air embolism, expel all air before pressure infusion.

4.3 Contraindications

Sodium Chloride 0.9 % w/v Intravenous Infusion must not be administered to patients in states of hyperhydration.

4.4 Special Warnings and Precautions for Use

Special warnings

Sodium Chloride 0.9 % w/v Intravenous Infusion should only be administered with caution in cases of:

– hypokalaemia

– hypernatraemia

– hyperchloraemia

– disorders where restriction of sodium intake is indicated, such as cardiac insufficiency, generalised oedema, pulmonary oedema, hypertension, eclampsia, severe renal insufficiency.

Precautions for use

Clinical monitoring should include checks of the serum electrolytes, the water balance, and the acid-base status.

High infusion rates should be avoided in cases of hypertonic dehydration because of possible increases of plasma osmolarity and plasma sodium concentration.

4.5 Interactions with Other Medicinal Products and Other Forms of Interaction

The risk of hypernatraemia is exacerbated by the use of salt retaining drugs such as NSAIs.

Lithium toxicity is made worse by sodium depletion

4.6 Pregnancy and Lactation

Sodium Chloride 0.9 % w/v Intravenous Infusion can be used as indicated.

4.7 Effects on Ability to Drive and Use Machines

Not applicable

4.8 Undesirable Effects

Administration of larger amounts may lead to hypernatraemia and hyperchloraemia. Clinical symptoms of excess sodium in the body include nausea, vomiting, diarrhoea, abdominal cramps, thirst, reduced salivation and lachrymation, sweating, fever, tachycardia, hypertension, renal failure, peripheral and pulmonary oedema, headache, dizziness, restlessness, convulsions, coma, respiratory arrest, and death.

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 at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Symptoms

Overdose may result in hypernatraemia, hyperchloraemia, overhydration, hyperosmolarity of the serum, and metabolic acidosis. Clinical symptoms see above.

Emergency treatment, antidotes

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

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

ATC code B05 B B01, Solutions affecting the electrolyte balance, Electrolytes

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.

5.2 Pharmacokinetic Properties

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).

The kidneys are the major regulator of the sodium and water balances. In cooperation with the hormonal control mechanisms (renin-angiotensin-aldosterone 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.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to those already stated in other sections of the SPC.

6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients

Water for injections

6.2 Incompatibilities

Compatibilities should be checked when additives are used, as additives may be incompatible. Any questions on compatibility should be directed to the manufacturer, i.e. B. Braun Melsungen AG.

As with all parenteral solutions, before adding medications, compatibility of these additives with the solution in the container must be assessed.

It is the responsibility of the user to judge the incompatibility of an additive medication with the Sodium Chloride 0.9 % w/v Infusion Solution by checking for eventual colour change and/or eventual precipitate, insoluble complexes or crystals.

Before introducing an additive verify it is soluble and stable in water at the pH of Sodium Chloride 0.9 % w/v Infusion Solution.

When a compatible medication is added to this formulation, the solution must be administered immediately, unless dilution has taken place in controlled and validated aseptic conditions

Those additives known to be incompatible should not be used.

6.3 Shelf life

Unopened:    36 months in polyethylene plastic container

20 months in plastic bags of 100 ml

24 months in plastic bags of 250 m, 500 ml 1000 ml

In-use shelf-life (Additives):

Chemical and physical stability of any additive medication at the pH of the Sodium Chloride 0.9 % w/v Infusion Solution in the container should be established prior to use.

From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions 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.

6.4 Special Precautions for Storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Polyethylene plastic containers, 50 ml, 100 ml in packs of 20.

Polyethylene plastic containers, 250 ml, 500 ml and 1000 ml in packs of 10.

Plastic bags, 100 ml, 250 ml, 500 ml in packs of 20.

Plastic bags, 1000 ml in packs of 10.

6.6 Instructions for Use, Handling and Disposal

Use only if the solution is clear, without visible particles and if the container is undamaged.

The solution should not be administered if the container or its closure show visible signs of damage.

For single use only. Discard unused contents. Do not reconnect partially used containers.

Administer immediately following the insertion of infusion set.

The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.

When additive is used, verify isotonicity prior to peripheral venous administration.

Thorough and careful aseptic mixing of any additive is mandatory.

Solutions containing additives should be used immediately after preparation, unless preparation has taken place in controlled and validated aseptic conditions.

In case of an adverse reaction, infusion must be stopped immediately.

7. MARKETING AUTHORISATION HOLDER

B. Braun Melsungen AG

Carl-Baun-Strasse 1

D-34212 Melsungen

Germany

8. MARKETING AUTHORISATION NUMBER(S)

PL 03551/0088

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

19/02/2009