SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Sodium Chloride 0.45% w/v Intravenous Infusion BP, solution for infusion

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1000 ml of solution contains

Sodium Chloride    4.5g

Electrolyte concentrations

Sodium    77 mmol/l

Chloride    77 mmol/l

Theoretical osmolarity: Titration acidity pH

Fo excipients see 6.1.

3. PHARMACEUTICAL FORM

Solution for infusion A clear, colourless aqueous solution

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

Treatment of dehydration or hypovolaemia in cases where supply of water and sodium chloride is required due to restriction of the intake of fluids and electrolytes by normal routes.

4.2 Posology and Method of Administration

Adults, the elderly and children

The dosage depends on the age, weight, clinical and biological (acid-base balance) conditions of the patient, concomitant therapy and should be determined by the prescribing physician.

General guidelines:

Up to 40 ml/kg body weight per day.

Infusion and drop rate:

Up to 5 ml/kg body weight per hour.

The prescribing doctor may determine individual adaptation of the dose and infusion rate, especially for children.

Monitoring

Adequate urine flow must be ensured and careful monitoring of serum electrolytes is essential.

Method of administration

Intravenous infusion

This container contains a significant volume of air. To avoid risk of air embolism, this product must not be administered by pressure infusion.

4.3 Contraindications

Sodium Chloride 0.45% w/v Intravenous Infusion BP must not be used in cases of

-    hyperhydration

-    hypotonic dehydration

4.4 Special Warnings and Precautions for Use

Sodium Chloride 0.45% w/v Intravenous Infusion BP should only be administered with caution in cases of hyponatraemia.

It should be administered with caution to patients with conditions associated with sodium retention (e.g. hypertension, heart failure).

Careful monitoring is required in patients with cardiac, pulmonary or renal failure.

Clinical supervision should include checks of the serum electrolytes and water balance.

Special attention should be paid to regular monitoring of the serum potassium concentration.

4.5 Interactions with Other Medicinal Products and Other Forms of Interaction

Lithium toxicity is made worse by sodium depletion.

Corticosteroids are associated with the retention of sodium and water.

4.6 Pregnancy and Lactation

There is no data reported on adverse effects regarding the use of Sodium Chloride 0.45% w/v during pregnancy or lactation. If used according to its intended purpose, Sodium Chloride 0.45% w/v can be administered during pregnancy and lactation.

4.7 Effects on Ability to Drive and Use Machines

Not applicable

4.8    Undesirable Effects

Adverse reactions may be associated with the technique of administration including febrile response, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis.

Adverse reactions may be associated with the medications added to the solution; the nature of the additive will determine the likelihood of any other undesirable effects.

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 electrolytes disturbances and acid-base imbalance. Retention of excess sodium may result in pulmonary and peripheral oedema.

Hypernatremia rarely occurs after therapeutic doses of sodium chloride. The most serious effect of hypernatraemia is dehydration of the brain, which causes somnolence and confusion progressing to convulsions, coma, respiratory failure and death. Other symptoms include thirst, reduced salivation and lacrimation, fever, tachycardia, hypertension, headache, dizziness, restlessness, irritability and weakness.

Excessive administration of chloride salts may cause a loss of bicarbonate with an acidifying effect.

In the event of accidental overdose, treatment should be discontinued and the patient should be observed for the appropriate signs and symptoms.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

The solution contains equimolar proportions of sodium and chloride corresponding to half the physiological concentration in the plasma. It is hypotonic and provides free water in addition to the sodium chloride.

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 results also means reduction of the body's free water content independent of the serum osmolality.

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

Preclinical safety data are not relevant since its constituents are physiological components of animal and human plasma.

6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients:

Water for injections

6.2 Incompatibilities

•    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 0.45 % w/v Intravenous Infusion 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 0.45%w/v Infusion Solution.

•    Those additives known to be incompatible should not be used.

6.3 Shelf Life

Shelf life of the medicinal product as packaged for sale

Unopened: 3 years

Shelf life after first opening the container

Not applicable. Product should be administered immediately after connecting to the giving set.

Shelf life after dilution or reconstitution according to directions In-use shelf-life (Additives)

Chemical and physical stability of any additive medication at the pH of the Sodium Chloride 0.45 % w/v Intravenous Infusion 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

Unopened: Do not store above 25 °C

6.5    Nature and Contents of Container

Polyethylene containers,

contents: 500 ml, 1000 ml in packs of 10.

6.6 Instructions for Use and Handling

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 an additive is used, verify isotonicity of the solution prior to parenteral administration.

Additives may be introduced before administration or during administration through the medication port.

Thorough and careful aseptic mixing of any additive is mandatory.

When a compatible medication is added to this formulation, the solution should be used immediately after preparation, unless preparation has taken place in controlled and validated aseptic conditions (cf. 6.3)

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

MARKETING AUTHORISATION HOLDER

B. Braun Melsungen AG,

Carl-Braun-Strasse 1 D-34212 Melsungen, Germany

8. MARKETING AUTHORISATION NUMBER

PL 03551/0089

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17/02/2009

10    DATE OF REVISION OF THE TEXT

04/09/2014