SODIUM CHLORIDE 0.9 %

Directions for Use

B. Braun Melsungen AG · 34209 Melsungen, Germany

0.9% w/v Sodium Chloride Injection BP

Composition

Each 1000 ml contains

Sodium Chloride

9.0 g

Water for Injections to

1000 ml

Osmolarity

308 mOsm/l

Electrolytes

mmol/l

Sodium

Chloride

Indications

Plasma isotonic fluid replacement. Vehicle solution for supplementary medication.

Externally for wound irrigation and moistening of wound dressings. Fluid and

electrolyte replacement in hypochloraemic alkalosis.

Chloride losses.

Dissolvent and carrier solution for injectable drugs.

Dosage

The dosage guideline for adults:

Average dose: 1000 ml per day.

Flow rate: Up to 180 drops/min, corresponding to 550 ml/h.

Maximum recommended dosage: 40 ml per KG body weight and per day, not more

than 2000 ml per day.

Dosage is dependent upon the age, weight and clinical condition of the patient as

well as laboratory determination.

Route of administration

I.V.; S.C. - in use as dissolvent and carrier; External.

Contraindications

Hyperhydration (e.g. water intoxication, oedema).

Hypernatraemia.

Caution is to be exercised in patients with hypokalaemia, hypernatraemia, and

diseases requiring limitation of sodium intake, such as heart insufficiency, general

oedema, pulmonary oedema, hypertension, eclampsia, severe kidney insufficiency,

cirrhotic disease, circulatory insufficiency, hypoproteinaemia.

Warnings

Fluid/solute overload; Excessive amounts of sodium chloride by any route may cause

hypokalaemia and acidosis.

Administration of IV solution can cause fluid or solute overload resulting in dilution of

serum electrolyte concentrations, congestive heart failure (CHF), overhydration,

congested states or acute pulmonary oedema, especially in patients with

cardiovascular disease and in patients receiving corticosteroids or corticotropin or

drugs that may give rise to sodium retention.

The risk of dilutional states is inversely proportional to the electrolyte concentration.

The risk of solute overload causing congested states with peripheral and pulmonary

oedema is directly proportional to the electrolyte concentration.

Infusion of > 1 L of isotonic (0.9%) sodium chloride may supply more sodium and

chloride than normally found in serum, resulting in hypernatraemia; this may cause

loss of bicarbonate ions, resulting in an acidifying effect.

Infusion during or immediately after surgery may result in excessive sodium retention.

Surgical patients should seldom receive salt-containing solutions immediately

following surgery unless factors producing salt depletion are present. Because of

renal retention of salt during surgery, additional electrolyte given IV may result in fluid

retention, oedema and overloading of the circulation.

Absorption: Irrigation fluids enter the systemic circulation in relatively large volumes

and must be regarded as a systemic drug. Absorption of large amounts can cause

fluid solute overload, resulting in dilution of serum electrolyte concentrations,

overhydration, congested states or pulmonary oedema.

Continuous irrigation: Observe caution when solution is used for continuous irrigation

or allowed to "dwell" inside body cavities because of possible absorption into

the blood stream and circulatory overload.

Precautions

Clinical supervision should include regular checks of serum electrolytes, acid-base

balance and water balance.

Caution must be exercised in the administration of Sodium Chloride Injection BP to

patients receiving corticosteroids or corticotropin.

Pregnancy: Category C.

Animal reproduction studies have not been conducted with Sodium Chloride Injection

BP. It is also not known whether Sodium Chloride Injection BP can cause fetal

harm when administered to a pregnant woman or can affect reproduction capacity.

Sodium Chloride Injection BP should be given to a pregnant woman only if clearly

needed.

Do not administer unless solution is clear and seal is intact.

No other medication or substance should be added to this solution unless it is known

to be compatible.

Extraordinary electrolyte losses (e.g. during protracted nasogastric suction, vomiting,

diarrhea, Gl fistula drainage) may necessitate additional electrolyte supplementation.

Supply additional essential electrolyte, minerals and vitamins as needed.

Hypokalaemia may result from excessive administration of potassium-free solutions.

If to be administered S.C. (as dissolvent and carrier), be aware that any additions to

the isotonic Normal Saline solution could render it hypertonic and thus cause pain at

the Injection site.

Undesirable effects

During infusion, hypernatraemia and hyperchloraemia may occur.

Reactions which may occur because of the solution or the technique of

administration include febrile response, infection at the site of injection, venous

thrombosis or phlebitis extending from the site of injection, extravasation, and

hypervolaemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient,

institute appropriate therapeutic counter-measures and save the remainder of the

fluid for examination if deemed necessary.

Postoperative salt intolerance: Symptoms include cellular dehydration, weakness,

disorientation, anorexia, nausea, distention, deep respiration, oliguria, increased

BUN.

Overdosage

Parenteral preparations are unlikely to pose a threat of sodium chloride or fluid

overload except possibly in newborn or very small infants. If these occur, reevaluate

the patient and institute appropriate corrective measures.

Expiry date

Do not store beyond the expiry date stated on the labeling.

Storage

Do not store above 25°C.

Presentation

LDPE ampoules Mini-Plasco -connect of 20x10 ml and 20x20 ml

LDPE Mini-Plasco of 20x10 ml and 20x20 ml

Polypropylene ampoules Mini-Plasco-Basic of 20x10 ml and 20x20 ml

License Number

112 93 25552 06

Manufacturer

B. Braun Melsungen AG

D-34209 Melsungen

License Holder

Lapidot Medical Import and Marketing Ltd.

8 Hashita st. Caesarea Industrial Zone 38900