Israel - English - Ministry of Health
Directions for Use
B. Braun Melsungen AG · 34209 Melsungen, Germany
0.9% w/v Sodium Chloride Injection BP
Each 1000 ml contains
Water for Injections to
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.
Dissolvent and carrier solution for injectable drugs.
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.
Hyperhydration (e.g. water intoxication, oedema).
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.
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.
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
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.
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
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
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.
Do not store beyond the expiry date stated on the labeling.
Do not store above 25°C.
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
112 93 25552 06
B. Braun Melsungen AG
Lapidot Medical Import and Marketing Ltd.
8 Hashita st. Caesarea Industrial Zone 38900