Directions for Use
`B. Braun Melsungen AG, 34209 Melsungen, Germany
`
`5/12610193/0111
`
`0.9% w/v
`Sodium Chloride
`Intravenous
`Infusion BP
`
`The format of this leaflet was determined by the Minis-
`try of Health and its content was checked and approved
`in December 2010
`
`Composition
`Each 1000 ml contains
`Sodium Chloride
`Water for Injections to
`Osmolarity
`Electrolytes
`Sodium
`Chloride
`
`9.0 g
`1000 ml
`308 mOsm/l
`mmol/l
`154
`154
`
`Indications
`Plasma isotonic fluid replacement.
`Vehicle solution for supplementary medication
`Fluid and electrolyte replacement in hypochloraemic
`alkalosis and Chloride losses, Externally for wound irri-
`gation and moistening of wound dressings. 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 determi-
`nation.
`
`Route of administration
`I.V., S.C., I.M. – in use as dissolvent and carrier; External.
`
`Contraindications
`Hyperhydration (e.g. water intoxication, oedema).
`Hypernatraemia.
`Caution is to be exercised in patients with hypokalae-
`mia, 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 chlo-
`ride 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), overhy-
`dration, 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 electro-
`lyte 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, odema and over-
`loading of the circulation.
`Absorption: Irrigation fluids enter the systemic circula-
`tion 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 elec-
`trolyte 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.
`
`B|BRAUN
`
`12610193_0,9_wv_SodiumChloride_GIF_A5_Israel.indd 1
`
`13.01.11 07:13
`
`schwarz
`
`Dokument = 148 x 210 mm
`2 Seiten
`
`GIF 0,9% w/v Sodium Chloride
`5/12610193/0111 – IL
`Glasflasche
`Standort Melsungen
`
`Lätus
`
`G 101528
`
`Hospira, Exh. 2024, p. 1
`
`

`
`5/12610193/0111
`
`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, reevalu-
`ate the patient and institute appropriate corrective
`measures.
`
`Shelf life
`36 months
`
`Storage
`Do not store above 25°C.
`
`Presentation
`50 ml, 100 ml, 500 ml and 1000 ml
`Polyethylene containers.
`
`License number
`112-93-25552
`
`Manufacturer
`B. Braun Melsungen AG
`D-34209 Melsungen
`
`License Holder
`Luxembourg Pharmaceuticals Ltd.
`8 Hashita St. Ceasarea Industrial zone 38900
`
`Precautions
`Clinical supervision should include regular checks of
`serum electrolytes, acid-base balance and water bal-
`ance. Caution must be exercised in the administration
`of Sodium Chloride intravenous Infusion BP to patients
`receiving corticosteroids or corticotropin.
`Pregnancy: Category C
`Animal reproduction studies have not been conducted
`with Sodium Chloride Intravenous infusion BP. It is also
`not known whether Sodium Chloride Intravenous infu-
`sion BP can cause fetal harm when administered to a
`pregnant woman or can affect reproduction capacity.
`Sodium Chloride Intravenous infusion 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 drain-
`age) may necessitate additional electrolyte supplemen-
`tation. 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, extravasa-
`tion, and hypervolaemia.
`If an adverse reaction does occur, discontinue the infu-
`sion, evaluate the patient, institute appropriate thera-
`peutic counter-measures and save the remainder of the
`fluid for examination if deemed necessary.
`Postoperative salt intolerance: Symptoms include cel-
`lular dehydration, weakness, disorientation, anorexia,
`nausea, distention, deep respiration, oliguria, increased
`BUN.
`
`B|BRAUN
`
`B. Braun Melsungen AG
`34209 Melsungen, Germany
`
`12610193_0,9_wv_SodiumChloride_GIF_A5_Israel.indd 2
`
`13.01.11 07:13
`
`Hospira, Exh. 2024, p. 2