DEXTROSE 4.3 % AND SODIUM CHLORIDE 0.18 % INJECTION

Israel - English - Ministry of Health

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Active ingredient:
GLUCOSE ANHYDROUS; SODIUM CHLORIDE
Available from:
NEOPHARM (ISRAEL) 1996 LTD
ATC code:
B05BB01
Pharmaceutical form:
SOLUTION FOR INJECTION
Composition:
SODIUM CHLORIDE 0.18 G / 100 ML; GLUCOSE ANHYDROUS 4.3 G / 100 ML
Administration route:
I.V
Prescription type:
Required
Manufactured by:
NEOPHARM (ISRAEL) LTD - CURE MEDICAL MANUFACTURING PLANT
Therapeutic group:
ELECTROLYTES
Therapeutic area:
ELECTROLYTES
Therapeutic indications:
Supply of water for administration of electrolytes or calories. Vehicle for therapeutic regimen.
Authorization number:
121 72 30164 00
Authorization date:
2011-01-31

NEOPHARM (ISRAEL) LTD. -

Intravenous Injections in Plastic Containers

1. Single Electrolyte Solutions

1. 0.45% Sodium Chloride Injection.

2. Single Electrolyte Solutions with Dextrose

1. 3.3% Dextrose and 0.3% Sodium Chloride Injection.

2. 4.3% Dextrose and 0.18% Sodium Chloride Injection.

3. 5% Dextrose and 0.33% Sodium Chloride Injection.

4. 5% Dextrose and 0.45% Sodium Chloride Injection.

5% Dextrose and 0.9% Sodium Chloride Injection.

3. Multiple Electrolyte Solutions with Dextrose

1. 5% Dextrose and 0.3% Sodium Chloride and 0.15% Potassium Chloride Injection.

DESCRIPTION

Intravenous solutions are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents or added buffers.

The composition, osmolarity and approx. pH values of the individual solutions are shown in

Table 1.

ACTIONS

Intravenous solutions provide electrolytes and/or calories, and are a source of water for hydration. All are capable of

inducing diuresis depending on the clinical condition of the patient. Solutions containing dextrose provide calories. See

Table 2 for calories per liter of the various solutions.

Solutions which are di-electrolytic or polyelectrolytic have value in maintaining or replenishing electrolytes. See Table 2

for ionic concentrations.

INDICATIONS

Supply of water, for administration of electrolytes or calories.

Vehicle for therapeutic regimen.

CONTRAINDICATIONS

Excess body water volume.

Diabetic coma with excessively high blood sugar (solutions containing glucose).

Hypovolaemia.

Cardiac insufficiency.

Edema, ascites ( cirrhosis related syndrome).

WARNINGS

Dispensing without a doctor's prescription is prohibited.

The administration of Intravenous Injections can cause fluid and/or solute overloading resulting in dilution of serum

electrolyte concentrations, overhydration, congestive conditions, or pulmonary edema. The risk of serum dilution is

inversely proportional to the electrolyte concentrations of the injections.

The risk of solute overload causing congestion with peripheral and pulmonary edema is directly proportional to the

electrolyte concentrations of the injections.

Excessive administration of potassium free solutions may result in significant hypokalemia.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in

sodium or potassium retention.

Administration by central venous catheter should be used only by those familiar with this technique and its

complications.

For Solutions containing Dextrose

Solutions containing dextrose with low electrolyte concentration should not be administered simultaneously with blood

through the same administration set because of the possibility of pseudoagglutination or hemolysis.

For Solutions containing Sodium

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure,

severe renal insufficiency, and in clinical conditions in which there exists edema with sodium retention.

For Solutions containing Potassium

Solutions containing potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal

failure, and in conditions in which potassium retention is present.

PREGNANCY: Category C.

Animal reproduction studies have not been conducted with these sterile solutions for injection. It is also not known

whether they can cause fetal harm when administered to a pregnant woman, or can affect reproducing capacity. These

solutions should be given to a pregnant woman only if clearly needed.

Use in Pediatrics

For solutions containing Dextrose

These products may be used with caution in infants of diabetic mothers, except as may be indicated in hypoglycemic

neonates.

PRECAUTIONS

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

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance,

electrolyte concentrations, and acid-base balance during prolonged parenteral therapy, or whenever the condition of

the patient warrants such evaluation.

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to

patients receiving corticosteroids or corticotropin.

Caution should be exercised in the administration of these injections to the very young and very elderly patients.

Administer so that extravasation does not occur. If thrombosis occurs during administration, stop injection and correct.

For Solutions Containing Dextrose

Solutions containing dextrose should be used with caution in patients with overt or subclinical diabetes mellitus or

carbohydrate intolerance.

Hyperglycemia and glycosuria may be functions of rate of administrationor metabolic insufficiency.

ADVERSE REACTIONS

Febrile response; infection at the site of injection; venous thrombosis or phlebitis extending from the site of injection;

extravasation; hypervolemia and hypernatremia. These may occur as a result of the solution or administration

technique.

Nausea, fever and flushing of the skin have occurred.

If an adverse reaction does occur discontinue the infusion, evaluate the patient and institute appropriate therapeutic

countermeasures, and save the remainder of the fluid for examination if deemed necessary.

DOSAGE AND ADMINISTRATION

Note : Do not administer unless solution is clear and seal is intact

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration

whenever solution or container permit. Use of a final filter is recommended during administration of all parenteral

solutions, where possible .

All injections in plastic containers are intended for intravenous administration using sterile equipment.

It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Additives may be incompatible- see updated literature.

If additives are introduced to the solution use an aseptic technique and mix thoroughly.

Do not store solutions containing additives.

Dosage is depended upon the age, weight and clinical condition of the patient, as well as laboratory determinations.

DIRECTIONS FOR USE:

Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air

being drawn from the primary container before administration of the fluid from the secondary container is completed.

To open

Do not remove units from overwrap until ready for use. Use all units promptly when pouch is opened.

The overwrap is a moisture barrier. The inner bag maintains the sterility of the product.

Tear Pouch down side at slit and remove solution container. Check for minute leaks by squeezing inner bag firmly. If

leaks are found, discard solution as sterility may be impaired. If supplemental medications is desired, follow directions

below before preparing for administration.

Preparing for Administration

1. Suspend container from eyelet support.

2. Remove plastic protector from outlet port at bottom of container.

3. Attach administration set. Refer to complete directions accompanying set.

To add Medication before solution Administration

Warning: Additives may be incompatible.

1. Prepare medication site.

2. Using syringe with 19-22 gauge needle, puncture medication port and inject.

3. Mix solution and medication thoroughly. For high density medication such as potassium chloride,

squeeze ports while ports are upright and mix thoroughly.

To add Medication during solution Administration

1. Close clamp on the set.

2. Prepare medication site.

3. Using syringe with 19-22 gauge needle, puncture resealable medication port and inject.

4. Remove container from IV pole and/or turn to an upright position.

5. Evacuate both orts by squeezing them while container is in the upright position.

6. Mix solution and medication thoroughly.

7.Return container to in use position and continue administration.

Overdosage

In the event of fluid or solute overload during parenteral fluids, reevaluate the patient's condition and institute

appropriate corrective treatment.

Storage

Do not store above 25°C

HOW SUPPLIED

Table 3 shows the available sizes of each injection in plastic containers and the number of units per carton. The

presence of the catalog code number indicates that the injection is available in that size.

Avoid storage at excessive heat.

Manufacturer:

Neopharm (Israel) – Cure Medical Manufacturing & Marketing

5 Beit Harishonim Str., Industrial Park Emek Hefer

Table 1

Composition,Approx., Osmolarity, and Approx. pH values.

COMPOSITION

Dextrose Monohydrate

(g/L)

Sodium Chloride

(g/L)

Potassium Chloride

(g/L)

Approx. 0smolarity*

(mOsm/L)

Approx. pH Values**

0.45% Sodium Chloride Injection

3.3% Dextrose & 0.3% Sodium

Chloride Injection

33.0

4.3% Dextrose & 0.18% Sodium

Chloride Injection

43.0

5% Dextrose & 0.33% Sodium

Chloride Injection

50.0

5% Dextrose & 0.45% Sodium

Chloride Injection

50.0

5% Dextrose & 0.9% Sodium

Chloride Injection

50.0

5% Dextrose & 0.3% Sodium

Chloride & 0.15% Potassium

Chloride Injection

50.0

* Normal physiologic isotonicity range is approximately 280-310 mOsm/L.

Administration of substantially hypotonic solutions may cause hemolysis, and

administration of substantially hypertonic solutions may cause vein damage.

** Approx. pH values are USP for applicable solutions, corporate specification for non-USP solutions.

Table 2

Approximate Ionic

Concentrations (mEq/L).

and Calories per Liter.

Sodium

Potassium

Chloride

Calories

per liter

0.45% Sodium Chloride Injection,

3.3% Dextrose & 0.3% Sodium

Chloride Injection

1,320,000

4.3% Dextrose & 0.18% Sodium

Chloride Injection

172,000

5% Dextrose & 0.33% Sodium

Chloride Injection

200,000

5% Dextrose & 0.45% Sodium

Chloride Injection

200,000

5% Dextrose & 0.9% Sodium Chloride

Injection

200,000

5% Dextrose and 0.3% Sodium

Chloride and 0.15% Potassium

Chloride Injection

200,000

UNIT SIZES OF INJECTIONS IN PLASTIC CONTAINERS

CATALOG CODE NUMBER INDICATES AVAILBILITY OF THE SIZE

Table 3

20 Units

per Carton

10 Units

per Carton

500 ml size

1000 ml size

0.45% Sodium Chloride Injection

F1800

F1850

3.3% Dextrose & 0.3% Sodium

Chloride Injection

F1530

F1550

4.3% Dextrose & 0.18% Sodium

Chloride Injection

F1560

F1570

5% Dextrose & 0.33% Sodium

Chloride Injection

F1760

F1770

5% Dextrose & 0.45% Sodium

Chloride Injection

F1700

F1750

5% Dextrose & 0.9% Sodium Chloride

Injection

F1600

F1650

5% Dextrose and 0.3% Sodium

Chloride and 0.15% Potassium

Chloride Injection

F1900

F1950

The format of this leaflet has been defined by the MOH, its content has been checked

and approved - February 2011.

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