SODIUM CHLORIDE INJECTION 0.9%

Israel - English - Ministry of Health

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Active ingredient:
SODIUM CHLORIDE
Available from:
TEVA MEDICAL LTD
ATC code:
B05XA03
Pharmaceutical form:
SOLUTION FOR INJECTION
Composition:
SODIUM CHLORIDE 0.9 G / 100 ML
Administration route:
I.V
Prescription type:
Required
Manufactured by:
TEVA MEDICAL LTD, ISRAEL
Therapeutic group:
SODIUM CHLORIDE
Therapeutic area:
SODIUM CHLORIDE
Therapeutic indications:
A source of water and electrolytes. Also indicated for use as priming solutions in hemodialysis procedures.
Authorization number:
015 89 24546 00
Authorization date:
2016-04-30

Sodium Chloride Injection 0.9% Solution for Injection in Non PVC Bags 8 5. 2013, RH

."רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ" :רשואמ ןולע

7/5/2013

“This leaflet format has been determined by the Ministry of Health and the content thereof has been

checked and approved.” Date of approval: 7/5/2013

Sodium Chloride Injection 0.9%

Solution for Injection.

In Non PVC Bags

Description

Sodium Chloride Injection 0.9% solution for injection in Non PVC Bags is sterile,

nonpyrogenic solution for fluid and electrolytes replenishment in single dose bags for

intravenous administration. It contains no antimicrobial agents. The composition,

osmolarity, and pH values are shown in Table 1.

Table 1

Composition, Osmolarity, and Approximate pH Values

Sodium Chloride Injection 0.9%

Solution for Injection

* 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.

Approximate ionic concentrations (mEq/L) and calories per liter are shown in Table 2.

Table 2

Approximate Ionic Concentrations (mEq/L) and Calories per liter

Sodium Chloride Injection 0.9%

Solution for Injection

Sodium Chloride Injection 0.9% Solution for Injection in Non PVC Bags 8 5. 2013, RH

Description of the Primary Bags:

Type and size: Non PVC plastic bag +overpouch; size: 1000 ml.

Material composition:

- Non PVC plastic film, based on polyethylene, polyamide, and polypropylene.

- Overpouch based on co-extruded blend: polypropylene/polyamide/polypropylene

film.

Clinical Pharmacology

As a source of water and electrolytes and capable of inducing diuresis depending on

the clinical condition of the patient.

For caloric value see Table 2.

Indications

A source of water and electrolytes.

Also indicated for use as priming solutions in hemodialysis procedures.

Contraindications

None known.

Warnings

General

Note: Dispensing without 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, congested

states, or pulmonary edema. The risk of dilutional states is inversely proportional to

the electrolyte concentrations of the injections. The risk of solute overload causing

congested states with peripheral and pulmonary edema is directly proportional to the

electrolyte concentrations of the injections.

Excessive

administration

potassium-free

solutions

result

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 Sodium Ions

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 states in which

there exists edema with sodium retention. In patients with diminished renal function,

administration of Sodium Chloride Injections may result in sodium retention.

Use in Pregnancy

Animal reproduction studies have not been conducted. It is also not known whether

these solutions can cause fetal harm when administered to a pregnant woman, or can

affect reproduction capacity. Therefore, these solutions should be given to a pregnant

woman only if clearly needed.

Use in Pediatrics

Use of electrolyte solutions in the pediatric population is referenced in the medical

literature. The warnings, precautions and adverse reactions identified in the label

copy should be observed in the pediatric population.

Sodium Chloride Injection 0.9% Solution for Injection in Non PVC Bags 8 5. 2013, RH

Adverse Reactions

General

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 hypervolemia.

Nausea, fever, and flushing of the skin have occurred.

If an adverse reaction does occur, the infusions should be discontinued, the patient

evaluated, appropriate therapeutic countermeasures instituted, and the remainder of

the fluid saved for examination if deemed necessary.

Precautions

General

Do not administer unless the solution is clear and the 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 should 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 to elderly patients.

Administer

that

extravasation

does

occur.

thrombosis

occurs

during

administration, stop injection and correct.

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 and container permit. Use of a

final filter is recommended during administration of all parenteral solutions, where

possible.

The dosage is usually dependent upon the age, weight and clinical condition of the

patient,

well

laboratory

determinations.

injections

plastic

bags

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 Complete information is not available. Those additives

known to be incompatible should not be used. A pharmacist should be consulted, if

available. If, in the informed judgment of the physician, it is deemed advisable to

introduce additives, aseptic technique should be used. Thorough mixing should be

performed when additives have been introduced. Solutions containing additives must

not be stored.

Directions for Use of Plastic Bags

Warning : Do not use plastic bags in series connections. Such use could result in air

embolism due to residual air being drawn from the primary bag before administration

of the fluid from the secondary bag 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.

Sodium Chloride Injection 0.9% Solution for Injection in Non PVC Bags 8 5. 2013, RH

Tear pouch down side at slit and remove solution bag. Check for minute leaks by

squeezing inner bag firmly. If leaks are found, discard solution as sterility may be

impaired.

supplemental

medication

desired,

follow

directions

below

before

preparing for administration.

Preparation for Administration

1. Suspend bag from eyelet support.

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

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 bag from IV pole and/or turn to an upright position.

5. Evacuate both ports by squeezing them while bag is in the upright position.

6. Mix solution and medication thoroughly.

7. Return bag 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

Avoid storage at excessive heat. It is recommended that the product be stored below

Registration Number

015 89 24546 00.

Presentation

500 ml, 1000 ml bags.

Manufacturer

Teva Medical Ltd.,

Haorgim Street 8, Ashdod 77100

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