SODIUM CHLORIDE 0.45 % SOLUTION FOR INFUSION BAXTER

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SODIUM CHLORIDE

Available from:

TEVA ISRAEL LTD

ATC code:

B05XA03

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

SODIUM CHLORIDE 0.45 %W/V

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BIEFFE MEDITAL S.A., SPAIN

Therapeutic area:

SODIUM CHLORIDE

Therapeutic indications:

Supply of water and electrolytes

Authorization date:

2020-03-24

Summary of Product characteristics

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Sodium Chloride 0.45% - 02/2023 Minor Changes
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.45% Solution for Infusion Baxter
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Sodium Chloride
0.45% w/v (4.500 g/l)
Each ml contains 4.5 mg sodium chloride.
Na
+
Cl
-
mmol/l
77
77
mEq/l
77
77
154 mOsm/l (approx.)
pH:
4.5 – 7.0
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
4. CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Sodium Chloride 0.45% Solution for Infusion is indicated for supply of
water and electrolytes.
4.2.
P
OSOLOGY AND
M
ETHOD OF
A
DMINISTRATION
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.
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Sodium Chloride 0.45% - 02/2023 Minor Changes
Do not store solutions containing additives.
Dosage is depended upon the age, weight and clinical condition of the
patient, as well as laboratory
determinations.
Method of Administration:
The equipment should be primed with the solution to prevent air
entering the system.
Do not connect flexible plastic containers in series in order to avoid
air embolism due to possible
residual air contained in the primary container.
Pressurizing intravenous solutions contained in flexible plastic
containers to increase flow rates can
result in air embolism if the residual air in the co