ISOTONIC SODIUM CHLORIDE- biofleks isotonic sodium chloride sterile injection

ISOTONIC SODIUM CHLORIDE by

Drug Labeling and Warnings

ISOTONIC SODIUM CHLORIDE by is a Prescription medication manufactured, distributed, or labeled by HAVER FARMA ILAC ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GENERAL PRECAUTIONS

ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet. Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored. Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only.

PRINCIPAL DISPLAY PANEL

biofleks
100 mL
0.9 % ISOTONIC
SODIUM CHLORIDE SOLUTION
STERILE

Per 100 mL
Sodium Chloride
Water for Injection

Electrolyte Concentrations (mEq/L)
ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet. Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored. Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only. Distributor: Vin Trading LLC
Phone: (201) 676-3232 / E-Mail: info@vintradingllc.com Address: 203 Lemoine Ave #118, Fort Lee, NJ 07024
OSEL llaç San. ve Tic. A.Ş.
Beykoz / İstanbul / TURKEY

100mL Bag

250mL Bag

500 mL Bag

1000mL Bag

INGREDIENTS AND APPEARANCE

ISOTONIC SODIUM CHLORIDE 
biofleks isotonic sodium chloride sterile injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 85184-0001
Route of Administration	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, IRRIGATION

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	0.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85184-0001-1	100 mL in 1 BAG; Type 0: Not a Combination Product	01/01/2025
2	NDC: 85184-0001-2	250 mL in 1 BAG; Type 0: Not a Combination Product	01/01/2025
3	NDC: 85184-0001-3	500 mL in 1 BAG; Type 0: Not a Combination Product	01/01/2025
4	NDC: 85184-0001-4	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Emergency Use Authorization		01/01/2025

Labeler - HAVER FARMA ILAC ANONIM SIRKETI (365593526)

Registrant - HAVER FARMA ILAC ANONIM SIRKETI (365593526)

Establishment
Name	Address	ID/FEI	Business Operations
HAVER FARMA ILAC ANONIM SIRKETI		365593526	manufacture(85184-0001)