BACTERIOSTATIC SODIUM CHLORIDE 9 mg/mL
BACTERIOSTATIC SODIUM CHLORIDE · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst
BACTERIOSTATIC SODIUM CHLORIDE is a injection, solution containing bacteriostatic sodium chloride at 9 mg/mL, taken intramuscular. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.
Key Facts
- Brand Name
- BACTERIOSTATIC SODIUM CHLORIDE
- Generic Name
- BACTERIOSTATIC SODIUM CHLORIDE
- NDC Code (Product)
51662-1259- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 9 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- NDA018800
- Marketing Start
- 09/19/2018
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Dosage & Administration
DOSAGE AND ADMINISTRATION The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
Warnings
WARNINGS Benzyl alcohol, a preservative in Bacteriostatic Sodium Chloride Injection, USP has been associated with toxicity in neonates. Data are unavailable on the toxicity of other preservatives in this age group. Preservative-free Sodium Chloride Injection should be used for flushing intravascular catheters. Where a sodium chloride solution is required for preparing or diluting medications for use in neonates, only preservative-free Sodium Chloride Injection should be used.
Contraindications
CONTRAINDICATIONS Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population. Parenteral preparations with benzyl alcohol should not be used for fluid or sodium chloride replacement. Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthetic procedures.
Adverse Reactions
ADVERSE REACTIONS Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. Administration of an estimated 9 mL to a 6 kg neonate or infant is potentially capable of producing blood pressure changes.
Frequently Asked Questions
What is BACTERIOSTATIC SODIUM CHLORIDE used for?
BACTERIOSTATIC SODIUM CHLORIDE contains BACTERIOSTATIC SODIUM CHLORIDE. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is BACTERIOSTATIC SODIUM CHLORIDE a controlled substance?
BACTERIOSTATIC SODIUM CHLORIDE is not classified as a controlled substance by the DEA.
What is the generic name for BACTERIOSTATIC SODIUM CHLORIDE?
The generic name for BACTERIOSTATIC SODIUM CHLORIDE is BACTERIOSTATIC SODIUM CHLORIDE. There are no other listed brand versions of BACTERIOSTATIC SODIUM CHLORIDE.
What is the NDC code for BACTERIOSTATIC SODIUM CHLORIDE 9 mg/mL?
The NDC (National Drug Code) for BACTERIOSTATIC SODIUM CHLORIDE 9 mg/mL is 51662-1259, listed by HF Acquisition Co LLC, DBA HealthFirst.
Other BACTERIOSTATIC SODIUM CHLORIDE Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)