sodium chloride
Generic: SODIUM CHLORIDE
Basic Information
Manufacturer
Medefil, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
d1468c0f-dd4f-4d38-a84c-c1d110303965
Indications & Usage
1 INDICATIONS & USAGE Sodium Chloride Injection, USP, 0.9% is indicated for: • Dilution or Dissolving the drugs for intravenous, intramuscular or subcutaneous injections ( 1.1 ).
1.1 Dilution or Dissolution of Drugs Sodium Chloride Injection, USP, 0.9% is indicated for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
1.1 Dilution or Dissolution of Drugs Sodium Chloride Injection, USP, 0.9% is indicated for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Adverse Reactions
6 ADVERSE REACTIONS Adverse reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include, but are not limited to, air embolization, 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 therapeutic countermeasures, and if possible, retrieve and save the remainder of unused vehicle for examination if deemed necessary.
• Reactions that may occur because of this solution, added drugs or the technique of reconstitution or administration include air embolization, 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 extravasations ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact MEDEFIL, INC.
at tel:1-630-682-4600 and http://www.medefilinc.com/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and if possible, retrieve and save the remainder of unused vehicle for examination if deemed necessary.
• Reactions that may occur because of this solution, added drugs or the technique of reconstitution or administration include air embolization, 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 extravasations ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact MEDEFIL, INC.
at tel:1-630-682-4600 and http://www.medefilinc.com/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.