Label: A3095-20 SINGLE SHOT EPIDURAL 20G TUOHY - regional anesthesia kit
- NDC Code(s): 51688-5122-2, 52380-0001-3, 65282-1510-1
- Packager: Smiths Medical ASD, Inc.
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Premarket Notification
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- PRINCIPAL DISPLAY PANEL
3/4 Fluid Ounce Povidone Iodine
Do not use
- if allergic to iodine
- in the eyes
For external use only
Ask a doctor before use if injuries are
- deep or puncture wounds
- serious burns
Stop use and ask a doctor if
- redness, irritation, swelling or pain persists or increases
- infection occurs
Avoid pooling beneath patient
Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Spectra Medical Devices, Inc.
INJECTION, USP, 0.9%
Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride 0.9% (9mg/mL) in Water for Injection containing no antimicrobial agent or other added substance. The pH is between 4.5 and 7.0. Its chloride and sodium ion concentrates are approximately 0.154 mEq of each per milliliter and its calculated osmolality is 0.308 milliosmols per mL.
Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium Chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl, and the molecular weight is 58.44.
- CLINICAL PHARMACOLOGY
Sodium chloride comprises over 90% of the inorganic constituents of the blood serum. Sodium chloride in water dissociates to provide sodium (Na+) and (Cl-) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. The small volume of fluid and amount of sodium chloride provided by Sodium Chloride Injection, USP, 0.9% when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in very small infants.
- INDICATIONS & USAGE
INDICATIONS AND USAGEClose
Sodium Chloride Injection is used to flush intravascular catheters or as a sterile, isontonic single dose vehicle, solvent, or diluent for substances to administered intravenously,k intramuscularly or sub-cutaneously and for other extemporaneously prepared single dose sterile solutions according to instructions of the manufacture of the drug to be administered.
Sodium Chloride must be used with caution in the presence of congestive heart failure, circulatory insufficiency, kidney dysfunction or hypoproteinemia.
Excessive amounts of sodium chloride by any route may cause hypokalemia and acidosis. Excessive amounts by parental routes may precipitate congestive heart failure and acute pulmonary edema, especially seen in patients with preexisting cardiovascular disease and those receiving coricos-teroids, corticotrophin or other drugs that may give rise to sodium retention. For use in newborns, when a Sodium Chloride solution is required for preparation or diluting medications, or in flushing intravenous catheters, only preservative-free Sodium Chloride Injection, USP, 0.9% should be used.Close
Since Sodium Chloride Injection does not contain antimicrobial agents and is intended for single use, any unused amount must be discarded immediately following withdrawal of any portion of the contents of the vial or ampul. Do not open ampul until it is to be used.
Consult the manufactures instructions for choice of vehicle, appropriate dilution or volume for dissolving the drug to be injected, including the route and rate of injection.Close
CATEGORY C-Animal reproduction studies have not been conducted with Sodium Chloride Injection. It is also not known whether Sodium Chloride Injection can cause fetal harm when administered to a pregnant woman or can effect reproduction capacity. Sodium Chloride Injection should be given to a pregnant woman only if clearly needed.
- 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 extravasations.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures and if possible, retrieve and save the remainder of unused vehicle for examination.
When used as a diluent, solvent or intravascular flushing solution, this parental preparation is unlikely to pose a threat of sodium chloride or fluid overload except possible in very small infants. In the event these should occur, reevaluate the patient and institute appropriate corrective measures.
- DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION
Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug;specific references should be checked for any possible incompatibility with sodium chloride. 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 manufacture.
Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered as recommended by the manufacture. Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.Close
- HOW SUPPLIED
5 mL ampuls packaged in box of 50 each (NDC-65282-1505-1)
10 mL ampuls packaged in box of 50 each (NDC-65282-1510-1)
30 mL ampuls packaged in box of 30 each (NDC-65282-1530-3)
- STORAGE AND HANDLING
Store at controlled room temperature 15-30 C (59-86 F). Avoid freezing.
Spectra Medical Devices, Inc. 260-F Fordham Road, Wilmington, MA 01887
By: KM. Pharm Co., LTD.
- PRINCIPAL DISPLAY PANEL
Package Label Display Panel
- INGREDIENTS AND APPEARANCE
A3095-20 SINGLE SHOT EPIDURAL 20G TUOHY
regional anesthesia kit kit
Product Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-5122 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:51688-5122-2 10 in 1 CASE 1 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKET 22.5 mL Part 2 1 AMPULE 10 mL Part 1 of 2 APLICARE POVIDONE-IODINE
Product Information Item Code (Source) NDC:52380-0001 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM HYDROXIDE (UNII: 55X04QC32I) NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52380-0001-3 22.5 mL in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/01/1984 Part 2 of 2 SODIUM CHLORIDE
sodium chloride solution
Product Information Item Code (Source) NDC:65282-1510 Route of Administration EPIDURAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65282-1510-1 10 mL in 1 AMPULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/01/2000 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date premarket notification K965017 12/14/2005 Labeler - Smiths Medical ASD, Inc. (137835299) Establishment Name Address ID/FEI Business Operations Smiths Medical ASD, Inc. 137835299 relabel, manufacture Establishment Name Address ID/FEI Business Operations Aplicare, Inc. 107255002 manufacture Establishment Name Address ID/FEI Business Operations Kwang Myung Pharm. Co., Ltd. 631099384 manufacture