A2629-17 SINGLE SHOT EPIDURAL 17G TUOHY - regional anesthesia kit   
Smiths Medical ASD, Inc.

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3/4 Fluid Ounce Povidone Iodine

Povidone-iodine 10%

Antiseptic

Warnings

            Do not use

            For external use only

            Ask a doctor before use if injuries are

            Stop use and ask a doctor if

            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.


Povidone Iodine Solution





Spectra Medical Devices, Inc.
SODIUM CHLORIDE
INJECTION, USP, 0.9%

DESCRIPTION
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 AND USAGE
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.

WARNING
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.

PRECAUTIONS
GENERAL

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.

PREGNANCY
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.

OVERDOSAGE
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 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.

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
Store at controlled room temperature 15-30 C (59-86 F).  Avoid freezing.

Manufactured for:
Spectra Medical Devices, Inc. 260-F Fordham Road, Wilmington, MA 01887
By: KM. Pharm Co., LTD.

Package Label Display Panel

A2629-17

A2629-17 SINGLE SHOT EPIDURAL 17G TUOHY 
regional anesthesia kit kit
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-9997
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NHRIC:51688-9997-2 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  
povidone-iodine solution
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) POVIDONE-IODINE 0.10 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

Revised: 11/2012
Document Id: 314a0074-17c6-4139-85b4-2f8a36de3f25
Set id: 3352d8bc-7fcf-4874-978f-f774f393a28d
Version: 1
Effective Time: 20121130
 
Smiths Medical ASD, Inc.