A4011 ARTERIAL LINE ANESTHESIA PREP TRAY - regional anesthesia kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L), ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)

Available from:

Smiths Medical ASD, Inc.

INN (International Name):

CHLORHEXIDINE GLUCONATE

Composition:

CHLORHEXIDINE GLUCONATE 20 mg in 1 mL

Therapeutic indications:

Antiseptic Antiseptic for the preparation of the patient's skin prior to surgery: Helps to reduce bacterial that potentially can cause skin infection. - in children less than 2 months of age because of the potential for excessive skin irritation and increased drug absorption - on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol - for lumbar puncture or in contact with the meninges - on open skin wounds or as a general skin cleanser - irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. - to reduce the risk of fire the following strategies are recommended: use in a well ventilated area avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. do not allow solution to pool tuck prep towels to absorb solution, and then remove remove wet material from prep area - use in a well ventilated area - avoid getting solution into hairy areas. Wet hair is flammable. Hair

Product summary:

Lidocaine Hydrochloride Injection, USP is supplied as follows: NDC Container Concentration Size Total (mg) Single-dose: 0409-4278-01 Glass Teartop Vial 0.5% (5 mg/mL) 50 mL 250 0409-4713-01 Glass Ampul 1% (10 mg/mL) 2 mL (bulk – 400 units) 20 0409-4713-02 Glass Ampul 1% (10 mg/mL) 5 mL 50 0409-4713-05 Glass Ampul 1% (10 mg/mL) 5 mL (bulk – 400 units) 50 0409-4713-20 Glass Ampul 1% (10 mg/mL) 20 mL 200 0409-4713-32 Glass Ampul 1% (10 mg/mL) 2 mL 20 0409-4713-62 Glass Ampul 1% (10 mg/mL) 2 mL (bulk – 800 units) 20 0409-4713-65 Glass Ampul 1% (10 mg/mL) 5 mL (bulk – 800 units) 50 0409-4279-02 Glass Teartop Vial 1% (10 mg/mL) 30 mL 300 0409-4270-01 Sterile Glass Teartop Vial 1% (10 mg/mL) 30 mL 300 0409-4776-01 Glass Ampul 1.5% (15 mg/mL) 20 mL 300 0409-4056-01 Sterile Glass Ampul 1.5% (15 mg/mL) 20 mL 300 0409-4282-01 Glass Ampul 2% (20 mg/mL) 2 mL 40 0409-4282-02 Glass Ampul 2% (20 mg/mL) 10 mL 200 Multiple-dose: 0409-4275-01 Plastic Fliptop Vial 0.5% (5 mg/mL) 50 mL 250 0409-4276-01 Plastic Fliptop Vial 1% (10 mg/mL) 20 mL 200 0409-4276-02 Plastic Fliptop Vial 1% (10 mg/mL) 50 mL 500 0409-4277-01 Plastic Fliptop Vial 2% (20 mg/mL) 20 mL 400 0409-4277-02 Plastic Fliptop Vial 2% (20 mg/mL) 50 mL 1000 Single-dose products are preservative-free. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS. Revised: February, 2010 Printed in USA                            EN-2421 Hospira, Inc., Lake Forest, IL 60045 USA 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)

Authorization status:

Premarket Notification

Summary of Product characteristics

A4011 ARTERIAL LINE ANESTHESIA PREP TRAY - REGIONAL ANESTHESIA KIT
SMITHS MEDICAL ASD, INC.
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CHLORAPREP ONE-STEP (chlorhexidine gluconate and isopropyl aclohol)
solution
[CareFusion 213 LLC]
Active ingredients
Chlorhexidine gluconate 2% w/v
Isopropyl alcohol 70% v/v
Purposes
Antiseptic
Antiseptic
Use
for the preparation of the patient's skin prior to surgery: Helps to
reduce bacterial that potentially can
cause skin infection.
Warnings
FOR EXTERNAL USE ONLY.
FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. TO REDUCE THE RISK OF FIRE,
PREP CAREFULLY:
solution contains alcohol and gives off FLAMMABLE VAPORS
do not drape or use ignition source (e.g., cautery, laser) until
solution is completely dry (minimum of
3 minutes on hairless skin; up to 1 hour in hair).
avoid getting solution into hairy areas. WET HAIR IS FLAMMABLE. Hair
may take up to 1 hour to dry.
do not allow solution to pool
remove wet materials from prep area
Do not use
in children less than 2 months of age because of the potential for
excessive skin irritation and
increased drug absorption
on patients with known allergies to chlorhexidine gluconate or
isopropyl alcohol
for lumbar puncture or in contact with the meninges
on open skin wounds or as a general skin cleanser
When using this product
keep out of eyes, ears, and mouth. May cause serious or permanent
injury if permitted to enter and
remain. If contact occurs, rinse with cold water right away and
contact a doctor.
Stop use and ask a doctor if
irritation, sensitization, or allergic reaction occurs. These may be
signs of a serious condition.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center
right away.
Directions
to reduce the risk of fire the following strategies are recommended:
use in a well ventilated area
avoid getting solution into hairy areas. WET HAIR IS FLAMMABLE. Hair
may take up to 1 hour to dry.
do not allow solution to pool
tuck prep towels to absorb solution, and then remove
remove wet material from prep area
maximal treatment area for