A4099-22 NERVE BLOCK - 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:

INDICATIONS AND USAGE Epinephrine is used to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of anesthetics. Its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. Epinephrine is used as a hemostatic agent. It is also used in treating mucosal congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. Epinephrine Injection can be utilized to prolong the action of anesthetics used in local and regional anesth

Product summary:

HOW SUPPLIED Epinephrine Injection, USP 1:1000 (1 mg/mL) is supplied in a 1 mL ampul single-dose container (NDC 0409-7241-61). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Revised: October, 2008 Printed in USA EN-1927 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) HOW SUPPLIED 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

Authorization status:

Premarket Notification

Summary of Product characteristics

A4099-22 NERVE BLOCK - REGIONAL ANESTHESIA KIT
SMITHS MEDICAL ASD, INC.
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DRUG FACTS
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 bacteria 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
•
avoid getting solution into hairy areas. Hair may take up to 1 hour to
dry. Wet hair is flammable.
•
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).
•
do not allow solution to pool
•
remove wet materials from prep area
Do not use
•
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
•
use with care in premature infants or infants under 2 months of age.
These products may cause irritation
or chemical burns.
•
use in a well ventilated area
•
maximal treatment area for one applicator is approximately 4 in. x 5
in. (130 cm2)
•
remove applicator from package; do not touch sponge
•
hold the applicator with the sponge down. Pinch wings only once to
activate the ampule and release the
antiseptic.
•
wet the