A3864-24 SPINAL 24G EUROPEAN PENCIL POINT- regional anesthesia kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)

Disponível em:

Smiths Medical ASD, Inc.

DCI (Denominação Comum Internacional):

EPINEPHRINE

Composição:

EPINEPHRINE 1 mg in 1 mL

Indicações terapêuticas:

Antiseptic patient preoperative skin preparation: for preparation of the skin prior to surgeryhelps reduce bacteria that potentially can cause skin infection at the end of the prep, discard any portion of the solution which is not required to cover the prep area. It is not necessary to use the entire amount available. Getting Patient Ready for Solution: use in well-ventilated areado not microwave or heat the solution applicatorapply to clean, completely dry, residue-free, intact skinwhen hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: grasp product by wrapping hand and fingers around the labeled portion of the applicator. Place thumb on the lever.with sponge face parallel to the floor, snap lever. Allow all fluid to flow into sponge. When Applying Solution: DO NOT SCRUB. Paint a single, uniform application and do not reprep area.do not allow solution to pool. Use sponge applicator to absorb

Resumo do produto:

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 Single-dose ampuls of 2 mL (15 mg bupivacaine hydrochloride with 165 mg dextrose), is supplied as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] MARCAINE Spinal solution may be autoclaved once at 15 pound pressure, 121°C (250°F) for 15 minutes. Do not administer any solution which is discolored or contains particulate matter. Revised: 08/2013 EN-3326 Hospira, Inc., Lake Forest, IL 60045 USA 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

Status de autorização:

Premarket Notification

Características técnicas

A3864-24 SPINAL 24G EUROPEAN PENCIL POINT- REGIONAL ANESTHESIA KIT
SMITHS MEDICAL ASD, INC.
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DRUG FACTS
Iodine povacrylex (0.7% available iodine)
Isopropyl alcohol, 74% w/w
Antiseptic
patient preoperative skin preparation:
for preparation of the skin prior to surgeryhelps reduce bacteria that
potentially can cause skin infection
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 vaporsdo 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 poolremove solution-stained material from prep
area
Do not use
on patients with known allergies to iodine or any other ingredients in
this producton open wounds, on
mucous membranes, or as a general skin cleanserin infants less than 2
months old due to the risk of
excessive skin irritation and transient hypothyroidism
When using this product
keep out of eyes, ears, and mouth. May cause serious injury if
permitted to enter and remain. If contact
occurs, flush with cold water right away and contact a doctor.to avoid
skin injury, care should be taken
when removing drapes, tapes, etc…applied over filmuse with caution
in women who are breast-feeding
due to the potential for transient hypothyroidism in the nursing
newborn
Stop use and ask a doctor if irritation, sensitization or allergic
reaction occurs. These may be signs of a
serious condition. On rare occasions, use of this product has been
associated with skin blistering.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right
away.
at the end of the prep, discard any portion of the solution which is
not required to cover the prep area. It
is not necessary to use the entire amount available.
Getting Patient Ready for Solution:
use in well-ventilated