A3665-25 SPINAL 25G WHITACRE - regional anesthesia kit

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Smiths Medical ASD, Inc.

INN (Isem Internazzjonali):

EPINEPHRINE

Kompożizzjoni:

EPINEPHRINE 1 mg in 1 mL

Indikazzjonijiet terapewtiċi:

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 anesthesia. Epinephrine is co

Sommarju tal-prodott:

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) 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 25ºC (68 to 77ºF). [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: 10/2011                                                                                                                   EN-2919 Hospira, Inc., Lake Forest, IL 60045 USA

L-istatus ta 'awtorizzazzjoni:

Premarket Notification

Karatteristiċi tal-prodott

A3665-25 SPINAL 25G WHITACRE - REGIONAL ANESTHESIA KIT
SMITHS MEDICAL ASD, INC.
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EPINEPHRINE INJECTION, USP
1:1000 (1 mg/mL)
AMPUL
PROTECT FROM LIGHT UNTIL READY TO USE.
RX ONLY
DES CRIPTION
Epinephrine Injection, USP 1:1000 is a sterile, nonpyrogenic solution.
Each mL contains epinephrine 1
mg; sodium chloride 9 mg; sodium metabisulfite 0.9 mg added. May
contain
hydrochloric acid for pH adjustment. The solution contains no
bacteriostat or antimicrobial agent. It is
administered by the following routes: intravenous, intracardiac (left
ventricular chamber), via
endotracheal tube into the bronchial tree, subcutaneous or
intramuscular. Epinephrine, USP is a
sympathomimetic (adrenergic) agent designated chemically as
4-[1-hydroxy-2 (methylamino) ethyl]-1,2
benzenediol, a white, microcrystalline powder. It has the following
structural formula:
Sodium Chloride, USP is chemically designated NaCl, a white,
crystalline compound freely soluble in
water.
CLINICAL PHARMACOLOGY
The actions of epinephrine resemble the effects of stimulation of
adrenergic nerves. To a variable
degree it acts on both alpha and beta receptor sites of sympathetic
effector cells. Its most prominent
actions are on the beta receptors of the heart, vascular and other
smooth muscle. When given by rapid
intravenous injection, it produces a rapid rise in blood pressure,
mainly systolic, by (1) direct
stimulation of cardiac muscle which increases the strength of
ventricular contraction, (2) increasing the
heart rate and (3) constriction of the arterioles in the skin, mucosa
and splanchnic areas of the
circulation. When given by slow intravenous injection epinephrine
usually produces only a moderate
rise in systolic and a fall in diastolic pressure. Although some
increase in pulse pressure occurs, there
is usually no great elevation in mean blood pressure. Accordingly, the
compensatory reflex mechanisms
that come into play with a pronounced increase in blood pressure do
not antagonize the direct cardiac
actions of epinephrine as much as with cate