15753-20 PEDIATRIC CONTINUOUS EPIDURAL 18G TUOHY - regional anesthesia kit

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Nusipirk tai dabar

Parsisiųsti Prekės savybės (SPC)
23-07-2012

Veiklioji medžiaga:

POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)

Prieinama:

Smiths Medical ASD, Inc.

INN (Tarptautinis Pavadinimas):

POVIDONE-IODINE

Sudėtis:

POVIDONE-IODINE 0.10 mg in 1 mL

Terapinės indikacijos:

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. Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Produkto santrauka:

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 and Epinephrine Injection, USP is supplied in single-dose and multiple-dose containers as shown below: NDC No. Container Size Drug Concentration Lidocaine HCl Epinephrine Single-dose 0409-3181-01 Fliptop Vial  30 mL 1.5% 1:200,000 0409-3183-01 Fliptop Vial  20 mL 2% 1:200,000 Epidural Test Dose (single-dose) 0409-1209-01 Ampul  5 mL 1.5% 1:200,000 0409-1209-05 Ampul  5 mL 1.5% 1:200,000 0409-1209-65 Ampul  5 mL 1.5% 1:200,000 Multiple-dose 0409-3177-01 Fliptop Vial  50 mL 0.5% 1:200,000 0409-3178-01 Fliptop Vial  20 mL 1% 1:100,000 0409-3178-02 Fliptop Vial  30 mL 1% 1:100,000 0409-3178-03 Fliptop Vial  50 mL 1% 1:100,000 0409-3182-01 Fliptop Vial  20 mL 2% 1:100,000 0409-3182-02 Fliptop Vial  30 mL 2% 1:100,000 0409-3182-03 Fliptop Vial  50 mL 2% 1:100,000 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]  Protect from light. Revised: March, 2010 Printed in USA                            EN-2440 Hospira, Inc., Lake Forest, IL 60045 USA

Autorizacija statusas:

Premarket Notification

Prekės savybės

                                15753-20 PEDIATRIC CONTINUOUS EPIDURAL 18G TUOHY - REGIONAL ANESTHESIA
KIT
SMITHS MEDICAL ASD, INC.
----------
3/4 Fluid Ounce Povidone Iodine
Povidone-iodine 10%
Antiseptic
Warnings
Do not use
if allergic to iodine
in the eyes
For external use only
Ask a doctor before use if injuries are
deep or puncture wounds
serious burns
Stop use and ask a doctor if
redness, irritation, swelling or pain persists or increases
infection occurs
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.
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
                                
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