DEXLIDO-M KIT- dexamethasone sodium phosphate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine kit

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

Dexamethasone Sodium Phosphate (UNII: AI9376Y64P) (Dexamethasone - UNII:7S5I7G3JQL)

Saadav alates:

Proficient Rx LP

INN (Rahvusvaheline Nimetus):

Dexamethasone Sodium Phosphate

Koostis:

Dexamethasone Phosphate 10 mg in 1 mL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

By intravenous or intramuscular injection when oral therapy is not feasible: 1. Endocrine Disorders      Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids      where applicable; in infancy, mineralocorticoid supplementation is of particular importance).      Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs      are used).      Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful.      Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.      Congenital adrenal hyperplasia      Nonsuppurative thyroiditis      Hypercalcemia associated with cancer 2. Rheumatic Disorders      As adjunctive therapy for short-term administration (t

Toote kokkuvõte:

Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) equivalent to 10 mg dexamethasone phosphate, is supplied in a single dose vial as follows: Product No. NDC No. Strength Vial Size 500601 63323-506-01 10 mg/mL 1 mL Packaged in twenty-fives. Dexamethasone Sodium Phosphate Injection, USP (Preserved) equivalent to 10 mg dexamethasone phosphate, is supplied in a multiple dose vial as follows: Product No. NDC No. Strength Vial Size 501610 63323-516-10 10 mg/mL 10 mL Packaged in tens. Vial stoppers do not contain natural rubber latex. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Sensitive to heat. Do not autoclave. Protect from freezing. Protect from light. Single dose vials–Store in container until time of use.  Discard unused portion. Multiple dose vials–Store in container until contents are used. 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 These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] MARCAINE ―Solutions of MARCAINE that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. NDC No. Container Fill Quantity 0.25%—Contains 2.5 mg bupivacaine hydrochloride per mL. 0409-1559-10 Single-dose vials 10 mL box of 10 0409-1559-30 Single-dose vials 30 mL box of 10 0409-1587-50 Multiple-dose vials 50 mL box of 1 0.5%—Contains 5 mg bupivacaine hydrochloride per mL. 0409-1560-10 Single-dose vials 10 mL box of 10 0409-1560-29 Single-dose vials 30 mL box of 10 0409-1610-50 Multiple-dose vials 50 mL box of 1 0.75%—Contains 7.5 mg bupivacaine hydrochloride per mL. 0409-1582-10 Single-dose vials 10 mL box of 10 0409-1582-29 Single-dose vials 30 mL box of 10 MARCAINE with epinephrine 1:200,000 (as bitartrate)―Solutions of MARCAINE that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. NDC No. Container Fill Quantity 0.25% with epinephrine 1:200,000—Contains 2.5 mg bupivacaine hydrochloride per mL. 0409-1746-10 Single-dose vials 10 mL box of 10 0409-1746-30 Single-dose vials 30 mL box of 10 0409-1752-50 Multiple-dose vials 50 mL box of 1 0.5% with epinephrine 1:200,000—Contains 5 mg bupivacaine hydrochloride per mL. 0409-1749-03 Single-dose ampuls 3 mL box of 10 0409-1749-10 Single-dose vials 10 mL box of 10 0409-1749-29 Single-dose vials 30 mL box of 10 0409-1755-50 Multiple-dose vials 50 mL box of 1 Revised: 10/2011   Printed in USA                           EN-2916         Hospira, Inc., Lake Forest, IL 60045 USA

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

DEXLIDO-M KIT- DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE
HYDROCHLORIDE, BUPIVACAINE
HYDROCHLORIDE, POVIDINE IODINE
PROFICIENT RX LP
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DEXAMETHASONE SODIUM PHOSPHATE INJECTION,USP
FOR INTRAVENOUS OR INTRAMUSCULAR USE ONLY
Rx only
DESCRIPTION
Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble
inorganic ester of dexamethasone
which produces a rapid response even when injected intramuscularly.
Dexamethasone Sodium Phosphate, USP chemically is
Pregna-1,4-diene-3,20-dione, 9-fluoro- 11,17-
dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α).
It occurs as a white to creamy white powder, is exceedingly
hygroscopic, is soluble in water and its
solutions have a pH between 7.0 and 8.5. It has the following
structural formula:
Each mL of Dexamethasone Sodium Phosphate Injection, USP (PRESERVATIVE
FREE) contains
dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone
phosphate; 24.75 mg sodium
citrate, dihydrate; and Water for Injection, q.s. pH adjusted with
citric acid or sodium hydroxide, if
necessary. pH: 7.0 to 8.5.
Each mL Dexamethasone Sodium Phosphate Injection, USP (PRESERVED)
contains dexamethasone
sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate;
13.5 mg sodium citrate,
dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH
adjusted with citric acid or sodium
hydroxide, if necessary. pH: 7.0 to 8.5.
CLINICAL PHARMACOLOGY
Dexamethasone sodium phosphate injection has a rapid onset but short
duration of action when
compared with less soluble preparations. Because of this, it is
suitable for the treatment of acute
disorders responsive to adrenocortical steroid therapy.
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-retaining
properties, are used as replacement therapy in adrenocortical
deficiency states. Their synthetic analogs,
including dexamethasone, are primarily used for their potent
anti-inflammatory effects in disorders of
many organ systems.
Glucocorticoids cause profound and varied metabo