DEXAMETHASONE SODIUM PHOSPHATE injection, solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Fresenius Kabi USA, LLC

INN (Rahvusvaheline Nimetus):

Dexamethasone Sodium Phosphate

Koostis:

Dexamethasone 4 mg in 1 mL

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

- Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 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

Toote kokkuvõte:

Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL is available as: 4 mg/mL in a 1 mL pre-filled disposable single-use syringe (NDC 76045-210-00). Available in a carton of twenty-four (24) syringes. NDC 76045-210-10. This product contains an RFID. 4 mg/mL in a 1 mL pre-filled disposable single-use syringe, NDC 76045-106-10 Available in a carton of twenty-four (24) syringes. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from light. Sensitive to heat – Do not autoclave. Do not place syringe on a sterile field.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE
INJECTION,
SOLUTION
Fresenius Kabi USA, LLC
----------
INSTRUCTIONS FOR USE
Figure 1: Outer Packaging and Prefilled Syringe
NOTES:
- Do not introduce any other fluid into the syringe at any time.
- Do not dilute for IV push.
- Do not re-sterilize the syringe.
- Do not use this product on a sterile field.
- This product is for single dose only.
1.
Inspect the outer packaging (blister pack) to confirm the integrity of
the packaging. Do not use if
the blister pack or the prefilled syringe has been damaged.
2.
Remove the syringe from the outer packaging. (See Figure 2)
Figure 2
3.
Visually inspect the syringe. Parenteral drug products should be
inspected visually for particulate
matter and discoloration prior to administration, whenever solution
and container permit.
4.
Twist off the syringe tip cap. Do not remove the label around the luer
lock collar. (See Figure 3)
Figure 3
5.
Expel air bubble(s). Adjust the dose (if applicable).
6.
Administer the dose ensuring that pressure is maintained on the
plunger rod during the entire
administration.
7.
Discard the used syringe into an appropriate receptacle.
For more information concerning this drug, please call Fresenius Kabi
USA, LLC at 1-800-551-7176.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC
at 1-800-551-7176
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The brand names mentioned in this document are the trademarks of their
respective owners.
U.S. Patent 9,731,082
www.fresenius-kabi.com/us
451612
Revised: 10/2020
Revised: 1/2021
Document Id: 916ef348-1e5b-40b4-9d12-508fc2ce567c
34391-3
Set id: 88d25d19-acff-477b-86c8-9797782045b8
Version: 13
Effective Time: 20210120
Fresenius Kabi USA, LLC

Toote omadused

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE
INJECTION,
SOLUTION
FRESENIUS KABI USA, LLC
----------
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP
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, C
H FNa O P, has a molecular weight of 516.41 and chemically
is Pregn-4-ene-3, 20-dione, 9-fluoro-11, 17-dihydroxy-16-methyl-21
(phosphonooxy)-, disodium salt,
(11β, 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:
Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg/mL.
Each mL of Dexamethasone Sodium Phosphate injection contains
Dexamethasone Sodium Phosphate,
USP equivalent to 4 mg of Dexamethasone Phosphate. Made isotonic with
sodium citrate. pH adjusted
with citric acid or sodium hydroxide.
ACTIONS
Naturally occurring glucocorticoids (hydrocortisone), which also have
salt-retaining properties, are
used as replacement therapy in adrenocortical deficiency states. Their
synthetic analogs are primarily
used for their potent anti-inflammatory effects in disorders of many
organ systems.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify the body's
immune responses to diverse stimuli.
INDICATIONS
A. INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION. When oral therapy is
not feasible and the strength,
dosage form, and route of administration of the drug reasonably lend
the preparation to the treatment
of the condition, those products labeled for intravenous or
intramuscular use are indicated as
follows:
1. _ ENDOCRINE DISORDERS._ Primary or secondary adrenocortical
insufficiency (hydrocortisone or
cortisone is the drug of choice; synthetic analogs may be used in
conjunction with
22
28
2
8
mineralocorticoids where applicable; in infancy, mineralocorticoid
suppl