SODIUM BICARBONATE injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

sodium bicarbonate (UNII: 8MDF5V39QO) (bicarbonate ion - UNII:HN1ZRA3Q20)

Dostupno od:

Phebra Pty Ltd

INN (International ime):

sodium bicarbonate

Sastav:

sodium bicarbonate 84 mg in 1 mL

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Sodium Bicarbonate Injection is indicated as an alkalinising agent in the treatment of metabolic acidosis which may occur in many conditions including diabetes, starvation, hepatitis, cardiac arrest, shock, severe dehydration, renal insufficiency, severe diarrhoea, Addison's disease or administration of acidifying salts (e.g. excessive sodium chloride, calcium chloride, ammonium chloride). Sodium Bicarbonate Injection is also used to increase urinary pH in order to increase the solubility of certain weak acids (e.g. cystine, sulphonamides, uric acid) and in the treatment of certain intoxications (e.g. methanol, phenobarbitone, salicylates, lithium) to decrease renal absorption of the drug or to correct acidosis. Sodium Bicarbonate Injection is contraindicated in patients with renal failure, respiratory or metabolic alkalosis, hypoventilation or chloride depletion, hypernatraemia, hypertension, oedema, congestive heart failure, eclampsia, aldosteronism, a history of urinary calculi and consistent potassium dep

Status autorizacije:

Unapproved drug for use in drug shortage

Svojstava lijeka

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION, SOLUTION
PHEBRA PTY LTD
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SODIUM BICARBONATE 8.4% INJECTION
840 MG/10 ML
NAME OF THE MEDICINE
IMPORTANT PRESCRIBING INFORMATION
SUBJECT: TEMPORARY IMPORTATION OF 8.4% SODIUM BICARBONATE INJECTION TO
ADDRESS DRUG SHORTAGE
IS S UES
June 14, 2019
Dear Healthcare Professional,
Due to the current critical shortage of Sodium Bicarbonate Injection,
USP in the United States (US)
market, Athenex Pharmaceutical Division, LLC (Athenex) is coordinating
with the U.S. Food and Drug
Administration (FDA) to increase the availability of Sodium
Bicarbonate Injection. Athenex has initiated
temporary importation of another manufacturer's 8.4% Sodium
Bicarbonate Injection (1 mEq/mL) into the
U.S. market. This product is manufactured and marketed in Australia by
Phebra Pty Ltd (Phebra).
At this time, no other entity except Athenex Pharmaceutical Division,
LLC is authorized by the FDA to
import or distribute Phebra's 8.4% Sodium Bicarbonate Injection, (1
mEq/mL), 10 mL vials, in the United
States. FDA has not approved Phebra's 8.4% Sodium Bicarbonate
Injection but does not object to its
importation into the United States. Effective immediately, and during
this temporary period, Athenex
will offer the following presentation of Sodium Bicarbonate Injection:
_Sodium Bicarbonate Injection, 8.4% (1mEq/mL), 10mL per vial, 10 vials
per carton_
_Ingredients: sodium bicarbonate, water for injection, disodium
edetate and sodium hydroxide (pH_
_adjustment)_
_Marketing Authorization Number in Australia is: 131067_
Phebra's Sodium Bicarbonate Injection contains the same active
ingredient, Sodium Bicarbonate, in the
same strength and concentration, 8.4% (1 mEq/mL) as the U.S.
registered Sodium Bicarbonate Injection,
USP by Pfizer's subsidiary, Hospira. However, it is important to note
that Phebra's Sodium Bic