CHLORURE DE POTASSIUM PROAMP- potassium chloride injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

potassium chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Available from:

Laboratoire Aguettant

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Unapproved drug for use in drug shortage

Summary of Product characteristics

CHLORURE DE POTASSIUM PROAMP- POTASSIUM CHLORIDE INJECTION, SOLUTION,
CONCENTRATE
LABORATOIRE AGUETTANT
_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._
----------
POTASSIUM CHLORIDE FOR INJECTION CONCENTRATE, USP
LA JOLLA
Pharmaceutical
AGUETTANT
ESSENTIAL
MEDICINES
IMPORTANT PRESCRIBING INFORMATION
SUBJECT: TEMPORARY IMPORTATION OF POTASSIUM CHLORIDE PROAMP® 0.15
G/ML (EQUIVALENT TO 2
MEQ/ML), CONCENTRATE FOR SOLUTION FOR INFUSION TO ADDRESS DRUG
SHORTAGE
June, 2018
Dear Healthcare Professional,
Due to the critical shortage of Potassium Chloride for Injection
Concentrate 2 mEq/mL, USP in the
United States (U.S.) market, Laboratoire Aguettant (Aguettant) is
coordinating with the U.S. Food and
Drug Administration (FDA) to increase the availability of Potassium
Chloride for Injection. Aguettant
has initiated temporary importation of its Potassium Chloride Proamp®
0.15 g/mL (equivalent to 2
mEq/mL) concentrate for solution for infusion. This product is
manufactured and marketed in France by
Aguettant.
Given the scale of this shortage, FDA is coordinating with several
firms to import Potassium Chloride
for Injection 2 mEq/mL. At this time, however, no other entity except
La Jolla Pharmaceutical Company
is authorized by the FDA to import or distribute Aguettant's Potassium
Chloride Proamp® 0.15 g/mL
(equivalent to 2 mEq/mL) concentrate for solution for infusion. FDA
has not approved Aguettant's
Potassium Chloride Proamp® 0.15 g/mL concentrate for solution for
infusion, but allows its temporary
importation into the United States. You may be provided with
additional letters for other imported
products you receive. Please read each letter in its entirety because
each letter may contain different,
product-specific information.
Effective immediately, and during this temporary period, Aguettant
will offer the following presentation
of Potassium Chloride for Injection:
PRODUCT NAME AND