PIPERACILLIN, TAZOBACTAM injection powder lyophilized for solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Piperacillin Sodium (UNII: M98T69Q7HP) (Piperacillin Anhydrous - UNII:9I628532GX)

Disponível em:

X-GEN Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

Piperacillin Sodium

Composição:

Piperacillin Anhydrous 3 g in 20 mL

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

Unapproved drug for use in drug shortage

Características técnicas

PIPERACILLIN, TAZOBACTAM- PIPERACILLIN, TAZOBACTAM INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
X-GEN PHARMACEUTICALS, INC.
_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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TEMPORARY IMPORTATION OF CANADIAN PIPERACILLIN AND TAZOBACTAM FOR
INJECTION TO ADDRESS DRUG
SHORTAGE
January 16, 2017
Dear Healthcare Professional:
Due to the current critical shortage of Piperacillin and Tazobactam
for Injection products in the United
States (U.S.) market, SteriMax Inc. (SteriMax) is coordinating with
the U.S. Food and Drug
Administration (FDA) to increase the availability of the drug.
SteriMax has initiated temporary
importation of non-FDA approved Piperacillin and Tazobactam for
Injection (3.375 g/vial, 4.5 g/vial, and
40.5 g/vial) into the U.S. market. The Piperacillin and Tazobactam for
Injection from SteriMax is
marketed in Canada and is manufactured at an FDA-inspected facility
that is in compliance with current
good manufacturing practice requirements.
X-Gen Pharmaceuticals will distribute SteriMax's Piperacillin and
Tazobactam for Injection to address
the critical shortage. At this time, no other entity except SteriMax
or its distributor X-Gen
Pharmaceuticals is authorized by the FDA to import or distribute
SteriMax's Piperacillin and
Tazobactam for Injection in the United States.
Effective immediately, X-Gen Pharmaceuticals will distribute the
following presentations of SteriMax's
Piperacillin and Tazobactam for Injection:
STERIMAX PIPERACILLIN AND TAZOBACTAM
FOR INJECTION
3.375 g/vial
(equivalent to 3 g of
piperacillin and 0.375 g of
tazobactam)
DIN:
02362627
(Canada)
4.5 g/vial
(equivalent to 4 g of
piperacillin and 0.5 g of
tazobactam)
DIN:
02362635
(Canada)
40.5 g/vial
(equivalent to 36 g of
piperacillin and 4.5 g of
tazobactam)
DIN:
02439131
(Canada)
Note: DIN refers to Drug Identification Number for products marketed
in Canada.
THE BARCODE MAY NOT REGISTER ACCURATEL