BUPIVACAINE HYDROCHLORIDE injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

BUPIVACAINE HYDROCHLORIDE ANHYDROUS (UNII: AKA908P8J1) (BUPIVACAINE - UNII:Y8335394RO)

Disponível em:

Areva Pharmaceuticals

Via de administração:

EPIDURAL

Tipo de prescrição:

PRESCRIPTION DRUG

Resumo do produto:

0.25% contains 2.5 mg bupivacaine hydrochloride per mL NDC 59923-717-05 5 mL single-dose vials (12.5 mg/5 mL) 10 ampules per carton NDC 59923-719-10 10 mL single-dose vials (25 mg/10 mL) 10 ampules per carton 0.5% contains 5 mg bupivacaine hydrochloride per mL NDC 59923-718-05 5 mL single-dose vials (25 mg/5 mL) 10 ampules per carton NDC 59923-720-10 10 mL single-dose vials (50 mg/10 mL) 10 ampules per carton Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Status de autorização:

Unapproved drug for use in drug shortage

Características técnicas

BUPIVACAINE HYDROCHLORIDE- BUPIVACAINE HYDROCHLORIDE INJECTION
AREVA PHARMACEUTICALS
_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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BUPIVACAINE HYDROCHLORIDE INJECTION
June 21, 2019
IMPORTANT PRESCRIBING INFORMATION
SUBJECT: TEMPORARY IMPORTATION OF BUPIVACAINE HYDROCHLORIDE INJECTION,
AMPULES TO ADDRESS
SUPPLY SHORTAGE
Dear Health Care Provider:
In order to address ongoing shortages of Bupivacaine Hydrochloride
Injection, Areva Pharmaceuticals
(Areva), is coordinating with the U.S. Food and Drug Administration
(FDA) to make available 5 mL and
10 mL Bupivacaine Hydrochloride Injection 0.25% and 0.5% Single-Dose
ampules manufactured by
Areva’s supplier, Fisiopharma, in Italy.
At this time, no other entity except Areva is authorized by the FDA to
import or distribute Bupivacaine
Hydrochloride Injection, 2.5 mg/mL and 5 mg/mL (equivalent to 0.25%
and 0.5%), 5 mL and 10 mL
Single-Dose Ampules in the United States. The FDA has not approved
this product manufactured by
Areva’s supplier in Italy.
Effective immediately, and during this temporary period, Areva will
offer the following:
PRODUCT NAME AND
DES CRIPTION
SIZE
NDC
STORE AT
Bupivacaine
Hydrochloride Injection,
2.5 mg/mL (equivalent to
0.25%)
5 mL glass
ampule
59923-
717-05
20°C to 25°C (68°F to 77°F). [See USP Controlled
Room Temperature.]
10 mL glass
ampule
59923-
719-10
Bupivacaine
Hydrochloride Injection,
5 mg/mL (equivalent to
0.5%)
5 mL glass
ampule
59923-
718-05
20°C to 25°C (68°F to 77°F). [See USP Controlled
Room Temperature.]
10 mL glass
ampule
59923-
720-10
There are key differences between the labeling of the FDA approved
Bupivacaine Hydrochloride
Injection and Areva’s imported Bupivicana Fisiopharma. It is
important to note the following:
Areva’s product is labeled Bupivacaina Fisiopharma 2,5 mg/mL which
means 2.5 mg/mL and is
equivalent to 0.25% bupivacaine hydrochloride. Bupivacaina Fis