ANTICHOLIUM- physostigmine salicylate injection

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

PHYSOSTIGMINE SALICYLATE (UNII: 2046ZRO9VU) (PHYSOSTIGMINE - UNII:9U1VM840SP)

Dostopno od:

Provepharm Inc.

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

ANTICHOLIUM® is indicated for: 1. the use as an antidote and/or antagonist in case of intoxication with and/or overdose of: - alcohol - tropane alkaloids (hyoscyamine, atropine, scopolamine, as e.g. in brugmansia, datura, atropa belladonna) - amanita pantherina and amanita muscaria - tricyclic antidepressants (amitriptyline, imipramine, trimipramine, clomipramine, doxepine) - antiemetics/antihistamines (phenothiazine, thioridazine, chlorpromazine, promethazine, diphenhydramine, dimenhydrinate) - neuroleptic drugs (especially butyrophenones) - benzodiazepines - tolterodine, oxybutynine - amantadine, diphenhydramine - baclofen - 4-hydroxybutyric acid (GHB) - inhalation anesthetics - ketamine - 3-quinuclidinyl benzilate 2. the treatment of postoperative disorders: - Central anticholinergic syndrome (CAS) - Delayed postoperative awakening - Shivering ANTICHOLIUM® should not be used in the presence of hypersensitivity to physostigmine salicylate, bronchial asthma, ulcers associated with tissue destruction (gang

Povzetek izdelek:

ANTICHOLIUM® is a clear, colorless to slightly reddish solution in glass ampules. Pack containing 5 ampules with 5 ml.

Status dovoljenje:

Unapproved drug for use in drug shortage

Lastnosti izdelka

ANTICHOLIUM- PHYSOSTIGMINE SALICYLATE INJECTION
PROVEPHARM 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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ANTICHOLIUM
SOLUTION FOR INJECTION OR INFUSION
HEALTH CARE PROVIDER LETTER
September 2023
IMPORTANT PRESCRIBING INFORMATION
SUBJECT:
TEMPORARY IMPORTATION OF ANTICHOLIUM® (PHYSOSTIGMINE SALICYLATE)
AMPULES WITH FOREIGN, NON-U.S. LABELING TO ADDRESS SUPPLY SHORTAGE
Dear Healthcare Provider,
To address the ongoing shortages of physostigmine salicylate injection
in the United
States, Dr. Franz Köhler Chemie GmbH (Koehler) in conjunction with
Provepharm Inc.
(Provepharm) and Direct Success, Inc. (Direct Success) is coordinating
with the U.S.
Food and Drug Administration (FDA) to temporarily import Anticholium
(Physostigmine
salicylate, 2mg/5ml, injection solution for intravenous use) into the
U.S. market.
Koehler’s Anticholium® (Physostigmine salicylate, 2mg/5ml,
injection solution for
intravenous use), marketed and manufactured in Germany for Koehler, is
not FDA-
approved.
At this time, no other entity except Provepharm or its distributor
Direct Success is
authorized by the FDA to import or distribute physostigmine salicylate
injection in the
U.S.
Effective immediately, Provepharm will distribute the following
presentations of
Anticholium® (physostigmine salicylate) to address the critical
shortage:
PRODUCT
DESCRIPTION
STRENGTH
PACKAGING NDC
NUMBER
LOT/
BATCH #
EXPIRATION
DATE
(LABELED)
Anticholium
(physostigmine
salicylate)
2 mg/5 mL (0.4
mg/mL) injection
for intravenous
use
5 x 5 mL
ampules
81284-
831-05
2315751 2026-05-
31
TO PLACE AN ORDER, please contact Direct Success at
[e-mail] or 1-
877-404-3338.
®
®
®
The U.S. imported Anticholium (physostigmine salicylate) injection
contains nitrogen even
though it is not listed on the enclosed Instructions for Use (IFU).
THE BARCODE ON THE IMPORTED PRODUCT LABEL MAY NOT REGISTER ACCURATE