LEUCOVORIN CALCIUM injection, powder, lyophilized, for solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

LEUCOVORIN CALCIUM (UNII: RPR1R4C0P4) (LEUCOVORIN - UNII:Q573I9DVLP)

Beszerezhető a:

Fresenius Kabi USA, LLC

INN (nemzetközi neve):

LEUCOVORIN CALCIUM

Összetétel:

LEUCOVORIN 200 mg in 20 mL

Az alkalmazás módja:

INTRAMUSCULAR

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma.   Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form. Leucovorin is improper therapy for pernicious anemia and other megaloblastic anemias secondary to the lack of vitamin B12 . A hematologic remission may occur while neurologic manifestations continue to progress.

Termék összefoglaló:

Leucovorin Calcium for Injection is supplied as follows: Store at 20°C to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light   (keep in outer carton).   The container closure is not made with natural rubber latex.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

LEUCOVORIN CALCIUM - LEUCOVORIN CALCIUM INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
FRESENIUS KABI USA, LLC
----------
LEUCOVORIN CALCIUM FOR INJECTION
RX ONLY
DESCRIPTION:
Leucovorin is one of several active, chemically reduced derivatives of
folic acid. It is
useful as an antidote to drugs which act as folic acid antagonists.
Also known as folinic acid, Citrovorum factor, or
5-formyl-5,6,7,8-tetrahydrofolic acid,
this compound has the chemical designation of Calcium
_N_-[_p_-[[[(6_RS_)-2-amino-5-formyl-
5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate
(1:1). The
structural formula of leucovorin calcium is:
C
H
CaN O M.W.
511.51
Leucovorin Calcium for Injection is a sterile product indicated for
intramuscular (IM) or
intravenous (IV) administration and is supplied in 200 mg and 500 mg
vials.
Each 200 mg vial of Leucovorin Calcium for Injection, when
reconstituted with 20 mL of
sterile diluent, contains leucovorin (as the calcium salt) 10 mg/mL.
Each 500 mg vial of Leucovorin Calcium for Injection, when
reconstituted with 50 mL of
sterile diluent, contains leucovorin (as the calcium salt) 10 mg/mL.
In each dosage form, one milligram of leucovorin calcium contains
0.002 mmol of
leucovorin and 0.002 mmol of calcium.
These lyophilized products contain no preservative. The inactive
ingredient is sodium
chloride added to adjust tonicity. Reconstitute with Bacteriostatic
Water for Injection,
USP, which contains benzyl alcohol (see WARNINGS), or with Sterile
Water for Injection,
USP.
The inactive ingredient is sodium chloride 180 mg/vial for the 200 mg
and 450 mg/vial for
the 500 mg. Sodium hydroxide and/or hydrochloric acid may be added for
pH
20
21
7
7
adjustment. pH adjusted to approximately 7.8.
There is 0.004 mEq of calcium per mg of leucovorin. Solution contains
no bacteriostat
or antimicrobial agents.
CLINICAL PHARMACOLOGY:
Leucovorin is a mixture of the diastereoisomers of the 5-formyl
derivative of
tetrahydrofolic acid (THF). The biologically active compound of the
mixture is the (-)