LEUCOVORIN CALCIUM injection, powder, lyophilized, for solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Hikma Pharmaceuticals USA Inc.

INN (שם בינלאומי):

LEUCOVORIN CALCIUM

הרכב:

LEUCOVORIN 50 mg in 5 mL

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Leucovorin Calcium, USP rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin Calcium, USP 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, USP is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin Calcium, USP 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.

leaflet_short:

Leucovorin Calcium for Injection, USP is supplied in sterile, single use vials as follows: NDC 0143-9555-01       50 mg individually boxed vial. NDC 0143-9554-01       100 mg individually boxed vial. NDC 0143-9553-01       200 mg individually boxed vial. NDC 0143-9552-01       350 mg individually boxed vial. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA, Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised October 2021 PIN404-WES/2

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

LEUCOVORIN CALCIUM- LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED,
FOR
SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
LEUCOVORIN CALCIUM FOR INJECTION, USP
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, USP is a sterile product indicated
for intramuscular (IM)
or intravenous (IV) administration and is supplied in 50 mg, 100 mg,
200 mg, and 350
mg vials.
Each 50 mg vial of Leucovorin Calcium for Injection, USP, when
reconstituted with 5 mL
of sterile diluent, contains leucovorin (as the calcium salt) 10
mg/mL.
Each 100 mg vial of Leucovorin Calcium for Injection, USP, when
reconstituted with 10
mL of sterile diluent, contains leucovorin (as the calcium salt) 10
mg/mL.
Each 200 mg vial of Leucovorin Calcium for Injection, USP, when
reconstituted with 20
mL of sterile diluent, contains leucovorin (as the calcium salt) 10
mg/mL.
Each 350 mg vial of Leucovorin Calcium for Injection, USP, when
reconstituted with 17.5
mL of sterile diluent, contains leucovorin (as the calcium salt) 20
mg/mL.
In each dosage form, one milligram of leucovorin calcium, USP 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. Sodium hydroxide and/or
hydrochloric acid may be
added for pH adjustment. pH adjusted to 7.0 to 8.5. Reconstitute with
Bacteriostatic
Water for Injection, which contains benzyl alcohol (see WARNINGS
section), or with
20
21
7
7
Sterile Water for Injection.
CLINICAL PHARMACOLOGY
Leucovorin is a mixt