LEUCOVORIN- leucovorin calcium injection, powder, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

BluePoint Laboratories

INN (International Name):

LEUCOVORIN CALCIUM

Sammensetning:

LEUCOVORIN 10 mg in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Leucovorin Calcium for Injection is supplied as follows: NDC Leucovorin Calcium for Injection Volume 68001-285-22 50 mg Single-Dose Vial 5 mL in 1 vial 68001-285-28 100 mg Single-Dose Vial 10 mL in 1 vial 68001-285-29 200 mg Single-Dose Vial 20 mL in 1 vial 68001-286-39 350 mg Single-Dose Vial 17.5 mL in 1 vial Leucovorin Calcium for Injection are packaged per the following: NDC Leucovorin Calcium for Injection 68001-285-40 50 mg Vial – 5 mL vials are packaged 10 vials per shelf pack 68001-285-36 100 mg Vial – 10 mL vials are packed individually per shelf pack 68001-285-37 200 mg Vial – 20 mL vials are packed individually per shelf pack 68001-286-38 350 mg Vial – 17.5 mL vials are packed individually per shelf pack Storage Conditions Store dry product and reconstituted solution at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Lyophilized. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Mfd. by Cadila Healthcare Ltd., Ahmedabad, India. For BluePoint Laboratories Revised: April 2016

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LEUCOVORIN- LEUCOVORIN CALCIUM INJECTION, POWDER, FOR SOLUTION
BLUEPOINT LABORATORIES
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LEUCOVORIN CALCIUM FOR INJECTION (FOR INTRAVENOUS OR INTRAMUSCULAR
USE)
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_-[[[(6RS)-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
20
21
7
7
Leucovorin Calcium for Injection 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, 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, 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, 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, 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 contains
0.002 mmol of leucovorin and
0.002 mmol of calcium.
These lyophilized products contain no preservative. The inactive
ingredient is Sodium Chloride, USP,
added to adjust tonicity. Sodium hydroxide and / or hydrochloric acid
may be used to adjust the pH. The
pH is between 6.5 and 8.5. Reconstitute with Bacteriostatic Water for
Injection, USP, which contains
benzyl alcohol (see WARNINGS section), or with Sterile Water for
Injection, USP.
CLINICAL PHARMACOLOGY
Leucovorin is a mixture of the diast