Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml) Technical Specification: 

Product Name:Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml)
Brand Name:Leucovorin
Strength:10mg/ml (50mg/5ml, 100mg/10ml, 175mg/17.5ml, 250mg/25ml, 300mg/30ml, 500mg/50ml – VIAL)
15mg/ 2ml – Ampoule
Dosage Form:Liquid Injection
Packing:SINGLE USE VIAL
Route of Administration:For I.M. and I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Folinic acid, also known as leucovorin, is a medication used alone or with other drugs to treat certain types of colorectal cancer and anemia and to lessen the toxic effects of the anticancer drug methotrexate or other substances that block the action of folic acid.
Storage:Store between 2°-8° C (36°-46°F). Do not freeze. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml)
    Each ml contains
    Calcium Folinate USP
    Equivalent to
    Folinic Acid……………….…….10mg
    Methyl paraben B.P………..0.08% w/v
    Propyl paraben B.P…………0.02% w/v
    Water for Injection B.P……q.s.

THERAPEUTIC INDICATION:

Folinic acid, also known as leucovorin, is a medication used alone or with other drugs to treat certain types of colorectal cancer and anemia and to lessen the toxic effects of the anticancer drug methotrexate or other substances that block the action of folic acid.

PACKING:

10mg/ml – VIAL

  • 50mg/5ml
  • 100mg/10ml
  • 175mg/17.5ml
  • 250mg/25ml
  • 300mg/30ml
  • 500mg/50ml

15mg/ 2ml – Ampoule

DIRECTION OF USE:

For I.M. and I.V. use only

See package insert for complete prescribing information.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after dilution.

CAUTION: Cytotoxic agent – Special Handling.

WARNING: Cytotoxic Agent – To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.

WARNINGS: IN THE TREATMENT OF ACCIDENTAL OVERDOSAGES OF FOLIC ACID ANTAGONISTS, INTRAVENOUS LEUCOVORIN SHOULD BE ADMINISTERED AS PROMPTLY AS POSSIBLE. AS THE TIME INTERVAL BETWEEN ANTIFOLATE ADMINISTRATION (E.G. METHOTREXATE) AND LEUCOVORIN RESCUE INCREASES, LEUCOVORIN’S EFFECTIVENESS IN COUNTERACTING TOXICITY DECREASES. IN THE TREATMENT OF ACCIDENTAL OVERDOSAGES OF INTRATHECALLY ADMINISTER LEUCOVORIN INTRATHECALLY, LEUCOVORIN MAY BE HARMFUL OR FATAL IF GIVEN INTRATHECALLY.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard any unused solution.

Keep out of reach of children.

STORAGE & DOSAGE:

Storage: Store between 2°-8° C (36°-46°F). Do not freeze. Protect from light.

Dosage: As directed by the Oncologist.

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml, 100mg/10ml, 175mg/17.5ml, 250mg/25ml, 300mg/30ml, 500mg/50ml - VIAL)
b) Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 15mg/ 2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml, 100mg/10ml, 175mg/17.5ml, 250mg/25ml, 300mg/30ml, 500mg/50ml - VIAL)
Each ml contains
Calcium Folinate USP
Equivalent to
Folinic Acid……………….…....10mg
Methyl paraben B.P………..0.08% w/v
Propyl paraben B.P………...0.02% w/v
Water for Injection B.P…...q.s.


b) Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 15mg/ 2ml
Each ml of 15 mg contains
Leucovorin Calcium USP
equivalent to Leucovorin………………..7.5 mg
Water for Injection …………………………q.s
The solution contains no preservatives

THERAPEUTIC INDICATION:

Folinic acid, also known as leucovorin, is a medication used alone or with other drugs to treat certain types of colorectal cancer and anemia and to lessen the toxic effects of the anticancer drug methotrexate or other substances that block the action of folic acid.

PACKING:

10mg/ml - VIAL
1) 50mg/5ml
2) 100mg/10ml
3) 175mg/17.5ml
4) 250mg/25ml
5) 300mg/30ml
6) 500mg/50ml

15mg/ 2ml – Ampoule

DIRECTION OF USE:

For I.M. and I.V. use only
See package insert for complete prescribing information.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after dilution.
CAUTION: Cytotoxic agent – Special Handling.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNINGS: IN THE TREATMENT OF ACCIDENTAL OVERDOSAGES OF FOLIC ACID ANTAGONISTS, INTRAVENOUS LEUCOVORIN SHOULD BE ADMINISTERED AS PROMPTLY AS POSSIBLE. AS THE TIME INTERVAL BETWEEN ANTIFOLATE ADMINISTRATION (E.G. METHOTREXATE) AND LEUCOVORIN RESCUE INCREASES, LEUCOVORIN’S EFFECTIVENESS IN COUNTERACTING TOXICITY DECREASES. IN THE TREATMENT OF ACCIDENTAL OVERDOSAGES OF INTRATHECALLY ADMINISTER LEUCOVORIN INTRATHECALLY, LEUCOVORIN MAY BE HARMFUL OR FATAL IF GIVEN INTRATHECALLY.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children.

STORAGE & DOSAGE:

Storage: Store between 2°-8° C (36°-46°F). Do not freeze. Protect from light.
Dosage: As directed by the Oncologist.