Fluorouracil Injection USP 50mg/ml (250mg/5ml) Technical Specification:

Product Name:Fluorouracil Injection USP 50mg/ml (250mg/5ml)
Brand Name:Fluorouracil
Strength:50mg/ml (500mg/10ml,1gm/20ml, 2.5gm/50ml, 5gm/100ml – VIAL), 50mg/ml (500mg/10ml, 250mg/5ml – AMPOULE)
Dosage Form:Liquid Injection
Packing:500mg/10ml, 250mg/5ml, 1gm/20ml – SINGLE USE VIAL
2.5gm/50ml, 5gm/100ml – BULK USE
500mg/10ml, 250mg/5ml – AMPOULE
Route of Administration:For 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: Fluorouracil is a cytotoxic chemotherapy medication it is used for treatment of colorectal cancer, oesophageal cancer, stomach cancer, pancreatic cancer, breast cancer, and cervical cancer.
Storage:Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Fluorouracil Injection USP 50mg/ml (250mg/5ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Fluorouracil Injection 50mg/ml (250mg/5ml)
    Each ml contains
    Fluorouracil USP……………….50mg
    Excipients…………………………q.s.
    Water for Injection USP……q.s.
    The PH of the solution has been adjusted to approximately 8.6 to 9.4 with sodium hydroxide.

THERAPEUTIC INDICATION:

Fluorouracil is a cytotoxic chemotherapy medication it is used for treatment of colorectal cancer, oesophageal cancer, stomach cancer, pancreatic cancer, breast cancer, and cervical cancer.

PACKING:

50mg/ml – VIAL

  • 500mg/10ml
  • 1gm/20ml
  • 5gm/50ml
  • 5gm/100ml

50mg/ml – Ampoule

  • 500mg/10ml
  • 250mg/5ml

DIRECTION OF USE:

For 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.

The product should be discarded if it appears brown or dark yellow in solution.

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

Fluorouracil Injection, 50mg/ml should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents.

Children:

No recommendations are made regarding the use of fluorouracil in children.

Elderly:

Fluorouracil should be used in the elderly with similar considerations as in younger adults, notwithstanding that incidence of concomitant medical illness is higher in the former group.

If a precipitate forms due to exposure to low temperature, resolubilize in a water bath maintained at 60°C (140° F) with vigorous shaking. Allow to cool to body temperature before using.

This container closure is not made with natural rubber latex.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard any unused solution.

Keep out of reach of children

For 2.5gm/50ml, 5gm/100ml – BULK USE VIAL

PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION

A single entry through the vial closure should be made with a sterile dispensing set or transfer device which will accept a syringe hub. Use of a syringe needle is not recommended. Withdraw contents into syringe through the set/ device. The above process should be carried out under a laminar flow hood using aseptic technique.

PROMPTLY DISPENSE CONTENTS OF THE PHARMACY BULK PACKAGE AFTER INSERTING STRILE TRANSFER DEVICE OR DISPENSE SET.

If dispensing cannot be performed promptly. DISCARD CONTENTS NO LATER THAN FOUR (4) HOURS AFTER INITIAL ENTRY. Use only if clear and seal is intact and undamaged.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

DO NOT FREEZE.

PROTECT FROM LIGHT.

Retain in carton until time of use.

Dosage: As directed by the Oncologist.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Fluorouracil Injection USP 50mg/ml (500mg/10ml, 1gm/20ml, 2.5gm/50ml, 5gm/100ml - VIAL), 50mg/ml (500mg/10ml, 250mg/5ml – AMPOULE)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Fluorouracil Injection 50mg/ml (500mg/10ml, 1gm/20ml, 2.5gm/50ml, 5gm/100ml - VIAL), 50mg/ml (500mg/10ml, 250mg/5ml – AMPOULE)
Each ml contains
Fluorouracil USP……………….50mg
Excipients…………………………q.s.
Water for Injection USP……q.s.
The PH of the solution has been adjusted to approximately 8.6 to 9.4 with sodium hydroxide.

THERAPEUTIC INDICATION:

Fluorouracil is a cytotoxic chemotherapy medication it is used for treatment of colorectal cancer, oesophageal cancer, stomach cancer, pancreatic cancer, breast cancer, and cervical cancer.

PACKING:

50mg/ml – VIAL
1) 500mg/10ml
2) 1gm/20ml
3) 2.5gm/50ml
4) 5gm/100ml

50mg/ml – Ampoule
1) 500mg/10ml
2) 250mg/5ml

DIRECTION OF USE:

For 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.
The product should be discarded if it appears brown or dark yellow in solution.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
Fluorouracil Injection, 50mg/ml should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents.
Children:
No recommendations are made regarding the use of fluorouracil in children.
Elderly:
Fluorouracil should be used in the elderly with similar considerations as in younger adults, notwithstanding that incidence of concomitant medical illness is higher in the former group.
If a precipitate forms due to exposure to low temperature, resolubilize in a water bath maintained at 60°C (140° F) with vigorous shaking. Allow to cool to body temperature before using.
This container closure is not made with natural rubber latex.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children
For 2.5gm/50ml, 5gm/100ml – BULK USE VIAL
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION

A single entry through the vial closure should be made with a sterile dispensing set or transfer device which will accept a syringe hub. Use of a syringe needle is not recommended. Withdraw contents into syringe through the set/ device. The above process should be carried out under a laminar flow hood using aseptic technique.
PROMPTLY DISPENSE CONTENTS OF THE PHARMACY BULK PACKAGE AFTER INSERTING STRILE TRANSFER DEVICE OR DISPENSE SET.
If dispensing cannot be performed promptly. DISCARD CONTENTS NO LATER THAN FOUR (4) HOURS AFTER INITIAL ENTRY. Use only if clear and seal is intact and undamaged.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
DONOT FREEZE.
PROTECT FROM LIGHT.
Retain in carton until time of use.
Dosage: As directed by the Oncologist.