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.

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.

Why Taj Pharmaceuticals?

“Experience excellence in cancer care with Taj Pharma’s Fluorouracil Injection USP. We are your dedicated partner in the fight against cancer, offering top-notch quality and affordability in every vial. At Taj Pharma, we prioritize your health and strive to make cancer treatment accessible to all. Our commitment to quality assurance means that every Fluorouracil Injection USP meets rigorous standards, ensuring its effectiveness and safety. With a global presence, Taj Pharma ensures that patients worldwide have access to this essential medication. Whether you require it at your local healthcare facility or in distant corners of the world, Taj Pharma is here to support your healthcare journey. Choose Taj Pharma for Fluorouracil Injection USP – where trust meets affordability, and your health is our unwavering commitment.”

What is Fluorouracil Injection USP and its use?

Fluorouracil Injection USP (United States Pharmacopeia) contains the active ingredient fluorouracil, which is a chemotherapy medication used in the treatment of various types of cancer. Here’s an overview of Fluorouracil Injection USP and its common uses:

Active Ingredient: Fluorouracil is the active ingredient in Fluorouracil Injection USP.

Uses:

Fluorouracil is utilized in the treatment of several types of cancer, including:

  • Colorectal Cancer: Fluorouracil is often used as part of combination chemotherapy regimens for the treatment of colorectal cancer. It can help slow down the growth and spread of cancer cells in the colon and rectum.
  • Breast Cancer: Fluorouracil may be employed in combination with other chemotherapy drugs for the treatment of breast cancer, particularly in certain stages or types of breast cancer.
  • Gastrointestinal Cancers: It is sometimes used to treat other gastrointestinal cancers, such as stomach cancer and pancreatic cancer.
  • Head and Neck Cancers: Fluorouracil may be used as part of a treatment plan for head and neck cancers, including oral and throat cancers.
  • Skin Cancers: In some cases, Fluorouracil can be applied topically as a cream or solution to treat certain types of skin cancers, including basal cell carcinoma and actinic keratosis.

How does Fluorouracil Injection USP work?

Fluorouracil Injection USP (United States Pharmacopeia) works by interfering with the DNA and RNA synthesis processes in cancer cells. It is classified as an antimetabolite, a type of chemotherapy drug that mimics the structure of naturally occurring molecules necessary for DNA and RNA production. Here’s how Fluorouracil Injection USP works:

  • Disruption of DNA and RNA Synthesis: In order to grow and divide, cancer cells require the synthesis of DNA and RNA, which are essential for the replication of genetic material and protein production. Fluorouracil closely resembles the building blocks (nucleotides) used in these processes.
  • Incorporation into Nucleic Acids: Fluorouracil is incorporated into the growing DNA and RNA chains in place of the normal nucleotides. Once incorporated, it disrupts the proper structure and function of these molecules.
  • Inhibition of Enzymes: Fluorouracil interferes with the activity of enzymes involved in DNA and RNA synthesis, particularly thymidylate synthase. Thymidylate synthase is necessary for the production of thymidine, a crucial building block for DNA.
  • Cell Cycle Arrest: By disrupting DNA and RNA synthesis, Fluorouracil prevents cancer cells from progressing through the cell cycle. This leads to cell cycle arrest, meaning that cancer cells are unable to replicate and divide.
  • Apoptosis Induction: As a result of halted cell division and impaired DNA function, cancer cells may undergo apoptosis, which is programmed cell death. This is a key mechanism by which Fluorouracil targets and reduces the population of cancer cells.

Overall, Fluorouracil’s interference with DNA and RNA synthesis effectively inhibits the growth and proliferation of cancer cells. Since cancer cells often divide more rapidly than normal cells, they are particularly vulnerable to the disruption of these processes.

Benefits:

  • Effective Cancer Treatment: Fluorouracil is an effective chemotherapy drug used to treat several types of cancer, including colorectal cancer, breast cancer, gastrointestinal cancers, and head and neck cancers.
  • Cell Growth Inhibition: Fluorouracil interferes with the synthesis of DNA and RNA in cancer cells, disrupting their ability to replicate and divide. This can slow down or stop the growth and spread of cancer cells.
  • Potential for Tumor Shrinkage: In some cases, Fluorouracil may lead to tumour shrinkage, providing relief from symptoms and improving the patient’s quality of life.
  • Combination Therapy: Fluorouracil is often used in combination with other chemotherapy drugs to enhance its effectiveness in treating cancer, allowing for more comprehensive treatment plans.

Side Effects:

  • Gastrointestinal Issues: Nausea, vomiting, diarrhea, and mouth sores are common gastrointestinal side effects of Fluorouracil. Anti-nausea medications and supportive care can help manage these symptoms.
  • Bone Marrow Suppression: Fluorouracil can reduce the production of blood cells in the bone marrow, leading to conditions such as anemia (low red blood cells), neutropenia (low white blood cells), and thrombocytopenia (low platelets). This can increase the risk of infections, fatigue, and bleeding.
  • Hand-Foot Syndrome: Some individuals may develop hand-foot syndrome, characterized by redness, swelling, pain, and peeling of the skin on the palms of the hands and soles of the feet.
  • Skin Changes: Fluorouracil can cause skin sensitivity, rashes, and increased sun sensitivity. Proper skincare and sun protection are important during treatment.
  • Fatigue: Many patients experience fatigue and weakness during treatment, which can affect daily activities.
  • Hair Loss: Hair thinning or hair loss can occur with Fluorouracil treatment, although it is usually reversible once treatment is completed.
  • Neurological Symptoms: Rarely, Fluorouracil can lead to neurological symptoms, including confusion, depression, and coordination problems. These should be reported to a healthcare provider immediately.
  • Injection Site Reactions: Pain, redness, and inflammation at the injection site are possible when Fluorouracil is administered intravenously.

Frequently asked questions about Fluorouracil Injection USP

  • What is Fluorouracil Injection USP used for?

Fluorouracil Injection USP is primarily used in the treatment of various cancers, including colorectal cancer, breast cancer, gastrointestinal cancers, and head and neck cancers.

  • How does Fluorouracil Injection USP work in treating cancer?

Fluorouracil interferes with the synthesis of DNA and RNA in cancer cells, disrupting their ability to replicate and divide, ultimately inhibiting cancer cell growth.

  • Is Fluorouracil Injection USP a cure for cancer?

Fluorouracil can be effective in treating cancer and may lead to tumour shrinkage, but its curative potential depends on factors such as the type and stage of cancer and the overall health of the patient.

  • How is Fluorouracil Injection USP administered?

Fluorouracil Injection USP is typically administered intravenously (IV) by a healthcare provider in a clinical setting.

  • What are the common side effects of Fluorouracil Injection USP?

Common side effects include gastrointestinal issues (nausea, vomiting, diarrhea), bone marrow suppression (anaemia, neutropenia, thrombocytopenia), handfoot syndrome, skin changes, fatigue, hair loss, and injection site reactions.

  • How can the side effects of Fluorouracil Injection USP be managed?

Management strategies for side effects may include the use of antinausea medications, supportive care for gastrointestinal symptoms, proper skincare, sun protection, and blood cell count monitoring.

  • Is Fluorouracil Injection USP safe during pregnancy or breastfeeding?

Fluorouracil is generally not recommended during pregnancy or breastfeeding due to potential harm to the fetus or infant. Consult with a healthcare provider for guidance.

  • Can I continue working or driving during Fluorouracil treatment?

Fatigue and potential side effects may affect your ability to work or drive. It’s important to discuss any limitations with your healthcare provider and make necessary adjustments to daily activities.

  • How long does Fluorouracil treatment typically last?

The duration of Fluorouracil treatment varies depending on the type and stage of cancer, as well as the individual patient’s response to therapy. Treatment may consist of cycles over several weeks or months.

  • Are there any drug interactions with Fluorouracil Injection USP?

It’s important to inform your healthcare provider about all medications, supplements, and herbal products you are taking, as some drugs may interact with Fluorouracil.

Patients should always consult their healthcare provider or oncologist for personalized information and guidance regarding Fluorouracil Injection USP and its use in their specific situations.

As Fluorouracil Injection USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Fluorouracil Injection USP product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Fluorouracil Injection USP Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Fluorouracil Injection USP, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274