Bendamustine

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  • For more information, please download leaflet.

    • BENDANIT® (BENDAMUSTINE HCl) is an alkylating agent.
    • BENDANIT® for Injection (25 mg/vial or 100 mg/vial lyophilized powder) is intended for intravenous infusion only after reconstitution with Sterile Water for Injection and after further dilution with either 0.9% Sodium Chloride Injection, or 2.5% Dextrose/0.45% SodiumChloride Injection.
    • It is supplied as a sterile non-pyrogenic white to off-white lyophilized powder in a single-dose vial.
    • Each 25-mg vial contains 25 mg of BENDAMUSTINE HCl

    1 INDICATIONS AND USAGE

    1.1. Chronic Lymphocytic Leukemia (CLL)

    BENDAMUSTINE Hydrochloride (Bendanit®) is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.

    1.2. Non-Hodgkin Lymphoma (NHL)

    BENDAMUSTINE HCL indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

    2 DOSAGE FORMS AND STRENGTHS

    BENDANIT®, BENDAMUSTINE HCL for injection:

    25 mg or 100 mg white to white-off lyophilized powder in a single dose vial for reconstitution.

    3 CONTRAINDICATIONS

    BENDAMUSTINE HCL is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine.

    4 USE IN SPECIAL POPULATIONS

      4.1. Pregnancy:

      Pregnancy Risk Factor: D

      Pregnancy Implications: BENDAMUSTINEHCL can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while receiving BENDAMUSTINE HCL and for 3 months after therapy has stopped. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to a fetus. Advise men receiving BENDAMUSTINE HCL to use reliable contraception for the same time period.

      4.2. NURSING MOTHERS:

      Excretion in breast milk unknown/not recommended Breast-Feeding Considerations: Due to the potential for serious adverse reactions in the nursing infant, the decision to discontinue Bendamustine or discontinue breast-feeding should take into account the benefits of treatment to the mother.

  • For more information, please download leaflet.

    • BENDANIT® (BENDAMUSTINE HCl) is an alkylating agent.
    • BENDANIT® for Injection (25 mg/vial or 100 mg/vial lyophilized powder) is intended for intravenous infusion only after reconstitution with Sterile Water for Injection and after further dilution with either 0.9% Sodium Chloride Injection, or 2.5% Dextrose/0.45% SodiumChloride Injection.
    • It is supplied as a sterile non-pyrogenic white to off-white lyophilized powder in a single-dose vial.
    • Each 25-mg vial contains 25 mg of BENDAMUSTINE HCl

    1 INDICATIONS AND USAGE

    1.1. Chronic Lymphocytic Leukemia (CLL)

    BENDAMUSTINE Hydrochloride (Bendanit®) is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.

    1.2. Non-Hodgkin Lymphoma (NHL)

    BENDAMUSTINE HCL indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

    2 DOSAGE FORMS AND STRENGTHS

    BENDANIT®, BENDAMUSTINE HCL for injection:

    25 mg or 100 mg white to white-off lyophilized powder in a single dose vial for reconstitution.

    3 CONTRAINDICATIONS

    BENDAMUSTINE HCL is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine.

    4 USE IN SPECIAL POPULATIONS

      4.1. Pregnancy:

      Pregnancy Risk Factor: D

      Pregnancy Implications: BENDAMUSTINEHCL can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while receiving BENDAMUSTINE HCL and for 3 months after therapy has stopped. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to a fetus. Advise men receiving BENDAMUSTINE HCL to use reliable contraception for the same time period.

      4.2. NURSING MOTHERS:

      Excretion in breast milk unknown/not recommended Breast-Feeding Considerations: Due to the potential for serious adverse reactions in the nursing infant, the decision to discontinue Bendamustine or discontinue breast-feeding should take into account the benefits of treatment to the mother.

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