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Hydroxycarbamide (Hydroxyurea) Tablets 1000mg Hydroxycarbamide (Hydroxyurea) Tablets 1000mg [THAROLAX] Hydroxycarbamide (Hydroxyurea) Tablets 1000mg [THAROLAX] Hydroxycarbamide (Hydroxyurea) Tablets 1000mg [THAROLAX] Hydroxycarbamide (Hydroxyurea) Tablets 1000mg [THAROLAX] Hydroxycarbamide (Hydroxyurea) Tablets 1000mg [THAROLAX] Hydroxycarbamide (Hydroxyurea) Tablets 1000mg [THAROLAX] Hydroxycarbamide (Hydroxyurea) Tablets 1000mg [THAROLAX] Hydroxycarbamide (Hydroxyurea) Tablets 1000mg [THAROLAX] Hydroxycarbamide (Hydroxyurea) Tablets 1000mg [THAROLAX] Hydroxycarbamide (Hydroxyurea) Tablets 1000mg [THAROLAX]

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Hydroxycarbamide (Hydroxyurea) Tablets 100mg [THAROLAX]
B) Hydroxycarbamide (Hydroxyurea) Tablets 500mg [THAROLAX]
C) Hydroxycarbamide (Hydroxyurea) Tablets 1000mg [THAROLAX]

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Hydroxycarbamide (Hydroxyurea) Tablets 100mg
Each film-coated tablet contains:
Hydroxyurea USP
Hydroxycarbamide………….100mg
Excipients…………………….….q.s.
Colour: Titanium Dioxide USP

B) Hydroxycarbamide (Hydroxyurea) Tablets 500mg
Each film-coated tablet contains:
Hydroxyurea USP
Hydroxycarbamide………….500mg
Excipients…………………….….q.s.
Colour: Titanium Dioxide USP

C) Hydroxycarbamide (Hydroxyurea) Tablets 1000mg
Each film-coated tablet contains:
Hydroxyurea USP
Hydroxycarbamide………….1000mg
Excipients…………………….….q.s.
Colour: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Hydroxyurea Tablets is used to treat cancer of the white blood cells called chronic myeloid leukemia (CML). It may also be given together with radiation treatment for head and neck cancer (advanced squamous cell cancer). Hydroxyurea interferes with the growth of cancer cells, which are eventually destroyed by the body. This medication is also used for sickle cell anaemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions in adults and children, 2 years of age and older.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: Cytotoxic Agent: To be supplied on demand from Cancer Hospitals, Institutions & on prescription of an Oncologist only
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Broken tablets must be stored in a bottle and must be used within three months.
Dosage: As directed by the Physician.
Take tablets 1 time a day at the same time each day.
Attach dispensing label as per end country.

Hydroxycarbamide (Hydroxyurea) Tablets 1000mg Technical Specification:

Product Name:Hydroxycarbamide (Hydroxyurea) Tablets
Brand Name:THAROLAX
Strength:100mg, 500mg, 1000mg
Dosage Form:Tablets (film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
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-anaemic, Sickle cell anaemia
Indication: Hydroxyurea Tablets is used to treat cancer of the white blood cells called chronic myeloid leukemia (CML). It may also be given together with radiation treatment for head and neck cancer (advanced squamous cell cancer). Hydroxyurea interferes with the growth of cancer cells, which are eventually destroyed by the body. This medication is also used for sickle cell anaemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions in adults and children, 2 years of age and older.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Hydroxycarbamide (Hydroxyurea) Tablets 100mg
  • Hydroxycarbamide (Hydroxyurea) Tablets 500mg
  • Hydroxycarbamide (Hydroxyurea) Tablets 1000mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Hydroxycarbamide (Hydroxyurea) Tablets 100mg
    Each film-coated tablet contains:
    Hydroxyurea USP
    Hydroxycarbamide………….100mg
    Excipients…………………….….q.s.
    Colour: Titanium Dioxide USP
  • Hydroxycarbamide (Hydroxyurea) Tablets 500mg
    Each film-coated tablet contains:
    Hydroxyurea USP
    Hydroxycarbamide………….500mg
    Excipients…………………….….q.s.
    Colour: Titanium Dioxide USP
  • Hydroxycarbamide (Hydroxyurea) Tablets 1000mg
    Each film-coated tablet contains:
    Hydroxyurea USP
    Hydroxycarbamide………….1000mg
    Excipients…………………….….q.s.
    Colour: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Hydroxyurea Tablets is used to treat cancer of the white blood cells called chronic myeloid leukemia (CML). It may also be given together with radiation treatment for head and neck cancer (advanced squamous cell cancer). Hydroxyurea interferes with the growth of cancer cells, which are eventually destroyed by the body. This medication is also used for sickle cell anaemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions in adults and children, 2 years of age and older.

CAUTION & WARNING:

CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.

WARNING: Cytotoxic Agent: To be supplied on demand from Cancer Hospitals, Institutions & on prescription of an Oncologist only.

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

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Broken tablets must be stored in a bottle and must be used within three months.
Dosage: As directed by the Physician.
Take tablets 1 time a day at the same time each day.
Attach dispensing label as per end country.