Temozolomide Capsules 5mg
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Temozolomide Capsules 5mg Technical Specification:

Product Name:Temozolomide Capsules 5mg
Brand Name:Temozolomide
Strength:5mg, 20mg, 100mg, 140mg, 180mg, 250mg
Dosage Form:Hard-Gelatin Capsules
Packing:5s, 14s
Route of Administration:For Oral 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: Temozolomide is used to treat specific types of brain cancer (eg – glioblastoma multiforme, anaplastic astrocytoma) in patients whose tumors have returned or whose tumors have just been diagnosed.
Storage:Store at 20°C to 25°C (68° to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Temozolomide Capsules 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Temozolomide Capsules 5mg
    Each hard-gelatin capsule contains:
    Temozolomide……………….5mg
    Excipients……………………………..q.s.
    Colours: Approved colours used in capsule shell.

THERAPEUTIC INDICATIONS:

Temozolomide is used to treat specific types of brain cancer (eg – glioblastoma multiforme, anaplastic astrocytoma) in patients whose tumors have returned or whose tumors have just been diagnosed.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.

Caution: Cytotoxic: Do not open the capsules. Swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

Caution: Cytotoxic Agent – Special Handling.

Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals/ Institutions and against prescription from a Cancer Specialist.

Attention Pharmacist: Special dispensing information included. Please review carefully.

Keep out of reach and sight of children.

STORAGE & DOSAGE:

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

Dispense in tight container, light-resistant containers as defined in the USP.

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Temozolomide Capsules 5mg
b) Temozolomide Capsules 20mg
c) Temozolomide Capsules 100mg
d) Temozolomide Capsules 140mg
e) Temozolomide Capsules 180mg
f) Temozolomide Capsules 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Temozolomide Capsules 5mg
Each hard-gelatin capsule contains:
Temozolomide ……………….5mg
Excipients……………………………..q.s.
Colours: Approved colours used in capsule shell.

b) Temozolomide Capsules USP 20mg
Each hard-gelatin capsule contains:
Temozolomide………………20mg
Excipients…………………………….q.s.
Colours: Approved colours used in capsule shell.

c) Temozolomide Capsules 100mg
Each hard-gelatin capsule contains:
Temozolomide……………100mg
Excipients…………………………..q.s.
Colours: Approved colours used in capsule shell.

d) Temozolomide Capsules 140mg
Each hard-gelatin capsule contains:
Temozolomide……………140mg
Excipients…………………………..q.s.
Colours: Approved colours used in capsule shell.

e) Temozolomide Capsules 180mg
Each hard-gelatin capsule contains:
Temozolomide…………….180mg
Excipients……………………………q.s.
Colours: Approved colours used in capsule shell.

f) Temozolomide Capsules 250mg
Each hard-gelatin capsule contains:
Temozolomide……………250mg
Excipients………………………….q.s.
Colours: Approved colours used in capsule shell.

THERAPEUTIC INDICATIONS:

Temozolomide is used to treat specific types of brain cancer (eg - glioblastoma multiforme, anaplastic astrocytoma) in patients whose tumors have returned or whose tumors have just been diagnosed.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Caution: Cytotoxic: Do not open the capsules. Swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.
Caution: Cytotoxic Agent – Special Handling.
Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals/ Institutions and against prescription from a Cancer Specialist.
Attention Pharmacist: Special dispensing information included. Please review carefully.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Dispense in tight container, light-resistant containers as defined in the USP.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.