GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Brivaracetam Tablets 25mg
B) Brivaracetam Tablets 50mg
C) Brivaracetam Tablets 75mg
D) Brivaracetam Tablets 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Brivaracetam Tablets 25mg
Each film-coated tablet contains:
Brivaracetam……………….25mg
Excipients…………………….q.s.
Colours: Carmoisine
B) Brivaracetam Tablets 50mg
Each film-coated tablet contains:
Brivaracetam………………..50mg
Excipients……………………..q.s.
Colours: Ferric Oxide Yellow USP-NF.
C) Brivaracetam Tablets 75mg
Each film-coated tablet contains:
Brivaracetam……………….75mg
Excipients…………………….q.s.
Colours: Ferric Oxide Red USP-NF.
D) Brivaracetam Tablets 100mg
Each film-coated tablet contains:
Brivaracetam………………..100mg
Excipients……………………...q.s.
Colours: Titanium Dioxide

THERAPEUTIC INDICATIONS:

Brivaracetam is used alone and in combination with other medications to control partial onset seizures (seizures that involve only one part of the brain) in adults, children, and infants 1 month of age and older. Brivaracetam is in a class of medications called anticonvulsants.

CAUTION & SCHEDULE:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.

Brivaracetam Tablets 50mg Technical Specification:

Product Name:Brivaracetam Tablets
Brand Name:Generic
Strength:25mg, 50mg, 75mg, 100mg
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, Stability Studies, GMP
Therapeutic use:Anticonvulsant, Anti-epileptic
Indication: Brivaracetam is an anti-epileptic drug, also called an anticonvulsant.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Brivaracetam Tablets 25mg
  • Brivaracetam Tablets 50mg
  • Brivaracetam Tablets 75mg
  • Brivaracetam Tablets 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Brivaracetam Tablets 25mg
    Each film-coated tablet contains:
    Brivaracetam……………….25mg
    Excipients…………………….q.s.
    Colours: Carmoisine
  • Brivaracetam Tablets 50mg
    Each film-coated tablet contains:
    Brivaracetam………………..50mg
    Excipients……………………..q.s.
    Colours: Ferric Oxide Yellow USP-NF.
  • Brivaracetam Tablets 75mg
    Each film-coated tablet contains:
    Brivaracetam……………….75mg
    Excipients…………………….q.s.
    Colours: Ferric Oxide Red USP-NF.
  • Brivaracetam Tablets 100mg
    Each film-coated tablet contains:
    Brivaracetam………………..100mg
    Excipients………………………q.s.
    Colours: Titanium Dioxide

THERAPEUTIC INDICATIONS:

Brivaracetam is used alone and in combination with other medications to control partial onset seizures (seizures that involve only one part of the brain) in adults, children, and infants 1 month of age and older. Brivaracetam is in a class of medications called anticonvulsants.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.