GENERIC NAME OF THE MEDICINAL PRODUCT

A. Deflazacort oral suspension 60ml
B. Deflazacort oral suspension 30ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Deflazacort oral suspension 30ml
Composition:
Each 5ml of Suspension contains:
Deflazacort …………………6mg
Excipients……………………...q.s.
Flavored Syrup Base
Colour: Quinoline Yellow

B. Deflazacort oral suspension 60ml
 Composition:
Each 5ml of Suspension contains:
Deflazacort …………………12mg
Excipients……………………...q.s.
Flavored Syrup Base
Colour: Quinoline Red

THERAPEUTIC INDICATIONS:

Deflazacort is used to treat Duchenne muscular dystrophy (DMD). DMD is a rare, inherited muscle disease that occurs usually in children and young adults and is caused by an absence of a protein called dystrophin, which helps keep muscle cells intact. Deflazacort is corticosteroid (cortisone-like medicine or steroid).

Direction OF USE:

Shake well before use.

CAUTION & WARNING:

CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FOR PAEDIATRIC USE ONLY.
SHAKE WELL BEFORE USE.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

STORAGE: Store in a dry place at a temperature below 30°C.
Keep in the box until just before use. Store below 30°C & Protect from freezing.
DEFLAZACORT IS A SYNTHETIC GLUCOCORTICOID. IT IS AN OXAZOLINE DERIVATIVE OF PREDNISOLONE WITH ANTI-INFLAMATORY AND IMMUNOSUPRESSIVE ACTIVITY.
DOSAGE: As directed by the physician.

Deflazacort oral suspension 60ml Technical Specification:

Product Name:Deflazacort oral suspension
Brand Name:Deflort
Strength:30ml, 60ml
Dosage Form:Suspension
Packing:30, 60ml
Route of Administration:For Oral Suspension.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antibiotic, Corticosteroids
Indication: Deflazacort is used to treat Duchenne muscular dystrophy (DMD). DMD is a rare, inherited muscle disease that occurs usually in children and young adults and is caused by an absence of a protein called dystrophin, which helps keep muscle cells intac.
Storage:Store in a dry place at a temperature below 30°C.

GENERIC NAME OF MEDICINAL PRODUCT:

  1. Deflazacort oral suspension 60ml
  2. Deflazacort oral suspension 30ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Deflazacort oral suspension 60ml
  • Composition:

Each 5ml of Suspension contains:
Deflazacort …………………12mg
Excipients………………………q.s.
Flavored Syrup Base
Colour: Quinoline Yellow

  1. Deflazacort oral suspension 30ml
  • Composition:

Each 5ml of Suspension contains:
Deflazacort …………………6mg
Excipients………………………q.s.
Flavored Syrup Base
Colour: Quinoline Red

THERAPEUTIC INDICATION:

Deflazacort is used to treat Duchenne muscular dystrophy (DMD). DMD is a rare, inherited muscle disease that occurs usually in children and young adults and is caused by an absence of a protein called dystrophin, which helps keep muscle cells intact. Deflazacort is corticosteroid (cortisone-like medicine or steroid).

DIRECTION OF USE:

Shake well before use.

CAUTION & WARNING:

CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

FOR PEDIATRIC USE ONLY.

SHAKE WELL BEFORE USE.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

STORAGE: Store in a dry place at a temperature below 30°C.

Keep in the box until just before use. Store below 30°C & Protect from freezing.

DEFLAZACORT IS A SYNTHETIC GLUCOCORTICOID. IT IS AN OXAZOLINE DERIVATIVE OF PREDNISOLONE WITH ANTI-INFLAMATORY AND IMMUNOSUPRESSIVE ACTIVITY.

DOSAGE: As directed by the Physician.