GENERIC NAME OF THE MEDICINAL PRODUCT

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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 30ml Technical Specification:

Product Name:Deflazacort oral suspension
Brand Name:Deflort
Strength:30ml, 60ml
Dosage Form:Suspension
Packing:30, 60ml Bottle
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 IMMUNOSUPPRESSIVE ACTIVITY.DEFLAZACORT WORK BY STOPPING THE RELEASE OF CERTAIN CHEMICALS IN YOUR BODY WHICH CAUSE INFLAMMATION IT SUPPRESSES THE IMMUNE SYSTEM SO CAN BE USED TO TREAT AUTOIMMUNE DISORDER.

DOSAGE: As directed by the Physician.