GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Budesonide inhalation powder 100mcg
B. Budesonide inhalation powder 200mcg
C. Budesonide inhalation powder 400mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Budesonide inhalation powder 100mcg
Composition:
Each actuation delivers:
Budesonide BP ………….100mcg
Suspended in
Propellant HFA 134a…... q.s.

B. Budesonide inhalation powder 200mcg
Composition:
Each actuation delivers:
Budesonide BP ………….200mcg
Suspended in
Propellant HFA 134a…... q.s.


C. Budesonide inhalation powder 400mcg
Composition:
Each actuation delivers:
Budesonide BP ………….400mcg
Suspended in
Propellant HFA 134a…... q.s.

THERAPEUTIC INDICATIONS:

Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Budesonide powder for oral inhalation (Pulmicort Flex haler) is used in adults and children 6 years of age and older.

DIRECTION OF USE:

For oral inhalation.

CAUTION & WARNING:

CAUTION: Do not use after the date shown on the body of your inhaler.
Replace cover properly after use.
CFC free
Read enclosed leaflet before use.
WARNING: Pressurised canister keep away from sunlight and heat. Do not puncture, break or burn even when apparently empty.
WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store below 25°.
Protect from heat & moisture.
Do not freeze.
Dosage: As directed by the Physician.

Budesonide inhalation powder 200mcg Technical Specification:

Product Name:Budesonide inhalation powder 200mcg
Brand Name:Asthacort
Strength:100mcg, 200mcg, 400mcg
Dosage Form:Inhalar
Route of Administration:For oral inhalation
Packing:60 metered doses, 120 metered doses
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Corticosteroids
Indication: Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Budesonide powder for oral inhalation (Pulmicort Flex haler) is used in adults and children 6 years of age and older.
Storage:Store below 25°. Protect from heat & moisture. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Budesonide inhalation powder 200mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Budesonide inhalation powder 200mcg
    Composition:
    Each actuation delivers:
    Budesonide BP ………….200mcg
    Suspended in
    Propellant HFA 134a…… q.s.

THERAPEUTIC INDICATIONS:

Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Budesonide powder for oral inhalation (Pulmicort Flex haler) is used in adults and children 6 years of age and older.

DIRECTION OF USE:

For oral inhalation.

CAUTION & WARNING:

CAUTION: Do not use after the date shown on the body of your inhaler.

Replace cover properly after use.

CFC free

Read enclosed leaflet before use.

WARNING:  Pressurised canister keep away from sunlight and heat. Do not puncture, break or burn even when apparently empty.

Warning: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

Keep medicine out of reach of children.  

STORAGE & DOSAGE:

Storage: Store below 25°. Protect from heat & moisture. Do not freeze.

Dosage:  As directed by the Physician.