GENERIC NAME OF THE MEDICINAL PRODUCT:

A Budesonide inhaler 100mcg
B Budesonide inhaler 200mcg

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.

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 & SCHEDULE:

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 inhaler 100mcg Technical Specification:

Product Name:Budesonide inhaler 100mcg
Brand Name:Asthacort
Strength:100mcg, 200mcg
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,Stability Studies, GMP
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 inhaler 100mcg
  • Budesonide inhaler 200mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

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.