GENERIC NAME OF THE MEDICINAL PRODUCT:

A)Budesonide Nebulizer Suspension 0.5mg/2ml
B) Budesonide Nebulizer Suspension 1mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Budesonide Nebulizer Suspension 0.5mg/2ml
Each 2ml respule contains
Badesonide IP …………….0.5mg
Water for Injection IP….q.s.
B) Budesonide Nebulizer Suspension 1mg/2ml
Each 2ml respule contains
Badesonide IP …………….1mg
Water for Injection IP….q.s.

THERAPEUTIC INDICATIONS:

BUDESONIDE (bue DES oh nide) prevents the symptoms of asthma. It works by decreasing inflammation of the airways, making it easier to breathe. It belongs to a group of medications called inhaled steroids. It is often called a controller medication.

CAUTION & SCHEDULE:

Even invisible damage to respule caused during storage or transit may result in contamination. Do not use, and return for replacement if the solution is discoloured, leak found on squeezing or contains visible black particles.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect From Light Do not freeze
.Store the respules in foil pouch at all times. Once the foil pouch is opened the respules should be used within one month.
Dosage: The product should be used with a respirator or nebuliser only, under the direction of physician. It is not to be injected or administered orally. Remove a pouch of combipack respule from the carton. Use a fresh respule for each dose.

Budesonide Nebulizer Suspension 1mg/2ml Technical Specification:

Product Name:Budesonide Nebulizer Suspension
Brand Name:Generic
Strength:0.5mg/2ml, 1mg/2ml
Dosage Form:Nebuliser / Respules for inhalation Only
Route of Administration:Via Inhalation Route Only
Packing:2ml Respules
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 (bue DES oh nide) prevents the symptoms of asthma. It works by decreasing inflammation of the airways, making it easier to breathe. It belongs to a group of medications called inhaled steroids. It is often called a controller medication.
Storage:Store below 30°C.Protect From Light Do not freeze.Store the respules in foil pouch at all times. Once the foil pouch is opened the respules should be used within one month.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Budesonide Nebulizer Suspension 0.5mg/2ml
  • Budesonide Nebulizer Suspension 1mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Budesonide Nebulizer Suspension 0.5mg/2ml <br>
    Each 2ml respule contains
    Badesonide IP …………….0.5mg
    Water for Injection IP….q.s.
  • Budesonide Nebulizer Suspension 1mg/2ml <br>
    Each 2ml respule contains
    Badesonide IP …………….1mg
    Water for Injection IP….q.s.

THERAPEUTIC INDICATIONS:

BUDESONIDE (bue DES oh nide) prevents the symptoms of asthma. It works by decreasing inflammation of the airways, making it easier to breathe. It belongs to a group of medications called inhaled steroids. It is often called a controller medication.

CAUTION & WARNING:

CAUTION:
Even invisible damage to respule caused during storage or transit may result in contamination.
Do not use, and return for replacement if the solution is discoloured, leak found on squeezing or contains visible black particles.
Read enclosed leaflet before use.
Keep medicine out of reach of children.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect From Light .
Do not freeze.
Store the respules in foil pouch at all times.
Once the foil pouch is opened the respules should be used within one month.
Dosage: The product should be used with a respirator or nebuliser only, under the direction of physician. It is not to be injected or administered orally. Remove a pouch of combipack respule from the carton.
Use a fresh respule for each dose.