Budesonide Nebuliser Suspension BP 0.5mg/2ml Technical Specification:

Product Name:Budesonide Nebuliser Suspension BP
Brand Name:Asthacort
Strength:0.5mg/2ml, 1mg/2ml
Dosage Form:Nebuliser / Respules for inhalation Only
**Preservative Free
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:Anti-asthmatic
Indication: Budesonide Nebuliser Suspension is used to prevent asthma attacks.
Storage:Store below 25°C. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  •  Budesonide Nebuliser Suspension BP 0.5mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Budesonide Nebuliser Suspension BP 0.5mg/2ml
    Each 2ml contains:
    Budesonide BP………….0.5mg

THERAPEUTIC INDICATIONS:

Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma.

Direction Of Use:

The product should be used with a nebuliser only, under the direction of a 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.

  1. Open the sealed aluminum foil envelope and remove one ampoule from the plastic strip. Record the space provided.
  2. Gently shake the ampoule using a circular motion. Before if use.
  3. Hold the ampoule upright without squeezing and open by twisting off the top.
  4. Place the open end of the ampoule into the nebulizer cup, and slowly squeeze out all of the contents. Discard the respules after use.

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.
shake well before use.

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

STORAGE & DOSAGE:

Storage: Store the respules in foil pouch at all times. Once the foil pouch is opened the respules should be used within one month.
Store below 25°C.
Protect from light.
Do not freeze.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Budesonide Nebuliser Suspension BP 0.5mg/2ml
B) Budesonide Nebuliser Suspension BP 1mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Budesonide Nebuliser Suspension BP 0.5mg/2ml
Each 2ml contains:
Budesonide BP………….0.5mg


B) Budesonide Nebuliser Suspension BP 1mg/2ml
Each 2ml contains:
Budesonide BP………….1mg

THERAPEUTIC INDICATIONS:

Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma.

Direction Of Use:

The product should be used with a nebuliser only, under the direction of a 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.
1. Open the sealed aluminum foil envelope and remove one ampoule from the plastic strip. Record the space provided.
2. Gently shake the ampoule using a circular motion. Before if use.
3. Hold the ampoule upright without squeezing and open by twisting off the top.
4. Place the open end of the ampoule into the nebulizer cup, and slowly squeeze out all of the contents. Discard the respules after use.

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.
SHAKE WELL BEFORE USE.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store the respules in foil pouch at all times. Once the foil pouch is opened the respules should be used within one month.
Store below 25°C.
Protect from light.
Do not freeze. Dosage: As directed by the Physician
Attach dispensing label as per end country.