GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Levosalbutamol Hydrochloride + Budesonide Inhalation Suspension 1.25mg+0.5mg/2ml
B) Levosalbutamol Hydrochloride + Budesonide Inhalation Suspension 1.25mg+1mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Levosalbutamol Hydrochloride + Budesonide Inhalation Suspension 1.25mg+0.5mg/2ml
Each Composition:
Each 2ml contains:
Levosalbutamol Sulphate BP
Eq. to Levosalbutamol…………………….1.25mg
Budenoside……………………………………..0.5mg
In an isotonic solution………………………….Q.S.
B) B) Levosalbutamol Hydrochloride + Budesonide Inhalation Suspension 1.25mg+1mg/2ml
Each Composition:
Each 2ml contains:
Levosalbutamol Sulphate BP
Eq. to Levosalbutamol…………………….1.25mg
Budenoside……………………………………..1mg
In an isotonic solution………………………….Q.S.

THERAPEUTIC INDICATIONS:

Levosalbutamol + Budesonide is a combination of two medicines that makes breathing easier for patients with asthma and chronic obstructive pulmonary disease (COPD). This medicine is for inhalation only.

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.
FOR ORAL ADMINISTRATION.
SHAKE THE BOTTLE 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: 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.

Levosalbutamol Hydrochloride + Budesonide Inhalation Suspension 1.25mg+0.5mg/2ml Technical Specification:

Product Name:Levosalbutamol Hydrochloride + Budesonide Inhalation Suspension
Brand Name:Mucoshield
Strength:1.25mg+0.5mg/2ml, 1.25mg+1mg/2ml
Dosage Form:Nebuliser / Respules for inhalation Only
Route of Administration:Via Inhalation Route Only
Packing:2 ml 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:Bronchodilators + Adrenergic β Agonist
Indication: Levosalbutamol + Budesonide is a combination of two medicines that makes breathing easier for patients with asthma and chronic obstructive pulmonary disease (COPD). This medicine is for inhalation only.
Storage:Store below 25°C. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  •  Levosalbutamol Hydrochloride + Budesonide Inhalation Suspension 1.25mg+0.5mg/2ml
  •  Levosalbutamol Hydrochloride + Budesonide Inhalation Suspension 1.25mg+1mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Levosalbutamol Hydrochloride + Budesonide Inhalation Suspension 1.25mg+0.5mg/2ml
    Each Composition:
    Each 2ml contains:
    Levosalbutamol Sulphate BP
    Eq. to Levosalbutamol…………………….1.25mg
    Budenoside……………………………………..0.5mg
    In an isotonic solution………………………….Q.S.
  • Levosalbutamol Hydrochloride + Budesonide Inhalation Suspension 1.25mg+1mg/2ml
    Each Composition:
    Each 2ml contains:
    Levosalbutamol Sulphate BP
    Eq. to Levosalbutamol…………………….1.25mg
    Budenoside……………………………………..1mg
    In an isotonic solution………………………….Q.S.

THERAPEUTIC INDICATIONS:

Levosalbutamol + Budesonide is a combination of two medicines that makes breathing easier for patients with asthma and chronic obstructive pulmonary disease (COPD). This medicine is for inhalation only.

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.
For oral administration.shake the bottle 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: 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.