GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Levosalbutamol and Ipratropium bromide Respiratory Solution 0.63mg+500mcg/2.5ml
B) Levosalbutamol and Ipratropium bromide Respiratory Solution 1.25mg+500mcg/2.5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Levosalbutamol and Ipratropium bromide Respiratory Solution 0.63mg+500mcg/2.5ml
Each Composition:
Each 2.5ml contains:
Levosalbutamol Sulphate BP
Eq. to Levosalbutamol…………………….0.63mg
Ipratropium bromide BP
Eq. to Ipratropium (Anhydrous)………….500mcg
In an isotonic solution………………………….Q.S.
B) Levosalbutamol and Ipratropium bromide Respiratory Solution 1.25mg+500mcg/2.5mlEach Composition:
Each 2.5ml contains:
Levosalbutamol Sulphate BP
Eq. to Levosalbutamol…………………….1.25mg
Ipratropium bromide BP
Eq. to Ipratropium (Anhydrous)………….500mcg
In an isotonic solution………………………….Q.S.

THERAPEUTIC INDICATIONS:

Levosalbutamol + Ipratropium is a combination of two medicines that makes breathing easier for patients with chronic obstructive pulmonary disease (COPD).
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.
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: Adults & Children more than 12 years: One respule three times a day, every 6 to 8 hours.
Children under 12 years: There is no experience of the use of the Mucoshiled Respules in children under 12 years.
Attach dispensing label as per end country.

Levosalbutamol and Ipratropium bromide Respiratory Solution 1.25mg+500mcg Technical Specification:

Product Name:Levosalbutamol and Ipratropium bromide Respiratory Solution
Brand Name:Generic
Strength:0.63mg+500mcg, 1.25mg+500mcg
Dosage Form:Nebuliser / Respules for inhalation Only .Preservative Free
Route of Administration:Via Inhalation Route Only
Packing:2.5ml 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, Chronic obstructive pulmonary disease (COPD)
Indication: Levosalbutamol + Ipratropium is a combination of two medicines that makes breathing easier for patients with chronic obstructive pulmonary disease (COPD).
Storage:Store below 25°C. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Levosalbutamol and Ipratropium bromide Respiratory Solution 0.63mg+500mcg/2.5ml
  • Levosalbutamol and Ipratropium bromide Respiratory Solution 1.25mg+500mcg/2.5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Levosalbutamol and Ipratropium bromide Respiratory Solution 0.63mg+500mcg/2.5ml
    Each Composition:
    Each 2.5ml contains:
    Levosalbutamol Sulphate BP
    Eq. to Levosalbutamol…………………….0.63mg
    Ipratropium bromide BP
    Eq. to Ipratropium (Anhydrous)………….500mcg
    In an isotonic solution………………………….Q.S.
  • Levosalbutamol and Ipratropium bromide Respiratory Solution 1.25mg+500mcg/2.5mlEach
    Composition:
    Each 2.5ml contains:
    Levosalbutamol Sulphate BP
    Eq. to Levosalbutamol…………………….1.25mg
    Ipratropium bromide BP
    Eq. to Ipratropium (Anhydrous)………….500mcg
    In an isotonic solution………………………….Q.S.

THERAPEUTIC INDICATIONS:

Levosalbutamol + Ipratropium is a combination of two medicines that makes breathing easier for patients with chronic obstructive pulmonary disease (COPD).
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.

  • Open the sealed aluminum foil envelope and remove one ampoule from the plastic strip. Record the space provided.
  • Gently shake the ampoule using a circular motion. Before if use.
  • Hold the ampoule upright without squeezing and open by twisting off the top.
  • 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.
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: Adults & Children more than 12 years: One respule three times a day, every 6 to 8 hours.
Children under 12 years: There is no experience of the use of the Mucoshiled Respules in children under 12 years.