GENERIC NAME OF THE MEDICINAL PRODUCT:

A)Ipratropium Nebuliser Solution 250mcg
B) Ipratropium Nebuliser Solution 500mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Ipratropium Nebuliser Solution 250mcg
Each 2 ml respule contains
Ipratropium Bromide IP
equivalent to Ipratropium Bromide (anhydrous).. 250 mcg
in isotonic Solution……………………………………………..q.s.
B) Ipratropium Nebuliser Solution 500mcg
Each 2 ml respule contains
Ipratropium Bromide IP
equivalent to Ipratropium Bromide (anhydrous).. 500 mcg
in isotonic Solution……………………………………………..q.s.

THERAPEUTIC INDICATIONS:

Ipratropium is used to control and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily.

CAUTION & SCHEDULE:

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 25°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.

Ipratropium Nebuliser Solution 500mcg Technical Specification:

Product Name:Ipratropium Nebuliser Solution
Brand Name:Generic
Strength:250mcg,500mcg
Dosage Form:Nebuliser / Respules for inhalation Only
Route of Administration:Via Inhalation Route Only
Packing:2ml, 2.5ml, 15ml
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
Indication: Ipratropium is used to control and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily.
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:

  • Ipratropium Nebuliser Solution 250mcg
  • Ipratropium Nebuliser Solution 500mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ipratropium Nebuliser Solution 250mcg
    Each 2 ml respule contains
    Ipratropium Bromide IP
    equivalent to Ipratropium Bromide (anhydrous).. 250 mcg
    in isotonic Solution……………………………………………..q.s.
  • Ipratropium Nebuliser Solution 500mcg <br>
    Each 2 ml respule contains
    Ipratropium Bromide IP
    equivalent to Ipratropium Bromide (anhydrous).. 500 mcg
    in isotonic Solution……………………………………………..q.s.

THERAPEUTIC INDICATIONS:

Ipratropium is used to control and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily.

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 25°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.