GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Glycopyrrate Inhalation Solution 25mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Glycopyrrate Inhalation Solution 25mcg
Each smartule contains:
Glycopyrrate IP
equivalent to glycopyrronium…….25mg
In isotonic solution………………………………Q.s.

THERAPEUTIC INDICATIONS:

Inhaled glycopyrrolate is used to treat air flow blockage and prevent worsening of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (difficulty with breathing).

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. SHAKE WELL BEFORE USE KEEP OUT OF REACH OF CHILDREN

Glycopyrrate Inhalation Solution 25mcg Technical Specification:

Product Name:Glycopyrrate Inhalation Solution
Brand Name:Generic
Strength:25mcg
Dosage Form:Nebuliser / Respules for inhalation Only
Route of Administration:Via Inhalation Route Only
Packing:1ml
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anticholinergics
Indication: Inhaled glycopyrrolate is used to treat air flow blockage and prevent worsening of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (difficulty with breathing).
Storage:Stone below 30°C .Protect From Light .Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Glycopyrrate Inhalation Solution 25mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Glycopyrrate Inhalation Solution 25mcg
    Each smartule contains:
    Glycopyrrate IP
    equivalent to glycopyrronium …….25mg
    In isotonic solution………………………………Q.s.

THERAPEUTIC INDICATIONS:

Inhaled glycopyrrolate is used to treat air flow blockage and prevent worsening of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (difficulty with breathing).

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. SHAKE WELL BEFORE USE KEEP OUT OF REACH OF CHILDREN.