GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Fluticasone Propionate Respirator Solution 0.5mg/2ml
B) Fluticasone Propionate Respirator Solution 2mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Fluticasone Propionate Respirator Solution 0.5mg/2ml
Each 2 ml respule contains:
Fluticasone Propionate IP ……………….0.5 mg
Water for Injections IP……………………. Q.s.
B) Fluticasone Propionate Respirator Solution 2mg/2ml

Each 2 ml respule contains:
Fluticasone Propionate IP ……………….2 mg
Water for Injections IP……………………. Q.s.

THERAPEUTIC INDICATIONS:

It is a medication primarily used to prevent and treat symptoms of asthma and chronic obstructive pulmonary diseases (COPD) such as shortness of breath or wheezing (whistling sound while 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

Fluticasone Propionate Respirator Solution 0.5mg/2ml Technical Specification:

Product Name:Fluticasone Propionate Respirator Solution
Brand Name:Generic
Strength:0.5mg/2ml, 2mg/2ml
Dosage Form:Nebuliser / Respules for inhalation Only
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:Corticosteroids
Indication: It is a medication primarily used to prevent and treat symptoms of asthma and chronic obstructive pulmonary diseases (COPD) such as shortness of breath or wheezing (whistling sound while breathing).
Storage:Stone below 30°C .Protect From Light .Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Fluticasone Propionate Respirator Solution 0.5mg/2ml
  • Fluticasone Propionate Respirator Solution 2mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Fluticasone Propionate Respirator Solution 0.5mg/2ml
    Each 2 ml respule contains:
    Fluticasone Propionate IP ……………….0.5 mg
    Water for Injections IP……………………. Q.s.
  • Fluticasone Propionate Respirator Solution 2mg/2ml
    Each 2 ml respule contains:
    Fluticasone Propionate IP ……………….2 mg
    Water for Injections IP……………………. Q.s.

THERAPEUTIC INDICATIONS:

It is a medication primarily used to prevent and treat symptoms of asthma and chronic obstructive pulmonary diseases (COPD) such as shortness of breath or wheezing (whistling sound while 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.