GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Formoterol Fumarate + Budesonide Respirator Suspension 20mg+0.5gm/2ml
B) Formoterol Fumarate + Budesonide Respirator Suspension 20mg+1gm/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Formoterol Fumarate + Budesonide Respirator Suspension 20mg+0.5gm/2ml
Each 2 ml respule contains:
Formoterol Fumarate Dihydrate IP
equivalent to formoterol Fumarate…….20mg
Budenoside IP……………………………………..0.5mg
in isotonic solution………………………………Q.s.
B) Formoterol Fumarate + Budesonide Respirator Suspension 20mg+1gm/2ml
Each 2 ml respule contains:
Formoterol Fumarate Dihydrate IP
equivalent to formoterol Fumarate…….20mg
Budenoside IP……………………………………..1mg
in isotonic solution………………………………Q.s.

THERAPEUTIC INDICATIONS:

Budesonide and formoterol combination is used to help control the symptoms of asthma and improve lung function. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day.

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

Formoterol Fumarate + Budesonide Respirator Suspension 20mg+0.5mg/2ml Technical Specification:

Product Name:Formoterol Fumarate + Budesonide Respirator Suspension
Brand Name:Generic
Strength:20mg+0.5mg/2ml, 20mg+1mg/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:Bronchodilators + Corticosteroids
Indication: Budesonide and formoterol combination is used to help control the symptoms of asthma and improve lung function. It is used when a patient’s asthma has not been controlled sufficiently on other asthma medicines, or when a patient’s condition is so severe that more than one medicine is needed every day
Storage:Stone below 30°C .Protect From Light .Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Formoterol Fumarate + Budesonide Respirator Suspension 20mg+0.5mg/2ml
  • Formoterol Fumarate + Budesonide Respirator Suspension 20mg+1mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Formoterol Fumarate + Budesonide Respirator Suspension 20mg+0.5mg/2ml
    Each 2 ml respule contains:
    Formoterol Fumarate Dihydrate IP
    equivalent to formoterol Fumarate…….20mg
    Budenoside IP……………………………………..0.5mg
    in isotonic solution………………………………Q.s.
  •  Formoterol Fumarate + Budesonide Respirator Suspension 20mg+1mg/2ml <br>
    Formoterol Fumarate Dihydrate IP
    equivalent to formoterol Fumarate…….20mg
    Budenoside IP……………………………………..1mg
    in isotonic solution………………………………Q.s.

THERAPEUTIC INDICATIONS:

Budesonide and formoterol combination is used to help control the symptoms of asthma and improve lung function. It is used when a patient’s asthma has not been controlled sufficiently on other asthma medicines, or when a patient’s condition is so severe that more than one medicine is needed every day.

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.