GENERIC NAME OF THE MEDICINAL PRODUCT:

a)Ciclesonide & Formoterol fumarate Inhaler 80+4.5mcg
b) Ciclesonide & Formoterol fumarate Inhaler 160+4.5mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Ciclesonide & Formoterol fumarate Inhaler 80+4.5mcg
Each actuation delivers
Ciclesonide IP………….80+4.5 mcg
Formaterol Fumarate
Dihydrate IP……………………………….6 mcg
Suspended in
propellant HFA 1340
B. Ciclesonide & Formoterol fumarate Inhaler 160+4.5mcg
Each actuation delivers
Ciclesonide IP………….160+4.5 mcg
Formaterol Fumarate
Dihydrate IP……………………………….6 mcg
Suspended in
propellant HFA 1340

THERAPEUTIC INDICATIONS:

Ciclesonide+Formoterol is used in the treatment of chronic obstructive pulmonary disease. Ciclesonide + Formoterol is a combination of two medicines: Ciclesonide and Formoterol. Ciclesonide is a steroid. It works by stopping the release of certain chemical messengers that cause inflammation (swelling) of the airways.

CAUTION & SCHEDULE:

CAUTION: Keep away from eyes. Keep away from children
Pressurised canister keep away from heat and light.
.do not puncture, break or burn. Do not exceed the recommended dose
SCHEDULE:Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store below 30 degree Celsius.
No Moisture
Dosage: See package insert for dosage information.
As directed by Physician

Ciclesonide & Formoterol fumarate Inhaler 160+4.5mcg Technical Specification:

Product Name:Ciclesonide & Formoterol fumarate Inhaler
Brand Name:Generics
Strength:80+4.5mcg, 160+4.5mcg
Dosage Form:Inhalers
Packing:120 Metered Dose
Route of Administration:Drugs administered by inhalation through the mouth.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:β-2 Adrenergic Receptor Agonist + Corticosteroids
Indication: Ciclesonide+Formoterol is used in the treatment of chronic obstructive pulmonary disease. Ciclesonide + Formoterol is a combination of two medicines: Ciclesonide and Formoterol. Ciclesonide is a steroid. It works by stopping the release of certain chemical messengers that cause inflammation (swelling) of the airways.
Storage:Store below 30 degree Celsius.No Moisture and do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ciclesonide & Formoterol fumarate Inhaler 80+4.5mcg
  • Ciclesonide & Formoterol fumarate Inhaler 160+4.5mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ciclesonide & Formoterol fumarate Inhaler 80+4.5mcg
    Each actuation delivers
    Ciclesonide IP………….80mcg
    Formaterol Fumarate
    Dihydrate IP……………………………….4.5mcg
    Suspended in
    propellant HFA 1340
  • Ciclesonide & Formoterol fumarate Inhaler 160+4.5mcg
    Each actuation delivers
    Ciclesonide IP………….160mcg
    Dihydrate IP……………………………….4.5 mcg
    Suspended in
    propellant HFA 1340

THERAPEUTIC INDICATION:

Ciclesonide+Formoterol is used in the treatment of chronic obstructive pulmonary disease. Ciclesonide + Formoterol is a combination of two medicines: Ciclesonide and Formoterol. Ciclesonide is a steroid. It works by stopping the release of certain chemical messengers that cause inflammation (swelling) of the airways.

CAUTION & SCHEDULE:

CAUTION:Keep away from eyes.
Keep away from children Pressurized
canister keep away from heat and light.
Do not puncture, break or burn. Do not exceed the recommended dose.
SCHEDULE:Not to be sold by retail without the prescription of registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:Store below 30 degree Celsius.
No Moisture.
Dosage:See package insert for dosage information.
As directed by Physician.