GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Glycopyrrolate + Formoterol Fumarate + Budesonide Inhaler 9+4.8+160mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Glycopyrrolate + Formoterol Fumarate + Budesonide Inhaler 9+4.8+160mcg
Each actuation delivers
Glycopyrrolate IP………………………9mcg
Formoterol Fumarate…………………..4.8mcg
(As Formoterol Fumarate Dihydrate IP)
Budeoside IP…………………………..160mg
suspended in inert propellant …….q.s.

THERAPEUTIC INDICATIONS:

Budesonide, glycopyrrolate, and formoterol combination is used as long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine helps improve and reduce the number of flare-ups of the symptoms of COPD.

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 and do not freeze
Dosage: See package insert for dosage information.
As directed by Physician

Glycopyrrolate + Formoterol Fumarate + Budesonide Inhaler 9+4.8+160mcg Technical Specification:

Product Name:Glycopyrrolate + Formoterol Fumarate + Budesonide Inhaler
Brand Name:Generics
Strength:9+4.8+160mcg
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:Anticholinergics + Long-Acting β Agonists + Corticosteroids
Indication: Budesonide, glycopyrrolate, and formoterol combination is used as long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine helps improve and reduce the number of flare-ups of the symptoms of COPD.
Storage:Store below 30 degree Celsius. No Moisture and do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Glycopyrrolate + Formoterol Fumarate + Budesonide Inhaler 9+4.8+160mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Glycopyrrolate + Formoterol Fumarate + Budesonide Inhaler 9+4.8+160mcg
    Each actuation delivers <br>
    Glycopyrrolate IP………………………9mcg
    Formoterol Fumarate…………………..4.8mcg
    (As Formoterol Fumarate Dihydrate IP)
    Budeoside IP…………………………..160mg
    suspended in inert propellant …….q.s.

THERAPEUTIC INDICATION:

Budesonide, glycopyrrolate, and formoterol combination is used as long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine helps improve and reduce the number of flare-ups of the symptoms of COPD.

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 and do not freeze.
Dosage:See package insert for dosage information.
As directed by Physician.