PULMICORT RESPULES

Country: Ինդոնեզիա

language: ինդոնեզերեն

source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

active_ingredient:

BUDESONIDE

MAH:

ASTRAZENECA INDONESIA - Indonesia

INN:

BUDESONIDE

dosage:

0.25 MG

pharmaceutical_form:

CAIRAN INHALASI

units_in_package:

DUS, 4 PAK @ 5 RESPULES @ 2 ML

manufactured_by:

ASTRAZENECA AB - Sweden

authorization_date:

2021-01-27

SPC

Pulmicort

Product Information (budesonide for inhalation), sterile
1 (15)
PULMICORT


(budesonide for oral inhalation)
Sterile
PRODUCT INFORMATION
QUALITATIVE & QUANTITATIVE COMPOSITION
One single dose unit contains 0.5 mg or 1.0 mg budesonide per 2 mL.
For excipients, see section LIST OF EXCIPIENTS.
PHARMACEUTICAL FORM
Sterile nebuliser suspension. White to off-white suspension in plastic
single dose units.
NAME OF THE DRUG
The active ingredient, budesonide, is a non-halogenated glucocorticoid
structurally related to
16α hydroxyprednisolone. The chemical name is 16α, 17α - 22R,
S-propylmethylenedioxy-pregna-1, 4-diene-11β, 21-diol-3, 20-dione; MW
430.5.
CAS Number: 51333-22-3
DESCRIPTION
Budesonide is a white to off-white powder, freely soluble in
chloroform, sparingly soluble in
ethanol and practically insoluble in water and heptane. Budesonide
melts with
decomposition between 224°C and 231.5°C.
PULMICORT RESPULES nebulising suspension for inhalation is a white to
off-white
suspension in plastic single dose units. PULMICORT RESPULES contain
budesonide 0.5
mg/2 mL or 1.0 mg/2 mL as the active ingredient plus, disodium
edetate, sodium chloride,
polysorbate 80 (E433) citric acid
–
anhydrous (E330), sodium citrate (E331) and water for
injections.
PHARMACOLOGY
Pharmacotherapeutic group: Inhalation drugs for obstructive airway
diseases.
ATC-code R03B A02
PULMICORT is a corticosteroid for inhalation use in the treatment and
prophylaxis of
asthma.
Studies in animals and humans have shown an advantageous ratio between
topical
anti-inflammatory activity and systemic glucocorticoid effect over a
wide dose range. This is
explained by the extensive first pass hepatic degradation of
budesonide after systemic
DISETUJUI OLEH BPOM: 21/11/2022
ID: EREG10042212000107
EREG10042212000108
Pulmicort

Product Information (budesonide for inhalation), sterile
2 (15)
absorption, approximately 85
–
90%, in combination with the low potency of formed
metabolites.
Budesonide is approximately twice as potent as beclomet