SYMBICORT RAPIHALER

Ülke: Endonezya

Dil: Endonezce

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

Aktif bileşen:

BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE

Mevcut itibaren:

ASTRAZENECA INDONESIA - Indonesia

INN (International Adı):

BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE

Doz:

160 Mcg /4.5 Mcg

Farmasötik formu:

SUSPENSI INHALASI

Paketteki üniteler:

DUS, 1 POUCH @ 1 RAPIHALER @ 120 DOSIS

Tarafından üretildi:

ASTRAZENECA DUNKERQUE - France

Yetkilendirme tarihi:

2020-08-06

Ürün özellikleri

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SYMBICORT
® RAPIHALER
160/4.5 MCG/DOSE
BUDESONIDE/FORMOTEROL FUMARATE DIHYDRATE
pressurised inhalation, suspension
COMPOSITION
Each single actuation (delivered dose, the amount of drug that leaves
the mouthpiece)
contains budesonide 160 micrograms and formoterol fumarate dihydrate
4.5 micrograms.
Formoterol fumarate dihydrate is hereafter referred to as
“formoterol.”
For excipients see section List of Excipients.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
THERAPEUTIC INDICATIONS
ASTHMA
Symbicort Rapihaler is indicated in the regular treatment of asthma
where use of a
combination (inhaled corticosteroid and long-acting β2 agonist) is
appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
"as needed" inhaled
short-acting beta2-agonists, or
-
patients already adequately controlled on both inhaled corticosteroids
and long-acting
beta2-agonists.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Symbicort Rapihaler is indicated for the symptomatic treatment of
patients with severe
COPD (FEV1
≤
50% predicted normal) and a history of repeated exacerbations, who
have
significant symptoms despite regular therapy with long-acting
bronchodilators.
POSOLOGY AND METHOD OF ADMINISTRATION
ASTHMA
Symbicort Rapihaler is not intended for the initial management of
asthma. The dosage of the
components of Symbicort Rapihaler is individual and should be adjusted
to the severity of
the disease. This should be considered not only when treatment with
combination product is
initiated but also when the maintenance dose is adjusted. If an
individual patient should
require a combination of doses other than those available in the
combination inhaler,
appropriate dose of beta2-agonists and/or corticosteroid by individual
inhalers should be
prescribed.
The dose should be titrated to the lowest dose at which effective
control of symptoms is
maintained. Patients should be regularly reassessed by their
prescriber/health care provider,
so that the dosage of SYMBICORT RAPIHALER remains optimal.