SYMBICORT

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

BUDESONIDE; FORMOTEROL FUMARATE

Tersedia dari:

ASTRAZENECA INDONESIA - Indonesia

INN (Nama Internasional):

BUDESONIDE; FORMOTEROL FUMARATE

Dosis:

160/4.5/DOSIS

Bentuk farmasi:

SERBUK INHALER

Unit dalam paket:

DUS,1 TURBUHALER @ 60 DOSIS

Diproduksi oleh:

ASTRAZENECA Pharmaceuticals - Sweden

Tanggal Otorisasi:

2017-01-31

Karakteristik produk

SYMBICORT
® TURBUHALER
® 160/4.5 MCG/DOSE
_budesonide/formoterol _
Inhalation Powder
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains
budesonide 160
micrograms/inhalation and formoterol fumarate dihydrate 4.5
micrograms/inhalation.
SYMBICORT Turbuhaler 160/4.5 micrograms/inhalation delivers the same
amount of
budesonide and formoterol as the corresponding Turbuhaler
monoproducts, i.e. budesonide
200 micrograms/inhalation (metered dose) and formoterol 6
micrograms/inhalation (metered
dose) alternatively labelled as 4.5 micrograms/inhalation (delivered
dose).
Excipient: Lactose monohydrate 730 micrograms per dose.
PHARMACEUTICAL FORM
Inhalation powder. White powder
THERAPEUTIC INDICATION
ASTHMA
Symbicort is indicated in adults and adolescents (aged 12 years and
older) for the treatment
of asthma to relieve symptoms and the reduction of the risk of
exacerbations, where the use
of inhaled corticosteroids is appropriate.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
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 is not intended for the initial management of asthma. The
dosage of the
components of SYMBICORT is individual and should be adjusted to
severity of the disease.
This should be considered not only when treatment with combination
products 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
doses of beta-agonist and/or corticosteroids 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 remains optimal