COMBIVENT UDV

País: Indonèsia

Idioma: indonesi

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

ingredients actius:

IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE

Disponible des:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

Designació comuna internacional (DCI):

IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE

Dosis:

0.52 MG /3.013 MG

formulario farmacéutico:

CAIRAN INHALASI

Unidades en paquete:

DUS, 20 VIAL @ 2,5 ML

Fabricat per:

LABORATOIRE UNITHER - France

Data d'autorització:

2020-10-20

Fitxa tècnica

PT. BOEHRINGER INGELHEIM INDONESIA
1.
Medical & Drug Regulatory Affairs
Red : COMBIVENT UDV 0204-07, Green : change position
No. 0204-07
11 April 2019
COMBIVENT
® UNIT DOSE VIALS
IPRATROPIUM BROMIDE
SALBUTAMOL SULPHATE
COMPOSITION
1 unit-dose vial (2.5 mL) solution for inhalation contains:
Ipratropium bromide
corresponding to 0.5 mg ipratropium bromide anhydrous
0.52 mg
Salbutamol sulphate
corresponding to 2.5 mg salbutamol base
3.01 mg
Excipients:
sodium chloride, hydrochloric acid, purified water
INDICATIONS
COMBIVENT UDV is indicated for the management of reversible
bronchospasm associated with
obstructive pulmonary diseases and acute asthma attack in patients who
require more than a single
bronchodilator.
DOSAGE AND ADMINISTRATION
COMBIVENT
®
has not been studied in patients with hepatic or renal insufficiency.
It should be used
with caution in those patient populations.
Patients should be advised to consult a physician
or the nearest hospital immediately in the case of
acute or rapidly worsening dyspnoea if additional inhalations of
COMBIVENT
®
do not produce an
adequate improvement.
If higher than recommended doses of COMBIVENT
®
are required to control symptoms, the patient's
therapy plan should be reviewed.
The following doses of COMBIVENT
®
are recommended for adults (including elderly patients):
COMBIVENT
®
solution for inhalation in unit dose vials
COMBIVENT inhalation solution in unit dose vials may be administered
from a suitable nebuliser or
an intermittent positive pressure ventilator.
Treatment should be initiated and administered under medical
supervision, e.g. in the hospital
setting. Home based treatment can be recommended in exceptional cases
(severe symptoms or
experienced
patients
requiring
higher
doses)
when
a
low
dose
rapid
acting
beta-agonist
bronchodilator has been insufficient in providing relief after
consultation with an experienced
physician.
The
treatment
with
the
nebuliser
solution
in UDVs
should
always
be
started
with the
lowest
recommended dose (1 UDV). In very severe cases