BAMBEC TABLET 10 mg

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

active_ingredient:

BAMBUTEROL HCl

MAH:

ASTRAZENECA SINGAPORE PTE LTD

ATC_code:

R03CC12

dosage:

10 mg

pharmaceutical_form:

TABLET

administration_route:

ORAL

prescription_type:

Pharmacy Only

manufactured_by:

ASTRAZENECA AB

authorization_date:

1997-03-06

PIL

1 

BAMBEC 10 MG AND 20 MG

_bambuterol hydrochloride _ 
TABLETS 

COMPOSITION 
_Tablets 10 mg_ 
One tablet contains: 
Bambuterol hydrochloride 10 mg 

_Tablets 20 mg _
One tablet contains: 
Bambuterol hydrochloride 20 mg 

PHARMACEUTICAL FORM 
Tablet.  

INDICATIONS 
Bronchial asthma. Chronic bronchitis, emphysema and other
lung diseases, where 
bronchospasm is a complicating factor. 

POSOLOGY AND METHOD OF ADMINISTRATION 
Bambec should be used as maintenance therapy in asthma and other
pulmonary 
diseases where bronchospasm is a complicating factor. 

Bambec is dosed once daily, preferably shortly before bed-time.
The dose should be 
individual. 
_ _
_Adults_: The recommended initial dose is 10 mg. The dose may be
increased to 20 mg 
after 1-2 weeks, depending on the clinical effect. In patients who
previously have 
tolerated oral 
E
2
-agonists well, the recommended initial dose is 20 mg. 

In patients with an impaired renal function (GFR 
d 50 ml/min) the recommended 
initial dose is 5 mg, which may be increased to 10 mg after
1-2 weeks, depending on 
the clinical effect. 

_Elderly:_ Dosage as for adults. 

_Children 2-5 years:_ The recommended normal dose is 10 mg and,
because of 
differences in kinetics, 5 mg  in Oriental children. 
2 

_Children 6-12 years_: The recommended initial dose is 10 mg. The
dose may be 
increased to 20 mg after 1-2 weeks, depending on the clinical
effect.  

Because of differences in kinetics, doses above 10 mg are not
recommended in 
Oriental children. 

CONTRAINDICATIONS 
Hypersensitivity to any of the ingredients or to terbutaline. 

SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
As terbutaline is excreted mainly via the kidneys, the dose of
Bambec should be 
halved in patients with an impaired renal function (GFR 
d50 ml/min). 

In patients with liver cirrhosis, and probably in patients
with other causes of severely 
impaired liver function, the daily