HFA-134A BECLOMETASONE DIPROPIONATE 50 %v/v Pressurised Inhalation Soln

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

BECLOMETASONE DIPROPIONATE

متاح من:

3M Health Care Limited

INN (الاسم الدولي):

BECLOMETASONE DIPROPIONATE

جرعة:

50 %v/v

الشكل الصيدلاني:

Pressurised Inhalation Soln

الوضع إذن:

Withdrawn

تاريخ الترخيص:

0000-00-00

خصائص المنتج

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
HFA-134a Beclometasone Dipropionate 50 micrograms pressurised
inhalation, solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose delivers Beclometasone Dipropionate 50
micrograms ex-valve into the mouthpiece of the 
actuator.
For excipients see 6.1
3 PHARMACEUTICAL FORM
Pressurised inhalation, solution.
Pressurised aluminium container closed with a metering valve and
inserted into a beige plastic actuator.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Prophylactic anti-inflammatory
treatment of reversible obstructive airway disease.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
NOTE: The recommended total daily
dose of beclometasone dipropionate extrafine aerosol from HFA-134a 
Beclometasone Dipropionate is lower than
that for current beclometasone dipropionate CFC product and
should be 
adjusted to the individual patient.
HFA-134a Beclometasone Dipropionate is for inhalation use only.
ADULTS STARTING AND MAINTENANCE DOSE:
For mild to moderate asthma: 50 micrograms to 200
micrograms twice daily.
In more severe cases: doses up to 400 micrograms twice daily.
The maximum recommended daily dose in adults is 800 micrograms.
When patients’ symptoms remain under satisfactory control,
the dose can be gradually reduced to the minimum 
effective dose to maintain control.
CHILDREN AGED FIVE YEARS AND OVER – STARTING AND MAINTENANCE DOSE:
The recommended dose is 50 micrograms twice daily.
Children with well controlled asthma on doses of up to 400
micrograms per day of CFC containing beclometasone 
dipropionate may be titrated to a dose of 50
micrograms twice daily of HFA-134a Beclometasone Dipropionate.
During periods of deterioration in asthma control, the dose may
be increased to 100 micrograms twice daily. The dose 
should be reduced to the minimum needed to maintain