HFA-134A BECLOMETASONE DIPROPIONATE 100 %v/v Pressurised Inhalation Soln

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

BECLOMETASONE DIPROPIONATE

থেকে পাওয়া:

3M Health Care Limited

INN (আন্তর্জাতিক নাম):

BECLOMETASONE DIPROPIONATE

ডোজ:

100 %v/v

ফার্মাসিউটিকাল ফর্ম:

Pressurised Inhalation Soln

অনুমোদন অবস্থা:

Withdrawn

অনুমোদন তারিখ:

0000-00-00

পণ্য বৈশিষ্ট্য

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
HFA-134a Beclometasone Dipropionate 100 micrograms pressurised
inhalation solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose delivers Beclometasone Dipropionate 100
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 mauve 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 mainta