RHINOCORT AQUA,64MCG/DOSE

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

BUDESONIDE

제공처:

JOHNSON & JOHNSON SDN BHD

INN (국제 이름):

BUDESONIDE

패키지 단위:

01Units Units

Manufactured by:

ASTRAZENECA AB

제품 특성 요약

PRODUCT
BRAND
COMPONENT CODE
VERSION
DESIGN
REPLACED COMP CODE
MARKET
DIELINE / TECH DRAWING REFERENCE
COLOR
ADDITIONAL
INFORMATION
CH020025
MY
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670014
Nasal Spray 64mcg Leaflet
Rhinocort
DALI-b
BLACK
J&J AD, HBG, SWE August 22, 2018 11:53:26
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2. Qualitative and Quantitative Composition
Table 1. Dosage Forms and Strengths
Dosage Form
Budesonide Strength
Suspension (Nasal Spray)
64 mcg
3. Pharmaceutical Form
Budesonide is formulated for intranasal administration and
available as a nasal spray
4. Clinical Particulars
4.1 Therapeutic Indications
•
Relieves symptoms of seasonal or perennial allergic rhinitis
(nasal congestion, runny nose, sneezing and itchy nose)
•
Treatment of allergic rhinoconjunctivitis (nasal congestion,
runny nose, sneezing, itchy nose, itchy and watery eyes)
•
Prevention of allergic rhinitis
Under the Supervision of a Healthcare Professional
•
Treatment of nasal polyps and prevention of nasal polyps after
polypectomy
•
Relieves symptoms of vasomotor rhinitis
4.2 Posology and Method of Administration
Some symptoms may get better on the first day of treatment. It
may take up to two weeks of daily use to feel the most symptom
relief.
For prevention, start therapy before anticipated exposure to the
allergens
64 mcg per spray Dose Formulation
Allergic Rhinitis and Vasomotor Rhinitis
Adults and Children 12 years and older:
•
Once daily, use up to 2 sprays in each nostril (256 mcg total
daily dose) while sniffing gently.
•
Once allergy symptoms improve, reduce dose to 1 spray in
each nostril daily
Children 6 years to less than 12 years of age:
•
An adult should supervise use in children under age 12
•
Once daily, use 1 spray in each nostril (total dose 128 mcg)
while sniffing gently.
•
If symptoms do not improve, dose can be increased up to
2 sprays per nostril (up to 256 mcg total daily dose)
•
Once allergy symptoms improve, reduce dose to 1 spray in
each nostril daily
•
Talk to your child’s physician if your child needs to use the
spray f