Singulair

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Montelukast sodium 10.4mg Equivalent to 10 mg montelukast free acid

थमां उपलब्ध:

Merck Sharp & Dohme (New Zealand) Limited

INN (इंटरनेशनल नाम):

Montelukast sodium 10.4 mg (Equivalent to 10 mg montelukast free acid)

डोज़:

10 mg

फार्मास्यूटिकल फॉर्म:

Film coated tablet

रचना:

Active: Montelukast sodium 10.4mg Equivalent to 10 mg montelukast free acid Excipient: Carnauba wax Croscarmellose sodium Hyprolose   Hypromellose Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Microcrystalline cellulose Titanium dioxide

पैकेज में यूनिट:

Blister pack, aluminium, sample pack, 7 tablets

वर्ग:

Prescription

प्रिस्क्रिप्शन प्रकार:

Prescription

द्वारा बनाया गया:

MSD International GmbH (Ireland)

चिकित्सीय संकेत:

Indicated in adults and paediatric patients 2 years of age and older for the relief of daytime and nighttime symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Blister pack, aluminium, sample pack - 7 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture - Blister pack, aluminium, sample pack - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture - Blister pack, aluminium - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture

प्राधिकरण की तारीख:

1997-03-17

सूचना पत्रक

NEW ZEALAND CONSUMER MEDICINE INFORMATION
SINGULAIR
®
_montelukast sodium _
4 mg, 5 mg & 10 mg tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about SINGULAIR. It does
not contain all
the available information. It does not take the place of talking to
your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
SINGULAIR against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT SINGULAIR IS USED FOR
SINGULAIR is used to treat:
•
asthma, including preventing asthma symptoms during the day and night.
It also
prevents the narrowing of airways triggered by exercise.
•
seasonal and year-round allergies, including daytime and nighttime
symptoms,
including nasal congestion, runny nose, nasal itching, and sneezing;
nasal congestion
upon awakening, difficulty going to sleep, and nighttime awakenings;
tearing, itchy, red,
and puffy eyes.
SINGULAIR can be used in children 2 years of age and older, teenagers
and adults.
SINGULAIR tablets are not used to treat an ACUTE attack of asthma. If
an acute attack
occurs, follow your doctor’s instructions for that situation.
Asthma is a lung disease and has the following characteristics:
•
narrowed airways causing breathing to become difficult
•
inflamed airways, which means the lining of airways become swollen
•
sensitive airways that react to many things, such as cigarette smoke,
pollen, or cold air.
Symptoms of asthma include coughing, wheezing and chest tightness. Not
all people with
asthma wheeze. For some, coughing may be the only symptom of asthma.
Symptoms
often occur during the night or after exercise.
Seasonal allergies (also known as hay fever) are triggered by outdoor
allergens such as
airborne pollens from trees, grasses and weeds.
Year-round allergies may occur year-round and are generally triggered
by indoor allergens
such as d

उत्पाद विशेषताएं

NEW ZEALAND DATA SHEET
NAME OF MEDICINE
SINGULAIR
®
montelukast sodium
10 mg tablet
5 mg chewable tablet
4 mg chewable tablet
PRESENTATION
10 mg tablet: A beige rounded square film-coated tablet engraved with
SINGULAIR on
one side and MSD117 on the other, containing 10.4 mg of montelukast
sodium which is
the molar equivalent of 10.0 mg of free acid. Dimensions: 7.87 x 7.87
mm.
5 mg chewable tablet: A pink round biconvex chewable tablet with a
cherry flavour
engraved SINGULAIR on one side and MSD275 on the other, containing 5.2
mg of
montelukast sodium which is the molar equivalent of 5.0 mg of free
acid. Dimensions:
9.525 mm diameter.
4 mg chewable tablet: A pink oval biconvex tablet with a cherry
flavour engraved
SINGULAIR on one side and MSD 711 on the other, containing 4.2 mg
montelukast
sodium which is the molar equivalent of 4.0 mg of free acid.
THERAPEUTIC CLASS
SINGULAIR (montelukast sodium) is a selective and orally active
leukotriene receptor
antagonist that specifically inhibits cysteinyl leukotriene CysLT
1
receptor.
INDICATIONS
SINGULAIR is indicated in adult and paediatric patients 2 years of age
and older for the
prophylaxis and chronic treatment of asthma, including the prevention
of day- and night-
time symptoms and the prevention of exercise-induced bronchospasm.
SINGULAIR is indicated in adults and paediatric patients 2 years of
age and older for the
relief of daytime and nighttime symptoms of seasonal allergic rhinitis
and perennial allergic
rhinitis.
DOSAGE AND ADMINISTRATION
SINGULAIR should be taken once daily. For asthma, the dose should be
taken in the
evening. For allergic rhinitis, the time of administration may be
individualised to suit
patient needs.
Patients with both asthma and allergic rhinitis should take only one
tablet daily in the
evening.
SINGULAIR Tablets Datasheet A160603v9
Page 1 of 11
ADULTS 15 YEARS OF AGE AND OLDER WITH ASTHMA AND/OR ALLERGIC RHINITIS
The dosage for adults 15 years of age and older is one 10 mg tablet
daily.
PAEDIATRIC PATIENTS 6 TO 14 YEARS OF AGE WITH