Zenhale Pressurized Inhalation Aerosol 1005mcgactuation

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Formoterol Fumarate, Dihydrate; Mometasone Furoate

Available from:

ORGANON SINGAPORE PTE. LTD.

ATC code:

R03AK07

Dosage:

0.0061mg

Pharmaceutical form:

AEROSOL, METERED

Composition:

Formoterol Fumarate, Dihydrate 0.0061mg; Mometasone Furoate 0.1210mg

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

Kindeva Drug Delivery Limited

Authorization status:

ACTIVE

Authorization date:

2012-07-11

Patient Information leaflet

 
1
CCDS-MK0887A-AO-062014 

1 
NAME OF THE MEDICINAL PRODUCT & PHARMACEUTICAL FORM 

ZENHALE
®
 50/5  
(mometasone furoate 50 mcg and formoterol fumarate dihydrate 5 mcg)
pressurized 
inhalation suspension [inhalation aerosol] 

ZENHALE
®
 100/5 
(mometasone furoate 100 mcg and formoterol fumarate dihydrate 5 mcg)
pressurized 
inhalation suspension [inhalation aerosol] 

ZENHALE
®
 200/5 
(mometasone furoate 200 mcg and formoterol fumarate dihydrate 5 mcg)
pressurized 
inhalation suspension [inhalation aerosol] 

_Description _
_Mometasone furoate _
Mometasone furoate is a synthetic, anti-inflammatory corticosteroid
with a chemical 
name of 9,21-dichloro-11
,17-dihydroxy-16-methylpregna-1,4-diene-3,20-dione 17-
(2)-furoate with the following chemical structure:   

Mometasone furoate has a molecular weight of 521.44 and its empirical
formula is 
C
27
H
30
CI
2
O
6
. 

_Formoterol fumarate  _
Formoterol fumarate dihydrate, a racemate, is a selective beta
2
-adrenergic 
bronchodilator with a chemical name of
(±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-
(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate
dihydrate with the 
following chemical structure: 

Formoterol fumarate dihydrate has a molecular weight of 840.9, and
its empirical 
formula is (C
19
H
24
N
2
O
4
)
2
•C
4
H
4
O
4
•2H
2
O.  

2
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

ZENHALE 50/5 delivers 50 mcg of mometasone furoate and 5 mcg of
formoterol 
fumarate dihydrate per actuation.    

ZENHALE 100/5 delivers 100 mcg of mometasone furoate and 5 mcg of
formoterol 
fumarate dihydrate per actuation.    

ZENHALE 200/5 delivers 200 mcg of mometasone furoate and 5 mcg of
formoterol 
fumarate dihydrate per actuation.  

For a full list of excipients, see section 3.1 List of Excipients of
Special Interest  

3 PHARMACEUTICAL 
PARTICULARS 

3.1 
LIST OF EXCIPIENTS OF SPECIAL INTEREST 

Hydrofluoroalkane (HFA-227) 
Anhydro

Summary of Product characteristics

CCDS-MK0887A-AO-102019
1
NAME OF THE MEDICINAL PRODUCT & PHARMACEUTICAL FORM
ZENHALEⓇ 50/5
(mometasone
furoate
50 mcg
and
formoterol
fumarate
dihydrate
5 mcg)
pressurized
inhalation
suspension [inhalation aerosol]
ZENHALEⓇ 100/5
(mometasone
furoate
100 mcg
and
formoterol
fumarate
dihydrate
5 mcg)
pressurized
inhalation
suspension [inhalation aerosol]
ZENHALEⓇ 200/5
(mometasone
furoate
200 mcg
and
formoterol
fumarate
dihydrate
5 mcg)
pressurized
inhalation
suspension [inhalation aerosol]
Description
Mometasone furoate
Mometasone furoate is a synthetic, anti-inflammatory corticosteroid
with a chemical name of 9,21-
dichloro-11 β ,17-dihydroxy-16 α -methylpregna-1,4-diene-3,20-dione
17-(2)-furoate
with
the
following
chemical structure:
Mometasone furoate has a molecular weight of 521.44 and its empirical
formula is C
27
H
30
CI
2
O
6
.
Formoterol fumarate
Formoterol fumarate dihydrate, a racemate, is a
selective beta
2
-adrenergic bronchodilator with a
chemical
name
of
(±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-
amino]ethyl]formanilide fumarate dihydrate with the following chemical
structure:
Formoterol
fumarate
dihydrate
has
a
molecular
weight
of
840.9,
and
its
empirical
formula
is
(C
19
H
24
N
2
O
4
)
2
•C
4
H
4
O
4
•2H
2
O.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZENHALE 50/5 delivers 50 mcg of mometasone furoate and 5 mcg of
formoterol fumarate dihydrate per
actuation.
ZENHALE 100/5 delivers 100 mcg of mometasone furoate and 5 mcg of
formoterol fumarate dihydrate
per actuation.
ZENHALE 200/5 delivers 200 mcg of mometasone furoate and 5 mcg of
formoterol fumarate dihydrate
per actuation.
For a full list of excipients, see section 3.1 List of Excipients of
Special Interest
3
PHARMACEUTICAL PARTICULARS
3.1
List of Excipients of Special Interest
Hydrofluoroalkane (HFA-227)
Anhydrous Alcohol
Oleic Acid
3.2
Incompatibilities
N/A
3.3
Instructions for Use and Handling and Disposal
ZENHALE should be primed before using for the first time by releasing
4 test sprays into t