Flixotide Nebules 0.5 mg/ 2ml Nebuliser Suspension

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

FLUTICASONE PROPIONATE

可用日期:

LTT Pharma Limited

ATC代码:

R03BA; R03BA05

INN（国际名称）:

FLUTICASONE PROPIONATE

剂量:

0.5 mg/2ml

药物剂型:

Nebuliser suspension

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Glucocorticoids; fluticasone

授权状态:

Authorised

授权日期:

2015-02-06

资料单张

•
If you have more than one medicine, be careful
not to confuse them.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
FLIXOTIDE
DO NOT USE FLIXOTIDE:
•
If you are allergic to fluticasone propionate or
any of the other ingredients of this medicine
(listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before
taking Flixotide if:
•
you have ever been treated for tuberculosis (TB)
•
you have ever had thrush in your mouth.
•
you are using Flixotide at the same time as
taking steroid tablets. Also if you have
just finished taking steroid tablets. In both cases,
you should carry a steroid warning card until
your doctor tells you not to carry one.
•
you have been diagnosed with diabetes mellitus
(Flixotide may increase your blood sugar)
Contact your doctor if you experience blurred
vision or other visual disturbances, which may be
caused by cataract or glaucoma.
If you are not sure if any of the above applies to
you, talk to your doctor, nurse or pharmacist
before using Flixotide.
If your breathing or wheezing gets worse straight
after using Flixotide Diskus, STOP USING IT AND TELL
YOUR DOCTOR IMMEDIATELY.
OTHER MEDICINES AND FLIXOTIDE
Tell your doctor, nurse or pharmacist if you are
taking, have recently taken or might take any other
medicines, including medicines obtained without a
prescription. This includes herbal medicines.
Remember to take this medicine with you if you
have to go into hospital.
In particular tell your doctor or pharmacist if you
are taking any of the following:
•
a type of antiviral medicine known as a ‘protease
inhibitor’ (such as ritonavir) or cobicistat
containing products which may increase the
effects of fluticasone propionate. Your doctor
may wish to monitor you carefully if you are
taking these medicines.
•
medicines used to treat fungal infections (such
as ketoconazole).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flixotide Nebules 0.5 mg/ 2ml Nebuliser Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each nebule contains 0.5mg Fluticasone propionate in a 2ml suspension.
Each ml of suspension contains 0.25mg Fluticasone propionate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser Suspension (Nebuliser Liquid)
_Product imported from Greece_
A white, opaque suspension.
4 CLINICAL PARTICULARS
As per PA1077/044/016.
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/044/016.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
polysorbate 20
sorbitan monolaurate
monosodium phosphate dihydrate
dibasic sodium phosphate
sodium chloride
water for injection
6.2 INCOMPATIBILITIES
This medicinal product must not be mixed with other medicinal products
except these mentioned in section 6.6.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the pouch and outer package of the product on the
market in the country of origin.
Once Nebules have been removed from their foil flow wrap pack, they
should be used within 28 days.
Opened Nebules should be used immediately.
If diluted with sodium chloride injection, use immediately (see
section 4.2 and 6.6).
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_6_
_/_
_0_
_2_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_2_
_1_
_5_
_6_
_6_
_6_
_2_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store