Telfast 30mg5ml Oral Suspension

Country: Малезија

Језик: Енглески

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

Активни састојак:

FEXOFENADINE HCL

Доступно од:

DKSH MALAYSIA SDN BHD

INN (Међународно име):

FEXOFENADINE HCL

Јединице у пакету:

60ml mL; 30ml mL

Произведен од:

SANOFI MEDLEY FARMACEUTICA LTDA

Информативни летак

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TELFAST
® ORAL SUSPENSION
Fexofenadine hydrochloride (30mg /5ml)
WHAT IS IN THIS LEAFLET
1.
What Telfast Oral Suspension is
used for
2.
How Telfast Oral Suspension
works
3.
Before you use Telfast Oral
Suspension
4.
How to use Telfast Oral
Suspension
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Telfast
Oral Suspension
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT TELFAST ORAL SUSPENSION IS
USED FOR
Telfast Oral Suspension is used in
children 2 to 11 years of age to relieve
the symptoms that occur with hay fever
(
SEASONAL ALLERGIC RHINITIS
) such as
sneezing, itchy, watery or red eyes,
itchy or runny nose, itchy throat and
nasal congestion.
Telfast Oral Suspension is also used to
relieve the symptoms of uncomplicated
long term hives, with no known cause
(
CHRONIC IDIOPATHIC URTICARIA
) in
children 6 months to 11 years of age.
HOW TELFAST ORAL SUSPENSION WORKS
Telfast Oral Suspension contains
fexofenadine hydrochloride, which is
an antihistamine. It works by blocking
the action of histamine in order to treat
allergy symptoms.
BEFORE YOU USE TELFAST ORAL
SUSPENSION
_-When you must not use it _
Do not take Telfast Oral Suspension if:
-You are allergic (hypersensitive) to
any ingredients of Telfast Oral
Suspension
-Signs of an allergic reaction include: a
rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue.
_-Before you start to use it _
Avoid the administration together with
high-fat foods.
_-Taking other medicines _
Please tell your doctor or pharmacist if
you are taking, have recently taken or
might take any other medicines.
•
Indigestion remedies (antacids)
containing aluminium hydroxide and
magnesium may affect the action of
Telfast Oral Suspension, by lowering
the amount of medicinal products
absorbed. It is recommended that you
leave about 2 hours between time that
you take Telfast and your indigestion
remedy.
PREGNANCY AND BREAST-FEEDING
Talk to yo

Карактеристике производа

000320975 30mg/5mL
_ _
_fexofenadine hydrochloride_
Oral Suspension
PEDIATRIC USE
FOR ORAL ADMINISTRATION
PHARMACEUTICAL FORM AND PACKAGING
Oral Suspension.
Packages containing one 30 mL or one 60mL
bottle with dosing syringe.
Not all pack size are marketed.
PRODUCT DESCRIPTION
White,
uniform
suspension
with
raspberry
cream aroma.
COMPOSITION
Each mL contains:
fexofenadine
hydrochloride
(equivalent
to
5.6mg of fexofenadine).6mg
excipients q.s to 1 mL
(propylene
glycol,
disodium
EDTA,
propylparaben,
butylparaben,
xanthan
gum,
poloxamer, titanium dioxide, sodium phosphate
monobasic
monohydrate,
sodium
phosphate
dibasic heptahydrate, raspberry flavour, sucrose,
xylitol and purified water).
PHARMACOLOGICAL CHARACTERISTICS
PHARMACODYNAMIC PROPERTIES
_Wheal and Flare: _Human histamine skin wheal
and flare studies in adults following single and
twice daily doses of 20 and 40 mg fexofenadine
hydrochloride
demonstrated
that
the
drug
exhibits
an
antihistamine
effect
by
1
hour,
achieves maximum effect at 2 to 3 hours, and
an effect is still seen at 12 hours. There was no
evidence of tolerance to these effects after 28
days of dosing. The clinical significance of these
observations is unknown.
Histamine skin wheal and flare studies in 7 to 12
year old subjects showed that following a single
dose of 30 or 60 mg, antihistamine effect was
observed at 1 hour and reached a maximum by
3 hours. Greater than 49% inhibition of wheal
area, and 74% inhibition of flare area were
maintained for 8 hours following the 30 and 60
mg dose.
No statistically significant increase in mean QTc
interval
compared
to
placebo
was
observed
in
714
adult
subjects
with
seasonal
allergic
rhinitis
given
fexofenadine
hydrochloride
capsules in doses of 60 to 240mg twice daily
for 2 weeks. Pediatric subjects from 2 placebo
controlled trials (n=855) treated with up to 60
mg
fexofenadine
hydrochloride
twice
daily
demonstrated
no
significant
treatment-
or
dose-related increases in QTc. In addition, no
statistically
significant
increase
in
mean
QTc
interval compar