Telfast Oral Liquid

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Fexofenadine hydrochloride 6 mg/mL; Fexofenadine hydrochloride 6 mg/mL

Pieejams no:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

SNN (starptautisko nepatentēto nosaukumu):

Fexofenadine hydrochloride 6 mg/mL

Deva:

6 mg/mL

Zāļu forma:

Oral suspension

Kompozīcija:

Active: Fexofenadine hydrochloride 6 mg/mL Excipient: Butyl hydroxybenzoate Dibasic sodium phosphate heptahydrate Disodium edetate Monobasic sodium phosphate monohydrate Poloxamer Propyl hydroxybenzoate Propylene glycol Purified water Raspberry flavour F-9950 PFC Sucrose Titanium dioxide Xanthan gum Xylitol Active: Fexofenadine hydrochloride 6 mg/mL Excipient: Dibasic sodium phosphate heptahydrate Disodium edetate Monobasic sodium phosphate monohydrate Poloxamer Potassium sorbate Propylene glycol Purified water Raspberry flavour F-9950 PFC Sucrose Titanium dioxide Xanthan gum Xylitol

Vienības iepakojumā:

Bottle, plastic, Amber PET bottle, polypropylene child resistant closure (not marketed), 30 mL

Klase:

Pharmacy only

Receptes veids:

Pharmacy only

Ražojis:

Sanofi-Aventis Deutschland GmbH

Ārstēšanas norādes:

Relief of symptoms associated with seasonal allergic rhinitis and allergic rhinitis in adults and children from 2 years of age.

Produktu pārskats:

Package - Contents - Shelf Life: Bottle, plastic, Amber PET bottle, polypropylene child resistant closure - 30 mL - 18 months from date of manufacture stored at or below 25°C - Bottle, plastic, Amber PET bottle, polypropylene child resistant closure - 60 mL - 24 months from date of manufacture stored at or below 30°C. Product manufactured at Sanofi-aventis Farmaceutica Ltda - Bottle, plastic, Amber PET bottle, polypropylene child resistant closure - 150 mL - 24 months from date of manufacture stored at or below 30°C. Product manufactured at Sanofi-aventis Farmaceutica Ltda - Bottle, plastic, Amber PET bottle, polypropylene child resistant closure - 300 mL - 24 months from date of manufacture stored at or below 25°C

Autorizācija datums:

2009-03-02

Lietošanas instrukcija

TELFAST
®
ORAL LIQUID REFORMULATION
1
TELFAST
®
_ORAL LIQUID REFORMULATION _
_Fexofenadine hydrochloride _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Telfast. Please read
the information carefully before
giving your child Telfast.
This leaflet provides a summary of
the information available; it does not
contain all the available information.
It does not take the place of talking to
your pharmacist or doctor, who have
more detailed information.
IF YOU HAVE ANY QUESTIONS ABOUT
TELFAST, OR IF YOUR CHILD EXPERIENCES
ANY PROBLEMS WHILE BEING GIVEN
TELFAST, SPEAK TO YOUR PHARMACIST
OR DOCTOR.
All medicines have benefits and
risks, so please discuss these with
your pharmacist or doctor to make
sure that the benefits of your child
taking Telfast outweigh any possible
risks.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TELFAST IS USED
FOR
Telfast contains an active ingredient
called fexofenadine hydrochloride. It
is one of a group of medicines called
antihistamines.
Antihistamines help reduce allergic
symptoms by preventing the effects
of a substance called histamine,
which your body produces when
exposed to certain substances.
Telfast is a non-sedating
antihistamine which means it has
been shown to not cause drowsiness.
Telfast is used to relieve the
symptoms of:
•
hayfever (seasonal allergic
rhinitis) and year-round allergies
(perennial allergic rhinitis).
Symptoms include runny, itchy,
blocked nose, sneezing and itchy,
watery, red eyes.
•
hives or nettle rash (chronic
idiopathic urticaria). Symptoms
include pink to red, itchy
swellings on the skin.
Your pharmacist or doctor may have
recommended this medicine for
another reason.
ASK YOUR PHARMACIST OR DOCTOR IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN
RECOMMENDED FOR YOUR CHILD.
BEFORE GIVING IT TO
YOUR CHILD
_WHEN IT MUST NOT BE GIVEN _
TELFAST MUST NOT BE GIVEN TO YOUR
CHILD IF YOUR CHILD HAS HAD AN
ALLERGIC REACTION TO FEXOFENADINE,
TERFENADINE (TELDANE

Produkta apraksts

telfast-ccdsv7-dsv19-22feb24
Page 1
Internal
NEW ZEALAND DATASHEET
1 PRODUCT NAME
Telfast® 6 – 11 years 30mg film coated tablets#
Telfast® 60mg film coated tablets
Telfast® 120mg film coated tablets
Telfast® 180mg film coated tablets
Telfast® Oral Liquid, 6mg/mL, suspension
Telfast® Oral Liquid, Re-formulation 6mg/mL, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
6 – 11 years 30mg film coated tablets#: Each tablet contains 30mg of
fexofenadine hydrochloride
equivalent to 28mg of fexofenadine.
60mg film coated tablets: Each tablet contains 60mg of fexofenadine
hydrochloride equivalent to
56mg of fexofenadine.
120mg film coated tablets: Each tablet contains 120mg of fexofenadine
hydrochloride equivalent
to 112mg of fexofenadine.
180mg film coated tablets: Each tablet contains 180mg of fexofenadine
hydrochloride equivalent
to 168mg of fexofenadine.
Oral liquid, 6mg/mL: Each mL of liquid contains 6mg (30mg/5mL) of
fexofenadine
hydrochloride equivalent to 5.6mg of fexofenadine.
Oral liquid re-formulation, 6mg/mL: Each mL of liquid contains 6mg
(30mg/5mL) of
fexofenadine hydrochloride equivalent to 5.6mg of fexofenadine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
6 – 11 years 30mg film coated tablets#: peach, round, standard
convex.
60mg film coated tablets: peach, oval, double convex.
telfast-ccdsv7-dsv19-22feb24
Page 2
Internal
120mg film coated tablets: peach, modified capsule shaped (6.1mm x
15.8mm).
180mg film coated tablets: peach, capsule shaped (7.6mm x 17.3mm).
Oral liquid: white uniform aqueous suspension, with a raspberry cream
flavour.
Oral liquid re-formulation: white uniform aqueous suspension, with a
raspberry cream flavour
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHARMACY ONLY MEDICINE
Relief of symptoms associated with seasonal allergic rhinitis and
allergic rhinitis in adults and
children from 2 years of age.
Relief of symptoms of urticaria in adults and children from 6 months
of age.
Telfast 6 – 11 years 30mg film coated tablets#: 20 tablet