GRAZAX standardised allergen extract of grass pollen from Timothy grass (Phleum pratense) 75,000 SQ-T sublingual tablets blister foil

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

Phleum pratense, Quantity: 75000 SQ-T

Disponibil de la:

Seqirus Pty Ltd

INN (nume internaţional):

Phleum pratense

Forma farmaceutică:

Tablet

Compoziție:

Excipient Ingredients: Gelatin; mannitol; sodium hydroxide; purified water

Calea de administrare:

Sublingual

Unități în pachet:

90 sublingual tablets, 30 sublingual tablets, 10 sublingual tablets, 100 sublingual tablets

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

GRAZAX is indicated for disease modifying treatment of grass pollen (Phleum pratense or allergens cross reacting with P. pratense) induced allergic rhinitis with or without conjunctivitis in adults, adolescents and children above the age of 5 years.

Rezumat produs:

Visual Identification: Tablets are white to off-white with an imprint on one side; Container Type: Blister Pack; Container Material: Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2017-03-07

Prospect

Grazax
®
Consumer Medicine Information
Page 1 of 5
GRAZAX
®
_(gra-zaks) _
Standardised allergen extract of Timothy grass pollen _(Phleum
pratense)_
_ _
_CONSUMER MEDICINE INFORMATION _
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
GRAZAX
®
. 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 GRAZAX
®
against the
benefits this medicine is
expected to 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 GRAZAX
® IS
USED FOR
GRAZAX
®
contains an
allergen extract of grass
pollen. It comes in a tablet
form which is intended to be
absorbed by the body by
placing it under the tongue.
GRAZAX
®
is used to treat
grass pollen allergies that
are characterised by rhinitis
(sneezing, runny or itchy
nose, nasal congestion) and
allergic conjunctivitis (itchy
eyes) in adults and children
5 years or older.
GRAZAX
®
works by
increasing your
immunological tolerance to
grass pollen, thereby
reducing the severity of your
allergic reactions over time.
Before starting treatment,
the doctor will check if
GRAZAX
®
is suitable for you
by performing the
appropriate blood and/or
skin prick tests.
GRAZAX
®
is only available
with a doctor’s prescription.
ASK YOUR DOCTOR IF YOU
HAVE ANY QUESTIONS ABOUT
WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another
reason.
This medicine is not
expected to affect your
ability to drive a car or
operate machinery.
BEFORE YOU TAKE
GRAZAX
®
_WHEN YOU MUST NOT TAKE _
_IT _
Do not take GRAZAX
®
if:
•
you have an allergy to
any of the ‘Other
ingredients’ listed at the
end of this leaflet
•
you have an illness
which affects your
immune system or have
cancer
•
you have severe asthma
(as assessed by your
doctor).
•
you have recently had a
tooth taken out,

Caracteristicilor produsului

Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION GRAZAX
® (_PHLEUM PRATENSE_)
SUBLINGUAL TABLETS
AUST R 267955
1.
NAME OF THE MEDICINE
_Phleum pratense. _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GRAZAX
®
sublingual tablets contain 75,000 SQ-T standardised allergen
extract of Timothy grass pollen (_Phleum pratense_) which is a
temperate grass.
SQ-T is the dose unit for GRAZAX
®
. SQ is a method for standardisation on
biological potency, major allergen content and complexity of the
allergen
extract._ _
GRAZAX
®
sublingual
tablets
75,000
SQ-T
also
contains
gelatine
(fish),
mannitol and sodium hydroxide.
3.
PHARMACEUTICAL FORM
GRAZAX
®
75,000
SQ-T
is
supplied
as
white
to
off-white
freeze-dried
debossed tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GRAZAX
®
is indicated for disease modifying treatment of grass pollen (_Phleum
_
_pratense_ or allergens cross reacting with _P. pratense)_ induced
allergic rhinitis
with or without conjunctivitis in adults, adolescents and children
above the age
of 5 years.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with GRAZAX
®
should be initiated by a clinician with experience in
treatment of allergies. Patients should have a confirmed clinical
history and
diagnosis by a positive test of grass pollen sensitisation to _Phleum
pratense_ or
cross reacting allergens (specific IgE and/or skin prick test) prior
to treatment.
The recommended dose is one sublingual tablet (75,000 SQ-T) daily.
It is recommended that the first sublingual tablet is taken under
medical
supervision and that the patient is monitored for 30 minutes, to
enable
discussion and possible treatment of any immediate side effects. See
also 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE. Management of
specific allergy symptoms should be discussed prior to initiation of
treatment.
The sublingual tablet should be taken with dry fingers from the
blister unit
immediately after opening the blister and placed under the tongue,
where it will
disperse. Swallowing should be avoided for approximately 1 minute.
Fo