ALUSTAL PLANTAIN POLLEN EXTRACT plantago lanceolata 10 IC/mL injection suspension vial

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

Plantago lanceolata

Предлага се от:

Stallergenes Australia Pty Ltd

INN (Международно Name):

Plantago lanceolata

Статус Оторизация:

Registered

Листовка

CONSUMER MEDICINE INFORMATION
ALUSTAL®
Page 1 of 8
ALUSTAL®
Pronounced (al-u-stal)
_Contains the active _
_ingredients of different _
_allergens _
_TABLE OF CONTENTS _
_What is in the leaflet.......p.1 _
_What Alustal is used for p.1 _
_Before you are given Alustal _
_........................................p.1 _
_How Alustal is given.......p.2 _
_While you are receiving _
_Alustal............................ p.3 _
_Side effects..................... p.3 _
_After using Alustal.........p.4 _
_Product description.......p.4 _
_Presentation..................p.4 _
_ _
____________________
WHAT IS IN THIS LEAFLET
____________________
This leaflet answers some
common questions about
Alustal allergen extracts.
It does not contain all of 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
giving you Alustal allergen
extracts against the expected
benefits it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
____________________
WHAT ALUSTAL IS USED FOR
____________________
Alustal belongs to a group
of medicines called
_anti-_
_allergy preparations _
and is
used in the treatment of
seasonal or perennial
rhinitis, conjunctivitis and
rhino-conjunctivitis with or
without associated asthma.
Alustal is given as a
subcutaneous treatment and
this is often referred to as
SIT (Subcutaneous
Immunotherapy Treatment)
_HOW IT WORKS: _
_ _
A list of allergen available
in Australia and New
Zeeland is provided at the
end of this leaflet. . The
exact type will depend on
your allergy and what your
doctor identifies as the
cause of your allergy. The
aim of treatment with
allergen extracts is to
prevent the more severe
allergic reactions you
experience.
Alustal works by slowly
increasing your tolerance to
specific allergens and
decreases the severity of
your allergic reactions.
The injection is specifically
designed according to
individual patient needs.
Alustal helps

Данни за продукта

Page 1 of 10
ALUSTAL PRODUCT INFORMATION
Ver. 11.2
ALUSTAL – SINGLE ALLERGENS
ALUSTAL – DISPENSED MIXTURES
IMPORTANT NOTE
Care should always be taken to ensure that the correct dosage schedule
is used.
NAME OF THE MEDICINE
ALUSTAL mite extracts and ALUSTAL pollen extracts are registered in
Australia as products that
contain either single allergen extract or combination allergen
extracts within the mite or pollen group
of allergens.
DESCRIPTION
ALUSTAL is prepared from freeze-dried allergen extracts adsorbed onto
aluminium hydroxide gel.
The freeze-dried allergen extracts are prepared by ammonium
bicarbonate extraction of the allergen
source materials e.g. pollen, mites. Specific allergen(s) are selected
by the physician for Specific
Immunotherapy Treatment (SIT) for the individual patient.
Each 5mL vial contains specific allergen extract(s) in suspension and
are available in various
concentrations. Different concentrations are identified by different
coloured caps on the vials.
YELLOW CAP: 0.1 IR/ML
OR
0.1 IC/ML
GREEN CAP:
1.0 IR/ML
OR
1.0 IC/ML
BLUE CAP:
10.0 IR/ML
OR
10.0 IC/ML

IR (Index of Reactivity): An allergen extract is said to have a titre
of 100 IR/mL if in a prick-test
performed using a Stallerpoint

in 30 subjects sensitised to the allergen in question, it produces a
wheal
measuring
7
mm
in
diameter
(geometric
mean).
Skin
reactivity
in
these
subjects
is
simultaneously demonstrated by a positive response to a prick-test
with codeine phosphate 9% or
histamine dihydrochloride 10 mg/mL.

IC (Index of Concentration): An allergen extract has an Index of
Concentration of 100 IC/mL when
its manufacturing parameters lead to the same dilution ratio as those
of standardized extracts at 100
IR/mL from the same family, taken as a reference.
When
the
family
does
not
contain
any
standardized
reference
extract,
the
value
100
IC/mL
corresponds to an extract where the dilution ratio is established
according to medical experience.
_ _
_Further Information: _
Other ingredients include aluminium hydroxide, s