ALUSTAL OLIVE TREE POLLEN EXTRACT INITIAL TREATMENT olea europaea injection suspension vial composite pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

Olea europaea, Quantity: 10 IR/mL

Tilgængelig fra:

Stallergenes Australia Pty Ltd

INN (International Name):

Olea europaea

Lægemiddelform:

Injection, suspension

Sammensætning:

Excipient Ingredients: sodium chloride; phenol; mannitol; aluminium hydroxide hydrate; water for injections

Indgivelsesvej:

Subcutaneous

Enheder i pakken:

3 vials: 1 each of 0.1 IR/mL, 1.0 IR/mL, 10.0 IR/mL

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Treatment of patients with Type 1 allergy (Gell and Coombs classification), particularly presenting as seasonal or perennial rhinitis, conjunctivitis, rhinoconjunctivitis, with or without associated asthma.

Produkt oversigt:

Visual Identification: Clear and colourless solution.; Container Type: Vial; Container Material: Glass; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisation status:

Licence status A

Autorisation dato:

2006-10-03

Indlægsseddel

CONSUMER MEDICINE INFORMATION
Version 10.1
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.
A

Produktets egenskaber

Version 11.7
1
IMPORTANT NOTE
Care should always be taken to ensure that the correct dosage schedule
is used
AUSTRALIAN PRODUCT INFORMATION- ALUSTAL OLIVE TREE POLLEN EXTRACT
(OLEA EUROPAEA POLLEN EXTRACT)
1
NAME OF THE MEDICINE
ALUSTAL Olive Tree Pollen Extract (Olea europaea pollen extract)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Suspension for injection
Version 11.7
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALUSTAL tr