Alustal Sorrel Pollen Extract
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
20-09-2012
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Active ingredient:
Allergen extracts 10 IC/mL (Rumex acetosa pollen extract)
Available from:
Ebos Group Ltd
INN (International Name):
Allergen extracts 10 IC/mL (Rumex acetosa pollen extract)
Dosage:
10 IC/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Allergen extracts 10 IC/mL (Rumex acetosa pollen extract) Excipient: Aluminium hydroxide gel Mannitol Phenol Sodium chloride Water
Units in package:
Vial, glass, multi-dose, 11mL (5mL fill volume), 5 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Stallergenes
Product summary:
Package - Contents - Shelf Life: Vial, glass, multi-dose, 11mL (5mL fill volume) - 5 mL - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 months opened stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization date:
2002-05-28
Summary of Product characteristics
NEW ZEALAND DATA SHEET
Version 2.5
Page 1 of 13
1 PRODUCT NAME
ALUSTAL – SINGLE ALLERGENS
ALUSTAL – DISPENSED MIXTURES
A range of various ALUSTAL allergen extracts are registered in New
Zealand either as a single
allergen extract or combination allergen extracts. These include mite
extracts, pollen extracts and
animal extracts.
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
3 PHARMACEUTICAL FORM
Suspension for injection
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
ALUS
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