Alustal Feathers Mix Extract

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Allergen extracts 10 IC/mL (Chicken (33%), Duck (33%), Goose (33%) feathers extract)

Предлага се от:

Ebos Group Ltd

INN (Международно Name):

Allergen extracts 10 IC/mL (Chicken (33%), Duck (33%), Goose (33%) feathers extract)

дозиране:

10 IC/mL

Лекарствена форма:

Solution for injection

Композиция:

Active: Allergen extracts 10 IC/mL (Chicken (33%), Duck (33%), Goose (33%) feathers extract) Excipient: Aluminium hydroxide gel Mannitol Phenol Sodium chloride Water

Броя в опаковка:

Vial, glass, multi-dose, 11mL (5mL fill volume), 5 mL

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

Stallergenes

Каталог на резюме:

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)

Дата Оторизация:

2002-05-28

Данни за продукта

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