Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Allergen extracts 10 IC/mL (Chicken (33%), Duck (33%), Goose (33%) feathers extract)
Ebos Group Ltd
Allergen extracts 10 IC/mL (Chicken (33%), Duck (33%), Goose (33%) feathers extract)
10 IC/mL
Solution for injection
Active: Allergen extracts 10 IC/mL (Chicken (33%), Duck (33%), Goose (33%) feathers extract) Excipient: Aluminium hydroxide gel Mannitol Phenol Sodium chloride Water
Vial, glass, multi-dose, 11mL (5mL fill volume), 5 mL
Prescription
Prescription
Stallergenes
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)
2002-05-28
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 Read the complete document