Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Allergen extracts 0.1 IC/mL (Equine epithelium extract); Allergen extracts 1 IC/mL (Equine epithelium extract); Allergen extracts 10 IC/mL (Equine epithelium extract)
Ebos Group Ltd
Allergen extracts 0.1 IC/mL (Equine epithelium extract)
Solution for injection
Active: Allergen extracts 0.1 IC/mL (Equine epithelium extract) Excipient: Aluminium hydroxide gel Mannitol Phenol Sodium chloride Water Active: Allergen extracts 1 IC/mL (Equine epithelium extract) Excipient: Aluminium hydroxide gel Mannitol Phenol Sodium chloride Water Active: Allergen extracts 10 IC/mL (Equine epithelium 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
CONSUMER MEDICINE INFORMATION Version 10. 1 ALUSTAL® Page 1 of 7 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. Lugege kogu dokumenti
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 Lugege kogu dokumenti