Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
honey bee venom, Quantity: 550 microgram
Stallergenes Australia Pty Ltd
honey bee venom
Injection, powder for
Excipient Ingredients: mannitol; sodium chloride
Intradermal, Intraepidermal, Subcutaneous
Pack containing one vial of freeze-dried bee venom 550 micrograms with 3 x 1.8ml vials of albumin-saline diluent and 1 x 9ml vial of albumin-saline diluent.
Medicine Registered
(S4) Prescription Only Medicine
Indicated use of allergenic extracts is for the diagnosis and treatment (hypo-sensitization therapy) of patients who experience allergic symptoms.
Visual Identification: White lyophilised powder which when reconstituted with diluent, is a clear yellow to brown hue;
Registered
2010-09-20
CONSUMER MEDICINE INFORMATION: Version 3.3 1 CONSUMER MEDICAL INFORMATION BROCHURE FOR ALBEY VENOM - Ver 3.4 ALBEY VENOM Pronounced (al-b-ay ve-n-om) _Contains the active ingredient (Allergen Extracts –there are three types of venom – _ _Paper Wasp Venom (Pollistes sp); Vespula sp (commonly known as European Wasp _ _or Yellow Jacket) and Honey Bee Venom (Apis Millefera) _ _Mannitol and Sodium chloride are included as an inactive component in Honey Bee _ _Venom _ _Mannitol is included as an inactive component in Paper Wasp and Yellow Jacket _ _Venom _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ALBEY VENOM. It does not contain all 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 you taking ALBEY VENOM against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS ALBEY VENOM USED FOR Up to 3% of the population in Australia may have an immediate allergic reaction to an insect sting. This can lead to death in some cases. An average of three deaths per year have been recorded in Australia. Venom immunotherapy or desensitisation can reduce the risk of severe reactions in adults from 30% -70% down to less than 2%. ALBEY VENOM is one type of immunotherapy your doctor may choose to administer to reduce the risk of a severe allergic reaction. ALBEY VENOM contains freeze dried extracts of venom protein known as allergens. ALBEY VENOM belongs to a group of medicines called _Antiallergy preparations_. CONSUMER MEDICINE INFORMATION: Version 3.3 2 _Antiallergy preparations _can be used for both diagnosis and desensitisation of insect stings. The exact mechanism by which ALBEY VENOM does this is not completely understood. Your doctor, however, may have prescribed ALBEY VENOM for another purpos Lire le document complet
Version 5.5 1 AUSTRALIAN PRODUCT INFORMATION – ALBEY (ALBEY BEE VENOM (APIS MELLIFERA) ALBEY YELLOW JACKET VENOM (VESPULA SPP. VENOM) ALBEY PAPER WASP VENOM (POLISTES SPP.VENOM)) POWDER FOR INJECTION 1 NAME OF THE MEDICINE ALBEY BEE VENOM (_Apis mellifera_) ALBEY YELLOW JACKET VENOM (_Vespula spp. venom_) ALBEY PAPER WASP VENOM (_Polistes spp.venom_) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The freeze dried honey bee venom consists of 550 μg protein / vial The freeze dried wasp venom consists of 550 μg protein / vial The freeze dried yellow jacket consists of 550 μg protein / vial For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Hymenoptera venom allergenic extracts. Freeze dried venom of honey bees (Apis mellifera), venom protein of wasps (Polistes sp.) and venom protein of yellow jacket (Vespula sp.), commonly known as the European Wasp. Final containers of freeze dried venom products are sealed under vacuum. This will result in the diluting fluid being forcibly drawn into the sealed vial when the syringe needle penetrates the seal during reconstitution (see 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Albey Honey Bee Venom, Wasp Venom and Yellow Jacket Venom are indicated for the diagnosis and treatment of hypersensitivity to honey bee venom, wasp venom and yellow jacket venom respectively. 4.2 D OSE AND METHOD OF ADMINISTRATION These freeze dried products should be dissolved in Albumin-Saline to a concentration of 100 μg/mL. Dilutions of this concentration should be made only with Albumin-Saline. (See 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and 4.2 DOSE AND METHOD OF ADMINISTRATION for details of dilutions for diagnosis and treatment.) Version 5.5 2 SKIN TESTING Prick testing should be done before intradermal testing. In both the prick and intradermal tests, a negative control test with diluent alone must be performed. The flexor surface of the forearm is the usual location for skin testing. It is impo Lire le document complet