Երկիր: Նոր Զելանդիա
Լեզու: անգլերեն
Աղբյուրը: Medsafe (Medicines Safety Authority)
Wasp venom protein 550ug (Yellow jacket)
Stallergenes Greer New Zealand Ltd
Wasp venom protein 550 µg (Yellow jacket)
550 mcg
Powder for injection
Active: Wasp venom protein 550ug (Yellow jacket) Excipient: Mannitol Albumin Phenol Sodium chloride Sodium octanoate Water for injection
Combination pack, active + diluent, 550 �g
Prescription
Prescription
Vespa Laboratories
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.
Package - Contents - Shelf Life: Combination pack, active + diluent - 550 ?g - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 months reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). at 100 µg/mL - see file for other strengths - Vial, glass, 3 x 1.8mL - 5.4 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, - 9 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, - 550 ?g - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1984-03-08
CONSUMER MEDICINE INFORMATION: 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: 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 purpose. ASK YOUR DOCTOR IF YO Կարդացեք ամբողջական փաստաթուղթը
Ver 2.5 Page 1 of 12 1 PRODUCT NAME ALBEY VENOM POWDER FOR INJECTION ALBEY BEE VENOM 550 ΜG (_Apis mellifera_) ALBEY YELLOW JACKET VENOM 550 ΜG (_Vespula spp. venom_) ALBEY PAPER WASP VENOM 550 ΜG (_Polistes spp.venom_) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The freeze dried honey bee venom consists of 550 μg protein 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 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 Therapeutic 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 Dose 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 Dosage and method of administration for details of dilutions for diagnosis and treatment). 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 important that a separate sterile syringe and needle be used for each extract and each patient. Prick tests are accomplished using a solution of 1 μg/mL venom protein. See Կարդացեք ամբողջական փաստաթուղթը