Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Bayer
ALBAY Honeybee Venom (Apis mellifera) ALBAY Honeybee Venom Treatment Set ALBAY Honeybee Venom Maintenance Set ALBAY Albumin-saline diluent ALBAY ® FOR SUBCUTANEOUS INJECTION USAGE GUIDE Please read this leaflet carefully before treatment commences PROPRIETARY NAME (and dosage form): ALBAY Honeybee Venom (Apis mellifera) T/30.1/699 ALBAY Honeybee Venom Treatment Set T/30.1/700 ALBAY Honeybee Venom Maintenance Set T/30.1/701 ALBAY Albumin-saline diluent T/30.1/703 DESCRIPTIVE NAME OF MEDICINE: Allergen diagnostic and hyposensitization treatment. PHARMACOLOGICAL CLASSIFICATION: A 30.1 Antigens SCHEDULING STATUS: S4 COMPOSITION: ALBAY lyophilised honeybee venom contains 2% (m/v) mannitol. ALBAY albumin saline diluent for reconstruction and dilution contains sodium chloride 0,9%, phenol 0,4%, normal human serum albumin 0,03% and sterile water. IDENTIFICATION: ALBAY honey bee venom is supplied in 10 mL vacuum-sealed vials each containing 550 micrograms (550 µg) freeze- dried venom protein. Sufficient ALBAY albumin-saline for reconstruction and dilution is included in the set. PHARMACOLOGICAL ACTION OF THE MEDICINE: Diluted solutions of honeybee venom injected intradermally will produce wheal and erythema reactions in patients who have significant IgE mediated Type I immediate hypersensitivity to stings of these insects. Repeated injections of increasing doses of honeybee venom extracts have been shown to ameliorate the intensity of allergic symptoms upon subsequent honeybee stings. Once maintenance level has been reached and maintained, reactions to honeybee stings have been shown to decrease considerably. INDICATIONS: 1. Diagnosis of allergy to honeybee stings. 1. Diagnosis of allergy to honeybee stings. 2. Hyposensitisation of patients allergic to honeybee stings. The usual precautionary measures applied by allergi Read the complete document