|1.||Diagnosis of allergy to honeybee stings.|
|2.||Hyposensitisation of patients allergic to honeybee stings.|
The usual precautionary measures applied by allergic patients should never be relaxed.
|HYPOSENSITIZATION INJECTIONS SHOULD NEVER BE GIVEN INTRAVENOUSLY.|
Hypersensitivity to bee stings can be acute and severe systemic reactions may result from the use of any pure venom preparation.
Systemic reactions can range from mild to life threatening anaphylaxis. Some form of systemic reaction can be expected in up to one third of the patients tested.
Doctors administering venom, whether performing initial sensitivity testing or hyposensitisation, should be experienced in both administering hyposensitisation therapy and in the treatment of severe systemic reactions. Adrenaline injection, emergency equipment and trained personnel should be at hand.
The patient should be fully informed of the possible risks and should be closely observed for at least 60 minutes after each injection.
Patients should be instructed to avoid medication such as antihistamines for a period of 72 hours or more prior to skin testing, as well as hyposensitisation therapy, since such medicines may interfere with the allergic response, which could indicate specific sensitivity and thus future regulation of dosage.
|Skin tests and specific IgE levels are mainly done to identify the stinging insect as well as the level of sensitivity of the patient. This information should be used in conjunction with the most recent specific case history of the patient.|
|The levels of venom which will give a positive skin test vary considerably from patient to patient and because of the intense allergenic potency of insect venoms, prick tests carried out with titration are recommended.|
|The initial concentration should be no greater than 1 µg/mL.|
|Patients should not be skin-tested until 4 to 6 weeks after any sting.|
|If prick testing is negative, intradermal testing should start with a concentration of 0,001 µg/mL.|
|If these results are negative, hyposensitisation should not be considered. If any of the concentrations show a positive reaction the patient should start at the recommended 1 µg/mL concentration.|
|It is recommended that albumin-saline diluent is used as a negative control.|
|Note: Extra diluents are available on request.|
|Hyposensitisation using ALBAY honeybee venom is recommended only for patients who demonstrate a clear history of reagin mediated allergenic reactions combined with a positive specific IgE or skin test. The patient's case history is of utmost importance. Where symptoms of a systemic nature have been recorded, the case history would be classified as a Type 1 allergic response.|
|Since individual patient's sensitivity to venom differs, it is not possible to provide a universally suitable dosage schedule. The schedule shown below used in clinical trials has been found suitable for the majority of patients.|
|N.B. See Precautions for any adverse reactions.|
|1.||Take 0,2 mL from the 100 µg/mL vial and add to the first 1,8 mL vial of diluent giving a concentration of 10 µg/mL with a one month expiry date.|
|2.||Then take 0,2 mL from the 10 µg/mL vial and add to the second 1,8 mL vial of diluent giving a concentration of 1 µg/mL with a one month expiry date.|
|Please note that after preparing the second dilution the remaining 10g/mL solution must be immediately discarded. Use the 1 µg/mL concentration for the first month's treatment.|
|3.||Again take 0,2 mL from the 100 µg/mL vial and add to the third 1,8 mL vial of diluent giving a concentration of 10 mg/mL with a one month expiry date. Use this for doses 5 - 8 inclusive during the second month of treatment.|
|4.||For the third and subsequent months of treatment (dose 9 onwards) use directly from the 100 µg/mL vial which has a six month expiry date.|
|Dose No.||Volume of 1 µg/mL||Dose No.||Volume of 10 µg/mL||Dose No.||Volume of 100 µg/mL|
|Venom concentration||Diluent||Recommended Expiry Date|
|100 µg/mL||Albumin-Saline||6 months|
|10 µg/mL||Albumin-Saline||1 month|
|1 µg/mL||Albumin-Saline||1 month|
|Note:||The date of expiry after reconstitution must not exceed the final expiry date indicated on the box.|
|Dose No.||Volume of 100 µg/mL||Date of Administration|
|16||1 mL||1 week after dose No.15|
|17||1 mL||2 weeks after dose No.16|
|18||1 mL||3 weeks after dose No.17|
|19||1 mL||4 weeks after dose No.18|
|further doses||1 mL||4 weeks after preceding dose|
|ZIMBABWE: PP 85/18.1.4/1888|