INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
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.
2.	Hyposensitisation of patients allergic to honeybee stings. The usual precautionary measures applied by allergic patients should never be relaxed.

CONTRA-INDICATIONS:
Hyposensitization should be avoided in patients with a bleeding tendency.

Since routine immunizations have been suspected of exacerbating auto-immune diseases, hyposensitization should be given cautiously to patients with other immunological diseases and only if the risk from insect stings is greater than the risk of exacerbating the underlying disorder.

Safety during pregnancy has not been established.

WARNINGS:
The product has not been tested under South African conditions.

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.

DOSAGE AND DIRECTIONS FOR USE:

1.	SKIN TESTING
	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.
2.	TREATMENT
	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.

Administration
ALBAY honeybee venom after reconstitution and dilution should be administered by SUBCUTANEOUS injection on the lower outer portion of the upper arm and by using a tuberculin syringe.

Reconstitution
ALBAY vacuum packed pure honeybee venom is reconstituted by adding 5,5 mL of ALBAY albumin-saline diluent to the vial using a sterile syringe.
The concentration of venom will be 100 µg/mL from which further dilutions are to be prepared. Swirl or rock the container to dissolve the venom completely.
DO NOT SHAKE, since this leads to foaming which can cause denaturation (inactivation) of the venom protein.
Record the 6 months expiry date of the reconstituted product in the space provided on the 100 µg/mL vial label.

N.B. The date of expiry after reconstitution MUST NOT exceed the final expiry date indicated on the box.

Dilutions:
Dilutions are made from the reconstituted solution by using the three 1,8 mL vials of albumin-saline diluent supplied. Aseptic technique should be used throughout. After dilution the concentration and expiry date of the contents should be recorded in the appropriate space on each vial label.

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.

THEN

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.

{Illustrated here}

Initial Treatment

Doses 1 - 15 to be administered at weekly intervals

Dose No.	Volume of 1 µg/mL	Dose No.	Volume of 10 µg/mL	Dose No.	Volume of 100 µg/mL
1 2 3 4	0,05 mL 0,1 mL 0,2 mL 0,4 mL	5 6 7 8	0,05 mL 0,1 mL 0,2 mL 0,4 mL	9 10 11 12 13 14 15	0,05 mL 0,1 mL 0,2 mL 0,4 mL 0,6 mL 0,8 mL 1,0 mL

Dose	Dilution	mL	Date	Remarks
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15

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.

Maintenance Therapy:
At present there is no evidence on which to base the duration of treatment for insect allergy and current recommendations are that maintenance injections should be continued for at least five years.

Maintenance therapy consists of subcutaneous injections of 1 mL of the 100 µg/mL concentration administered at four to six week intervals as follows:

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

In the second year of therapy the top dose may be administered at 6 week intervals

Dose	Dilution	mL	Date	Remarks
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Please also refer to the WARNINGS:

ALWAYS determine, and record, weather any reaction occurred after the previous injection before administering the next.

If a wheal and/or erythema of 1 - 3 cm appears after an injection the same dose is repeated at subsequent patient visits until the diameter of the local reaction is 1 cm or less. If the local reaction is larger than 3 cm in diameter, the next dose is reduced to the level of the last tolerated dose. If a systemic reaction occurs, the next dose is reduced to one-tenth of the last tolerated dose.

Local reactions at the site of injection in the form of a wheal or swelling occur frequently. If the swelling persists the dosage may need adjustment. Prolonged pain, or pain radiating up the arm is an indication that the injection has been given intramuscularly and not subcutaneously as recommended. Frequent application of cold to the area will ameliorate the discomfort. Reactions usually subside in 24 - 36 hours. Adrenal corticosteroids can be used to hasten clearing of the local reaction.

Systemic reactions which may range from mild to life-threatening anaphylaxis can occur at any time after skin testing or hyposensitization.

If a systemic reaction does occur, inject intramuscularly or subcutaneously 0,3 to 0,5 mL of 1:1000 adrenaline injection into the opposite arm. The dose may be repeated in 5 - 10 minutes if necessary. The adrenaline injection 1:1000 dose for children is 0,01 mL per kg body mass. If adrenaline injection is ineffective, intravenous fluids and vasoactive drugs may be needed to reverse lowered blood pressure. Oxygen should be given by mask.

Intravenous antihistamine, theophylline, ethylenediamine or adrenal corticosteroids may be used if necessary, after adrenaline and circulatory support have been given.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of an anaphylactic reaction from overdose or inadvertent injection into the blood stream, treat with adrenaline as directed under SIDE EFFECTS AND SPECIAL PRECAUTIONS.

PRESENTATION:
ALBAY Honeybee Venom Treatment Set:
550 µg of freeze dried venom in a vacuum-sealed vial and 1 vial containing 9,0 mL Albumin-Saline diluent and 3 vials containing 1,8 mL Albumin-Saline diluent

ALBAY Honeybee Venom Maintenance Set:
550 µg of freeze dried venom in a vacuum-sealed vial and 1 vial containing 9,0 mL Albumin-Saline diluent

ALBAY Albumin-saline diluent:
Vials containing either 9,0 mL or 1,8 mL of albumin-saline diluent

STORAGE INSTRUCTIONS:
Store the vials of freeze-dried honeybee venom, the albumin-saline diluent and the reconstituted product between 2° and 8°C.
DO NOT FREEZE
KEEP OUT OF REACH OF CHILDREN.

NAME AND ADDRESS OF APPLICANT:
BAYER (PTY) LTD
27 Wrench Road
ISANDO 1600
(Reg. No. 68/11192/07)

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 1995

ZIMBABWE: PP 85/18.1.4/1888

ALBAY^® is a registered trade mark

WARNING:
A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

C3021/0496
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