Albey Paper Wasp Venom
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
19-04-2020
Summary of Product characteristics
(SPC)
03-07-2019
Active ingredient:
Wasp venom protein 550ug (Polistes)
Available from:
Stallergenes Greer New Zealand Ltd
INN (International Name):
Wasp venom protein 550 µg (Polistes)
Dosage:
550 mcg
Pharmaceutical form:
Powder for injection
Composition:
Active: Wasp venom protein 550ug (Polistes) Excipient: Mannitol Albumin Phenol Sodium chloride Sodium octanoate Water for injection
Units in package:
Combination pack, active + diluent, 550 �g
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Vespa Laboratories
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.
Product summary:
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)
Authorization date:
1981-09-24
Patient Information leaflet
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
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Summary of Product characteristics
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
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