ALBEY BEE VENOM honey bee venom 550 microgram powder for injection vial with 4 vials of Albumin saline diluent

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

honey bee venom, Quantity: 550 microgram

Tilgjengelig fra:

Stallergenes Australia Pty Ltd

INN (International Name):

honey bee venom

Legemiddelform:

Injection, powder for

Sammensetning:

Excipient Ingredients: mannitol; sodium chloride

Administreringsrute:

Intradermal, Intraepidermal, Subcutaneous

Enheter i pakken:

Pack containing one vial of freeze-dried bee venom 550 micrograms with 3 x 1.8ml vials of albumin-saline diluent and 1 x 9ml vial of albumin-saline diluent.

Klasse:

Medicine Registered

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Indicated use of allergenic extracts is for the diagnosis and treatment (hypo-sensitization therapy) of patients who experience allergic symptoms.

Produkt oppsummering:

Visual Identification: White lyophilised powder which when reconstituted with diluent, is a clear yellow to brown hue;

Autorisasjon status:

Registered

Autorisasjon dato:

2010-09-20

Informasjon til brukeren

CONSUMER MEDICINE INFORMATION:
Version 3.3
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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:
Version 3.3
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
purpos

Preparatomtale

Version 5.5
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AUSTRALIAN PRODUCT INFORMATION – ALBEY (ALBEY BEE VENOM
(APIS MELLIFERA) ALBEY YELLOW JACKET VENOM (VESPULA SPP.
VENOM) ALBEY PAPER WASP VENOM (POLISTES SPP.VENOM))
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
ALBEY BEE VENOM (_Apis mellifera_)
ALBEY YELLOW JACKET VENOM (_Vespula spp. venom_)
ALBEY PAPER WASP VENOM (_Polistes spp.venom_)
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QUALITATIVE AND QUANTITATIVE COMPOSITION
The freeze dried honey bee venom consists of 550 μg protein / vial
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 List of excipients.
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
T
HERAPEUTIC 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
D
OSE 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 DOSE AND METHOD OF
ADMINISTRATION for details of dilutions for diagnosis and treatment.)
Version 5.5
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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 impo