Problems with immunotherapy - allergy testing/shots (ingredients)

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ingredients in allergy shots

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www.mgh.harvard.edu/forum/CreutzfeldtJakobsF/Albumininallergyex

tract.html

Albumin in allergy extract

This response submitted by Zambenini , RN on 2/7/98.

Email Address: lzambeni@...

Ask any allergist what the " diluents " are. They are either a

combination of HSA (human serum albumin),normal saline, and phenol OR

glycerol, normal saline and phenol. The glycerol based solution is

almost always used for skin testing since it has higher viscosity and

thus tends not to " bleed " into adjacent test sites and obscure

results. From my experience working in an Immunization/Travel clinic

it seems most extracts are HSA based, not glycerol. Glycerol is not

used as often because it tends to cause more reactivity and sterile

abcesses especially at larger doses. All this info can be found in

the " Immunofacts " book which we have at our office -it is an

excellent resource book on vaccines and immunobiologicals. I can get

you the publisher and ISBN # if you want it. Also, patients who are

RAST tested for allergies (blood test) instead of skin tested have

their allergy extracts ordered from and produced by large

pharmaceutical companies who deal in immunobiologicals, rather than

having the allergist formulate them in the office. Bayer and Allermed

are a couple of the companies that come to mind. When we get these

vials of allergy extract to administer to a patient they come with

extensive package inserts (you practically need a microscope to read)

just like any other prescription drug. They all use different

formulations - some mix cat pelt allergen using the HSA mixture,

others use this for their dust mites etc... I have read this on the

ingredient list on the package inserts. HSA is used as a protein

stabilizer (as is glycerol) to extend shelf life. Without HSA or

glycerol (ie: just normal saline and phenol} the allergy extract is

only good a short time- I beleive just a few hours or days. Maybe you

could get a package insert from an allergist that employs RAST

testing, or from Bayer if you are interested. Allergy extract

formulated in the allergist's office almost never list the diluents

used - just the allergens (cat,dust, mold, ragweed, pollens,

cockroach,dog etc...).

I learned about allergy extract diluents accidently about 2 weeks ago

when I was flipping through our " Immunofacts " book looking for some

info about a vaccine. There was a single page dedicated to allergenic

diluents - I was quite surprised to learn that HSA was used. I always

thought they were formulated with saline or glycerol and phenol. I

also get allergy shots and contacted my allergist. Sure enough my

dust mites vial was diluted with the HSA diluent. I asked my

allergist to reformulate it and told him my concerns. He has agreed

to do this but made a point of saying it is FDA approved , which it

is. However, I choose to have control over what goes in my body till

more is known. I do not beleive non-essential products (like allergy

extracts) should contain HSA; till more is known these should be

reformulated , which is possible, to eliminate any risk.

http://www.greerlabs.com/47.aspx

WARNINGS

Concentrated extracts must be diluted with a sterile diluent (such as

normal saline, buffered saline, saline with human serum albumin, or

saline with 10% glycerin) prior to use in a patient for intradermal

testing. Concentrates of Allergenic Extracts are manufactured to

assure high potency and have the ability to cause serious local and

systemic reactions including death in sensitive patients. Most

reactions occur within 20 minutes after injection, but may occur

later. To minimize the potential for local or systemic reactions, the

relative sensitivity of the patient must be assessed from the

allergic history and from clinical observations. Patients should be

informed of the possibility of these reactions and the precautions

should be discussed prior to testing

http://www.wramc.amedd.army.mil/departments/allergy/CAEL/product.htm

1. Aqueous Extract Solutions Sterile aqueous stock solutions comprise

the vast majority of allergen extracts on the shelves of the USACAEL.

A typical aqueous extract solution as prepared by our contract

manufacturer, Bayer Laboratories, will contain the active ingredients

or allergens as noted on the label (pollen, dander, molds, dust

etc.). The preservative is 50% V/V glycerin, 0.4% phenol or in a few

instances where phenol cannot be used 0.1% thimerosal. Additional

ingredients include 0.5% sodium chloride and 0.275% sodium

bicarbonate. These solutions should be clear and free from any

particulate matter. The supplied concentration of these solutions is

usually expressed as Protein Nitrogen Units per ml (ie. 10,000 or

20,000 PNU/ml) or Weight per Volume (ie. 1:10 or 1:20 W/V)

concentrations from the manufacturer. The large part of our inventory

(attached) are stocked at PNU/ml and W/V concentrations. The FDA is

working hard to better standardize allergen extract products. The

continued utilization of these products and scientific advances have

aided in the gradual refinement of earlier allergen extract products.

The perfect allergenic extract as been defined as one that contains

all the potential allergens in their native form, in the proper ratio

and with all irrelevant material removed. Currently, however, only a

few relevant " allergens " have been isolated in only a small number of

extract products (Fel d 1 or Cat Allergen 1 in Cat extracts and

Antigen E in Short ragweed extract for example).

Diluents and Preservatives Dilutions of concentrated extracts

prepared for diagnostic testing materials and treatment sets retain

potency longer when diluted with Human Serum Albumin saline diluent

(HSA) than with plain buffered or phenol saline alone. Glycerin is a

superb stabilizer and extracts in 50% solution retain their potency

for considerable periods of time. It must be noted, however, that

when extracts containing more than 10% glycerin are injected, a

burning sensation occurs at the site of injection which is not well

tolerated by patients. Thus, intradermal testing materials (ID) are

diluted with HSA diluent rather than a 50% glycerin solution. Prick

or scratch testing materials, on the other hand, may be diluted and

stabilized with glycerin. This is due to the fact that glycerin is

not irritating on the surface of the skin. Thus, prick or scratch

testing materials are in 50% glycerin. Immunotherapy treatment sets

for patients are diluted down with HSA diluent except where Center-

Al or Allpyral extracts are being used. In instances where these alum-

precipitated extracts are being used the preferred diluent is phenol

saline diluent (0.9% sodium chloride and 0.4% phenol).

Finally found a package insert!

http://www.hollister-stier.com/download_pdfs/385407-H02.pdf

OVERDOSAGE: See ADVERSE REACTIONS Section.

DOSAGE AND ADMINISTRATION:

1. General

Sterile aqueous diluent containing albumin (human) [Albumin Saline

with Phenol (0.4%)] or diluent

of 50% glycerin may be used when preparing dilutions of the

concentrate for immunotherapy. For

intradermal testing dilutions, Albumin Saline with Phenol (0.4%) is

recommended.

Dilutions should be made accurately and aseptically, using sterile

diluent, vials, syringes, etc. Mix

thoroughly and gently by rocking or swirling.

Parenteral drug products should be inspected visually for particulate

matter and discoloration prior

to administration whenever solution and container permit.

--------------------------------------------------------

Sheri Nakken, R.N., MA, Classical Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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