FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Allergen Pack Gs Ragweed Mix Kit Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Allergenic extracts can elicit adverse local and systemic reactions if initial dosage or rate of dosage increase is too high. These factors must be carefully evaluated by the
physician based on history, degree of sensitivity, and skin test results prior to commencement or continuation of therapy. Any person administering a biological
product should be aware of the risk of local or systemic reactions if improperly used and be capable of handling such reactions. (See below under Adverse Reactions.)
Patients receiving allergenic extracts should be kept under observation a minimum of thirty (30) minutes so that any adverse reaction can be observed and properly
handled. See information above in Description category for information on transferring patients from non-standardized to standardized extracts.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Hyposensitization is indicated when careful testing and patient history can pinpoint allergens responsible for allergic symptoms, and when it is not possible or practical to
avoid these allergens. Allergenic extracts are administered to reduce symptoms of allergy of a seasonal or perennial nature.
History
There is currently no drug history available for this drug.
Other Information
Each vial contains an extract of Short Ragweed (Ambrosia elatior) pollen or of equal parts Short and Giant Ragweed (A. trifida) pollen extracts. Extracts are supplied in a buffered saline solution with or without glycerin (50%) added as a stabilizer. Extracts are supplied as a sterile solution intended for subcutaneous or intracutaneous administration.
Each lot of Short Ragweed extract or Mixed Ragweed extract is assayed for Antigen E content using a radial immunodiffusion test1 employing known Antigen E
standards and anti-Antigen E antisera. Extracts containing Short Ragweed at a concentration of 1:20 or stronger are assayed for Antigen E. Extracts more dilute
than this are not assayed but the Antigen E content is obtained by calculation based on the Antigen E content of the concentrate.
Antigen E, a protein with a molecular weight of approximately 38,000, has been found to be a major antigenic component of Short Ragweed pollen.2,3 Antigen E
content has been shown to correlate well with skin test reactivity of ragweed extracts.4 For this reason, Antigen E content is being used to standardize Short
Ragweed extracts in addition to the protein nitrogen content or weight to volume ratios as have been used.
When transferring patients from non-standardized extracts to a standardized extract, it is advisable to compare the potency of the different lots by comparative skin testing
using the same concentrations of each extract. Marked differences in skin reactivity will indicate differences in potency and the need to adjust dosages so as to avoid
possible severe reaction.
Sources
Allergen Pack Gs Ragweed Mix Kit Manufacturers
-
Alvix Laboratories, Llc
Allergen Pack Gs Ragweed Mix Kit | Alvix Laboratories, Llc
Testing1. Scratch and Prick testing normally employ 1:20 glycerinated extracts, which contain 125-250 units Antigen E per mL (Short Ragweed) or 75-150 units
Antigen E per mL (Ragweed Mix).
2. Intradermal testing with Short Ragweed and G.S. Ragweed Mix is routinely performed using 1:1000 w/v and 1,000 PNU/mL or more dilute material. It has
been reported that as little as 10-6 unit (0.000001 μg) is sufficient to cause a positive skin test. In another study of 25 Antigen E sensitive individuals, the
dose required for a 2+ reaction (8-10 mm wheal) ranged from 10-6 to 10-1 μg Antigen per mL using a 0.5 mL dose.Individual sensitivity to Ragweed extracts will vary greatly and it is recommended that intradermal testing be started at low concentrations (i.e. 0.05 mL at 0.1 μg/mL- dose equals 0.005 μg Antigen E). If no reaction occurs, testing may be repeated with a stonger dilution.
TreatmentInitial and subsequent treatment dosage must be based on careful testing procedures and evaluation of patient history. Studies have shown a definite correlation between symptom amelioration and maximum or cumulative dosage achieved. One study5 has shown significant clinical improvement with an average cumulative preseasonal dosage equivalent to 252 μg of Antigen E, but no significant improvement with an average cumulative dosage of 32 μg Antigen E. In another study8 a mean cumulative dosage of 84.9 μg Antigen E (as whole ragweed extract) was significantly effective in reducing allergenic symptoms compared to placebo.
The dosage schedule shown below, based on Antigen E content, will deliver approximately 85 μg Antigen E in 18 injections. Initial and subsequent treatment dosage must be based on careful testing procedures and patient history. Highly sensitive individuals will require lower initial dosage, more moderate dosage increase, and may not tolerate as high a maintenance dosage as the moderately sensitive individual. The suggested schedule shown below is for a moderately sensitive individual and must be modified by the physician to suit each patient if necessary.
SUGGESTED DOSAGE SCHEDULE
OF SHORT RAGWEED AND G.S. RAGWEED MIX
ANTIGEN E STANDARDInjection Number
Vial Number
Antigen E per mL
Volume (mL)
Dose AgE
1
1
0.3
0.05
0.015
2
1
0.3
0.10
0.03
3
1
0.3
0.20
0.06
4
1
0.3
0.40
0.12
5
1
0.3
0.70
0.21
6
2
3.0
0.10
0.30
7
2
3.0
0.20
0.60
8
2
3.0
0.30
0.90
9
2
3.0
0.50
1.50
10
2
3.0
0.70
2.10
11
3
3.0
0.10
3.0
12
3
3.0
0.15
4.50
13
3
3.0
0.20
6.00
14
3
3.0
0.30
9.00
15
3
3.0
0.40
12.00
16
3
3.0
0.50
15.00*
17
3
3.0
0.50
15.00*
18
3
3.0
0.50
15.00*
*Maintenance dosage
It is recommended that patients receive injections at five to seven day intervals until maintenance dosage is achieved. Maintenance dosage can be given at 2 to 4 week
intervals. All doses of allergenic extract are administered subcutaneously in the lateral aspect of the upper arm or thigh. Avoid injecting directly into any blood vessel
and use a 26 or 27 gauge needle 3/8" in length.1. Scratch and Prick testing normally employ 1:20 glycerinated extracts, which contain 125-250 units Antigen E per mL (Short Ragweed) or 75-150 units
Antigen E per mL (Ragweed Mix).
2. Intradermal testing with Short Ragweed and G.S. Ragweed Mix is routinely performed using 1:1000 w/v and 1,000 PNU/mL or more dilute material. It has
been reported that as little as 10-6 unit (0.000001 μg) is sufficient to cause a positive skin test. In another study of 25 Antigen E sensitive individuals, the
dose required for a 2+ reaction (8-10 mm wheal) ranged from 10-6 to 10-1 μg Antigen per mL using a 0.5 mL dose.Individual sensitivity to Ragweed extracts will vary greatly and it is recommended that intradermal testing be started at low concentrations (i.e. 0.05 mL at 0.1 μg/mL- dose equals 0.005 μg Antigen E). If no reaction occurs, testing may be repeated with a stonger dilution.
TreatmentInitial and subsequent treatment dosage must be based on careful testing procedures and evaluation of patient history. Studies have shown a definite correlation between symptom amelioration and maximum or cumulative dosage achieved. One study5 has shown significant clinical improvement with an average cumulative preseasonal dosage equivalent to 252 μg of Antigen E, but no significant improvement with an average cumulative dosage of 32 μg Antigen E. In another study8 a mean cumulative dosage of 84.9 μg Antigen E (as whole ragweed extract) was significantly effective in reducing allergenic symptoms compared to placebo.
The dosage schedule shown below, based on Antigen E content, will deliver approximately 85 μg Antigen E in 18 injections. Initial and subsequent treatment dosage must be based on careful testing procedures and patient history. Highly sensitive individuals will require lower initial dosage, more moderate dosage increase, and may not tolerate as high a maintenance dosage as the moderately sensitive individual. The suggested schedule shown below is for a moderately sensitive individual and must be modified by the physician to suit each patient if necessary.
SUGGESTED DOSAGE SCHEDULE
OF SHORT RAGWEED AND G.S. RAGWEED MIX
ANTIGEN E STANDARDInjection Number
Vial Number
Antigen E per mL
Volume (mL)
Dose AgE
1
1
0.3
0.05
0.015
2
1
0.3
0.10
0.03
3
1
0.3
0.20
0.06
4
1
0.3
0.40
0.12
5
1
0.3
0.70
0.21
6
2
3.0
0.10
0.30
7
2
3.0
0.20
0.60
8
2
3.0
0.30
0.90
9
2
3.0
0.50
1.50
10
2
3.0
0.70
2.10
11
3
3.0
0.10
3.0
12
3
3.0
0.15
4.50
13
3
3.0
0.20
6.00
14
3
3.0
0.30
9.00
15
3
3.0
0.40
12.00
16
3
3.0
0.50
15.00*
17
3
3.0
0.50
15.00*
18
3
3.0
0.50
15.00*
*Maintenance dosage
It is recommended that patients receive injections at five to seven day intervals until maintenance dosage is achieved. Maintenance dosage can be given at 2 to 4 week
intervals. All doses of allergenic extract are administered subcutaneously in the lateral aspect of the upper arm or thigh. Avoid injecting directly into any blood vessel
and use a 26 or 27 gauge needle 3/8" in length.
Login To Your Free Account