Pollens – Weeds And Garden Plants
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Side Effects & Adverse Reactions
See WARNINGS box at the beginning of this package insert. See also PRECAUTIONS.
Allergenic extracts must be temporarily withheld from patients or the dose adjusted downward if any of the following conditions exist: (1) severe symptoms of rhinitis and/or asthma; (2) infection or flu accompanied by fever; (3) any evidence of an excessively large local or generalized reaction during the initial stages of immunotherapy or during maintenance therapy, and/or (4) exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection.
Do not administer immunotherapy during a period of symptoms due to exposure. Since the individual components of the extract are those to which the patient is allergic, and to which s/he will be exposed, typical allergic symptoms may follow shortly after the injection, particularly when the antigen load from exposure plus the injected antigen exceeds the patient's antigen tolerance.
THE CONCENTRATE MUST NOT BE INJECTED AT ANY TIME UNLESS TOLERANCE HAS BEEN ESTABLISHED. DILUTE CONCENTRATED EXTRACTS WITH STERILE DILUENT FOR INTRADERMAL TESTING AND IMMUNOTHERAPY.
INJECTIONS MUST NEVER BE GIVEN INTRAVENOUSLY. Subcutaneous injection is recommended. Intracutaneous or intramuscular injection may produce large local reactions or be excessively painful. AFTER INSERTING NEEDLE SUBCUTANEOUSLY, BUT BEFORE INJECTING, ALWAYS WITHDRAW THE PLUNGER SLIGHTLY. IF BLOOD APPEARS IN THE SYRINGE, CHANGE NEEDLE AND GIVE THE INJECTION IN ANOTHER SITE.
IF THE EXTRACT PREVIOUSLY USED WAS FROM ANOTHER MANUFACTURER: Since manufacturing processes and sources of raw materials differ among manufacturers, the interchangeability of extracts from different manufacturers cannot be insured. The starting dose of the extract therefore should be greatly decreased even though the extract is the same formula and dilution. In general, a dose reduction of 50% of the previous product dose should be adequate, but each situation must be evaluated separately considering the patient's history of sensitivity, tolerance of previous injections, and other factors. If the patient tolerates a 50% decrease, the next dose could be raised to the previous dose amount. If the decrease is greater than 50%, the next dose would need to be determined by the allergist, depending on the situation. Dose intervals should not exceed one week when rebuilding dose. See DOSAGE AND ADMINISTRATION.
IF A PROLONGED PERIOD OF TIME HAS ELAPSED SINCE THE LAST INJECTION: Patients may lose tolerance for allergen injections during prolonged periods between doses. The duration of tolerance is an individual characteristic and varies from patient to patient. In general, the longer the lapse in the injection schedule, the greater dose reduction required. If the interval since last dose is over four weeks, perform skin tests to determine starting dose. See DOSAGE AND ADMINISTRATION.
IF THE PREVIOUS EXTRACT WAS OUTDATED: The dating period for allergenic extracts indicates the time that they can be expected to remain potent under refrigerated storage conditions (2° - 8°C). During the storage of extracts, even under ideal conditions, some loss of potency occurs. For this reason, extracts should not be used beyond their expiration date. If a patient has been receiving injections of an outdated extract, s/he may experience excessive local or systemic reactions when changed to a new and possibly more potent extract. In general, the longer the material has been outdated, the greater the dose reduction necessary for the fresh extract.
IF CHANGING FROM ALUM-ADSORBED TO AQUEOUS OR GLYCERINATED EXTRACTS: When the patient previously has been receiving alum-adsorbed or alum-precipitated extract, the safest course is to start over as though the patient had not been receiving immunotherapy. See DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS. IF ANY OTHER CHANGES HAVE BEEN MADE IN THE EXTRACT CONCENTRATE FORMULA: Changes other than those listed above may include situations such as a redistribution of component parts or percentages, a difference in extracting fluid (i.e., change from non-glycerin extracts to 50% glycerin extracts), combining two or more stock concentrates, or any other change.
It should be recognized that any change in formula can affect a patient's tolerance of the treatment. The usual 1/2 of the previous dose for a new extract may produce an adverse reaction: extra dilutions are recommended whenever starting a revised formula. The greater the change, the greater the number of dilutions required.
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Manufacturer Warnings
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Uses
20, 21, 22, 23 Allergenic extracts are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific environmental allergens. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing.
24, 25
The use of mixes of unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction; while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed antigen.
Statistically controlled blind studies have demonstrated the effectiveness of therapy with Amb a 1.
26 However, double blind studies have demonstrated a greater effectiveness for whole Short Ragweed extract when compared to Amb a 1 alone.
27 Short Ragweed Extracts, standardized on the basis of Amb a 1 extract, would seem to be a logical choice for immunotherapy.
Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen.
History
There is currently no drug history available for this drug.
Other Information
The sterile Short Ragweed or Giant and Short Ragweed Mix Allergenic Extract in this vial may be supplied for scratch, prick or puncture testing; intradermal testing; treatment; or as a "bulk" extract which is designed primarily for the physician equipped to prepare dilutions and mixtures as required.
Each concentrated lot of Short Ragweed and Giant and Short Ragweed Mix is assayed for Amb a 1
3 (also known as Antigen E) and submitted to the Center for Biologics Evaluation and Research for official release
The Amb a 1 concentrations for dilutions of extracts greater than 1:20 w/v have been obtained by calculation from the assayed value. The following is a brief description of the three expressions of concentration applied to these extracts.
1. Weight to volume (w:v). The amount of allergenic source material added to the extracting fluid. A 1:20 extract indicates that the solution contains the extractable material from one gram of raw material added to each 20 mL of extracting fluid. The amount and composition of extracted materials will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables.
2. Protein Nitrogen Units (PNU). One protein nitrogen unit represents 0.00001 mg phosphotungstic acid precipitable protein nitrogen dis solved in one mL of antigen extract. The PNU content of extracts of the same antigen may vary according to the method of measuring the PNU. Thus, the PNU content of extracts from different manufacturers is not comparable unless the PNU method is known to be the same and is reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract.
3. Of the many allergens from Short Ragweed which have been purified and characterized (Amb a 1, Amb a 2
3 (also known as Antigen K),Ra-3
4, Ra-4 (BPA-R)
5, Ra-56, Ra6, Ra
7and Ra8
7, and cytochrome C
8), Amb a 1 is considered the most important and has been selected as the basis for standardization. Extracts of Short Ragweed containing Amb a 1 are diffused in agar against standard anti-serum to Amb a 1, and compared to the diffusion of standard Amb a 1 solutions. The amount of Amb a 1 is expressed as units of Amb a 1 per mL of extract. Amb a 1 units are approximately equal to micrograms previously used to measure Amb a 1 concentration. The Amb a 1 assay therefore provides an absolute measure of extract potency related to the Amb a 1 antigen in Short Ragweed, rather than only an expression of extract strength.
Ingredients: Active ingredients are the allergen(s) noted on the vial label. Preservative is 50% (v/v) glycerin or 0.4% phenol, as indicated on the vial label. Glycerinated extracts contain 0.5% sodium chloride, 0.275% sodium bicarbonate and 50% glycerin (v/v) as a preservative. Non-glycerinated extracts contain 0.5% sodium chloride, 0.275% sodium bicarbonate and 0.4% phenol (w/v) as a preservative.
Sources
Pollens – Weeds And Garden Plants Manufacturers
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Jubilant Hollisterstier Llc
![Pollens – Weeds And Garden Plants, Short Ragweed, Ambrosia Artemisiifolia (Short Ragweed, Ambrosia Artemisiifolia) Injection, Solution Pollens – Weeds And Garden Plants, Short Ragweed, Ambrosia Artemisiifolia (Short Ragweed, Ambrosia Artemisiifolia) Injection, Solution Pollens – Weeds And Garden Plants, Ragweed, Mixed Ambrosia (Ragweed, Mixed Ambrosia ) Injection, Solution [Jubilant Hollisterstier Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pollens – Weeds And Garden Plants | Jubilant Hollisterstier Llc
21, 22, 23
1. General
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Sterile aqueous diluent containing human serum albumin [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. Maintain stock solutions and dilutions constantly at 2° - 8°C.2. Pediatric Use
The dose for the pediatric population is the same as for adults. (See PRECAUTIONS.)
3. Geriatric Use
The dose for the elderly patients is the same as for adult patients under 65.404. Diagnosis
A positive reaction consists of an urticarial wheal with surrounding erythema (resembling somewhat a mosquito bite reaction) larger than the control site. The smallest reaction considered positive is erythema with a central papule at least 5 mm in diameter, however certain skin test devices may elicit a smaller positive reaction. Check the device manufacturer's recommendations. In some instances with no reaction at the control site, erythema may be considered an indication of sensitivity.A positive skin reaction to any allergen must be interpreted in light of the patient's history of symptoms, time of year, and known exposures. THE SKIN TESTS ARE IN NO WAY A SUBSTITUTE FOR A CAREFUL ALLERGIC HISTORY. THEY SERVE AS ADDITIONAL INFORMATION TO AID IN IDENTIFYING CAUSATIVE ALLERGENS IN PATIENTS WITH ALLERGIC DISORDERS.
Skin tests are graded in terms of the wheal and erythema response noted at 15 minutes. Wheal and erythema size may be recorded by actual measurement of the extent of both responses.
Refer to the following table to determine the skin test sensitivity class. The corresponding ∑E (sum of the longest diameter and the mid-point orthogonal diameters of erythema) is also presented.
Class
Wheal Diameter
Erythema Diameter
Corresponding ∑E
0
< 5 mm
<5 mm
<10 mm
±
5-10 mm
5-10 mm
10-20 mm
1+
5-10 mm
11-20 mm
20-40 mm
2+
5-10 mm
21-30 mm
40-60 mm
3+
10-15 mm a
31-40 mm
60-80 mm
4+
>15 mm b
>40 mm
>80 mm
a. or with pseudopods
b. or with many pseudopods
a. Scratch, Prick or Puncture Testing
To identify highly sensitive individuals and as a safety precaution, it is recommended that a scratch, prick or puncture test using a drop of the extract concentrate be performed prior to initiating intradermal testing. Short Ragweed extract at 1:20 w/v in 50% glycerin containing approximately 100 to 300 units of Amb a 1/mL or Giant and Short Ragweed Mix at 1:20 w/v in 50% glycerin containing approximately 50 to 150 units of Amb a 1/mL are usually used for scratch, prick or puncture testing.Scratch tests are performed by first scarifying the skin, then applying the extract to the scratch. Prick tests are performed by placing a drop of extract on the skin and piercing through the drop into the skin with a slight lifting motion. The prick is superficial and should not draw blood. Puncture tests are performed by placing a drop of extract on the skin and piercing through the drop perpendicular to the skin with a device such as a Prick Lancetter. After about 1 minute the extract may be wiped away with a dry sponge.
The diameter of wheal and erythema reactions are measured 15 minutes after the scratch, prick or puncture is made, and the sensitivity class of the patient determined by the table presented at the end of the diagnosis section. Less sensitive individuals (Class 0 to 1+) can be tested intradermally with the recommended dilutions of the extract concentrate (see Intradermal Testing )
b. Intradermal Testing
Intradermal tests should be done only on patients with a negative scratch, prick or puncture test. Patients who do not react to a valid scratch, prick or puncture test should be tested intradermally with 0.02 to 0.05 mL of extract solution. The intradermal strength for Short Ragweed extract is usually 500 PNU which by calculation contains approximately 0.7 to 3 units of Amb a 1/mL. For Giant and Short Ragweed mix, the suggested intradermal strength is 500 PNU which by calculation contains 0.4 to 1.5 units of Amb a 1/mL. These strengths are usually safe for testing patients previously having negative scratch, prick or puncture test reactions. A 1:10 dilution of the stock intradermal strength should be used in preliminary testing of patients not previously screened by scratch, prick or puncture tests. If the intradermal dilutions were prepared from glycerinated concentrate, the negative control used with this latter dilution should contain 5% glycerol. A site should be injected with 0.02 mL of the control solution. False positive reactions are sometimes encountered in intradermal testing and the possibility of irritation reactions should always be taken into consideration.
A study of ragweed sensitive patients, 42 indicates that intradermal tests, using 0.05 mL of extract, produce positive reactions (1+ to 2+) at Amb a 1 concentrations of 2.7x10 -1 to 2.7x10 -6 units per mL. The equivalent PNU range was 100 to 0.001 PNU per mL.5. Immunotherapy
Dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, his or her clinical response, and tolerance to the extract administered during the early phases of an injection regimen.Allergen extracts should be administered using a sterile syringe with 0.01 mL gradations and a 25-27 gauge X 1/2" to 5/8" needle. The injections are given subcutaneously. The most common sites of injection are the lateral aspect of the upper arm or thigh. Intracutaneous or intramuscular injections may produce large local reactions which may be very painful.
To prepare dilutions for intradermal and therapeutic use, make a 1:10 dilution by adding 1.0 mL of the concentrate to 9.0 mL of the sterile aqueous diluent. Subsequent serial dilutions are made in a similar manner.
Following is a suggested schedule for average patients that will be satisfactory in most cases. However, the degree of sensitivity varies in many patients. The size of the dose should be adjusted and should be regulated by the patient's tolerance and reaction. Decrease the size of the dose if the previous injection resulted in marked local or the slightest general reaction. Another dose should never be given until all local reactions resulting from the previous dose have disappeared.
The starting dose should be based on skin tests of the extract to be used for immunotherapy. To determine the starting dose, begin intradermal testing with the most dilute extract preparation. Inject 0.02 mL and read the reaction after 15 minutes. Intradermal testing is continued with increasing concentrations of the extract until a reaction of 10-20 mm erythema (∑E 20-40 mm) and/or a 5 mm wheal occurs. This concentration at a dose of 0.03 mL then can serve as a starting dose for immunotherapy and be increased by 0.03 mL to as high as 0.12 mL increments each time until 0.3 mL is reached, at which time a dilution 10 times as strong can be used, starting with 0.03 mL. Proceed in this way until a tolerance dose is reached or symptoms are controlled. Suggested maintenance dose is 0.2 mL of the concentrate. Occasionally, higher doses are necessary to relieve symptoms. Special caution is required in administering doses greater than 0.2 mL. The interval between doses is normally 3 to 7 days during dose building regimen.
In some patients, the dosage may be increased more rapidly than called for in the schedule. In seasonal allergies, treatment should be started and the interval between doses regulated so that at least the first 20 doses will have been administered by the time symptoms are expected. Thus, the shorter the interval between the start of immunotherapy and the expected onset of symptoms, the shorter the interval between each dose. Some patients may even tolerate daily doses.
Should symptoms develop before the next injection is scheduled, the interval between doses should be decreased. Should allergic symptoms or local reactions develop shortly after the dose is administered, the size of the dose should be decreased. In seasonal allergies, it is often advisable to decrease the dose to one-half or one-quarter of the maximum dose previously attained if the patient has any seasonal symptoms.
A maintenance dose, the largest dose tolerated by the patient that relieves symptoms without producing undesirable local or general reactions, is recommended for most patients. The upper limits of dosage have not been established; however, doses larger than 0.2 mL of the glycerinated concentrate may be painful due to the glycerin content. The dosage of allergenic extract does not vary significantly with the respiratory allergic disease under treatment. The size of this dose and the interval between doses will vary and can be adjusted as necessary.
The interval between maintenance doses can be increased gradually from one week to 10 days, to two weeks, to three weeks, or even to four weeks, if tolerated. Repeat the doses at a given interval three or four times to check for untoward reactions before further increasing the interval. Protection is lost rapidly if the interval between doses is more than four weeks. (See WARNINGS Section.)
The usual duration of treatment has not been established. A period of two or three years of injection therapy constitutes an average minimum course of treatment.
In two hyposensitization studies using Amb a 1 27, 43 the amount administered over a pre-seasonal course of injections varied from 4 to 2,000 units of Amb a 1. The maximum individual dose attained ranged up to 170 units in one series.
Short Ragweed pollen extracted at 1:20 (w/v) usually assays within a range of 50,000 to 70,000 PNU/mL and 100 to 300 units Amb a 1/mL. Most treatment programs use a w/v concentrate of 1:100 to 1:20 or a PNU/mL concentrate of 20,000 to 40,000. This would approximate a 100 units Amb a 1/mL average concentration of Short Ragweed extract (Giant and Short Ragweed mix would be one-half this value). The following suggested dose schedule is based on this average concentration of 100 Units/mL.
The Amb a 1 content of different batches of Short Ragweed extract will vary so it will be necessary to dilute extract concentrate to the same Amb a 1 concentration when using a new lot of antigen.
Formula for calculating dilutions:
A 1C 1 = A 2C 2
A 1 = Amount of extract you wish to prepare.
C 1 = Concentration you wish to prepare.
A 2 = Amount of extract you will need for dilution.
C 2 = Concentration of extract you will use.
Formula for determining diluent required:
A 1 minus A 2 = Amount of diluent required.
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