Standardized Cat Pelt
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Questions & Answers
Side Effects & Adverse Reactions
See WARNINGS at the beginning of this instruction sheet. Allergenic extract should 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; or (3) exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection. Do not start 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.
IF THE PREVIOUS EXTRACT WAS NON-STANDARDIZED OR WAS STANDARDIZED AND LABELED IN ALLERGY UNITS PER mL (AU/mL): This standardized extract may be more potent than non-standardized extracts. Initiate therapy as though patient had not been receiving immunotherapy, or determine initial dose by skin test using serial dilutions of the extract. See PRECAUTIONS and DOSAGE AND ADMINISTRATION Sections.
IF CHANGING TO A DIFFERENT LOT OF EXTRACT: Even though it is the same formula and concentration, the first dose of the new extract should not exceed 50% of the last administered dose from the previous extract.
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. Initiate therapy as though patient had not been receiving immunotherapy, or determine initial dose by skin test using serial dilutions of the extract. See DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS Sections.
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.
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, 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 in product instructions.
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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FDA Labeling Changes
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Uses
3, 16, 17, 18 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.
19, 20
The use of mixed or 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 allergen.
Avoidance of allergens is to be advocated if possible, but cannot always be attained, e.g., allergy to cat dander in kennel owners and employees, cat breeders, research workers, veterinarians, etc.
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
Allergenic extracts for subcutaneous injection and prick or puncture for diagnosis are sterile solutions containing the extractables of the source material and components of the extraction fluid. Standardized Cat Pelt is available as an extract from acetone precipitated source material in two different extraction fluids described below.
Source Material:
Cat Pelt source material consists of hair and whole epidermis which have undergone an acetone precipitation process. AP™ Acetone Precipitated Cat Pelt is derived from precipitate formed when acetone is added to an aqueous extract.
Extracting Fluids:
Glycero-Coca's: Contains 0.5% sodium chloride, 0.275% sodium bicarbonate, and 50% glycerin (v/v) as a preservative.
Product Concentration:
1. Bioequivalent Allergy Units. When originally licensed, standardized cat extracts containing 10 - 20 Fel d 1 units/mL were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method 23 was used to determine that standardized cat extracts containing 10 to 19.9 Fel d 1 units/mL should be assigned 10,000 AU/mL rather than 100,000 AU/mL. To avoid possible confusion about this change in allergy unit assignment, the nomenclature changed for cat extracts, and such products are labeled in Bioequivalent Allergy Units (BAU/mL).
Each lot of Standardized Cat Pelt extract is standardized by quantitating the Fel d 1 content based on standards on file with the Center for Biologics Evaluation and Research (CBER) of the U.S.
Food and Drug Administration. Test extracts are diffused in agar containing standard anti-serum to Fel d 1 and compared to the diffusion of a reference cat allergen preparation.2 The potency of the extract is expressed as units of Fel d 1 per mL, and extracts containing 10-19.9 Fel d 1 units per mL are labeled at 10,000 BAU/mL.
It has been recognized that there are differences in the levels of non Fel d 1 allergens among standardized cat extracts which utilize different source materials. Isoelectric focusing (IEF) patterns have been shown to be predictive of the presence of non Fel d 1 allergens. Therefore, each lot of Standardized Cat Pelt is compared by IEF to a Cat Pelt Extract Reference and a Cat Hair Extract Reference on file with the CBER. The labeled name of the cat extract (i.e., Cat Hair Extract or Cat Pelt Extract) must be supported by matching the IEF profile of the corresponding reference.
2. Concentrate. Concentrate label terminology applies to allergenic extract mixtures where the individual allergens being combined vary in strength or the designation of strength.
| e.g. |
Concentrate |
| 50% |
Short Ragweed 1:20 w/v |
| 25% |
Std. Cat Pelt 10,000 BAU/mL |
| 25% |
Std. Mite D. farinae 10,000 AU/mL |
Should the physician choose to calculate the actual strength of each component in the "Concentrate" mixture, the following formulation may be used:
| Actual Allergen Strength in concentrate Mixture |
= |
Allergen Manufacturing Strength |
x |
% Allergen in Formulation (by volume or parts) |
Ingredients:
Active ingredients are the allergen(s) noted on the vial label. Preservative is 50% (v/v) glycerin. Glycerinated extracts contain 0.5% sodium chloride, 0.275% sodium bicarbonate and 50% glycerin (v/v) as a preservative.
Sources
Standardized Cat Pelt Manufacturers
-
Jubilant Hollisterstier Llc
![Standardized Cat Pelt Injection, Solution [Jubilant Hollisterstier Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Standardized Cat Pelt | Jubilant Hollisterstier Llc
3, 16, 17 ,18
1. General
Sterile aqueous diluent containing human serum albumin is recommended when preparing dilutions of the concentrate for intradermal testing or immunotherapy. 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.
2. Diagnosis
To identify highly sensitive individuals and as a safety precaution, it is recommended that a prick or puncture test using a drop of the extract concentrate be performed prior to initiating intradermal testing. 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. 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 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). The skin test concentration of 10,000 BAU/mL (10-19.9 Fel d 1 Units/mL) in dropper vials is used for prick or puncture testing. Puncture tests performed on 15 highly sensitive subjects showed the following:
Product
Mean Sum of Wheal
± 1 Std. Dev (mm)
Mean Sum of Erythema
± Std. Dev. (mm)
Standardized Cat Pelt
13.9 ± 4.3
67.3 ± 13.3
The sum of a skin response is the sum of the longest diameter and the midpoint orthogonal diameter.
Intradermal endpoint titration (IET) tests were completed using the same 15 subjects to determine the mean concentration required to produce a ∑E of 50mm (D 50). That concentration contained 0.042 BAU/mL (range 0.002 to 0.890 BAU/mL).
Intradermal extract should be used as follows:
Intradermal Tests should be done only on patients with a negative prick or puncture test. Patients who do not react to a valid prick or puncture test should be tested intradermally with 0.02 to 0.05 mL of a 100 BAU/mL extract solution. If this test is negative, a second intradermal test may be performed using a 1,000 BAU/mL extract solution. If the intradermal dilutions were prepared from glycerinated concentrate, the negative control used with this latter dilution should contain 5% glycerol. 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 mma 31-40 mm 60-80 mm 4+ >15 mmb >40 mm >80 mm a. or with pseudopods
b. or with many pseudopods
3. Immunotherapy
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.
Dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, his clinical response, and tolerance to the extract administered during the early phases of an injection regimen. The starting dose should be based on skin tests of the extract to be used for immunotherapy. 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 sterile aqueous diluent. Subsequent serial dilutions are made in a similar manner. (See Table I.) 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 normally is 3 to 7 days.
This is offered as a suggested schedule for average patients and 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. The size of the dose should be decreased 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.
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. 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. 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. 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.
TABLE 1
TEN-FOLD DILUTION SERIES
Standardized Extracts Labeled 10,000 BAU/mL
Dilution
Extract
+ Diluent
=
BAU/mL
Concentration
0
Concentrate
+0 mL
=
10,000
1
1 mL concentrate
+9 mL
=
1,000
2
1 mL dilution #1
+9 mL =
100
3
1 mL dilution #2
+9 mL =
10
4
1 mL dilution #3
+9 mL =
1
5
1 mL dilution #4
+9 mL =
0.1
6
1 mL dilution #5
+9 mL =
0.01
7
1 mL dilution #6
+9 mL =
0.001
(4) PEDIATRIC USEThe dose for the pediatric population is the same as for adults. (See PRECAUTIONS.) (5) GERIATRIC USEThe dose for elderly patients is the same as for adults patients under 65. 28
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