Cat Hair, Standardized: Package Insert and Label Information (Page 2 of 2)

Overdosage:

See Adverse Reactions section.

DOSAGE AND ADMINISTRATION

Dilution

Allergenic extract concentrates must be diluted before use in intradermal skin testing or the initial stages of immunotherapy. As with any parenteral product, always use careful aseptic technique in preparing dilutions, assuring that the vials, diluents, and syringes are sterile, and that the dilutions are prepared under aseptic conditions, Sterile diluents that can be used include Normal Saline, Buffered Saline, 50% glycerin or Albumin Saline (HSA).

To obtain the concentrations required for intradermal testing or for the initial stages of immunotherapy, prepare serial 5 or 10 fold dilutions of the concentrate, to achieve the concentrations specified in Table 2 or 3, below. The relatively small 0.5 ml volume conserves the original concentrate, and is convenient because sterile diluent is readily available in prefilled 2.0 and 4.5 ml volumes.

Table 2 Examples of Ten-fold Dilution Series
DilutionNumber Add ThisVolume/Dilutionof Extract To thisDiluentVolume To Obtain Extractat the FollowingConcentration (BAU/ml)
0123456 Concentrate0.5 ml concentrate0.5 ml dilution #10.5 ml dilution #20.5 ml dilution #30.5 ml dilution #40.5 ml dilution #5 __4.5 ml4.5 ml4.5 ml4.5 ml4.5 ml4.5 ml 10,0001,000100101.00.100.01
Table 3 Examples of Five-fold Dilution Series
DilutionNumber Add ThisVolume/Dilutionof Extract To thisDiluentVolume To Obtain Extractat the FollowingConcentration (BAU/ml)
0123456 Concentrate0.5 ml concentrate0.5 ml dilution #10.5 ml dilution #20.5 ml dilution #30.5 ml dilution #40.5 ml dilution #5 __2.0 ml2.0 ml2.0 ml2.0 ml2.0 ml2.0 ml 5,0001,0002004081.60.32

For each vial, record the date of dilution on the label.

Skin Testing

Scratch or prick-puncture testing should be performed using the 10,000 BAU/ml concentrate, a negative control (diluent) and a positive control (histamine 1.8 mg/ml). Extract for intradermal testing can be prepared by diluting the concentrate with any appropriate aqueous sterile diluent, as described above. A 100 BAU/ml concentration is also available for intradermal testing.

The following skin testing protocol can be recommended:

  1. The location for both prick and intradermal testing is usually the flexor surface of the forearm. Use aseptic technique throughout.
  2. Perform a preliminary skin prick test with the extract concentrate, by placing a drop of the extract on the skin and then using a needle to prick the skin gently through the drop. Use a normal diluent as negative control and histamine as a positive control. Read the test after 15 minutes. Patients reacting strongly to the prick test should be considered highly sensitive to the extract, and suitable precautions should be taken. A suggested grading system appears in Table 4. If the histamine control is negative, the possibility of skin non-reactivity must be considered.
  3. Begin intradermal testing, generally starting at the 100 BAU/ml dilution if the prick test was negative, or at 0.1 or 0.01 BAU/ml if the test was positive or if no prick test was done. Use a separate, sterilized syringe and needle for each extract and each patient. Introduce the needle into the superficial skin layers until the bevel is completely buried, then slowly inject approximately 0.02 — 0.05 ml.
  4. Measure the wheal and erythema after 15 minutes, and determine the degree of response to the injection, in comparison to the negative control. A suggested grading system appears in Table 5.
  5. If the intradermal reaction is negative at the initial concentration, continue intradermal testing with 10-fold increments in the concentration until a clearly positive response has been obtained or a peak concentration of 100 BAU/ml has been tested, whichever occurs first.
Table 4 Skin Test Grading System12
Grade Wheal Results
0 + ++ +++ ++++ No Wheal/same size as negative<Half the Histamine DiameterHalf the Histamine DiameterSame Size as Histamine ControlSize of Histamine Control +2mm
Table 5 Intradermal Skin Test Grading System13
Mean Diameters (mm)
Grade Wheal Erythema
0±1+2+3+4+ <5.05.0-10.05.0-10.05.0-10.05.0-10.0 or pseudopods>15.0, many pseudopods <5.05.0-10.011.0-20.021.0-30.031.0-40.0>40.0

The interpretation of the skin response is based on the size of the wheal, the size of the erythema, and the appearance of irregular, spreading, pseudopodllike projections from the test area. The presence of the latter indicates marked hypersensitivity. A patient is considered sensitive to the test extract if there is a reaction of 1 + or greater at a concentration of 100 BAU/ml or less, providing that the 1 + reaction is in relation to the negative control.

Immunotherapy

Administer the extract solution subcutaneously, using a suitable sterile 1 ml syringe and a 25-27 gauge 1/4 to 5/8 inch needle. The injections are typically given in the lateral aspect of the upper arm.

Dosage of allergenic extracts is a highly individualized matter1 2 , and varies according to the degree of sensitivity of the patient, the clinical response, and tolerance of the extract administered previously.

A safe starting dose for any allergic patient is that dose which on intradermal testing produces a 1 + reaction. For most patients a starting dose that is 0.1 ml of 0.01 BAU/ml dilution of the extract concentrate should be well tolerated, although in some very sensitive patients a more dilute concentration may be required.

If no untoward symptoms are observed following the initial injection, the dose can be increased gradually for each subsequent injection until the injection volume reaches 0.6 -0.8 ml. Then begin using the next more concentrated ten-fold dilution, and proceed with this dosage pattern until the maintenance dose-defined as that dose that either relieves the patient’s symptoms or is the highest that the patient can tolerate is reached. Care must be taken, however, in administering a volume greater than 0.2 ml of any extract in 50% glycerin; such injections can be painful to the patient due to the glycerin content.

After each injection, evaluate the patient’s skin reaction and overall response to determine whether the next scheduled dose can be given:

  • If a single dose results in more than a moderate local reaction (>50 mm wheal) within 1/2 hour, the same dose should be repeated at the next visit — or visits — until the patient has tolerated it.
  • lf any systemic manifestation of sensitivity occurs during or following a visit, or if a single dose results in an excessive local reaction (> 100 mm wheal) within ½ hour, the total dosage for the next visit should be reduced to half of the dose that caused the reaction.
  • Delayed local reactions (occurring 24-48 hours after injection) are relatively common, and do not appear to predict difficulties with future doses. As a rule, therefore, dosage adjustment is not required in most instances. However, at the physician’s discretion and for the comfort of the patient, if delayed large local reactions over 10 mm are reported, the subsequent dose should be held at the same level as the one causing the reaction.

The optimal interval between doses of allergenic extract has not been definitely established. However, as is customarily practiced, injections are given 1, 2, or 3 times per week until the maintenance dose of extract is reached. At this time, the injection interval may be increased to 2 weeks, then to 3 weeks and finally to 4 weeks depending on the clinical status. lf the patient does not return for 6 to 8 weeks after the last injection, the dose should be reduced to 25% of the last dose.

If longer than 8 weeks, a dose reduction of one, two or three dilutions may be made depending on a consideration of the components and the patient’s sensitivity. The dosage and the interval between injections may need to be modified according to the clinical response of the patient. When switching patients to fresh extract, the initial dose should be reduced to one-quarter of the previous dose.

Duration of treatment: Careful selection of allergens and cautious progression to maximally tolerated doses are important elements in the success of immunotherapy. The optimal length of treatment with allergen immunotherapy is unknown. A treatment period of 3 to 5 years is common, although continuation for longer periods may be appropriate1 3.

Allergenic extracts, as any parenteral drug product should be inspected visually for evidence of foreign material or discoloration prior to administration. Some variation in color is normal and a minor level of extract precipitate may occur with some extracts, but do not use the extract if there is any question of its condition exists.

HOW SUPPLIED

These allergenic extract concentrates are supplied as sterile solutions in rubber stoppered glass vials. The concentrate is available in 5, 10, 30 and 50 ml size serum vials for Immunotherapy at 5,000 BAU/ml and 10,000 BAU/mI; intradermal dilution is available in 5 ml vial size at a concentration of 100 BAU/ml; and the scratch test products are available in 5 ml dropper vials at a concentration of 10,000 BAU/ml.

To ensure maximum potency for the entire dating period, extract concentrates contain 50% glycerin (v/v) unless otherwise instructed by the physician.

Diluted extracts, special mixtures and prescription treatment sets are available at tile request of the physician.

Storage: The extract concentrate and all dilutions should be kept refrigerated at 2-8ºC. Do not freeze, and do not use the extract concentrate after the expiration date printed on the vial label. Extracts that contain less than 50% v/v glycerin are less stable,

LIMITED WARRANTY

We warrant that this product was prepared and tested according to the applicable standards of the FDA and was true to label when it left our hands. Because of biological differences in individuals, because this product is manufactured to be potent, and because we have no control over the conditions of use, we cannot and do not warrant either a good effect, or against an ill effect following its use. This label sets forth the complete and excluding statement of all the terms of any warranty, express or implied (including the warranty of merchantability) between ALK-Abelló, Inc., the prescriber, and the user of this product. Such representations and warranties shall not be varied, supplemented, qualified or interpreted by any prior course of dealing between the parties, or by any usage of trade unless specifically authorized in writing, signed by any officer of the corporation.

ALK-AbeIló, Inc.

US License 1256

800-252-9778

In TX: 512-251-0037

Revised October 2008 731B

REFERENCES

  1. Reid, M.J., et aI.:2 Survey of fatalities from Skin testing and immunotherapy 1985-1989. J. Allergy Clin. Immunnol. 92:6-15, 1993.
  2. Ohman, J.L., Marsh, D.G., Goldman, M.: Antibody response following immunotherapy with cat pelt extract. J Allergy Clin. Immunol, 69:320-326, 1982, .
  3. Turkeltaub, P.C., Rastogi, S.C., Baer, H.: OBRR skin test method for evaluation of subject sensitivity to standardized allergenic extracts and for assignment of allergy units to reference preparations using ID5OEAL method.
  4. Methods Manual, Laboratory of Allergenic Products, Food and Drug Administration, October 1 993.
  5. Van Metre, T.E., and Adklnson, N.F. in: Allergy Principles and Practice, Fourth Edition, 1489-1509, 1993. C.V, Moseby Co.
  6. Lilja, G., Sundin, B,, Graff-Lonnevig, V., Heidlin, G., Heilborn, H., Norrlind, K., Pegelow, K-O., Lowenstein, H.: Immunotherapy with cat and dog dander extracts, IV. Effects of 2 years of treatment. J Allergy Clin. Immunol. 83:37-44,1 1989.
  7. Alvarez-Cuesta, E,, Cuesta, J., Puyana, J., Cureta, C., Bianco, A.: Clinical effectiveness of immunotherapy with cat extract (Abstract). J Allergy Clin. lmmunol. 87:198, 1991.
  8. Anderson, J,A,, et, aI.: Personnel And Equipment To Treat Systemic Reactions Caused By Immunotherapy With Allergenic extracts. J. Allergy Clin Immunol 77(2):271 -273, 1986.
  9. Jacobs, R.L. et. Al.: Potentiated Anaphylaxis In Patients with Drug Induced Beta Adrenergic Blockade. J. Allergy Clin Immunol 68: 125, 1981.
  10. Bickell, W.H., and Dice, W.H.: Military Antishock Trousers ln A Patient With Adrenergic Resistant Anaphylaxis. Ann Emerg Med. 13:189, 1984.
  11. Norman, P.S., and Van Metre, T.E.: The Safety of Allergenic Immunotherapy. J. Allergy Clin lmmunol.85: 522, 1990.
  12. Middleton, E,, et aI: Allergy: Principles and Practice C.V. Mosely Co. 1993.
  13. Spector, S. L. and Nicklas, R. A.: ”Practice Parameters for Diagnosis and Treatment of Asthma,”J, Allergy Clin lmmunol, 96:(5): 810, 1995.

PRINCIPAL DISPLAY PANEL

ALLERGENIC EXTRACT
GTIN:
5mL sterile multiple dose vial
STANDARDIZED CAT HAIR10,000 BAU/mL

PRINCIPAL DISPLAY PANEL
ALLERGENIC EXTRACT
GTIN:
5mL sterile multiple dose vial
STANDARDIZED CAT HAIR
10,000 BAU/mL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

ALLERGENIC EXTRACT
GTIN:
10mL sterile multiple dose vial
STANDARDIZED CAT HAIR10,000 BAU/mL

PRINCIPAL DISPLAY PANEL
ALLERGENIC EXTRACT
GTIN:
10mL sterile multiple dose vial
STANDARDIZED CAT HAIR
10,000 BAU/mL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

ALLERGENIC EXTRACT
GTIN:
50mL sterile multiple dose vial
STANDARDIZED CAT HAIR10,000 BAU/mL

PRINCIPAL DISPLAY PANEL
ALLERGENIC EXTRACT
GTIN:
50mL sterile multiple dose vial
STANDARDIZED CAT HAIR
10,000 BAU/mL
(click image for full-size original)

CAT HAIR, STANDARDIZED cat hair, standardized injection, solution
Product Information
Product Type Item Code (Source) NDC:0268-2000
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELIS CATUS HAIR (FELIS CATUS HAIR) FELIS CATUS HAIR 10000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE 0.0025 g in 1 mL
SODIUM CHLORIDE 0.005 g in 1 mL
GLYCERIN 0.5 mL in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-2000-10 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:0268-2000-50 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103810 11/28/2003
CAT HAIR, STANDARDIZED cat hair, standardized solution
Product Information
Product Type Item Code (Source) NDC:0268-2001
Route of Administration PERCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FELIS CATUS HAIR (FELIS CATUS HAIR) FELIS CATUS HAIR 10000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE 0.0025 g in 1 mL
SODIUM CHLORIDE 0.005 g in 1 mL
GLYCERIN 0.5 mL in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0268-2001-06 5 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103810 11/28/2003
Labeler — ALK-Abello, Inc. (809998847)

Revised: 06/2020 ALK-Abello, Inc.

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