Standardized Mite Dermatophagoides Pteronyssinus

16, 17, 18, 26 Standardized glycerinated 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.20, 21
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. 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.

1. General

The presence of asthmatic signs and symptoms appear to be an indicator for severe reactions following allergy injections.1, 32, 33, 34, 35 An assessment of airway obstruction either by measurement of peak flow or an alternate procedure may provide a useful indicator as to the advisability of administering an allergy injection.
Concentrated extracts must be diluted prior to use; See DOSAGE AND ADMINISTRATION Section for detailed instructions on the dilution of standardized glycerinated allergenic extracts.
Any evidence of local or generalized reaction requires a reduction in dosage during the initial stages of immunotherapy, as well as during maintenance therapy.
Allergenic extracts diluted with Albumin Saline with Phenol (0.4%) may be more potent than extracts diluted with diluents which do not contain stabilizers. When switching from non-stabilized to stabilized diluent, consider weaker initial dilutions for both intradermal testing and immunotherapy.
Sterile solutions, vials, syringes, etc. should be used and aseptic precautions observed in making dilutions.
To avoid cross-contamination, do not use the same needle to withdraw materials from vials of more than one extract, or extract followed by diluent.
A sterile tuberculin syringe graduated in 0.01 mL units should be used to measure each dose from the appropriate dilution. Aseptic techniques should always be employed when injections of allergenic extracts are being administered.
A separate sterile syringe should be used for each patient to prevent transmission of homologous serum hepatitis and other infectious agents from one person to another.
Patient reactions to previous injections should be reviewed before each new injection. A conservative dosage schedule should be followed by the physician until a pattern of local responses is established which can be used to monitor increases in dosage.
Rarely, a patient is encountered who develops systemic reactions to minute doses of allergen and does not demonstrate increasing tolerance to injections after several months of treatment. If systemic reactions or excessive local responses occur persistently at very small doses, efforts at immunotherapy should be stopped.
PATIENTS SHOULD BE OBSERVED IN THE OFFICE FOR 30 MINUTES AFTER EACH TREATMENT INJECTION. Most severe reactions will occur within this time period, and rapid treatment measures should be instituted.
See ADVERSE REACTIONS Section for such treatment measures.

2. Information for Patients

Patients should be instructed in the recognition of adverse reactions to immunotherapy, and in particular, to the symptoms of shock. Patients should be made to understand the importance of a 30 minute observation period, and be warned to return to the office promptly if symptoms occur after leaving.

3. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been conducted with allergenic extracts to determine their potential for carcinogenicity, mutagenicity or impairment of fertility.

4. Pregnancy

30
Pregnancy Category C. Allergenic Extracts. Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extracts should be given to a pregnant woman only if clearly needed.
For women who have been getting maintenance doses of allergen without side effect, the occurrence of pregnancy is not an indication to stop immunotherapy.

5. Nursing Mothers

There are no current studies on secretion of the allergenic extract components in human milk, or of their effect on the nursing infant. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.

6. Pediatric Use

Since dosage for the pediatric population is the same as for adults 26, 27, the larger volumes of solution may produce excessive discomfort. Therefore, in order to achieve the total dose required, the volume of the dose may need to be divided into more than one injection per visit.

7. Geriatric Use

The reactions from immunotherapy can be expected to be the same in elderly patients as in younger ones. Elderly patients may be more likely to be on medication that could block the effect of epinephrine which could be used to treat serious reactions, or they could be more sensitive to the cardiovascular side effect of epinephrine because of pre-existing cardiovascular disease.29

8. Drug Interactions

Patients on non-selective beta blockers may be more reactive to allergens given for diagnosis or treatment, and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.19
Certain medications may lessen the skin test wheal and erythema responses elicited by allergens and histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing.2 Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing.2, 3
Tricyclic antidepressants such as Doxepin should be withheld for at least 7 days before skin testing.31 Topical local anesthetics may suppress the flare responses and should be avoided in skin test sites.4

1. Local Reactions
Some erythema, swelling or pruritus at the site of injection are common, the extent varying with the patient. Such reactions should not be considered significant unless they persist for at least 24 hours.
Local reactions (erythema or swelling) which exceed 4-5 cm in diameter are not only uncomfortable, but also indicate the possibility of a systemic reaction if dosage is increased. In such cases the dosage should be reduced to the last level not causing the reaction and maintained at this level for two or three treatments before cautiously increasing again.
Large persistent local reactions may be treated by local cold, wet dressings and/or the use of oral antihistamines. They should be considered a warning of possible severe systemic reactions and an indication of the need for temporarily reduced dosages.
A mild burning immediately after the injection is to be expected. This usually leaves in 10 to 20 seconds.

2. Systemic Reactions
With careful attention to dosage and administration, systemic reactions occur infrequently, but it cannot be overemphasized that in sensitive individuals, any injection could result in anaphylactic shock. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions.
Other possible systemic reactions which may occur in varying degrees of severity are laryngeal edema, fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis, and urticaria. Adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low.1, 28
If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject 1:1000 epinephrine-hydrochloride intramuscularly or subcutaneously into the opposite arm. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.

EPINEPHRINE DOSAGE:
ADULT DOSAGE: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary.
PEDIATRIC DOSAGE: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg (mL) per square meter of body surface area. Suggested dosage for infants to 2 years of age is 0.05 to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient.
After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and possibly vasoactive drugs. Airway patency should be insured. Oxygen should be given by mask. Intravenous antihistamine, theophylline and/or corticosteroids may be used if necessary after adequate epinephrine and circulatory support has been given.
Emergency resuscitation measures and personnel trained in their use should be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures [Ref. J. Allergy and Clinical Immunology, 77(2): p. 271-273, 1986].
Rarely are all of the above measures necessary; the tourniquet and epinephrine usually produce prompt responses. However, the physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment measures is of utmost importance.
Severe systemic reactions mandate a decrease of at least 50% in the next dose, followed by cautious increases. Repeated systemic reactions, even of a mild nature, are sufficient reason for the cessation of further attempts to increase the reaction-causing dose.

Standardized allergenic extracts are supplied for diagnostic and therapeutic use:

Diagnostics:
Extracts: D. pteronyssinus and D. farinae
Scratch, prick or puncture tests, 30,000 AU/mL [50% glycerin (v/v)] in 5 mL dropper vial. Intradermal Tests [Aqueous] of 30 AU/mL in 5 mL vial, and 300 AU/mL in 5 mL vial.

Bulk Therapeutics [50% glycerin (v/v)] in multiple dose vials:
Extracts: D. pteronyssinus and D. farinae
10 mL vial, 30,000 AU/mL or 10,000 AU/mL
30 mL vial, 30,000 AU/mL or 10,000 AU/mL
50 mL vial, 10,000 AU/mL
A mixture of the two mite species, in equal parts, resulting in D. pteronyssinus at 15,000 AU/mL and D. farinae at 15,000 AU/mL is available for therapeutic use in 10 mL and 30 mL vials. A mixture of the two species is also available at 5,000 AU/mL each species in 10 mL, 30 mL and 50 mL.

The expiration date of the mite extract in 50% glycerin is listed on the container label. The extract should be stored at 2° - 8°C and kept in this temperature range during office use. Dilutions containing less than 50% glycerin are less stable, and if loss of potency is suspected, should be checked by skin testing with equal units of a freshly prepared dilution on known mite allergic individuals. The expiration date of the intradermal tests is listed on container labels. Store at 2° - 8°C.

1. Lockey, Richard F., Linda M. Benedict, Paul C. Turkeltaub, Samuel C. Bukantz. Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol., 79 (4): 660-677, 1987.
2. Pipkorn, Ulf. Pharmacological influence of anti-allergic medication on In Vivo allergen testing. Allergy. 43: 81-86, 1988.
3. Andersson, M.and U. Pipkorn. Inhibition of the dermal immediate allergic reaction through prolonged treatment with topical glucocorticosteroids. J. Allergy Clin. Immunol. 79 (2): 345-349, February 1987.
4. Pipkorn, Ulf, and M. Andersson. Topical dermal anesthesia inhibits the flare but not the wheal response to allergen and histamine in the skin prick test. Clinical Allergy. 17: 307-311, 1987.
5. Turkeltaub, Paul C., MD, and Suresh C. Rastogi, PhD. Quantitative intradermal test procedure for evaluation of subject sensitivity to standardized allergenic extracts and for assignment of allergy units to reference preparations using the ID50EAL method, Allergenics Products Testing Laboratory, Center for Biologics Evaluation and Research (CBER), FDA. Revised: November 1994.
6. Lowell, F.C., W. Franklin. A "double-blind" study of treatment with aqueous allergenic extracts in cases of allergic rhinitis. J. Allergy, 34 (2): 165-182, 1983.
7. Lowell, F.C., W. Franklin. A double-blind study of the effectiveness and specificity of injection therapy in ragweed hay fever. N. Eng. J. Med., 273 (13): 675-679, 1965.
8. Zavazal, V., A. Stajner. Immunologic changes during specific treatment of the atopic state. II. Acta. Allergol., 25 (1): 11-17, 1970.
9. Reisman, R.E., J.I. Wypych, E.E. Arbesman. Relationship of immunotherapy, seasonal pollen exposure and clinical response to serum concentrations of total IgE and ragweed-specific IgE. Int. Arch. Allergy Appl. Immunol., 48 (6): 721-730, 1975.
10. Taylor, W.W., J.L. Ohman, F.C. Lowell. Immunotherapy in cat-induced asthma; double-blind trial with evaluation of bronchial responses to cat allergen and histamine. J. Allergy Clin. Immunol., 61 (5): 283-287, 1978.
11. Smith. A.P. Hyposensitization with Dermatophagoides pteronyssinus antigen: Trial in asthma induced by house dust. Br. Med. J., 4: 204-206, 1971.
12. Chapman, M.D., T.A.E. Platts-Mills, M. Gabriel, H.K. Ng, W.G.L. Allen, L.E. Hill, A.J. Nunn. Antibody response following prolonged hyposensitization with Dermatophagoides pteronyssinus extract. Int. Arch. Allergy Appl. Immunol., 61: 431-440, 1980.
13. Norman, P.S. Postgraduate course presentation. An overview of immunotherapy, implications for the future. J. Allergy Clin. Immunol., 65 (2): 87-96, 1980.
14. Norman, P.S., W.L. Winkenwerder. Maintenance immunotherapy in ragweed hay fever. J. Allergy, 74: 273-282, 1971.
15. Norman, P.S., W.L. Winkenwerder, L.M. Lichtenstein. Immunotherapy of hay fever with ragweed antigen E; comparisons with whole pollen extract and placebos. J. Allergy, 42: 93-108, 1968.
16. Sheldon, J.M., R.G. Lovell, K.P. Matthews. A Manual of Clinical Allergy. Second Edition. W.B. Saunders, Philadelphia, 1967, pp. 107-112.
17. Sherman, W.B. Hypersensitivity Mechanism and Management. W.B. Sanders, Philadelphia, 1968, pp. 169-172.
18. Swineford, O. Asthma and Hay Fever. Charles C. Thomas, Springfield, IL, 1971, pp. 148-155.
19. Jacobs, R.L., G.W. Rake, Jr., et al. Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade. J. Allergy Clin. Immunol., 68 (2): 125-127, August 1981.
20. Pauli, G., J.C. Bessot, R. Thierry, and A. Lamensons. Correlation between skin tests, inhalation tests and specific IgE in a study of 120 subjects to house dust and Dermatophagoides pteronyssinus. Clin. Allergy, 7:337, 1977.
21. Murray, A.B., A.C. Ferguson and B.J. Morrison. Diagnosis of house dust mite allergy in asthmatic children: what constitutes positive history? J. Allergy Clin. Immunol. 71:21, 1983.
22. Wharton, G.W. House Dust Mites. J. Med. Entomol. 12:577, 1976.
23. Voorhorst, R., F.Th.M. Spieksma and H. Varekamp. House Dust Atopy and the House Mite. Leiden, Stafleu's Scientific Publishing Co., 1969.
24. Baer, H. Allergy to House Dust Mites. Immuno. Allergy Practice, 5:356, 1983.
25. Lang, J.D. and S. Mulla. Distribution and abundance of house dust mites, Dermatophagoides (spp.) in different climatic zones of southern California. Environmental Entomology, 6:213-216, 1977.
26. Patterson, Roy, et al. Allergy Principles and Practice, 2nd ed. E. Middleton, Jr., C.E. Reed, E.F. Ellis, Ed., C.V. Mosby Co., 1983, St. Louis, MO, 1983, Chapter 52.
27. Levy, D.A., L.M. Lichtenstein, E.O. Goldstein, and K. Ishizaka. Immunologic and cellular changes accompanying the therapy of pollen allergy. J. Clinical Investigation, 50:360, 1971.
28. Turkeltaub, Paul C., MD, and Peter J. Gergen, MD. The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture, and body measurements: data from the second National Health and Nutrition Examination Survey, 1976-80 (NHANES II). J. Allergy Clin. Immunol. 84(6): 886-890, Dec. 1989.
29. Peebles, Ray Stokes, Jr., B. Bochner, Howard J. Zeitz, ed. Anaphylaxis in the elderly. Immunology and Allergy Clinics of North America. 13 (3): 627-646, August 1993.
30. Metzger, W.J., E. Turner and R. Patterson. The study of immunotherapy during pregnancy. J. Allergy Clin. Immunol. 61 (4): 268-272, 1978.
31. Rao, Kamineni S., et al. Duration of suppressive effect of tricyclic anti-depressants on histamine induced wheal and flare reactions on human skin. J. Allergy Clin. Immunol. 82: 752-757, November 1988.
32. Reid, M.J., R.F. Lockey, P.C. Turkletaub, T.A.E. Platts-Mills. Survey of fatalities from skin testing and immunotherapy. J. Allergy Clin. Immunol. 92 (1): 6-15, July 1993.
33. Reid, M.J., G. Gurka. Deaths associated with skin testing and immunotherapy. J. Allergy Clin. Immunol. 97 (1) Part 3:231, Abstract 195, January 1996.
34. Thompson, R.A. et al, report of a WHO/IUIS working group. The current status of allergen immunotherapy (hyposensitization). Allergy. 44: 369-379, 1989.
35. Malling, H.-J., B. Weeke, et al, The European Academy of Allergology and Clinical Immunology. Position Papers. Allergy. 48 (Supplement 14): 9-82, 1993.

STANDARDIZED MITE MIX, DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE, 10000 AU PER ML  standardized mite mix, dermatophagoides pteronyssinus and dermatophagoides farinae, 10000 au per ml injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-6691 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dermatophagoides farinae (Dermatophagoides farinae) Dermatophagoides farinae 5000 [AU]  in 1 mL Dermatophagoides pteronyssinus (Dermatophagoides pteronyssinus) Dermatophagoides pteronyssinus 5000 [AU]  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   SODIUM CHLORIDE   SODIUM BICARBONATE

Packaging # Item Code Package Description 1 NDC:65044-6691-2 10 mL in 1 VIAL 2 NDC:65044-6691-3 30 mL in 1 VIAL 3 NDC:65044-6691-4 50 mL in 1 VIAL

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103870 05/26/1988

STANDARDIZED MITE MIX, DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE, 30000 AU PER ML  standardized mite mix, dermatophagoides pteronyssinus and dermatophagoides farinae, 30000 au per ml injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-6690 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dermatophagoides farinae (Dermatophagoides farinae) Dermatophagoides farinae 15000 [AU]  in 1 mL Dermatophagoides pteronyssinus (Dermatophagoides pteronyssinus) Dermatophagoides pteronyssinus 15000 [AU]  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   SODIUM CHLORIDE   SODIUM BICARBONATE

Packaging # Item Code Package Description 1 NDC:65044-6690-2 10 mL in 1 VIAL 2 NDC:65044-6690-3 30 mL in 1 VIAL

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103870 05/26/1988

STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, INTRADERMAL, 30 AU PER ML  standardized mite, dermatophagoides pteronyssinus, intradermal, 30 au per ml injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-6693 Route of Administration INTRADERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dermatophagoides pteronyssinus (Dermatophagoides pteronyssinus) Dermatophagoides pteronyssinus 30 [AU]  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   SODIUM CHLORIDE   SODIUM BICARBONATE   ALBUMIN (HUMAN)   PHENOL

Packaging # Item Code Package Description 1 NDC:65044-6693-5 5 mL in 1 VIAL

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103871 05/26/1988

STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, INTRADERMAL, 300 AU PER ML  standardized mite, dermatophagoides pteronyssinus, intradermal, 300 au per ml injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-6694 Route of Administration INTRADERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dermatophagoides pteronyssinus (Dermatophagoides pteronyssinus ) Dermatophagoides pteronyssinus 300 [AU]  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   SODIUM CHLORIDE   SODIUM BICARBONATE   ALBUMIN (HUMAN)   PHENOL

Packaging # Item Code Package Description 1 NDC:65044-6694-5 5 mL in 1 VIAL

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103871 05/26/1988

STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, BULK, 10000 AU PER ML  standardized mite, dermatophagoides pteronyssinus, bulk, 10000 au per ml injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-6695 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dermatophagoides pteronyssinus (Dermatophagoides pteronyssinus) Dermatophagoides pteronyssinus 10000 [AU]  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   SODIUM CHLORIDE   SODIUM BICARBONATE

Packaging # Item Code Package Description 1 NDC:65044-6695-2 10 mL in 1 VIAL 2 NDC:65044-6695-3 30 mL in 1 VIAL 3 NDC:65044-6695-4 50 mL in 1 VIAL

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103871 05/26/1988

STANDARDIZED MITE, DERMATOPHAGOIDES PTERONYSSINUS, SCRATCH OR BULK, 30000 AU PER ML  standardized mite, dermatophagoides pteronyssinus, scratch or bulk, 30000 au per ml injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-6692 Route of Administration SUBCUTANEOUS, PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dermatophagoides pteronyssinus (Dermatophagoides pteronyssinus) Dermatophagoides pteronyssinus 30000 [AU]  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   SODIUM CHLORIDE   SODIUM BICARBONATE

Packaging # Item Code Package Description 1 NDC:65044-6692-1 5 mL in 1 VIAL 2 NDC:65044-6692-2 10 mL in 1 VIAL 3 NDC:65044-6692-3 30 mL in 1 VIAL

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103871 05/26/1988

STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, INTRADERMAL, 30 AU PER ML  standardized mite, dermatophagoides farinae, intradermal, 30 au per ml injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-6721 Route of Administration INTRADERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dermatophagoides farinae (Dermatophagoides farinae) Dermatophagoides farinae 30 [AU]  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   SODIUM CHLORIDE   SODIUM BICARBONATE   ALBUMIN (HUMAN)   PHENOL

Packaging # Item Code Package Description 1 NDC:65044-6721-5 5 mL in 1 VIAL

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103870 05/26/1988

STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, INTRADERMAL, 300 AU PER ML  standardized mite, dermatophagoides farinae, intradermal, 300 au per ml injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-6722 Route of Administration INTRADERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dermatophagoides farinae (Dermatophagoides farinae) Dermatophagoides farinae 300 [AU]  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   SODIUM CHLORIDE   SODIUM BICARBONATE   ALBUMIN (HUMAN)   PHENOL

Packaging # Item Code Package Description 1 NDC:65044-6722-5 5 mL in 1 VIAL

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103870 05/26/1988

STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, BULK, 10000 AU PER ML  standardized mite, dermatophagoides farinae, bulk, 10000 au per ml injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-6723 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dermatophagoides farinae (Dermatophagoides farinae ) Dermatophagoides farinae 10000 [AU]  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   SODIUM CHLORIDE   SODIUM BICARBONATE

Packaging # Item Code Package Description 1 NDC:65044-6723-2 10 mL in 1 VIAL 2 NDC:65044-6723-3 30 mL in 1 VIAL 3 NDC:65044-6723-4 50 mL in 1 VIAL

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103870 05/26/1988

STANDARDIZED MITE, DERMATOPHAGOIDES FARINAE, SCRATCH OR BULK, 30000 AU PER ML  standardized mite, dermatophagoides farinae, scratch or bulk, 30000 au per ml injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65044-6720 Route of Administration SUBCUTANEOUS, PERCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dermatophagoides farinae (Dermatophagoides farinae) Dermatophagoides farinae 30000 [AU]  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   SODIUM CHLORIDE   SODIUM BICARBONATE

Packaging # Item Code Package Description 1 NDC:65044-6720-1 5 mL in 1 VIAL 2 NDC:65044-6720-2 10 mL in 1 VIAL 3 NDC:65044-6720-3 30 mL in 1 VIAL

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103870 05/26/1988

Labeler - Hollister-Stier Laboratories LLC (069263643)

Registrant - Hollister-Stier Laboratories LLC (069263643)

Establishment
Name	Address	ID/FEI	Operations
Hollister-Stier Laboratories LLC		069263643	manufacture

Revised: 01/2010   Hollister-Stier Laboratories LLC