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Domestic Dust Mite Allergen Vaccine; Pure Mite Bodies Allergen Vaccine; Dust Mite Allergen Vaccine.

Category Diagnostic agent; active immunizing agent.

      House Dust Mite Allergen Vaccine is a sterile liquid or freeze-dried preparation of one or more species obtained from suitable strains of Dermatophagoides pteronyssinus, Dermatophagoides farinae or other species of Dermatophagoides. It is intended for the diagnosis and treatment of dust mite allergy.

      The vaccine, reconstituted as stated on the label, complies with the requirements stated under Vaccines, with the following modifications.

Description Colourless transparent liquid. Freezedried vaccine consists of solid exhibiting the characteristic structure of a freeze-dried solid. When reconstituted, it becomes a colourless transparent liquid.

Strength available 10,000 AU per ml.

Dose Diagnosis: Skin prick test or intradermal, as prescribed by the physician.

      Treatment: Subcutaneous, initial and increasing dose as prescribed by the physician, using optimal maintenance dose for each patient, 5 to 20 μg of major allergen.

Contra-indication​

1. It is not for intramuscular or intravenous administration.

2. It is contra-indicated in patients with febrile conditions, serious immunological illness, or acute asthma and during periods of exacerbation of symptoms.

3. It is contra-indicated in patients with high degree of hypersensitivity by skin testing or specific IgE measurements.

Warning ​

1. Risk-benefit should be considered if it is to be used in pregnant or nursing women.

2. Pain, redness and/or swelling at the injection site and/or fever may occur.

3. Concomitant use with β-blockers should be avoided.

Precaution​

1. The dose should be decreased if previous injection causes severe skin and/or systemic reactions.

2. Decreasing dose should be considered when new vial is used.

3. Emergency equipment must be available when performing allergen immunotherapy.

Additional information

          1. Patients should be kept under medical observations for at least 30 to 60 minutes after treatment.

          2. If a patient is receiving two different allergen extracts concurrently, try to avoid giving injections of both on the same day. If this is unavoidable, give the injections in different arms and allow at least 30 minutes between injections.

          3. If possible, avoid all other immunization procedures (e.g., for poliomyelitis) during treatment with allergen extracts. If they are essential, give immunization one week after allergen injection. The next allergen injection should be 2 weeks after immunization and the dose reduced by 50 per cent.  

Expiration date When stored under the prescribed conditions, the expiration date is not later than 1 year from the date of the last satisfactory test for potency.

Packaging and storage Liquid Vaccine shall be stored at a temperature not exceeding 4º, protected from light. Do not freeze.

      Freeze-Dried Vaccine shall be stored at a temperature below 25º, protected from light, unless otherwise specified by manufacturers.

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition the label on the container states (1) the species of Dermatophagoides; (2) the protein content and/or total allergenic activity and individual allergens; (3) the route of administration and the intended use; (4) for freeze-dried preparation, the period of time within which the preparation is to be used after reconstitution; (5) where applicable the name and amount of adsorbent.

Identification It is identified by a suitable immunochemical method (Appendix 14.5). The protein composition corresponds to that of the International Standard.

Water Not more than 5.0 per cent w/w for freeze-dried vaccine (Appendix 4.12).

Aluminium For the adsorbed Vaccine containing aluminium, not less than 80 per cent and not more than 120 per cent of the stated amount but in any case not more than 1.25 mg of aluminium per single human dose, when determined by the method described under the “Determination of Aluminium”, p. 178.

Calcium For the adsorbed Vaccine containing calcium, not less than 80 per cent and not more than 120 per cent of the stated amount but in any case not more than 1.3 mg of calcium per single human dose, when determined by the method described under the “Determination of Calcium”, p. 178.

Abnormal toxicity Complies with the “Abnormal Toxicity Test” (appendix 8.1).

Antigen profile The antigens are identified by means of a suitable immunochemical method using antigenspecific animal antibodies (Appendix 14.5).

Allergen profile Relevant allergenic components are identified by means of a suitable immunochemical method using allergen-specific human antibodies (Appendix 14.5). 

Protein profile The protein composition determined by suitable methods corresponds to that of the In-House Reference Preparation (IHRP1 ) (Appendix 3.7).

Protein content Not less than 80 per cent and not more than 120 per cent of the stated content of a given batch (Appendix 6.7). If the biological potency can be determined, then the test for protein content may be omitted. 

Individual allergens Not less than 50 per cent and not more than 200 per cent of the stated amount, determined by a suitable immunochemical method (Appendix 14.5).

Total allergenic activity The activity is not less than 50 per cent and not more than 200 per cent of the stated amount as assayed by inhibition of the binding capacity of specific immunoglobulin E antibodies (Appendix 14.5) or a suitable equivalent in vitro method.

 

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¹The preparation prepared from In-House reference serum pool which is collected from whole blood of the house dust mite allergic patients who have positive history and positive skin prick testing to house dust mite vaccine.