ΠΡΟΙΟΝΤΑ - Lais-in 10 BU/mL
Name of the medicinal product. Lais-in 10 BU/mL. Injectable suspension. Chemically modified allergenic extract (monomeric allergoid) adsorbed on Calcium Phosphate. Depot subcutaneous specific immunotherapy.
Qualitative and quantitative composition. Active ingredient: chemically modified allergenic extracts (monomeric allergoid) of Dermatophagoides (Dermatophagoides pteronyssinus 50%, Dermatophagoides farinae 50%).
Excipients: sodium chloride 7.8 mg/mL, phenol 4 mg/mL, calcium phosphate up to 1.3 mg/mL, water for injection q.b. to 1 mL. The biological unit of the subcutaneous specific immunotherapy Lais-iV? is the Biological Unit BU/mL, standardised on the basis of cutaneous tests in sensitised subjects. The allergenic strength of each production batch is kept consistent by means of the EAST-inhibition technique in comparison to an In House Reference Preparation-IHRP. The BU is a drug unit equivalent to 1/100 of the concentration of extract which, before being chemically modified, induces at Prick testing a mean wheal equivalent to histamine 10 mg/mL.
Therapeutic indications. Treatment of type 1 IgE-mediated allergic diseases such as rhinits, conjunctivitis and bronchial asthma caused by sensitivity to house-dust mites.
Posology and method of administration. The specific immunotherapy Lais-m is administered by a physician by means of a subcutaneous injection at the back or side of the upper arm. The skin around the injection area should be carefully disinfected first. Prior to drawing up the quantity of allergen to be injected, softly shake the vial until forming a homogenous, foam-free suspension. The dosage regimen is individualised based on the clinical progress and tolerability of the patient. The treatment schedule suggested in this package leaflet has been provided for guidance only and may be adapted to the patient's needs by the physician.
Induction Phase:Start the treatment with the lowest dose, gradually using higher doses if the last dose administered was well-tolerated. The interval between administrations is 1 week during the induction phase. Example of a dosage regimen during the induction phase (the vial contains 10 BU/mL): Γ week 0.10 mL, 1 BU; 2° week 0.20 mL, 2 BU; 3° week 0.30 mL, 3 BU; 4° week 0.50 mL, 5 BU, 5° week 0.70 mL, 7 BU. The dosage regimen allows the patient to reach the maximum tolerated dose, which may be the maximum foreseen dose (0.70 mL) or any of the lower doses. The dosage should not be increased if the last dose administered was not well-tolerated.
Maintenance Treatment: Once the maximum tolerated dose has been reached, repeat the treatment every 4 weeks unless otherwise prescribed by the physician. In the case of perennial allergens such as house-dust mites, treatment can start at any time of the year and can be continued without interruption after the maximum tolerated dose has been reached. It is recommended that the treatment continue for a period of 3-5 consecutive years.
Contra-indications. Hypersensitivity to any of the excipients. The specific immunotherapy is contraindicated in cases of serious systemic diseases, fever, shock organ affections, concomitant treatment with beta-blockers and diseases in which the use of adrenaline is contraindicated.
Precautions for use. Subcutaneous immunotherapy should only be administered by a physician who has immediate access to emergency first aid. After the injection, patient shall be submitted to medical surveillance for at least 30 minutes. The physician should carefully check the dose to be administered to the patient before extracting the amount of allergen to be injected from the vial. Do not administer the drug intradermal^, endovenously or intramuscularly. The subcutaneous injection should be performed slowly, using a graduated 1 mL syringe. Introduce the needle under the skin and aspirate the syringe with the piston before injecting the allergen to make sure that the needle has not accidentally penetrated a vein; for higher doses, it is recommended that the syringe be aspirated again whilst injecting. If the needle has accidentally penetrated a vein, immediately withdraw the syringe and wait 20-30 minutes before using a new one to inject into another site. Do not massage the injection site after the injection. Enter the injected dose, date, the injection site and any side effects in the diary.
If treatment is interrupted for a week during the induction phase, repeat the last dose tolerated by the patient. If treatment is interrupted for two or moreweeks, reduce the injected dose by 50% and increase the dosage weekly until the maximum recommended or tolerated dose is reached. Use the sameprecautions during maintenance therapy each time a new vial is used. If the patient needs any type of anti-pathogenic, antiviral or anti-bacterial vaccination, wait at least 4-5 days between the last administration of the immunotherapy and the vaccination. The immunotherapy may continue approximately 2 weeks after vaccination. A physician should be consulted in the case of infectious and/or inflammatory illness. Avoid alcohol, intense physical activity, hot baths and saunas immediately after the injection.
Undesirable effects. Side effects which may occur include rhinitis, tearing, or swelling and itching at the injection site. Delayed reactions several hours after administration of the vaccine may occur. Anaphylactic reactions are rare. The occurrence of local and/or systemic side effects during specific immunotherapy should be carefully evaluated by the physician who will adjust the dosage and, in the case of an anaphylactic reaction, prescribe suitable anti-allergy treatment depending upon the severity of situation.
Overdose. There are no known cases of overdose, however, an overdose may cause a local or systemic allergic reaction. Symptoms should be controlled by anti-allergy drugs based on the severity.
Shelf life and storage. Store in the refrigerator at a temperature between 2°C and 8°C after receipt. Do not freeze the product. Do not use the product if it has been frozen.
Pharmaceutical form and content. Injectable suspension. Package of 1 or 2 vials containing 3.5 mL of chemically modified extract at a concentration of 10 BU/mL.
Date of first authorization in Italy. Marketing conforms to the Decree entitled "Provisions applicable to radiopharmaceuticals and allergens" of December 13,1991.