ΠΡΟΙΟΝΤΑ - Lais 3000 AU/mL drops
Name of the medicinal product. Lais 3000 AU/mL drops. Chemically modified allergenic extract (monomeric allergoid) 3000 AU/mL drops.
Qualitative and quantitative composition. Active substances: chemically modified allergenic extracts (monomeric allergoid) from pollens of: Grass (Holcus lanatus 33%, Phleum pratense 33%, Poa pratensis 33%), or Pellitory (Parietaria judaica 50%, Parietaria officinalis 50%), or Ragweed (Ambrosia artemisiifolia 100%), or Olive (Olea europea 100%), or Birch (Alnus incana 50%, Betula pendula 50%), Bermuda (Cynodon dactylon 100%), or Mugwort (Artemisia vulgaris 100%), or Cypress (Cupressus arizonica 100%); or chemically modified allergenic extracts of Mites (Dermatophagoides pteronyssinus 50%, Dermatophagoides farinae 50%) or Cat (Felis domesticus 100%) or Alternaria (Alternaria tenuis 100%) at the following doses: 3,000 Allergenic Units (AU)/mL The biological unit of measurement used in the specific oromucosal sublingual immunotherapy with monomeric allergoid is the Allergenic Unit A.U., equivalent of 1/40 the corresponding unmodified allergen challenge dose assessed by nasal challenge test in volunteers suffering from allergic rhinitis
Therapeutic indications. For treatment of allergic affections caused by inhalation: bronchial asthma, rhinitis, rhino-conjunctivitis.
Posology and method of administration. Oromucosal use. Drops shall be put into patient's oral cavity, for example by means of a tea spoon, and possibly retained for 1 or 2 minutes before swallowing. Every drop contains 150 AU. Take the drops if possible on an empty stomach.
The treatment starts with an induction phase that lasts 5 days with the following posological scheme: day 1: 2 drops (equivalent to 300 AU); day 2:4 drops (equivalent to 600 AU); day 3: 6 drops (equivalent to 900 AU); day 4: 6 drops (equivalent to 900 AU); day 5: 6 drops (equivalent to 900 AU).
The following weeks the treatment continues with the remaining drops and after the first bottle, the treatment continues with a further bottle taking 6 drops/day (equivalent to 900 AU) with a variable posology from 2 to 5 times a week according to the doctor's opinion:
- For the seasonal treatment (e.g. for the pollens) take 6 drops/day for 5 times a week (e.g. from Monday to Friday) before and during the pollen season.
- For the perennial treatment (e.g. for the house dust mites) take 6 drops/day for 2 times a week (e. g. Monday and Friday) during all year.
Should treatment be discontinued for 2 weeks or less, it shall be started again by administering the last well tolerated dose; in case of discontinuation
exceeding a 2 week period, consult the physician for a posology adjustment.
The physician may deviate from these dosage schemes to meet patient's clinical and therapeutic needs.
The guidelines on allergic vaccination suggest to take the treatment for a period from 3 to 5 years.
Contra-indications. Hypersensitivity to any of the excipients. Specific immunotherapy is contra-indicated in case of a severe systemic disease, cardio-vascular diseases and severe pulmonary diseases, a concomitant treatment with beta-blockers and those pathologies where the use of adrenaline is contra-indicated.
Special warnings and precautions for use. Specific immunotherapy shall always be administered according to a patient-specific treatment schedule. Dose levels and times of administration shall be adjusted by the physician according to the illness course. Suggested treatment schedules have been provided for guidance only. Patient shall be recommended to consult a physician for a posology adjustment, if any, in case he/she would suffer from a feverish flu state or an airways infection. Should patient require a vaccination to viral or bacterial pathogenic agents, immunotherapy may be stopped one week before and resumed two weeks after the aforesaid vaccination. Alcohol intake and strong physical performance shall be avoided in the hours immediately after dosing. Keep out of reach of children.
Undesirable effects. Being the product in question a chemically modified allergen (monomeric allergoid), undesirable effects during treatment are very rare. Even though, the appearance of rhinitis, skin rush, generally moderate dyspnoea and delayed reactions in the first few hours after dosing cannot be excluded. Any local (for example mouth or lip itching) and/or systemic undesirable effect arising when a specific immunotherapy is ongoing shall promptly be reported to the physician, who will adjust the treatment schedule and administer an appropriate antiallergic therapy, if any, according to the severity of the clinical picture Patient shall also inform the physician about the appearance of any side effect other than those listed in the package leaflet that he/she has experienced during treatment.
Overdose. No overdose-related side effects have been reported. However, the administration of an excessive dose may result into local or systemic allergic reactions. Any symptom shall be controlled by administering antiallergic drugs according to the severity of the clinical picture and on physician's prescription.
List of excipients. Sodium chloride, sodium bicarbonate, glycerine, purified water.
Shelf life. 2 years. Do not use the product after the expiration date.
Special precautions for storage. Store between 2°C and 8°C after opening.
Nature and contents of container and packages. Yellow glass bottles with polyethylene droppers, childproof UT18 white polypropylene cap and inner polythene gasket, each of them containing: 6 mL of a 3,000 AU/mL solution.
Packages. 1 bottle, 2 bottles, 3 bottles, 4 bottles. The bottles are contained in a carton box.
Date of first authorization in Italy. Marketing conforms to the Decree entitled "Provisions applicable to radiopharmaceuticals and allergens" of December 13,1991.