Stallergenes S.a

Stallergenes S.a Drugs

• Oralair
  

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  Oralair

  

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    For sublingual use only.

  2.1 Dose

  For adults 18 through 65 years of age, the dose is 300 IR (index of reactivity) daily. For children and adolescents 10 through 17 years of age, the dose is increased over the first three days as shown in Table 1.

  Table 1. Dosage for Adults and Children for the Days 1-3 (and following) Age (years) Dose Day 1 Day 2 Day 3 and following 10-17 100 IR 2× 100 IR 300 IR 18-65 300 IR 300 IR 300 IR

  2.2 Administration

  Administer the first dose of ORALAIR in a healthcare setting in which acute allergic reactions can be treated under the supervision of a physician with experience in the diagnosis and treatment of severe allergic reactions. After receiving the first dose of ORALAIR, observe the patient for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, the patient may take subsequent doses at home.

  Administer ORALAIR to children under adult supervision.

  Remove the ORALAIR tablet from the blister just prior to dosing.

  Place the ORALAIR tablet immediately under the tongue until complete dissolution for at least 1 minute before swallowing.

  Wash hands after handling the ORALAIR tablet.

  Do not take the ORALAIR tablet with food or beverage. To avoid swallowing allergen extract, food or beverage should not be taken for 5 minutes following dissolution of the tablet.

  Initiate treatment 4 months before the expected onset of each grass pollen season and maintain it throughout the grass pollen season.

  Data regarding the safety of starting treatment during the pollen season or restarting treatment after missing a dose of ORALAIR are not available.

  It is recommended that auto-injectable epinephrine be made available to patients prescribed ORALAIR. Patients who are prescribed epinephrine while receiving immunotherapy should be instructed in the proper use of emergency self-injection of epinephrine [See Warnings and Precautions (5.2)].

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