ITULAZAX 12SQ-BET Oral lyophilisate Ref.[50425] Active ingredients:

Posology

The recommended dose for adult patients is one oral lyophilisate (12 SQ-Bet) daily.

It is recommended that treatment with ITULAZAX should be initiated outside the pollen season and continued during the tree pollen season. Clinical effect during the tree (birch homologous group) pollen season has been demonstrated when treatment is initiated at least 16 weeks prior to the expected start of the tree (birch homologous group) pollen season and continued throughout the season. There are no clinical data available for an in-season treatment start.

International treatment guidelines refer to a treatment period of 3 years for allergy immunotherapy to achieve disease modification. Long-term efficacy has not yet been established. If no improvement is observed during the first year of treatment with ITULAZAX there is no indication for continuing treatment.

Elderly population

Clincial experience in patients ≥65 years of age is limited.

Paediatric population

Clinical experience with ITULAZAX in children aged 12-17 years is limited and in children <12 years of age, safety and efficacy data have not been established. Therefore, ITULAZAX is not intended for use in patients <18 years of age. Currently available adolescent data are described in section 5.1, but no recommendation on a posology can be made and current data do not yet support its' use in this population.

Method of administration

ITULAZAX treatment should be initiated by physicians with experience in treatment of allergic diseases. The first oral lyophilisate should be taken under medical supervision and the patient should be monitored for at least half an hour to enable discussion and possible treatment of any immediate side effect.

ITULAZAX is an oral lyophilisate. The oral lyophilisate should be taken with dry fingers from the blister unit immediately after opening the blister and placed under the tongue, where it will disperse. Swallowing should be avoided for approximately 1 minute. Food and beverages should not be taken for the following 5 minutes.

If treatment with ITULAZAX is interrupted for a period of up to 7 days, treatment can be resumed by the patient. If the treatment is interrupted for more than 7 days it is recommended to contact a physician before resuming the treatment.

In a phase I trial, adult subjects with allergic rhinitis and/or conjunctivitis induced by birch pollen were exposed to doses of up to 24 SQ-Bet. For adolescents, no data are available for exposure above the recommended daily dose of 12 SQ-Bet.

If doses higher than the recommended daily dose are taken, the risk of side effects may increase, including the risk of severe systemic allergic reactions or local allergic reactions. In case of severe systemic allergic reactions, severe asthma exacerbation, severe pharyngeal oedema, difficulty in swallowing, difficulty in breathing, changes in voice, hypotension or feeling of fullness in the throat, immediate medical evaluation is needed. These reactions should be treated with relevant symptomatic medication.

3 years.

Store in the original blister in order to protect from moisture. This medicinal product does not require any special temperature storage conditions.

Aluminium/aluminium blister cards in outer carton. Each blister card contains 10 oral lyophilisates.

Pack sizes: 30 and 90.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.