ITULAZAX 12SQ-BET Oral lyophilisate (2022)
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Περιεχόμενα
1. Name of the medicinal product
Itulazax 12SQ-Bet Oral Lyophilisate.
2. Qualitative and quantitative composition
Standardised allergen extract of pollen from white birch (<em>Betula verrucosa</em>) 12 SQ-Bet* per oral lyophilisate. For the full list of excipients, see section 6.1. * [SQ-Bet is the dose unit for ITULAZAX. ...
3. Pharmaceutical form
Oral lyophilisate. White to off-white freeze-dried debossed oral lyophilisate.
4.1. Therapeutic indications
ITULAZAX is indicated in adult patients for the treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch homologous group<sup>1</sup>. ITULAZAX is indicated ...
4.2. Posology and method of administration
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 ...
4.3. Contraindications
Hypersensitivity to any of the excipients (for a full list of excipients, see section 6.1). Patients with FEV<sub>1</sub> <70% of predicted value (after adequate pharmacological treatment) at initiation ...
4.4. Special warnings and precautions for use
Severe systemic allergic reactions Treatment should be discontinued and a physician should be contacted immediately in case of severe systemic allergic reactions, severe asthma exacerbation, severe pharyngeal ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction trials have been conducted in humans and no potential drug interactions have been identified from any source. Concomitant therapy with symptomatic anti-allergic medications may increase ...
4.6. Fertility, pregnancy and lactation
Pregnancy There is no data on the clinical experience for the use of ITULAZAX in pregnant women. Animal studies do not indicate increased risk to the foetus. Treatment with ITULAZAX should not be initiated ...
4.7. Effects on ability to drive and use machines
Treatment with ITULAZAX has no or negligible influence on the ability to drive or use machines.
4.8. Undesirable effects
Summary of the safety profile Patients taking ITULAZAX should primarily expect mild to moderate local allergic reactions to occur within the first few days of treatment and disappear within a few months ...
4.9. Overdose
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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Allergen extracts, tree pollen <b>ATC code:</b> V01AA05 Mechanism of action ITULAZAX is an allergen extract for immunotherapy of tree (birch homologous group) pollen-induced ...
5.2. Pharmacokinetic properties
No clinical studies investigating the pharmacokinetic profile and metabolism of ITULAZAX have been conducted. The effect of allergy immunotherapy is mediated through immunological mechanisms, and there ...
5.3. Preclinical safety data
Conventional studies of general toxicology, genotoxicity and toxicity in relation to reproduction in mice have revealed no special hazards to humans.
6.1. List of excipients
Gelatine (fish source) Mannitol Sodium hydroxide (for pH adjustment)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store in the original blister in order to protect from moisture. This medicinal product does not require any special temperature storage conditions.
6.5. Nature and contents of container
Aluminium/aluminium blister cards in outer carton. Each blister card contains 10 oral lyophilisates. <u>Pack sizes:</u> 30 and 90. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
ALK-Abello A/S, Boge Alle 6-8, DK-2970 Horsholm, Denmark
8. Marketing authorization number(s)
PA1255/007/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 13<sup>th</sup> September 2019
10. Date of revision of the text
February 2022
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