ITULAZAX 12 SQ-Bet sublingual lyophilisate

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Betula verrucosa

Saadav alates:

ALK-Abello A/S

ATC kood:

V01AA; V01AA05

INN (Rahvusvaheline Nimetus):

Betula verrucosa

Annus:

12

Ravimvorm:

Oral lyophilisate

Terapeutiline ala:

Allergen extracts; tree pollen

Volitamisolek:

Marketed

Loa andmise kuupäev:

2019-09-13

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
ITULAZAX 12 SQ-BET, SUBLINGUAL LYOPHILISATE
For use in adults
Standardised allergen extract of pollen from
white birch (
Betula verrucosa
)
This medicine is subject to additional
monitoring. This will allow quick identification of
new safety information. You can help by reporting any
side effects you may get. See the end of section 4 for
how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
or pharmacist.
- This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What ITULAZAX is and what it is used for
2. What you need to know before you take ITULAZAX
3. How to take ITULAZAX
4. Possible side effects
5. How to store ITULAZAX
6. Contents of the pack and other information
1. WHAT ITULAZAX IS AND WHAT IT IS USED FOR
WHAT ITULAZAX IS
ITULAZAX contains an allergen extract of birch pollen.
It comes in a form known as a sublingual lyophilisate,
which is like a tablet but much softer and absorbed
into the body by putting it under the tongue.
WHAT ITULAZAX IS USED FOR
Treatment of:
- ‘allergic rhinitis’ and/or
- ‘conjunctivitis’
when these are caused by tree pollen from birch,
alder, hazel, hornbeam, oak and beech trees.
ÿ
- ‘Allergic rhinitis’ is where the inside of the nose is
inflamed – making you sneeze or have a stuffy or
runny nose.
- ‘Conjunctivitis’ is where the eyes are inflamed –
making them red, itchy or watery.
ITULAZAX is used in adults.
ITULAZAX is prescribed by doctors with experience in
treating allergies.
HOW ITULAZAX WORKS
Itulazax works by increasing the immunological
tolerance (

Toote omadused

Health Products Regulatory Authority
05 March 2024
CRN00F5PW
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
▼ This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions. See section 4.8 for how to report adverse
reactions.
1 NAME OF THE MEDICINAL PRODUCT
ITULAZAX 12 SQ-Bet sublingual lyophilisate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Standardised allergen extract of pollen from white birch (_Betula
verrucosa)_ 12 SQ-Bet* per sublingual lyophilisate.
For the full list of excipients, see section 6.1.
* [SQ-Bet is the dose unit for ITULAZAX. SQ is a method for
standardisation on biological potency, major allergen content and
complexity of the allergen extract. Bet is an abbreviation for
Betula.]
3 PHARMACEUTICAL FORM
Sublingual lyophilisate
White to off-white freeze-dried debossed sublingual lyophilisate
4 CLINICAL PARTICULARS
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
1
ITULAZAX is indicated in patients with a clinical history of symptoms
despite use
of symptom-relieving medication and a positive test of sensitisation
to a member of the birch homologous group (skin prick
test and/or specific IgE).
[1]
Birch homologous group: (_Betula verrucosa_ (birch), _Alnus glutinosa_
(alder), _Carpinus betulus_ (hornbeam), _Corylus avellana_
(hazel), _Quercus alba_ (oak), and _Fagus sylvatica_ (beech).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for adult patients is one sublingual 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 exp