Xolair
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
21-12-2023
Valmisteyhteenveto
(SPC)
21-12-2023
Julkisesta arviointikertomuksesta
(PAR)
24-08-2020
Aktiivinen ainesosa:
omalizumab
Saatavilla:
Novartis Europharm Limited
ATC-koodi:
R03DX05
INN (Kansainvälinen yleisnimi):
omalizumab
Terapeuttinen ryhmä:
Drugs for obstructive airway diseases,
Terapeuttinen alue:
Asthma; Urticaria
Käyttöaiheet:
Allergic asthmaXolair is indicated in adults, adolescents and children (6 to
Tuoteyhteenveto:
Revision: 48
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2005-10-25
Pakkausseloste
156
B. PACKAGE LEAFLET
157
PACKAGE LEAFLET: INFORMATION FOR THE USER
XOLAIR 75 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
(pre-filled syringe with 26-gauge staked needle, blue syringe guard)
omalizumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xolair is and what it is used for
2.
What you need to know before you use Xolair
3.
How to use Xolair
4.
Possible side effects
5.
How to store Xolair
6.
Contents of the pack and other information
1.
WHAT XOLAIR IS AND WHAT IT IS USED FOR
Xolair contains the active substance omalizumab. Omalizumab is a
man-made protein that is similar to
natural proteins produced by the body. It belongs to a class of
medicines called monoclonal antibodies.
Xolair is used for the treatment of:
-
allergic asthma
-
chronic rhinosinusitis (inflammation of the nose and sinuses) with
nasal polyps
Allergic asthma
This medicine is used to prevent asthma from getting worse by
controlling symptoms of severe
allergic asthma in adults, adolescents and children (6 years of age
and older) who are already receiving
asthma medicine, but whose asthma symptoms are not well controlled by
medicines such as high-dose
steroid inhalers and beta-agonist inhalers.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal
polyps in adults (18 years of age and
older) who are already receiving intranasal corticosteroids
(corticosteroid nasal spray), but whose
symptoms are not well controlled by these medicines. Nasal polyps are
sm
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xolair 75 mg solution for injection in pre-filled syringe
Xolair 75 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xolair 75 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 75 mg of omalizumab* in 0.5 ml
solution.
Xolair 75 mg solution for injection in pre-filled pen
Each pre-filled pen contains 75 mg of omalizumab* in 0.5 ml solution.
*Omalizumab is a humanised monoclonal antibody produced in a Chinese
hamster ovary (CHO)
mammalian cell line by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
Clear to slightly opalescent, colourless to pale brownish-yellow
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Allergic asthma
Xolair is indicated in adults, adolescents and children (6 to <12
years of age).
Xolair treatment should only be considered for patients with
convincing IgE (immunoglobulin E)
mediated asthma (see section 4.2).
_Adults and adolescents (12 years of age and older) _
Xolair is indicated as add-on therapy to improve asthma control in
patients with severe persistent
allergic asthma who have a positive skin test or
_in vitro_
reactivity to a perennial aeroallergen and who
have reduced lung function (FEV
1
<80%) as well as frequent daytime symptoms or night-time
awakenings and who have had multiple documented severe asthma
exacerbations despite daily high-
dose inhaled corticosteroids, plus a long-acting inhaled
beta2-agonist.
_Children (6 to <12 years of age) _
Xolair is indicated as add-on therapy to improve asthma control in
patients with severe persistent
allergic asthma who have a positive skin test or
_in vitro_
reactivity to a perennial aeroallergen and
frequent daytime symptoms or night-time awakenings and who have had
multiple documented severe
asthma exacerbations despite daily high-dose inhaled corticosteroids,
plus a long-acting inhaled beta2
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