Xolair 75mg0.5ml solution for injection pre-filled syringes

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Omalizumab

Доступно од:

Novartis Pharmaceuticals UK Ltd

АТЦ код:

R03DX05

INN (Међународно име):

Omalizumab

Дозирање:

150mg/1ml

Фармацеутски облик:

Solution for injection

Пут администрације:

Subcutaneous

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: ; GTIN: 5010678924039

Информативни летак

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
XOLAIR
® 75 MG SOLUTION FOR INJECTION
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.
-
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 are given Xolair
3.
How Xolair is given
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
The active substance of Xolair is 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. It is used to prevent asthma from getting worse by
controlling symptoms of severe allergic
asthma in adults and adolescents (12 years of age and older) and
children (6 to less than 12 years of
age) who are already receiving asthma medicine, but whose asthma
symptoms are not well controlled
by medicines such as high-dose steroid inhalers or beta-agonist
inhalers.
Xolair works by blocking a substance called immunoglobulin E (IgE),
which is produced by the body.
IgE plays a key role in causing allergic asthma.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN XOLAIR
YOU SHOULD NOT BE GIVEN XOLAIR
-
if you are allergic to omalizumab or any of the other ingredients of
this medicine (listed in
section 6).
If you think you may be allergic to any of the ingredients, tell your
doctor as you should not be given
Xolair.
WARNINGS AND PRECAUTIONS
Xolair contains a protein, and proteins can cause serious allergic
reactions in some people. Signs
include rash, difficulty in breathing, swelling or feeling faint. If
you have an allergic reaction after
taking Xolair, contact

Карактеристике производа

OBJECT 1
XOLAIR 75MG SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 17-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Xolair
®
75 mg solution for injection
2. Qualitative and quantitative composition
Each pre-filled syringe of 0.5 ml solution contains 75 mg of
omalizumab*.
*Omalizumab is a humanised monoclonal antibody manufactured by
recombinant DNA technology in a
Chinese hamster ovary (CHO) mammalian cell line.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear to slightly opalescent, colourless to pale brownish-yellow
solution.
4. Clinical particulars
4.1 Therapeutic indications
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-agonist.
4.2 Posology and method of administration
Xolair treatment should be initiated by physicians experienced in the
diagnosis and treatment of severe
persistent asthma.
Posology
The appropriate