Xolair 150mg1ml solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Omalizumab

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

R03DX05

INN (International Name):

Omalizumab

Dosage:

150mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5010678924046

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
XOLAIR
® 150 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
Xolair is used for the treatment of allergic asthma and chronic
spontaneous urticaria (CSU). 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. 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 or CSU.
Allergic asthma
This medicine 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.
Chronic spontaneous urticaria (CSU)
This medicine is used to treat chronic spontaneous urticaria in adults
and adolescents (12 years of age
or older) who are already receiving antihistamines but whose CSU
symptoms are not well controlled
by these medicines.
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

Summary of Product characteristics

OBJECT 1
XOLAIR 150MG SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 17-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Xolair
®
150 mg solution for injection
2. Qualitative and quantitative composition
Each pre-filled syringe of 1 ml solution contains 150 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
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-agonist.
Chronic spontaneous urticaria (CSU)
Xolair is indicated as add-on therapy for the treatment of chronic
spontaneous urticaria in adult and
adolescent (12 years and abo