Xolair 75mg0.5ml Solution for Injection in Pre-filled Syringe

Land: Malaysia

Språk: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv ingrediens:

Omalizumab

Tilgjengelig fra:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

Omalizumab

Enheter i pakken:

1 Pre-Filled Syringes

Produsert av:

Vetter Pharma-Fertigung GmbH & Co. KG

Informasjon til brukeren

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
XOLAIR
®
_ _
Omalizumab (75mg/0.5ml and 150mg/ml) solution for injection in
pre-filled syringe
1
WHAT IS IN THIS LEAFLET
1. WHAT XOLAIR IS USED FOR
2. HOW XOLAIR WORKS
3. BEFORE YOU USE XOLAIR
4. HOW TO USE XOLAIR
5. WHILE YOU ARE USING IT
6. SIDE EFFECTS
7. STORAGE AND DISPOSAL OF XOLAIR
8. PRODUCT DESCRIPTION
9. MANUFACTURER
10. PRODUCT REGISTRATION HOLDER
11. DATE OF REVISION
12. SERIAL NUMBER
13. INSTRUCTION FOR USE
WHAT XOLAIR IS USED FOR
_ALLERGIC ASTHMA (ADULTS AND ADOLESCENTS _
_– 12 YEARS OF AGE AND ABOVE) _
Xolair (omalizumab) is indicated for
adults and adolescents (12 years of age
and above) with moderate to severe
persistent allergic asthma whose
symptoms are inadequately controlled
with inhaled corticosteroids (ICS).
_ALLERGIC ASTHMA (CHILDREN – 6 TO < 12 _
_YEARS OF AGE) _
Xolair is indicated as add-on therapy to
improve asthma control 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.
Xolair has been shown to decrease the
incidence of asthma exacerbations in
these patients. Safety and efficacy have
not been established in other allergic
conditions.
_CHRONIC RHINOSINUSITIS WITH NASAL POLYPS _
_(CRSWNP) _
Xolair is used to treat CRSwNP in adults
(18 years of age and older) whose disease
is not well controlled with their current
CRSwNP medicines. Xolair helps reduce
the size of the polyps and improves
symptoms caused by CRSwNP including
nasal congestion, loss of sense of smell,
post-nasal drip and runny nose.
_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 above) patients with inadequate
response to H1 antihistamine treatment.
HOW IT WORKS
_ALLERGIC AS

Preparatomtale

Novartis
Page 2
Malaysia Package Leaflet
11 Dec 2019
Xolair
XOLAIR

Systemic drug for obstructive airway diseases.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Powder: white to off-white lyophilizate in a glass vial.
Solvent: clear and colorless solution in a glass ampoule
One vial of Xolair
®
75 mg powder and solvent for solution for injection delivers 75 mg of
omalizumab. Reconstituted Xolair contains 125 mg/mL of omalizumab (75
mg in 0.6 mL).
One vial of Xolair
®
150 mg powder and solvent for solution for injection delivers 150 mg
of
omalizumab. Reconstituted Xolair contains 125 mg/mL of omalizumab (150
mg in 1.2 mL).
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Clear to slightly opalescent, colorless to pale brownish-yellow
solution in a pre-filled syringe.
Each pre-filled syringe of 0.5 mL contains 75 mg of omalizumab.
Each pre-filled syringe of 1 mL contains 150 mg of omalizumab.
ACTIVE SUBSTANCE
Omalizumab is a humanized monoclonal antibody manufactured from a
mammalian cell line.
Certain dosage strengths and dosage forms may not be available in all
countries.
EXCIPIENTS
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Powder:
Sucrose, L-histidine, L-histidine hydrochloride monohydrate,
polysorbate 20
Solvent:
Water for injection
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
L-arginine hydrochloride, L-histidine hydrochloride, L-histidine,
polysorbate 20, water for
injection.
Pharmaceutical formulations may vary between countries.
INDICATIONS
ALLERGIC ASTHMA
ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND ABOVE)
Xolair (omalizumab) is indicated for adults and adolescents (12 years
of age and above) with
moderate to severe persistent allergic asthma whose symptoms are
inadequately controlled with
inhaled corticosteroids (ICS).
Novartis
Page 3
Malaysia Package Leaflet
11 Dec 2019
Xolair
CHILDREN (6 TO < 12 YEARS OF AGE)
Xolair is indicated as add-on therapy to improve asthma control with
severe persistent allergic
asthma who have a positive skin test or in vit