XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 75MG0.5ML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Omalizumab

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

R03DX05

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Omalizumab 75mg/0.5ml

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Vetter Pharma-Fertigung GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

2021-03-04

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
XOLAIR
®
75 mg, 150 mg powder and solvent for solution for injection
XOLAIR
®
75 mg, 150 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Xolair 75mg:
One dose (reconstituted) contains 75 mg of omalizumab whereas one vial
(before reconstitution) contains
129.6
mg
of
omalizumab.
Omalizumab
is
a
humanised
monoclonal
antibody
manufactured
by
recombinant
DNA
technology
in
a
Chinese
hamster
ovary
(CHO)
mammalian
cell
line.
After
reconstitution the vial contains 125 mg/ml of omalizumab (75 mg in 0.6
ml).
Xolair 150mg:
One dose (reconstituted) contains 150mg of omalizumab whereas one vial
(before reconstitution) contains
202.5mg
of
omalizumab.
Omalizumab
is
a
humanised
monoclonal
antibody
manufactured
by
recombinant
DNA
technology
in
a
Chinese
hamster
ovary
(CHO)
mammalian
cell
line.
After
reconstitution the vial contains 125 mg/ml of omalizumab (150 mg in
1.2 ml).
SOLUTION FOR INJECTION IN 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.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
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.
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Clear to slightly opalescent, colorless to pale brownish-yellow
solution in a pre-filled syringe.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALLERGIC ASTHMA
Xolair treatment should only be considered for patients with
convincing IgE mediated asthma (see
section 4.2).
ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND ABOVE)
Xolair is indicated as add-on therapy to improve asthma control in
adult and adolescent (12 years of age
and above) with severe persistent allergic asthma who have a positive
skin test or
_in vitro _
reactivity to a
Xolair Jun 2023.SIN Page 2 of 31
perennial aeroallergen and who