Xolair

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Omalizumab 150 mg/mL;  

Saatavilla:

Novartis New Zealand Ltd

INN (Kansainvälinen yleisnimi):

Omalizumab 150 mg/mL

Annos:

150 mg/mL

Lääkemuoto:

Solution for injection

Koostumus:

Active: Omalizumab 150 mg/mL   Excipient: Arginine hydrochloride Histidine Histidine hydrochloride monohydrate Polysorbate 20 Water for injection

Prescription tyyppi:

Prescription

Valmistaja:

Novartis Pharma SAS

Käyttöaiheet:

Xolair (omalizumab) is indicated for the reduction of asthma exacerbations and control of asthma symptoms when given as add-on therapy for adult and adolescent patients, 6 years and older, with severe persistent allergic asthma who have IgE greater than or equal to 30 IU/mL, a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Syringe, glass, Type 1, with bromobutyl rubber plunger, 1mL - 1 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 48 hours not refrigerated stored at or below 25°C - Syringe, glass, Type 1, with bromobutyl rubber plunger, 1mL - 4 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 48 hours not refrigerated stored at or below 25°C - Syringe, glass, Type 1, with bromobutyl rubber plunger, 1mL - 10 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 48 hours not refrigerated stored at or below 25°C

Valtuutus päivämäärä:

2015-04-22

Pakkausseloste

__________________________________________________________________________________________________
XOLAIR

1
XOLAIR
®
_Omalizumab (rch) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xolair
.
It does not contain all the available
information
.
It does not take the place
of talking to your doctor, pharmacist
or healthcare provider.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Xolair
against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT XOLAIR IS USED
FOR
ALLERGIC ASTHMA
Xolair is used to prevent or relieve
the symptoms of allergic asthma in
people who are already using
preventer puffers containing steroids.
Asthma is a disease where the lining
of the lungs becomes inflamed (red
and swollen), making it difficult to
breathe. This may be due to a
reaction to house dust mites, smoke
or other irritants.
This medicine can be used in adults
and in children aged 6 years or over
for the treatment of allergic asthma.
CHRONIC RHINOSINUSITIS WITH NASAL
POLYPS (NASAL POLYPS)
Xolair is used to treat nasal polyps in
adults (18 years of age and older)
whose severe disease is not well
controlled with their current nasal
polyps medicines. Xolair helps
reduce the size of the polyps and
improves symptoms caused by nasal
polyps including nasal congestion,
loss of sense of smell, post-nasal drip
and runny nose.
This medicine can be used in adults
aged 18

Valmisteyhteenveto

XOLAIR® solution for injection
Page 1 of 39
XOLAIR
®
OMALIZUMAB
1.
PRODUCT NAME
Xolair 75 mg solution for injection in pre-filled syringe
Xolair 150 mg solution for injection in pre-filled syringe
Xolair 150 mg powder vial and diluent for solution for injection*
* _Not marketed strength or dosage form_
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Powder and diluent for solution for injection:
One vial of Xolair 150 mg powder and diluent for solution for
injection contains 150 mg of
omalizumab. Reconstituted Xolair contains 125 mg/mL of omalizumab (150
mg in 1.2 mL).
Omalizumab is a humanized monoclonal antibody manufactured from a
mammalian cell line.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe:
Clear to slightly opalescent, colorless to pale brownish-yellow
solution in a pre-filled syringe.
Powder and diluent for solution for injection:
Powder: white to off-white lyohilisate in a glass vial.
Diluent: clear and colorless solution in a glass ampoule
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Allergic Asthma
Xolair (omalizumab) is indicated for the reduction of asthma
exacerbations and control of asthma
symptoms when given as add-on therapy for adult and adolescent
patients, 6 years and older, with
severe persistent allergic asthma who have IgE ≥ 30 IU/mL, a
positive skin test or in vitro reactivity to
a perennial aeroallergen and whose symptoms are inadequately
controlled with inhaled
corticosteroids.
XOLAIR® solution for injection
Page 2 of 39
Chronic rhinosinusitis with nasal polyps (CRSwNP)
Xolair is indicated as add-on treatment in adult patients (18 years of
age and above) for the treatment
of severe CRSwNP with inadequate response to intranasal
corticosteroids. Recommended dosing is
determined by serum immunoglobulin E levels and body weight
corresponding