XOLAIR omalizumab (rch) 75mg powder for injection vial with diluent ampoule

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

Omalizumab, Quantity: 75 mg

Saatavilla:

Novartis Pharmaceuticals Australia Pty Ltd

INN (Kansainvälinen yleisnimi):

Omalizumab

Lääkemuoto:

Injection, solution

Koostumus:

Excipient Ingredients: water for injections

Antoreitti:

Subcutaneous

Kpl paketissa:

1 active vial & 1 diluent ampoule

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

Allergic Asthma,Children 6 to < 12 years of age - In children aged 6 to <12 years, Xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Adults and adolescents 12 years of age and above -Xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin E levels corresponding to the recommended dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,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 to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).,Chronic Spontaneous Urticaria (CSU),Xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.

Tuoteyhteenveto:

Visual Identification: Clear, colourless solution.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2006-01-10

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION – XOLAIR
® (OMALIZUMAB)
SOLUTION FOR INJECTION AND POWDER FOR SOLUTION FOR
INJECTION
1
NAME OF THE MEDICINE
Omalizumab (rch)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Omalizumab is a recombinant DNA-derived humanised monoclonal antibody
produced in Chinese
hamster ovary cells that selectively binds to human immunoglobulin E
(IgE).
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 for injection vial with diluent for solution for injection
One vial of Xolair® 75 mg powder for injection contains 75mg of
omalizumab. A reconstituted single
use vial delivers 75 mg omalizumab per 0.6 mL (125 mg/mL).
One vial of Xolair® 150 mg powder for injection contains 150 mg of
omalizumab. A reconstituted single
use vial delivers 150mg omalizumab per 1.2 mL (125 mg/mL).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe
Clear to slightly opalescent, colourless to pale brownish-yellow
preservative free solution in a pre-
filled syringe.
Powder for injection vial with diluent
Xolair is a sterile, white, preservative free lyophilised powder that
is reconstituted with water for
injections and administered as a subcutaneous (SC) injection.
Powder: white to off-white lyophilizate in a glass vial.
Diluent: clear and colourless solution in a glass ampoule.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ALLERGIC ASTHMA
_Children 6 to < 12 years of age _
2
In children aged 6 to <12 years, Xolair is indicated as add-on therapy
to improve asthma control in
patients with severe allergic asthma who have documented exacerbations
despite daily high dose
inhaled corticosteroids, and who have immunoglobulin E levels
corresponding to the recommended
dose range (see Table 1 in Section 4.2 DOSE AND METHOD OF
ADMINISTRATION).
_Adults and adolescents ≥ 12 years of age _
Xolair is indicated for the ma