XOLAIR 75mg Solution for injection in pre-filled syringe (2019)
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Περιεχόμενα
Name of the medicinal product
Xolair 75 mg solution for injection in pre-filled syringe.
Qualitative and quantitative composition
Each pre-filled syringe of 0.5 ml solution contains 75 mg of omalizumab*. * Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian ...
Pharmaceutical form
Solution for injection in pre-filled syringe (injection). Clear to slightly opalescent, colourless to pale brownish-yellow solution.
Therapeutic indications
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 ...
Posology and method of administration
Xolair treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma. Posology The appropriate dose and frequency of Xolair is determined by baseline ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
General Xolair is not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus. Xolair has not been studied in patients with hyperimmunoglobulin E syndrome or ...
Interaction with other medicinal products and other forms of interaction
Since IgE may be involved in the immunological response to some helminth infections, Xolair may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic infections ...
Fertility, pregnancy and lactation
Pregnancy A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) based on pregnancy registry and post-marketing spontaneous reports, indicates no malformative or foeto/neonatal ...
Effects on ability to drive and use machines
Xolair has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile During clinical trials in adult and adolescent patients 12 years of age and older, the most commonly reported adverse reactions were headaches and injection site reactions, ...
Overdose
Maximum tolerated dose of Xolair has not been determined. Single intravenous doses up to 4,000 mg have been administered to patients without evidence of dose-limiting toxicities. The highest cumulative ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases ATC code: R03DX05 Omalizumab is a recombinant DNA-derived humanised monoclonal antibody ...
Pharmacokinetic properties
The pharmacokinetics of omalizumab have been studied in adult and adolescent patients with allergic asthma. Absorption After subcutaneous administration, omalizumab is absorbed with an average absolute ...
Preclinical safety data
The safety of omalizumab has been studied in the cynomolgus monkey, since omalizumab binds to cynomolgus and human IgE with similar affinity. Antibodies to omalizumab were detected in some monkeys following ...
List of excipients
L-arginine hydrochloride L-histidine hydrochloride L-histidine Polysorbate 20 Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products.
Shelf life
15 months. The shelf life includes potential temperature excursions. The product may be kept for a total of 4 hours at 25°C. If necessary, the product may be returned to the refrigerator for later use, ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light.
Nature and contents of container
0.5 ml solution in a pre-filled syringe barrel (type I glass) with staked needle (stainless steel), (type I) plunger stopper and needle cap. Pack containing 1 pre-filled syringe, and multipacks containing ...
Special precautions for disposal and other handling
Xolair 75 mg solution for injection is supplied in a single-use pre-filled syringe for individual use. The syringe should be taken out of the refrigerator 20 minutes before injecting to allow it to reach ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/05/319/005 EU/1/05/319/006 EU/1/05/319/007
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 October 2005 Date of latest renewal: 22 June 2015
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