XOLAIR 75 mg Solution for injection (2024)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Xolair 75 mg solution for injection in pre-filled syringe. Xolair 75 mg solution for injection in pre-filled pen.
Qualitative and quantitative composition
<u>Xolair 75 mg solution for injection in pre-filled syringe:</u> Each pre-filled syringe contains 75 mg of omalizumab* in 0.5 ml solution. <u>Xolair 75 mg solution for injection in pre-filled pen:</u> ...
Pharmaceutical form
Solution for injection (injection). Clear to slightly opalescent, colourless to pale brownish-yellow solution.
Therapeutic indications
Allergic asthma 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 ...
Posology and method of administration
Treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma or chronic rhinosinusitis with nasal polyps (CRSwNP). Posology Dosing for allergic asthma ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General Omalizumab is not indicated ...
Interaction with other medicinal products and other forms of interaction
Since IgE may be involved in the immunological response to some helminth infections, omalizumab may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic ...
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
Omalizumab has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) Summary of the safety profile During allergic asthma clinical trials in adult and adolescent patients 12 years of age and older, the ...
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
<b>Pharmacotherapeutic group:</b> Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases <b>ATC code:</b> R03DX05 Mechanism of action Omalizumab is a recombinant DNA-derived ...
Pharmacokinetic properties
The pharmacokinetics of omalizumab have been studied in adult and adolescent patients with allergic asthma as well as in adult patients with CRSwNP. The general pharmacokinetic characteristics of omalizumab ...
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
Arginine hydrochloride Histidine hydrochloride monohydrate Histidine Polysorbate 20 Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products.
Shelf life
18 months. The product may be kept for a total of 48 hours at 25°C.
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
Xolair 75 mg solution for injection in pre-filled syringe (26-gauge staked needle, blue syringe guard) Xolair 75 mg solution for injection in pre-filled syringe is supplied as 0.5 ml solution in a pre-filled ...
Special precautions for disposal and other handling
Pre-filled syringe The single-use pre-filled syringe is for individual use. It should be taken out of the refrigerator 30 minutes before injecting to allow it to reach room temperature. Pre-filled pen ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
<u>Xolair 75 mg solution for injection in pre-filled syringe:</u> EU/1/05/319/005 EU/1/05/319/006 EU/1/05/319/007 EU/1/05/319/018 EU/1/05/319/019 EU/1/05/319/020 <u>Xolair 75 mg solution for injection ...
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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