FASENRA Solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Fasenra 30 mg solution for injection in pre-filled syringe. Fasenra 30 mg solution for injection in pre-filled pen.
Qualitative and quantitative composition
Pre-filled syringe: Each pre-filled syringe contains 30 mg benralizumab* in 1 mL. Pre-filled pen: Each pre-filled pen contains 30 mg benralizumab* in 1 mL. * Benralizumab is a humanised monoclonal antibody ...
Pharmaceutical form
Solution for injection in pre-filled syringe (injection). Solution for injection in pre-filled pen (injection) (Fasenra Pen). Clear to opalescent, colourless to yellow solution and may contain translucent ...
Therapeutic indications
Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists (see ...
Posology and method of administration
Fasenra treatment should be initiated by a physician experienced in the diagnosis and treatment of severe asthma. After proper training in the subcutaneous injection technique and education about signs ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Fasenra should not be used to treat acute asthma exacerbations. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment. Abrupt ...
Interaction with other medicinal products and other forms of interaction
In a randomized, double-blind parallel-group study of 103 patients aged between 12 and 21 years with severe asthma, the humoral antibody responses induced by seasonal influenza virus vaccination do not ...
Pregnancy and lactation
Pregnancy There is a limited amount of data (less than 300 pregnancy outcomes) from the use of benralizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect ...
Effects on ability to drive and use machines
Fasenra has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions during treatment are headache (8%) and pharyngitis (3%). Anaphylactic reactions have been reported. Tabulated list of adverse ...
Overdose
Doses of up to 200 mg were administered subcutaneously in clinical trials to patients with eosinophilic asthma without evidence of dose-related toxicities. There is no specific treatment for an overdose ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases ATC code: R03DX10 Mechanism of action Benralizumab is an anti-eosinophil, humanised ...
Pharmacokinetic properties
The pharmacokinetics of benralizumab were dose-proportional in patients with asthma following subcutaneous administration over a dose range of 2 to 200 mg. Absorption Following subcutaneous administration ...
Preclinical safety data
As benralizumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been conducted. Animal toxicology and/or pharmacology Non-clinical data reveal no special hazards for humans based ...
List of excipients
Histidine Histidine hydrochloride monohydrate Trehalose dihydrate Polysorbate 20 Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store in a refrigerator (2°C to 8°C). Fasenra may be kept at room temperature up to 25°C for a maximum of 14 days. After removal from the refrigerator, Fasenra must be used within 14 days or discarded. ...
Nature and contents of container
Pre-filled syringe: One mL solution in a single-use pre-filled syringe made from type I glass with a staked 29-gauge 1⁄2-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated ...
Special precautions for disposal and other handling
Fasenra solution for injection is supplied in a sterile single-use pre-filled syringe or pre-filled pen for individual use. Do not shake. Do not freeze. Prior to administration, warm Fasenra by leaving ...
Marketing authorization holder
AstraZeneca AB, SE-151 85 Södertälje, Sweden
Marketing authorization number(s)
EU/1/17/1252/001 1 pre-filled syringe EU/1/17/1252/002 1 pre-filled pen
Date of first authorization / renewal of the authorization
Date of first authorisation: 8 January 2018
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