FIRAZYR Solution for injection (2020)
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Περιεχόμενα
1. Name of the medicinal product
Firazyr 30 mg solution for injection in pre-filled syringe.
2. Qualitative and quantitative composition
Each pre-filled syringe of 3 ml contains icatibant acetate equivalent to 30 mg icatibant. Each ml of the solution contains 10 mg of icatibant. <u>Excipient(s) with known effect:</u> For the full list of ...
3. Pharmaceutical form
Solution for injection. The solution is a clear and colourless liquid.
4.1. Therapeutic indications
Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.
4.2. Posology and method of administration
Firazyr is intended for use under the guidance of a healthcare professional. Posology Adults The recommended dose for adults is a single subcutaneous injection of Firazyr 30 mg. In the majority of cases ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Laryngeal attacks Patients with laryngeal attacks should be managed in an appropriate medical institution after injection until the physician considers discharge to be safe. Ischemic heart disease Under ...
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacokinetic drug interactions involving CYP450 are not expected (see section 5.2). Co-administration of Firazyr with angiotensin-converting-enzyme (ACE) inhibitors has not been studied. ACE inhibitors ...
4.6. Fertility, pregnancy and lactation
Pregnancy For icatibant, no clinical data on exposed pregnancies are available. Animal studies showed effects on uterine implantation and parturition (see section 5.3), but the potential risk for humans ...
4.7. Effects on ability to drive and use machines
Firazyr has minor influence on the ability to drive and use machines. Fatigue, lethargy, tiredness, somnolence, and dizziness have been reported following the use of Firazyr. These symptoms may occur as ...
4.8. Undesirable effects
Summary of the safety profile In clinical studies used for registration, a total of 999 HAE attacks have been treated with 30 mg Firazyr administered subcutaneously by a healthcare professional. Firazyr ...
4.9. Overdose
No clinical information on overdose is available. A dose of 3.2 mg/kg intravenously (approximately 8 times the therapeutic dose) caused transient erythema, itching, flushing or hypotension in healthy subjects. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other haematological agents, drugs used to treat hereditary angioedema <b>ATC code:</b> B06AC02 Mechanism of action HAE (an autosomal dominant disease) is caused by an ...
5.2. Pharmacokinetic properties
The pharmacokinetics of icatibant has been characterized by studies using both intravenous and subcutaneous administration to healthy volunteers and patients. The pharmacokinetic profile of icatibant in ...
5.3. Preclinical safety data
Repeated-dose studies of up to 6-months duration in rats and 9-months duration in dogs have been conducted. In both rats and dogs, there was a dose-related reduction in circulating sex hormone levels and ...
6.1. List of excipients
Sodium chloride Acetic acid, glacial (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 25°C. Do not freeze.
6.5. Nature and contents of container
3 ml of solution in a 3 ml pre-filled syringe (type I glass) with plunger stopper (bromobutyl coated with fluorocarbon polymer). A hypodermic needle (25 G; 16 mm) is included in the pack. Pack size of ...
6.6. Special precautions for disposal and other handling
The solution should be clear and colourless and free from visible particles. Use in the paediatric population The appropriate dose to be administered is based on body weight (see section 4.2). Where the ...
7. Marketing authorization holder
Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, D02 Y754, Ireland
8. Marketing authorization number(s)
EU/1/08/461/001 EU/1/08/461/002
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 11 July 2008 Date of latest renewal: 13 March 2013
10. Date of revision of the text
10/2020
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