BEOVU Solution for injection (2022)
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Περιεχόμενα
1. Name of the medicinal product
Beovu 120 mg/ml solution for injection in pre-filled syringe. Beovu 120 mg/ml solution for injection.
2. Qualitative and quantitative composition
One ml solution for injection contains 120 mg of brolucizumab*. * Brolucizumab is a humanised monoclonal single-chain Fv (scFv) antibody fragment produced in Escherichia coli cells by recombinant DNA technology. ...
3. Pharmaceutical form
Solution for injection (injection). Clear to slightly opalescent, colourless to slightly brownish-yellow aqueous solution.
4.1. Therapeutic indications
Beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (AMD).
4.2. Posology and method of administration
Beovu must be administered by a qualified ophthalmologist experienced in intravitreal injections. Posology The recommended dose is 6 mg brolucizumab (0.05 ml solution) administered by intravitreal injection ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with active or suspected ocular or periocular infections. Patients with active intraocular inflammation. ...
4.4. 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. Endophthalmitis, intraocular inflammation, ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should use effective contraception during treatment with brolucizumab and for at least one month after the last dose when stopping treatment.with ...
4.7. Effects on ability to drive and use machines
Beovu has a minor influence on the ability to drive and use machines due to possible temporary visual disturbances following the intravitreal injection and the associated eye examination. Patients should ...
4.8. Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions were reduced visual acuity (7.3%), cataract (7.0%), conjunctival haemorrhage (6.3%) and vitreous floaters (5.1%). The most serious ...
4.9. Overdose
Overdosing with greater than recommended injection volume may increase intraocular pressure. In the event of overdose, intraocular pressure should therefore be monitored and, if deemed necessary by the ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals, antineovascularisation agents ATC code: S01LA06 Mechanism of action Brolucizumab is a humanised monoclonal single chain Fv (scFv) antibody fragment with a ...
5.2. Pharmacokinetic properties
Beovu is administered directly into the vitreous to exert local effects in the eye. Absorption and distribution After intravitreal administration of 6 mg brolucizumab per eye to patients with nAMD, the ...
5.3. Preclinical safety data
No studies have been conducted on the carcinogenic or mutagenic potential of brolucizumab. No animal reproduction studies have been conducted.
6.1. List of excipients
Sodium citrate Sucrose Polysorbate 80 Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
Pre-filled syringe: 2 years. Vial: 2 years.
6.4. Special precautions for storage
Pre-filled syringe Store in a refrigerator (2°C 8°C). Do not freeze. Keep the pre-filled syringe in its sealed blister and in the outer carton in order to protect from light. Prior to use, the unopened ...
6.5. Nature and contents of container
Pre-filled syringe 0.165 ml sterile solution in a pre-filled syringe (type I glass) with a bromobutyl rubber plunger stopper and a syringe cap consisting of a white, tamper-evident rigid seal with a grey ...
6.6. Special precautions for disposal and other handling
Pre-filled syringe The pre-filled syringe contains more than the recommended dose of 6 mg. The extractable volume of the pre-filled syringe (0.165 ml) is not to be used in total. The excess volume should ...
7. Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
8. Marketing authorization number(s)
EU/1/19/1417/001-002
9. Date of first authorization / renewal of the authorization
13 February 2020
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