VABYSMO Solution for injection (2024)
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Περιεχόμενα
1. Name of the medicinal product
Vabysmo 120 mg/mL solution for injection.
2. Qualitative and quantitative composition
Faricimab is a humanised antibody produced in mammalian Chinese Hamster Ovary (CHO) cell culture by recombinant DNA technology. One mL of solution contains 120 mg of faricimab. Each vial contains 28.8 ...
3. Pharmaceutical form
Solution for injection. Clear to opalescent, colourless to brownish-yellow solution, with a pH of 5.5 and an osmolality of 270-370 mOsm/kg.
4.1. Therapeutic indications
Vabysmo is indicated for the treatment of adult patients with: neovascular (wet) age-related macular degeneration (nAMD), visual impairment due to diabetic macular oedema (DME), visual impairment due to ...
4.2. Posology and method of administration
This medicinal product must be administered by a qualified physician experienced in intravitreal injections. Each vial should only be used for the treatment of a single eye. Posology Neovascular (wet) ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active or suspected ocular or periocular infections. 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 medicinal product should be clearly recorded. Intravitreal injection-related ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Based on the biotransformation and elimination of faricimab (see section 5.2), no interactions are expected. However, faricimab should not be administered concurrently ...
4.6. Pregnancy and lactation
Women of childbearing potential Women of childbearing potential should use effective contraception during treatment and for at least 3 months following the last intravitreal injection of faricimab. Pregnancy ...
4.7. Effects on ability to drive and use machines
Vabysmo has a minor influence on the ability to drive and use machines. Temporary visual disturbances may occur 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 cataract (10%), conjunctival haemorrhage (7%), vitreous detachment (4%), IOP increased (4%), vitreous floaters (4%), eye ...
4.9. Overdose
Overdosing with greater than recommended injection volume may increase intraocular pressure. In the event of overdose, IOP should be monitored and, if deemed necessary by the treating physician, appropriate ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Ophthalmologicals, antineovascularisation agents <b>ATC code:</b> S01LA09 Mechanism of action Faricimab is a humanised bispecific immunoglobulin G1 (IgG1) antibody that ...
5.2. Pharmacokinetic properties
Faricimab is administered intravitreally to exert local effects in the eye. Absorption and distribution Based on a population pharmacokinetic analysis (including nAMD and DME N=2 246), maximum free (unbound ...
5.3. Preclinical safety data
No studies have been conducted on the carcinogenic or mutagenic potential of faricimab. In pregnant cynomolgus monkeys, IV injections of faricimab resulting in serum exposure (C<sub>max</sub>) more than ...
6.1. List of excipients
L-histidine Acetic acid 30% (for pH adjustment) (E260) L-methionine Polysorbate 20 (E432) Sodium chloride D-sucrose 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
30 months.
6.4. Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. Prior to use, the unopened vial may be kept at room temperature, 20°C to 25°C, for up ...
6.5. Nature and contents of container
0.24 mL sterile, solution in a glass vial with a coated rubber stopper sealed with an aluminum cap with a yellow plastic flip-off disk. Pack size of 1 vial and 1 blunt transfer filter needle (18-gauge ...
6.6. Special precautions for disposal and other handling
Do not shake. The vial contains more than the recommended dose of 6 mg. The fill volume of the vial (0.24 mL) is not to be used in total. The excess volume should be expelled prior to injection. Injecting ...
7. Marketing authorization holder
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
8. Marketing authorization number(s)
EU/1/22/1683/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 15 September 2022
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