BYOOVIZ Solution for injection (2022)
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Περιεχόμενα
1. Name of the medicinal product
Byooviz 10 mg/ml solution for injection.
2. Qualitative and quantitative composition
One ml contains 10 mg ranibizumab*. Each vial contains 2.3 mg of ranibizumab in 0.23 ml solution. This provides a usable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab to adult ...
3. Pharmaceutical form
Solution for injection. Clear, colourless to pale yellow aqueous solution.
4.1. Therapeutic indications
Byooviz is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD). The treatment of visual impairment due to diabetic macular oedema (DME). The treatment of ...
4.2. Posology and method of administration
Byooviz must be administered by a qualified ophthalmologist experienced in intravitreal injections. Posology Adults The recommended dose for Byooviz in adults is 0.5 mg given as a single 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 severe 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. Intravitreal injection-related ...
4.5. Interaction with other medicinal products and other forms of interaction
No formal interaction studies have been performed. For the adjunctive use of verteporfin photodynamic therapy (PDT) and ranibizumab in wet AMD and PM, see section 5.1. For the adjunctive use of laser photocoagulation ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential/contraception in females Women of childbearing potential should use effective contraception during treatment. Pregnancy For ranibizumab no clinical data on exposed pregnancies ...
4.7. Effects on ability to drive and use machines
The treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines (see section 4.8). Patients who experience these signs must not drive or use machines ...
4.8. Undesirable effects
Summary of the safety profile The majority of adverse reactions reported following administration of ranibizumab are related to the intravitreal injection procedure. The most frequently reported ocular ...
4.9. Overdose
Cases of accidental overdose have been reported from the clinical studies in wet AMD and post-marketing data. Adverse reactions associated with these reported cases were intraocular pressure increased, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Ophthalmologicals, antineovascularisation agents <b>ATC code:</b> S01LA04 Byooviz is a biosimilar medicinal product. Detailed information is available on the website of ...
5.2. Pharmacokinetic properties
Following monthly intravitreal administration of ranibizumab to patients with neovascular AMD, serum concentrations of ranibizumab were generally low, with maximum levels (C<sub>max</sub>) generally below ...
5.3. Preclinical safety data
Bilateral intravitreal administration of ranibizumab to cynomolgus monkeys at doses between 0.25 mg/eye and 2.0 mg/eye once every 2 weeks for up to 26 weeks resulted in dose-dependent ocular effects. ...
6.1. List of excipients
α,α-trehalose dihydrate Histidine hydrochloride, monohydrate Histidine Polysorbate 20 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
3 years.
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 stored at temperatures not exceeding 30°C for ...
6.5. Nature and contents of container
<u>Vial-only pack:</u> One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution. <u>Vial + filter needle + injection needle pack:</u> One vial (type I glass) with ...
6.6. Special precautions for disposal and other handling
Vial-only pack The vial is for single use only. After injection any unused product must be discarded. Any vial showing signs of damage or tampering must not be used. The sterility cannot be guaranteed ...
7. Marketing authorization holder
Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands
8. Marketing authorization number(s)
EU/1/21/1572/001 EU/1/21/1572/002
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 18 August 2021
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