Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - byooviz

Document Subject

Generated Narrative: MedicinalProductDefinition mpb4d9b93668736e17b1df580d2cd21bf6

identifier: http://ema.europa.eu/identifier/EU/1/21/1572/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Byooviz 10 mg/ml solution for injection

type: Full name

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part: nan

type: Invented name part

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part: nan

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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-b4d9b93668736e17b1df580d2cd21bf6

identifier: http://ema.europa.eu/identifier/EU/1/21/1572/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - byooviz

Attesters

What is in this leaflet

1. What Byooviz is and what it is used for
2. What you need to know before you are given Byooviz
3. How Byooviz is given
4. Possible side effects
5. How to store Byooviz
6. Contents of the pack and other information

What Byooviz is Byooviz is a solution which is injected into the eye. Byooviz belongs to a group of medicines called antineovascularisation agents. It contains the active substance called ranibizumab.

What Byooviz is used for Byooviz is used in adults to treat several eye diseases causing vision impairment.

These diseases result from damage to the retina (light-sensitive layer at the back of the eye) caused by:

• Growth of leaky, abnormal blood vessels. This is observed in diseases such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes). It may also be associated with choroidal neovascularisation (CNV) due to pathologic myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV.
• Macular oedema (swelling of the centre of the retina). This swelling can be caused by diabetes (a disease called diabetic macular oedema (DME)) or by the blockage of retinal veins of the retina (a disease called retinal vein occlusion (RVO)).

How Byooviz works Byooviz specifically recognises and binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eye. In excess, VEGF-A causes abnormal blood vessel growth and swelling in the eye which can lead to impairment of vision in diseases like AMD, DME, PDR, RVO, PM and CNV. By binding to VEGF-A, Byooviz can block its actions and prevent this abnormal growth and swelling.

In these diseases, Byooviz can help to stabilise and in many cases improve your vision.

You must not receive Byooviz

• If you are allergic to ranibizumab or any of the other ingredients of this medicine (listed in section 6).
• If you have an infection in or around your eye.
• If you have pain or redness (severe intraocular inflammation) in your eye.

Warnings and precautions Talk to your doctor before you are given Byooviz.

• Byooviz is given as an injection into the eye. Occasionally, an infection in the internal portion of the eye, pain or redness (inflammation), detachment or tear of one of the layers in the back of the eye (retinal detachment or tear and retinal pigment epithelial detachment or tear), or clouding of the lens (cataract) may occur after Byooviz treatment. It is important to identify and treat such an infection or retinal detachment as soon as possible. Please tell your doctor immediately if you develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light.
• In some patients the eye pressure may increase for a short period directly after the injection. This is something you may not notice, therefore your doctor may monitor this after each injection.
• Inform your doctor if you have a prior history of eye conditions or eye treatments, or if you have had a stroke or experienced transient signs of stroke (weakness or paralysis of limbs or face, difficulty speaking or understanding). This information will be taken into account to evaluate if Byooviz is the appropriate treatment for you.

Please see section 4 ( Possible side effects ) for more detailed information on side effects that could occur during Byooviz therapy.

Children and adolescents (below 18 years of age) The use of Byooviz in children and adolescents has not been established and is therefore not recommended.

Other medicines and Byooviz Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

• Women who could become pregnant must use effective contraception during treatment and for at least three further months after the last injection of Byooviz.
• There is no experience of using Byooviz in pregnant women. Byooviz should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child. If you are pregnant, think you may be pregnant or planning to become pregnant, discuss this with your doctor before treatment with Byooviz.
• Small amounts of ranibizumab may pass into breast milk, therefore Byooviz is not recommended during breast-feeding. Ask your doctor or pharmacist for advice before Byooviz treatment.

Driving and using machines After Byooviz treatment you may experience some temporary vision blurring. If this happens, do not drive or use machines until this resolves.

Byooviz is administered as a single injection into your eye by your eye doctor under a local anaesthetic. The usual dose of an injection is 0.05 ml (which contains 0.5 mg of active substance). The interval between two doses injected into the same eye should be at least four weeks. All injections will be administered by your eye doctor.

Before the injection, your doctor will wash your eye carefully to prevent infection. Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection.

The treatment is started with one injection of Byooviz per month. Your doctor will monitor the condition of your eye and, depending on how you respond to the treatment, will decide if and when you need to receive further treatment.

Detailed instructions for use are given at the end of the leaflet under How to prepare and administer Byooviz .

Elderly (age 65 years and over) Byooviz can be used for people of 65 years of age and over without dose adjustment.

Before stopping Byooviz treatment If you are considering stopping Byooviz treatment, please go to your next appointment and discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Byooviz.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects associated with the administration of Byooviz are either due to the medicine itself or the injection procedure and mostly affect the eye.

The most serious side effects are described below: Common serious side effects (may affect up to 1 in 10 people): Detachment or tear of the layer in the back of the eye (retinal detachment or tear), resulting in flashes of light with floaters progressing to a temporary loss of sight, or a clouding of the lens (cataract). Uncommon serious side effects (may affect up to 1 in 100 people): Blindness, infection of the eyeball (endophthalmitis) with inflammation of the inside of the eye.

The symptoms you might experience are pain or increased discomfort in your eye, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light. Please tell your doctor immediately if you develop any of these side effects.

The most frequently reported side effects are described below: Very common side effects (may affect more than 1 in 10 people) Visual side effects include: Inflammation of the eye, bleeding in the back of the eye (retinal bleeding), visual disturbances, eye pain, small particles or spots in your vision (floaters), bloodshot eye, eye irritation, a feeling of having something in the eye, increased tear production, inflammation or infection of the eyelid margins, dry eye, redness or itching of the eye and increased eye pressure. Non-visual side effects include: Sore throat, nasal congestion, runny nose, headache and joint pain.

Other side effects which may occur following Byooviz treatment are described below: Common side effects Visual side effects include: Decreased sharpness of vision, swelling of a section of the eye (uvea, cornea), inflammation of the cornea (front part of eye), small marks on the surface of the eye, blurred vision, bleeding at the site of injection, bleeding in the eye, discharge from the eye with itching, redness and swelling (conjunctivitis), light sensitivity, eye discomfort, swelling of the eyelid, eyelid pain. Non-visual side effects include: Urinary tract infection, low red blood cells count (with symptoms such as tiredness, breathlessness, dizziness, pale skin), anxiety, cough, nausea, allergic reactions like rash, hives, itching and skin reddening. Uncommon side effects Visual side effects include: Inflammation and bleeding in the front part of the eye, sac of pus on the eye, changes of the central part of the eye surface, pain or irritation at the site of injection, abnormal sensation in the eye, irritation of the eyelid.

Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.
• Store in a refrigerator (2 C 8 C). Do not freeze.
• Prior to use, the unopened vial may be stored at temperatures not exceeding 30 C for up to 2 months.
• Keep the vial in the outer carton in order to protect from light.
• Do not use any pack that is damaged.

What Byooviz contains

• The active substance is ranibizumab. Each ml contains 10 mg ranibizumab. Each vial contains 2.3 mg ranibizumab in 0.23 ml solution. This provides a suitable amount to deliver a single dose of 0.05 ml containing 0.5 mg ranibizumab.
• The other ingredients are , -trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections.

What Byooviz looks like and contents of the pack Byooviz is a solution for injection in a vial (0.23 ml). The solution is clear, colourless to pale yellow and aqueous.

Two different pack types are available:

Vial-only pack
Pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper. The vial is for single use only.

Vial + filter needle + injection needle pack Pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper, one blunt filter needle (18G x 1 , 1.2 mm x 40 mm, 5 micrometres) for withdrawal of the vial contents, and one injection needle (30G x , 0.3 mm x 13 mm). All components are for single use only.

Not all pack types may be marketed.

Marketing Authorisation Holder and Manufacturer Samsung Bioepis NL B.V. Olof Palmestraat 2616 LR Delft The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Biogen Belgium NV/S.A T l/Tel: + 32 (0)2 808 5Lietuva Biogen Lithuania UAB Tel: +370 52 07 91
Ewopharma AG Representative Office Te .: + 359 249 176 Luxembourg/Luxemburg Biogen Belgium NV/SA T l/Tel: +35 227 772 esk republika Biogen (Czech Republic) s.r.o. Tel: + 420 228 884 Magyarorsz g Biogen Hungary Kft. Tel.: + 36 1 848 04 Danmark Biogen (Denmark) A/S Tlf: + 45 78 79 37 Malta Pharma.MT Ltd Tel: + 356 27 78 15 Deutschland Biogen GmbH
Tel: + 49 (0)89 996 177 Nederland Biogen Netherlands B.V. Tel: + 31 (0)20 808 02 Eesti Biogen Estonia O
Tel: + 372 6 68 30 Norge Biogen Norway AS Tlf: + 47 21 93 95
Genesis Pharma S.A. : + 30 211 176 8 sterreich Biogen Austria GmbH Tel: + 43 (0)1 267 51 Espa a Biogen Spain, S.L. Tel: + 34 931 790 Polska Biogen Poland Sp. z o.o. Tel.: + 48 22 116 86 France Biogen France SAS T l: + 33 (0)1 776 968 Portugal Biogen Portugal Sociedade Farmac utica, Unipessoal, Lda Tel: + 351 308 800 Hrvatska Ewopharma d.o.o Tel: + 385 (0)1 777 64 Rom nia Ewopharma AG Representative Office Tel: + 40 377 881 Ireland Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 513 33 Slovenija Biogen Pharma d.o.o. Tel: + 386 (0)1 888 81 sland Icepharma hf. S mi: + 354 800 9Slovensk republika Biogen Slovakia s.r.o.
Tel: + 421 (0)2 333 257 Italia Biogen Italia s.r.l. Tel: + 39 (0)6 899 701 Suomi/Finland Biogen Finland Oy Puh/Tel: + 358 (0)9 427 041
Genesis Pharma (Cyprus) Ltd : + 357 22 00 04 Sverige Biogen Sweden AB Tel: +46 (0)8 525 038 Latvija Biogen Latvia SIA Tel: + 371 66 16 40 United Kingdom (Northern Ireland) Biogen Idec (Ireland) Ltd. Tel: +44 (0)20 360 886 This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: