BYOOVIZ 10 mg /Ml Roztwór Do Wstrzykiwań

Treść ulotki

1. Byooviz 10 mg/mL injectable solution
   1. What is Byooviz and what is it used for
   2. What you need to know before you are given Byooviz
   3. How Byooviz will be administered to you
   4. Possible side effects
   5. How to store Byooviz
   6. Contents of the pack and other information

Byooviz 10 mg/mL injectable solution

ranibizumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects experienced during
the use of this medicine. See the end of section 4 for information on how to report adverse effects.

ADULTS
Read this leaflet carefully before you are given this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of 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 will be given to you
• 4. Possible side effects
• 5. How to store Byooviz
• 6. Contents of the pack and other information

1. What is Byooviz and what is it used for

What is Byooviz
Byooviz is a solution that must be injected into the eye. Byooviz belongs to a group of
medicines called anti-neovascularization agents. It contains an active substance called
ranibizumab.

What is Byooviz used for
Byooviz is used in adults to treat various eye conditions that cause a decrease
in vision.
These conditions are caused by damage to the retina (the light-sensitive layer at the back
of the eye) caused by:

• Growth of abnormal blood vessels that leak fluid. This is observed in conditions such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a condition caused by diabetes). It may be associated with choroidal neovascularization (CNV) due to pathological myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV.
• Macular edema (swelling in the center of the retina). This swelling can be caused by diabetes (a condition called diabetic macular edema (DME)) or blockage of the retinal veins (a condition called retinal vein occlusion (RVO)).

How Byooviz works
Byooviz recognizes and specifically binds to a protein called vascular endothelial growth factor
human A (VEGF-A) present in the eye. When in excess, VEGF-A causes abnormal growth of
blood vessels and swelling in the eye that can lead to decreased vision in conditions
such as AMD, DME, PDR, RVO, PM and CNV. By binding to VEGF-A, Byooviz can block its action and
prevent abnormal growth and swelling.
In these conditions, Byooviz can help stabilize and in many cases improve vision.

2. What you need to know before you are given Byooviz

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 an eye or the surrounding area.
• if you have pain or redness (severe eye inflammation) in an eye.

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

• Byooviz is given by an injection into the eye. Occasionally, after treatment with Byooviz, an infection inside the eye, pain or redness (inflammation), detachment or tear of one of the layers in the back of the eye (retinal or retinal pigment epithelium detachment or tear), or clouding of the lens (cataract) can occur. It is important to identify and treat an infection or retinal detachment as soon as possible. Tell your doctor immediately if you experience signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increase in the number of floaters in your vision, or increased sensitivity to light.
• In some patients, the pressure in the eye may increase briefly immediately after the injection. This event is something you may not notice, so the doctor must perform a check after each injection.
• Tell your doctor if you have had previous eye problems or treatments, or if you have had a stroke or signs of transient ischemic attacks (weakness or paralysis of the limbs or face, difficulty speaking or understanding). This information will be taken into consideration to assess whether Byooviz is the appropriate treatment for you.

See section 4 (“Possible side effects”) for more detailed information about the side effects that may occur during therapy with Byooviz.

Children and adolescents (under 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 taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding

• Women of childbearing potential must use effective contraception during treatment and for at least three months after the last injection of Byooviz.
• There is no experience with the use of Byooviz in pregnant women. Byooviz should not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus. If you are pregnant, suspect you are pregnant or are planning a pregnancy, talk to your doctor before taking Byooviz.
• The use of Byooviz during breastfeeding is not recommended as small amounts of ranibizumab may pass into breast milk. Ask your doctor or pharmacist for advice before treatment with Byooviz.

Driving and operating machinery
Temporary blurred vision may occur after treatment with Byooviz. If this
happens, do not drive or operate machinery until this condition has resolved.

3. How Byooviz will be administered to you

Byooviz is administered by the ophthalmologist as a single injection into the eye under local anesthesia
Byooviz is administered by the ophthalmologist as a single injection into the eye under local anesthesia. 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 must be at least four weeks. All
injections will be administered to you by the ophthalmologist.
Before the injection, the doctor will carefully clean the eye to prevent infection. The doctor will also give
you a local anesthetic to reduce or prevent any pain that may occur with the injection.
Treatment is started with a monthly injection of Byooviz. The doctor will monitor the condition
of the eye and, based on the response to treatment, will decide whether and when further
treatment is necessary.
prepare and administer Byooviz”.

Elderly (65 years of age and over)
Byooviz can be used for patients aged 65 years and over without dose adjustments.

Before stopping treatment with Byooviz
If you are considering stopping treatment with Byooviz, attend your next visit and discuss it
with your doctor. The doctor will advise you and decide how long you should be treated with Byooviz.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects associated with the administration of Byooviz are due to both the medicine itself and
the injection procedure and mostly affect the eye.
The most serious side effects are described below:

Serious common side effects(may affect up to 1 in 10 people): detachment or tear
in the back of the eye (retinal detachment or tear), which manifests with flashes of light with
floaters up to a temporary reduction in vision, or clouding of the lens of the eye (cataract).

Serious uncommon side effects(may affect up to 1 in 100 people): blindness, infection of the
eye (endophthalmitis) with inflammation inside the eye.
The symptoms you may experience are eye pain or increased eye discomfort, worsening
eye redness, blurred or decreased vision, increased number of floaters in
vision or increased sensitivity to light. Contact your doctor immediately if any of these
side effects occur.
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: eye inflammation, bleeding in the back of the
eye (retinal hemorrhage), visual disturbances, eye pain, floaters or spots in vision
(floaters), localized eye redness, eye irritation, foreign body sensation
in the eye, increased tear production, inflammation or infection of the eyelid margin,
dry eye, eye redness or itching, and increased pressure inside the eye.
Non-visual side effects include: sore throat, nasal congestion, runny nose, headache, and
joint pain.
Other side effects that may occur following treatment with Byooviz are described below:

Common side effects
Visual side effects include: decreased visual acuity, swelling of a part
of the eye (uvea, cornea), inflammation of the cornea (front of the eye), small marks on
the surface of the eye, blurred vision, bleeding at the injection site, bleeding in the eye,
eye discharge with itching, redness and swelling (conjunctivitis), light sensitivity, eye discomfort,
eyelid swelling, eyelid pain.
Non-visual side effects include: urinary tract infection, decreased red blood cells
(with symptoms such as fatigue, shortness of breath, dizziness, pallor), anxiety, cough, nausea, allergic reactions
such as rash, hives, itching, and redness of the skin.

Uncommon side effects
Visual side effects include: inflammation and bleeding in the front
of the eye, pus collection in the eye, changes in the central part of the eye surface,
pain or irritation at the injection site, abnormal sensation in the eye, eyelid irritation.
If you experience any side effects, including those not listed in this leaflet, tell your
doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system reported in Annex V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Byooviz

• 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 package and on the vial label after scad. and after EXP. The expiry date refers to the last day of that month.
• Store in a refrigerator (2 ° C - 8 ° C). Do not freeze.
• Before use, the unopened vial can be stored at temperatures not exceeding 30°C for a maximum of 2 months.
• Keep the vial in the outer packaging to protect the medicine from light.
• Do not use a package that is damaged.

6. Contents of the pack and other information

What Byooviz contains

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

Description of the appearance of Byooviz and contents of the pack
Byooviz is an injectable solution in a vial (0.23 mL). The solution is aqueous, clear, from
colorless to pale yellow.
Two different packs are available:
Vial alone
Pack containing a glass vial of ranibizumab with a chlorobutyl rubber stopper. The
vial is for single use.
Vial + filter needle + injection needle
Pack containing a glass vial of ranibizumab with a chlorobutyl rubber stopper, a bevelled filter needle
(18G x 1½″, 1.2 mm x 40 mm, 5 micrometers) for drawing up the contents of the vial and an injection
needle (30G x 1½″, 0.3 mm x 13 mm). All components are for single use.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
Netherlands
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Biogen Belgium NV/S.A
Tél/Tel: + 32 (0)2 808 5947

Lietuva
Biogen Lithuania UAB
Tel: +370 52 07 91 38

България
Ewopharma AG Representative Office
Teл.: + 359 249 176 81

Luxembourg/Luxemburg
Biogen Belgium NV/SA
Tél/Tel: +35 227 772 038

Česká republika
Biogen (Czech Republic) s.r.o.
Tel: + 420 228 884 152

Magyarország
Biogen Hungary Kft.
Tel.: + 36 1 848 04 64

Danmark
Biogen (Denmark) A/S
Tlf: + 45 78 79 37 53

Malta
Pharma.MT Ltd
Tel: + 356 27 78 15 79

Deutschland
Biogen GmbH
Tel: + 49 (0)30 223 864 72

Nederland
Biogen Netherlands B.V.
Tel: + 31 (0)20 808 02 70

Eesti
Biogen Estonia OÜ
Tel: + 372 6 68 30 56

Norge
Biogen Norway AS
Tlf: + 47 21 93 95 87

Ελλάδα
Genesis Pharma S.A.
Τηλ: + 30 211 176 8555

Österreich
Biogen Austria GmbH
Tel: + 43 (0)1 267 51 42

España
Biogen Spain, S.L.
Tel: + 34 931 790 519

Polska
Biogen Poland Sp. z o.o.
Tel.: + 48 22 116 86 94

France
Biogen France SAS
Tél: + 33 (0)1 776 968 14

Portugal
Biogen Portugal Sociedade Farmacêutica,
Unipessoal, Lda
Tel: + 351 308 800 792

Hrvatska
Ewopharma d.o.o
Tel: + 385 (0)1 777 64 37

România
Ewopharma AG Representative Office
Tel: + 40 377 881 045

Ireland
Biogen Idec (Ireland) Ltd.
Tel: +353 (0)1 513 33 33

Slovenija
Biogen Pharma d.o.o.
Tel: + 386 (0)1 888 81 07

Ísland
Icepharma hf.
Sími: + 354 800 9836

Slovenská republika
Biogen Slovakia s.r.o.
Tel: + 421 (0)2 333 257 10

Italia
Biogen Italia s.r.l.
Tel: + 39 (0)6 899 701 50

Suomi/Finland
Biogen Finland Oy
Puh/Tel: + 358 (0)9 427 041 08

Κύπρος
Genesis Pharma (Cyprus) Ltd
Τηλ: + 357 22 00 04 93

Sverige
Biogen Sweden AB
Tel: +46 (0)8 525 038 36

Latvija
Biogen Latvia SIA
Tel: + 371 66 16 40 32

United Kingdom (Northern Ireland)
Biogen Idec (Ireland) Ltd.
Tel: +44 (0)20 360 886 22

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu

THE FOLLOWING INFORMATION IS FOR HEALTHCARE PROFESSIONALS ONLY:
Please also refer to section 3 “How Byooviz will be administered to you”.

How to prepare and administer Byooviz to adults
Single-use vials, for intravitreal use only.
Byooviz must be administered by a qualified ophthalmologist experienced in intravitreal injections.
In wet AMD, CNV, PDR and visual impairment due to DME, or macular oedema secondary to BRVO, the
recommended dose of Byooviz is 0.5 mg in a single intravitreal injection. This corresponds to an injected
volume of 0.05 mL. The interval between two injected doses in the same eye must be at least four weeks.
Treatment is initiated with an injection every month until maximum visual acuity is achieved and/or there are
no signs of disease activity such as changes in visual acuity and alterations in other signs and symptoms of
the disease during continued treatment. In patients with wet AMD, DME, PDR and BRVO, it may be
necessary to start therapy with three or more consecutive monthly injections.
Therefore, monitoring and treatment intervals should be decided by the physician and should be based on
disease activity, as assessed by visual acuity assessment and/or anatomical parameters.
If, in the opinion of the physician, visual acuity and anatomical parameters indicate that the patient is not
benefiting from continued treatment, Byooviz should be discontinued.
Monitoring of disease activity may include clinical examination, functional assessments or imaging techniques
(e.g. optical coherence tomography or fluorescein angiography).
If patients are treated according to a “treat-and-extend” regimen, upon achieving maximum visual acuity
and/or in the absence of signs of disease activity, treatment intervals may be gradually extended until signs of
the disease recur or a worsening of visual function is observed. The treatment interval should be gradually
extended by a maximum of two weeks in patients with wet AMD and may be extended up to one month in
patients with DME. Treatment intervals may also be gradually extended in the treatment of BRVO and PDR,
however, there is insufficient data to establish the duration of these intervals. Upon recurrence of disease
activity, the treatment interval should be reduced accordingly.
Treatment of visual impairment caused by CNV should be determined individually for each patient based on
disease activity. Some patients may only need one injection during the first 12 months; others may need more
frequent treatment, up to one injection per month. For CNV secondary to pathological myopia (PM), many
patients may only need one or two injections during the first year.

Ranibizumab and argon laser photocoagulation in DME and macular oedema secondary to BRVO
There is some experience of ranibizumab administered in conjunction with argon laser photocoagulation.
When used on the same day, ranibizumab should be administered at least 30 minutes after argon laser
photocoagulation. Ranibizumab may be administered to patients who have previously received argon laser
photocoagulation.

Ranibizumab and photodynamic therapy with verteporfin in CNV secondary to PM
There is no experience with the administration of ranibizumab in association with verteporfin.
Before administration, Byooviz should be visually inspected for the presence of particles and colour changes.
The injection procedure must be performed under aseptic conditions, including surgical scrubbing of the hands,
sterile gloves, a sterile drape (or equivalent) and the possibility of performing a sterile paracentesis (if
necessary). The patient’s history for hypersensitivity reactions should be carefully assessed before performing
the intravitreal procedure. Adequate anaesthesia and a broad-spectrum topical antimicrobial should be
administered before the injection to disinfect the periocular, ocular and eyelid surface, as per clinical practice.
Vial alone
The vial is for single use. After the injection, unused product must be discarded. Any vial showing signs of
damage or tampering must not be used. Sterility cannot be guaranteed if the package seal is broken.
The following single-use medical devices are required for preparation and intravitreal injection:

• a 5 µm filter needle (18G)
• an injection needle (30G x ½″)
• a sterile 1 mL syringe (with a 0.05 mL mark). These devices are not included in the Byooviz pack.

Vial + filter needle + injection needle
All components are sterile and for single use. Any component with packaging showing signs of damage or
tampering must not be used. Sterility cannot be guaranteed if the package seal of the component is broken.
Re-use can cause infection or other injury/illness.
The following single-use medical devices are required for preparation and intravitreal injection:

• a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, supplied)
• an injection needle (30G x 1½″, 0.3 mm x 13 mm, supplied)
• a sterile 1 mL syringe (with a 0.05 mL mark not included in the Byooviz pack)

To prepare Byooviz for intravitreal injection in adult patients, please follow these instructions:

• 1. Disinfect the outer surface of the rubber stopper of the vial before drawing up.

• 2. Attach a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 µm) to a 1 mL syringe aseptically. Insert the bevelled filter needle into the centre of the stopper until it touches the bottom of the vial.
• 3. Draw up all the liquid from the vial while holding it vertically, slightly tilted to facilitate complete withdrawal.
• 4. Make sure that the syringe plunger is pulled back sufficiently when emptying the vial so as to completely empty the filter needle.

• 5. Leave the bevelled filter needle in the vial and detach the syringe from it. Discard the filter needle after drawing up the contents of the vial and do not use it for intravitreal injection.

• 6. Firmly attach an injection needle (30G x ½″, 0.3 mm x 13 mm) to the syringe aseptically.

• 7. Carefully remove the cap from the injection needle without disconnecting the injection needle from the syringe.

Note: hold the base of the injection needle while removing the
cap.

• 8. Carefully expel air and excess solution from the syringe and adjust the dose to 0.05 mL marked on the syringe. The syringe is ready for injection.

Note :do not clean the injection needle. Do not pull back the
plunger.
Insert the injection needle 3.5-4.0 mm posterior to the limbus, into the vitreous cavity, avoiding the horizontal
meridian and directing the needle towards the centre of the eyeball. Inject the injection volume of 0.05 mL;
change the scleral site for subsequent injections.
After the injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together
with the needle in an appropriate container or in accordance with local regulations.