RANIVISIO 10 mg /Ml Roztwór Do Wstrzykiwań

Treść ulotki

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

Ranivisio 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 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 you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What is Ranivisio and what is it used for

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

What is Ranivisio used for
Ranivisio 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 Ranivisio works
Ranivisio recognizes and specifically binds to a protein called vascular endothelial growth
factor 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 a decrease in
vision in conditions such as AMD, DME, PDR, RVO, PM and CNV. By binding to VEGF-A, Ranivisio
can block its action and prevent abnormal growth and swelling.
In these conditions, Ranivisio can help stabilize and, in many cases, improve vision.

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

You must not receive Ranivisio

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

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

• Ranivisio is given by an injection into your eye. Occasionally, after treatment with Ranivisio, an infection inside the eye, pain or redness (inflammation), detachment or tear of one of the layers at the back of the eye (retinal detachment or tear and detachment or tear of the retinal pigment epithelium), or clouding of the lens of the eye (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 redness of the eye, 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 your eye may increase briefly immediately after the injection. This may be something you do not notice, so your doctor must 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 ischaemic attacks (weakness or paralysis of the limbs or face, difficulty speaking or understanding). This information will be taken into consideration to assess whether Ranivisio is the appropriate treatment for you.

See section 4 ("Possible side effects") for more detailed information about the side effects that can occur during therapy with Ranivisio.

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

Other medicines and Ranivisio
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 Ranivisio.
• There is no experience with the use of Ranivisio in pregnant women. Ranivisio 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 to become pregnant, talk to your doctor before taking Ranivisio.
• The use of Ranivisio during breastfeeding is not recommended as small amounts of Ranivisio may pass into breast milk. Ask your doctor or pharmacist for advice before treatment with Ranivisio.

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

Ranivisio contains polysorbate
This medicine contains 0.005 mg of polysorbate 20 in each delivered dose of 0.05 ml,
equivalent to 0.10 mg/ml. Polysorbates can cause allergic reactions. Tell your doctor if you have
any known allergies.

3. How Ranivisio will be administered to you

Ranivisio 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 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 Ranivisio. The doctor will monitor the condition
of the eye and, based on the response to treatment, will decide if and when further
treatment is necessary.
prepare and administer Ranivisio.”

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

Before stopping treatment with Ranivisio
If you are considering stopping treatment with Ranivisio, attend your next visit and discuss it
with your doctor. The doctor will advise you and decide how long you should be treated
with Ranivisio.
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 Ranivisio 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 floating spots 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 eyeball (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, an increase in the number of floaters in
your vision, or increased sensitivity to light. Seek medical attention 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, redness or itching of the eye, 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 Ranivisio 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 part 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), sensitivity
to light, 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.

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

5. How to store Ranivisio

• 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 pack after ‘Scad.’ and on the 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.
• Before use, the closed vial can be stored at room temperature (25 °C) for a maximum of 24 hours.
• Keep the vial in the outer packaging to protect the medicine from light.
• Do not use a pack that is damaged.

6. Contents of the pack and other information

What Ranivisio 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 a sufficient amount for administering 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 (E 432); water for injections.

Description of the appearance of Ranivisio and contents of the pack
Ranivisio is an injectable solution in a vial (0.23 ml). The solution is aqueous, clear, from
colourless to pale yellow.

Available pack size:
Pack containing one glass vial of ranibizumab with a chlorobutyl rubber stopper. The
vial is for single use only.

Marketing Authorisation Holder and Manufacturer
Midas Pharma GmbH
Rheinstraße 49
D-55218 Ingelheim
Germany
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./A.G.
Tel/Tél: +32 3 820 73 73

Lietuva
UAB Teva Baltics
Tel: +370 5 266 02 03

България
Тева Фарма ЕАД
Tel: +359 2 489 95 85

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./A.G.,
Tél: +32 3 820 73 73

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251 007 111

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 1 288 6400

Danmark
Teva Denmark A/S
Tlf.: +45 44 98 55 11

Malta
Teva Pharmaceuticals Ireland, L-Irlanda
Τel: +353 (0)1912 7700

Deutschland
ratiopharm GmbH
Tel: +49 731 402 02

Nederland
Teva Nederland B.V.
Tel: +31 (0) 800 0228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 661 0801

Norge
Teva Norway AS
Tlf: +47 66 77 55 90

Ελλάδα
Specifar ΑΒΕΕ
Τηλ: +30 211 880 5000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1 970070

España
Teva Pharma, S.L.U.
Tel: +34 91 387 32 80

Polska
Zakłady Farmaceutyczne Polpharma S.A.
Tel. + 48 22 364 61 01

France
Teva Santé
Tél: +33 1 55 91 78 00

Portugal
Teva Pharma - Produtos Farmacêuticos Lda
Tel: +351 214 767 550

Hrvatska
Pliva Hrvatska d.o.o
Tel: + 385 1 37 20 000

România
Teva Pharmaceuticals S.R.L
Tel: +40 21 230 65 24

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 (0) 207 540 7117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 1 58 90 390

Ísland
Teva Pharma Iceland ehf.
Sími: + 354 550 3300

Slovenská republika
Teva Pharmaceuticals Slovakia s.r.o.
Tel: +421 2 5726 7911

Italia
Teva Italia S.r.l.
Tel: +39 0289 17981

Suomi/Finland
ratiopharm Oy
Puh/Tel: +358 20 180 5900

Κύπρος
Specifar ΑΒΕΕ, Ελλάδα
Τηλ: +30 211 880 5000

Sverige
Teva Sweden AB
Tel: +46 42 12 11 00

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67 323 666

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

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

How to prepare and administer Ranivisio
Single-use vial, for intravitreal use only.
Ranivisio must be administered by a qualified ophthalmologist experienced in intravitreal injections.
In exudative AMD, CNV, PDR and visual impairment due to DME, or macular oedema secondary to BRVO, the recommended dose of Ranivisio is 0.5 mg in a single intravitreal injection.
This corresponds to an injected volume of 0.05 ml. The interval between two injections into 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
in the absence of signs of disease activity such as changes in visual acuity and alterations in other
signs and symptoms of the disease during continuous treatment. In patients with exudative AMD,
DME, PDR and BRVO, it may be necessary to start therapy with three or more consecutive monthly injections.
Therefore, monitoring and treatment intervals must be decided by the physician and must be based on
disease activity, as determined by assessment of visual acuity and/or anatomical parameters.
If, in the opinion of the physician, visual acuity and anatomical parameters indicate that the patient is not
benefiting from continuous treatment, Ranivisio 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 reaching
maximum visual acuity and/or in the absence of signs of disease activity, treatment intervals
may be gradually extended until signs of the disease reappear or a worsening of visual function is observed. The treatment interval should be gradually extended by a maximum of two weeks in patients with exudative 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
a monthly injection. For CNV secondary to pathological myopia (PM), many patients may
only need one or two injections during the first year.

Ranivisio 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, Ranivisio should be administered at least 30 minutes after
argon laser photocoagulation. Ranivisio may be administered to patients who have previously received
argon laser photocoagulation.

Ranivisio 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, Ranivisio 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 and a sterile blepharostat (or
equivalent) and the possibility of performing a sterile paracentesis (if necessary). Before performing the
intravitreal procedure, the patient’s history should be carefully assessed for
hypersensitivity reactions. Adequate anaesthesia and a broad-spectrum antimicrobial topical agent should be administered before the injection to disinfect the periocular, ocular and eyelid surface,
as per clinical practice.
The vial is for single use only. After 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.

• a 5 μm (18G) filter needle
• a sterile 1 ml syringe (with a 0.05 ml mark)
• an injection needle (30G x ½″). These medical devices are not included in the Ranivisio pack. They can be obtained separately or found within third-party intravitreal injection kits (e.g. the Vortex Surgical I2 injection kit).

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

• 1. Before drawing, remove the vial cap and clean the vial stopper (e.g. with a 70% alcohol swab).
• 2. Attach a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 µm) to a 1 ml syringe in aseptic conditions. Insert the bevelled filter needle into the centre of the stopper until it touches the bottom of the vial.
• 3. Draw all the liquid from the vial while holding it vertically, slightly tilted to facilitate complete withdrawal.

• 4. Make sure the syringe plunger is pulled back sufficiently when emptying the vial 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 the contents of the vial and do not use it for the intravitreal injection.

• 6. Firmly attach an injection needle (30G x ½″, 0.3 mm x 13 mm) to the syringe in aseptic conditions.
• 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 as 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 sclerotic site for subsequent injections.
After the injection, do not recap or detach the needle from the syringe. Dispose of the used syringe together with
the needle in a suitable container or in accordance with local regulations.

Ranivisio 10 mg/ml injectable solution in pre-filled syringe

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 encountered during the use of this medicine. See section 4 for information on how to report adverse effects.

Read this leaflet carefully before this medicine is administered to you, 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 Ranivisio is and what it is used for
• 2. What you need to know before Ranivisio is administered to you
• 3. How Ranivisio will be administered to you
• 4. Possible side effects
• 5. How to store Ranivisio
• 6. Contents of the pack and other information

1. What is Ranivisio and what is it used for

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

What is Ranivisio used for
Ranivisio 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 Ranivisio works
Ranivisio recognizes and specifically binds to a protein called vascular endothelial growth
factor 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 a decrease in
vision in conditions such as AMD, DME, PDR, RVO, PM and CNV. By binding to VEGF-A, Ranivisio
can block its action and prevent abnormal growth and swelling.
In these conditions, Ranivisio can help stabilize and, in many cases, improve vision.

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

Do not receive Ranivisio

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

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

• Ranivisio is given by an injection into the eye. Occasionally, after treatment with Ranivisio, an infection inside the eye, pain or redness (inflammation), detachment or tear of one of the layers at the back of the eye (retinal and retinal pigment epithelium detachment or tear), or clouding of the lens of the eye (cataract) may 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 of 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, therefore your 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 Ranivisio 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 Ranivisio.

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

Other medicines and Ranivisio
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding

• Women of childbearing potential should use effective contraception during treatment and for at least three months after the last injection of Ranivisio.
• There is no experience with the use of Ranivisio in pregnant women. Ranivisio 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 to become pregnant, talk to your doctor before taking Ranivisio.
• The use of Ranivisio during breastfeeding is not recommended as small amounts of Ranivisio may pass into breast milk. Ask your doctor or pharmacist for advice before treatment with Ranivisio.

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

Ranivisio contains polysorbate
This medicine contains 0.005 mg of polysorbate 20 in each administered dose of 0.05 ml,
equivalent to 0.10 mg/ml. Polysorbates can cause allergic reactions. Tell your doctor if you have
any known allergies.

3. How Ranivisio will be administered to you

Ranivisio 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
pre-filled syringe contains a volume greater than the recommended dose of 0.5 mg. The drawable
volume must not be used completely. The excess volume must be discarded before proceeding with the
injection. Injecting the entire volume of the pre-filled syringe may cause an overdose.
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 Ranivisio. 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 Ranivisio”.

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

Before stopping treatment with Ranivisio
If you are considering stopping treatment with Ranivisio, attend your next visit and discuss it with
your doctor. The doctor will advise you and decide how long you should be treated
with Ranivisio.
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 Ranivisio 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 floating spots up to temporary vision loss, 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 eyeball (endophthalmitis) with inflammation inside the eye.
Symptoms you may experience include eye pain or increased eye discomfort, worsening eye redness,
blurred or decreased vision, increased number of spots in your vision, or increased sensitivity to light. Contact your doctor immediately if any of these side effects occur.
The more 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, spots or blemishes 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 Ranivisio 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 part 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), sensitivity to light, 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, paleness), anxiety, cough, nausea, allergic reactions such as
rash, hives, itching, and skin redness.

Uncommon side effects
Visual side effects include: inflammation and bleeding in the front part 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.

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

5. How to store Ranivisio

• 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 pack after ‘Scad.’ and on the pre-filled syringe 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.
• Before use, the sealed tray can be stored at room temperature (25 °C) for a maximum of 24 hours.
• Keep the pre-filled syringe in its sealed tray in the pack to protect the medicine from light.
• Do not use a pack that is damaged.

6. Content of the pack and other information

What Ranivisio contains

• The active substance is ranibizumab. Each ml contains 10 mg of ranibizumab. One pre-filled syringe contains 0.165 ml, equivalent to 1.65 mg of ranibizumab. This provides an amount sufficient for the administration of a single dose of 0.05 ml containing 0.5 mg of ranibizumab.
• The other components are α,α-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20 (E 432); water for injections.

Description of the appearance of Ranivisio and contents of the pack
Ranivisio is an injectable solution in a pre-filled syringe. The pre-filled syringe contains
0.165 ml of a sterile, aqueous solution, clear, from colourless to pale yellow. The pre-filled
syringe contains a volume greater than the recommended dose of 0.5 mg. The drawable volume must not
be used completely. The excess volume must be discarded before proceeding with the injection.
Injection of the entire volume of the pre-filled syringe may cause overdose.

A type of pack is available:
The pack contains one pre-filled syringe, packaged in a sealed tray. The pre-filled
syringe is for single use only.

Marketing Authorisation Holder and Manufacturer
Midas Pharma GmbH
Rheinstraße 49
D-55218 Ingelheim
Germany
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./A.G.
Tel/Tél: +32 3 820 73 73

Lietuva
UAB Teva Baltics
Tel: +370 5 266 02 03

България
Тева Фарма ЕАД
Tel: +359 2 489 95 85

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./A.G.,
Tél: +32 3 820 73 73

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251 007 111

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 1 288 6400

Danmark
Teva Denmark A/S
Tlf.: +45 44 98 55 11

Malta
Teva Pharmaceuticals Ireland, L-Irlanda
Τel: +353 (0)1912 7700

Deutschland
ratiopharm GmbH
Tel: +49 731 402 02

Nederland
Teva Nederland B.V.
Tel: +31 (0) 800 0228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 661 0801

Norge
Teva Norway AS
Tlf: +47 66 77 55 90

Ελλάδα
Specifar ΑΒΕΕ
Τηλ: +30 211 880 5000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1 970070

España
Teva Pharma, S.L.U.
Tel: +34 91 387 32 80

Polska
Zakłady Farmaceutyczne Polpharma S.A.
Tel. + 48 22 364 61 01

France
Teva Santé
Tél: +33 1 55 91 78 00

Portugal
Teva Pharma - Produtos Farmacêuticos Lda
Tel: +351 214 767 550

Hrvatska
Pliva Hrvatska d.o.o
Tel: + 385 1 37 20 000

România
Teva Pharmaceuticals S.R.L
Tel: +40 21 230 65 24

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 (0) 207 540 7117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 1 58 90 390

Ísland
Teva Pharma Iceland ehf.
Sími: + 354 550 3300

Slovenská republika
Teva Pharmaceuticals Slovakia s.r.o.
Tel: +421 2 5726 7911

Italia
Teva Italia S.r.l.
Tel: +39 0289 17981

Suomi/Finland
ratiopharm Oy
Puh/Tel: +358 20 180 5900

Κύπρος
Specifar ΑΒΕΕ, Ελλάδα
Τηλ: +30 211 880 5000

Sverige
Teva Sweden AB
Tel: +46 42 12 11 00

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67 323 666

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

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

How to prepare and administer Ranivisio
Single-use pre-filled syringe, for intravitreal use only.
Ranivisio must be administered by a qualified ophthalmologist experienced in intravitreal injections.
In exudative AMD, CNV, PDR and visual impairment due to DME, or in macular oedema secondary to BRVO, the recommended dose of Ranivisio 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 a monthly injection until maximum visual acuity is achieved and/or
in the absence of 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 exudative AMD,
DME, PDR and BRVO, it may be necessary to start therapy with three or more consecutive monthly injections.
Therefore, monitoring and treatment intervals must be decided by the physician and must
be based on disease activity, as determined by assessment of visual acuity 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, Ranivisio 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 reaching
maximum visual acuity and/or in the absence of signs of disease activity, treatment intervals
may be gradually extended until signs of the disease reappear or a worsening of visual function is observed.
The treatment interval should be gradually extended by a maximum of two weeks in patients with exudative 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
a monthly injection. For CNV secondary to pathological myopia (PM), many patients may
only need one or two injections during the first year.

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

Ranivisio 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, Ranivisio should be visually inspected for the presence of
particles and chromatic alterations.
The injection procedure must be performed under aseptic conditions, including
surgical scrubbing of the hands, sterile gloves, a sterile drape and a sterile paracentesis (if necessary). Before performing the
intravitreal procedure, the patient’s history should be carefully assessed for
hypersensitivity reactions. Adequate anaesthesia and a broad-spectrum topical antimicrobial agent should be administered before the injection to disinfect the periocular, ocular and eyelid surface,
as per clinical practice.
The pre-filled syringe is for single use only. The pre-filled syringe is sterile. Do not use the
product if the packaging is damaged. The sterility of the pre-filled syringe cannot be
guaranteed if the tray is not intact. Do not use the pre-filled syringe if the solution is discoloured,
cloudy, or contains particles.
The pre-filled syringe contains a volume greater than the recommended dose of 0.5 mg. The volume
drawable from the pre-filled syringe (0.1 ml) must not be used completely. The excess volume
must be discarded before proceeding with the injection. Injection of the entire volume of the syringe
may cause overdose. To expel air bubbles and excess medicinal product,
gently push the plunger to align the lower edge of the rubber stopper dome
with the black measurement line on the syringe (equivalent to 0.05 ml, i.e. 0.5 mg of ranibizumab).
A sterile 30G x ½″ injection needle should be used for intravitreal injection.
This medical device is not included in this pack.
To prepare Ranivisio for intravitreal injection, please follow the instructions for use:

Introduction	n Read all instructions carefully before using the pre-filled syringe. a The pre-filled syringe is for single use only. The pre-filled syringe is sterile. Do not use the product if the packaging is damaged. Opening i the sealed tray and all subsequent operations must be performed under l asepsis. Note: The dose must be set to 0.05 ml.
Description of the pre-filled syringe e	a t Syringe cap Rubber stopper Grip I a i z Luer lock 0.05 ml dose measurement line Plunger Figure 1
g Preparation A	1. Ensure that the pack contains: One sterile pre-filled syringe in a sealed tray. 2. Lift the lid of the syringe tray and, under aseptic conditions, carefully remove the syringe.

Syringe check	3. Check that: The syringe cap is not detached from the Luer lock adapter. o The syringe is not damaged. The solution appears clear, from colourless to pale yellow and does not contain c particles. 4. If any of the above conditions are not met, discard the pre-filled syringe and use a new one.
Removing the syringe cap	5. Rotate (do not detach) the syringe cap (see Figure 2). 6. Dispose of the syringe cap (see l e d a n	a m r a F Figure 2 Figure 3
Inserting the needle	a 7. Firmly insert a sterile 30G x ½″ injection needle onto the syringe i by screwing it tightly onto the Luer lock l (see Figure 4). a 8. Carefully remove the needle cap by pulling it (see I Note: Never clean the needle. a i z	Figure 4 Figure 5

• 9. Hold the syringe vertically.
• 10. If there are any air bubbles, tap Expellingair bubbles

the syringe gently with your finger until
they rise to the surface (see
Figure 6).

Figure 6
Setting the dose

• 11. Hold the syringe at eye level and gently push the plunger until the lower edge of the rubber stopper domeis aligned with the dose measurement line (see Figure 7). This will expel the air and excess solution and set the dose to 0.05 ml. Note: The plunger is not attached to the rubber stopper - this is to prevent air frombeing drawn into the syringe.

Figure 7
InjectionThe injection procedure must be performed under aseptic conditions.

• 12. Insert the injection needle 3.5-4.0 mm posterior to the limbus, into the vitreous chamber, avoiding the horizontal meridian and directing the needle towards the center of the eyeball.
• 13. Inject slowly until the dome of the rubber stopper reaches the bottom of the syringe to achieve the injected volume of 0.05 ml.
• 14. A different scleral site must be used for subsequent injections.
• 15. After the injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the needle in a suitable container or in accordance with current local regulations.