Ranivisio
Italy
Table of Contents
Package leaflet: Information for the adult patient
Ranivisio 10 mg/ml solution for injection
ranibizumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
ADULTS
Please 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, consult your doctor.
- If you experience any side effects, including those not listed in this leaflet, consult your doctor. See section 4.
Contents of this leaflet
- What Ranivisio is and what it is used for
- What you need to know before you are given Ranivisio
- How Ranivisio will be administered to you
- Possible side effects
- How to store Ranivisio
- Contents of the pack and other information
1. What Ranivisio is and what it is used for
What Ranivisio is
Ranivisio is a solution to be injected into the eye. Ranivisio belongs to a group of
medicines called anti-angiogenesis agents. It contains an active substance called
ranibizumab.
What Ranivisio is used for
Ranivisio is used in adults to treat various eye conditions that cause vision loss.
These conditions arise from 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 occurs in conditions such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a condition caused by diabetes). It may also 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 may be caused by diabetes (a condition called diabetic macular edema (DME)) or by blockage of retinal veins (a condition called retinal vein occlusion (RVO)).
How Ranivisio works
Ranivisio specifically recognizes and binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eye. When present in excess, VEGF-A causes abnormal growth of blood vessels and swelling in the eye, which can lead to vision loss in conditions such as AMD, DME, PDR, RVO, PM, and CNV. By binding to VEGF-A, Ranivisio blocks its activity and prevents abnormal vessel growth and swelling.
In these conditions, Ranivisio can help stabilize vision and, in many cases, improve it.
2. What you need to know before you are given Ranivisio
Do not receive Ranivisio
- if you are allergic to ranibizumab or to any of the other ingredients of this medicine (listed in section 6).
- if you have an infection in one eye or in the surrounding area.
- if you have pain or redness (severe intraocular inflammation) in one eye.
Warnings and precautions
Talk to your doctor before receiving Ranivisio.
- Ranivisio is administered by an injection into the eye. Occasionally, after treatment with Ranivisio, an infection inside the eye, 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 (cataract) may occur. It is important to identify and treat an infection or retinal detachment as soon as possible. Immediately inform your doctor if you experience symptoms such as eye pain or increased discomfort, worsening of eye redness, blurred or decreased vision, an increase in floaters, or increased sensitivity to light.
- In some patients, eye pressure may temporarily increase shortly after the injection. This event may go unnoticed, therefore your doctor must check your eye pressure after each injection.
- Inform 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 limbs or face, difficulty speaking or understanding). This information will be considered when evaluating whether Ranivisio is the appropriate treatment for you.
See section 4 ("Possible side effects") for more detailed information on side effects that may occur during treatment with Ranivisio.
Children and adolescents (under 18 years of age)
The use of Ranivisio has not been established in children and adolescents and is therefore not recommended.
Other medicines and Ranivisio
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
- Women of childbearing potential must use an effective method of 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 must not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, discuss this with your doctor before taking Ranivisio.
- 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 using machines
After treatment with Ranivisio, temporary blurred vision may occur. If this happens, do not drive and do not operate machinery until this condition has resolved.
Ranivisio contains polysorbate 20 (E 432)
This medicine contains 0.005 mg of polysorbate 20 in each administered dose of 0.05 ml, equivalent to 0.10 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.
3. How Ranivisio will be administered
Ranivisio is administered by an ophthalmologist as a single injection into the eye under local anaesthesia. The usual dose of one injection is 0.05 ml (containing 0.5 mg of active substance). The interval between two injections given 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. You will also be given a local anaesthetic to reduce or prevent any pain that may occur during the injection.
Treatment starts with one monthly injection of Ranivisio. Your doctor will monitor the condition of your eye and, based on your response to treatment, will decide whether and when further treatment is needed.
Detailed instructions for the user can be found at the end of this leaflet under the section “How to prepare and administer Ranivisio”.
Elderly patients (aged 65 years and over)
Ranivisio can be used in 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 scheduled appointment and discuss this with your doctor. Your doctor will advise you and decide how long you should continue treatment with Ranivisio.
If you have any doubts about using this medicine, consult your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects associated with Ranivisio administration are due both to the medicine itself and to the injection procedure, and most of them 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 in the back of the eye (retinal detachment or tear), presenting as flashes of light, floaters, temporary reduction in vision, or 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 inside the eye.
Symptoms may include eye pain or increased eye discomfort, worsening eye redness, blurred vision or loss of vision, increased number of floaters, or increased sensitivity to light. Seek immediate medical advice 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 haemorrhage), visual disturbances, eye pain, floaters or spots in vision (floaters), localized eye redness, eye irritation, sensation of a foreign body in the eye, increased tear production, inflammation or infection of the eyelid margin, dry eye, eye redness or itching, and increased intraocular pressure.
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 part of the eye (uvea, cornea), corneal inflammation (front part of the eye), small lesions on the eye surface, 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, reduced red blood cells (with symptoms such as fatigue, shortness of breath, dizziness, pallor), anxiety, cough, nausea, allergic reactions such as skin rash, urticaria, itching, and skin redness.
Uncommon side effects
Visual side effects include: inflammation and bleeding in the front part of the eye, accumulation of pus 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 experience any side effect, including those not listed in this leaflet, please inform your doctor. You may also report side effects directly via the national reporting system listed 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 stated on the carton after 'Exp.' and on the label of the vial 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 may 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 any pack that is damaged.
6. Package contents 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 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 package contents
Ranivisio is an injectable solution in a vial (0.23 ml). The solution is aqueous, clear, from colourless to pale yellow.
One type of pack is available:
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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./A.G. UAB Teva Baltics
Tel/Tél: +32 3 820 73 73 Tel: +370 5 266 02 03
България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./A.G.,
Tel: +359 2 489 95 85 Tél: +32 3 820 73 73
Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251 007 111 Tel.: +36 1 288 6400
Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland, L-Irlanda
Tlf.: +45 44 98 55 11 Τel: +353 (0)1912 7700
Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 731 402 02 Tel: +31 (0) 800 0228400
Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 661 0801 Tlf: +47 66 77 55 90
Ελλάδα Österreich
Specifar ΑΒΕΕ ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 211 880 5000 Tel: +43 1 970070
España Polska
Teva Pharma, S.L.U. Zakłady Farmaceutyczne Polpharma S.A.
Tel: +34 91 387 32 80 Tel. + 48 22 364 61 01
France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos Lda
Tél: +33 1 55 91 78 00 Tel: +351 214 767 550
Hrvatska România
Pliva Hrvatska d.o.o Teva Pharmaceuticals S.R.L
Tel: + 385 1 37 20 000 Tel: +40 21 230 65 24
Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 (0) 207 540 7117 Tel: +386 1 58 90 390
Ísland Slovenská republika
Teva Pharma Iceland ehf. Teva Pharmaceuticals Slovakia s.r.o.
Sími: + 354 550 3300 Tel: +421 2 5726 7911
Italia Suomi/Finland
Teva Italia S.r.l. ratiopharm Oy
Tel: +39 0289 17981 Puh/Tel: +358 20 180 5900
Κύπρος Sverige
Specifar ΑΒΕΕ, Ελλάδα Teva Sweden AB
Τηλ: +30 211 880 5000 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 FOR HEALTHCARE PROFESSIONALS ONLY:
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 neovascular (wet) AMD, CNV, PDR and vision loss due to DME, or macular oedema secondary to RVO, the recommended dose of Ranivisio is 0.5 mg as a single intravitreal injection. This corresponds to an injected volume of 0.05 ml. The interval between two injections administered into the same eye must be at least four weeks.
Treatment is initiated with monthly injections until maximum visual acuity is achieved and/or 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 neovascular AMD, DME, PDR and RVO, it may be necessary to initiate therapy with three or more consecutive monthly injections.
Therefore, monitoring and treatment intervals should be determined by the physician and should be based on disease activity, as assessed by evaluation of visual acuity and/or anatomical parameters.
If, in the physician’s opinion, 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 achieving maximum visual acuity and/or absence of signs of disease activity, treatment intervals may be gradually extended until signs of disease recur or a decline in visual function is observed. The treatment interval should be gradually extended by up to two weeks in patients with neovascular AMD and may be extended up to one month in patients with DME. Treatment intervals may also be gradually extended in the treatment of RVO and PDR, although there are insufficient data to establish the duration of these intervals. Upon recurrence of disease activity, the treatment interval should be reduced accordingly.
Treatment of vision loss caused by CNV should be individually determined for each patient based on disease activity. Some patients may require only one injection during the first 12 months; others may require more frequent treatment, up to monthly injections. For CNV secondary to pathological myopia (PM), many patients may require only one or two injections during the first year.
Ranivisio and laser photocoagulation in DME and macular oedema secondary to BRVO
There is some experience with ranibizumab administered concomitantly 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 administration of ranibizumab in combination 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 hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum (or equivalent), and the possibility of performing a sterile paracentesis (if necessary). Prior to performing the intravitreal procedure, the patient’s history should be carefully evaluated for hypersensitivity reactions. Prior to injection, adequate anaesthesia and a broad-spectrum topical antimicrobial should be administered to disinfect the periocular, ocular and eyelid surfaces, as per clinical practice.
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. Sterility cannot be guaranteed if the package seal is not intact.
The following single-use medical devices are required for preparation and intravitreal injection:
- a 5 μm filter needle (18G)
- a sterile 1 ml syringe (with a mark at 0.05 ml)
- an injection needle (30G x ½″). These medical devices are not included in the Ranivisio pack. They may be obtained separately or found within third-party intravitreal injection kits (e.g. the I2 injection kit from Vortex Surgical).
To prepare Ranivisio for intravitreal injection in adult patients, please follow the instructions below:
- Before withdrawal, remove the closure cap from the vial and clean the vial stopper (e.g. with a 70% alcohol swab).
- Aseptically attach a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 µm) to a 1 ml syringe. Insert the filter needle vertically into the centre of the stopper until it touches the bottom of the vial.
- Withdraw all liquid from the vial while holding it in a vertical position, slightly tilted to facilitate complete withdrawal.
- Ensure the syringe plunger is pulled back sufficiently when emptying the vial to completely empty the filter needle.
- Leave the filter needle inserted in the vial and detach the syringe. Discard the filter needle after withdrawing the vial contents and do not use it for intravitreal injection.
- Aseptically and securely attach an injection needle (30G x ½″, 0.3 mm x 13 mm) to the syringe.
- Carefully remove the cap from the injection needle without disconnecting the needle from the syringe.
Note: Hold the base of the injection needle while removing the cap.
- 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 now 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 toward the centre of the globe. Inject the 0.05 ml dose; change the scleral site for subsequent injections.
After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe with the attached needle in a designated sharps container or in accordance with local regulations.
Patient Information Leaflet
Ranivisio 10 mg/ml solution for injection in pre-filled syringe
ranibizumab
This medicinal product is subject to additional monitoring. This will allow any new safety information to be identified quickly. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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 effect, including those not listed in this leaflet, tell your doctor. See section 4.
Contents of this leaflet
- What Ranivisio is and what it is used for
- What you need to know before you are given Ranivisio
- How Ranivisio will be administered to you
- Possible side effects
- How to store Ranivisio
- Contents of the pack and other information
1. What Ranivisio is and what it is used for
What Ranivisio is
Ranivisio is a solution to be injected into the eye. Ranivisio belongs to a group of
medicines called anti-angiogenesis agents. It contains an active substance called
ranibizumab.
What Ranivisio is used for
Ranivisio is used in adults to treat several eye conditions that cause vision loss.
These conditions result from 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 occurs in conditions such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a condition caused by diabetes). It may also 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 may be caused by diabetes (a condition called diabetic macular edema (DME)) or by blockage of the retinal veins (a condition called retinal venous occlusion (RVO)).
How Ranivisio works
Ranivisio specifically recognizes and binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eye. When present in excess, VEGF-A causes abnormal growth of blood vessels and swelling in the eye, which can lead to vision loss in conditions such as AMD, DME, PDR, RVO, PM, and CNV. By binding to VEGF-A, Ranivisio can block its action and prevent abnormal blood vessel growth and swelling.
In these conditions, Ranivisio may help stabilize vision and, in many cases, improve it.
2. What you should know before being given Ranivisio
Do not receive Ranivisio
- if you are allergic to ranibizumab or to any of the other ingredients of this medicine (listed in section 6).
- if you have an infection in or around one eye.
- if you have eye pain or redness (severe intraocular inflammation) in one eye.
Warnings and precautions
Talk to your doctor before receiving Ranivisio.
- Ranivisio is administered by injection into the eye. Occasionally, after treatment with Ranivisio, an infection inside the eye, eye pain or redness (inflammation), detachment or tear in one of the layers at the back of the eye (retinal detachment or tear and retinal pigment epithelial detachment or tear), or clouding of the lens (cataract) may occur. It is important to identify and treat an infection or retinal detachment as soon as possible. Immediately inform your doctor if you experience symptoms such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increase in floaters, or increased sensitivity to light.
- In some patients, eye pressure may increase shortly after the injection for a short period. This is something you may not notice, so your doctor must perform a check after each injection.
- Inform 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 limbs or face, difficulty speaking or understanding). This information will be considered when evaluating whether Ranivisio is the appropriate treatment for you.
See section 4 ("Possible side effects") for more detailed information on side effects that may occur during treatment 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
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
- Women of childbearing potential must use an effective method of 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 must not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, discuss this with 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 using machines
After treatment with Ranivisio, you may experience temporary blurred vision. If this occurs, do not drive and do not operate machinery until this condition has resolved.
Ranivisio contains polysorbate 20 (E 432)
This medicine contains 0.005 mg of polysorbate 20 in each administered dose of 0.05 ml, equivalent to 0.10 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.
3. How Ranivisio will be administered to you
Ranivisio is administered by an ophthalmologist as a single injection into the eye under local anaesthesia. The usual dose of one injection is 0.05 ml (containing 0.5 mg of active substance). The pre-filled syringe contains a volume greater than the recommended dose of 0.5 mg. The extractable volume should not be used completely. The excess volume must be discarded before proceeding with the injection. Injecting the entire contents of the pre-filled syringe may result in overdose.
The interval between two injections given in the same eye must be at least four weeks. All injections will be administered by your ophthalmologist.
Before the injection, the doctor will carefully clean your eye to prevent infection. The doctor will also give you a local anaesthetic to reduce or prevent any pain that may occur during the injection.
Treatment is initiated with one monthly injection of Ranivisio. Your doctor will monitor the condition of your eye and, based on your response to treatment, will decide whether and when further treatment is needed.
Detailed instructions for the user can be found at the end of this leaflet under the section “How to prepare and administer Ranivisio”.
Elderly (aged 65 years and over)
Ranivisio can be used in 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 scheduled appointment and discuss this with your doctor. Your doctor will advise you and decide how long you should continue treatment with Ranivisio.
If you have any doubts about the use of this medicine, consult 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 Ranivisio administration are due to both the medicine itself and the injection procedure, and most of them affect the eye.
The most serious side effects are described below:
Common severe side effects (may affect up to 1 in 10 people)
Detachment or tear in the back of the eye (retinal detachment or tear), presenting as flashes of light, floaters, and possibly leading to temporary vision loss or lens opacity (cataract).
Uncommon severe 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 of eye redness, blurred vision or vision loss, increased number of floaters, 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 haemorrhage), visual disturbances, eye pain, floaters or spots in vision (floaters), localized eye redness, eye irritation, sensation of a foreign body in the eye, increased tear production, inflammation or infection of the eyelid margin, dry eye, eye redness or itching, and increased intraocular pressure.
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 part of the eye (uvea, cornea), corneal inflammation (front part of the eye), small lesions on the eye surface, 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 skin rash, urticaria, itching, and skin redness.
Uncommon side effects
Visual side effects include: inflammation and bleeding in the front part of the eye, pus accumulation 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 experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed 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 carton after “Exp.” and on the label of the pre-filled syringe 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 may be stored at room temperature (25 °C) for up to 24 hours.
- Keep the pre-filled syringe in its sealed tray inside the carton to protect the medicine from light.
- Do not use any pack that is damaged.
6. Package Contents and Other Information
What Ranivisio Contains
- The active substance is ranibizumab. Each ml contains 10 mg of ranibizumab. A pre-filled syringe contains 0.165 ml, equivalent to 1.65 mg of ranibizumab. This provides a sufficient amount for 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 Package
Ranivisio is an injectable solution in a pre-filled syringe. The pre-filled syringe contains 0.165 ml of a sterile, aqueous, clear, colourless to pale yellow solution. The pre-filled syringe contains a volume greater than the recommended dose of 0.5 mg. The extractable volume must not be used entirely. The excess volume must be discarded before injection. Injecting the entire content of the pre-filled syringe may result in overdose.
One pack size 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 about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./A.G. UAB Teva Baltics
Tel/Tél: +32 3 820 73 73 Tel: +370 5 266 02 03
България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./A.G.,
Tel: +359 2 489 95 85 Tél: +32 3 820 73 73
Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251 007 111 Tel.: +36 1 288 6400
Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland, L-Irlanda
Tlf.: +45 44 98 55 11 Τel: +353 (0)1912 7700
Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 731 402 02 Tel: +31 (0) 800 0228400
Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 661 0801 Tlf: +47 66 77 55 90
Ελλάδα Österreich
Specifar ΑΒΕΕ ratiopharm Arzneimittel Vertriebs-GmbH
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Teva Pharma, S.L.U. Zakłady Farmaceutyczne Polpharma S.A.
Tel: +34 91 387 32 80 Tel. + 48 22 364 61 01
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Teva Santé Teva Pharma - Produtos Farmacêuticos Lda
Tél: +33 1 55 91 78 00 Tel: +351 214 767 550
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Pliva Hrvatska d.o.o Teva Pharmaceuticals S.R.L
Tel: + 385 1 37 20 000 Tel: +40 21 230 65 24
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Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 (0) 207 540 7117 Tel: +386 1 58 90 390
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Teva Pharma Iceland ehf. Teva Pharmaceuticals Slovakia s.r.o.
Sími: + 354 550 3300 Tel: +421 2 5726 7911
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Teva Italia S.r.l. ratiopharm Oy
Tel: +39 0289 17981 Puh/Tel: +358 20 180 5900
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Specifar ΑΒΕΕ, Ελλάδα Teva Sweden AB
Τηλ: +30 211 880 5000 Tel: +46 42 12 11 00
Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67 323 666
Additional 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 neovascular (wet) AMD, CNV, PDR, and vision loss due to DME, or macular oedema secondary to RVO, the recommended dose of Ranivisio is 0.5 mg administered as a single intravitreal injection. This corresponds to an injected volume of 0.05 ml. The interval between two injections in the same eye must be at least four weeks.
Treatment is initiated with monthly injections until maximum visual acuity is achieved and/or until there are no 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 neovascular AMD, DME, PDR, and RVO, it may be necessary to initiate therapy with three or more consecutive monthly injections.
Therefore, monitoring and treatment intervals must be determined by the physician and should be based on disease activity, as assessed by evaluation of visual acuity and/or anatomical parameters.
If, in the physician’s opinion, 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 being treated according to a “treat-and-extend” regimen, upon achieving maximum visual acuity and/or absence of signs of disease activity, treatment intervals may be gradually extended until signs of disease recur or a decline in visual function becomes evident. The treatment interval should be extended by up to two weeks at a time in patients with neovascular AMD, and may be extended up to one month in patients with DME. Treatment intervals may also be gradually extended in the treatment of RVO and PDR; however, there are insufficient data to establish the duration of these intervals. When disease activity re-emerges, the treatment interval should be reduced accordingly.
Treatment of vision loss caused by CNV should be individually determined based on disease activity. Some patients may require only one injection during the first 12 months; others may require more frequent treatment, up to monthly injections. For CNV secondary to pathological myopia (PM), many patients may require only one or two injections during the first year.
Ranivisio and Laser Photocoagulation in DME and Macular Oedema Secondary to BRVO
There is some experience with ranibizumab administered concomitantly 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 ranibizumab administered in combination with verteporfin.
Before administration, Ranivisio should be visually inspected for the presence of particles and discoloration.
The injection procedure must be performed under aseptic conditions, including surgical hand disinfection, sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent), with the possibility of performing a sterile paracentesis (if necessary). Prior to the intravitreal procedure, the patient’s history should be carefully evaluated for hypersensitivity reactions. Prior to injection, adequate anaesthesia and a broad-spectrum topical antimicrobial agent should be administered to disinfect the periocular, ocular, and eyelid surfaces, 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 extractable volume from the pre-filled syringe (0.1 ml) must not be used entirely. The excess volume must be discarded before injection. Injecting the entire content of the pre-filled syringe may result in overdose. To expel air bubbles and excess medication, gently push the plunger to align the lower edge of the rubber stopper with the black graduation mark on the syringe (corresponding to 0.05 ml, i.e., 0.5 mg of ranibizumab).
A sterile 30G x ½″ injection needle must be used for intravitreal injection.
This medical device is not included in this package.
To prepare Ranivisio for intravitreal injection, please follow the instructions for use:
| Introduction | Read all instructions carefully before using the pre-filled syringe. 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 the sealed tray and all subsequent operations must be performed under aseptic conditions. Note: The dose must be set to 0.05 ml. |
| Description of the pre-filled syringe | Syringe cap Rubber stopper Luer lock hub Dose measurement mark at 0.05 ml Plunger Figure 1 |
| Preparation |
|
| Syringe inspection |
 | |
| Removing the syringe cap | 5. Rotate (do not detach) the syringe cap (see Figure 2). 6. Dispose of the syringe cap (see Figure 3). | Figure 2 Figure 3 |
| Attaching the needle | 7. Firmly insert a sterile 30G x ½″ injection needle onto the syringe by screwing it tightly onto the Luer lock (see Figure 4). 8. Carefully remove the needle cap by pulling it off (see Figure 5). Note: Never clean the needle. | Figure 4 Figure 5 |
Expulsion 9. Hold the syringe vertically.
Air bubbles 10. If there are air bubbles, gently tap
the syringe with your finger until the bubbles rise to the surface (see
Figure 6).
Figure 6
Setting the 11. Hold the syringe at eye level and
dose gently push the plunger
until the lower edge of the rubber stopper's dome
is aligned with the dose marking line (see
Figure 7). This will remove any air and excess solution,
and set the dose to 0.05 ml.
Note: The plunger is not attached to the rubber stopper – this prevents air from being drawn into the syringe.
Figure 7
Injection The injection procedure must be performed under aseptic conditions.
- Insert the 3.5–4.0 mm injection needle posterior to the limbus, into the vitreous chamber, avoiding the horizontal meridian, and direct the needle toward the center of the eyeball.
- Inject slowly until the dome of the rubber stopper reaches the bottom of the syringe, delivering a volume of 0.05 ml.
- For subsequent injections, a different scleral site must be used.
- After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the needle in a dedicated sharps container or in accordance with local regulations.