Lucentis
Italy
Table of Contents
- Patient information leaflet
- Lucentis 10 mg/ml solution for injection
- Patient information leaflet: information for the patient
- Lucentis 10 mg/ml solution for injection in pre-filled syringe
- Patient Information Leaflet: Information for Carers of Prematurely Born Children
- Lucentis 10 mg/ml solution for injection
Patient information leaflet
Lucentis 10 mg/ml solution for injection
ranibizumab
ADULTS
Information for prematurely born children can be found on the other side of this leaflet.
Please read this leaflet carefully before you are given this medicine because 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
- What Lucentis is and what it is used for
- What you need to know before you are given Lucentis
- How Lucentis will be administered to you
- Possible side effects
- How to store Lucentis
- Contents of the pack and other information
1. What Lucentis is and what it is used for
What Lucentis is
Lucentis is a solution that must be injected into the eye. Lucentis belongs to a group of
medicines called anti-angiogenic agents. It contains an active substance called
ranibizumab.
What Lucentis is used for
Lucentis 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 diabetes-related condition). 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 venous occlusion (RVO)).
How Lucentis works
Lucentis 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, Lucentis blocks its action and prevents abnormal blood vessel growth and swelling.
In these conditions, Lucentis can help stabilize vision and, in many cases, improve it.
2. What you need to know before you are given Lucentis
Do not receive Lucentis
- 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 the eye.
- if you have eye pain or redness (severe intraocular inflammation).
Warnings and precautions
Talk to your doctor before receiving Lucentis.
- Lucentis is administered by an injection into the eye. Occasionally, after treatment with Lucentis, 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 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 perform a check-up 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 Lucentis 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 Lucentis.
Children and adolescents (under 18 years of age)
Except for retinopathy of prematurity, the use of Lucentis in children and adolescents has not been established and is therefore not recommended. For the treatment of premature infants with retinopathy of prematurity (ROP), see the other side of this patient information leaflet.
Other medicines and Lucentis
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 Lucentis.
- There is no experience with the use of Lucentis in pregnant women. Lucentis should 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 Lucentis.
- Lucentis is not recommended during breastfeeding as small amounts of Lucentis may pass into breast milk. Ask your doctor or pharmacist for advice before treatment with Lucentis.
Driving and using machines
After treatment with Lucentis, you may experience temporary blurred vision. If this occurs, do not drive and do not operate machinery until this condition has resolved.
3. How Lucentis will be administered to you
Lucentis is administered by your 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 in the same eye must be at least four weeks. All injections will be administered by your ophthalmologist.
Before the injection, your doctor will carefully clean your eye to prevent infection. Your doctor will also give you a local anaesthetic to reduce or prevent any pain that may occur during the injection.
Treatment is started with one monthly injection of Lucentis. 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 heading “How to prepare and administer Lucentis to adults”.
Elderly (65 years of age and over)
Lucentis can be used in patients aged 65 years and over without dose adjustments.
Before stopping Lucentis treatment
If you are considering stopping Lucentis treatment, 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 Lucentis.
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 everybody gets them.
The side effects associated with Lucentis administration are due to both the medicine itself and the injection procedure, and most 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), which manifests 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.
The symptoms you may experience 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 Lucentis 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 spots 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, paleness), 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.
If you experience any side effect, including those not listed in this leaflet, consult your doctor.
Reporting of side effects
If you get 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. Reporting side effects can help provide more information on the safety of this medicine.
5. How to store Lucentis
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton and on the label of the vial after "scad." and "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 up to 24 hours.
- Keep the vial in the outer packaging to protect the medicine from light.
- Do not use any pack if damaged.
6. Package contents and other information
What Lucentis 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 sufficient volume 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; water for injections.
Description of the appearance of Lucentis and contents of the pack
Lucentis is an injectable solution in a vial (0.23 ml). The solution is aqueous, clear, from colourless to pale yellow-brown.
Two different pack sizes are available:
Single vial
Pack containing one glass vial of ranibizumab with a chlorobutyl rubber stopper. The vial is for single use only.
Vial + filter needle
Pack containing one glass vial of ranibizumab with a chlorobutyl rubber stopper and a blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 micrometres) for withdrawal of the vial contents. All components are for single use only.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana, 1526
Slovenia
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50
България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11
Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00
Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872
Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111
Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00
Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570
España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888
France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600
Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01
Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50
Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439
Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200
Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00
Latvija
SIA Novartis Baltics
Tel: +371 67 887 070
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
THE FOLLOWING INFORMATION IS INTENDED EXCLUSIVELY FOR HEALTHCARE PROFESSIONALS:
Please also refer to section 3 “How Lucentis will be given to you”.
How to prepare and administer Lucentis to adults
Single-use vials, for intravitreal use only.
Lucentis 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 Lucentis is 0.5 mg 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 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 neovascular AMD, DME, PDR and RVO, therapy may need to be initiated 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, Lucentis 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 recurrence or worsening of visual function occur. 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; however, 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.
Lucentis and laser photocoagulation in DME and macular oedema secondary to BRVO
There is some experience with Lucentis administered concomitantly with laser photocoagulation. When used on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation. Lucentis may be administered to patients who have previously received laser photocoagulation.
Lucentis and photodynamic therapy with verteporfin in CNV secondary to PM
There is no experience with administering Lucentis in combination with verteporfin.
Prior to administration, Lucentis 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 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 agent should be administered to disinfect the periocular, ocular, and eyelid surfaces, as per standard clinical practice.
Single vial
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.
For preparation and intravitreal injection, the following single-use medical devices are required:
- 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 devices are not included in the Lucentis package.
Vial + filter needle
All components are sterile and for single use only. Any component with packaging showing signs of damage or tampering must not be used. Sterility cannot be guaranteed if the component’s package seal is not intact. Reuse may cause infection or other injury.
For preparation and intravitreal injection, the following single-use medical devices are required:
- a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, provided)
- a sterile 1 ml syringe (with a mark at 0.05 ml, not included in the Lucentis package)
- an injection needle (30G x ½″; not included in the Lucentis package)
To prepare Lucentis for intravitreal injection in adult patients, please follow these instructions:
- Before withdrawal, remove the vial cap 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 pointed filter needle into the centre of the stopper until it reaches the bottom of the vial.
-
Withdraw all liquid from the vial while holding it in an upright 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 pointed filter needle in the vial and detach the syringe from it. 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.
0.05 ml
Insert the 30G 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 volume; change the scleral site for subsequent injections.
After injection, do not recap or detach the needle from the syringe. Dispose of the used syringe with the attached needle in a dedicated sharps container or in accordance with local regulations.
Patient information leaflet: information for the patient
Lucentis 10 mg/ml solution for injection in pre-filled syringe
ranibizumab
Please 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, 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 Lucentis is and what it is used for
- What you must know before Lucentis is administered to you
- How Lucentis will be administered to you
- Possible side effects
- How to store Lucentis
- Contents of the pack and other information
1. What Lucentis is and what it is used for
What Lucentis is
Lucentis is a solution to be injected into the eye. Lucentis belongs to a group of medicines called anti-angiogenic agents. It contains an active substance called ranibizumab.
What Lucentis is used for
Lucentis is used in adults to treat several 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 diabetes-related condition). 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 known as diabetic macular edema (DME)) or by blockage of retinal veins (a condition called retinal venous occlusion (RVO)).
How Lucentis works
Lucentis 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 blood vessel growth 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, Lucentis blocks its action and helps prevent abnormal vessel growth and swelling.
In these conditions, Lucentis can help stabilize vision and, in many cases, improve it.
2. What you need to know before you are given Lucentis
Do not receive Lucentis
- 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 Lucentis.
- Lucentis is administered by injection into the eye. Occasionally, after treatment with Lucentis, 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 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 increasing discomfort, worsening of 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 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 Lucentis 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 Lucentis.
Children and adolescents (under 18 years of age)
The use of Lucentis in children and adolescents has not been established and is therefore not recommended.
Other medicines and Lucentis
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 Lucentis.
- There is no experience with the use of Lucentis in pregnant women. Lucentis 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 Lucentis.
- Lucentis is not recommended during breastfeeding, as small amounts of Lucentis may pass into breast milk. Ask your doctor or pharmacist for advice before treatment with Lucentis.
Driving and using machines
After treatment with Lucentis, you may experience temporary blurred vision. If this occurs, do not drive and do not operate machinery until this condition has resolved.
3. How Lucentis will be administered to you
Lucentis is administered by your 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 must 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 doses injected into the same eye must be at least four weeks. All injections will be administered by your ophthalmologist.
Before the injection, your doctor will carefully clean your eye to prevent infection. Your doctor will also give you a local anaesthetic to reduce or prevent any pain that may occur during the injection.
Treatment starts with one monthly injection of Lucentis. 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 Lucentis”.
Elderly patients (65 years of age and over)
Lucentis can be used in patients aged 65 years and over without dose adjustments.
Before stopping treatment with Lucentis
If you are considering stopping treatment with Lucentis, please 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 Lucentis.
If you have any doubts about how to use this medicine, consult your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects associated with Lucentis administration are due either to the medicine itself or 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 patients): detachment or tear in the back of the eye (retinal detachment or tear), manifesting 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 patients): blindness, infection of the eyeball (endophthalmitis) with inflammation inside the eye.
The symptoms you may experience include eye pain or increased discomfort, worsening eye redness, blurred vision or loss of vision, an increase in the number of small floating particles in your 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 patients)
Visual side effects include: eye inflammation, bleeding in the back of the eye (retinal haemorrhage), visual disturbances, eye pain, floating spots or specks 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 Lucentis 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 spots 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.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor.
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 Lucentis
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton and on the label of the pre-filled syringe 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 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 a package that is damaged.
6. Package contents and other information
What Lucentis 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 sufficient quantity for 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 Lucentis and contents of the pack
Lucentis is an injectable solution in a pre-filled syringe. The pre-filled syringe contains 0.165 ml of an aqueous solution, clear, colourless to pale yellow-brown. The pre-filled syringe contains a volume greater than the recommended dose of 0.5 mg. The extractable volume must not be used completely. The excess volume must be discarded before proceeding with the injection. Injection of the entire contents of the pre-filled syringe may result in overdose.
The pack contains one single pre-filled syringe, packaged in a sealed tray. The pre-filled syringe is for single use only.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50
България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11
Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00
Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872
Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111
Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00
Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570
España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888
France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600
Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01
Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50
Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439
Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200
Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00
Latvija
SIA Novartis Baltics
Tel: +371 67 887 070
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
The following information is intended for healthcare professionals only:
Please also refer to section 3 “How Lucentis will be administered to you”.
How to prepare and administer Lucentis
Single-use pre-filled syringe, for intravitreal use only
Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.
In neovascular AMD, CNV, PDR and vision loss due to DME, or macular oedema secondary to RVO, the recommended dose of Lucentis is 0.5 mg given as a single intravitreal injection. This corresponds to an injected volume of 0.05 ml. The interval between two injections administered in the same eye must be at least four weeks.
Treatment is initiated with monthly injections 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 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, Lucentis 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 disease recur or visual function worsens. The treatment interval may 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; however, there are insufficient data to establish the duration of these intervals. Upon recurrence of disease activity, the treatment interval must 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.
Lucentis and laser photocoagulation in DME and macular oedema secondary to BRVO
There is some experience with Lucentis administered concomitantly with laser photocoagulation. When used on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation. Lucentis may be administered to patients who have previously received laser photocoagulation.
Lucentis and photodynamic therapy with verteporfin in CNV secondary to PM
There is no experience with administration of Lucentis in combination with verteporfin.
Before administration, Lucentis must 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, appropriate anaesthesia and a broad-spectrum topical antimicrobial 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 completely used. The excess volume must be discarded before proceeding with the injection. Injection of the entire contents 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 plunger stopper with the black graduation mark on the syringe (equivalent to 0.05 ml, i.e., 0.5 mg of ranibizumab).
For intravitreal injection, a sterile 30G x ½″ injection needle must be used.
To prepare Lucentis for intravitreal injection, please follow the instructions for use:
| Introduction | Read all instructions carefully before using the prefilled syringe. The prefilled syringe is for single use only. The prefilled syringe is sterile. Do not use the product if the packaging is damaged. Opening the sealed tray and all subsequent steps must be performed under aseptic conditions. Note: The dose must be set to 0.05 ml. |
| Description of the prefilled syringe | Figure 1 Syringe cap Dose marking line for 0.05 ml Gripping area Plunger Rubber stopper Luer lock |
| Preparation |
|
| Syringe inspection |
| |
| Removal of syringe cap |
| Figure 2 Figure 3  |
| Attaching the needle |
| Figure 4 Figure 5 |
| Expelling air bubbles |
| Figure 6 |
| Setting the dose |
| Figure 7 |
| Injection | The injection procedure must be performed under aseptic conditions. 12. 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. 13. Inject slowly until the dome of the rubber stopper reaches the bottom of the syringe, delivering a volume of 0.05 mL. 14. For subsequent injections, a different scleral site must be used. 15. After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe with the attached needle in a dedicated sharps container or in accordance with local regulations. | |
Patient Information Leaflet: Information for Carers of Prematurely Born Children
Lucentis 10 mg/ml solution for injection
ranibizumab
PRETERM NEWBORNS
Information for adults is on the other side of this leaflet.
Please read this leaflet carefully before this medicine is administered to the child
as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your child's doctor.
- If your child experiences any side effects, including those not listed in this leaflet, tell your child's doctor. See section 4.
Contents of this leaflet
- What Lucentis is and what it is used for
- What you must know before Lucentis is administered to the child
- How Lucentis will be administered
- Possible side effects
- How to store Lucentis
- Contents of the pack and other information
1. What Lucentis is and what it is used for
What Lucentis is
Lucentis is a solution that must be injected into the eye. Lucentis belongs to a group of
medicines called anti-angiogenesis agents. It contains the active substance called ranibizumab.
What Lucentis is used for
Lucentis is used in premature babies for the treatment of retinopathy of prematurity (ROP), a disease that causes visual impairment due to damage to the back of the eye (the retina) caused by abnormal growth of blood vessels.
How Lucentis works
Lucentis specifically recognizes and binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eye. When in excess, VEGF-A causes abnormal growth of blood vessels in the eye. Lucentis can block its action and prevent this abnormal growth.
2. What you should know before Lucentis is administered to your child
Your child must not receive Lucentis
- If your child is allergic to ranibizumab or to any of the other ingredients of this medicine (listed in section 6).
- If your child has an infection in or around the eye.
- If your child has eye pain or redness (severe intraocular inflammation).
Warnings and precautions
Talk to your child's doctor before your child receives Lucentis.
- Lucentis is administered by injection into the eye. Occasionally, after treatment with Lucentis, 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, or 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. Inform the doctor immediately if your child develops symptoms such as eye pain or worsening eye redness.
- In some patients, eye pressure may temporarily increase shortly after the injection. Your child's doctor may monitor this after each injection.
See section 4 ("Possible side effects") for more detailed information on side effects that may occur during treatment with Lucentis.
Other medicines and Lucentis
Tell your child's doctor if your child is taking, has recently taken, or might take any other medicines.
3. How Lucentis will be administered
Lucentis is administered by the ophthalmologist as a single injection into the child's eye,
usually under local anaesthesia. The usual dose of one injection is 0.02 ml (containing 0.2 mg
of active substance). The interval between two injections given in the same eye must be at least four
weeks. All injections will be administered by the ophthalmologist.
Before the injection, the child's doctor will carefully clean the child's eyes to prevent
infection. The doctor will also give the child a local anaesthetic to reduce or prevent any
pain.
Treatment is initiated with one injection of Lucentis in each eye (some children may require
treatment in only one eye). The doctor will monitor the condition of the child's eye(s) and, based on the child's response to treatment, will decide whether and when further treatment is needed.
Detailed instructions for use can be found at the end of this leaflet under the section “How to prepare
and administer Lucentis to preterm infants”.
Before stopping Lucentis treatment
If you are considering stopping your child's treatment with Lucentis, please attend the next
appointment and discuss this with your child's doctor. The doctor will advise you and decide
how long your child should continue treatment with Lucentis.
If you have any doubts about using this medicine, consult your child's doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects associated with Lucentis administration are due to both the medicine itself and the
injection procedure, and most of them affect the eye.
The most common side effects in premature babies are listed below:
Visual side effects include: bleeding in the back of the eye (retinal haemorrhage), bleeding in the eye or
at the injection site, and bloodshot eye (conjunctival haemorrhage).
Non-visual side effects include: sore throat, nasal congestion and runny nose, low red blood cell count
(with symptoms such as fatigue, shortness of breath, pale skin), cough, urinary tract infection, allergic
reactions such as skin rash and skin redness.
Additional side effects observed with Lucentis in adults. These side effects may also occur in
premature babies.
The most serious side effects in adults are listed below:
Serious common side effects (may affect up to 1 in 10 patients): detachment or tear in the back of the
eye (retinal detachment or tear), leading to temporary vision loss, or clouding of the lens (cataract).
Serious uncommon side effects (may affect up to 1 in 100 patients): blindness, infection of the eyeball
(endophthalmitis) with inflammation inside the eye.
It is important to identify and treat serious side effects such as eye infection or retinal tear as soon as
possible. Inform the doctor immediately if the child develops symptoms such as eye pain or worsening
eye redness.
Other side effects observed in adults are listed below:
Very common side effects (may affect more than 1 in 10 patients)
Visual side effects include: eye inflammation, visual disturbances, eye pain, spots or floaters in vision
(floating bodies), eye irritation, sensation of 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: headache and joint pain.
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 marks on the eye surface, blurred vision, eye discharge with
itching, redness and swelling (conjunctivitis), light sensitivity, eye discomfort, eyelid swelling, eyelid
pain.
Non-visual side effects include: anxiety, nausea.
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.
If you have any questions about any side effect, consult the child's doctor.
Reporting of side effects
If you observe any side effect in the child, including those not listed in this leaflet, consult the child's
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 Lucentis
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton and on the label of the vial after "scad." and "EXP." The expiry date refers to the last day of that month.
- Store in the 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 Lucentis 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 sufficient volume for administration of a single dose of 0.02 ml containing 0.2 mg of ranibizumab.
- The other components are α,α-trehalose dihydrate; histidine hydrochloride monohydrate; histidine; polysorbate 20; water for injections.
Description of the appearance of Lucentis and contents of the pack
Lucentis is an injectable solution in a vial (0.23 ml). The solution is aqueous, clear, from colourless to pale yellowish-brown.
Two different pack sizes are available:
Vial only
Pack containing one glass vial of ranibizumab with a chlorobutyl rubber stopper. The vial is for single use only.
Vial + filter needle
Pack containing one glass vial of ranibizumab with a chlorobutyl rubber stopper and a blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 micrometres) for withdrawal of the contents of the vial. All components are for single use only.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana, 1526
Slovenia
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50
България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11
Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00
Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872
Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111
Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00
Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570
España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888
France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600
Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01
Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50
Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439
Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200
Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00
Latvija
SIA Novartis Baltics
Tel: +371 67 887 070
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
THE FOLLOWING INFORMATION IS INTENDED EXCLUSIVELY FOR HEALTHCARE PROFESSIONALS:
Please also refer to section 3 “How Lucentis will be administered”.
How to prepare and administer Lucentis in preterm neonates
Single-use vials, for intravitreal use only.
Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections in preterm neonates.
For the treatment of preterm neonates, use the high-precision low-volume syringe,
supplied together with an injection needle (30G x ½″) in the VISISURE kit.
The recommended dose of Lucentis in preterm neonates is 0.2 mg administered via a single intravitreal injection. This corresponds to an injected volume of 0.02 ml. In preterm neonates, treatment of retinopathy of prematurity (ROP) is initiated with a single injection per eye and may be administered bilaterally on the same day. In total, up to three injections per eye may be administered within six months from the start of treatment if there are signs of disease activity. The majority of patients (78%) in the 24-week RAINBOW clinical study received one injection per eye. Patients treated with 0.2 mg in this clinical study did not require additional treatment in the subsequent long-term extension study, which followed patients up to five years of age. Administration of more than three injections per eye has not been studied. The interval between two doses injected into the same eye must be at least four weeks.
Before administration, Lucentis must 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). Before 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 agent should be administered to disinfect the periocular, ocular, and eyelid surfaces, according to clinical practice.
Vial only
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); not included in the Lucentis pack
- a sterile, high-precision, low-volume syringe (supplied separately in the VISISURE kit)
- an injection needle (30G x ½″) (supplied separately in the VISISURE kit).
Vial + filter needle
All components are sterile and for single use only. Any component with packaging showing signs of damage or tampering must not be used. Sterility cannot be guaranteed if the component’s packaging seal is not intact. Reuse may cause infection or other illness/injury.
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)
- a sterile, high-precision, low-volume syringe (supplied separately in the VISISURE kit)
- an injection needle (30G x ½″) (supplied separately in the VISISURE kit).
To prepare Lucentis for intravitreal administration in preterm neonates, please follow the instructions for use included in the VISISURE kit.
Insert the injection needle into the eye 1.0–2.0 mm posterior to the limbus, directing the needle towards the optic nerve. Inject the volume of 0.02 ml.