LUCENTIS 10 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet:information for the adult patient

Lucentis 10mg/ml solution for injection

ranibizumab

ADULTS

Information for premature infants is on the other side of the leaflet.

Read all of 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 further questions, ask your doctor.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Lucentis and what is it used for

What is Lucentis

Lucentis is a solution that is injected into the eye. Lucentis belongs to a group of medicines called anti-angiogenic agents. It contains the active substance called ranibizumab.

What Lucentis is used for

Lucentis is used in adults to treat several eye diseases that cause vision problems.

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

• The growth of abnormal blood vessels that leak fluid. This is seen in diseases such as age-related macular degeneration (AMD) and diabetic retinopathy (a disease caused by diabetes). It may also be associated with choroidal neovascularization (CNV) due to pathologic myopia (PM), angioid streaks, central serous chorioretinopathy, or inflammatory CNV.
• Macular edema (swelling of the center of the retina). The cause of this swelling may be diabetes (a disease known as diabetic macular edema (DME)) or a blockage of the retinal veins in the retina (a disease known as retinal vein occlusion (RVO)).

How Lucentis works

Lucentis recognizes and binds specifically to a protein called vascular endothelial growth factor A (VEGF-A) present in the eyes. In excess, VEGF-A causes the growth of abnormal blood vessels and swelling in the eye that can lead to vision problems in diseases such as AMD, DME, diabetic retinopathy, RVO, PM, and CNV. By binding to VEGF-A, Lucentis can prevent it from working and prevent such abnormal growth and swelling.

In these diseases, Lucentis can help stabilize and, in many cases, improve your vision.

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

Lucentis must not be given to you

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

Warnings and precautions

Talk to your doctor before you are given Lucentis

• Lucentis is given by injection into the eye. Occasionally, after treatment with Lucentis, an infection in the inner eye, pain or redness (inflammation), or a tear in one of the layers at the back of the eye (retinal tear or detachment and retinal pigment epithelial tear or detachment), or clouding of the lens (cataract) may occur. It is important to identify and treat such an infection or retinal detachment as soon as possible. Tell your doctor immediately if you notice signs such as eye pain or increased discomfort in the eye, if the redness in the eye gets worse, blurred vision or decreased vision, an increase in the number of small spots in your vision, or increased sensitivity to light.
• In some patients, after the injection, the pressure in the eye may increase for a short time. You may not be aware of this, so your doctor may check your eye pressure after each injection.
• Tell your doctor if you have had eye diseases or have received any previous treatment in the eyes, or if you have had a stroke or have had transient stroke-like symptoms (weakness or paralysis of a limb or face, difficulty speaking or understanding). This information will be taken into account to assess whether Lucentis is the right treatment for you.

For more detailed information on the side effects that may occur during treatment with Lucentis, see section 4 ("Possible side effects").

Children and adolescents (under 18 years)

Except for retinopathy of prematurity, Lucentis is not recommended for use in children and adolescents as it has not been established in these age groups. For the treatment of premature infants with retinopathy of prematurity (ROP), see the other side of the leaflet.

Other medicines and Lucentis

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

Pregnancy and breastfeeding

• Women who may become pregnant should use an effective method of birth control during treatment and for at least 3 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 or think you may be pregnant, or plan to become pregnant, talk to your doctor before treatment with Lucentis.
• Small amounts of Lucentis may pass into breast milk, so it is not recommended to use Lucentis during breastfeeding. Talk to your doctor or pharmacist before treatment with Lucentis.

Driving and using machines

After treatment with Lucentis, you may experience temporary blurred vision. If this happens, do not drive or use machines until this symptom disappears.

3. How Lucentis is given

Lucentis is given by an ophthalmologist as a single injection into the eye under local anesthesia. The usual dose of an injection is 0.05 ml (which contains 0.5 mg of the active substance). The interval between two doses given in the same eye must be at least 4 weeks. All injections will be given by an ophthalmologist.

To prevent infection, before the injection, your doctor will carefully clean your eye. Your doctor will also give you a local anesthetic to reduce or prevent any pain you may feel with the injection.

Treatment starts with an injection of Lucentis once a month. Your doctor will monitor the disease in your eye and, depending on how you respond to treatment, will decide whether you need further treatment and when you need to be treated.

At the end of the leaflet, under "How to prepare and administer Lucentis in adults", detailed instructions for use are given.

Elderly patients (65 years and over)

Lucentis can be used in people 65 years of age or older, and no dose adjustment is necessary.

Before stopping treatment with Lucentis

If you are considering stopping treatment with Lucentis, go to your next appointment and discuss it with your doctor first. Your doctor will advise you and decide how long you should be treated with Lucentis.

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

4. Possible side effects

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

The side effects associated with Lucentis are either due to the medicine itself or the injection procedure, and most affect the eye.

The following are the most serious side effects:

Common serious side effects(may affect up to 1 in 10 patients): Detachment or tear of a layer in the inner eye (retinal detachment or tear), which results in flashes of light with floating particles progressing to transient vision loss 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 of the inner eye.

The symptoms you may experience are pain or increased discomfort in the eye, if the redness in the eye gets worse, blurred vision or decreased vision, an increase in the number of small spots in your vision, or increased sensitivity to light. Tell your doctor immediately if you experience any of these side effects.

The following are the most commonly reported side effects:

Very common side effects(may affect more than 1 in 10 patients)

Ocular side effects include: Eye inflammation, bleeding in the back of the eye (retinal hemorrhage), visual disturbances, eye pain, small particles or spots in the vision (floaters), blood in the eye, eye irritation, feeling of having something in the eye, increased tear production, inflammation or infection of the eyelid margin, dry eye, redness or itching of the eye, and increased pressure in the eye.

Non-ocular side effects include: Sore throat, nasal congestion, runny nose, headache, and joint pain.

The following are other side effects that may occur after treatment with Lucentis:

Common side effects

Ocular side effects include: Decreased sharpness of vision, swelling of a section of the eye (uvea, cornea), inflammation of the cornea (front part of the eye), small marks on the surface of the eye, blurred vision, bleeding at the injection site, bleeding in the eye, eye discharge with itching, redness, and swelling (conjunctivitis), sensitivity to light, eye discomfort, eyelid swelling, eyelid pain.

Non-ocular side effects include: Urinary tract infection, low red blood cell count (with symptoms such as tiredness, difficulty breathing, dizziness, paleness), anxiety, cough, nausea, allergic reactions such as rash, hives, itching, and redness of the skin.

Uncommon side effects

Ocular 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 effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 after CAD and on the label of the vial after EXP. The expiry date is the last day of the month shown.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Before use, the unopened vial can be stored at room temperature (25°C) for a maximum of 24 hours.
• Keep the vial in the outer packaging to protect it from light.
• Do not use any damaged packaging.

6. Contents of the pack and additional information

Composition of Lucentis

• 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 quantity to deliver a single dose of 0.05 ml, which contains 0.5 mg of ranibizumab.
• The other ingredients are α,α-trehalose dihydrate; histidine hydrochloride monohydrate; histidine; polysorbate 20; water for injections.

Appearance and pack contents of the product

Lucentis is an injectable solution contained in a vial (0.23 ml). The solution is clear, colorless to pale yellowish and aqueous.

There are two different types of packaging available:

Single vial pack

Pack containing a glass vial with ranibizumab, with a chlorobutyl rubber stopper. The vial is for single use.

Vial and needle pack with filter

Pack containing a glass vial with ranibizumab, with a chlorobutyl rubber stopper and a blunt needle with filter (18G x 1½″, 1.2 mm x 40 mm, 5 microns) for extracting the contents of the vial. All components are for single use.

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 Nürnberg

Germany

You can request more information about this medicinal product from the local representative of the marketing authorisation holder:

Date of last revision of this prospectus:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

This information is intended only for healthcare professionals:

See also section 3 "How to administer Lucentis".

How to prepare and administer Lucentis in adults

Single-use vial. For intravitreal use only.

Lucentis should be administered by an ophthalmologist experienced in the administration of intravitreal injections.

In exudative age-related macular degeneration (AMD), in neovascular age-related macular degeneration (NVC), in retinal pigment epithelial detachment (RDP), and in visual impairment due to diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO), the recommended dose of Lucentis is 0.5 mg administered as a single intravitreal injection. This corresponds to a volume of 0.05 ml. The interval between two doses injected into the same eye should be at least four weeks.

Treatment is initiated with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity, i.e., no change in visual acuity or other signs and symptoms of the disease under continued treatment. In patients with exudative AMD, DME, RDP, and RVO, initially, three or more consecutive injections administered monthly may be necessary.

From that point on, the monitoring and treatment intervals should be determined based on medical judgment and depending on the activity of the disease, assessed by visual acuity and/or anatomical parameters.

Treatment with Lucentis should be discontinued if, in the physician's judgment, the visual and anatomical parameters indicate that the patient is not benefiting from continued treatment.

Monitoring to determine the activity of the disease may include clinical examination, functional testing, or imaging techniques (e.g., optical coherence tomography or fluorescein angiography).

If patients are being treated according to a treat-and-extend regimen, once maximum visual acuity has been achieved and/or there are no signs of disease activity, treatment intervals can be gradually extended until signs of disease activity or visual impairment recur. In the case of exudative AMD, the treatment interval should not be extended by more than two weeks at a time, and in the case of DME, it can be extended up to one month at a time. For RDP and RVO, treatment intervals can also be gradually extended; however, the available data are not sufficient to determine the duration of these intervals. If disease activity recurs, the treatment interval should be shortened accordingly.

Treatment of visual impairment due to NVC should be determined on an individual basis for each patient, depending on the activity of the disease. Some patients may require only one injection during the first 12 months; others may require more frequent treatment, including monthly injections. In the case of NVC secondary to pathologic myopia (PM), many patients may require only one or two injections during the first year.

Lucentis and laser photocoagulation in DME and macular edema secondary to branch retinal vein occlusion (BRVO)

There is some experience with Lucentis administered concomitantly with laser photocoagulation. When administered on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation. Lucentis can be administered in patients who have previously received laser photocoagulation.

Lucentis and photodynamic therapy with verteporfin in NVC secondary to PM

There is no experience with the concomitant administration of Lucentis and verteporfin.

Before administering Lucentis, the absence of particles and discoloration should be checked visually.

The injection procedure should be carried out under aseptic conditions, which include surgical hand washing, the use of sterile gloves, a sterile field, a sterile blepharostat (or equivalent), and the availability of a sterile paracentesis (if necessary). Before performing the intravitreal injection procedure, the patient's medical history should be thoroughly evaluated for hypersensitivity reactions. Before injection, adequate anesthesia and a broad-spectrum topical microbicidal agent should be administered to disinfect the periocular skin, eyelid, and ocular surface, according to local practice.

Single vial pack

The vial is for single use. After injection, any unused product should be discarded. Do not use any vial that shows signs of damage or tampering. Sterility can only be guaranteed if the packaging seal remains intact.

For preparation and intravitreal injection, the following medical devices (for single use) are required:

• a 5 µm filter needle (18G)
• a sterile 1 ml syringe (including a 0.05 ml mark)
• a 30G x ½″ injection needle

These medical devices are not included in the Lucentis packaging.

Vial and needle pack with filter

All components are sterile and for single use. Do not use any component whose packaging shows signs of damage or tampering. Sterility can only be guaranteed if the packaging seal of the components remains intact. Reuse may lead to infection or other disease/injury.

For preparation and intravitreal injection, the following medical devices (for single use) are required:

• a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, supplied)
• a sterile 1 ml syringe (including a 0.05 ml mark, not included in the Lucentis packaging)
• a 30G x ½″ injection needle (not included in the Lucentis packaging)

To prepare Lucentis for intravitreal administration in adult patients, follow these instructions:

The injection needle should be inserted 3.5-4.0 mm behind the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the center of the globe. The injection volume of 0.05 ml should then be delivered; subsequent injections should be applied to a different scleral location each time.

After injection, do not cover the needle with the needle cap or separate it from the syringe. Dispose of the used syringe and needle in a puncture-resistant container or dispose of according to local regulations.

Package Leaflet: Information for caregivers of premature babies

Lucentis 10 mg/ml solution for injection

ranibizumab

PREMATURE BABIES

Information for adults is on the other side of the package leaflet.

Read this package leaflet carefully before this medicine is given to your baby, as it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your baby's doctor.
• If your baby experiences any side effects, consult your baby's doctor, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What is Lucentis and what is it used for

What is Lucentis

Lucentis is a solution that is injected into the eye. Lucentis belongs to a group of medicines called anti-angiogenic agents. It contains the active substance called ranibizumab.

What is Lucentis used for

Lucentis is used in premature babies to treat retinopathy of prematurity (ROP), a disease that causes visual impairment due to injury 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 vascular endothelial growth factor A (VEGF-A) present in the eyes. In excess, VEGF-A causes the growth of abnormal blood vessels in the eye. Lucentis can prevent it from working and prevent such abnormal growth.

1. What you need to know before Lucentis is given to your baby

Lucentis must not be given to your baby

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

Warnings and precautions

Consult your baby's doctor before Lucentis is given to your baby

• Lucentis is given by injection into the eye. Occasionally, after treatment with Lucentis, an infection in the inner eye, pain or redness (inflammation), or detachment or tear of one of the layers at the back of the eye (retinal detachment and retinal pigment epithelial tear) may occur. It is essential to identify and treat such infection or retinal detachment as soon as possible. Inform your baby's doctor immediately if your baby shows signs such as eye pain or if the redness in the eye worsens.

In some patients, after injection, the pressure in the eye may increase for a short period. Your baby's doctor may monitor the eye pressure after each injection.

For more detailed information on side effects that may occur during treatment with Lucentis, see section 4 ("Possible side effects").

Other medicines and Lucentis

Tell your baby's doctor if your baby is taking, has recently taken, or might take any other medicines.

1. How Lucentis is given

Lucentis is given by the ophthalmologist as a single injection into your baby's eye, usually under local anesthesia. The usual dose of an injection is 0.02 ml (which contains 0.2 mg of active substance). The interval between two doses injected into the same eye should be at least four weeks. All injections will be given by the ophthalmologist.

To prevent infection, before injection, your baby's doctor will carefully clean your baby's eyes. The doctor will also administer a local anesthetic to your baby to reduce or prevent any pain.

Treatment is initiated with one injection of Lucentis in each eye (some babies may require treatment in only one eye). The doctor will monitor the disease in your baby's eye(s) and, depending on how your baby responds to treatment, will decide whether your baby needs further treatment and when.

At the end of the package leaflet, in the section "How to prepare and administer Lucentis in premature babies", detailed instructions for use are provided.

Before stopping treatment with Lucentis

If you are considering stopping treatment with Lucentis in your baby, consult your baby's doctor before the next appointment and discuss it with them. Your baby's doctor will advise and decide accordingly.

For how long your baby should be treated with Lucentis.

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

1. Possible side effects

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

The side effects associated with the administration of Lucentis are either related to the drug itself or the injection procedure and most of them affect the eye.

The following are the most frequent side effects in premature babies:

Ocular side effects include: bleeding in the back of the eye (retinal hemorrhage), bleeding in the eye or at the injection site, and blood in the eye (conjunctival hemorrhage).

Non-ocular side effects include: sore throat, nasal congestion and nasal discharge, low red blood cell count (with symptoms such as fatigue, difficulty breathing, and pale skin), cough, urinary tract infection, allergic reactions such as rash and skin redness.

The following are additional side effects that have been observed with Lucentis in adults. These side effects may also occur in premature babies.

The following are the most serious side effects in adults:

Common serious side effects (may affect up to 1 in 10 patients): Detachment or tear of a layer in the inner part of the eye (retinal detachment or tear) that progresses to transient vision loss 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 of the inner part of the eye.

It is essential to identify and treat serious side effects as soon as possible, such as eye infection or retinal detachment. Tell your baby's doctor immediately if your baby shows signs such as eye pain or worsening eye redness.

The following are the most frequently reported side effects in adults:

Very common side effects (may affect more than 1 in 10 patients)

Ocular side effects include: Eye inflammation, visual disturbances, eye pain, small particles or spots in vision (floaters), eye irritation, sensation of having something in the eye, increased tear production, inflammation or infection of the eyelid margin, dry eye, eye redness or itching, and increased pressure in the eye.

Non-ocular side effects include: Headache and joint pain.

Common side effects

Ocular side effects include: Decreased sharpness of vision, swelling of a section of the eye (uvea, cornea), inflammation of the cornea (front part of the eye), small marks on the surface of the eye, blurred vision, eye discharge with itching, redness, and swelling (conjunctivitis), sensitivity to light, eye discomfort, eyelid swelling, eyelid pain.

Non-ocular side effects include: Anxiety, nausea.

Uncommon side effects

Ocular 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 ocular surface, pain or irritation at the injection site, abnormal sensation in the eye, eyelid irritation.

If you have any doubts about side effects, ask your baby's doctor.

Reporting of side effects

If your baby experiences any side effects, consult your baby's doctor, even if they are possible side effects not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

1. Storage of 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 after CAD and on the vial label after EXP. The expiry date is the last day of the month stated.
• Store in a refrigerator (between 2°C and 8°C). Do not freeze.
• Before use, the unopened vial may be stored at room temperature (25°C) for a maximum of 24 hours.
• Store the vial in the outer packaging to protect it from light.
• Do not use any packaging that is damaged.

1. Package contents and further information

Composition of Lucentis

• 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 quantity to deliver a single dose of 0.02 ml, which contains 0.2 mg of ranibizumab.
• The other ingredients are α,α-trehalose dihydrate; histidine hydrochloride monohydrate; histidine; polysorbate 20; water for injections.

Appearance and package contents of the product

Lucentis is an injectable solution contained in a vial (0.23 ml). The solution is clear, colorless to pale yellowish and aqueous.

Two different packaging types are available:

Vial only packaging

Packaging containing a glass vial with ranibizumab, with a chlorobutyl rubber stopper. The vial is for single use.

Vial and needle with filter packaging

Packaging containing a glass vial with ranibizumab, with a chlorobutyl rubber stopper and a blunt needle with filter (18G x 1½″, 1.2 mm x 40 mm, 5 microns) for extracting the vial contents. All components are for single use.

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 Nürnberg

Germany

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

This information is intended only for healthcare professionals:

See also section 3 “How to administer Lucentis”.

How to prepare and administer Lucentis in preterm infants

Single-use vial. For intravitreal use only.

Lucentis should be administered by an ophthalmologist experienced in the administration of intravitreal injections in preterm infants.

For the treatment of preterm infants, use the low-volume, high-precision syringe provided with an injection needle (30G x ½″) in the VISISURE kit.

For preterm infants, the recommended dose of Lucentis is 0.2 mg administered as a single intravitreal injection.This corresponds to an injection volume of 0.02 ml. In preterm infants, treatment of retinopathy of prematurity (ROP) is initiated with a single injection per eye and may be administered bilaterally on the same day. Up to three injections may be administered in each eye within the six months following the start of treatment if signs of disease activity are present. In the 24-week RAINBOW clinical trial, most patients (78%) received one injection per eye. Patients treated with 0.2 mg in this clinical trial did not require additional treatment in the subsequent long-term extension study that 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 should be at least four weeks.

Before administration of Lucentis, the absence of particles and discoloration should be checked visually.

The injection procedure should be carried out under aseptic conditions, including surgical hand washing, use of sterile gloves, a sterile field, a sterile blepharostat (or equivalent), and availability of a sterile paracentesis (if needed). Before performing the intravitreal injection procedure, the patient's medical history should be thoroughly evaluated for hypersensitivity reactions. Before injection, adequate anesthesia and a broad-spectrum topical microbicide should be administered to disinfect the periocular skin, eyelid, and ocular surface, in accordance with local practice.

Vial only packaging

The vial is for single use. After injection, any unused product should be discarded. Do not use any vial that shows signs of damage or tampering. Sterility can only be guaranteed if the packaging seal remains intact.

The following medical devices are required for preparation and intravitreal injection (for single use):

• a 5 µm filter needle (18G); not included in the Lucentis packaging
• a sterile, high-precision, low-volume syringe (provided separately within the VISISURE kit)
• an injection needle (30G x ½″); (provided separately within the VISISURE kit)

Vial and needle with filter packaging

All components are sterile and for single use. Do not use any component whose packaging shows signs of damage or tampering. Sterility can only be guaranteed if the packaging seal of the components remains intact. Reuse may lead to infection or other disease/injury.

The following medical devices are required for preparation and intravitreal injection (for single use):

• a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, supplied)
• a sterile, high-precision, low-volume syringe (provided separately within the VISISURE kit)
• an injection needle (30G x ½″); (provided separately within the VISISURE kit)

To prepare Lucentis for intravitreal administration in preterm infants, follow the instructions for use of the VISISURE kit.

The injection needle should be inserted 1.0 to 2.0 mm behind the limbus into the vitreous cavity, with the needle directed towards the optic nerve. The injection volume of 0.02 ml should then be released.