Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ximluci

Document Subject

Generated Narrative: MedicinalProductDefinition mp11587ff1554abe28faf73fc5e54ae7a8

identifier: http://ema.europa.eu/identifier/EU/1/22/1691/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ximluci 10 mg/mL solution for injection

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-11587ff1554abe28faf73fc5e54ae7a8

identifier: http://ema.europa.eu/identifier/EU/1/22/1691/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ximluci

Attesters

What is in this leaflet

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

What Ximluci is Ximluci is a solution which is injected into the eye. Ximluci belongs to a group of medicines called antineovascularisation agents. It contains the active substance called ranibizumab. What Ximluci is used for Ximluci is used in adults to treat several eye diseases causing vision impairment. These diseases result from damage to the retina (light-sensitive layer at the back of the eye) caused by:

Growth of leaky, abnormal blood vessels. This is observed in diseases such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes). It may also be associated with choroidal neovascularisation (CNV) due to pathologic myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV.

Macular oedema (swelling of the centre of the retina). This swelling can be caused by diabetes (a disease called diabetic macular oedema (DME)) or by the blockage of retinal veins of the retina (a disease called retinal vein occlusion (RVO)). How Ximluci works Ximluci specifically recognises and binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eye. In excess, VEGF-A causes abnormal blood vessel growth and swelling in the eye which can lead to impairment of vision in diseases like AMD, DME, PDR, RVO, PM and CNV. By binding to VEGF-A, Ximluci can block its actions and prevent this abnormal growth and swelling. In these diseases, Ximluci can help to stabilise and in many cases improve your vision.

You must not receive Ximluci

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 or around your eye.

If you have pain or redness (severe intraocular inflammation) in your eye. Warnings and precautions Talk to your doctor before you are given Ximluci.

Ximluci is given as an injection into the eye. Occasionally, an infection in the internal portion of the eye, pain or redness (inflammation), detachment or tear of one of the layers in the back of the eye (retinal detachment or tear and retinal pigment epithelial detachment or tear), or clouding of the lens (cataract) may occur after Ximluci treatment. It is important to identify and treat such an infection or retinal detachment as soon as possible. Please tell your doctor immediately if you develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light.

In some patients the eye pressure may increase for a short period directly after the injection. This is something you may not notice, therefore your doctor may monitor this after each injection.

Inform your doctor if you have a prior history of eye conditions or eye treatments, or if you have had a stroke or experienced transient signs of stroke (weakness or paralysis of limbs or face, difficulty speaking or understanding). This information will be taken into account to evaluate if Ximluci is the appropriate treatment for you. Please see section 4 ( Possible side effects ) for more detailed information on side effects that could occur during Ximluci therapy. Children and adolescents (below 18 years of age) The use of Ximluci in children and adolescents has not been established and is therefore not recommended. Other medicines and Ximluci Tell your doctor if you are using, have recently used or might use any other medicines. Pregnancy and breast-feeding

Women who could become pregnant must use effective contraception during treatment and for at least three further months after the last injection of Ximluci.

There is no experience of using Ximluci in pregnant women. Ximluci should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child. If you are pregnant, think you may be pregnant or planning to become pregnant, discuss this with your doctor before treatment with Ximluci.

Ximluci is not recommended during breast-feeding because it is not known whether Ximluci passes into human milk. Ask your doctor or pharmacist for advice before Ximluci treatment. Driving and using machines After Ximluci treatment you may experience some temporary vision blurring. If this happens, do not drive or use machines until this resolves.

Ximluci is administered as a single injection into your eye by your eye doctor under a local anaesthetic. The usual dose of an injection is 0.05 mL (which contains 0.5 mg of active substance). The interval between two doses injected into the same eye should be at least four weeks. All injections will be administered by your eye doctor. Before the injection, your doctor will wash your eye carefully to prevent infection. Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection. The treatment is started with one injection of Ximluci per month. Your doctor will monitor the condition of your eye and, depending on how you respond to the treatment, will decide if and when you need to receive further treatment. Detailed instructions for use are given at the end of the leaflet under How to prepare and administer Ximluci to adults . Elderly (age 65 years and over) Ximluci can be used for people of 65 years of age and over without dose adjustment. Before stopping Ximluci treatment If you are considering stopping Ximluci treatment, please go to your next appointment and discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Ximluci. If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects associated with the administration of Ximluci are either due to the medicine itself or due to the injection procedure and mostly affect the eye. Serious side effects: Common (may affect up to 1 in 10 people)

detachment or tear of the layer in the back of the eye (retinal detachment or tear), resulting in flashes of light with floaters progressing to a temporary loss of sight, or a clouding of the lens (cataract) Uncommon (may affect up to 1 in 100 people)

blindness

infection of the eyeball (endophthalmitis) with inflammation of the inside of the eye The symptoms you might experience are:

pain or increased discomfort in your eye

worsening eye redness

blurred or decreased vision

an increased number of small particles in your vision

increased sensitivity to light. Please tell your doctor immediately if you develop any of these side effects. Other side effects: Very common (may affect more than 1 in 10 people) Visual side effects include

inflammation of the eye

bleeding in the back of the eye (retinal bleeding)

visual disturbances

eye pain

small particles or spots in your vision (floaters)

bloodshot eye

eye irritation

a feeling of having something in the eye

increased tear production

inflammation or infection of the eyelid margins

dry eye

redness or itching of the eye

increased eye pressure Non-visual side effects include

sore throat, nasal congestion, runny nose

headache

joint pain Common (may affect up to 1 in 10 people) Visual side effects include

decreased sharpness of vision

swelling of a section of the eye (uvea, cornea)

inflammation of the cornea (front part of eye)

small marks on the surface of the eye

blurred vision

bleeding at the site of injection

bleeding in the eye

discharge from the eye with itching, redness and swelling (conjunctivitis)

light sensitivity

eye discomfort

swelling of the eyelid

eyelid pain Non-visual side effects include

urinary tract infection

low red blood cells count (with symptoms such as tiredness, breathlessness, dizziness, pale skin)

anxiety

cough

nausea

allergic reactions like rash, hives, itching and skin reddening Uncommon (may affect up to 1 in 100 people) Visual side effects include

inflammation and bleeding in the front part of the eye

sac of pus on the eye

changes of the central part of the eye surface

pain or irritation at the site of injection

abnormal sensation in the eye

irritation of the eyelid Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects 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.

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 the vial label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C). Do not freeze.

Prior to use, the unopened vial may be kept at room temperature (25 C) for up to 48 hours.

Keep the vial in the outer carton in order to protect from light.

Do not use any pack that is damaged.

What Ximluci contains

The active substance is ranibizumab. Each mL contains 10 mg ranibizumab. Each vial contains 2.3 mg ranibizumab in 0.23 mL solution. This provides a usable amount to deliver a single dose of 0.05 mL containing 0.5 mg ranibizumab.

The other ingredients are trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections. What Ximluci looks like and contents of the pack Ximluci is a clear to slightly opalescent, colourless to slightly brownish solution for injection in a vial (0.23 mL). Two different pack types are available: Vial-only pack Pack containing one glass vial of ranibizumab with bromobutyl rubber stopper. The vial is for single use only. Vial + filter needle pack Pack containing one glass vial of ranibizumab with bromobutyl rubber stopper and one sterile, blunt 5 m filter needle (18G x 1 , 1.2 mm x 40 mm) for withdrawal of the vial contents. All components are for single use only. Marketing Authorisation Holder and Manufacturer STADA Arzneimittel AG Stadastrasse 2-61118 Bad Vilbel Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien EG (Eurogenerics) NV T l/Tel: + 32 4797Lietuva UAB STADA Baltics Tel: + 370 52603 STADA Bulgaria EOOD Te .: + 359 29624Luxembourg/Luxemburg EG (Eurogenerics) NV T l/Tel: + 32 4797 esk republika STADA PHARMA CZ s.r.o. Tel: + 420 257888Magyarorsz g STADA Hungary Kft Tel.: + 36 18009Danmark STADA Nordic ApS Tlf: + 45 44859Malta Pharma MT Ltd Tel: + 356 21337Deutschland STADAPHARM GmbH Tel: + 49 61016Nederland Centrafarm B.V. Tel.: + 31 765081Eesti UAB STADA Baltics Tel: + 370 52603Norge STADA Nordic ApS Tlf: + 45 44859 RAFARM A.E.B.E. : +30 2106776 sterreich STADA Arzneimittel GmbH Tel: + 43 136785Espa a Laboratorio STADA, S.L. Tel: + 34 934738Polska STADA Poland Sp. z.o o. Tel: + 48 227377France EG LABO - Laboratoires EuroGenerics T l: + 33 146948Portugal Stada, Lda. Tel: + 351 211209Hrvatska STADA d.o.o. Tel: + 385 13764Rom nia STADA M&D SRL Tel: + 40 213160Ireland Clonmel Healthcare Ltd. Tel: + 353 526177Slovenija Stada d.o.o. Tel: + 386 15896 sland STADA Arzneimittel AG S mi: + 49 61016Slovensk republika STADA PHARMA Slovakia, s.r.o. Tel: + 421 252621Italia EG SpA Tel: + 39 028310Suomi/Finland STADA Nordic ApS, Suomen sivuliike Puh/Tel: + 358 207416 STADA Arzneimittel AG : +30 2106664Sverige STADA Nordic ApS Tel: + 45 44859Latvija UAB STADA Baltics Tel: + 370 52603United Kingdom (Northern Ireland) STADA Arzneimittel AG Tel: +49 61016This leaflet was last revised in . Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY: Please also refer to section 3 How Ximluci is given . How to prepare and administer Ximluci to adults Single-use vial for intravitreal use only. Ximluci must be administered by a qualified ophthalmologist experienced in intravitreal injections. In wet AMD, in CNV, in PDR and in visual impairment due to DME or to macular oedema secondary to RVO the recommended dose for Ximluci is 0.5 mg given as a single intravitreal injection. This corresponds to an injection 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 and in other signs and symptoms of the disease under continued treatment. In patients with wet AMD, DME, PDR and RVO, initially, three or more consecutive, monthly injections may be needed. Thereafter, monitoring and treatment intervals should be determined by the physician and should be based on disease activity, as assessed by visual acuity and/or anatomical parameters. If, in the physician s opinion, visual and anatomical parameters indicate that the patient is not benefiting from continued treatment, Ximluci should be discontinued. Monitoring for disease activity 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 is achieved and/or there are no signs of disease activity, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. The treatment interval should be extended by no more than two weeks at a time for wet AMD and may be extended by up to one month at a time for DME. For PDR and RVO, treatment intervals may also be gradually extended, however there are insufficient data to conclude on the length of these intervals. If disease activity recurs, the treatment interval should be shortened accordingly. The treatment of visual impairment due to CNV should be determined individually per patient based on disease activity. Some patients may only need one injection during the first 12 months; others may need more frequent treatment, including a monthly injection. For CNV secondary to pathologic myopia (PM), many patients may only need one or two injections during the first year. Ximluci and laser photocoagulation in DME and macular oedema secondary to BRVO There is some experience of Ximluci administered concomitantly with laser photocoagulation. When given on the same day, Ximluci should be administered at least 30 minutes after laser photocoagulation. Ximluci can be administered in patients who have received previous laser photocoagulation. Ximluci and verteporfin photodynamic therapy in CNV secondary to PM There is no experience of concomitant administration of Ximluci and verteporfin. Ximluci should be inspected visually for particulate matter and discolouration prior to administration. The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required). The patient s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure. Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection, in accordance with local practice. Vial-only pack 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. The sterility cannot be guaranteed unless the packaging seal remains intact. For preparation and intravitreal injection the following medical devices for single use are needed:

a sterile 5 m filter needle (18G x 1 , 1.2 mm x 40 mm)

a 1 mL sterile syringe (including a 0.05 mL mark)

an injection needle (30G x , 0.3 mm x 13 mm). These medical devices are not included within the Ximluci pack. Vial + filter needle pack All components are sterile and for single use only. Any component with packaging showing signs of damage or tampering must not be used. The sterility cannot be guaranteed unless the component packaging seal remains intact. Re-use may lead to infection or other illness/injury. For preparation and intravitreal injection the following medical devices for single use are needed:

a sterile 5 m filter needle (18G x 1 , 1.2 mm x 40 mm, provided)

a 1 mL sterile syringe (including a 0.05 mL mark, not included within the Ximluci pack)

an injection needle (30G x , 0.3 mm x 13 mm; not included within the Ximluci pack) To prepare Ximluci for intravitreal administration to adult patients, please adhere to the following instructions:

1. Before withdrawal, remove the vial cap and clean the vial septum (e.g. with 70% alcohol swab).
2. Assemble a 5 m filter needle (18G x 1 , 1.2 mm x 40 mm) onto a 1 mL syringe using aseptic technique. Push the blunt filter needle into the centre of the vial stopper until the needle touches the bottom edge of the vial.
3. Withdraw all the liquid from the vial, keeping the vial in an upright position, slightly inclined to ease complete withdrawal.
4. Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely emptythe filter needle.
5. Leave the blunt filter needle in the vial and disconnect the syringe from the blunt filter needle. The filter needle should be discarded after withdrawal of the vial contents and should not be used for the intravitreal injection.
6. Aseptically and firmly assemble an injection needle (30G x , 0.3 mm x 13 mm) onto the syringe.
7. Carefully remove the cap from the injection needle without disconnecting the injection needle from the syringe. Note: Grip at the hub of the injection needle while removing the cap.
8. Carefully expel the air along with the excess solution from the syringe and adjust the dose to the 0.05 mL mark on the syringe. The syringe is ready for injection. Note: Do not wipe the injection needle. Do not pull back on the plunger. The injection needle should be inserted 3.5 4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 mL is then delivered; a different scleral site should be used for subsequent injections. After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements.