XIMLUCI 10 mg /Ml Инъекционный Раствор

Содержание инструкции

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

Ximluci 10 mg/mL injectable solution

ranibizumab

ADULTS

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before this medicine is administered to you 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 any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What is Ximluci and what is it used for

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

What is Ximluci used for
Ximluci is used in adults to treat various eye conditions that cause a decrease in
vision.
These conditions are caused by damage to the retina (the light-sensitive layer at the back of
the eye) caused by:

• Growth of abnormal blood vessels that leak fluid. This is observed in conditions such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a condition caused by diabetes). It may be associated with choroidal neovascularization (CNV) due to pathological myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV.
• Macular edema (swelling in the center of the retina). This swelling can be caused by diabetes (a condition called diabetic macular edema (DME)) or blockage of the retinal veins (a condition called retinal vein occlusion (RVO)).

How does Ximluci work
Ximluci recognizes and specifically binds to a protein called vascular endothelial growth factor
human A (VEGF-A) present in the eye. When in excess, VEGF-A causes abnormal growth of
blood vessels and swelling in the eye that can lead to a decrease in vision in conditions
such as AMD, DME, PDR, RVO, PM and CNV. By binding VEGF-A, Ximluci can block its action
and prevent abnormal growth and swelling.
In these conditions, Ximluci can help stabilize and, in many cases, improve vision.

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

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

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

• Ximluci is given by an injection into your eye. Occasionally, after treatment with Ximluci, an infection inside the eye, pain or redness (inflammation), detachment or tear of one of the layers at the back of the eye (retinal detachment or tear and detachment or tear of the retinal pigment epithelium), or clouding of the lens of the eye (cataract) can occur. It is important to identify and treat an infection or retinal detachment as soon as possible. Tell your doctor immediately if you experience signs such as eye pain or increased discomfort, worsening of eye redness, blurred or decreased vision, an increase in the number of floaters in your vision, or increased sensitivity to light.
• In some patients, the pressure in your eye may increase briefly immediately after the injection. This may be something you do not notice, so your doctor must check after each injection.
• Tell your doctor if you have had previous eye problems or treatments, or if you have had a stroke or signs of transient ischaemic attacks (weakness or paralysis of the limbs or face, difficulty speaking or understanding). This information will be taken into consideration to assess whether Ximluci is the appropriate treatment for you.

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

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

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

Pregnancy and breastfeeding

• Women of childbearing potential must use effective contraception during treatment and for at least three months after the last injection of Ximluci.
• There is no experience with the use of Ximluci in pregnant women. Ximluci should not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus. If you are pregnant, suspect you are pregnant or are planning to become pregnant, talk to your doctor before taking Ximluci.
• The use of Ximluci is not recommended during breastfeeding as it is not known whether Ximluci is excreted in human milk. Ask your doctor or pharmacist for advice before treatment with Ximluci.

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

3. How Ximluci will be administered to you

Ximluci is administered by the ophthalmologist as a single injection into the eye under local anesthesia
The usual dose of an injection is 0.05 mL (which contains 0.5 mg of active substance).
The interval between two doses injected into the same eye must be at least four weeks. All
injections will be administered by the ophthalmologist.
Before the injection, the doctor will carefully clean the eye to prevent infection. The doctor will also
give you a local anesthetic to reduce or prevent any pain that may occur with the injection.
Treatment is started with a monthly injection of Ximluci. The doctor will monitor the condition
of the eye and, based on the response to treatment, will decide if and when further
treatment is necessary.
prepare and administer Ximluci to adults”.

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

Before stopping treatment with Ximluci
If you are considering stopping treatment with Ximluci, attend your next visit and discuss it with your doctor. The doctor will advise you and decide how long you should be treated with
Ximluci.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects associated with the administration of Ximluci are due to both the medicine itself
and the injection procedure and mostly affect the eye.
Serious side effects:

Common(may affect up to 1 in 10 people):

• detachment or tear in the back of the eye (retinal detachment or tear), which manifests with flashes of light with floating spots up to a temporary reduction in vision, or clouding of the lens of the eye (cataract)

Uncommon(may affect up to 1 in 100 people):

• blindness
• infection of the eyeball (endophthalmitis) with inflammation inside the eye

The symptoms you may experience are

• eye pain or increased eye discomfort
• worsening eye redness
• blurred or decreased vision
• increased number of floaters in vision
• increased sensitivity to light

See your doctor immediately if any of these side effects occur.
Other side effects:

Very common(may affect more than 1 in 10 people)
Visual side effects include:

• eye inflammation
• bleeding in the back of the eye (retinal hemorrhage)
• visual disturbances
• eye pain
• floaters or spots in vision (mobile bodies)
• localized eye redness
• eye irritation
• foreign body sensation in the eye
• increased tear production
• inflammation or infection of the eyelid margin
• dry eye
• eye redness or itching
• increased pressure inside the eye

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 visual acuity
• swelling of a part of the eye (uvea, cornea)
• inflammation of the cornea (front part of the eye)
• small marks on the surface of the eye
• blurred vision
• bleeding at the injection site
• bleeding in the eye
• eye discharge with itching, redness and swelling (conjunctivitis)
• sensitivity to light
• eye discomfort
• eyelid swelling
• eyelid pain

Non-visual side effects include:

• urinary tract infection
• decreased red blood cells (with symptoms such as fatigue, shortness of breath, dizziness, pallor)
• anxiety
• cough
• nausea
• allergic reactions such as rash, hives, itching and redness of the skin

Uncommon(may affect up to 1 in 100 people):
Visual side effects include:

• inflammation and bleeding in the front of the eye
• collection 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

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

5. How to store Ximluci

• 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 package and on the vial label 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 closed vial can be stored at room temperature (25°C) for a maximum of 48 hours.
• Keep the vial in the outer packaging to protect the medicine from light.
• Do not use a package that is damaged.

6. Contents of the pack and other information

What Ximluci contains

• The active substance is ranibizumab. Each mL contains 10 mg of ranibizumab. Each vial contains 2.3 mg of ranibizumab in 0.23 mL of solution. This provides a volume sufficient for the administration of a single dose of 0.05 mL containing 0.5 mg of ranibizumab.
• The other ingredients are trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections.

Description of the appearance of Ximluci and contents of the pack
Ximluci is an injectable solution from clear to slightly opalescent, from colorless to slightly
brownish in a vial (0.23 mL).
2 different packs are available:
Vial alone
Pack containing a glass vial of ranibizumab with a bromobutyl rubber stopper. The
vial is for single use.
Vial + filter needle
Pack containing only a glass vial of ranibizumab with a bromobutyl rubber stopper and
a sterile bevelled 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm) for withdrawing the contents of the
vial. All components are for single use.

Marketing Authorisation Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
EG (Eurogenerics) NV
Tél/Tel: + 32 4797878

Lietuva
UAB „STADA Baltics“
Tel: + 370 52603926

България
STADA Bulgaria EOOD
Тел.: + 359 29624626

Luxembourg/Luxemburg
EG (Eurogenerics) NV
Tél/Tel: + 32 4797878

Česká republika
STADA PHARMA CZ s.r.o.
Tel: + 420 257888111

Magyarország
STADA Hungary Kft
Tel.: + 36 18009747

Danmark
STADA Nordic ApS
Tlf: + 45 44859999

Malta
Pharma MT Ltd
Tel: + 356 21337008

Deutschland
STADAPHARM GmbH
Tel: + 49 61016030

Nederland
Centrafarm B.V.
Tel: + 31 765081000

Eesti
UAB „STADA Baltics“
Tel: + 370 52603926

Norge
STADA Nordic ApS
Tlf: + 45 44859999

Ελλάδα
RAFARM A.E.B.E.
Τηλ: +30 2106776550

Österreich
STADA Arzneimittel GmbH
Tel: + 43 136785850

España
Laboratorio STADA, S.L.
Tel: + 34 934738889

Polska
STADA Poland Sp. z.o o.
Tel.: + 48 227377920

France
EG LABO - Laboratoires EuroGenerics
Tél: + 33 146948686

Portugal
Stada, Lda.
Tel: + 351 211209870

Hrvatska
STADA d.o.o.
Tel. + 385 13764111

România
STADA M&D SRL
Tel: + 40 213160640

Ireland
Clonmel Healthcare Ltd.
Tel: + 353 526177777

Slovenija
Stada d.o.o.
Tel: + 386 15896710

Ísland
STADA Arzneimittel AG
Sími: + 49 61016030

Slovenská republika
STADA PHARMA Slovakia, s.r.o.
Tel: + 421 252621933

Italia
EG SpA
Tel: + 39 028310371

Suomi/Finland
STADA Nordic ApS, Suomen sivuliike
Puh/Tel: + 358 207416888

Κύπρος
STADA Arzneimittel AG
Τηλ: +30 2106664667

Sverige
STADA Nordic ApS
Tel: + 45 44859999

Latvija
UAB „STADA Baltics“
Tel: + 370 52603926

United Kingdom (Northern Ireland)
STADA Arzneimittel AG
Tel: +49 61016030

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

How to prepare and administer Ximluci to adults
Single-use vials, for intravitreal use only.
Ximluci must be administered by a qualified ophthalmologist experienced in intravitreal injections.
In exudative AMD, CNV, PDR and visual impairment due to DME, or macular oedema secondary to BRVO, the recommended dose of Ximluci is 0.5 mg in a single intravitreal injection.
This corresponds to an injected volume of 0.05 mL. The interval between two injections into the same eye must be at least four weeks.
Treatment is initiated with an injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity such as changes in visual acuity and alterations of other signs and
symptoms of the disease during continued treatment. In patients with exudative AMD, DME, PDR and BRVO, it may be necessary to start therapy with three or more consecutive monthly injections.
Therefore, monitoring and treatment intervals must be decided by the physician and must be based on the activity of the disease, as determined by assessment of visual acuity and/or anatomical parameters.
If, in the opinion of the physician, visual acuity and anatomical parameters indicate that the patient is not benefiting from continued treatment, Ximluci should be discontinued.
Monitoring of disease activity may include clinical examination, functional assessments or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
If patients are treated according to a “treat-and-extend” regimen, upon reaching maximum visual acuity and/or in the absence of signs of disease activity, treatment intervals may be gradually extended until signs of the disease reappear or a worsening of visual function is observed. The treatment interval should be gradually extended by a maximum of two weeks in patients with exudative AMD and may be extended up to one month in patients with DME. Treatment intervals may also be gradually extended in the treatment of BRVO and PDR, however, there is insufficient data to establish the duration of these intervals. Upon recurrence of disease activity, the treatment interval should be reduced accordingly.
The treatment of visual impairment caused by CNV must be determined individually for each patient based on the activity of the disease. Some patients may only need one injection during the first 12 months; others may need more frequent treatment, up to a monthly injection. For CNV secondary to pathological myopia (PM), many patients may only need one or two injections during the first year.

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

Ximluci and photodynamic therapy with verteporfin in CNV secondary to PM
There is no experience with the administration of Ximluci in association with verteporfin.
Before administration, Ximluci should be visually inspected for the presence of particles and colour changes.
The injection procedure must be performed under aseptic conditions, including surgical scrubbing of the hands, sterile gloves, a sterile drape and a sterile blepharostat (or equivalent) and the possibility of performing a sterile paracentesis (if necessary). Before performing the intravitreal procedure, the patient’s history should be carefully assessed for hypersensitivity reactions. Adequate anaesthesia and a broad-spectrum topical antimicrobial agent should be administered before the injection to disinfect the periocular, ocular and eyelid surface, as per clinical practice.
Vial alone
The vial is for single use. After injection, unused product must be discarded. Any vial showing signs of damage or tampering must not be used. Sterility cannot be guaranteed if the package seal is broken.
The following single-use medical devices are required for preparation and intravitreal injection:

• a sterile 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm)
• a sterile 1 mL syringe (with a 0.05 mL mark)
• an injection needle (30G x ½″, 0.3 mm x 13 mm). These devices are not included in the Ximluci pack.

Vial + filter needle
All components are sterile and for single use. Any component with packaging showing signs of damage or tampering must not be used. Sterility cannot be guaranteed if the package seal of the component is broken. Reuse may cause infection or other illness/injury.
The following single-use medical devices are required for preparation and intravitreal injection:

• a sterile 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, supplied)
• a sterile 1 mL syringe (with a 0.05 mL mark not included in the Ximluci pack)
• an injection needle (30G x½″, 0.3 mm x 13 mm; not included in the Ximluci pack)

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

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

• 4. Make sure the syringe plunger is pulled back sufficiently when emptying the vial so as to completely empty the filter needle.
• 5. Leave the bevelled filter needle in the vial and detach the syringe from it. Discard the filter needle after withdrawing the contents of the vial and do not use it for intravitreal injection.

• 6. Firmly and aseptically mount an injection needle (30G x ½″, 0.3 mm x 13 mm) onto the syringe.
• 7. Carefully remove the needle cap without disconnecting the injection needle from the syringe.

Note: Hold the base of the
injection needle while removing
the cap.

• 8. Carefully expel air and excess solution from the syringe and adjust the dose to 0.05 mL as marked on the syringe. The syringe is ready for injection.

Note :Do not clean the injection
needle. Do not pull back the
plunger.

Insert the injection needle 3.5-4.0 mm posterior to the limbus, into the vitreous cavity, avoiding the horizontal meridian and directing the needle towards the centre of the eyeball. Inject the injection volume of 0.05 mL; change the sclerotic site for subsequent injections.
After the injection, do not recap or detach the needle from the syringe. Dispose of the used syringe together with the needle in a suitable container or in accordance with local regulations.