RANIBIZUMAB 10 mg /Ml Roztwór Do Wstrzykiwań

Treść ulotki

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

Ranibizumab Midas 10 mg/ml injectable solution

ranibizumab

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.

ADULTS
Read this leaflet carefully before you are given this medicine as
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What is Ranibizumab Midas and what is it used for

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

What is Ranibizumab Midas used for
Ranibizumab Midas is used in adults to treat various eye conditions that cause a
decrease in vision.
These conditions are due to 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 Ranibizumab Midas works
Ranibizumab Midas 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 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 to VEGF-
A, Ranibizumab Midas can block its action and prevent abnormal growth and swelling.
In these conditions, Ranibizumab Midas can help to stabilize and, in many cases, improve
vision.

2. What you need to know before you are given Ranibizumab Midas

You must not receive Ranibizumab Midas

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

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

• Ranibizumab Midas is given by an injection into the eye. Occasionally, after treatment with Ranibizumab Midas, 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 redness of the eye, blurred or decreased vision, an increase in the number of floaters in your vision, or increased sensitivity to light.
• In some patients, the pressure inside the eye may increase briefly immediately after the injection. This may be something you do not notice, therefore 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 Ranibizumab Midas is the appropriate treatment for you.

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

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

Other medicines and Ranibizumab Midas
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 Ranibizumab Midas.
• There is no experience on the use of Ranibizumab Midas in pregnant women. Ranibizumab Midas 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, talk to your doctor before taking Ranibizumab Midas.
• The use of Ranibizumab Midas during breastfeeding is not recommended as small amounts of Ranibizumab Midas may pass into breast milk. Ask your doctor or pharmacist for advice before treatment with Ranibizumab Midas.

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

3. How Ranibizumab Midas will be administered to you

Ranibizumab Midas 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 (containing 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 Ranibizumab Midas. 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 Ranibizumab Midas”.

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

Before stopping treatment with Ranibizumab Midas
If you are considering stopping treatment with Ranibizumab Midas, attend your next
visit and discuss it with your doctor. The doctor will advise you and decide how long you should be
treated with Ranibizumab Midas.
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 Ranibizumab Midas are due to both the
medicine itself and the injection procedure and mostly affect the eye.
The more serious side effects are described below:

Serious common 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 with flashes of
light with floaters up to a temporary reduction in vision, or clouding of the lens (cataract).

Serious uncommon 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 are eye pain or increased eye discomfort, worsening eye redness,
blurred or decreased vision, increased number of floaters in vision, or increased sensitivity to light. Contact your doctor immediately if any of these
side effects occur.
The more 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 hemorrhage), visual
disturbances, eye pain, floaters or spots in vision (floaters), 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, and increased pressure inside the eye.
Non-visual side effects include: sore throat, nasal congestion, runny nose, headache, and joint pain.
Other side effects that may occur following treatment with Ranibizumab Midas are described below:

Common side effects
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, paleness), anxiety, cough, nausea, allergic reactions such as rash,
hives, itching and redness of the skin.

Uncommon side effects
Visual side effects include: inflammation and bleeding in the front of the eye, pus collection 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 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
indicated in Annex V. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Ranibizumab Midas

• 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 pack 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 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 the medicine from light.
• Do not use a pack that is damaged.

6. Contents of the pack and other information

What Ranibizumab Midas 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 usable amount for administering 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 Ranibizumab Midas and contents of the pack
Ranibizumab Midas is an injectable solution in a vial (0.23 ml). The solution is aqueous,
clear, from colourless to pale yellow.

A type of pack is available:
Pack containing one glass vial of ranibizumab with a chlorobutyl rubber stopper. The
vial is for single use only.

Marketing authorisation holder and manufacturer
Midas Pharma GmbH
Rheinstraße 49
D-55218 Ingelheim
Germany

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu

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

How to prepare and administer Ranibizumab Midas to adults
Vial for single use, for intravitreal use only.
Ranibizumab Midas 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 Ranibizumab Midas is 0.5 mg in a single
intravitreal injection. This corresponds to an injected volume of 0.05 ml. The interval between two doses
injected into the same eye must be at least four weeks.
Treatment is initiated with an injection every 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 assessed by visual acuity assessment 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, Ranibizumab Midas must 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. If disease activity recurs, the treatment interval should be reduced
accordingly.
Treatment of visual impairment caused by CNV should be determined individually for
each patient based on disease activity. 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.

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

Ranibizumab Midas and photodynamic therapy with verteporfin in CNV secondary to PM
There is no experience with the administration of ranibizumab in association with verteporfin.
Before administration, Ranibizumab Midas 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 and a sterile blepharostat (or
equivalent) and the possibility of performing a sterile paracentesis (if necessary). Before performing the
intravitreal procedure, the patient's medical history should be carefully assessed for
hypersensitivity reactions. Adequate anaesthesia and a broad-spectrum topical antimicrobial should be administered before the injection to disinfect the periocular, ocular and eyelid surface,
as per clinical practice.
The vial is for single use only. 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 not intact.
The following single-use medical devices are required for preparing and intravitreal injection:

• a 5 μm filter needle (18G)
• a sterile 1 ml syringe (with a 0.05 ml mark)
• an injection needle (30G x ½″). These medical devices are not included in the packaging of Ranibizumab Midas. They can be obtained separately or found in third-party intravitreal injection kits (e.g. the Vortex Surgical I2 injection kit).

To prepare Ranibizumab Midas for intravitreal injection in adult patients, please follow the
following instructions:

• 1. Before withdrawal, remove the vial cap and clean the vial stopper (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 cap from the injection needle 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 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 scleral site for subsequent injections.
After 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.