Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ranivisio

Document Subject

Generated Narrative: MedicinalProductDefinition mp95a6c6d44fd775697ee8966bf749780c

identifier: http://ema.europa.eu/identifier/EU/1/22/1673/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Ranivisio 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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Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-95a6c6d44fd775697ee8966bf749780c

identifier: http://ema.europa.eu/identifier/EU/1/22/1673/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - ranivisio

Attesters

What is in this leaflet

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

What Ranivisio is
Ranivisio is a solution which is injected into the eye. Ranivisio belongs to a group of medicines called antineovascularisation agents. It contains the active substance called ranibizumab.

What Ranivisio is used for
Ranivisio 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 Ranivisio works
Ranivisio 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, Ranivisio can block its actions and prevent this abnormal growth and swelling.

In these diseases, Ranivisio can help to stabilise and in many cases improve your vision.

You must not receive Ranivisio

• 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 Ranivisio.

• Ranivisio 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 Ranivisio 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 Ranivisio is the appropriate treatment for you.

Please see section 4 ( Possible side effects ) for more detailed information on side effects that could occur during Ranivisio therapy.

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

Other medicines and Ranivisio 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 Ranivisio.
• There is no experience of using Ranivisio in pregnant women. Ranivisio 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 Ranivisio.
• Small amounts of Ranivisio may pass into breast milk, therefore Ranivisio is not recommended during breast-feeding. Ask your doctor or pharmacist for advice before Ranivisio treatment.

Driving and using machines
After Ranivisio treatment you may experience some temporary vision blurring. If this happens, do not drive or use machines until this resolves.

Ranivisio 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 Ranivisio 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 Ranivisio .

Elderly (age 65 years and over)
Ranivisio can be used for people of 65 years of age and over without dose adjustment.

Before stopping Ranivisio treatment
If you are considering stopping Ranivisio 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 Ranivisio.

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 Ranivisio are either due to the medicine itself or the injection procedure and mostly 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 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 serious side effects (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 or increased sensitivity to light. Please tell your doctor immediately if you develop any of these side effects.

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: 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 and increased eye pressure.
Non-visual side effects include: Sore throat, nasal congestion, runny nose, headache and joint pain.

Other side effects which may occur following Ranivisio treatment are described below:
Common side effects
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 side effects
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 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 24 hours.
• Keep the vial in the outer carton in order to protect from light.
• Do not use any pack that is damaged.

What Ranivisio 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 suitable 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 Ranivisio looks like and contents of the pack Ranivisio is a solution for injection in a vial (0.23 ml). The solution is clear, colourless to pale yellow and aqueous.

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

Marketing Authorisation Holder and Manufacturer
Midas Pharma GmbH Rheinstra e D-55218 Ingelheim Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien
Teva Pharma Belgium N.V./S.A./A.G. Tel/T l: +32 3 820 73 Lietuva UAB Teva Baltics Tel: +370 5 266 02

Tel: +359 2 489 95 Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./A.G.,
T l: +32 3 820 73 esk republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251 007 Magyarorsz g
Teva Gy gyszergy r Zrt. Tel.: +36 1 288 6Danmark
Teva Denmark A/S
Tlf: +45 44 98 55 Malta
Teva Pharmaceuticals Ireland, L-Irlanda el: +353 (0)1912 7Deutschland ratiopharm GmbH Tel: +49 731 402 Nederland
Teva Nederland B.V. Tel: +31 (0) 800 0228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 661 0Norge Teva Norway AS Tlf: +47 66 77 55
Specifar
: +30 211 880 5 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 970Espa a Teva Pharma, S.L.U. Tel: +34 91 387 32 Polska Zak ady Farmaceutyczne Polpharma S.A. Tel. + 48 22 364 61 France Teva Sant
T l: +33 1 55 91 78 Portugal Teva Pharma - Produtos Farmac uticos Lda Tel: +351 214 767 Hrvatska Pliva Hrvatska d.o.o Tel: + 385 1 37 20 Rom nia Teva Pharmaceuticals S.R.L Tel: +40 21 230 65 Ireland Teva Pharmaceuticals Ireland Tel: +353 (0)1912 7Slovenija Pliva Ljubljana d.o.o. Tel: +386 1 58 90 sland Teva Pharma Iceland ehf. S mi: + 354 550 3Slovensk republika Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 2 5726 7Italia Teva Italia S.r.l. Tel: +39 0289 17Suomi/Finland ratiopharm Oy Puh/Tel: +358 20 180 5
Specifar ,
: +30 211 880 5Sverige Teva Sweden AB Tel: +46 42 12 11 Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67 323 United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Tel: +44 (0) 207 540 7This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: