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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 06831/0389.
Ximluci 10 mg/mL solution for injection
Ximluci 10 mg/mL solution for injection
ranibizumab
▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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
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.
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:
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.
Talk to your doctor before you are given Ximluci.
Please see section 4 (“Possible side effects”) for more detailed information on side effects that could occur during Ximluci therapy.
The use of Ximluci in children and adolescents has not been established and is therefore not recommended.
Tell your doctor if you are using, have recently used or might use any other medicines.
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”.
Ximluci can be used for people of 65 years of age and over without dose adjustment.
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)
Uncommon (may affect up to 1 in 100 people)
The symptoms you might experience are:
Other side effects:
Very common (may affect more than 1 in 10 people)
Visual side effects include
Non-visual side effects include
Common (may affect up to 1 in 10 people)
Visual side effects include
Non-visual side effects include
Uncommon (may affect up to 1 in 100 people)
Visual side effects include
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 µm filter needle (18G x 1½″, 1.2 mm x 40 mm) for withdrawal of the vial contents. All components are for single use only.
Great Britain:
Northern Ireland:
For any information about this medicine, please contact:
Great Britain
Northern Ireland
This leaflet was last revised in September 2022.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
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