Eylea 40 mg/mL solution for injection in pre-filled syringe
*Company:
Bayer LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
File name
Eylea Prescriber Guide-Mar 2024.pdf
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- Add New Doc
File name
Eylea Patient Guide-Mar2024.pdf
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File name
Bayer 8mg.mp4
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Bayer EYLEA_Track 6 (mCNV)_Mar2024_BP23051.wav
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Bayer EYLEA_Track 5 (BRVO)_Mar2024_BP23051.wav
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Bayer EYLEA_Track 4 (CRVO)_Mar2024_BP23051.wav
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Bayer EYLEA_Track 3 (DME)_Mar2024_BP23051.wav
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Bayer EYLEA_Track 2 (AMD)_Mar2024_BP23051.wav
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Updated on 15 February 2024
File name
20230911_PIL_EYLEA_40mg per ml_PFS.pdf
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- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
PIL File name updated.
Updated on 15 February 2024
File name
20230911_PIL_EYLEA_40mg per ml_PFS.pdf
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
PIL File name updated.
Updated on 15 February 2024
File name
20230911_PIL_EYLEA_40mg per ml_PFS.pdf
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- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
PIL File name updated.
Updated on 23 January 2024
File name
20230911_PIL_Adult+Baby_EYL_PFS_CC_PSUSA.pdf
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- Correction of spelling/typing errors
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Eylea_Intravitreal injection procedure Video_BP23008.mp4
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Eylea_Intravitreal injection procedure Video_BP23008.mp4
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Updated on 19 October 2023
File name
20230911_PIL_Adult+Baby_EYL_PFS_CC_PSUSA.pdf
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- Changes to therapeutic indications
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Information for guardians of babies born prematurely has been added.
Updated on 14 September 2023
File name
20230911_PIL_Adult ONLY_EYL_PFS_CC_PSUSA.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PSUSA/00010020/202211 (REC31695, 31108, 31718)
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Text in black = unchanged text
Text in blue = added text
Text in red with strikethrough = deleted text
2. What you need to know before you are given Eylea
Pregnancy and breast-feeding
[….]
- Small amounts of Eylea may pass into human milk. The effects on breast-fed newborns/infants are unknown. Eylea is not recommended during breast-feeding. If you are a breastfeeding woman, discuss this with your doctor before treatment with Eylea. Eylea is not recommended during breast-feeding as it is not known whether Eylea passes into human milk. Ask your doctor for advice before starting Eylea treatment.
6. Contents of the pack and other information
This leaflet was last revised in 09/2023
Updated on 14 September 2023
File name
20230911_SPC_EYL_PFS_CC_PSUSA.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
PSUSA/00010020/202211 (REC31695, 31108, 31718)
Note:
Text in black = unchanged text
Text in blue = added text
Text in red with strikethrough = deleted text
4.6 Fertility, pregnancy and lactation
Breast-feeding
Based on very limited human data, aflibercept may be excreted in human milk at low levels. Aflibercept is a large protein molecule and the amount of medication absorbed by the infant is expected to be minimal. The effects of aflibercept on a breast-fed newborn/infant are unknown.
As a precautionary measure, breast-feeding is not recommended during the use of Eylea.
It is unknown whether aflibercept is excreted in human milk. A risk to the breast-fed child cannot be excluded.
Eylea is not recommended during breast-feeding. A decision must be made whether to discontinue breast-feeding or to abstain from Eylea therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
10. DATE OF REVISION OF THE TEXT
September 2023
Updated on 09 January 2023
File name
20221216_PIL_Adult only_EYL_PFS_CC_Paed PIL box deleted.pdf
Reasons for updating
- Change to Section 1 - what the product is
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Correction (relating to REC20818+20826+ 20947_Var 77)
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Text in red with strikethrough = deleted text
Updated on 20 December 2022
File name
20221216_SPC_EYL_PFS_CC_REC20818_20826_20947.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
REC20818+20826+ 20947_Var 77
Note:
Text in black = unchanged text
Text in blue = added text
Text in red with strikethrough = deleted text
