Kyleena 19.5 mg intrauterine delivery system
*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
Updated on 26 September 2024
File name
20240926_PIL&TIL_CC_KYL_BP23055.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
REC32386_BP23055
The PIL is revised to be in plain language
Updated on 17 July 2024
File name
20240716_SmPC_CC_ KYL_BP23039.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - 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
REC30572+REC31963_BP23039
Note:
Text in black = unchanged text
Text in blue = added text
Text in red with strikethrough = deleted text
Text in green = re positioned text
3 Pharmaceutical form
The product consists of a whitish or pale yellow white or almost white drug core covered with a semi-opaque membrane, which is mounted on the vertical stem of a T-body.
4.2 Posology and method of administration
Removal/Replacement
Kyleena is removed by gently pulling on the threads with a forceps. The use of excessive force/sharp instruments during removal may cause breakage of the system. After removal of Kyleena, the system should be examined to ensure that it is intact and has been completely removed. If the threads are not visible determine the location of the system via ultrasound or other method. If and the system is found to be in the uterine cavity on ultrasound examination, it may be removed using a narrow forceps. This may require dilatation of the cervical canal or other surgical intervention. After removal of Kyleena, the system should be examined to ensure that it is intact.
Method of administration
Removal/replacement
Kyleena is removed by gently pulling on the threads with a forceps (Figure 8).
[….]
After removal of Kyleena, the system should be examined to ensure that it is intact and has been completely removed.
4.4 Special warnings and precautions for use
Precautions at time of removal
The use of excessive force/sharp instruments during removal may cause breakage of the system (see section 4.2). After removal of Kyleena, the system should be examined to ensure that it is intact and has been completely removed.
4.6 Fertility, pregnancy, lactation
Pregnancy
The use of Kyleena during an existing or suspected a pregnancy is contraindicated, see section 4.3. [….]
10 Date of revision of the text
April 2023 July 2024
Updated on 17 July 2024
File name
20240716_Kyleena package leaflet_BP23039.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
REC30572+REC31963_BP23039
Note:
Text in black = unchanged text
Text in blue = added text
Text in red with strikethrough = deleted text
6 Contents of the pack and other information
This leaflet was last revised in March 2023 July 2024.
[….]
The following information is intended for healthcare professionals only:
Insertion Instructions
Removal/ replacement
Kyleena is removed by gently pulling on the threads with a forceps (Figure 8).
[….]
After removal of Kyleena, the system should be examined to ensure that it is intact and has been completely removed.
Updated on 17 April 2023
File name
20230414_SmPC_CC_ KYL_BP22015.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC for BP22015, REC30367 re uploaded.
Updated on 17 April 2023
File name
20230314_PL&TIL_CC_KYL_BP22015.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Updated on 17 April 2023
File name
20230414_SmPC_CC_JAY_BP22015.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)