Kyleena 19.5 mg intrauterine delivery system

*
Pharmacy Only: Prescription
  • Company:

    Bayer Limited
  • Status:

    No Recent Update
  • Legal 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)

Free text change information supplied by the pharmaceutical company