Jaydess 13.5 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):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 19 July 2024
File name
20240716_SmPC_CC_JAY_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.
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4.2 Posology and method of administration
Removal/Replacement
Jaydess 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 Jaydess, 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 exam, it may be removed using a narrow forceps. This may require dilatation of the cervical canal or other surgical intervention. After removal of Jaydess, the system should be examined to ensure that it is intact.
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Method of administration
Removal/replacement
Jaydess is removed by gently pulling on the threads with a forceps (Figure 8).
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After removal of Jaydess, 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 Jaydess, 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 Jaydess during an existing or suspected a pregnancy is contraindicated, see section 4.3. [….]
10 Date of revision of the text
April 2023July 2024
Updated on 19 July 2024
File name
20240716_Jaydess 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
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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· If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
6 Contents of the pack and other information
This medicine is authorised in the Member States of the European Economic Area under the following names:
· Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Romania, Spain, Sweden: Jaydess
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This leaflet was last revised in March 2023July 2024.
The following information is intended for healthcare professionals only:
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Removal/ replacement
Jaydess is removed by gently pulling on the threads with a forceps.
[….]
After removal of Jaydess, the system should be examined to ensure that it is intact and has been completely removed.
Updated on 17 April 2023
File name
20230314_PL&TIL_CC_JAY_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)