Jaydess 13.5 mg intrauterine delivery system

REC30572+REC31963_BP23039

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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

REC30572+REC31963_BP23039

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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.

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After removal of Jaydess, the system should be examined to ensure that it is intact and has been completely removed.