Jaydess 13.5mg intrauterine device

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Levonorgestrel

可用日期:

Bayer Plc

ATC代码:

G03AC03

INN（国际名称）:

Levonorgestrel

剂量:

13.5mg

药物剂型:

Intrauterine device

给药途径:

Intrauterine

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 07030203; GTIN: 5010605180507

资料单张

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Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
_If you have any doubts or queries about your medication, please
contact _
_your doctor or pharmacist. _
_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
JAYDESS 13.5 MG INTRAUTERINE DELIVERY SYSTEM
levonorgestrel
Patient’s name: <….>
Doctor’s name: <….>
Doctor’s phone number: <….>
Date of insertion: <….>
Date of removal: <….>
First check-up visit: <….>
Next visits:
1.
<….>
2.
<….>
3.
<….>
_ _
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects, you may get.
See the end of section 4 for how to
report side effects.
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Jaydess is and what it is used for
2.
What you need to know before you use Jaydess
3.
How to use Jaydess
4.
Possible side effects
5.
How to store Jaydess
6.
Contents of the pack and other information
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1.
WHAT JAYDESS IS AND WHAT IT IS USED FOR
Jaydess is used for the prevention of pregnancy (contraception) for up
to three years.
Jaydess is a T-shaped intrauterine delivery system (IUS) which after
placement inside the womb slowly
releases a small amount of the hormone levonorgestrel.
Jaydess works by reducing the monthly growth of the lining of the womb
and thickening the cervical mucus.
These actions preve

产品特点

OBJECT 1
JAYDESS 13.5 MG INTRAUTERINE DELIVERY SYSTEM
Summary of Product Characteristics Updated 25-Sep-2017 | Bayer plc
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Jaydess 13.5 mg intrauterine delivery system.
2. Qualitative and quantitative composition
The intrauterine delivery system contains 13.5 mg levonorgestrel.
For the full list of excipients, see section 6.1.
For details of release rates, see section 5.2.
3. Pharmaceutical form
Intrauterine delivery system (IUS).
The product consists of a whitish or pale yellow drug core covered
with a semi-opaque membrane, which
is mounted on the vertical stem of a T-body. In addition, the vertical
stem contains a silver ring located
close to the horizontal arms. The white T-body has a loop at one end
of the vertical stem and two
horizontal arms at the other end. Brown coloured removal threads are
attached to the loop. The vertical
stem of the IUS is loaded in the insertion tube at the tip of the
inserter. The IUS and inserter are
essentially free of visible impurities.
Dimensions of Jaydess: 28 x 30 x 1.55 mm
4. Clinical particulars
4.1 Therapeutic indications
Contraception for up to 3 years.
4.2 Posology and method of administration
Posology
Jaydess is inserted into the uterine cavity and is effective for up to
three years.
_Insertion and removal/ replacement_
It is recommended that Jaydess should only be inserted by physicians/
healthcare providers who are
experienced in IUS insertions and/ or have undergone training on the
Jaydess insertion procedure.
Jaydess is to be inserted into the uterine cavity within seven days of
the onset of menstruation. Jaydess
can be replaced by a new system at any time in the cycle. Jaydess can
also be inserted immediately after
first trimester abortion.
Postpartum insertions should be postponed u