ENDOMETRIN 100mg Vaginal Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

PROGESTERONE

Boleh didapati daripada:

Ferring Sdn. Bhd.

INN (Nama Antarabangsa):

PROGESTERONE

Unit dalam pakej:

21tablet Tablets

Dikeluarkan oleh:

Q Pharma AB

Risalah maklumat

ENDOMETRIN
®
Vaginal Tablet
Progesterone (100mg)
Consumer Medication Information Leaflet (RiMUP)
1
For Internal Use - Internal
READ THE ENTIRE LEAFLET
CAREFULLY BEFORE 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.
It may harm them, even if
their signs of illness are
the same as yours.
-
If you get any side effects
talk to your doctor or
nurse. This includes any
possible side effects not
listed in the leaflet
WHAT IS IN THIS LEAFLET
:
1.
What ENDOMETRIN is
used for
2.
How ENDOMETRIN
works
3.
Before you use
ENDOMETRIN
4.
How to use ENDOMETRIN
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
ENDOMETRIN
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
1. WHAT ENDOMETRIN IS
USED FOR
ENDOMETRIN is provided as a
pessary (or vaginal tablet) that
contains the natural female
hormone, progesterone.
ENDOMETRIN is for women
who need extra progesterone
while undergoing treatment in an
Assisted Reproductive
Technology (ART) programme.
2. HOW ENDOMETRIN
WORKS
Each ENDOMETRIN vaginal
tablet contains 100 mg of
progesterone.
Progesterone acts on the lining
of the uterus (womb) and it helps
you to become and to stay
pregnant when you are treated
for infertility.
3. BEFORE YOU USE
ENDOMETRIN
®
_- Before you start to use it _
Before starting treatment with
ENDOMETRIN, you and your
partner should be evaluated by a
doctor for the causes of your
fertility problems. In particular
you should be checked for the
following conditions so that
appropriate treatment can be
given:
•
Mild to moderate hepatic
dysfunction
•
A history of depression
•
Epilepsy, migraine, asthma,
cardiac or renal dysfunction
•
Diabetes
•
Smoking and > 35 years old
If you know you have any of the
conditions listed above
,
please
tell your doctor before starting
treatment with ENDOM

Ciri produk

Proposed packaging material
Code 73-I-MY -01.0 4 Size 900x210mm or 297x210mm or 640x210mm
Submission ☒NDA ☐Renewal ☐Variation change detail no.: Deficiency email by NPRA dated 2 3-03-201 7 Code of p revious version 73-I-MY -01.0 3 Change s include a graphic demonstration of the administration of Endometrin (follow Sweden PIL) ☐CCDS version:
☐Core PIL version:
☐SPC country/version/date:
☒LAC no.: Approved_619 (posology follow AUS SPC -#29931 -v4A, approved LAC 716 (addendum)
Name & Date JIWO, 2 3-Mar -2017
ENDOMETRIN ® 100 mg
Vaginal tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vaginal tablet contains 100 mg progesterone.
Excipients: Silica, hydrophobic colloidal, lactose monohydrate, pregelatinized maize starch , povidone, adipic acid,
sodium hydrogen carbonate, sodium laurilsulfate and magnesium stearate.
PHARMACEUTICAL FORM
Vaginal tablet
White to off -white convex and oblong tablets debossed with “FPI” on one side and “100” on the other side.
The vaginal tablets are supplied with one polyethylene vaginal applicator.
THERAPEUTIC INDICATI ONS
ENDOMETRIN ® is indicated for luteal support as part of an A ssisted Reproductive Technology (ART) treatment program
for infertile women.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The dose of ENDOMETRIN ® is 100 mg administered vaginally three times daily starting at oocyte retrieval and
continuing for up to 10 weeks total duration (or 12 weeks of gestation).
ENDOMETRIN ® administered into the vagina twice daily (BD) and three times daily (TDS) dosing have both been shown
to be efficacious. However specific populations may derive greater benefits from BD or TDS dosing
regimen and the clinician can tailor treatment to the patient. For women < 35 years of age and those patients with
adequate ovarian reserve, ENDOMETRIN ® BD would be the appropriate dose. For patients aged 35 and older and
those with diminished ovarian reserve, TDS dosing would be the preferred regimen. Serum progesterone levels may be
measured 7 days post fertilisa