Endometrin

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

Progesterone

Verfügbar ab:

Ferring Pharmaceuticals Pty Ltd

Klasse:

Medicine Registered

Gebrauchsinformation

ENDOMETRIN
®
PESSARIES

_Progesterone 100 mg_
VAGINAL TABLETS
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Endometrin
Pessaries.
The leaflet does not contain all the
available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Endometrin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
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 (e.g. IVF).
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.
Your doctor may have prescribed
Endometrin for another purpose. Ask
your doctor if you have any questions
why this medicine has been
prescribed for you.
Endometrin is available only with a
doctor's prescription.
This medicine is not addictive.
BEFORE YOU USE
ENDOMETRIN
_WHEN YOU MUST NOT USE IT_
DO NOT USE ENDOMETRIN IF YOU HAVE
AN ALLERGY TO:
•
ANY MEDICINE CONTAINING
PROGESTERONE
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
may include:
•
skin rash, itching or hives
•
swelling of the face, lips, tongue
or other parts of the body
•
shortness of breath, wheezing or
difficulty breathing.
DO NOT USE ENDOMETRIN IF YOU HAVE
OR HAVE HAD ANY OF THE FOLLOWING
CONDITIONS:
•
unusual vaginal bleeding that has
not been evaluated by your doctor
•
missed abortion or ectopic
pregnancy (pregnancy outside of
the womb)
•
severe liver problems
•
known or suspected cancer of the
breast or genital tract
•
blood clots in the leg

Fachinformation

 
Page | 1 
#29931-v4A 
PRODUCT INFORMATION 

NAME OF THE MEDICINE 
ENDOMETRIN
®
 PESSARIES progesterone100 mg vaginal tablets.  

DESCRIPTION 
Progesterone is a white or almost white, crystalline powder
or colourless crystals which is practically 
insoluble in water, freely soluble in ethanol,
sparingly soluble in acetone and in fatty oils.   

The structural formula of progesterone is: 

The chemical name for progesterone
is pregn-4-ene-3, 20-dione.  It has an empirical formula of 
C [http://en.wikipedia.org/wiki/Carbon]
21 [http://en.wikipedia.org/wiki/Carbon]
H [http://en.wikipedia.org/wiki/Hydrogen]
30 [http://en.wikipedia.org/wiki/Hydrogen]
O [http://en.wikipedia.org/wiki/Oxygen]
2 [http://en.wikipedia.org/wiki/Oxygen] 
and a molecular weight of 314.5.  CAS 57-83-0. 

ENDOMETRIN PESSARIES (vaginal tablets) contain
 100

mg progesterone (micronised) and also the 
following excipients:

Colloidal anhydrous silica
, 
Lactose, Pregelatinised maize starch, Povidone, 
Adipic acid, Sodium bicarbonate, Sodium lauryl sulfate, Magnesium stearate. _ _

PHARMACOLOGY 
PHARMACODYNAMICS 
Progesterone is a naturally occurring steroid that is secreted
by the ovary, placenta, and adrenal 
gland. In the presence
of adequate oestrogen, progesterone transforms a proliferative endometrium 
into a secretory endometrium.  Progesterone is necessary to increase
endometrial receptivity for 
implantation of an embryo. Once an embryo is implanted,
progesterone acts to maintain the 
pregnancy. 

PHARMACOKINETICS 
ABSORPTION 
Progesterone serum concentrations increased following
the administration of the ENDOMETRIN 
vaginal tablets in 12 healthy premenopausal females. On
single dosing, the mean C
max
 of 
endogenous and exogenous progesterone was 17.0 ng/mL in
the ENDOMETRIN twice daily (BID) 
group and 19.8 ng/mL in the END