ENDOMETRIN

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

PROGESTERONE

MAH:

FERRING PHARMACEUTICALS LTD

ATC_code:

G03DA04

pharmaceutical_form:

VAGINAL TABLETS

composition:

PROGESTERONE 100 MG

administration_route:

VAGINAL

prescription_type:

Required

manufactured_by:

FERRING PHARMACEUTICALS A/S, DENMARK

therapeutic_group:

PROGESTERONE

therapeutic_area:

PROGESTERONE

therapeutic_indication:

Progesterone supplementation or replacement in cases such as treatment of infertile women and IVF.

authorization_date:

2022-07-31

PIL

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS )PREPARATIONS( - 1986
This medicine is dispensed with a doctor’s prescription only
ENDOMETRIN
VAGINAL TABLETS
ACTIVE INGREDIENT - Each tablet contains 100 mg progesterone
Inactive ingredients and allergens: See section 6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This
leaflet contains concise information about this medicine. If you have
any further
questions, ask your doctor or pharmacist.
Endometrin has been prescribed for you. Do not pass it on to others.
It may
harm them, even if it seems to you that their medical condition is
similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Endometrin is provided as a supplement or replacement of the hormone
progesterone in cases of infertility and during in-vitro fertilization
)IVF( treatments.
THERAPEUTIC GROUP:
Progestogenic hormones. Endometrin is provided as a vaginal tablet
that contains
the natural female sex hormone progesterone.
Progesterone acts on the lining of the womb and helps you to become
and to
stay pregnant when you are treated for infertility.
2. BEFORE USING THIS MEDICINE
Endometrin can only be used in women who are undergoing infertility
treatments.
The treatment starts on the day of egg retrieval. Your doctor will
tell you when
to begin the treatment.
DO NOT USE THIS MEDICINE IF:
You are sensitive )allergic( to progesterone or to any of the other
ingredients
in this medicine )see section 6(.
You have unusual vaginal bleeding that has not been evaluated by the
doctor.
You had a miscarriage and your doctor suspects some tissue is still in
the
uterus or pregnancy outside of the womb.
You currently have or have had severe liver problems.
You have known or suspected breast or genital tract cancer.
You have or have had blood clots in the legs, lungs, eyes or elsewhere
in
the body.
You have porphyria disorders )a group of inherited or acquired
disorders of
certain enzymes).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
TAKE SPECIAL

SPC

1
1.
NAME OF THE MEDICINAL PRODUCT
Endometrin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vaginal tablet contains 100 mg progesterone.
Excipient with known effect: 1 vaginal tablet contains approximately
760 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Vaginal tablets, white to off-white flat and oval tablet with the
inscriptions “FPI” on one side and “100” on
the other side.
The vaginal tablets are supplied with one polyethylene vaginal
applicator.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Progesterone supplementation or replacement in cases such as treatment
of infertile women and IVF
4.2
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 12 weeks total duration.
_Paediatric population _
There is no relevant use of Endometrin in the paediatric population.
_Elderly _
No clinical data have been collected in patients over age 65.
_Use in special populations _
There is no experience with use of Endometrin in patients with
impaired liver or renal function.
Method of Administration
Endometrin is to be placed directly into the vagina by the applicator
provided.
4.3
CONTRAINDICATIONS
Endometrin should not be used in individuals with any of the following
conditions:
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Undiagnosed vaginal bleeding
•
Known missed abortion or ectopic pregnancy
•
Severe hepatic dysfunction or disease
2
•
Known or suspected breast or genital tract cancer
•
Active arterial or venous thromboembolism or severe thrombophlebitis,
or a history of these events
•
Porphyria
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Endometrin should be discontinued if any of the following conditions
are suspected:
myocardial infarction, cerebrovascular disorders, arterial or venous
thromboembolism (venous
thromboembolism or pulmonary embolism), thr